Rinvoq

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ANNEX I

SUMMARY OF PRODUCT CHARACTERISTICS



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This medicinal product is subject to additional monitoring. This will allow quick identification of 
new safety information. Healthcare professionals are asked to report any suspected adverse reactions. 
See section 4.8 for how to report adverse reactions.

1. NAME OF THE MEDICINAL PRODUCT

RINVOQ 15 mg prolonged-release tablets

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each prolonged-release tablet contains upadacitinib hemihydrate, equivalent to 15 mg of upadacitinib.

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Prolonged-release tablet.

Purple 14 x 8 mm, oblong biconvex prolonged-release tablets imprinted on one side with ‘a15’.

4. CLINICAL PARTICULARS

4.1 Therapeutic indications

RINVOQ is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult 
patients who have responded inadequately to, or who are intolerant to one or more disease-modifying 
anti-rheumatic drugs (DMARDs). RINVOQ may be used as monotherapy or in combination with 
methotrexate.

4.2 Posology and method of administration

Treatment with upadacitinib should be initiated and supervised by physicians experienced in the 
diagnosis and treatment of rheumatoid arthritis.

Posology

The recommended dose of upadacitinib is 15 mg once daily.

Treatment should not be initiated in patients with an absolute lymphocyte count (ALC) that is 
< 500 cells/mm3, an absolute neutrophil count (ANC) that is < 1,000 cells/mm3 or who have 
haemoglobin (Hb) levels that are < 8 g/dL (see sections 4.4 and 4.8).

Dose interruption

Treatment should be interrupted if a patient develops a serious infection until the infection is 
controlled.

Interruption of dosing may be needed for management of laboratory abnormalities as described in 
Table 1.



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Table 1. Laboratory measures and monitoring guidance

Laboratory measure Action Monitoring guidance

Absolute Neutrophil Count (ANC)

Treatment should be interrupted 
if ANC is < 1,000 cells/mm3 and 
may be restarted once ANC 
returns above this value

Evaluate at baseline and 
thereafter according to 
routine patient 
management

Absolute Lymphocyte Count 
(ALC)

Treatment should be interrupted 
if ALC is < 500 cells/mm3 and 
may be restarted once ALC 
returns above this value

Haemoglobin (Hb)

Treatment should be interrupted 
if Hb is < 8 g/dL and may be 
restarted once Hb returns above 
this value

Hepatic transaminases
Treatment should be temporarily 
interrupted if drug-induced liver 
injury is suspected

Lipids
Patients should be managed 
according to international clinical 
guidelines for hyperlipidaemia

12 weeks after initiation 
of treatment and 
thereafter according to 
international clinical 
guidelines for 
hyperlipidaemia

Special populations

Elderly

No dose adjustment is required in patients aged 65 years and older. There are limited data in patients 
aged 75 years and older.

Renal impairment

No dose adjustment is required in patients with mild or moderate renal impairment. There are limited 
data on the use of upadacitinib in subjects with severe renal impairment (see section 5.2). Upadacitinib 
should be used with caution in patients with severe renal impairment. The use of upadacitinib has not 
been studied in subjects with end stage renal disease.

Hepatic impairment

No dose adjustment is required in patients with mild (Child Pugh A) or moderate (Child Pugh B) 
hepatic impairment (see section 5.2). Upadacitinib should not be used in patients with severe (Child 
Pugh C) hepatic impairment (see section 4.3).

Paediatric population

The safety and efficacy of RINVOQ in children and adolescents aged 0 to less than 18 years have not 
yet been established. No data are available.



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Method of administration

RINVOQ is to be taken orally once daily with or without food and may be taken at any time of the 
day. Tablets should be swallowed whole and should not be split, crushed, or chewed.

4.3 Contraindications

 Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
 Active tuberculosis (TB) or active serious infections (see section 4.4).
 Severe hepatic impairment (see section 4.2).
 Pregnancy (see section 4.6).

4.4 Special warnings and precautions for use

Immunosuppressive medicinal products

Combination with other potent immunosuppressants such as azathioprine, ciclosporin, tacrolimus, and 
biologic DMARDs or other Janus kinase (JAK) inhibitors has not been evaluated in clinical studies 
and is not recommended as a risk of additive immunosuppression cannot be excluded.

Serious infections

Serious and sometimes fatal infections have been reported in patients receiving upadacitinib. The most 
frequent serious infections reported with upadacitinib included pneumonia and cellulitis (see 
section 4.8). Cases of bacterial meningitis have been reported in patients receiving upadacitinib.
Among opportunistic infections, tuberculosis, multidermatomal herpes zoster, oral/oesophageal 
candidiasis, and cryptococcosis were reported with upadacitinib.

Upadacitinib should not be initiated in patients with an active, serious infection, including localised 
infections.

Consider the risks and benefits of treatment prior to initiating upadacitinib in patients:

 with chronic or recurrent infection
 who have been exposed to tuberculosis
 with a history of a serious or an opportunistic infection
 who have resided or travelled in areas of endemic tuberculosis or endemic mycoses; or
 with underlying conditions that may predispose them to infection.

Patients should be closely monitored for the development of signs and symptoms of infection during 
and after treatment with upadacitinib. Upadacitinib therapy should be interrupted if a patient develops 
a serious or opportunistic infection. A patient who develops a new infection during treatment with 
upadacitinib should undergo prompt and complete diagnostic testing appropriate for an 
immunocompromised patient; appropriate antimicrobial therapy should be initiated, the patient should 
be closely monitored, and upadacitinib therapy should be interrupted if the patient is not responding to 
antimicrobial therapy. Upadacitinib therapy may be resumed once the infection is controlled.

As there is a higher incidence of infections in the elderly ≥ 75 years of age, caution should be used 
when treating this population.

Tuberculosis 

Patients should be screened for tuberculosis (TB) before starting upadacitinib therapy. Upadacitinib
should not be given to patients with active TB (see section 4.3). Anti-TB therapy should be considered 
prior to initiation of upadacitinib in patients with previously untreated latent TB or in patients with risk 
factors for TB infection.



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Consultation with a physician with expertise in the treatment of TB is recommended to aid in the 
decision about whether initiating anti-TB therapy is appropriate for an individual patient.

Patients should be monitored for the development of signs and symptoms of TB, including patients 
who tested negative for latent TB infection prior to initiating therapy.

Viral reactivation 

Viral reactivation, including cases of herpes virus reactivation (e.g., herpes zoster), was reported in 
clinical studies (see section 4.8). If a patient develops herpes zoster, interruption of upadacitinib 
therapy should be considered until the episode resolves.

Screening for viral hepatitis and monitoring for reactivation should be performed before starting and 
during therapy with upadacitinib. Patients who were positive for hepatitis C antibody and hepatitis C 
virus RNA were excluded from clinical studies. Patients who were positive for hepatitis B surface 
antigen or hepatitis B virus DNA were excluded from clinical studies. If hepatitis B virus DNA is 
detected while receiving upadacitinib, a liver specialist should be consulted.

Vaccination

No data are available on the response to vaccination with live or inactivated vaccines in patients 
receiving upadacitinib. Use of live, attenuated vaccines during or immediately prior to upadacitinib
therapy is not recommended. Prior to initiating upadacitinib, it is recommended that patients be 
brought up to date with all immunisations, including prophylactic zoster vaccinations, in agreement 
with current immunisation guidelines.

Malignancy

The risk of malignancies, including lymphoma is increased in patients with rheumatoid arthritis. 
Immunomodulatory medicinal products may increase the risk of malignancies, including lymphoma. 
The clinical data are currently limited and long-term studies are ongoing.

Malignancies were observed in clinical studies of upadacitinib. The risks and benefits of upadacitinib
treatment should be considered prior to initiating therapy in patients with a known malignancy other 
than a successfully treated non-melanoma skin cancer (NMSC) or when considering continuing 
upadacitinib therapy in patients who develop a malignancy.

Non-melanoma skin cancer

NMSCs have been reported in patients treated with upadacitinib. Periodic skin examination is 
recommended for patients who are at increased risk for skin cancer.

Haematological abnormalities

Absolute Neutrophil Count (ANC) < 1 x 109 cells/L, Absolute Lymphocyte Count (ALC) < 0.5 x 109

cells/L and haemoglobin < 8 g/dL were reported in ≤1 % of patients in clinical trials (see section 4.8).
Treatment should not be initiated, or should be temporarily interrupted, in patients with an ANC < 1 
x 109 cells/L, ALC < 0.5 x 109 cells/L or haemoglobin < 8 g/dL observed during routine patient 
management (see section 4.2).

Cardiovascular risk

Rheumatoid arthritis patients have an increased risk for cardiovascular disorders. Patients treated with 
upadacitinib should have risk factors (e.g., hypertension, hyperlipidaemia) managed as part of usual 
standard of care.



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Lipids

Treatment with upadacitinib was associated with increases in lipid parameters, including total 
cholesterol, low-density lipoprotein (LDL) cholesterol, and high-density lipoprotein (HDL) cholesterol
(see section 4.8). Elevations in LDL cholesterol decreased to pre-treatment levels in response to statin 
therapy, although evidence is limited. The effect of these lipid parameter elevations on cardiovascular 
morbidity and mortality has not been determined (see section 4.2 for monitoring guidance).

Hepatic transaminase elevations

Treatment with upadacitinib was associated with an increased incidence of liver enzyme elevation 
compared to placebo.

Evaluate at baseline and thereafter according to routine patient management. Prompt investigation of 
the cause of liver enzyme elevation is recommended to identify potential cases of drug-induced liver 
injury.

If increases in ALT or AST are observed during routine patient management and drug-induced liver 
injury is suspected, upadacitinib therapy should be interrupted until this diagnosis is excluded.

Venous thromboembolism

Events of deep venous thrombosis (DVT) and pulmonary embolism (PE) have been reported in 
patients receiving JAK inhibitors including upadacitinib. Upadacitinib should be used with caution in 
patients at high risk for DVT/PE. Risk factors that should be considered in determining the patient’s 
risk for DVT/PE include older age, obesity, a medical history of DVT/PE, patients undergoing major 
surgery, and prolonged immobilisation. If clinical features of DVT/PE occur, upadacitinib treatment 
should be discontinued and patients should be evaluated promptly, followed by appropriate treatment.

4.5 Interaction with other medicinal products and other forms of interaction

Potential for other medicinal products to affect the pharmacokinetics of upadacitinib

Upadacitinib is metabolised mainly by CYP3A4. Therefore, upadacitinib plasma exposures can be 
affected by medicinal products that strongly inhibit or induce CYP3A4.

Coadministration with CYP3A4 inhibitors

Upadacitinib exposure is increased when co-administered with strong CYP3A4 inhibitors (such as 
ketoconazole, itraconazole, posaconazole, voriconazole, and clarithromycin). In a clinical study, 
coadministration of upadacitinib with ketoconazole resulted in 70% and 75% increases in upadacitinib 
Cmax and AUC, respectively. Upadacitinib should be used with caution in patients receiving chronic 
treatment with strong CYP3A4 inhibitors. Consider alternatives to strong CYP3A4 inhibitor 
medications when used in the long-term.

Coadministration with CYP3A4 inducers

Upadacitinib exposure is decreased when co-administered with strong CYP3A4 inducers (such as 
rifampin and phenytoin), which may lead to reduced therapeutic effect of upadacitinib. In a clinical 
study, coadministration of upadacitinib after multiple doses of rifampicin (strong CYP3A inducer) 
resulted in approximately 50% and 60% decreases in upadacitinib Cmax and AUC, respectively. 
Patients should be monitored for changes in disease activity if upadacitinib is co-administered with 
strong CYP3A4 inducers.

Methotrexate and pH modifying medicinal products (e.g., antacids or proton pump inhibitors) have no 
effect on upadacitinib plasma exposures. 



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Potential for upadacitinib to affect the pharmacokinetics of other medicinal products

Administration of multiple 30 mg once daily doses of upadacitinib (a dose that is twice the 
recommended upadacitinib dose) to healthy subjects had a limited effect on midazolam (sensitive drug 
substrate for CYP3A) plasma exposures (26% decrease in midazolam AUC and Cmax), indicating that
upadacitinib 30 mg once daily may have a weak induction effect on CYP3A. In a clinical study, 
rosuvastatin and atorvastatin AUC were decreased by 33% and 23%, respectively, and rosuvastatin 
Cmax was decreased by 23% following the administration of multiple 30 mg once daily doses of 
upadacitinib to healthy subjects. Upadacitinib had no relevant effect on atorvastatin Cmax or on plasma 
exposures of ortho-hydroxyatorvastatin (major active metabolite for atorvastatin). No dose adjustment 
is recommended for CYP3A substrates or for rosuvastatin or atorvastatin when coadministered with 
upadacitinib.

Upadacitinib has no relevant effects on plasma exposures of ethinylestradiol, levonorgestrel, 
methotrexate, or medicinal products that are substrates for metabolism by CYP1A2, CYP2B6, 
CYP2C9, CYP2C19, or CYP2D6.

4.6 Fertility, pregnancy and lactation

Women of childbearing potential

Women of childbearing potential should be advised to use effective contraception during treatment 
and for 4 weeks following the final dose of upadacitinib.

Pregnancy

There are no or limited data on the use of upadacitinib in pregnant women. Studies in animals have 
shown reproductive toxicity (see section 5.3). Upadacitinib was teratogenic in rats and rabbits with 
effects in bones in rat foetuses and in the heart in rabbit foetuses when exposed in utero.

Upadacitinib is contraindicated during pregnancy (see section 4.3).

If a patient becomes pregnant while taking upadacitinib the parents should be informed of the potential 
risk to the foetus.

Breast-feeding

It is unknown whether upadacitinib/metabolites are excreted in human milk. Available 
pharmacodynamic/toxicological data in animals have shown excretion of upadacitinib in milk (see 
section 5.3).

A risk to newborns/infants cannot be excluded.

Upadacitinib should not be used during breast-feeding. A decision must be made whether to 
discontinue breast-feeding or to discontinue upadacitinib therapy taking into account the benefit of 
breast-feeding for the child and the benefit of therapy for the woman.

Fertility

The effect of upadacitinib on human fertility has not been evaluated. Animal studies do not indicate 
effects with respect to fertility (see section 5.3).



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4.7 Effects on ability to drive and use machines

Upadacitinib has no or negligible influence on the ability to drive and use machines.

4.8 Undesirable effects

Summary of the safety profile

The most commonly reported adverse drug reactions (ADRs) are upper respiratory tract infections
(13.5%), nausea (3.5%), blood creatine phosphokinase (CPK) increased (2.5%) and cough (2.2%). The 
most common serious adverse reactions were serious infections (see section 4.4).

Tabulated list of adverse reactions

The following list of adverse reactions is based on experience from registrational clinical studies.
The frequency of adverse reactions listed below is defined using the following convention: very 
common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100). Within each 
frequency grouping, undesirable effects are presented in order of decreasing seriousness.

Table 2. Adverse reactions

System Organ Class Very common Common Uncommon
Infections and 
infestations

Upper respiratory 
tract infections 
(URTI)*

Pneumonia
Herpes zoster 
Herpes simplex**
Oral candidiasis

Blood and lymphatic 
system disorders

Neutropaenia

Metabolism and 
nutrition disorders

Hypercholesterolaemia Hypertriglyceridaemia

Respiratory, thoracic 
and mediastinal 
disorders

Cough

Gastrointestinal 
disorders

Nausea

General disorders and 
administration site 
conditions

Pyrexia

Investigations Blood CPK increased 
ALT increased
AST increased
Weight increased

* URTI includes: acute sinusitis, laryngitis, nasopharyngitis, oropharyngeal pain, pharyngitis, 
pharyngotonsillitis, rhinitis, sinusitis, tonsillitis, viral upper respiratory tract infection
** Herpes simplex includes oral herpes 

Description of selected adverse reactions

Infections

In placebo-controlled clinical studies with background DMARDs, the frequency of infection over 
12/14 weeks in the upadacitinib 15 mg group was 27.4% compared to 20.9% in the placebo group. In 
methotrexate (MTX)-controlled studies, the frequency of infection over 12/14 weeks in the 
upadacitinib 15 mg monotherapy group was 19.5% compared to 24.0% in the MTX group. The overall 
long-term rate of infections for the upadacitinib 15 mg group across all five Phase 3 clinical studies 
(2,630 patients) was 93.7 events per 100 patient-years.



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In placebo-controlled clinical studies with background DMARDs, the frequency of serious infection 
over 12/14 weeks in the upadacitinib 15 mg group was 1.2% compared to 0.6% in the placebo group. 
In MTX-controlled studies, the frequency of serious infection over 12/14 weeks in the upadacitinib 
15 mg monotherapy group was 0.6% compared to 0.4% in the MTX group. The overall long-term rate 
of serious infections for the upadacitinib 15 mg group across all five Phase 3 clinical studies was 3.8 
events per 100 patient-years. The most common serious infection was pneumonia. The rate of serious 
infections remained stable with long-term exposure.

There was a higher rate of serious infections in patients ≥ 75 years of age, although data are limited.

The frequencies of infection ADRs for upadacitinib compared to placebo were: URTI (13.5% vs 
9.5%), pneumonia (0.5% vs 0.3%), herpes zoster (0.7% vs 0.2%), herpes simplex (0.8% v 0.5%), and 
oral candidiasis (0.4% vs. <0.1%). Most of the herpes zoster events involved a single dermatome and 
were non-serious.

Opportunistic infections (excluding tuberculosis)

In placebo-controlled clinical studies with background DMARDs, the frequency of opportunistic 
infections over 12/14 weeks in the upadacitinib 15 mg group was 0.5% compared to 0.3% in the 
placebo group. In MTX-controlled studies, there were no cases of opportunistic infection over 12/14
weeks in the upadacitinib 15 mg monotherapy group and 0.2% in the MTX group. The overall long-
term rate of opportunistic infections for the upadacitinib 15 mg group across all five Phase 3 clinical 
studies was 0.6 events per 100 patient-years.

Hepatic transaminase elevations

In placebo-controlled studies with background DMARDs, for up to 12/14 weeks, alanine transaminase 
(ALT) and aspartate transaminase (AST) elevations ≥ 3 x upper limit of normal (ULN) in at least one 
measurement were observed in 2.1% and 1.5% of patients treated with upadacitinib 15 mg, compared 
to 1.5% and 0.7%, respectively, of patients treated with placebo. Most cases of hepatic transaminase 
elevations were asymptomatic and transient.

In MTX-controlled studies, for up to 12/14 weeks, ALT and AST elevations ≥ 3 x ULN in at least one 
measurement were observed in 0.8% and 0.4% of patients treated with upadacitinib 15 mg, compared 
to 1.9% and 0.9%, respectively, of patients treated with MTX.

The pattern and incidence of elevation in ALT/AST remained stable over time including in long term 
extension studies.

Lipid elevations

Upadacitinib 15 mg treatment was associated with dose-dependent increases in lipid parameters 
including total cholesterol, triglycerides, LDL cholesterol and HDL cholesterol. There was no change 
in the LDL/HDL ratio. Elevations were observed at 2 to 4 weeks of treatment and remained stable 
with longer-term treatment. Among patients in the controlled studies with baseline values below the 
specified limits, the following frequencies of patients were observed to shift to above the specified 
limits on at least one occasion during 12/14 weeks (including patients who had an isolated elevated 
value):



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 Total cholesterol ≥ 5.17 mmol/L (200 mg/dL): 62% vs. 31%, in the upadacitinib 15 mg and 
placebo groups, respectively

 LDL cholesterol ≥ 3.36 mmol/L (130 mg/dL): 42% vs. 19%, in the upadacitinib 15 mg and 
placebo groups, respectively

 HDL cholesterol ≥ 1.03 mmol/L (40 mg/dL): 89% vs. 61%, in the upadacitinib 15 mg and 
placebo groups, respectively

 Triglycerides ≥ 2.26 mmol/L (200 mg/dL): 25% vs. 15%, in the upadacitinib 15 mg and placebo 
groups, respectively

Creatine phosphokinase

In placebo-controlled studies with background DMARDs, for up to 12/14 weeks, increases in CPK
values were observed. CPK elevations > 5 x upper limit of normal (ULN) were reported in 1.0% and 
0.3% of patients over 12/14 weeks in the upadacitinib 15 mg and placebo groups, respectively. Most 
elevations > 5 x ULN were transient and did not require treatment discontinuation. Mean CPK values 
increased by 4 weeks with a mean increase of 60 U/L at 12 weeks and then remained stable at an 
increased value thereafter including with extended therapy.

Neutropaenia

In placebo-controlled studies with background DMARDs, for up to 12/14 weeks, decreases in 
neutrophil counts below 1,000 cells/mm3 in at least one measurement occurred in 1.1% and <0.1% of 
patients in the upadacitinib 15 mg and placebo groups, respectively. In clinical studies, treatment was 
interrupted in response to ANC < 1,000 cells/mm3 (see section 4.2). Mean neutrophil counts decreased 
over 4 to 8 weeks. The decreases in neutrophil counts remained stable at a lower value than baseline 
over time including with extended therapy.

Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It 
allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare 
professionals are asked to report any suspected adverse reactions via the national reporting system 
listed in Appendix V.

4.9 Overdose

Upadacitinib was administered in clinical studies up to doses equivalent in daily AUC to 60 mg 
prolonged-release once daily. Adverse reactions were comparable to those seen at lower doses and no 
specific toxicities were identified. Approximately 90% of upadacitinib in the systemic circulation is 
eliminated within 24 hours of dosing (within the range of doses evaluated in clinical studies). In case 
of an overdose, it is recommended that the patient be monitored for signs and symptoms of adverse 
reactions. Patients who develop adverse reactions should receive appropriate treatment.

5. PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Immunosuppressants, selective immunosuppressants ATC code:
L04AA44

Mechanism of action

Janus Kinases (JAKs) are intracellular enzymes that transmit cytokine or growth factor signals 
involved in a broad range of cellular processes including inflammatory responses, hematopoiesis and 
immune surveillance. The JAK family of enzymes contains four members, JAK1, JAK2, JAK3 and 
TYK2 which work in pairs to phosphorylate and activate signal transducers and activators of 
transcription (STATs). This phosphorylation, in turn, modulates gene expression and cellular function. 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


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JAK1 is important in inflammatory cytokine signals while JAK2 is important for red blood cell 
maturation and JAK3 signals play a role in immune surveillance and lymphocyte function.

Upadacitinib is a selective and reversible JAK inhibitor. In human cellular assays, upadacitinib 
preferentially inhibits signalling by JAK1 or JAK1/3 with functional selectivity over cytokine 
receptors that signal via pairs of JAK2.

Pharmacodynamic effects

Inhibition of IL-6 induced STAT3 and IL-7 induced STAT5 phosphorylation

In healthy volunteers, the administration of upadacitinib (immediate release formulation) resulted in a 
dose- and concentration-dependent inhibition of IL-6 (JAK1/JAK2) - induced STAT3 and IL-7 
(JAK1/JAK3)-induced STAT5 phosphorylation in whole blood. The maximal inhibition was observed 
1 hour after dosing which returned to near baseline by the end of dosing interval.

Lymphocytes

Treatment with upadacitinib was associated with a small, transient increase in mean ALC from 
baseline up to Week 36 which gradually returned to at or near baseline levels with continued 
treatment.

hsCRP

Treatment with upadacitinib was associated with decreases from baseline in mean hsCRP levels as 
early as Week 1 which were maintained with continued treatment.

Clinical efficacy and safety

The efficacy and safety of upadacitinib 15 mg once daily was assessed in five Phase 3 randomised, 
double-blind, multicentre studies in patients with moderately to severely active rheumatoid arthritis 
and fulfilling the ACR/EULAR 2010 classification criteria (see Table 3). Patients 18 years of age and 
older were eligible to participate. The presence of at least 6 tender and 6 swollen joints and evidence 
of systemic inflammation based on elevation of hsCRP was required at baseline. All studies included 
long-term extensions for up to 5 years.

The primary analysis for each of these studies included all randomised subjects who received at least 1 
dose of study drug, and non-responder imputation was used for categorical endpoints.

Across the Phase 3 studies, the efficacy seen with upadacitinib 15 mg QD was generally similar to that 
observed with upadacitinib 30 mg QD.

Table 3: Clinical trials summary

Study name Population (n) Treatment arms Key outcome measures
SELECT-EARLY  MTX-naivea

(947)
Upadacitinib 15 mg
Upadacitinib 30 mg
MTX

Monotherapy

 Primary endpoint: clinical remission 
(DAS28-CRP) at week 24 

 Low disease activity (DAS28-CRP) 
 ACR50
 Radiographic progression (mTSS) 
 Physical function (HAQ-DI)
 SF-36 PCS



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SELECT-
MONOTHERAPY

MTX-IRb

(648)
Upadacitinib 15 mg
Upadacitinib 30 mg
MTX

Monotherapy

 Primary endpoint: low disease activity 
(DAS28-CRP) at week 14

 Clinical remission (DAS28-CRP)
 ACR20
 Physical function (HAQ-DI)
 SF-36 PCS
 Morning stiffness

SELECT-NEXT csDMARD-IRc

(661)
Upadacitinib 15 mg
Upadacitinib 30 mg
Placebo

On background 
csDMARDs

 Primary endpoint: low disease activity 
(DAS28-CRP) at week 12

 Clinical remission (DAS28-CRP)
 ACR20
 Physical function (HAQ-DI)
 SF-36 PCS
 Low disease activity (CDAI)
 Morning stiffness
 FACIT-F

SELECT-
COMPARE

MTX-IRd

(1,629)
Upadacitinib 15 mg
Placebo
Adalimumab 40 mg

On background MTX

Primary endpoint: clinical remission 
(DAS28-CRP) at week 12

Low disease activity (DAS28-CRP)
ACR20
Low disease activity (DAS28-CRP) vs 

adalimumab 
Radiographic progression (mTSS)
Physical function (HAQ-DI) 
SF-36 PCS
Low disease activity (CDAI)
Morning stiffness
FACIT-F

SELECT-
BEYOND

bDMARD-IRe

(499)
Upadacitinib 15 mg
Upadacitinib 30 mg
Placebo

On background 
csDMARDs

 Primary endpoint: low disease activity 
(DAS28-CRP) at week 12

 ACR20
 Physical function (HAQ-DI)
 SF-36 PCS

Abbreviations: ACR20 (or 50) = American College of Rheumatology ≥20% (or ≥50%) improvement;
bDMARD = biologic disease-modifying anti-rheumatic drug, CRP = C-Reactive Protein, DAS28 = Disease 
Activity Score 28 joints, mTSS = modified Total Sharp Score, csDMARD = conventional synthetic disease-
modifying anti-rheumatic drug, HAQ-DI = Health Assessment Questionnaire Disability Index, SF-36 PCS = 
Short Form (36) Health Survey (SF-36) Physical Component Score, CDAI = Clinical Disease Activity 
Index, FACIT-F = Functional Assessment of Chronic Illness Therapy-Fatigue score, IR = inadequate 
responder, MTX = methotrexate, n = number randomised
a. Patients were naïve to MTX or received no more than 3 weekly MTX doses
b Patients had inadequate response to MTX
c Patients who had an inadequate response to csDMARDs; patients with prior exposure to at most one 
bDMARD were eligible (up to 20% of total number of patients) if they had either limited exposure (<3 
months) or had to discontinue the bDMARD due to intolerability
d Patients who had an inadequate response to MTX; patients with prior exposure to at most one bDMARD 
(except adalimumab) were eligible (up to 20% of total study number of patients) if they had either limited 
exposure (<3 months) or had to discontinue the bDMARD due to intolerability
e Patients who had an inadequate response or intolerance to at least one bDMARD



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Clinical Response:

Remission and low disease activity

In the studies, a significantly higher proportion of patients treated with upadacitinib 15 mg achieved 
low disease activity (DAS28-CRP ≤3.2) and clinical remission (DAS28-CRP <2.6) compared to 
placebo, MTX or adalimumab (Table 4). Compared to adalimumab, significantly higher rates of low 
disease activity were achieved at week 12 in SELECT-COMPARE. Overall, both low disease activity 
and clinical remission rates were consistent across patient populations, with or without MTX.

ACR Response

In all studies, more patients treated with upadacitinib 15 mg achieved ACR20, ACR50, and ACR70 
responses at 12 weeks compared to placebo, MTX, or adalimumab (Table 4). Time to onset of efficacy 
was rapid across measures with greater responses seen as early as week 1 for ACR20. Durable 
response rates were observed (with or without MTX), with ACR20/50/70 responses maintained for at 
least 1 year.

Treatment with upadacitinib 15 mg, alone or in combination with csDMARDs, resulted in 
improvements in individual ACR components, including tender and swollen joint counts, patient and 
physician global assessments, HAQ-DI, pain assessment and hsCRP.

Table 4: Response and remission

Study

SELECT
EARLY

MTX-Naїve

SELECT
MONO

MTX-IR

SELECT
NEXT

csDMARD-IR

SELECT
COMPARE

MTX-IR

SELECT
BEYOND

bDMARD-IR

MTX
UPA
15mg MTX

UPA
15mg PBO

UPA
15mg PBO

UPA
15mg

ADA
40mg PBO

UPA
15mg

N 314 317 216 217 221 221 651 651 327 169 164

Week
LDA DAS28-CRP ≤3.2 (% of patients)

12a/14b 28 53g 19 45e 17 48e 14 45e,h 29 14 43e

24c26d 32 60f 18 55g,h 39

48 39 59g 50h 35

CR DAS28-CRP <2.6 (% of patients)

12a/14b 14 36g 8 28e 10 31e 6 29e,h 18 9 29g

24c26d 18 48e 9 41g,h 27

48 29 49g 38i 28

ACR20 (% of patients)

12a/14b 54 76g 41 68e 36 64e 36 71e,j 63 28 65e

24c/26d 59 79g 36 67g,i 57

48 57 74g 65i 54

ACR50 (% of patients)

12a/14b 28 52g 15 42g 15 38g 15 45g,h 29 12 34g

24c/26d 33 60e 21 54g,h 42

48 43 63g 49i 40

ACR70 (% of patients)

12a/14b 14 32g 3 23g 6 21g 5 25g,h 13 7 12

24c/26d 18 44g 10 35g,h 23

48 29 51g 36h 23

CDAI ≤10 (% of patients)

12a/14b 30 46g 25 35l 19 40e 16 40e,h 30 14 32g



14

Radiographic response

Inhibition of progression of structural joint damage was assessed using the modified Total Sharp Score 
(mTSS) and its components, the erosion score and joint space narrowing score, at weeks 24/26 and 
week 48 in SELECT-EARLY and SELECT-COMPARE.

Treatment with upadacitinib 15 mg resulted in significantly greater inhibition of the progression of 
structural joint damage compared to placebo in combination with MTX in SELECT-COMPARE and 
as monotherapy compared to MTX in SELECT-EARLY (Table 5). Analyses of erosion and joint 
space narrowing scores were consistent with the overall scores. The proportion of patients with no 
radiographic progression (mTSS change ≤ 0) was significantly higher with upadacitinib 15 mg in both 
studies.

24c/26d 38 56g 22 53g,h 38

48 43 60g 47h 34

Abbreviations: ACR20 (or 50 or 70) = American College of Rheumatology ≥20% (or ≥50% or ≥70%) 
improvement; ADA = adalimumab; CDAI = Clinical Disease Activity Index; CR = Clinical Remission; 
CRP = C-Reactive Protein, DAS28 = Disease Activity Score 28 joints; IR = inadequate responder; LDA = 
Low Disease Activity; MTX = methotrexate; PBO = placebo; UPA= upadacitinib
a SELECT-NEXT, SELECT-EARLY, SELECT-COMPARE, SELECT-BEYOND
b SELECT-MONOTHERAPY
c SELECT-EARLY
d SELECT-COMPARE
e multiplicity controlled p≤0.001upadacitinib vs placebo or MTX comparison
f multiplicity controlled p≤0.01 upadacitinib vs placebo or MTX comparison
g nominal p≤0.001 upadacitinib vs placebo or MTX comparison
h nominal p≤0.001upadacitinib vs adalimumab comparison
i nominal p≤0.01 upadacitinib vs adalimumab comparison
j nominal p<0.05 upadacitinib vs adalimumab comparison
k nominal p≤0.01 upadacitinib vs placebo or MTX comparison
l nominal p<0.05 upadacitinib vs MTX comparison
Note: Week 48-data derived from analysis on Full Analysis set (FAS) by randomised group using Non-
Responder Imputation



15

Table 5: Radiographic changes

Study

SELECT
EARLY

MTX-Naїve

SELECT
COMPARE

MTX-IR

Treatment Group MTX
UPA

15 mg PBOa

UPA
15 mg

ADA 
40 mg

Modified Total Sharps Score, mean change from baseline
Week 24b/26c 0.7 0.1f 0.9 0.2g 0.1
Week 48 1.0 0.03e 1.7 0.3e 0.4
Proportion of patients with no radiographic progressiond

Week 24b/26c 77.7 87.5f 76.0 83.5f 86.8
Week 48 74.3 89.9e 74.1 86.4e 87.9
Abbreviations: ADA = adalimumab; IR = inadequate responder; MTX = methotrexate; PBO = placebo; 
UPA= upadacitinib
a All placebo data at week 48 derived using linear extrapolation
b SELECT-EARLY
c SELECT-COMPARE
d No progression defined as mTSS change ≤ 0
e nominal p≤0.001 upadacitinib vs placebo or MTX comparison
f multiplicity controlled p≤0.01 upadacitinib vs placebo or MTX comparison
g multiplicity controlled p≤0.001 upadacitinib vs placebo or MTX comparison

Physical function response and health-related outcomes

Treatment with upadacitinib 15 mg, alone or in combination with csDMARDs, resulted in a 
significantly greater improvement in physical function compared to all comparators as measured by 
HAQ-DI (see Table 6).



16

Table 6: Mean change from baseline in HAQ-DIa,b

Study

SELECT
EARLY

MTX-Naїve

SELECT
MONO

MTX-IR

SELECT
NEXT

csDMARD-IR

SELECT
COMPARE

MTX-IR

SELECT
BEYOND
BIO-IR

Treatment 
group MTX

UPA
15mg MTX

UPA
15mg PBO

UPA
15mg PBO

UPA
15mg

ADA
40mg PBO

UPA
15mg

N 313 317 216 216 220 216 648 644 324 165 163

Baseline 
score, 
mean

1.6 1.6 1.5 1.5 1.4 1.5 1.6 1.6 1.6 1.6 1.7

Week 
12c/14d -0.5 -0.8h -0.3 -0.7g -0.3 -0.6g -0.3 -0.6g,i -0.5 -0.2 -0.4g

Week 
24e/26f -0.6 -0.9g -0.3 -0.7h,i -0.6

Abbreviations: ADA = adalimumab; HAQ-DI = Health Assessment Questionnaire Disability Index; IR = 
inadequate responder; MTX = methotrexate; PBO = placebo; UPA = upadacitinib
a Data shown are mean
b Health Assessment Questionnaire-Disability Index: 0=best, 3=worst; 20 questions; 8 categories: 
dressing and grooming, arising, eating, walking, hygiene, reach, grip, and activities.
c SELECT-EARLY, SELECT-NEXT, SELECT-COMPARE, SELECT-BEYOND
d SELECT-MONOTHERAPY
e SELECT-EARLY
f SELECT-COMPARE
g multiplicity controlled p≤0.001 upadacitinib vs placebo or MTX comparison
h nominal p≤0.001 upadacitinib vs placebo or MTX comparison
i nominal p≤0.01 upadacitinib vs adalimumab comparison

In the studies SELECT-MONOTHERAPY, SELECT-NEXT, and SELECT-COMPARE, treatment 
with upadacitinib 15 mg resulted in a significantly greater improvement in the mean duration of 
morning joint stiffness compared to placebo or MTX.

In the clinical studies, upadacitinib treated patients reported significant improvements in patient-
reported quality of life, as measured by the Short Form (36) Health Survey (SF-36) Physical 
Component Score compared to placebo and MTX. Moreover, upadacitinib treated patients reported 
significant improvements in fatigue, as measured by the Functional Assessment of Chronic Illness 
Therapy-Fatigue score (FACIT-F) compared to placebo.

Paediatric population

The European Medicines Agency has deferred the obligation to submit the results of studies with 
RINVOQ in one or more subsets of the paediatric population in chronic idiopathic arthritis (including 
rheumatoid arthritis, psoriatic arthritis, spondyloarthritis and juvenile idiopathic arthritis) (see section 
4.2 for information on paediatric use).

5.2 Pharmacokinetic properties

Upadacitinib plasma exposures are proportional to dose over the therapeutic dose range. Steady-state 
plasma concentrations are achieved within 4 days with minimal accumulation after multiple once-daily 
administrations.

Absorption

Following oral administration of upadacitinib prolonged-release formulation, upadacitinib is absorbed 
with a median Tmax of 2 to 4 hours. Coadministration of upadacitinib with a high-fat meal had no 



17

clinically relevant effect on upadacitinib exposures (increased AUC by 29% and Cmax by 39%). In 
clinical trials, upadacitinib was administered without regard to meals (see section 4.2). In vitro, 
upadacitinib is a substrate for the efflux transporters P-gp and BCRP.

Distribution

Upadacitinib is 52% bound to plasma proteins. Upadacitinib partitions similarly between plasma and 
blood cellular components, as indicated by the blood to plasma ratio of 1.0.

Metabolism

Upadacitinib metabolism is mediated by CYP3A4 with a potential minor contribution from CYP2D6. 
The pharmacologic activity of upadacitinib is attributed to the parent molecule. In a human 
radiolabeled study, unchanged upadacitinib accounted for 79% of the total radioactivity in plasma 
while the main metabolite (product of monooxidation followed by glucuronidation) accounted for 13% 
of the total plasma radioactivity. No active metabolites have been identified for upadacitinib.

Elimination

Following single dose administration of [14C]-upadacitinib immediate-release solution, upadacitinib 
was eliminated predominantly as the unchanged parent substance in urine (24%) and faeces (38%). 
Approximately 34% of upadacitinib dose was excreted as metabolites. Upadacitinib mean terminal 
elimination half-life ranged from 9 to 14 hours.

Renal impairment

Renal impairment has no clinically relevant effect on upadacitinib exposure. Upadacitinib AUC was 
18%, 33%, and 44% higher in subjects with mild (estimated glomerular filtration rate 60 to 
89 mL/min/1.73 m2), moderate (estimated glomerular filtration rate 30 to 59 mL/min/1.73 m2), and 
severe (estimated glomerular filtration rate 15 to 29 mL/min/1.73 m2) renal impairment, respectively, 
compared to subjects with normal renal function. Upadacitinib Cmax was similar in subjects with 
normal and impaired renal function.

Hepatic impairment

Mild (Child-Pugh A) and moderate (Child-Pugh B) hepatic impairment has no clinically relevant 
effect on upadacitinib exposure. Upadacitinib AUC was 28% and 24% higher in subjects with mild 
and moderate hepatic impairment, respectively, compared to subjects with normal liver function. 
Upadacitinib Cmax was unchanged in subjects with mild hepatic impairment and 43% higher in 
subjects with moderate hepatic impairment compared to subjects with normal liver function. 
Upadacitinib was not studied in patients with severe (Child-Pugh C) hepatic impairment.

Paediatric population

The pharmacokinetics of upadacitinib have not yet been evaluated in a paediatric population (see 
section 4.2).

Intrinsic factors

Age, sex, body weight, race, and ethnicity did not have a clinically meaningful effect on upadacitinib 
exposure.

5.3 Preclinical safety data

Non-clinical data reveal no special hazard for humans based on conventional studies of safety 
pharmacology.



18

Upadacitinib, at exposures (based on AUC) approximately 4 and 10 times the clinical dose of 15 mg in 
male and female Sprague-Dawley rats, respectively, was not carcinogenic in a 2-year carcinogenicity 
study in Sprague-Dawley rats. Upadacitinib was not carcinogenic in a 26-week carcinogenicity study 
in CByB6F1-Tg(HRAS)2Jic transgenic mice.

Upadacitinib was not mutagenic or genotoxic based on the results of in vitro and in vivo tests for gene 
mutations and chromosomal aberrations.

Upadacitinib had no effect on fertility in male or female rats at doses up to 50 mg/kg/day in males and 
75 mg/kg/day in females in a fertility and early embryonic development study. Dose related increases 
in foetal resorptions associated with post-implantation losses at 25 and 75 mg/kg/day in this study in 
rats were attributed to the developmental/teratogenic effects of upadacitinib. Upadacitinib was 
teratogenic in both rats and rabbits. In a pre-/postnatal development study in rats, there were no 
maternal effects, no effects on parturition, lactation or maternal behaviour and no effects on their 
offspring.

Following administration of upadacitinib to lactating rats, the concentrations of upadacitinib in milk 
over time generally paralleled those in plasma, with approximately 30-fold higher exposure in milk 
relative to maternal plasma. Approximately 97% of drug-related material in milk was parent drug.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Tablet contents:

Microcrystalline cellulose
Hypromellose
Mannitol
Tartaric acid
Silica, colloidal anhydrous
Magnesium stearate

Film coating:

Poly(vinyl alcohol)
Macrogol
Talc
Titanium dioxide (E171)
Iron oxide black (E172)
Iron oxide red (E172)

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

Prolonged-release tablets in blisters: 2 years
Prolonged-release tablets in bottles: 3 years

6.4 Special precautions for storage

This medicinal product does not require any special temperature storage conditions.

Store in the original blister or bottle in order to protect from moisture. Keep the bottle tightly closed.



19

6.5 Nature and contents of container

Polyvinylchloride/polyethylene/polychlorotrifluoroethylene - aluminium calendar blisters in packs 
containing 28 or 98 prolonged-release tablets, or multipacks containing 84 (3 packs of 28) prolonged-
release tablets.

HDPE bottles with desiccant and polypropylene cap in carton containing 30 prolonged-release tablets.
Pack size: 1 bottle (30 prolonged-release tablets) or 3 bottles (90 prolonged-release tablets).

Not all pack sizes may be marketed.

6.6 Special precautions for disposal

Any unused medicinal product or waste material should be disposed of in accordance with local 
requirements.

7. MARKETING AUTHORISATION HOLDER

AbbVie Deutschland GmbH & Co. KG
Knollstrasse
67061 Ludwigshafen
Germany

8. MARKETING AUTHORISATION NUMBER(S)

EU/1/19/1404/001
EU/1/19/1404/002
EU/1/19/1404/003
EU/1/19/1404/004
EU/1/19/1404/005

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 16 December 2019

10. DATE OF REVISION OF THE TEXT

Detailed information on this medicinal product is available on the website of the European Medicines 
Agency http://www.ema.europa.eu.

http://www.ema.europa.eu/


20

ANNEX II

A. MANUFACTURER(S) RESPONSIBLE FOR BATCH 
RELEASE

B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY 
AND USE

C. OTHER CONDITIONS AND REQUIREMENTS OF THE 
MARKETING AUTHORISATION

D. CONDITIONS OR RESTRICTIONS WITH REGARD TO 
THE SAFE AND EFFECTIVE USE OF THE MEDICINAL 
PRODUCT



21

A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE

Name and address of the manufacturers responsible for batch release

AbbVie S.r.l.
148, Pontina Km 52 snc
04011
Campoverde di Aprilia (LT)
ITALY

And

AbbVie Logistics B.V
Zuiderzeelaan 53
8017 JV Zwolle
NETHERLANDS

The printed package leaflet of the medicinal product must state the name and address of the 
manufacturer responsible for the release of the concerned batch.

B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE

Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product 
Characteristics, section 4.2).

C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 
AUTHORISATION

 Periodic safety update reports (PSURs)

The requirements for submission of PSURs for this medicinal product are set out in the list of 
Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC
and any subsequent updates published on the European medicines web-portal.

The marketing authorisation holder (MAH) shall submit the first PSUR for this product within 
6 months following authorisation.

D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND 
EFFECTIVE USE OF THE MEDICINAL PRODUCT

 Risk management plan (RMP)

The MAH shall perform the required pharmacovigilance activities and interventions detailed in 
the agreed RMP presented in Module 1.8.2 of the marketing authorisation and any agreed 
subsequent updates of the RMP.

An updated RMP should be submitted:

 At the request of the European Medicines Agency;

 Whenever the risk management system is modified, especially as the result of new 
information being received that may lead to a significant change to the benefit/risk 
profile or as the result of an important (pharmacovigilance or risk minimisation) 
milestone being reached. 



22

 Additional risk minimisation measures
Prior to launch of RINVOQ in each Member State the Marketing Authorisation Holder (MAH) 
must agree about the content and format of the educational programme, including 
communication media, distribution modalities, and any other aspects of the programme, with 
the National Competent Authority. 

The objective of the programme is to increase awareness of HCPs and patients on the risks of 
serious and opportunistic infections including TB, herpes zoster, foetal malformation 
(pregnancy risk), MACE, and VTEs and how to manage these risks.

The MAH shall ensure that in each Member State where RINVOQ is marketed, all healthcare 
professionals and patients/carers who are expected to prescribe, dispense or use RINVOQ have 
access to/are provided with the following educational package:

The physician educational material should contain:
 The Summary of Product Characteristics
 Guide for healthcare professionals 
 Patient Alert Card (PAC)

The Guide for healthcare professionals shall contain the following key elements:
 General introductory language that the HCP measure contains important information to 

assist the discussion with patients when prescribing upadacitinib. The brochure also 
informs on steps which can be taken to reduce a patient's risk for key safety aspects of 
upadacitinib.

 Language for HCPs to inform patients of the importance of the PAC
 Risk of serious and opportunistic infections including TB

o Language on the risk of infections during treatment with upadacitinib
o Details on how to reduce the risk of infection with specific clinical measures 

(what laboratory parameters should be used to initiate upadacitinib, screening 
for TB, and getting patients immunised as per local guidelines, and interruption 
of upadacitinib if an infection develops)

o Language on avoidance of live vaccines (i.e., Zostavax) prior to and during 
upadacitinib treatment

o Details to advise patients on signs/symptoms of infection to be aware of, so that 
patients can seek medical attention quickly.

 Risk of herpes zoster
o Language on the risk of herpes zoster during treatment with upadacitinib
o Details to advise patients on signs/symptoms of infection to be aware of, so that 

patients can seek medical attention quickly.
 Risk of foetal malformation

o Language on teratogenicity of upadacitinib in animals
o Details on how to reduce the risk of exposure during pregnancy for women of 

childbearing potential based on the following: upadacitinib is contraindicated 
during pregnancy, women of childbearing potential should be advised to use 
effective contraception both during treatment and for 4 weeks after the final 
dose of upadacitinib treatment, and to advise patients to inform their HCP 
immediately if they think they could be pregnant or if pregnancy is confirmed.

 Risk of MACE
o Language on the increased risk of MACE in RA patients and the need to 

consider typical CV risk factors (e.g., hypertension, hyperlipidaemia) when 
treating RA patients

o Language on the risk of MACE during treatment with upadacitinib
o Language on the risk of hyperlipidaemia during upadacitinib therapy
o Details on monitoring of lipid levels and management of elevated lipid levels 

per clinical guidelines



23

 Risk of VTE
o Examples of the risk factors which may put a patient at higher risk for VTE and 

in whom caution is needed when using upadacitinib.
o Language on the risk of VTE during treatment with upadacitinib
o Language on need for discontinuation of upadacitinib, evaluation, and 

appropriate treatment for VTE if clinical features of deep venous thrombosis or 
pulmonary embolism develop

 Instructions for how to access digital HCP information
 Instructions on where to report AEs

The patient information pack should contain:
 Patient information leaflet
 A patient alert card

 The patient alert card shall contain the following key messages:
o Contact details of the upadacitinib prescriber
o Language that the PAC should be carried by the patient at any time and to share it 

with HCPs involved in their care (i.e., non-upadacitinib prescribers, emergency 
room HCPs, etc.)

o Description of signs/symptoms of infections the patient needs to be aware of, so 
that they can seek attention from their HCP:
 Language to advise patients and their HCPs about the risk of live vaccinations 

when given during upadacitinib therapy
o Description of targeted risks for awareness by the patient and for HCPs involved in 

their care including:
 Elevations in plasma lipids and the need for monitoring and lipid lowering 

treatment
 A reminder to use contraception, that upadacitinib is contraindicated during 

pregnancy, and to notify their HCPs if they become pregnant while taking 
upadacitinib

o Description of signs/symptoms of deep venous thrombosis or pulmonary embolism 
which the patient needs to be aware of, so that they can seek attention from an HCP. 



24

ANNEX III

LABELLING AND PACKAGE LEAFLET



25

A. LABELLING



26

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

Blister Carton (Individual carton)

1. NAME OF THE MEDICINAL PRODUCT

RINVOQ 15 mg prolonged-release tablets
upadacitinib

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each prolonged-release tablet contains upadacitinib hemihydrate, equivalent to 15 mg upadacitinib.

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

28 prolonged-release tablets

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Oral use

Do not chew, crush or break the tablet. Swallow whole.

QR code to be included
For more information and support on taking RINVOQ go to www.rinvoq.eu 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 
OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Store in the original blister in order to protect from moisture.



27

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

AbbVie Deutschland GmbH & Co. KG
Knollstrasse
67061 Ludwigshafen
Germany

12. MARKETING AUTHORISATION NUMBER(S) 

EU/1/19/1404/001

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

rinvoq

17. UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA

PC
SN
NN



28

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

Outer carton for 84 tablet multipack (with Blue Box)

1. NAME OF THE MEDICINAL PRODUCT

RINVOQ 15 mg prolonged-release tablets
upadacitinib

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each prolonged-release tablet contains upadacitinib hemihydrate, equivalent to 15 mg upadacitinib.

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

Multipack: 84 (3 packs of 28) prolonged-release tablets

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Oral use

Do not chew, crush or break the tablet. Swallow whole.

QR code to be included 
For more information and support on taking RINVOQ go to www.rinvoq.eu 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 
OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Store in the original blister in order to protect from moisture.



29

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

AbbVie Deutschland GmbH & Co. KG
Knollstrasse
67061 Ludwigshafen
Germany

12. MARKETING AUTHORISATION NUMBER(S) 

EU/1/19/1404/003

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

rinvoq

17. UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA

PC
SN
NN



30

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

Intermediate carton of 84 tablet multipack (without Blue Box)

1. NAME OF THE MEDICINAL PRODUCT

RINVOQ 15 mg prolonged-release tablets
upadacitinib

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each prolonged-release tablet contains upadacitinib hemihydrate, equivalent to 15 mg upadacitinib.

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

28 prolonged-release tablets.
Component of a multipack, can’t be sold separately.

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Oral use

Do not chew, crush or break the tablet. Swallow whole.

QR code to be included 
For more information and support on taking RINVOQ go to www.rinvoq.eu

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 
OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP



31

9. SPECIAL STORAGE CONDITIONS

Store in the original blister in order to protect from moisture.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

AbbVie Deutschland GmbH & Co. KG
Knollstrasse
67061 Ludwigshafen
Germany

12. MARKETING AUTHORISATION NUMBER(S) 

EU/1/19/1404/003

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

rinvoq

17. UNIQUE IDENTIFIER – 2D BARCODE

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA



32

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

Outer carton of 98 tablets

1. NAME OF THE MEDICINAL PRODUCT

RINVOQ 15 mg prolonged-release tablets
upadacitinib

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each prolonged-release tablet contains upadacitinib hemihydrate, equivalent to 15 mg upadacitinib.

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

98 prolonged-release tablets.

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Oral use

Do not chew, crush or break the tablet. Swallow whole.

QR code to be included 
For more information and support on taking RINVOQ go to www.rinvoq.eu 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 
OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Store in the original blister in order to protect from moisture.



33

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

AbbVie Deutschland GmbH & Co. KG
Knollstrasse
67061 Ludwigshafen
Germany

12. MARKETING AUTHORISATION NUMBER(S) 

EU/1/19/1404/005

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

rinvoq

17. UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA

PC
SN
NN



34

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

Inner carton of 49 tablets (for the 98 pack)

1. NAME OF THE MEDICINAL PRODUCT

RINVOQ 15 mg prolonged-release tablets
upadacitinib

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each prolonged-release tablet contains upadacitinib hemihydrate, equivalent to 15 mg upadacitinib.

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

49 prolonged-release tablets.

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Oral use

Do not chew, crush or break the tablet. Swallow whole.

QR code to be included 
For more information and support on taking RINVOQ go to www.rinvoq.eu 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 
OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Store in the original blister in order to protect from moisture.



35

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

AbbVie Deutschland GmbH & Co. KG
Knollstrasse
67061 Ludwigshafen
Germany

12. MARKETING AUTHORISATION NUMBER(S) 

EU/1/19/1404/005

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

rinvoq

17. UNIQUE IDENTIFIER – 2D BARCODE

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA



36

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

Blister

1. NAME OF THE MEDICINAL PRODUCT

RINVOQ 15 mg prolonged-release tablets
upadacitinib

2. NAME OF THE MARKETING AUTHORISATION HOLDER

AbbVie (as logo)

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. OTHER

Mon. Tue. Wed. Thu. Fri. Sat. Sun.

PC



37

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

Bottle Carton (30 and 90 pack)

1. NAME OF THE MEDICINAL PRODUCT

RINVOQ 15 mg prolonged-release tablets
upadacitinib

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each prolonged-release tablet contains upadacitinib hemihydrate, equivalent to 15 mg upadacitinib.

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

30 prolonged-release tablets
90 prolonged-release tablets

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Oral use
Do not chew, crush or break the tablet. Swallow whole. Do not swallow the desiccant.

QR code to be included 
For more information and support on taking RINVOQ go to www.rinvoq.eu

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 
OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP



38

9. SPECIAL STORAGE CONDITIONS

Store in the original bottle and keep the bottle tightly closed in order to protect from moisture.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

AbbVie Deutschland GmbH & Co. KG
Knollstrasse
67061 Ludwigshafen
Germany

12. MARKETING AUTHORISATION NUMBER(S) 

EU/1/19/1404/002
EU/1/19/1404/004

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

rinvoq

17. UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA

PC
SN
NN



39

PARTICULARS TO APPEAR ON THE INTERMEDIATE PACKAGING

Bottle Label

1. NAME OF THE MEDICINAL PRODUCT

RINVOQ 15 mg prolonged-release tablets
upadacitinib

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each prolonged-release tablet contains upadacitinib hemihydrate, equivalent to 15 mg upadacitinib 

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

30 prolonged-release tablets

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Oral use

Do not chew, crush or break the tablet. Swallow whole. Do not swallow the desiccant.

Important to open

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 
OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Store in the original bottle and keep the bottle tightly closed in order to protect from moisture.



40

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

AbbVie (as logo)

12. MARKETING AUTHORISATION NUMBER(S) 

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

17. UNIQUE IDENTIFIER – 2D BARCODE

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA



41

B. PACKAGE LEAFLET



42

Package leaflet: Information for the patient

RINVOQ 15 mg prolonged-release tablets
upadacitinib

This medicine is subject to additional monitoring. This will allow quick identification of new 
safety information. You can help by reporting any side effects you may get. See the end of section 4 
for how to report side effects.

Read all of this leaflet carefully before you start taking this medicine because it contains 
important information for you.

- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor, pharmacist, or nurse.
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, 

even if their signs of illness are the same as yours.
- If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible 

side effects not listed in this leaflet. See section 4.

What is in this leaflet

1. What RINVOQ is and what it is used for
2. What you need to know before you take RINVOQ
3. How to take RINVOQ
4. Possible side effects
5. How to store RINVOQ
6. Contents of the pack and other information

1. What RINVOQ is and what it is used for

RINVOQ contains the active substance upadacitinib. It belongs to a group of medicines called Janus 
kinase inhibitors, which help reduce inflammation.

RINVOQ is used to treat adults with rheumatoid arthritis. Rheumatoid arthritis is a disease that causes 
inflamed joints. If you have moderate to severe active rheumatoid arthritis, you may first be given 
other medicines, one of which will usually be methotrexate. If these medicines do not work well 
enough, you will be given RINVOQ either alone or in combination with methotrexate to treat your 
rheumatoid arthritis.

RINVOQ works by reducing the activity of an enzyme in the body called ‘Janus kinase’. By reducing 
the activity of this enzyme, RINVOQ can help to reduce pain, stiffness and swelling in your joints, 
reduce tiredness and it can slow down damage to the bone and cartilage in your joints. These effects 
can ease your normal daily activities and so improve your quality of life.

2. What you need to know before you take RINVOQ

Do not take RINVOQ
 if you are allergic to upadacitinib or any of the other ingredients of this medicine (listed in 

section 6)
 if you have a severe infection (such as pneumonia or bacterial skin infection)
 if you have active tuberculosis (TB)
 if you have severe liver problems
 if you are pregnant (see section Pregnancy, breast-feeding and contraception)

Warnings and precautions



43

Talk to your doctor or pharmacist before and during treatment with RINVOQ if:
 you have an infection (fever, sweating, or chills, shortness of breath, warm, red, or painful skin 

or sores on your body, feeling tired, cough, burning sensation when you pass urine or passing 
urine more often than normal, severe headache with stiff neck), or if you have ever had an 
infection that keeps coming back – RINVOQ can reduce your body’s ability to fight infections 
and so may worsen an infection that you already have, or make it more likely for you to get a 
new infection 

 you have had tuberculosis or have been in close contact with someone with tuberculosis. Your 
doctor will test you for tuberculosis before starting RINVOQ and may retest during treatment

 you have had a herpes zoster infection (shingles), because RINVOQ may allow it to come back. 
Tell your doctor if you get a painful skin rash with blisters as these can be signs of shingles

 you have ever had hepatitis B or C
 you have recently had or plan to have a vaccination (immunisation) - this is because live 

vaccines are not recommended while using RINVOQ
 you have cancer - because your doctor will have to decide if you can still be given RINVOQ
 you are at high risk of developing skin cancer, your doctor may recommend preventive 

measures such as regular skin examinations while taking RINVOQ. Talk to your doctor if you 
develop a new lesion or any change in the appearance of an area on the skin. Some patients 
receiving RINVOQ have developed skin cancers 

 you have heart problems, high blood pressure, or high cholesterol
 your liver does not work as well as it should
 you have had blood clots in the veins of your legs (deep vein thrombosis) or lungs (pulmonary 

embolism). Tell your doctor if you get a painful swollen leg, chest pain, or shortness of breath 
as these can be signs of blood clots in the veins.

Blood tests
You will need blood tests before you start taking RINVOQ, or while you are taking it. This is to check 
for a low red blood cell count (anaemia), low white blood cell count (neutropaenia or lymphopaenia), 
high blood fat (cholesterol) or high levels of liver enzymes. The tests are to check that treatment with 
RINVOQ is not causing problems.

Children and adolescents
RINVOQ is not recommended for use in children and adolescents under 18 years of age. This is 
because it has not been studied in this age group.

Other medicines and RINVOQ
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other 
medicines. This is because some medicines may reduce how well RINVOQ works or may increase the 
risk of getting side effects. It is very important to talk to your doctor or pharmacist if you are taking 
any of the following:
 medicines to treat fungal infections (such as itraconazole, posaconazole or voriconazole)
 medicines to treat bacterial infections (such as clarithromycin)
 medicines to treat Cushing’s syndrome (such as ketoconazole) 
 medicines to treat tuberculosis (such as rifampicin)
 medicines to treat seizures or fits (such as phenytoin) 
 medicines that affect your immune system (such as azathioprine, ciclosporin and tacrolimus)

If any of the above apply to you or you are not sure, talk to your doctor or pharmacist before taking 
RINVOQ.

Pregnancy, breast-feeding and contraception

Pregnancy
RINVOQ must not be used during pregnancy.



44

Breast-feeding
If you are breast-feeding or are planning to breast-feed, talk to your doctor before taking this medicine. 
You should not use RINVOQ while breast-feeding as it is not known if this medicine passes into 
breast milk. You and your doctor should decide if you will breast-feed or use RINVOQ. You should 
not do both.

Contraception
If you are a woman of child-bearing potential, you must use effective contraception to avoid becoming 
pregnant while taking RINVOQ and for at least 4 weeks after your last dose of RINVOQ. If you 
become pregnant during this time, you must talk to your doctor straight away.

Driving and using machines
RINVOQ has no effect on the ability to drive and use machines.

3. How to take RINVOQ

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your 
doctor or pharmacist if you are not sure.

The recommended dose is one 15 mg tablet once a day.
 Swallow the tablet whole with water. Do not split, crush, chew or break the tablet before 

swallowing as it may change how much medicine gets into your body.
 To help you remember to take RINVOQ, take it at the same time every day.
 The tablets can be taken with or without food.
 Do not swallow the desiccant.

If you take more RINVOQ than you should
If you take more RINVOQ than you should, contact your doctor. You may get some of the side effects 
listed in section 4.

If you forget to take RINVOQ
 If you miss a dose, take it as soon as you remember.
 If you forget your dose for an entire day, just skip the missed dose and take only a single dose as 

usual the following day.
 Do not take a double dose to make up for a forgotten tablet.

If you stop taking RINVOQ
Do not stop taking RINVOQ unless your doctor tells you to stop taking it.

How to open the bottle

Foil Cutting Tool - on the cap of the bottle



45

1. How to puncture the foil
1a. Remove the cap from the bottle by 
pushing down and while still pushing, turn 
the cap anti-clockwise.
1b. Turn the cap over and place the cutting 
tool near the edge of the foil seal.

2. Push down to make a hole in the foil and 
move the cutting tool round the edge of the 
foil to continue cutting the foil.

3. When you have taken your tablet, put the 
cap back on and close the bottle.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, RINVOQ can cause side effects, although not everybody gets them.

Serious side effects

Talk to your doctor or get medical help straight away if you get any signs of infection such as:

 shingles or painful skin rash with blisters (herpes zoster) 
 infection of the lung (pneumonia), which may cause shortness of breath, fever, and a cough with 

mucus 
The above side effects are uncommon (may affect up to 1 in 100 people).

Other side effects

Talk to your doctor if you notice any of the following side effects:

Very common (may affect more than 1 in 10 people)

 throat and nose infections



46

Common (may affect up to 1 in 10 people)
 cough
 fever
 feeling sick in the stomach (nausea)
 increase in an enzyme called creatine kinase, shown by blood tests
 low white blood cell counts shown in blood tests 
 increased levels of cholesterol (a type of fat in the blood) as shown in tests
 increased levels of liver enzymes, shown by blood tests (sign of liver problems)
 weight gain

Uncommon (may affect up to 1 in 100 people)
 cold sores (herpes simplex)
 thrush in the mouth (white patches in the mouth)
 increased levels of triglycerides (a type of fat in the blood) as shown in tests

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side 
effects not listed in this leaflet. You can also report side effects directly via the national reporting 
system listed in Appendix V. By reporting side effects you can help provide more information on the 
safety of this medicine.

5. How to store RINVOQ

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the blister label and carton after 
‘EXP’.

This medicine does not require any special temperature storage conditions.

Store in original blister or bottle with the lid tightly closed to protect from moisture.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to 
throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What RINVOQ contains
 The active substance is upadacitinib. Each prolonged-release tablet contains 15 mg of 

upadacitinib (as upadacitinib hemihydrate).
 The other ingredients are:

 Core tablet: microcrystalline cellulose, mannitol, tartaric acid, hypromellose, silica colloidal 
anhydrous, magnesium stearate.

 Film coating: poly(vinyl alcohol), macrogol, talc, titanium dioxide, iron oxide red (E172), iron 
oxide black (E172).

What RINVOQ looks like and contents of the pack
RINVOQ 15 mg prolonged-release tablets are purple, oblong, biconvex tablets imprinted on one side 
with ‘a15’.

The tablets are provided in blisters or bottles.

RINVOQ is available in packs containing 28 or 98 prolonged-release tablets and in multipacks of 84 
comprising 3 cartons, each containing 28 prolonged-release tablets.

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


47

Each calendar blister contains 7 tablets.

RINVOQ is available in bottles with desiccant containing 30 prolonged-release tablets, each pack 
contains 1 bottle (30 tablet pack) or 3 bottles (90 tablet pack).

Not all pack sizes may be marketed.

Marketing Authorisation Holder
AbbVie Deutschland GmbH & Co. KG
Knollstrasse
67061 Ludwigshafen
Germany

Manufacturer
AbbVie S.r.l. 
S.R. 148 Pontina, km 52 SNC 
04011 Campoverde di Aprilia (Latina) 
Italy

AbbVie Logistics B.V.
Zuiderzeelaan 53
Zwolle, 8017 JV, 
Netherlands

For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder:

België/Belgique/Belgien
AbbVie SA
Tél/Tel: +32 10 477811

Lietuva
AbbVie UAB 
Tel: +370 5 205 3023

България
АбВи ЕООД
Тел.:+359 2 90 30 430

Luxembourg/Luxemburg
AbbVie SA
Belgique/Belgien
Tél/Tel: +32 10 477811

Česká republika
AbbVie s.r.o. 
Tel: +420 233 098 111

Magyarország
AbbVie Kft.
Tel.:+36 1 455 8600

Danmark
AbbVie A/S
Tlf: +45 72 30-20-28

Malta
V.J.Salomone Pharma Limited 
Tel: +356 22983201

Deutschland
AbbVie Deutschland GmbH & Co. KG
Tel: 00800 222843 33 (gebührenfrei)
Tel: +49 (0) 611 / 1720-0

Nederland
AbbVie B.V.
Tel:  +31 (0)88 322 2843

Eesti
AbbVie Biopharmaceuticals GmbH Eesti filiaal 
Tel: +372 623 1011

Norge
AbbVie AS
Tlf: +47 67 81 80 00

Ελλάδα
AbbVie ΦΑΡΜΑΚΕΥΤΙΚΗ Α.Ε.
Τηλ: +30 214 4165 555

Österreich
AbbVie GmbH 
Tel: +43 1 20589-0



48

España
AbbVie Spain, S.L.U.
Tel:  +34 91 384 09 10

Polska
AbbVie Polska Sp. z o.o.
Tel.: +48 22 372 78 00 

France
AbbVie
Tél: +33 (0) 1 45 60 13 00

Portugal
AbbVie, Lda. 
Tel: +351 (0)21 1908400

Hrvatska 
AbbVie d.o.o.
Tel + 385 (0)1 5625 501

România
AbbVie S.R.L.
Tel: +40 21 529 30 35

Ireland
AbbVie Limited 
Tel: +353 (0)1 4287900

Slovenija
AbbVie Biofarmacevtska družba d.o.o.
Tel: +386 (1)32 08 060

Ísland
Vistor hf.
Tel: +354 535 7000

Slovenská republika
AbbVie s.r.o.
Tel: +421 2 5050 0777

Italia
AbbVie S.r.l. 
Tel: +39 06 928921

Suomi/Finland
AbbVie Oy 
Puh/Tel:  +358 (0)10 2411 200

Κύπρος
Lifepharma (Z.A.M.) Ltd
Τηλ.: +357 22 34 74 40

Sverige
AbbVie AB
Tel:  +46 (0)8 684 44 600

Latvija
AbbVie SIA 
Tel: +371 67605000

United Kingdom
AbbVie Ltd 
Tel: +44 (0)1628 561090

This leaflet was last revised in

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu.

Detailed and updated information on this product is available by scanning the QR code included below 
or on the outer carton with a smart phone. The same information is also available on the following 
URL: www.rinvoq.eu

QR code to be included

To listen to or request a copy of this leaflet in <Braille>, <large print> or <audio>, please contact 
the local representative of the Marketing Authorisation Holder.

http://www.rinvoq.eu/

	SUMMARY OF PRODUCT CHARACTERISTICS
	A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
	B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
	C.  OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
	D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
	A. LABELLING
	B. PACKAGE LEAFLET