natgillin/translations-raw huggingface dataset:
5. 2).
Paediatric population INTELENCE is not recommended for use in children and adolescents due to insufficient data on safety and efficacy (see section 5.2).
Der bør derfor udvises forsigtighed ved anvendelse til denne patientgruppe.
Elderly There is limited information regarding the use of INTELENCE in patients > 65 years of age (see section 5.2), therefore caution should be used in this population.
INTELENCE bør anvendes med forsigtighed til patienter med moderat
Hepatic impairment No dose adjustment is suggested in patients with mild or moderate hepatic impairment (Child-Pugh Class A or B); INTELENCE should be used with caution in patients with moderate hepatic
2 nedsat leverfunktion.
2 impairment.
Etravirins farmakokinetik er ikke undersøgt til patienter med svært nedsat leverfunktion (Child- Pugh- klasse C).
The pharmacokinetics of etravirine have not been studied in patients with severe hepatic impairment (Child-Pugh Class C).
4. 4 og 5. 2).
Therefore, INTELENCE is not recommended in patients with severe hepatic impairment (see sections 4.4 and 5.2).
5. 2).
Renal impairment No dose adjustment is required in patients with renal impairment (see section 5.2).
Hvis en patient glemmer at tage INTELENCE og kommer i tanke om dette inden for 6 timer efter det tidspunkt, hvor patienten skulle have taget lægemidlet, skal patienten have besked på at tage den pågældende dosis efter et måltid så hurtigt som muligt og dernæst tage den følgende dosis på det sædvanlige tidspunkt.
If the patient misses a dose of INTELENCE within 6 hours of the time it is usually taken, the patient should be told to take it following a meal as soon as possible and then take the next dose at the regularly scheduled time.
Hvis en patient glemmer at tage en dosis mere end 6 timer efter det tidspunkt, hvor den normalt tages, skal patienten have besked på ikke at tage den glemte dosis og blot fortsætte med den sædvanlige dosis.
If a patient misses a dose by more than 6 hours of the time it is usually taken, the patient should be told not to take the missed dose and simply resume the usual dosing schedule.
Patienterne bør informeres om, at den aktuelle antiretrovirale behandling ikke kurerer HIV, og at det ikke er påvist, at den forebygger overførsel af HIV til andre via blod eller seksuel kontakt.
Patients should be advised that current antiretroviral therapy does not cure HIV and has not been proven to prevent the transmission of HIV to others through blood or sexual contact.
Relevante forholdsregler bør fortsat tages.
Appropriate precautions should continue to be employed.
5. 1).
INTELENCE should optimally be combined with other antiretrovirals that exhibit activity against the patient’ s virus (see section 5.1).
5. 1).
A decreased virologic response to etravirine was observed in patients with viral strains harbouring 3 or more among the following mutations V90I, A98G, L100I, K101E/ P, V106I, V179D/ F, Y181C/ I/ V, and G190A/ S (see section 5.1).
4. 5) vedrørende kombination af etravirin med raltegravir eller maraviroc.
No data other than drug-drug interaction data (see section 4.5) are available when etravirine is combined with raltegravir or maraviroc.
Der er i sjældne tilfælde (< 0, 1%) rapporteret Stevens- Johnsons- syndrom og erythema multiforme.
Cutaneous reactions Severe cutaneous adverse drug reactions have been reported with INTELENCE; Stevens-Johnson Syndrome and erythema multiforme have been rarely (< 0.1%) reported.
De kutane reaktioner var i de fleste tilfælde lette eller moderate og optrådte hyppigst i anden behandlingsuge og sjældent efter uge 4.
Cutaneous reactions were most frequently mild to moderate, mostly occurred in the second week of therapy, and were infrequent after week 4.
4. 8).
Cutaneous reactions were mostly self-limiting and generally resolved within 1-2 weeks on continued therapy (see section 4.8).
De kliniske data er begrænsede, og en øget risiko for kutane reaktioner hos patienter med tidligere NNRTI- associerede kutane reaktioner kan ikke udelukkes.
The clinical data are limited and an increased risk of cutaneous reactions in patients with a history of NNRTI-associated cutaneous reactions cannot be excluded.
Hvis INTELENCE ordineres til kvinder, bør det tages i betragtning, at incidensen af kutane reaktioner var højere hos kvinder end hos mænd i etraviringruppen.
When prescribing INTELENCE to women, prescribers should be aware that the incidence of cutaneous reactions was higher in women compared to men in the etravirine arm.
I fase III- forsøgene blev INTELENCE givet til seks patienter i alderen 65 år eller derover og 53 patienter i alderen 56- 64 år.
Elderly Experience in geriatric patients is limited: in the Phase III trials, 6 patients aged 65 years or older and 53 patients aged 56-64 years received INTELENCE.
4. 2 og 5. 2).
The type and incidence of adverse reactions in patients > 55 years of age were similar to the ones in younger patients (see section 4.2 and 5.2).
3 Patienter med andre samtidige tilstande Nedsat leverfunktion Etravirin metaboliseres og elimineres primært via leveren og er stærkt bundet til plasmaproteiner.
3 Patients with coexisting conditions Hepatic impairment Etravirine is primarily metabolised and eliminated by the liver and highly bound to plasma proteins.
Der kan forventes virkninger ved eksponering af det ubundne (er ikke undersøgt), hvorfor forsigtighed tilrådes hos patienter med moderat nedsat leverfunktion.
Effects on unbound exposure could be expected (has not been studied) therefore caution is advised in patients with moderate hepatic impairment.
INTELENCE er ikke undersøgt hos patienter med svært nedsat leverfunktion (Child- Pugh- klasse C), og brugen anbefales derfor ikke til denne patientgruppe (se pkt 4. 2 og 5. 2).
INTELENCE has not been studied in patients with severe hepatic impairment (Child-Pugh Class C) and its use is therefore not recommended in this group of patients (see sections 4.2 and 5.2).
Co- infektion med HBV eller HCV Der bør udvises forsigtighed hos patienter med samtidig infektion med hepatitis B - eller C- virus på grund af de begrænsede data.
Co-infection with HBV or HCV Caution should be exercised in patients co-infected with hepatitis B or C virus due to the current limited data available.
En potentiel øget risiko for forhøjelse af leverenzymer kan ikke udelukkes.
A potential increased risk of liver enzymes increase cannot be excluded.
Fedtomfordeling Antiretroviral kombinationsbehandling (CART) er hos HIV- inficerede patienter blevet forbundet med omfordeling af legemsfedt (lipodystrofi).
Fat redistribution Combination antiretroviral therapy (CART) has been associated with redistribution of body fat (lipodystrophy) in HIV infected patients.
Kendskab til virkningsmekanismen er ufuldstændig.
Knowledge about the mechanism is incomplete.
Der er fremsat hypoteser om en forbindelse mellem visceral lipomatose og proteasehæmmere (PI) samt lipoatrofi og nukleosid revers transkriptasehæmmere (NRTI).
A connection between visceral lipomatosis and protease inhibitors (PIs), and lipoatrophy and nucleoside reverse transcriptase inhibitors (NRTIs), has been hypothesised.
En forøget risiko for lipodystrofi er blevet associeret med individuelle faktorer som højere alder og med behandlingsrelaterede faktorer som langvarig antiretroviral behandling og med metaboliske forstyrrelser.
A higher risk of lipodystrophy has been associated with individual factors such as older age, and with treatment related factors such as longer duration of antiretroviral treatment and associated metabolic disturbances.
4. 8).
Clinical examination should include evaluation for physical signs of fat redistribution (see section 4.8).
Immunreaktiveringssyndrom Hos HIV- inficerede patienter med svær immuninsufficiens på tidspunktet for opstart af antiretroviral kombinationsbehandling (CART) kan asymptomatiske eller residuale opportunistiske patogener fremelske en inflammatorisk reaktion, som kan forårsage alvorlige kliniske tilstande eller forværre allerede tilstedeværende symptomer.
Immune reconstitution syndrome In HIV infected patients with severe immune deficiency at the time of institution of CART, an inflammatory reaction to asymptomatic or residual opportunistic pathogens may arise and cause serious clinical conditions, or aggravation of symptoms.
Sådanne reaktioner er typisk observeret inden for de første uger eller måneder efter initiering af antiretroviral kombinationsbehandling.
Typically, such reactions have been observed within the first weeks or months of initiation of CART.
Relevante eksempler er retinitis forårsaget af cytomegalovirus, generaliserede og/ eller fokale mykobakterielle infektioner og Pneumocystis jiroveci- pneumoni.
Relevant examples are cytomegalovirus retinitis, generalised and/ or focal mycobacterial infections and Pneumocystis jiroveci pneumonia.
4. 8).
Any inflammatory symptoms should be evaluated and treatment instituted when necessary (see section 4.8).
Ætiologien anses dog for at være multifaktoriel (omfattende anvendelse af kortikosteroider, alkoholforbrug, svær immunsuppression, højere body mass index).
Osteonecrosis Although the etiology is considered to be multifactorial (including corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index), cases of osteonecrosis have been reported particularly in patients with advanced HIV disease and/ or long-term exposure to CART.
Interaktion med lægemidler Det anbefales ikke at kombinere etravirin med tipranavir/ ritonavir på grund af en udtalt farmakokinetisk interaktion (76% reduktion i etravirins AUC), som i væsentligt omfang kan nedsætte det virologiske respons på etravirin.
Interactions with medicinal products It is not recommended to combine etravirine with tipranavir/ ritonavir, due to a marked pharmacokinetic interaction (76% decrease of etravirine AUC) that could significantly impair the virologic response to etravirine.
4. 5.
For further information on interactions with medicinal products see section 4.5.
Lactoseintolerans og lactasemangel Hver tablet indeholder 160 mg lactose.
Lactose intolerance and lactase deficiency Each tablet contains 160 mg of lactose.
Patienter med sjældne arvelige problemer med galactoseintolerans, Lapps- lactasemangel eller glucose- galactosemalabsorption bør ikke tage dette lægemiddel.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
4 Etravirin metaboliseres af CYP3A4, CYP2C9 og CYP2C19 efterfulgt af glucuronidering via uridindifosfatglucuronosyltransferase (UDPGT).
Medicinal products that affect etravirine exposure Etravirine is metabolised by CYP3A4, CYP2C9 and CYP2C19 followed by glucuronidation by uridine diphosphate glucuronosyl transferase (UDPGT).
Samtidig indgift af INTELENCE og lægemidler, der hæmmer CYP3A4, CYP2C9 eller CYP2C19, kan reducere clearance af etravirin og øge plasmakoncentrationen af etravirin.
4 Co-administration of INTELENCE and medicinal products that inhibit CYP3A4, CYP2C9 or CYP2C19 may decrease the clearance of etravirine and may result in increased plasma concentrations of etravirine.
Lægemidler, som påvirkes af etravirin Etravirin er en svag inducer af CYP3A4.
Medicinal products that are affected by the use of etravirine Etravirine is a weak inducer of CYP3A4.
Samtidig indgift af lægemidler, som primært metaboliseres af CYP2C9 eller CYP2C19, kan resultere i en øget plasmakoncentration af disse lægemidler, hvilket kan øge eller forlænge deres terapeutiske virkning eller ændre deres bivirkningsprofil.
Co-administration with medicinal products primarily metabolised by CYP2C9 or CYP2C19 may result in increased plasma concentrations of such medicinal products, which could increase or prolong their therapeutic effect or alter their adverse events profile.
Kendte og teoretiske interaktioner med udvalgte antiretrovirale og non- antiretrovirale lægemidler er angivet i tabellen nedenfor.
Known and theoretical interactions with selected antiretrovirals and non-antiretroviral medicinal products are listed in the table below.
Interaktionstabel Interaktioner mellem etravirin og samtidigt indgivne lægemidler angives i nedenstående tabel (forhøjelse angives med "↑", reduktion angives med "↓", ingen ændring angives med "↔", ikke undersøgt angives med "ND", én gang dagligt angives med "q. d.", to gange dagligt angives med "b. i. d.", konfidensinterval angives med "CI").
Interaction table Interactions between etravirine and co-administered medicinal products are listed in the table below (increase is indicated as “↑”, decrease as “↓”, no change as “↔”, not done as “ ND”, once daily as “ q. d.”, twice daily as “ b. i. d.”, confidence interval as “ CI”).
INTERAKTIONER OG DOSISANBEFALINGER MED ANDRE LÆGEMIDLER Lægemidler efter terapeutisk område ANTIINFEKTIVA Antiretrovirale midler NRTI- midler
INTERACTIONS AND DOSE RECOMMENDATIONS WITH OTHER MEDICINAL PRODUCTS Medicinal products by therapeutic areas ANTI-INFECTIVES Antiretrovirals NRTIs
Virkninger på lægemiddelniveau Least squareMiddelværdi (90% CI, 1, 00 = ingen virkning)
Effects on drug levels Least Squares Mean Ratio (90% CI; 1.00 = No effect)
didanosin AUC ↔ 0, 99 (0, 79- 1, 25) didanosin Cmin ND didanosin Cmax ↔ 0, 91 (0, 58- 1, 42) etravirin AUC ↔ 1, 11 (0, 99- 1, 25) etravirin Cmin ↔ 1, 05 (0, 93- 1, 18) etravirin Cmax ↔ 1, 16 (1, 02- 1, 32)
didanosine AUC ↔ 0.99 (0.79-1.25) didanosine Cmin ND didanosine Cmax ↔ 0.91 (0.58-1.42) etravirine AUC ↔ 1.11 (0.99-1.25) etravirine Cmin ↔ 1.05 (0.93-1.18) etravirine Cmax ↔ 1.16 (1.02-1.32)
tenofovir AUC ↔ 1, 15 (1, 09- 1, 21) tenofovir Cmin ↑ 1, 19 (1, 13- 1, 26) tenofovir Cmax ↑ 1, 15 (1, 04- 1, 27) etravirin AUC ↓ 0, 81 (0, 75- 0, 88) etravirin Cmin ↓ 0, 82 (0, 73- 0, 91) etravirin Cmax ↓ 0, 81 (0, 75- 0, 88)
tenofovir AUC ↔ 1.15 (1.09-1.21) tenofovir Cmin ↑ 1.19 (1.13-1.26) tenofovir Cmax ↑ 1.15 (1.04-1.27) etravirine AUC ↓ 0.81 (0.75-0.88) etravirine Cmin ↓ 0.82 (0.73-0.91) etravirine Cmax ↓ 0.81 (0.75-0.88)
Andre NRTI- midler
Other NRTIs
elimineres via nyrerne (f. eks. abacavir, emtricitabin, lamivudin, stavudin og zidovudin).
Not studied, but no interaction expected based on Etravirine can be used with the primary renal elimination route for other these NRTIs without dose NRTIs (e. g., abacavir, emtricitabine, lamivudine, adjustment. stavudine and zidovudine).
midler uden dosisjustering.
NNRTIs
Efavirenz
Efavirenz Nevirapine
Kombination af to NNRTI- midler har ikke vist
Combining two NNRTIs has not been shown to be beneficial.
Det anbefales ikke at indgive
It is not recommended to co-administer INTELENCE with other NNRTIs.
Ikke- boostede proteasehæmmere (dvs. uden samtidig indgift af lavdosis ritonavir)
PIs - Unboosted (i. e. without co-administration of low-dose ritonavir)
Det anbefales ikke at indgive INTELENCE samtidig med nelfinavir.
It is not recommended to co-administer INTELENCE with nelfinavir.
Samtidig indgift af INTELENCE og indinavir kan forårsage signifikant reduktion i plasmakoncentrationen af indinavir og tab af den terapeutiske virkning af indinavir.
Concomitant use of INTELENCE with indinavir It is not recommended to may cause a significant decrease in the plasma co-administer INTELENCE concentration of indinavir and loss of therapeutic with indinavir. effect of indinavir.
Det anbefales ikke at indgive INTELENCE samtidig med indinavir.
5
Boostede proteasehæmmere (med lavdosis ritonavir)
PIs - Boosted (with low-dose ritonavir)
tipranavir AUC ↑ 1, 18 (1, 03- 1, 36) tipranavir Cmin ↑ 1, 24 (0, 96- 1, 59) tipranavir Cmax ↑ 1, 14 (1, 02- 1, 27) etravirin AUC ↓ 0, 24 (0, 18- 0, 33) etravirin Cmin ↓ 0, 18 (0, 13- 0, 25) etravirin Cmax ↓ 0, 29 (0, 22- 0, 40)
tipranavir AUC ↑ 1.18 (1.03-1.36) tipranavir Cmin ↑ 1.24 (0.96-1.59) tipranavir Cmax ↑ 1.14 (1.02-1.27) etravirine AUC ↓ 0.24 (0.18-0.33) etravirine Cmin ↓ 0.18 (0.13-0.25) etravirine Cmax ↓ 0.29 (0.22-0.40)
4. 4).
It is not recommended to co-administer tipranavir/ ritonavir and INTELENCE (see section 4.4).
Fosamprenavir/ ritonavir 700/ 100 mg b. i. d.
Fosamprenavir/ ritonavir amprenavir AUC ↑ 1.69 (1.53-1.86) 700/ 100 mg b. i. d. amprenavir Cmin ↑ 1.77 (1.39-2.25) amprenavir Cmax ↑ 1.62 (1.47-1.79) etravirine AUC ↔ a etravirine Cmin ↔ a etravirine Cmax ↔ a
Det kan være nødvendigt at reducere dosis af amprenavir/ ritonavir og fosamprenavir/ ritonavir ved indgift samtidig med INTELENCE.
Amprenavir/ ritonavir and fosamprenavir/ ritonavir may require dose reduction when co-administered with INTELENCE.
Atazanavir/ ritonavir 300/ 100 mg q. d.
Atazanavir/ ritonavir atazanavir AUC ↓ 0.86 (0.79-0.93) 300/ 100 mg q. d. atazanavir Cmin ↓ 0.62 (0.55-0.71) atazanavir Cmax ↔ 0.97 (0.89-1.05) etravirine AUC ↑ 1.30 (1.18-1.44) etravirine Cmin ↑ 1.26 (1.12-1.42) etravirine Cmax ↑ 1.30 (1.17-1.44)
INTELENCE og atazanavir/ ritonavir kan anvendes uden dosisjustering.
INTELENCE and atazanavir/ ritonavir can be used without dose adjustment.
Darunavir/ ritonavir 600/ 100 mg b. i. d.
Darunavir/ ritonavir darunavir AUC ↔ 1.15 (1.05-1.26) 600/ 100 mg b. i. d. darunavir Cmin ↔ 1.02 (0.90-1.17) darunavir Cmax ↔ 1.11 (1.01-1.22) etravirine AUC ↓ 0.63 (0.54-0.73) etravirine Cmin ↓ 0.51 (0.44-0.61) etravirine Cmax ↓ 0.68 (0.57-0.82)
5. 1).
INTELENCE and darunavir/ ritonavir can be used without dose adjustments (see also section 5.1).
Lopinavir/ ritonavir (blød kapsel) 400/ 100 mg b. i. d.
Lopinavir/ ritonavir lopinavir AUC ↓ 0.80 (0.49-1.07) (soft capsule) lopinavir Cmin ↓ 0.92 (0.15-1.68) 400/ 100 mg b. i. d. lopinavir Cmax ↓ 0.85 (0.62-1.05) etravirine AUC ↑ 1.17 (0.96-1.43) etravirine Cmin ↑ 1.23 (0.98-1.53) etravirine Cmax ↑ 1.15 (0.94-1.41)
INTELENCE og lopinavir/ ritonavir kan anvendes uden dosisjustering.
INTELENCE and lopinavir/ ritonavir can be used without dose adjustments.
Saquinavir/ ritonavir 1. 000/ 100 mg b. i. d.
Saquinavir/ ritonavir saquinavir AUC ↔ 0.95 (0.64-1.42) 1,000/ 100 mg b. i. d. saquinavir Cmin ↓ 0.80 (0.46-1.38) saquinavir Cmax ↔ 1.00 (0.70-1.42) etravirine AUC ↓ 0.67 (0.56-0.80) etravirine Cmin ↓ 0.71 (0.58-0.87) etravirine Cmax ↓ 0.63 (0.53-0.75)
INTELENCE og saquinavir/ ritonavir kan anvendes uden dosisjustering.
INTELENCE and saquinavir/ ritonavir can be used without dose adjustments.
Adgangsblokerende stoffer (Entry Inhibitors)
Entry Inhibitors
Maraviroc 300 mg b. i. d.
Maraviroc 300 mg b. i. d.
maraviroc AUC ↓ 0, 47 (0, 38- 0, 58) maraviroc Cmin ↓ 0, 61 (0, 53- 0, 71) maraviroc Cmax ↓ 0, 40 (0, 28- 0, 57) etravirin AUC ↔ 1, 06 (0, 99- 1, 14) etravirin Cmin ↔ 1, 08 (0, 98- 1, 19) etravirin Cmax ↔ 1, 05 (0, 95- 1, 17)
maraviroc AUC ↓ 0.47 (0.38-0.58) maraviroc Cmin ↓ 0.61 (0.53-0.71) maraviroc Cmax ↓ 0.40 (0.28-0.57) etravirine AUC ↔ 1.06 (0.99-1.14) etravirine Cmin ↔ 1.08 (0.98-1.19) etravirine Cmax ↔ 1.05 (0.95-1.17)
Den anbefalede dosis af maraviroc i kombination med INTELENCE ved tilstedeværelse af potente CYP3A- hæmmere (f. eks. boostede proteasehæmmere)
The recommended dose for maraviroc when combined with INTELENCE in the presence of potent CYP3A inhibitors (e. g. boosted PIs) is 150 mg b. i. d. except for
Maraviroc/ darunavir / ritonavir 150/ 600/ 100 mg b. i. d.
Maraviroc/ darunavir/ ritonavir 150/ 600/ 100 mg b. i. d.
maraviroc AUC ↑ 3, 10 * (2, 57- 3, 74) maraviroc Cmin ↑ 5, 27 * (4, 51- 6, 15) maraviroc Cmax ↑ 1, 77 * (1, 20- 2, 60) * sammenlignet med maraviroc 150 mg b. i. d.
maraviroc AUC ↑ 3.10* (2.57-3.74) maraviroc Cmin ↑ 5.27* (4.51-6.15) maraviroc Cmax ↑ 1.77* (1.20-2.60) * compared to maraviroc 150 mg b. i. d.
er 150 mg b. i. d. bortset fra fosamprenavir/ ritonavir (maravirocdosis 300 mg b. i. d.).
fosamprenavir/ ritonavir (maraviroc dose 300 mg b. i. d.).
Dosisjustering er ikke påkrævet for INTELENCE.
No dose adjustment for INTELENCE is necessary.
Fusionshæmmere
Fusion Inhibitors
Der forventes ingen virkning. * baseret på farmakokinetiske populationsanalyser
etravirine* AUC ↔ a etravirine* C0h ↔ a Enfuvirtide concentrations not studied, no effect is expected. * based on population pharmacokinetic analyses
6 Integrasehæmmere
Integrase Strand Transfer Inhibitors
raltegravir AUC ↓ 0, 90 (0, 68- 1, 18) raltegravir Cmin ↓ 0, 66 (0, 34- 1, 26) raltegravir Cmax ↓ 0, 89 (0, 68- 1, 15) etravirin AUC ↔ 1, 10 (1, 03- 1, 16) etravirin Cmin ↔ 1, 17 (1, 10- 1, 26) etravirin Cmax ↔ 1, 04 (0, 97- 1, 12)
raltegravir AUC ↓ 0.90 (0.68-1.18) raltegravir Cmin ↓ 0.66 (0.34-1.26) raltegravir Cmax ↓ 0.89 (0.68-1.15) etravirine AUC ↔ 1.10 (1.03-1.16) etravirine Cmin ↔ 1.17 (1.10-1.26) etravirine Cmax ↔ 1.04 (0.97-1.12)
Digoxin 0, 5 mg enkeltdosis
Digoxin 0.5 mg single dose
digoxin AUC ↑ 1, 18 (0, 90- 1, 56) digoxin Cmin ND digoxin Cmax ↑ 1, 19 (0, 96- 1, 49)
digoxin AUC ↑ 1.18 (0.90-1.56) digoxin Cmin ND digoxin Cmax ↑ 1.19 (0.96-1.49)
Amiodaron Bepridil Disopyramid Flecainid Lidocain (systemisk) Mexiletin Propafenon Quinidin
Amiodarone Bepridil Disopyramide Flecainide Lidocaine (systemic) Mexiletine Propafenone Quinidine
Clarithromycin 500 mg b. i. d.
Clarithromycin 500 mg b. i. d.
clarithromycin AUC ↓ 0, 61 (0, 53- 0, 69) clarithromycin Cmin ↓ 0, 47 (0, 38- 0, 57) clarithromycin Cmax ↓ 0, 66 (0, 57- 0, 77) 14- OH- clarithromycin AUC ↑ 1, 21 (1, 05- 1, 39) 14- OH- clarithromycin Cmin ↔ 1, 05 (0, 90- 1, 22) 14- OH- clarithromycin Cmax ↑ 1, 33 (1, 13- 1, 56) etravirin AUC ↑ 1, 42 (1, 34- 1, 50) etravirin Cmin ↑ 1, 46 (1, 36- 1, 58) etravirin Cmax ↑ 1, 46 (1, 38- 1, 56)
clarithromycin AUC ↓ 0.61 (0.53-0.69) clarithromycin Cmin ↓ 0.47 (0.38-0.57) clarithromycin Cmax ↓ 0.66 (0.57-0.77) 14-OH-clarithromycin AUC ↑ 1.21 (1.05-1.39) 14-OH-clarithromycin Cmin ↔ 1.05 (0.90-1.22) 14-OH-clarithromycin Cmax ↑ 1.33 (1.13-1.56) etravirine AUC ↑ 1.42 (1.34-1.50) etravirine Cmin ↑ 1.46 (1.36-1.58) etravirine Cmax ↑ 1.46 (1.38-1.56)
Clarithromycineksponeringen blev reduceret af etravirin, men koncentrationen af den aktive metabolit, 14- OH- clarithromycin, blev forøget.
Clarithromycin exposure was decreased by etravirine; however, concentrations of the active metabolite, 14-OH-clarithromycin, were increased.
Derfor bør alternativer til clarithromycin overvejes til behandling af MAC.
Because 14-OH-clarithromycin has reduced activity against Mycobacterium avium complex (MAC), overall activity against this pathogen may be altered; therefore alternatives to clarithromycin should be considered for the treatment of MAC.
Carbamazepin Fenobarbital Fenytoin
Carbamazepine Phenobarbital Phenytoin
Carbazamepin, fenobarbital og fenytoin forventes at reducere plasmakoncentrationen af etravirin.
Carbazamepine, phenobarbital and phenytoin are expected to decrease plasma concentrations of etravirine.
Kombination anbefales ikke.
Combination not recommended.
Fluconazol Itraconazol Ketoconazol Posaconazol Voriconazol
Fluconazole Itraconazole Ketoconazole Posaconazole Voriconazole
Begge stoffer kan øge plasmakoncentrationen af etravirin.
Posaconazole is a potent inhibitor of CYP3A4 and fluconazole is a potent inhibitor of CYP2C9; both may increase plasma concentrations of etravirine.
Itraconazol og ketoconazol er potente CYP3A4- hæmmere og - substrater.
Itraconazole and ketoconazole are potent inhibitors as well as substrates of CYP3A4.
Voriconazol er et CYP2C19 - substrat og en CYP3A4 - og CYP2C- hæmmer.
Voriconazole is a CYP2C19 substrate and CYP3A4 and CYP2C inhibitor.
Samtidig brug af voriconazol og INTELENCE kan øge plasmakoncentrationen af begge stoffer.
Concomitant use of voriconazole and INTELENCE may increase plasma concentrations of both drugs.
INTELENCE og antimykotika kan anvendes uden dosisjustering.
INTELENCE and antifungals can be used without dose adjustments.
Rifampicin og rifapentin forventes at reducere plasmakoncentrationen af etravirin.
Rifampicin and rifapentine are expected to decrease plasma concentrations of etravirine.