Ravulizumab

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# Black Box Warning

# Overview
Ravulizumab is a monoclonal antibody that is FDA approved for the treatment of adults with a disease called Paroxysmal Nocturnal Hemoglobinuria (PNH), and for adults and children 1 month of age and older with a disease called atypical hemolytic uremic syndrome (aHUS). ULTOMIRIS is only available through a program called the ULTOMIRIS REMS. There is a Black Box Warning for this drug as shown here.  Common adverse reactions include respiratory tract infection, headache, diarrhea and fever
ULTOMIRIS is a prescription medicine called a monoclonal antibody..

# Adult Indications and Dosage

## FDA-Labeled Indications and Dosage (Adult)

### ULTOMIRIS is indicated for:
- The treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH).
- The treatment of adults and pediatric patients one month of age and older with atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy (TMA).

### Limitations of Use
- ULTOMIRIS is not indicated for the treatment of patients with Shiga toxin E. coli related hemolytic uremic syndrome (STEC-HUS).

### Recommended Vaccination and Prophylaxis
- Provide 2 weeks of antibacterial drug prophylaxis to patients if ULTOMIRIS must be initiated immediately and vaccines are administered less than 2 weeks before starting ULTOMIRIS therapy.

### Recommended Weight-Based Dosage Regimen - PNH
- The recommended dosing regimen in adult patients with PNH weighing 40 kg or greater, consists of a loading dose followed by maintenance dosing, administered by intravenous infusion. Administer the doses based on the patients body weight.
- Starting 2 weeks after the loading dose administration, begin maintenance doses at a once every 8-week interval.
- The dosing schedule is allowed to occasionally vary within 7 days of the scheduled infusion day (except for the first maintenance dose of ULTOMIRIS); but the subsequent doses should be administered according to the original schedule.

### Recommended Weight-Based Dosage Regimen - aHUS
- The recommended dosing regimen in adult and pediatric patients one month of age and older with aHUS weighing 5 kg or greater, consists of a loading dose followed by maintenance dosing, administered by intravenous infusion.
- Administer the doses basedon the patients body weight
- Starting 2 weeks after the loading dose administration, begin maintenance doses once every 8 weeks or every 4 weeks (depending on body weight).
- The dosing schedule is allowed to occasionally vary within 7 days of the scheduled infusion day (except for the first maintenance dose of ULTOMIRIS); but the subsequent doses should be administered according to the original schedule.

### Dosing Considerations
- For patients switching from eculizumab to ULTOMIRIS, administer the loading dose of ULTOMIRIS 2 weeks after the last eculizumab infusion, and then administer maintenance doses once every 8 weeks or every 4 weeks (depending on body weight), starting 2 weeks after loading dose administration.
- Administration of PE/PI (plasmapheresis or plasma exchange, or fresh frozen plasma infusion) may reduce ULTOMIRIS serum levels. There is no experience with administration of supplemental doses of ULTOMIRIS.

### Preparation of ULTOMIRIS
- Each vial of ULTOMIRIS is intended for single-dose only.
- ULTOMIRIS requires dilution to a final concentration of 5 mg/mL.
- Use aseptic technique to prepare ULTOMIRIS as follows:
1. The number of vials to be diluted is determined based on the individual patients weight and the prescribed dose
2. Prior to dilution, visually inspect the solution in the vials; the solution should be free of any particulate matter or precipitation. Do not use if there is evidence of particulate matter or precipitation.
3. Withdraw the calculated volume of ULTOMIRIS from the appropriate number of vials and dilute in an infusion bag using 0.9% Sodium Chloride Injection, USP to a final concentration of 5 mg/mL. The product should be mixed gently. Do not shake. Protect from light. Do not freeze.
4. Administer the prepared solution immediately following preparation. Infusion must be administered through a 0.2 or 0.22 micron filter.
5. If the diluted ULTOMIRIS infusion solution is not used immediately, storage under refrigeration at 2C - 8C (36F - 46F) must not exceed 24 hours taking into account the expected infusion time. Once removed from refrigeration, administer the diluted ULTOMIRIS infusion solution within 6 hours.
- 1. The number of vials to be diluted is determined based on the individual patients weight and the prescribed dose
- 2. Prior to dilution, visually inspect the solution in the vials; the solution should be free of any particulate matter or precipitation. Do not use if there is evidence of particulate matter or precipitation.
- 3. Withdraw the calculated volume of ULTOMIRIS from the appropriate number of vials and dilute in an infusion bag using 0.9% Sodium Chloride Injection, USP to a final concentration of 5 mg/mL. The product should be mixed gently. Do not shake. Protect from light. Do not freeze.
- 4. Administer the prepared solution immediately following preparation. Infusion must be administered through a 0.2 or 0.22 micron filter.
- 5. If the diluted ULTOMIRIS infusion solution is not used immediately, storage under refrigeration at 2C - 8C (36F - 46F) must not exceed 24 hours taking into account the expected infusion time. Once removed from refrigeration, administer the diluted ULTOMIRIS infusion solution within 6 hours.

### Administration of ULTOMIRIS
- Only administer as an intravenous infusion.
- Dilute ULTOMIRIS to a final concentration of 5 mg/mL.
- Administer ULTOMIRIS only through a 0.2 or 0.22 micron filter.
- Prior to administration, allow the admixture to adjust to room temperature (18C-25C, 64F-77F). Do not heat the admixture in a microwave or with any heat source other than ambient air temperature.
- Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

## Off-Label Use and Dosage (Adult)

### Guideline-Supported Use
There is limited information regarding ULTOMIRIS Off-Label Guideline-Supported Use and Dosage (Adult) in the drug label.

### NonGuideline-Supported Use
There is limited information regarding ULTOMIRIS Off-Label Non-Guideline-Supported Use and Dosage (Adult) in the drug label.

# Pediatric Indications and Dosage

## FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding ULTOMIRIS FDA-Labeled Indications and Dosage (Pediatric) in the drug label.

## Off-Label Use and Dosage (Pediatric)

### Guideline-Supported Use
There is limited information regarding ULTOMIRIS Off-Label Guideline-Supported Use and Dosage (Pediatric) in the drug label.

### NonGuideline-Supported Use
There is limited information regarding ULTOMIRIS Off-Label Non-Guideline-Supported Use and Dosage (Pediatric) in the drug label.

# Contraindications
- Patients with unresolved Neisseria meningitidis infection.
- Patients who are not currently vaccinated against Neisseria meningitidis, unless the risks of delaying ULTOMIRIS treatment outweigh the risks of developing a meningococcal infection

# Warnings

### Serious Meningococcal Infections
- The use of ULTOMIRIS increases a patients susceptibility to serious meningococcal infections (septicemia and/or meningitis). Meningococcal disease due to any serogroup may occur.
- Immunize patients without a history of meningococcal vaccination at least 2 weeks prior to receiving the first dose of ULTOMIRIS. If urgent ULTOMIRIS therapy is indicated in an unvaccinated patient, administer meningococcal vaccine(s) as soon as possible and provide patients with 2 weeks of antibacterial drug prophylaxis.
- Vaccination reduces, but does not eliminate, the risk of meningococcal infections.
- Closely monitor patients for early signs and symptoms of meningococcal infection and evaluate patients immediately if infection is suspected.
- If ULTOMIRIS therapy is administered to patients with active systemic infections, monitor closely for signs and symptoms of worsening infection.
- In clinical studies, 59 patients with PNH were treated with ULTOMIRIS less than 2 weeks after meningococcal vaccination. All of these patients received antibiotics for prophylaxis of meningococcal infection until at least 2 weeks after meningococcal vaccination. The benefits and risks of antibiotic prophylaxis for prevention of meningococcal infections in patients receiving ULTOMIRIS have not been established.
- In PNH clinical studies, 3 out of 261 PNH patients developed serious meningococcal infections/sepsis while receiving treatment with ULTOMIRIS; all 3 had been vaccinated. These 3 patients recovered while continuing treatment with ULTOMIRIS.
- ULTOMIRIS blocks terminal complement activation; therefore, patients may have increased susceptibility to encapsulated bacteria infections, especially infections caused by Neisseria meningitidis but also Streptococcus pneumoniae, Haemophilus influenzae, and to a lesser extent, Neisseria gonorrhoeae.
- Children treated with ULTOMIRIS may be at increased risk of developing serious infections due to Streptococcus pneumoniae and Haemophilus influenzae type b (Hib).
Administer vaccinations for the prevention of Streptococcus pneumoniae and Haemophilus influenzae type b (Hib) infections accordingto ACIP guidelines.
- Administer vaccinations for the prevention of Streptococcus pneumoniae and Haemophilus influenzae type b (Hib) infections accordingto ACIP guidelines.
Treatment Discontinuation for PNH
- After discontinuing treatment with ULTOMIRIS, closely monitor for signs and symptoms of hemolysis, identified by elevated LDH along with sudden decrease in PNH clone size or hemoglobin, or re-appearance of symptoms such as fatigue, hemoglobinuria, abdominal pain, shortness of breath (dyspnea), major adverse vascular event (including thrombosis), dysphagia, or erectile dysfunction.
Monitor any patient who discontinues ULTOMIRIS for at least 16 weeks to detect hemolysis and other reactions.
If signs and symptoms of hemolysis occur after discontinuation, including elevated LDH, consider restarting treatment with ULTOMIRIS.
- Monitor any patient who discontinues ULTOMIRIS for at least 16 weeks to detect hemolysis and other reactions.
- If signs and symptoms of hemolysis occur after discontinuation, including elevated LDH, consider restarting treatment with ULTOMIRIS.
Treatment Discontinuation for aHUS
- ULTOMIRIS treatment of aHUS should be a minimum duration of 6 months.
- Patients should be monitored for clinical symptoms and laboratory signs of TMA complications for at least 12 months.
- TMA complications post-discontinuation can be identified if any of the following is observed:
Changes in mental status, seizures, angina, dyspnea, thrombosis or increasing blood pressure
At least two of the following laboratory signs observed concurrently and results should be confirmed by a second measurement 28 days apart with no interruption:
A decrease in platelet count of 25% or more as compared to either baseline or to peak platelet count during ULTOMIRIS treatment;
An increase in serum creatinine of 25% or more as compared to baseline or to nadir during ULTOMIRIS treatment
An increase in serum LDH of 25% or more as compared to baseline or to nadir during ULTOMIRIS treatment
- Changes in mental status, seizures, angina, dyspnea, thrombosis or increasing blood pressure
- At least two of the following laboratory signs observed concurrently and results should be confirmed by a second measurement 28 days apart with no interruption:
A decrease in platelet count of 25% or more as compared to either baseline or to peak platelet count during ULTOMIRIS treatment;
An increase in serum creatinine of 25% or more as compared to baseline or to nadir during ULTOMIRIS treatment
An increase in serum LDH of 25% or more as compared to baseline or to nadir during ULTOMIRIS treatment
- A decrease in platelet count of 25% or more as compared to either baseline or to peak platelet count during ULTOMIRIS treatment;
- An increase in serum creatinine of 25% or more as compared to baseline or to nadir during ULTOMIRIS treatment
- An increase in serum LDH of 25% or more as compared to baseline or to nadir during ULTOMIRIS treatment
- If TMA complications occur after ULTOMIRIS discontinuation, consider reinitiation of ULTOMIRIS treatment or appropriate organ-specific supportive measures.

### Infusion Reactions
- In clinical trials, 5 out of 296 patients treated with ULTOMIRIS experienced infusion reactions (lower back pain, drop in blood pressure, infusion-related pain, elevation in blood pressure and limb discomfort) during ULTOMIRIS administration.
- Interrupt ULTOMIRIS infusion and institute appropriate supportive measures if signs of cardiovascular instability or respiratory compromise occur.

# Adverse Reactions

## Clinical Trials Experience

### Paroxysmal Nocturnal Hemoglobinuria (PNH)
- Most common adverse reactions in patients with PNH (incidence 10%) were upper respiratory tract infection and headache

### Atypical Hemolytic Uremic Syndrome (aHUS)
- Most common adverse reactions in patients with aHUS (incidence 20%) were upper respiratory tract infection, diarrhea, nausea, vomiting, headache, hypertension and pyrexia

### Immunogenicity
- The immunogenicity of ravulizumab-cwvz has been evaluated using an enzyme-linked immunosorbent assay (ELISA) for the detection of binding anti-ravulizumab-cwvz antibodies. For patients whose sera tested positive in the screening immunoassay, an in vitro biological assay was performed to detect neutralizing antibodies.
- In clinical studies, treatment-emergent antibodies to ravulizumab-cwvz were detected in 1 of 206 (0.5%) patients with PNH and 1 of 71 (1.4%) patients with aHUS.
- No apparent correlation of antibody development to altered pharmacokinetic profile, clinical response, or adverse events was observed.

## Postmarketing Experience
There is limited information regarding Ravulizumab Postmarketing Experience in the drug label.

# Drug Interactions
There is limited information regarding Ravulizumab Drug Interactions in the drug label.

# Use in Specific Populations

### Pregnancy
Pregnancy Category (FDA): 
There are no available data on ULTOMIRIS use in pregnant women to inform a drugassociated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.
Pregnancy Category (AUS): 
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Ravulizumab in women who are pregnant.

### Labor and Delivery
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.

### Nursing Mothers
There is no FDA guidance on the use of Ravulizumab in women who are nursing.

### Pediatric Use
The safety and efficacy of Ultomiris for the treatment of PNH in pediatric patients have not been established.

### Geriatic Use
Clinical studies of Ultomiris did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

### Gender
There is no FDA guidance on the use of Ultomiris with respect to specific gender populations.

### Race
There is no FDA guidance on the use of Ultomiris with respect to specific racial populations.

### Renal Impairment
There is no FDA guidance on the use of Ultomiris in patients with renal impairment.

### Hepatic Impairment
There is no FDA guidance on the use of Ultomiris in patients with hepatic impairment.

### Females of Reproductive Potential and Males
There is no FDA guidance on the use of Ultomiris in women of reproductive potentials and males.

### Immunocompromised Patients
There is no FDA guidance one the use of Ultomiris in patients who are immunocompromised.

# Administration and Monitoring

### Administration
- Injection: 300 mg/30 mL (10 mg/mL) as a clear to translucent, slight whitish color solution in a single-dose vial.

### Monitoring
- Monitor patients for early signs and symptoms of meningococcal infection.
- Monitor the patient for at least one hour following completion of the infusion for signs or symptoms of an infusion reaction.
- After discontinuing treatment with ULTOMIRIS, patients should be monitored for clinical symptoms and laboratory signs of TMA complications for at least 12 months.
Clinical symptoms of TMA include changes in mental status, seizures, angina, dyspnea, thrombosis or increasing blood pressure.
- Clinical symptoms of TMA include changes in mental status, seizures, angina, dyspnea, thrombosis or increasing blood pressure.

# IV Compatibility
There is limited information regarding the compatibility of Ravulizumab and IV administrations.

# Overdosage
There is limited information regarding Andexanet alfa overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

# Pharmacology

## Mechanism of Action
- Ravulizumab-cwvz is a terminal complement inhibitor that specifically binds to the complement protein C5 with high affinity, thereby inhibiting its cleavage to C5a (the proinflammatory anaphylatoxin) and C5b (the initiating subunit of the terminal complement complex ) and preventing the generation of the terminal complement complex C5b9.
- ULTOMIRIS inhibits terminal complement-mediated intravascular hemolysis in patients with PNH and complement-mediated thrombotic microangiopathy (TMA) in patients with aHUS.

## Structure
There is limited information regarding Ultomiris Structure in the drug label.

## Pharmacodynamics
- The extent and duration of the pharmacodynamic response in patients with PNH and aHUS were exposure-dependent for ULTOMIRIS. Free C5 levels of <0.5 mcg/mL were correlated with maximal intravascular hemolysis control and complete terminal complement inhibition in patients with PNH.
- Complete terminal complement inhibition following initiation of ULTOMIRIS treatment led to normalization of serum LDH by week 4 in complement-inhibitor naive patients with PNH, and maintained LDH normalization in patients previously treated with eculizumab with PNH.

## Pharmacokinetics
Ravulizumab-cwvz pharmacokinetics increase proportionally over a dose range of 200 to 5400 mg.
The mean (%CV) volume of distribution at steady state was 5.34 (17.2) L and 5.22 (35.4) L in patients with PNH and aHUS, respectively.
The mean (%CV) terminal elimination half-life of ravulizumab-cwvz in patients with
PNH and aHUS are 49.7 (18.0) days and 51.8 (31.3) days, respectively. The mean (%CV)
clearance of ravulizumab-cwvz in patients with PNH and aHUS are 0.08 (29.5) L/day
and 0.08 (53.3) L/day, respectively.
No clinically significant differences in the pharmacokinetics of ravulizumab-cwvz were observed based on sex, age (10 months to 83 years), race, hepatic impairment, or any degree of renal impairment, including patients with proteinuria or receiving dialysis. Body weight was a clinically significant covariate on the pharmacokinetics of ravulizumab-cwvz.

## Nonclinical Toxicology

### Carcinogenesis, Mutagenesis, Impairment of Fertility
- No animal studies were performed to evaluate the effects of ravulizumab-cwvz on carcinogenesis, or mutagenesis.
- Effects of ravulizumab-cwvz upon fertility have not been studied in animals.
Intravenous injections of male and female mice with a murine anti-C5 antibody at up to 0.8-2.2 times the equivalent of the clinical dose of ULTOMIRIS had no adverse effects on mating or fertility.
- Intravenous injections of male and female mice with a murine anti-C5 antibody at up to 0.8-2.2 times the equivalent of the clinical dose of ULTOMIRIS had no adverse effects on mating or fertility.

# Clinical Studies
- The safety and efficacy of ULTOMIRIS in patients with PNH was assessed in two openlabel, randomized, active-controlled, non-inferiority Phase 3 studies: PNH Study 301 and PNH Study 302.
- ULTOMIRIS was dosed intravenously in accordance with the weightbased dosing (4 infusions of ULTOMIRIS over 26 weeks). Eculizumab was administered on Days 1, 8, 15, and 22, followed by maintenance treatment with 900 mg of eculizumab on Day 29 and every 2 weeks (q2w) thereafter for a total of 26 weeks of treatment, according to the approved dosing regimen of eculizumab which was the standard-of-care for PNH at the time of studies.
- Patients were vaccinated against meningococcal infection prior to or at the time of initiating treatment with ULTOMIRIS or eculizumab, or received prophylactic treatment with appropriate antibiotics until 2 weeks after vaccination.
- There was no observable difference in fatigue between ULTOMIRIS and eculizumab after 26 weeks of treatment compared to baseline as measured by the FACIT-fatigue instrument. Patient-reported fatigue may be an under-or over-estimation, because patients were not blinded to treatment assignment.

### PNH Study 301  
- enrolled patients with PNH who were complement inhibitor naive and had active hemolysis
- 26-week, multicenter, open-label, randomized, active-controlled, non-inferiority Phase 3 study conducted in 246 patients naive to complement inhibitor treatment prior to study entry
- Patients with PNH with flow cytometric confirmation of at least 5% PNH cells were randomized 1:1 to either ULTOMIRIS or eculizumab.

### PNH Study 302  
- Enrolled patients with PNH who were clinically stable after having been treated with eculizumab for at least the past 6 months.
- Patients who demonstrated clinically stable disease after being treated with eculizumab for at least the prior 6 months were randomized 1:1 to either continue eculizumab or to switch to ULTOMIRIS.
- The efficacy of ULTOMIRIS in patients with aHUS was assessed in 2 open-label,single-arm studies. Study ALXN1210-aHUS-311 and  ALXN1210-aHUS-312.
- In order to qualify for enrollment, patients were required to have a platelet count 150 x109/L, evidence of hemolysis such as an elevation in serum LDH, and serum creatinine level 97.5% percentile at screening or required dialysis.
- Enrollment criteria excluded patients presenting with TMA due to a disintegrin and metalloproteinase with a thrombospondin type 1 motif, member 13 (ADAMTS13) deficiency, Shiga toxin Escherichia coli related hemolytic uremic syndrome (STEC-HUS) and genetic defect in cobalamin C metabolism.

### Study in Adult Patients with aHUS 
- Conducted in patients who were naive to complement inhibitor treatment prior to study entry.
- The study consisted of a 26-week Initial Evaluation Period and patients were allowed to enter an extension period for up to 4.5 years.
- A total of 56 patients with aHUS were evaluated for efficacy.
- Ninety-three percent of patients had extra-renal signs (cardiovascular, pulmonary, central nervous system, gastrointestinal, skin, skeletal muscle) or symptoms of aHUS at baseline.
- At baseline,71.4% (n = 40) of patients had Stage 5 chronic kidney disease (CKD). Fourteen percent had a medical history of kidney transplant and 51.8% were on dialysis at study entry. Eight patients entered the study with evidence of TMA for > 3 days after childbirth (ie, postpartum).
- Renal function, as measured by eGFR, was improved or maintained during ULTOMIRIS therapy.

### Study in Pediatric Patients with aHUS 
- A total of 14 eculizumab-naive patients with documented diagnosis of aHUS were enrolled and included in this interim analysis.
- Complete TMA Response was observed in 10 of the 14 patients (71%) during the 26-week Initial Evaluation Period.
- Four of the 5 patients who required dialysis at study entry were able to discontinue dialysis after the first month in study and for the duration of ULTOMIRIS treatment.

# How Supplied
- ULTOMIRIS (ravulizumab-cwvz) injection is a clear to translucent, slight whitish color preservative-free, solution supplied as one 300 mg/30 mL (10 mg/mL) single-dose vial per carton. NDC 25682-022-01.

## Storage
- Store ULTOMIRIS vials refrigerated at 2C - 8C (36F - 46F) in the original carton to protect from light. Do not freeze. Do not shake.

# Images

## Drug Images

## Package and Label Display Panel

# Patient Counseling Information
- Inform patients that they are required to receive meningococcal vaccination at least 2 weeks prior to receiving the first dose of ULTOMIRIS, if they have not previously been vaccinated.
- They are required to be revaccinated according to current medical guidelines for meningococcal vaccines use while on ULTOMIRIS therapy.
- Inform patients about the signs and symptoms of meningococcal infection/sepsis, and strongly advise patients to seek immediate medical attention if these signs or symptoms occur. These signs and symptoms are as follows:
headache with nausea or vomiting
headache and a fever
headache with a stiff neck or stiff back
fever
fever and a rash
confusion
muscle aches with flu-like symptoms
eyes sensitive to light
- headache with nausea or vomiting
- headache and a fever
- headache with a stiff neck or stiff back
- fever
- fever and a rash
- confusion
- muscle aches with flu-like symptoms
- eyes sensitive to light
- Inform patients that they will be given an ULTOMIRIS Patient Safety Card that they should carry with them at all times.

### Other Infections
- Counsel patients of the increased risk of infections, particularly those due to encapsulated bacteria, especially Neisseria species.
- Counsel patients about gonorrhea prevention and advise regular testing for patients at risk.

### Discontinuation
- Inform patients with PNH or aHUS that they may develop hemolysis or TMA, respectively, when ULTOMIRIS is discontinued and that they will be monitored by their healthcare professional for at least 16 weeks for PNH or at least 12 months for aHUS following ULTOMIRIS discontinuation.
- Inform patients who discontinue ULTOMIRIS to keep the ULTOMIRIS Patient Safety Card with them for eight months after the last ULTOMIRIS dose.

### Infusion reactions
- Advise patients that administration of ULTOMIRIS may result in infusion reactions.

# Precautions with Alcohol
Alcohol-Ravulizumab interaction has not been established. Talk to your doctor regarding the effects of taking alcohol with this medication.

# Brand Names
Ultomiris

# Look-Alike Drug Names
There is limited information regarding Ultomiris Look-Alike Drug Names in the drug label.

# Drug Shortage Status
Drug Shortage

# Price