Ravulizumab (Monograph)

Brand name: Ultomiris
Drug class: Complement Inhibitors

Medically reviewed by Drugs.com on Feb 10, 2024. Written by ASHP.

Introduction

Terminal complement inhibitor; humanized monoclonal antibody.

Uses for Ravulizumab

Paroxysmal Nocturnal Hemoglobinuria

Treatment of paroxysmal nocturnal hemoglobinuria (PNH) in adults and pediatric patients ≥1 month of age (designated an orphan drug by FDA for this use).

Options for PNH management include supportive care (e.g., iron supplementation, RBC transfusion, antibiotics for bacterial infection, anticoagulation, corticosteroids), allogeneic bone marrow transplantation, and/or terminal complement inhibitors (e.g., ravulizumab, eculizumab); choice of therapy depends on PNH classification and symptom severity.

Atypical Hemolytic Uremic Syndrome

Treatment of atypical hemolytic uremic syndrome (aHUS) in adults and pediatric patients ≥1 month of age to inhibit complement-mediated thrombotic microangiopathy (designated an orphan drug by FDA for this use).

Not indicated for treatment of patients with Shiga toxin E. coli-related hemolytic uremic syndrome.

Options for aHUS management include supportive care (e.g., packed RBCs for anemia, fluid and electrolytes, management of hypertension and renal impairment), plasma exchange or infusion, and complement inhibitors. Complement inhibitor therapy may provide an alternative option to plasma therapy.

Myasthenia Gravis

Treatment of generalized myasthenia gravis in adult patients who are anti-acetylcholine receptor (anti-AChR) antibody positive (designated an orphan drug by FDA for this use).

Conventional therapy includes immunosuppressive agents, plasma exchange, and, in some cases, thymectomy. Complement inhibitors (e.g., eculizumab, ravulizumab) may play a role in treatment of AChR-positive generalized myasthenia gravis by reducing deposition of complement and membrane attack complexes at the neuromuscular junction.

Ravulizumab Dosage and Administration

General

Pretreatment Screening

• Assess immunization status prior to initiating ravulizumab-cwvz therapy.

Patient Monitoring

• Closely monitor patients for early signs and symptoms of meningococcal infections during treatment with ravulizumab-cwvz, and evaluate immediately if infection is suspected.

• Monitor (or, for self-administered sub-Q injection, instruct patient to monitor) for signs and symptoms of reactions for ≥1 hour following completion of ravulizumab-cwvz sub-Q injection or IV infusion.

• Monitor closely for signs of worsening infection in patients with active systemic infection.

• Monitor for signs and symptoms of hemolysis and other reactions for ≥16 weeks in patients with PNH who discontinue ravulizumab-cwvz.

• Monitor for clinical symptoms and laboratory signs of thrombotic microangiopathy complications for ≥12 months in patients with aHUS who discontinue ravulizumab-cwvz.

Premedication and Prophylaxis

• Vaccinate or revaccinate patients for meningococcal disease according to current Advisory Committee on Immunization Practices (ACIP) guidelines for patients with complement deficiencies. Immunize patients without history of meningococcal vaccination ≥2 weeks prior to the first dose of ravulizumab-cwvz; if ravulizumab-cwvz must be started immediately and vaccines are administered <2 weeks prior to starting therapy, provide 2 weeks of antibacterial drug prophylaxis.

• Consider premedication in patients with known allergy to acrylic adhesive who require treatment with the sub-Q ravulizumab-cwvz on-body injector.

REMS

• Because of the risk of meningococcal infections, ravulizumab-cwvz can only be obtained through a restricted distribution program called the Ultomiris Risk Evaluation and Mitigation Strategy (Ultomiris REMS). The drug may be prescribed only by clinicians who are enrolled in the Ultomiris REMS program. In addition, clinicians must agree to counsel patients regarding the risk of meningococcal infection/sepsis, provide educational materials, and ensure that patients are compliant with meningococcal vaccine and antibacterial drug prophylaxis requirements. To obtain additional information or to enroll in the program, clinicians may call 888-765-4747 or visit [Web].

Administration

May be administered by IV infusion in adults and pediatric patients ≥1 month of age or by sub-Q injection in adults receiving maintenance therapy. Sub-Q ravulizumab-cwvz not indicated for use in adults with generalized myasthenia gravis, or in pediatric patients for any indication.

Available for IV use in single-dose vials containing ravulizumab-cwvz 100 mg/mL (3 and 11 mL vials) or ravulizumab-cwvz 10 mg/mL (30 mL vial). Must be diluted before IV administration.

Available for sub-Q use in prefilled, single-dose cartridges containing ravulizumab-cwvz 70 mg/mL (245 mg/3.5 mL); cartridges are only for use with supplied single-use on-body injector.

IV Administration

Single-dose vials intended for IV administration by healthcare professional after dilution. For use in adults or pediatric patients ≥1 month of age.

Do not use if particulate matter or precipitation observed.

Patients should contact a clinican immediately if a dose is missed. IV dosing schedule may occasionally vary within 7 days of the scheduled infusion day (except for the first maintenance dose of ravulizumab-cwvz), but subsequent doses should be administered according to the original schedule.

Dilution

Dilute ravulizumab-cwvz solution before IV infusion. Do not mix ravulizumab-cwvz 100 mg/mL (3 mL and 11 mL vials) and 10 mg/mL (30 mL vial) concentrations together.

Determine the number of vials to be diluted based on body weight and the prescribed dosage.

Withdraw the calculated volume from the appropriate number of vials and dilute to a final concentration of 50 mg/mL (for the 3 mL and 11 mL vial sizes) or 5 mg/mL (for the 30 mL vial size) in an infusion bag using 0.9% sodium chloride. Consult the full prescribing information for important instructions on the preparation of diluted solutions.

Mix the product gently; protect diluted solution from light and do not shake or freeze.

Rate of Administration

Prior to administration, allow admixture to adjust to room temperature (18–25ºC); do not heat in a microwave or with any heat source other than ambient air temperature.

Only administer as an IV infusion through a 0.2 or 0.22 micron filter.

Refer to full prescribing information for minimum infusion times and maximum infusion rates. If an adverse reaction occurs during IV administration, stop or slow the infusion.

Sub-Q Administration

On-body delivery system intended for sub-Q administration by patients or caregivers after proper training from a healthcare provider. For use in adults only.

On-body injector with prefilled cartridge not made with natural rubber latex.

Do not shake or drop, or allow on-body injector to become wet from water or other liquids.

To use, remove 2 cartons of the on-body delivery system from the refrigerator (2 on-body injectors and 2 prefilled cartridges are required for a full dose of 490 mg). Wait ≥45 minutes for on-body injectors and prefilled cartridges to naturally reach room temperature prior to administration. Do not return systems to the refrigerator. Discard after 3 days if unused.

Visually inspect solution prior to administration; do not inject if flakes or particles present, or if solution is cloudy or discolored.

Can administer the 2 on-body delivery systems sequentially or concurrently. To administer, load a clean cartridge into the first on-body injector, secure in place, then close the cartridge door. Do not insert the cartridge >5 minutes before administration to avoid drying out the solution. Then, remove the adhesive backing of the on-body injector and apply to clean, dry skin of the thigh, abdomen, or upper arm. Firmly press and release the blue start button to start the injection. Do not remove the on-body delivery system until the injection is complete (indicated by solid green status light, 3 beeping sounds, and white plunger filling the medicine window). Each injection is delivered over approximately 10 minutes.

​Rotate injection sites with each use. Do not inject into areas where the skin is tender, bruised, red, or hard, or areas with scars or stretch marks.

If allergic reaction occurs during sub-Q administration, stop treatment, remove the on-body injector(s), and seek medical attention prior to further administration.

Contact a clinician immediately following a missed or partial dose. Sub-Q dosing schedule allowed to occasionally vary by 1 day before or after the scheduled dose day, but the subsequent dose should be administered according to the original schedule.

Dosage

Pediatric Patients

PNH

IV

Dosage based on weight (see Table 1).

In patients not currently on ravulizumab-cwvz or eculizumab treatment, initiate IV ravulizumab-cwvz maintenance dosage 2 weeks after the loading dose.

In patients switching directly from eculizumab treatment to IV ravulizumab-cwvz, administer the IV ravulizumab-cwvz loading dose at the time of the next scheduled eculizumab dose, and initiate the ravulizumab-cwvz maintenance dosage 2 weeks after the loading dose.

aHUS

IV

Dosage based on weight (see Table 1).

In patients not currently on ravulizumab-cwvz or eculizumab treatment, initiate IV ravulizumab-cwvz maintenance dosage 2 weeks after the loading dose.

In patients switching directly from eculizumab treatment to IV ravulizumab-cwvz, administer the IV ravulizumab-cwvz loading dose at the time of the next scheduled eculizumab dose, and initiate the ravulizumab-cwvz maintenance dosage 2 weeks after the loading dose.

Adults

PNH

IV

Dosage based on weight (see Table 1).

In patients not currently on ravulizumab-cwvz or eculizumab treatment, initiate IV ravulizumab-cwvz maintenance dosage 2 weeks after the loading dose.

In patients switching directly from eculizumab treatment to IV ravulizumab-cwvz, administer the IV ravulizumab-cwvz loading dose at the time of the next scheduled eculizumab dose, and initiate the ravulizumab-cwvz maintenance dosage 2 weeks after the loading dose.

In patients currently being treated with sub-Q ravulizumab switching to IV ravulizumab-cwvz, initiate the IV ravulizumab-cwvz maintenance dosage 1 week after the last sub-Q maintenance dose; no loading dose required.

Sub-Q

For adults weighing ≥40 kg: 490 mg once weekly.

Use 2 on-body delivery systems to deliver each 490 mg dose.

In patients not currently on ravulizumab-cwvz or eculizumab treatment, a loading dose of IV ravulizumab-cwvz is required at the start of treatment (see Table 1 for recommended weight-based loading dose); initiate sub-Q ravulizumab-cwvz maintenance dosage 2 weeks after the IV loading dose.

In patients currently receiving eculizumab and switching to sub-Q ravulizumab-cwvz, administer a loading dose of IV ravulizumab-cwvz at the time of the next scheduled eculizumab dose (see Table 1 for recommended weight-based loading dose); initiate sub-Q ravulizumab-cwvz maintenance dosage 2 weeks after the IV loading dose.

In patients currently receiving IV ravulizumab-cwvz and switching to sub-Q ravulizumab-cwvz, no loading dose of IV ravulizumab-cwvz is necessary; initiate sub-Q ravulizumab-cwvz maintenance dosage 8 weeks after the last IV maintenance dose.

aHUS

IV

Dosage based on weight (see Table 1).

In patients not currently on ravulizumab-cwvz or eculizumab treatment, initiate IV ravulizumab-cwvz maintenance dosage 2 weeks after the loading dose.

In patients switching directly from eculizumab treatment to IV ravulizumab-cwvz, administer the IV ravulizumab-cwvz loading dose at the time of the next scheduled eculizumab dose, and initiate the ravulizumab-cwvz maintenance dosage 2 weeks after the loading dose.

In patients currently being treated with sub-Q ravulizumab switching to IV ravulizumab-cwvz, initiate the IV ravulizumab-cwvz maintenance dosage 1 week after the last sub-Q maintenance dose; no loading dose required.

Sub-Q

For adults weighing ≥40 kg: 490 mg once weekly.

Use 2 on-body delivery systems to deliver each 490 mg dose.

In patients not currently on ravulizumab-cwvz or eculizumab treatment, a loading dose of IV ravulizumab-cwvz is required at the start of treatment (see Table 1 for recommended weight-based loading dose); initiate sub-Q ravulizumab-cwvz maintenance dosage 2 weeks after the IV loading dose.

In patients currently receiving eculizumab and switching to sub-Q ravulizumab-cwvz, administer a loading dose of IV ravulizumab-cwvz at the time of the next scheduled eculizumab dose (see Table 1 for recommended weight-based loading dose); initiate sub-Q ravulizumab-cwvz maintenance dosage 2 weeks after the IV loading dose.

In patients currently receiving IV ravulizumab-cwvz and switching to sub-Q ravulizumab-cwvz, no loading dose of IV ravulizumab-cwvz is necessary; initiate sub-Q ravulizumab-cwvz maintenance dosage 8 weeks after the last IV maintenance dose.

Myasthenia Gravis

IV

For adults weighing ≥40 kg: dosage based on weight (see Table 2).

In patients not currently on ravulizumab-cwvz or eculizumab treatment, initiate IV ravulizumab-cwvz maintenance dosage 2 weeks after the loading dose.

In patients switching directly from eculizumab treatment to IV ravulizumab-cwvz, administer the IV ravulizumab-cwvz loading dose at the time of the next scheduled eculizumab dose, and initiate the ravulizumab-cwvz maintenance dosage 2 weeks after the loading dose.

Dosage Modification with Concomitant Use with Plasma Exchange, Plasmapheresis, or Intravenous Immunoglobulin (IVIG)

Administer supplemental dose of IV ravulizumab-cwvz within 4 hours following each plasma exchange or plasmapheresis intervention or within 4 hours following completion of an IVIG cycle. Refer to Table 3 for supplemental dosages.

Special Populations

Hepatic Impairment

No specific dosage recommendations.

Renal Impairment

No specific dosage recommendations.

Geriatric Patients

No specific dosage recommendations.

Cautions for Ravulizumab

Contraindications

• Unresolved Neisseria meningitidis infection.

• Lack of adequate vaccination against Neisseria meningitidis, unless the risks of delaying ravulizumab-cwvz therapy outweigh those of developing a meningococcal infection.

Warnings/Precautions

Warnings

Serious Meningococcal Infections

Risk of serious meningococcal infections. (See Boxed Warning.)

Vaccinate for meningococcal disease in accordance with current Advisory Committee on Immunization Practices (ACIP) recommendations for patients with complement deficiencies. Revaccinate patients according to ACIP recommendations with consideration of duration of ravulizumab-cwvz therapy. Immunize patients without a history of meningococcal vaccination ≥2 weeks prior to administering the first dose of ravulizumab-cwvz. In patients who initiate ravulizumab-cwvz therapy <2 weeks after receiving meningococcal vaccine(s), administer appropriate prophylactic antibiotics until 2 weeks after vaccination. Benefits and risks of antibiotic prophylaxis for prevention of meningococcal infections not established.

Monitor for early signs and symptoms of meningococcal infection. Evaluate promptly if infection suspected.

Consider ravulizumab discontinuation in patients undergoing treatment for serious meningococcal infection.

Due to risk of meningococcal infections, ravulizumab-cwvz is available only through a REMS program. (See REMS under Dosage and Administration.)

<C> Other Warnings and Precautions

Other Infections

Blocks terminal complement activation and may increase susceptibility to infections, especially those caused by encapsulated bacteria such as Neisseria meningitidis, Streptococcus pneumoniae, Haemophilus influenzae, and, to a lesser extent, Neisseria gonorrhoeae. Pediatric patients may be at increased risk for serious Streptococcus pneumoniaeand Haemophilus influenzae type b (Hib) infections.

Vaccinate patients for the prevention of Streptococcus pneumoniae and Hib infections in accordance with current ACIP guidelines.

If administered to patients with active systemic infections, monitor closely for signs and symptoms of worsening infection.

Monitoring Disease Manifestations After Treatment Discontinuation

Closely monitor patients with PNH for ≥16 weeks following ravulizumab discontinuation to detect hemolysis and other reactions. Signs and symptoms include elevated LDH along with sudden decrease in PNH clone size or hemoglobin, or reappearance of symptoms such as fatigue, hemoglobinuria, abdominal pain, dyspnea, major adverse vascular events (including thrombosis), dysphagia, or erectile dysfunction.

If signs and symptoms of hemolysis (including elevated LDH) occur after treatment discontinuation, consider restarting ravulizumab.

For treatment of aHUS, ravulizumab should be given for a minimum of 6 months; treatment duration beyond 6 months should be individualized.

Closely monitor patients with aHUS for ≥12 months following ravulizumab discontinuation for signs and symptoms of thrombotic microangiopathy complications. Thrombotic microangiopathy complications may be identified by clinical symptoms (e.g., changes in mental status, seizures, angina, dyspnea, thrombosis, or increasing BP) in addition to ≥2 of the following laboratory values observed concurrently (and confirmed by a second measurement 28 days later with no interruption): platelet count decreased ≥25% compared to baseline or to peak platelet count during treatment; serum creatinine increased ≥25% compared to baseline or to nadir during treatment; or LDH increased ≥25% compared to baseline or to nadir during treatment.

If thrombotic microangiopathy complications occur after discontinuation, consider restarting treatment with ravulizumab or using appropriate organ-specific supportive measures.

Thromboembolic Event Management

Ravulizumab should not alter anticoagulant management; effect of anticoagulant therapy withdrawal during ravulizumab therapy unknown.

Infusion-related Reactions

Systemic infusion-related reactions, including anaphylaxis and hypersensitivity reactions, reported.

Monitor (or, for self-administered sub-Q injection, instruct patient to monitor) for ≥1 hour following completion of IV infusion or sub-Q injection for signs or symptoms of an infusion-related reaction.

If signs of cardiovascular instability or respiratory compromise occur, interrupt the IV infusion and manage supportively.

If an allergic reaction occurs during sub-Q administration, stop treatment, remove the on-body injector(s), and instruct patient to seek medical attention prior to further administration.

Allergies to Acrylic Adhesives

Sub-Q on-body injector uses acrylic adhesive; allergic reactions may occur if used by patients with known allergy to acrylic adhesive.

Consider premedication and initiate supportive therapy if allergic reaction occurs.

Immunogenicity

Potential for immunogenicity.

Treatment-emergent anti-ravulizumab antibodies detected in patients with PNH and aHUS receiving IV ravulizumab-cwvz. No apparent correlation of antibody development to altered pharmacokinetic profile, clinical response, or adverse events observed.

No treatment-emergent anti-ravulizumab antibodies detected in patients with generalized myasthenia gravis.

No treatment-emergent anti-ravulizumab antibodies observed in patients receiving sub-Q ravulizumab-cwvz.

Specific Populations

Pregnancy

No data available in pregnant women to inform a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.

Untreated PNH and aHUS in pregnancy associated with adverse maternal and fetal outcomes.

Increased rates of developmental abnormalities and increased rate of dead and moribund offspring observed in animal reproduction studies.

Lactation

Unknown whether ravulizumab distributes into human milk, or affects milk production or the breast-fed infant.

Advise women to not breast-feed during treatment with ravulizumab and for 8 months after the last dose.

Pediatric Use

Safety and efficacy of IV ravulizumab-cwvz for PNH established in pediatric patients ≥1 month of age. Safety and efficacy appear similar in pediatric and adult patients.

Safety and efficacy of IV ravulizumab-cwvz for aHUS established in pediatric patients ≥1 month of age. Safety and efficacy appear similar in pediatric and adult patients.

Safety and efficacy for generalized myasthenia gravis in pediatric patients not established.

Sub-Q ravulizumab-cwvz not studied in pediatric patients and not approved for use in this population.

Geriatric Use

Ravulizumab-cwvz studies did not include sufficient numbers of geriatric patients (≥65 years of age) to determine whether they respond differently from younger patients.

No differences in responses between geriatric and younger patients identified in other reported clinical experience.

Hepatic Impairment

No clinically important differences in ravulizumab pharmacokinetics observed based on hepatic impairment.

Renal Impairment

No clinically important differences in ravulizumab pharmacokinetics observed based on any degree of renal impairment (including patients with proteinuria or receiving dialysis).

Common Adverse Effects

PNH

Adverse effects (≥10%) in patients with PNH include upper respiratory tract infection and headache. Injection site reactions and diarrhea occurred in patients (≥10%) receiving sub-Q ravulizumab-cwvz.

aHUS

Adverse effects (≥20%) in patients with aHUS include upper respiratory tract infection, diarrhea, nausea, vomiting, headache, hypertension, pyrexia, and (in adults) arthralgia.

Myasthenia Gravis

Adverse effects (≥10%) in patients with generalized myasthenia gravis include diarrhea and upper respiratory tract infection.

Drug Interactions

No drug-drug interaction studies performed with ravulizumab-cwvz.

Specific Drugs and Therapies

Ravulizumab Pharmacokinetics

Absorption

Bioavailability

Following IV administration, ravulizumab pharmacokinetics increase proportionally over dose range of 200–5400 mg.

Estimated bioavailability of sub-Q ravulizumab: approximately 79%.

Distribution

Extent

Unknown whether distributes into human milk.

Elimination

Half-life

IV: 49.6 days in adult and pediatric patients with PNH; 51.8 days in adult and pediatric patients with aHUS; 56.6 days in adult patients with generalized myasthenia gravis.

Sub-Q: 52.4 days in adult patients with PNH.

Special Populations

No clinically important differences in ravulizumab pharmacokinetics observed based on sex, age (10 months to 83 years), race, hepatic impairment, or degree of renal impairment (including patients with proteinuria or undergoing dialysis).

Body weight was a clinically important covariate on ravulizumab pharmacokinetics.

Stability

Storage

Parenteral

Injection for IV Use

Unopened vials: Store under refrigeration at 2–8ºC; do not freeze or shake. Store in original carton to protect from light.

Diluted solution: If not used immediately after preparation, store under refrigeration (2–8ºC) for no longer than 24 hours, taking into account the expected infusion time. Protect from light. Prior to administration, allow admixture to adjust to room temperature (18–25ºC); do not heat in microwave or with any heat source other than ambient air temperature. Once removed from refrigeration, administer diluted solution within 6 hours if prepared with 30 mL vials or within 4 hours if prepared with 3 mL or 11 mL vials.

Injection for Sub-Q Use

Store prefilled cartridges and on-body injectors under refrigeration at 2–8ºC; do not freeze. Store in original carton to protect from light and physical damage. Do not shake or drop. Do not allow on-body injector to become wet from water or other liquids.

If removed from refrigerator, store prefilled cartridges and on-body injectors in the original carton box at room temperature (20–25ºC) for up to 3 days. If stored at room temperature, discard after 3 days.

Actions

• Humanized monoclonal antibody and terminal complement inhibitor.

• Specifically binds to the complement protein C5 with high affinity, inhibiting its cleavage to C5a (the proinflammatory anaphylatoxin) and C5b (the initiating subunit of the membrane attack complex [C5b-9]); this prevents membrane attack complex formation.

• Inhibits terminal complement-mediated intravascular hemolysis in patients with PNH and complement-mediated thrombotic microangiopathy in patients with aHUS.

• Exact mechanism in patients with generalized myasthenia gravis not fully elucidated; presumed to involve reduction of terminal complement complex C5b-9 deposition at the neuromuscular junction.

Advice to Patients

• Advise patients to read the manufacturer's medication guide and instructions for use.

• Advise patients of the risk of meningococcal infection or sepsis with ravulizumab-cwvz. Inform patients that meningococcal vaccination is required ≥2 weeks prior to receiving the first dose of ravulizumab-cwvz if they have not previously been vaccinated, and that revaccination according to current medical guidelines is required during ravulizumab-cwvz therapy. Inform patients that vaccination may not prevent meningococcal infection. Inform patients about the signs and symptoms of meningococcal infection/sepsis (e.g., headache with nausea or vomiting, headache with fever, headache with a stiff neck or stiff back, fever with or without rash, confusion, muscle aches with flu-like symptoms, eyes sensitive to light). Strongly advise patients to seek immediate medical attention if these signs or symptoms occur.

• Inform patients that they will receive a Patient Safety Card about the risk of meningococcal infection. Instruct patients to carry their Patient Safety Card with them at all times during treatment with ravulizumab-cwvz and for 8 months following treatment discontinuation.

• Inform patients that ravulizumab-cwvz is available only through a restricted program called Ultomiris REMS, and that this program requires patients to receive counseling (including written educational materials) about the risk of serious meningococcal infections, as well as comply with the most current recommendations for meningococcal vaccination.

• Advise patients of the increased risk of other infections, particularly those due to encapsulated bacteria such as Neisseria species. Inform patients about gonorrhea prevention and advise regular testing for patients at risk. Advise patients to report any new signs and symptoms of infection.

• Inform patients with paroxysmal nocturnal hemoglobinuria that they may develop hemolysis when ravulizumab-cwvz is discontinued and that they will be monitored by their clinician for ≥16 weeks following treatment discontinuation.

• Inform patients with atypical hemolytic uremic syndrome that they may develop thrombotic microangiopathy when ravulizumab-cwvz is discontinued and that they will be monitored by their clinician for ≥12 months following treatment discontinuation.

• Advise patients that infusion-related reactions may occur with administration of ravulizumab-cwvz.

• Advise patients that the ravulizumab-cwvz single-use on-body injector used for sub-Q administration may cause allergic reactions in those who are sensitive to acrylic adhesives.

• Instruct patients and caregivers on proper sub-Q administration of the single-use on-body injector with prefilled cartridge. Inform patients that 2 on-body delivery systems (on-body injector with prefilled cartridge) are required for a full dose, and that it will take about 10 minutes to administer each on-body delivery system. Instruct patients to refer to the manufacturer’s full instructions on how to use the on-body delivery system.

• Advise patients to inform their clinician of existing or contemplated concomitant therapy, including prescription and OTC drugs and dietary or herbal supplements, as well as any concomitant illnesses.

• Advise women to inform their clinician if they are or plan to become pregnant or plan to breast-feed. Advise patients that breast-feeding is not recommended during treatment with ravulizumab-cwvz and for 8 months after the final dose.

• Inform patients of other important precautionary information.

Additional Information

The American Society of Health-System Pharmacists, Inc. represents that the information provided in the accompanying monograph was formulated with a reasonable standard of care, and in conformity with professional standards in the field. Readers are advised that decisions regarding use of drugs are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and that the information contained in the monograph is provided for informational purposes only. The manufacturer’s labeling should be consulted for more detailed information. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information contained in the monograph is not a substitute for medical care.

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

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