Nipocalimab-aahu (Monograph)

Brand name: Imaavy
Drug class: Neonatal Fc Receptor Blockers

Introduction

Nipocalimab-aahu, a human IgG1 monoclonal antibody, is a neonatal Fc receptor blocker.¹

Uses for Nipocalimab-aahu

Nipocalimab-aahu has the following uses:

Nipocalimab-aahu is indicated for the treatment of generalized myasthenia gravis (gMG) in adult and pediatric patients 12 years of age and older who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive.¹

Nipocalimab-aahu Dosage and Administration

General

Nipocalimab-aahu is available in the following dosage form(s) and strength(s):

• Injection: 300 mg/1.62 mL (185 mg/mL) in a single-dose vial¹

• Injection: 1200 mg/6.5 mL (185 mg/mL) in a single-dose vial¹

Dosage

It is essential that the manufacturer's labeling be consulted for more detailed information on dosage and administration of this drug. Dosage summary:

Adults and Pediatric Patients ≥ 12 Years of Age

• Evaluate the need to administer age-appropriate vaccines according to immunization guidelines before initiation of nipocalimab-aahu.¹

• Administer via IV infusion only; must dilute commercially available injection concentrate with 0.9% sodium chloride injection prior to administration.¹

• Administer as an IV infusion via a 0.2 micron in-line or add-on filter.¹

• The recommended initial dosage is 30 mg/kg once via IV infusion over at least 30 minutes.¹ Two weeks after the initial dosage, administer a maintenance dosage of 15 mg/kg via IV infusion over at least 15 minutes, and continue every 2 weeks thereafter.¹

• If an adverse reaction occurs during administration of nipocalimab-aahu, the infusion may be slowed or stopped at the discretion of the healthcare professional.¹

• Monitor the patient for 30 minutes after each infusion for signs or symptoms of an infusion-related or hypersensitivity reaction.¹

• See Full Prescribing Information for additional instructions on dosage, preparation, and administration. ¹

Cautions for Nipocalimab-aahu

Contraindications

Nipocalimab-aahu is contraindicated in patients with a history of serious hypersensitivity reaction to nipocalimab or to any of the excipients in the formulation.¹

Warnings/Precautions

Infections

Nipocalimab-aahu may increase the risk of infection.¹ In the principal efficacy study, 42 (43%) out of 98 patients treated with nipocalimab-aahu reported 71 events of infection.¹ Across the double-blind treatment period and the open-label extension, out of 186 patients treated with nipocalimab-aahu, 132 (71%) patients reported 360 events of infection.¹ Serious infections were reported in 7% of patients treated with nipocalimab-aahu.¹ Delay nipocalimab-aahu administration in patients with an active infection until the infection is resolved.¹ Monitor for clinical signs and symptoms of infection during treatment.¹ If a serious infection occurs, administer appropriate treatment and consider withholding nipocalimab-aahu until the infection has resolved. ¹

Latent Viral Infections

Patients treated with nipocalimab-aahu may be at an increased risk of activation of latent viral infections, such as herpes zoster.¹ In the extension period of the principal efficacy study, there were 2 patients with serious adverse reactions related to Epstein-Barr virus (EBV) infection, and 1 of these patients had fatal complications.¹ Patients who screened positive for hepatitis were excluded from the study.¹ Follow standard vaccination guidelines. ¹

Immunization

The safety of immunization with live vaccines and the immune response to vaccination during treatment with nipocalimab-aahu are unknown.¹ Because nipocalimab-aahu causes a reduction in IgG levels, vaccination with live vaccines is not recommended during treatment with the drug.¹

Evaluate the need to administer age-appropriate vaccines according to immunization guidelines before initiation of treatment with nipocalimab-aahu.¹

Hypersensitivity Reactions

In clinical trials, hypersensitivity reactions, including angioedema, anaphylaxis, rash, urticaria, and eczema were observed in patients treated with nipocalimab-aahu.¹ In the principal efficacy study, hypersensitivity reactions were mild or moderate and occurred within 1 hour to 2 weeks of administration.¹ One patient experienced a hypersensitivity reaction (urticaria) that led to treatment discontinuation. ¹

Management of hypersensitivity reactions depends on the type and severity of the reaction.¹ Monitor the patient during treatment with nipocalimab-aahu and for 30 minutes after administration is complete for clinical signs and symptoms of hypersensitivity reactions.¹ If a hypersensitivity reaction occurs during administration, discontinue nipocalimab-aahu infusion and institute appropriate supportive measures if needed.¹ Nipocalimab-aahu is contraindicated in patients with a history of serious hypersensitivity to nipocalimab or any of the excipients in the formulation.¹

Infusion-related Reactions

In clinical trials, infusion-related reactions, including headache, influenza-like illness, rash, nausea, fatigue, dizziness, chills, and erythema were observed in patients treated with nipocalimab-aahu.¹ In the principal efficacy study, infusion-related reactions were mild to moderate in severity and occurred within 1 hour to 2 days of administration.¹

Monitor patients during treatment with nipocalimab-aahu and for 30 minutes after each infusion.¹ If a severe infusion-related reaction occurs, discontinue the infusion and initiate appropriate therapy.¹ Consider the risks and benefits of readministering nipocalimab-aahu following a severe infusion-related reaction.¹ If a mild to moderate infusion related reaction occurs, patients may be rechallenged with close clinical observation, slower infusion rates, and premedication. ¹

Specific Populations

Pregnancy

There are limited data on the use of nipocalimab-aahu in pregnant women to inform a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.¹

There was no evidence of direct adverse effects on fetal development following administration of nipocalimab-aahu to pregnant monkeys; however, adverse effects on the placenta were associated with fetal loss at both doses tested. ¹

The background risk of major birth defects and miscarriage for the indicated population is unknown.¹ All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.¹ In the U.S. general population, the estimated background rate of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.¹

There is a pregnancy safety study for nipocalimab-aahu.¹ If nipocalimab-aahu is administered during pregnancy, or if a patient becomes pregnant while receiving nipocalimab-aahu, healthcare providers should report nipocalimab-aahu exposure by contacting Janssen at 1-800-526-7736.¹

Monoclonal antibodies are increasingly transported across the placenta as pregnancy progresses, with the largest amount transferred during the third trimester.¹ Because nipocalimab-aahu reduces maternal serum IgG concentration and impedes placental IgG transfer to the fetus, passive immunity in the infant may be reduced for 6 months or more.¹ The effectiveness of vaccines may be reduced.¹ Consider the risks and benefits prior to administering live vaccines to infants exposed to nipocalimab-aahu in utero. ¹

Lactation

Nipocalimab-aahu is excreted in human colostrum and breastmilk based on limited data from an investigational study of 13 pregnant women administered the drug during pregnancy where colostrum and breastmilk was assessed in the first 8 days after birth.¹ There are insufficient data on the effect of nipocalimab-aahu in the breastfed infant.¹ There are no data on the effect of nipocalimab on milk production.¹ The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for nipocalimab-aahu, and any potential adverse effects on the breastfed infant from the drug or from the underlying maternal condition.¹

Pediatric Use

The safety and effectiveness of nipocalimab-aahu for the treatment of generalized myasthenia gravis (gMG) have been established in pediatric patients 12 years of age and older.¹ Use of nipocalimab-aahu in pediatric patients for this indication is supported by evidence from an adequate and well-controlled trial in adults with additional pharmacokinetic and safety data in pediatric patients 12 years of age and older. ¹

Safety and effectiveness of nipocalimab-aahu for the treatment of gMG in pediatric patients below the age of 12 years have not been established.¹

Geriatric Use

Clinical studies of nipocalimab-aahu did not include sufficient numbers of patients 65 years of age and over to determine whether they respond differently from younger adult patients.¹

Common Adverse Effects

The most common adverse reactions (≥10%) in patients with gMG treated with nipocalimab-aahu were respiratory tract infections, peripheral edema, and muscle spasms.¹

Drug Interactions

Specific Drugs

It is essential that the manufacturer's labeling be consulted for more detailed information on interactions with this drug, including possible dosage adjustments. Interaction highlights:

Closely monitor for reduced effectiveness of medications that bind to the human neonatal Fc receptor.¹ When concomitant long-term use of such medications is essential for patient care, consider discontinuing nipocalimab-aahu and using alternative therapies.¹

Actions

Mechanism of Action

Nipocalimab-aahu is a human IgG1 monoclonal antibody that binds to neonatal Fc receptor (FcRn), resulting in the reduction of circulating IgG levels.¹

Advice to Patients

• Advise the patient and/or caregiver to read the FDA-approved patient labeling (Patient Information).¹

• Instruct patients to communicate any history of infections to the healthcare provider and to contact their healthcare provider if they develop any symptoms of an infection. ¹

• Advise patients to complete all age-appropriate vaccines according to immunization guidelines prior to initiation of treatment with nipocalimab-aahu.¹ Administration of live vaccines is not recommended during treatment with the drug.¹ Instruct patients to inform the healthcare provider that they are being treated with nipocalimab-aahu prior to a potential vaccination. ¹

• Inform patients that hypersensitivity reactions, including anaphylaxis, angioedema, rash, urticaria, and eczema have occurred in patients treated with nipocalimab-aahu.¹ Inform patients about the signs and symptoms of hypersensitivity reactions.¹ Advise patients to contact their healthcare provider immediately if these occur. ¹

• Advise patients that administration of nipocalimab-aahu may result in infusion-related reactions.¹

• Advise patients that there is a pregnancy safety study that monitors pregnancy outcomes in women exposed to nipocalimab-aahu during pregnancy, and they can be enrolled by calling 1-800-526-7736. ¹

Additional Information

AHFSfirstRelease^™. For additional information until a more detailed monograph is developed and published, the manufacturer's labeling should be consulted. It is essential that the manufacturer's labeling be consulted for more detailed information on usual uses, dosage and administration, cautions, precautions, contraindications, potential drug interactions, laboratory test interferences, and acute toxicity.

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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