Nipocalimab

Nipocalimab is a prescription medication 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.

Nipocalimab is available under the following different brand names: Imaavy, nipocalimab-aahu.

Common side effects of Nipocalimab include:

• respiratory tract infection
• peripheral edema
• muscle spasms

Serious side effects of Nipocalimab include:

• increased risk of infection with symptoms such as fever, chills, shivering, cough, sore throat, fever blisters, or burning urination.
• symptoms of allergic reactions may include swelling of the face, lips, mouth, tongue, or throat, difficulty swallowing or breathing, itchy rash (hives), chest pain, or tightness
• infusion-related reactions may cause symptoms such as headache, rash, nausea, fatigue, dizziness, chills, flu-like symptoms, redness of skin

Rare side effects of Nipocalimab include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, coordination loss, unsteady, very stiff muscles, high fever, profuse sweating, or tremors.
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights.
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult and pediatric dosage

Injection, solution

• 185 mg/mL (300 mg/1.62 mL or 1,200 mg/6.5 mL single-dose vial)

Myasthenia Gravis

Adult and pediatric dosage

• Initial: 30 mg/kg IV once, then
• Maintenance: 15 mg/kg IV starting 2 weeks after the initial dose; continue maintenance dose every 2 weeks thereafter

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your doctor has directed you to use this medication, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

Drug interaction overview

Immunization

• Avoid live vaccines
• Evaluate the need to administer age-appropriate vaccines before initiating
• Because nipocalimab causes a transient reduction in IgG levels, vaccination with live vaccines is not recommended during treatment

Medications that bind FcRn

• Avoid
• Coadministration with medications that bind to FcRn (.eg, immunoglobulin products, monoclonal antibodies, or antibody derivatives containing human Fc domain of the IgG subclass) may lower systemic exposures and reduce effectiveness of such medications
• Closely monitor for reduced effectiveness of medications that bind to human neonatal Fc receptor
• If coadministration is essential, consider discontinuing Nipocalimab and using alternate therapies

Contraindications

• None

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Nipocalimab?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Nipocalimab?”

Cautions

Infections

• May increase the risk of infection
• Monitor for clinical signs and symptoms of infection
• If a serious infection occurs, administer appropriate treatment and consider withholding Nipocalimab until the infection resolves
• Latent viral infections
• May increase risk of activation of latent viral infections (eg, herpes zoster, Epstein-Barr virus)
• Follow standard vaccination guidelines as applicable

Hypersensitivity reactions

• Hypersensitivity reactions (e.g., angioedema, anaphylaxis, rash, urticaria, eczema) observed during clinical trials
• Reactions were mild or moderate and occurred within 1 hour to 2 weeks of administration
• Management depends on reaction type and severity
• Monitor for clinical signs and symptoms of hypersensitivity reactions during treatment and for 30 minutes after administration is complete
• If a hypersensitivity reaction occurs during administration, discontinue infusion and institute appropriate supportive measures if needed
• Contraindicated in patients with a history of serious hypersensitivity to Nipocalimab or any of its excipients

Infusion-related reactions

• Infusion-related reactions reported (eg, headache, influenza-like illness, rash, nausea, fatigue, dizziness, chills, erythema)
• Monitor during treatment and for 30 minutes after each infusion
• If a severe infusion-related reaction occurs, discontinue infusion and initiate appropriate therapy
• Consider the risks and benefits of resuming therapy following a severe infusion-related reaction
• If a mild-to-moderate infusion-related reaction occurs, patients may be rechallenged with close clinical observation, slower infusion rates, and premedication

Pregnancy and Lactation

• Data are limited regarding use during pregnancy to assess drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes
• Pregnancy safety study: If administered during pregnancy, or if a patient becomes pregnant during treatment, healthcare providers should report exposure by contacting Janssen at 1-800-526-7736 or www.IMAAVY.com

Clinical considerations

• Monoclonal antibody placental transport increases as pregnancy progresses, with the largest amount transferred during in third trimester
• Nipocalimab reduces maternal serum IgG concentration and impedes placental IgG transfer to the fetus
• Passive immunity in infants may be reduced for 6 months and more
• Considerations for the infant
  • Monitor for the development of serious infection
  • The effectiveness of vaccines may be reduced
  • Consider risks and benefits before administering live vaccines to infants exposed to in utero

Lactation

• Excreted in human colostrum and breastmilk
• Data are insufficient regarding the effect on breastfed infants
• There are no data regarding the effect of this drug on milk production