Nipocalimab-aahu

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Nipocalimab-aahu
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Anum Ijaz M.B.B.S., M.D.[2]

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Overview

Nipocalimab-aahu is a neonatal Fc receptor blocker that is FDA approved 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.. Common adverse reactions include respiratory tract infections, peripheral edema, and muscle spasms ( in patients with gMG treated with IMAAVY >10%)..

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

FDA-labeled Indications

IMAAVY 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.

Evaluate the need to administer age-appropriate vaccines according to immunization guidelines before initiation of IMAAVY. Because IMAAVY causes transient reduction in IgG levels, vaccination with live vaccines is not recommended during treatment with IMAAVY.

  • Dilute IMAAVY prior to administration. Administer via intravenous infusion only.
  • The recommended initial dosage of IMAAVY is 30 mg/kg administered once via intravenous infusion over at least 30 minutes.
  • Two weeks after the initial dosage administer a maintenance dosage of 15 mg/kg via intravenous infusion over at least 15 minutes. Continue the maintenance dosage every two weeks thereafter.
  • If a scheduled infusion appointment is missed, the maintenance dosage of IMAAVY should be administered as soon as possible. Resume dosing every two weeks thereafter.

Dosage Forms and Strengths

Injection: colorless to slightly brownish, clear to slightly opalescent solution available as:

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

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Nipocalimab-aahu in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Nipocalimab-aahu in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

FDA-labeled Indications

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

Evaluate the need to administer age-appropriate vaccines according to immunization guidelines before initiation of IMAAVY. Because IMAAVY causes transient reduction in IgG levels, vaccination with live vaccines is not recommended during treatment with IMAAVY.

  • Dilute IMAAVY prior to administration. Administer via intravenous infusion only.
  • The recommended initial dosage of IMAAVY is 30 mg/kg administered once via intravenous infusion over at least 30 minutes.
  • Two weeks after the initial dosage administer a maintenance dosage of 15 mg/kg via intravenous infusion over at least 15 minutes. Continue the maintenance dosage every two weeks thereafter.
  • If a scheduled infusion appointment is missed, the maintenance dosage of IMAAVY should be administered as soon as possible. Resume dosing every two weeks thereafter.

Dosage Forms and Strengths

Injection: colorless to slightly brownish, clear to slightly opalescent solution available as:

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

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Nipocalimab-aahu in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Nipocalimab-aahu in pediatric patients.

Contraindications

IMAAVY is contraindicated in patients with a history of serious hypersensitivity reaction to nipocalimab or any of the excipients in IMAAVY. Reactions have included anaphylaxis and angioedema.

Warnings

Infections

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

Latent Viral Infections

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

Immunization

  • The safety of immunization with live vaccines and the immune response to vaccination during treatment with IMAAVY are unknown.
  • Because IMAAVY causes a reduction in IgG levels, vaccination with live vaccines is not recommended during treatment with IMAAVY.
  • Evaluate the need to administer age-appropriate vaccines according to immunization guidelines before initiation of treatment with IMAAVY.

Hypersensitivity Reactions

  • In clinical trials, hypersensitivity reactions, including angioedema, anaphylaxis, rash, urticaria, and eczema were observed in patients treated with IMAAVY.
  • In Study 1, hypersensitivity reactions were mild or moderate, occurred within one hour to 2 weeks of administration. One patient experienced a hypersensitivity reaction (urticaria) that led to treatment discontinuation.
  • Management of hypersensitivity reactions depends on the type and severity of the reaction. Monitor the patient during treatment with IMAAVY and for 30 minutes after the administration is complete for clinical signs and symptoms of hypersensitivity reactions.
  • If a hypersensitivity reaction occurs during administration, discontinue IMAAVY infusion and institute appropriate supportive measures if needed.
  • IMAAVY is contraindicated in patients with a history of serious hypersensitivity to nipocalimab or any of the excipients of IMAAVY.

In clinical trials, infusion-related reactions, including headache, influenza-like illness, rash, nausea, fatigue, dizziness, chills, and erythema were observed in patients treated with IMAAVY. In Study 1, infusion-related reactions were mild to moderate in severity and occurred within one hour to 2 days of administration [see Adverse Reactions (6.1)] .

Monitor patients during treatment with IMAAVY and for 30 minutes after each infusion [see Dosage and Administration (2.3)] . If a severe infusion-related reaction occurs, discontinue IMAAVY infusion and initiate appropriate therapy. Consider the risks and benefits of readministering IMAAVY 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 pre-medication.

Adverse Reactions

Clinical Trials Experience

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Adults

  • In Study 1 and its extension study the safety of IMAAVY was evaluated in 186 patients with gMG who received at least one dose of IMAAVY.
  • Of those patients, 168 patients were exposed to IMAAVY every 2 weeks for at least 6 months, and 140 patients were exposed for at least 12 months.
  • In Study 1, 98 adult patients with gMG received IMAAVY 15 mg/kg every two weeks (after 30 mg/kg initial dose). Of these 98 patients, approximately 67% were female, 67% were White, 29% were Asian, and 10% were of Hispanic or Latino ethnicity. The mean age at study entry was 53 years (range 20 to 81).
  • The most common adverse reactions (reported in at least 10% of patients treated with IMAAVY) were respiratory tract infection, peripheral edema, and muscle spasms.

Infections

  • In Study 1 and its extension study, infections that occurred in patients treated with IMAAVY (n=186) included upper respiratory tract infection (46%), respiratory tract infection (28%; including pneumonia, bronchitis, COVID-19), urinary tract infection (15%), herpes (8%; including herpes simplex, herpes zoster, herpes zoster oticus), influenza (8%), oral infection (8%; including candidiasis and dental infections), and skin infection (7%; including cellulitis).
  • Two (1%) cases of infections (cellulitis and urinary tract infection) led to discontinuation of IMAAVY.

Hypersensitivity Reactions

  • In Study 1 and its extension study, out of 186 patients treated with IMAAVY, 30 (16%) patients experienced hypersensitivity reactions, which occurred within one hour to two weeks of administration.
  • One patient experienced hypersensitivity reaction (urticaria) that required discontinuation of IMAAVY.

Infusion-Related Reactions

  • In Study 1 and its extension study, out of 186 patients treated with IMAAVY, 20 (11%) patients experienced infusion-related reactions, which occurred within one hour to 2 days of administration.
  • No patients experienced infusion-related reaction that required discontinuation of IMAAVY.

Laboratory Findings

Lipids

  • In Study 1 (N=98), patients treated with IMAAVY had elevations from normal to high of fasting total cholesterol ( ≥240 mg/dL) and LDL cholesterol ( ≥160 mg/dL) (24% and 11% of patients, respectively).
  • In Study 1, these changes from baseline peaked at Week 4, then decreased and plateaued by Week 24 to mean increases of 14 mg/dL and 7 mg/dL, respectively.
  • Five percent of patients treated with IMAAVY had decreases from normal to low (<40 mg/dL of fasting HDL cholesterol).

Pediatric Patients 12 Years of Age and Older In a 24-week, single arm study evaluating the safety of IMAAVY in 7 pediatric patients age 12 to 16 years with gMG who were AChR positive, adverse reactions were consistent with those observed in adult patients with gMG

Postmarketing Experience

There is limited information regarding Nipocalimab-aahu Postmarketing Experience in the drug label.

Drug Interactions

Effect of IMAAVY on Other Drugs

  • Concomitant use of IMAAVY with medications that bind to the human neonatal Fc receptor (FcRn) (e.g., immunoglobulin products, monoclonal antibodies, or antibody derivates containing the 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 the human neonatal Fc receptor. When concomitant long-term use of such medications is essential for patient care, consider discontinuing IMAAVY, and using alternative therapies.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): Risk Summary

  • There are limited data on the use of IMAAVY in pregnant women to inform a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.
  • 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 (see Data).
  • The 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 rate of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
  • There is a pregnancy safety study for IMAAVY. If IMAAVY is administered during pregnancy, or if a patient becomes pregnant while receiving IMAAVY, healthcare providers should report IMAAVY exposure by contacting Janssen at 1-800-526-7736 or www.IMAAVY.com

Clinical Considerations

Fetal/Neonatal Adverse Reactions

  • Monoclonal antibodies are increasingly transported across the placenta as pregnancy progresses, with the largest amount transferred during the third trimester.
  • Because IMAAVY 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; therefore:
Monitor for the development of serious infection.
Effectiveness of vaccines may be reduced.
Consider the risks and benefits prior to administering live vaccines to infants  exposed to IMAAVY in utero.

Animal Data

  • Intravenous administration of nipocalimab-aahu (0, 100, or 300 mg/kg) to pregnant monkeys weekly from the end of organogenesis (gestation day 45) through parturition resulted in placental ischemia, associated with fetal loss and decreased levels of IgG in the offspring at both doses tested.
  • IgG levels in offspring returned to normal levels and no adverse effects on immune function were evident by 6 months after birth.
  • The doses tested are 6 and 20 times the recommended human maintenance dose (15 mg/kg) on a mg/kg basis.


Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Nipocalimab-aahu in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Nipocalimab-aahu during labor and delivery.

Nursing Mothers

Risk Summary

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

Pediatric Use

The safety and effectiveness of IMAAVY for the treatment of gMG have been established in pediatric patients 12 years of age and older.

  • Use of IMAAVY 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 who are 12 years of age and older.
  • Safety and effectiveness of IMAAVY for the treatment of gMG in pediatric patients below the age of 12 years have not been established.

Geriatic Use

  • Clinical studies of IMAAVY did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger adult patients.

Gender

There is no FDA guidance on the use of Nipocalimab-aahu with respect to specific gender populations.

Race

There is no FDA guidance on the use of Nipocalimab-aahu with respect to specific racial populations.

Renal Impairment

  • No dedicated pharmacokinetic study has been conducted in patients with renal impairment.
  • Renal impairment is not expected to affect the pharmacokinetics of nipocalimab.
  • Based on a population pharmacokinetic analysis, which included healthy volunteers and patients with gMG with mild to moderate renal impairment, renal function (estimated glomerular filtration rate [eGFR] 30–89 mL/min/1.73 m 2) had no clinically significant effect on nipocalimab-aahu clearance.
  • No dose adjustment is required in patients with renal impairment.

Hepatic Impairment

  • No dedicated pharmacokinetic study has been performed in patients with hepatic impairment.
  • Nipocalimab is not metabolized by cytochrome P450 enzymes, and hepatic impairment is not expected to affect the pharmacokinetics of nipocalimab.
  • Based on a population pharmacokinetic analysis, which included healthy volunteers and patients with gMG with mild to moderate hepatic impairment, there was no clinically significant effect on nipocalimab-aahu clearance.
  • No dose adjustment is required in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Nipocalimab-aahu in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Nipocalimab-aahu in patients who are immunocompromised.

Administration and Monitoring

Administration

Prior to administration, dilute IMAAVY single-dose vials with only 0.9% sodium chloride injection using the instructions below. For patients who weigh 40 kg or more, the total volume to be administered is 250 mL; for patients who are 12 years or older and weigh less than 40 kg, the total volume to be administered is 100 mL.

Preparation

Prepare the solution for infusion using aseptic technique as follows:

  • Calculate the dosage (mg), total drug volume (mL) of IMAAVY solution required, and the number of IMAAVY vials needed, based on the patient's current weight.
  • Each single-dose vial of IMAAVY is at a concentration of 185 mg/mL.
  • Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
  • Check that the solution in each vial is colorless to slightly brownish, clear to slightly opalescent, and free of visible particles. Do not use if visible particles are present or if the solution is discolored (other than colorless to slightly brownish).
  • Gently withdraw the calculated volume of IMAAVY from the vial(s). Discard any unused portion of the vials.
  • Dilute total volume withdrawn of IMAAVY by adding to an infusion container containing 0.9% sodium chloride injection to a final volume of:
   250 mL for patients who weigh 40 kg or more, or
   100 mL for patients who weigh less than 40 kg.
  • Only use infusion containers made of polyolefin, polypropylene, or polyvinylchloride.
  • Gently invert the infusion container at least 10 times to mix the solution. Do not shake.
  • Verify that a uniform solution has been achieved by visual inspection. Do not use if particulate matter or discoloration is present.

Administration

  • If the diluted solution is refrigerated prior to administration, allow to warm to room temperature. Do not use external heat sources to warm IMAAVY.
  • Administer the diluted solution by intravenous infusion only using an infusion set with an in-line or add-on, sterile, non-pyrogenic, low protein-binding filter made of polyethersulfone or polysulfone (pore size 0.2 micrometer or less).
  • Administration sets must be made of either polybutadiene, polyethylene, polyurethane, polypropylene, or polyvinylchloride.
  • Do not infuse IMAAVY concomitantly in the same intravenous line with other agents.
  • Administer IMAAVY infusion intravenously over at least 30 minutes for the initial dose (30 mg/kg) and at least 15 minutes for subsequent doses (15 mg/kg).
  • If an adverse reaction occurs during administration of IMAAVY, the infusion may be slowed or stopped at the discretion of the healthcare professional.
  • Monitor the patient for 30 minutes after each infusion for signs or symptoms of an infusion-related or hypersensitivity reaction.

Monitoring

During treatment with IMAAVY, monitor for clinical signs and symptoms of infection. If serious infection occurs, administer appropriate treatment and consider withholding IMAAVY until the infection has resolved.

IV Compatibility

There is limited information regarding the compatibility of Nipocalimab-aahu and IV administrations.

Overdosage

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

Pharmacology

There is limited information regarding Nipocalimab-aahu Pharmacology in the drug label.

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.

Structure

Nipocalimab-aahu, a neonatal Fc receptor blocker, is a recombinant human immunoglobulin G1 lambda (IgG1λ) monoclonal antibody, expressed in a genetically engineered Chinese hamster ovary cell line. Nipocalimab-aahu has an aglycosylated Fc region, therefore it lacks effector functions. Nipocalimab-aahu has an approximate molecular weight of 142 kilodaltons (kDa).

Pharmacodynamics

  • In Clinical Trial (Study 1), the pharmacological effect of nipocalimab-aahu was assessed by measuring the decrease in serum IgG levels and anti-AChR and anti-MuSK autoantibody levels.
  • In patients positive for AChR and MuSK autoantibodies who were treated with IMAAVY, there was a reduction in AChR and MuSK autoantibodies relative to baseline. Decreases in total IgG levels followed a similar pattern.
  • A similar reduction in AChR autoantibodies was observed in adolescent patients with gMG compared to adults.

Pharmacokinetics

  • Nipocalimab exhibits nonlinear pharmacokinetics. Following a single intravenous infusion of IMAAVY at doses ranging from 0.3 to 60 mg/kg (4 times the recommended maintenance dosage) in healthy participants, C max of nipocalimab-aahu increased in a dose-proportional manner while AUC increased in a greater than dose-proportional manner.
  • Distribution

Mean volume of distribution of nipocalimab is 2.67 L.

  • Metabolism

Nipocalimab is expected to be degraded by proteolytic enzymes into small peptides and amino acids.

  • Elimination

Nipocalimab exhibits concentration-dependent pharmacokinetics. After a single intravenous administration of 15 mg/kg nipocalimab-aahu, the mean clearance is 0.0627 L/h and half-life is 29.3 hours.

  • Specific Populations

Age, Sex, and Race

The pharmacokinetics of nipocalimab were not affected by age, sex, or race based on a population pharmacokinetics analysis.

Pediatric Patients

Following the recommended intravenous doses of IMAAVY in adolescent patients 12 to 16 years of age with gMG (N=7), the observed steady-state serum nipocalimab-aahu concentrations were within the range of those observed for adult patients with gMG.

Patients with Renal Impairment

No dedicated pharmacokinetic study has been conducted in patients with renal impairment. Renal impairment is not expected to affect the pharmacokinetics of nipocalimab. Based on a population pharmacokinetic analysis, which included healthy volunteers and patients with gMG with mild to moderate renal impairment, renal function (estimated glomerular filtration rate [eGFR] 30–89 mL/min/1.73 m 2) had no clinically significant effect on nipocalimab-aahu clearance. No dose adjustment is required in patients with renal impairment.

Patients with Hepatic Impairment No dedicated pharmacokinetic study has been performed in patients with hepatic impairment. Nipocalimab is not metabolized by cytochrome P450 enzymes, and hepatic impairment is not expected to affect the pharmacokinetics of nipocalimab. Based on a population pharmacokinetic analysis, which included healthy volunteers and patients with gMG with mild to moderate hepatic impairment, there was no clinically significant effect on nipocalimab-aahu clearance. No dose adjustment is required in patients with hepatic impairment.

Immunogenecitiy

  • The observed incidence of anti-drug antibodies is highly dependent on the sensitivity and specificity of the assay.
  • Differences in assay methods preclude meaningful comparisons of the incidence of anti-drug antibodies in the studies described below with the incidence of anti-drug antibodies in other studies, including those of nipocalimab-aahu or of other nipocalimab products.
  • In clinical trials, antibodies to nipocalimab-aahu were detected in 49/102 (48%) adult and pediatric patients 12 years of age and older during 24-week treatment period.
  • Out of the 49 patients who were positive for antibodies to nipocalimab-aahu, 19 (38.8%) patients had neutralizing antibodies to nipocalimab-aahu.
  • There was no identified clinically relevant effect of antibodies, including neutralizing antibodies, to nipocalimab-aahu on the pharmacokinetics, pharmacodynamics, safety, or effectiveness of IMAAVY.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis

  • Studies to assess the carcinogenic potential of nipocalimab-aahu have not been conducted.

Mutagenesis

  • Studies to assess the genotoxic potential of nipocalimab-aahu have not been conducted. As an antibody, nipocalimab-aahu is not expected to interact directly with DNA.

Impairment of Fertility

  • Once or twice weekly intravenous administration of nipocalimab-aahu (0, 20, 50, 100, or 300 mg/kg) to male and female monkeys for 26 weeks resulted in no adverse effects on reproductive organs upon histopathological examination.
  • The highest dose tested was 20 times the recommended human maintenance dose (15 mg/kg) on a mg/kg basis.

Clinical Studies

Clinical Studies

  • The efficacy of IMAAVY for the treatment of gMG in adults who are anti-AChR or anti-MuSK antibody positive was established in a 24-week, multicenter, randomized, double-blind, placebo-controlled study (Study 1; NCT04951622).
  • Study 1 enrolled patients with gMG who met the following criteria:

Myasthenia Gravis Foundation of America (MGFA) Clinical Classification Class II to IV Myasthenia Gravis-Activities of Daily Living (MG-ADL) total score of at least 6 On stable dose of standard of care MG therapy prior to baseline that included acetylcholinesterase (AChE) inhibitors, steroids or non-steroidal immunosuppressive therapies (NSISTs), either in combination or alone.

  • In Study 1, a total of 196 patients were randomized 1:1 to receive IMAAVY (n=98) or placebo (n=98).
  • Baseline characteristics were similar between treatment groups. For the primary efficacy analysis population (n=153), patients had a median age of 52 years at screening (range 20 to 81 years) and a median time since diagnosis of 6 years.
  • Sixty percent of patients were female; 63% were White; 32% were Asian; 1% were Black or African-American; and <1% were American Indian or Alaskan Native. At baseline, median MG-ADL total score was 9, and median Quantitative Myasthenia Gravis (QMG) total score was 15. Eighty-eight percent (n=134) of patients were positive for AChR antibodies and 10% (n=16) were positive for MuSK antibodies.
  • At baseline, in each group, 85% of patients received AChE inhibitors, 66% of patients received steroids, and 54% of patients received NSISTs at stable doses.
  • The efficacy of IMAAVY was measured using the MG-ADL scale, which assesses the impact of gMG on daily functions of 8 signs and symptoms that are typically affected in gMG.
  • Each item is assessed on a 4-point scale, where a score of 0 represents normal function and a score of 3 represents loss of ability to perform that function. A total score ranges from 0 to 24, with the higher scores indicating more impairment.
  • The primary efficacy endpoint was the comparison of the mean change from baseline to Weeks 22, 23, and 24 between treatment groups in the MG-ADL total score.
  • The efficacy of IMAAVY was also measured using the QMG total score, which is a 13-item categorial grading system that assesses muscle weakness.
  • Each item is assessed on a 4 -point scale, where a score of 0 represents no weakness, and a score of 3 represents severe weakness. A total possible score ranges from 0 to 39, where higher scores indicate more severe impairment.
  • The secondary endpoint was the comparison of the mean change from baseline to Weeks 22 and 24 between treatment groups in the QMG total score.

How Supplied

  • IMAAVY™ (nipocalimab-aahu) injection is a sterile, preservative-free, colorless to slightly brownish, clear to slightly opalescent solution for intravenous use after dilution.
  • IMAAVY is supplied in cartons containing a single-dose vial per carton as:
      300 mg/1.62 mL (185 mg/mL)
      1,200 mg/6.5 mL (185 mg/mL)

Storage and Handling

Unopened Vials

Store vials refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light until the time of use. Do not freeze. Do not shake.

Diluted Solution

For storage of the diluted IMAAVY solution.

Storage

  • Administer the diluted IMAAVY solution immediately after preparation.
  • If the diluted IMAAVY solution is not used immediately:
  • Protect from light.
  • Store refrigerated at 2°C to 8°C (36°F to 46°F) for no more than 24 hours.
  • Do not freeze.
  • After preparation or removal from the refrigerator, use or discard the IMAAVY diluted solution within 12 hours, including infusion time.
  • During these 12 hours, store under ambient light at 15°C to 30°C (59°F to 86°F).

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

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

  • Infections

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.

  • Administration of Vaccines

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

  • Hypersensitivity Reactions

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

  • Infusion-Related Reactions

Advise patients that administration of IMAAVY may result in infusion-related reactions.

  • Pregnancy

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

Precautions with Alcohol

Alcohol-Nipocalimab-aahu interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

IMAAVY

Look-Alike Drug Names

There is limited information regarding Nipocalimab-aahu Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

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