IMAAVY

/ J-C Health Care Ltd

The recommended initial dosage 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.
Preparation and Administration Instructions: Prior to administration, with only 0.9% sodium chloride injection. 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.
Recommended Vaccination: Evaluate the need to administer age-appropriate vaccines according to immunization guidelines before initiation. Because nipocalimab causes transient reduction in IgG levels, vaccination with live vaccines is not recommended during treatment.
See prescribing information for full details.

Hypersensitivity to the active substance or to any of the excipients

Infections
This medical product may increase the risk of infection. In Study 1, 42 (43%) out of 98 patients treated reported 71 events of infection.
Across Study 1 (double blind period) and its extension study (open label-period), out of 186 patients treated, 132 (71%) patients reported 360 events of infection. Serious infections were reported in 7% of patients. Delay administration in patients with an active infection until the infection is resolved. During treatment, monitor for clinical signs and symptoms of infection. If serious infection occurs, administer appropriate treatment and consider withholding until the infection has resolved.
Latent Viral Infections
Patients treated with nipocalimab may be at an increased risk of activation of latent viral infections, such as herpes zoster.
Immunization
The safety of immunization with live vaccines and the immune response to vaccination during treatment are unknown. Because nipocalimab causes a reduction in IgG levels, vaccination with live vaccines is not recommended during treatment.
Hypersensitivity Reactions
In clinical trials, hypersensitivity reactions, including angioedema, anaphylaxis, rash, urticaria, and eczema were observed.
Hypersensitivity reactions were mild or moderate, occurred within one hour to 2 weeks of administration. Monitor the patient during treatment 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 infusion and institute appropriate supportive measures if needed.
Infusion-Related Reactions
In clinical trials, infusion-related reactions, including headache, influenza-like illness, rash, nausea, fatigue, dizziness, chills, and erythema were observed.
infusion-related reactions were mild to moderate in severity and occurred within one
hour to 2 days of administration.
Monitor patients 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 readministering.
Increased plasma lipid levels
Increased plasma lipid levels are very common during treatment, both in adolescent and adult patients of all ages.
Plasma lipid levels should therefore be measured approximately
12 weeks following treatment initiation. In adolescents (12 to <18 years) and in patients with high body weight/BMI (e.g. ≥125 kg or BMI >35 kg/m²), consider closer periodic monitoring thereafter.

The most common adverse reactions were respiratory tract infection, peripheral edema, and muscle spasms.
See prescribing information for full details.

Effect of Nipocalimab on Other Drugs
Concomitant use 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 this medical product, and using alternative therapies.

Pregnancy: There are limited data on the use in pregnant women.
Monoclonal antibodies are increasingly transported across the placenta as pregnancy progresses, with the largest amount transferred during the third trimester. Because this medical product 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
nipocalimab in utero.
Lactation: Nipocalimab is excreted in human colostrum and breastmilk based on limited data from an investigational study of 13 pregnant women administered nipocalimab during pregnancy where colostrum and breastmilk was assessed in the first 8 days after birth. There are insufficient data on the effect in the breastfed infant. There are no data on the effect of nipocalimab on milk production.
See prescribing information for full details.