Introduction

Rozanolixizumab-noli, a humanized IgG4 monoclonal antibody, is a neonatal Fc receptor blocker.

Uses for Rozanolixizumab (Systemic)

Rozanolixizumab-noli has the following uses:

Rozanolixizumab-noli is indicated for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive.

Rozanolixizumab (Systemic) Dosage and Administration

General

Rozanolixizumab-noli is available in the following dosage form(s) and strength(s):

Injection: 280 mg/2 mL (140 mg/mL) in a single-dose vial for subcutaneous infusion.

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

Dosage and Administration

• Evaluate the need to administer age-appropriate vaccines according to immunization guidelines before initiation of a new treatment cycle with rozanolixizumab-noli.

• For subcutaneous infusion only using an infusion pump.

• Rozanolixizumab-noli is administered as a subcutaneous infusion once weekly for 6 weeks. Infuse the drug at a constant flow rate up to 20 mL/hour. The recommended dosage is based on body weight as shown in the table below.

• Administer subsequent treatment cycles based on clinical evaluation; the safety of initiating subsequent cycles sooner than 63 days from the start of the previous treatment cycle has not been established.

• See Full Prescribing Information for additional instructions on preparation and administration of the drug.

Contraindications

None.

Warnings/Precautions

Infections

Rozanolixizumab-noli may increase the risk of infection. Delay administration in patients with an active infection until the infection is resolved. During treatment with the drug, monitor for clinical signs and symptoms of infection. If serious infection occurs, administer appropriate treatment and consider withholding rozanolixizumab-noli until the infection has resolved.

Immunization

Immunization with vaccines during rozanolixizumab-noli treatment has not been studied. The safety of immunization with live or live-attenuated vaccines and the response to immunization with any vaccine are unknown. Because rozanolixizumab-noli causes a reduction in IgG levels, vaccination with live-attenuated or live vaccines is not recommended during treatment with the drug. Evaluate the need to administer age-appropriate vaccines according to immunization guidelines before initiation of a new treatment cycle with rozanolixizumab-noli.

Aseptic Meningitis

Serious adverse reactions of aseptic meningitis (also called drug-induced aseptic meningitis) have been reported in patients treated with rozanolixizumab-noli. If symptoms consistent with aseptic meningitis develop, diagnostic workup and treatment should be initiated according to the standard of care.

Hypersensitivity Reactions

Hypersensitivity reactions, including angioedema and rash, were observed in patients treated with rozanolixizumab-noli. Management of hypersensitivity reactions depend on the type and severity of the reaction. Monitor patients during treatment with rozanolixizumab-noli and for 15 minutes after the administration is complete for clinical signs and symptoms of hypersensitivity reactions. If a hypersensitivity reaction occurs, the healthcare professional should institute appropriate measures if needed or the patient should seek medical attention.

Specific Populations

Pregnancy

There are limited data on rozanolixizumab-noli use in pregnant women to inform a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Following administration of rozanolixizumab-noli to pregnant monkeys at doses greater than those used clinically, increases in embryonic death, reduced body weight, and impaired immune function were observed in the absence of maternal toxicity.

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

Lactation

There are no data on the presence of rozanolixizumab-noli in human milk, the effects on the breastfed infant, or the effects on milk production. Maternal IgG is known to be present in human milk.

The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for rozanolixizumab-noli and any potential adverse effects on the breastfed child from the drug or from the underlying maternal condition.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Geriatric Use

Clinical studies of rozanolixizumab-noli did not include sufficient numbers of patients 65 years of age and older to determine whether they respond differently from younger adult patients.

Common Adverse Effects

The most common adverse reactions (≥10%) in patients with generalized myasthenia gravis are headache, infections, diarrhea, pyrexia, hypersensitivity reactions, and nausea.

General

Rozanolixizumab-noli is available in the following dosage form(s) and strength(s):

Injection: 280 mg/2 mL (140 mg/mL) in a single-dose vial for subcutaneous infusion.

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

Dosage and Administration

• Evaluate the need to administer age-appropriate vaccines according to immunization guidelines before initiation of a new treatment cycle with rozanolixizumab-noli.

• For subcutaneous infusion only using an infusion pump.

• Rozanolixizumab-noli is administered as a subcutaneous infusion once weekly for 6 weeks. Infuse the drug at a constant flow rate up to 20 mL/hour. The recommended dosage is based on body weight as shown in the table below.

• Administer subsequent treatment cycles based on clinical evaluation; the safety of initiating subsequent cycles sooner than 63 days from the start of the previous treatment cycle has not been established.

• See Full Prescribing Information for additional instructions on preparation and administration of the drug.

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. When concomitant long-term use of such medications is essential for patient care, consider discontinuing rozanolixizumab-noli and using alternate therapies.