Rozanolixizumab

Rozanolixizumab is a prescription medication used for the treatment of generalized myasthenia gravis (gMG) in adults who are anti-acetylcholine receptor (AChR) or antimuscle-specific tyrosine kinase (MuSK) antibody positive.

• Rozanolixizumab is available under the following different brand names: Rystiggo, rozanolixizumab-noli

Common side effects of Rozanolixizumab include:

• headache
• infection
• diarrhea
• pyrexia
• nausea

Serious side effects of Rozanolixizumab include:

• hives
• shortness of breath
• rash
• serious infections

Rare side effects of Rozanolixizumab 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 dosage

Injectable solution

• 140 mg/mL (2-mL single-dose vial)

Myasthenia Gravis

Adult dosage

• Weighing less than 50 kg: 420 mg SC infusion every week for 6 weeks
• Weighing between 50 kg to 99 kg: 560 mg SC infusion every week for 6 weeks
• Weighing 100 kg and more: 840 mg SC infusion every week for 6 weeks

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, 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.

• Rozanolixizumab has severe interactions with the following drug:
  • upadacitinib
• Rozanolixizumab has serious interactions with no other drugs
• Rozanolixizumab has moderate interactions with at least 80 other drugs
• Rozanolixizumab has minor interactions with no other drugs

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• None

Effects of drug abuse

• None

Short-Term Effects

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

Long-Term Effects

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

Cautions

• Serious adverse reactions of aseptic meningitis (also called drug-induced aseptic meningitis) reported
• Infections
  • May increase the risk of infection
  • 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 therapy until the infection has resolved
• Hypersensitivity reactions
  • Hypersensitivity reactions (eg, angioedema, rash) observed
  • Manage hypersensitivity reactions depending on the type and severity of the reaction
  • Monitor during treatment and for 15 minutes after administration is complete for clinical signs and symptoms of hypersensitivity reactions
  • If a hypersensitivity reaction occurs, institute appropriate measures if needed or the patient should seek medical attention
• Drug interaction overview
  • Immunization
    • Vaccinations of live-attenuated or live vaccines are not recommended
    • Immunization with vaccines during treatment not studied
    • Safety of immunization with live or live-attenuated vaccines and response to immunization with any vaccine is unknown
    • Evaluate the need to administer age-appropriate vaccines according to immunization guidelines before initiation of a new treatment cycle
  • Drugs that bind to Fc receptor
    • Closely monitor for reduced effectiveness of medications that bind to the human neonatal Fc receptor (FcRn)
    • When concomitant long-term use of such medications is essential for patient care, consider discontinuing therapy and using alternative therapies
    • Rozanolixizumab may lower systemic exposures and reduce the effectiveness of medications that bind to FcRn (eg, immunoglobulin products, monoclonal antibodies, antibody derivatives containing the human Fc domain of the IgG subclass)

Pregnancy and Lactation

• There are limited data on use in pregnant women to inform a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes
• Lactation
  • There are no data on the presence of rozanolixizumab in human milk, its effects on breastfed infants, or milk production
  • Maternal IgG is known to be present in human milk