Rozanolixizumab (Systemic)
Brand names: Rystiggo
Drug class:
Antineoplastic Agents
Usage of 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.
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How to use Rozanolixizumab (Systemic)
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 AdministrationBody Weight of Patient
Dose
Volume to be Infused
Less than 50 kg
420 mg
3 mL
50 kg to less than 100 kg
560 mg
4 mL
100 kg and above
840 mg
6 mL
Warnings
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.
ImmunizationImmunization 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
PregnancyThere 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.
LactationThere 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 UseSafety and effectiveness in pediatric patients have not been established.
Geriatric UseClinical 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.
What other drugs will affect Rozanolixizumab (Systemic)
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:
Disclaimer
Every effort has been made to ensure that the information provided by Drugslib.com is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Drugslib.com information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Drugslib.com does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Drugslib.com's drug information does not endorse drugs, diagnose patients or recommend therapy. Drugslib.com's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.
The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Drugslib.com does not assume any responsibility for any aspect of healthcare administered with the aid of information Drugslib.com provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
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