Rozanolixizumab-noli
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Muhammad Waleed, M.B.B.S. [2]
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Overview
Rozanolixizumab-noli is a Neonatal Fc receptor blocker that is FDA approved for the treatment of Rystiggo 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.. Common adverse reactions include Common Adverse Reactions: Include headache, infections, diarrhea, pyrexia, hypersensitivity reactions, and nausea. The most frequent infections reported were upper respiratory tract infections, COVID-19, urinary tract infections, and herpes simplex..
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
The recommended dosage is based on body weight and administered as a subcutaneous infusion once weekly for 6 weeks. • 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) • Administer subsequent treatment cycles based on clinical evaluation; safety of initiating subsequent cycles sooner than 63 days from the start of the previous treatment cycle has not been established.
Off-Label Use and Dosage (Adult)
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding Rozanolixizumab-noli FDA-Labeled Indications and Dosage (Pediatric) in the drug label.
Off-Label Use and Dosage (Pediatric)
Contraindications
There is limited information regarding Rozanolixizumab-noli Contraindications in the drug label.
Warnings
There is limited information regarding Rozanolixizumab-noli Warnings' in the drug label.
Adverse Reactions
Clinical Trials Experience
• Headache: 44% of patients treated with Rystiggo experienced headaches compared to 19% in the placebo group. • Infections: 23% reported, with specific types including: • Upper respiratory tract infection: 8% • COVID-19: Incidence not specified, but noted as part of common infections. • Urinary tract infections: Incidence not specified, but noted. • Herpes simplex: Incidence not specified. • Diarrhea: 20% of patients experienced diarrhea, compared to 13% in the placebo group. • Pyrexia (fever): 17% of patients experienced fever, compared to 2% in the placebo group. • Hypersensitivity reactions: 11% reported, which included symptoms such as angioedema and rash. • Nausea: 10% of patients experienced nausea, compared to 8% in the placebo group. • Administration site reactions: 8%, included local reactions like pain or irritation at the infusion site. • Abdominal pain: 8% reported. • Arthralgia (joint pain): 7% reported. Some serious adverse reactions reported are as follows • Serious infections: Reported in 4% of patients treated with Rystiggo. These included cases of pneumonia which were fatal in some instances. • Aseptic Meningitis: Serious events of aseptic meningitis have been reported, which required hospitalization and discontinuation of Rystiggo in the affected patients.
Postmarketing Experience
There is limited information regarding Rozanolixizumab-noli Postmarketing Experience in the drug label.
Drug Interactions
Rozanolixizumab-noli may lower systemic exposures of other medications that bind to the human neonatal Fc receptor (FcRn). These include immunoglobulin products, monoclonal antibodies, or antibody derivatives containing the human Fc domain of the IgG subclass. The reduction in systemic exposure can potentially decrease the effectiveness of these drugs. It is recommended to closely monitor for reduced effectiveness of medications that interact with the FcRn when used concomitantly with Rystiggo. If necessary, especially when long-term use of these interacting medications is essential for patient care, consider discontinuing Rystiggo and using alternative therapies
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Rozanolixizumab-noli in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Rozanolixizumab-noli in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Rozanolixizumab-noli during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Rozanolixizumab-noli in women who are nursing.
Pediatric Use
There is no FDA guidance on the use of Rozanolixizumab-noli in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Rozanolixizumab-noli in geriatric settings.
Gender
There is no FDA guidance on the use of Rozanolixizumab-noli with respect to specific gender populations.
Race
There is no FDA guidance on the use of Rozanolixizumab-noli with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Rozanolixizumab-noli in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Rozanolixizumab-noli in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Rozanolixizumab-noli in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Rozanolixizumab-noli in patients who are immunocompromised.
Administration and Monitoring
Administration
There is limited information regarding Rozanolixizumab-noli Administration in the drug label.
Monitoring
There is limited information regarding Rozanolixizumab-noli Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of Rozanolixizumab-noli and IV administrations.
Overdosage
There is limited information regarding Rozanolixizumab-noli 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 Rozanolixizumab-noli Pharmacology in the drug label.
Mechanism of Action
There is limited information regarding Rozanolixizumab-noli Mechanism of Action in the drug label.
Structure
There is limited information regarding Rozanolixizumab-noli Structure in the drug label.
Pharmacodynamics
There is limited information regarding Rozanolixizumab-noli Pharmacodynamics in the drug label.
Pharmacokinetics
There is limited information regarding Rozanolixizumab-noli Pharmacokinetics in the drug label.
Nonclinical Toxicology
There is limited information regarding Rozanolixizumab-noli Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Rozanolixizumab-noli Clinical Studies in the drug label.
How Supplied
There is limited information regarding Rozanolixizumab-noli How Supplied in the drug label.
Storage
There is limited information regarding Rozanolixizumab-noli Storage in the drug label.
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
There is limited information regarding Rozanolixizumab-noli Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol-Rozanolixizumab-noli interaction has not been established. Talk to your doctor regarding the effects of taking alcohol with this medication.
Brand Names
There is limited information regarding Rozanolixizumab-noli Brand Names in the drug label.
Look-Alike Drug Names
There is limited information regarding Rozanolixizumab-noli 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.