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
Rystiggo may increase the risk of infections. The drug should be used with caution in patients with an active infection.Delay administration of Rystiggo in patients with an active infection until the infection has resolved. Monitor patients for signs and symptoms of infections during treatment. If a serious infection occurs, consider appropriate treatment and withholding Rystiggo until the infection resolves. Serious cases of aseptic meningitis have been reported in patients treated with Rystiggo.Monitor for symptoms indicative of aseptic meningitis. If suspected, perform appropriate diagnostic workup and provide standard care for aseptic meningitis. Consider withholding Rystiggo until resolution.
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 limited human data available on the use of Rystiggo in pregnant women. Animal studies in monkeys have shown an increased incidence of embryonic loss and reduced fetal growth at doses higher than those used clinically, suggesting potential risks to the fetus.
Nursing Mothers
There is no FDA guidance on the use of Rozanolixizumab-noli in women who are nursing.
Pediatric Use
For Rozanolixizumab-noli (Rystiggo), the use in pediatric populations is currently not established.
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
No dosage adjustment is required for patients with renal impairment.
Hepatic Impairment
No dosage adjustment is suggested for 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
ozanolixizumab-noli (Rystiggo) is administered subcutaneously, tailored to body weight, with a weekly dosage for six weeks. Specific dosages include 420 mg for patients under 50 kg, 560 mg for those between 50 kg and 100 kg, and 840 mg for those over 100 kg. Preparation of the drug should follow strict aseptic techniques, allowing vials to warm to room temperature for about 30 minutes before use, without shaking. The solution should be inspected for particulate matter or discoloration prior to administration. It should be infused using an infusion pump set to a rate of up to 20 mL/hour, with the prepared infusion used within four hours of vial puncture. Patients should be monitored during the infusion and for 15 minutes afterward for any signs of hypersensitivity reactions, such as rashes or breathing difficulties. Due to the immunosuppressive nature of Rystiggo, it’s crucial to monitor for signs of infection throughout the treatment period.
Monitoring
Ongoing monitoring should include evaluations of the drug’s efficacy, particularly after the initial 6-week treatment cycle, with adjustments made based on the patient’s response. Safety monitoring for adverse reactions like aseptic meningitis and infection is also recommended. If a dose is missed, it can be administered up to four days later; otherwise, the regular dosing schedule should resume. Post-administration, the infusion line should not be flushed to account for the volume adjustments already made for line losses. These guidelines ensure the safe and effective use of Rystiggo, optimizing therapeutic benefits while minimizing potential risks.
IV Compatibility
Rozanolixizumab-noli (Rystiggo) is specifically formulated for subcutaneous administration, not for intravenous (IV) use.
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
Targeting FcRn: Rozanolixizumab-noli is a humanized monoclonal antibody that binds selectively to the neonatal Fc receptor (FcRn). The FcRn is predominantly expressed in endothelial cells and immune cells and is responsible for the protection and recycling of IgG antibodies. This receptor binds to IgG at a low pH in the endosomes, preventing IgG degradation and allowing it to be recycled back to the cell surface where it’s released into the bloodstream at physiological pH. Reduction of IgG Levels: By binding to FcRn, rozanolixizumab-noli blocks the receptor’s ability to recycle IgG, leading to increased catabolism and decreased circulating levels of IgG, including autoantibodies. Since IgG autoantibodies are implicated in the pathogenesis of diseases like generalized myasthenia gravis (gMG), reducing their levels can alleviate the symptoms associated with these conditions.
Structure
There is limited information regarding Rozanolixizumab-noli Structure in the drug label.
Pharmacodynamics
Rozanolixizumab-noli binds to the neonatal Fc receptor (FcRn) on the surface of cells, which is responsible for the recycling and extended half-life of IgG antibodies. By inhibiting this receptor, the drug decreases the recycling of IgG, leading to an increased degradation of IgG antibodies, including pathogenic autoantibodies involved in autoimmune diseases like generalized myasthenia gravis.
Pharmacokinetics
Absorption: Following subcutaneous administration, Rozanolixizumab-noli is absorbed into the bloodstream, reaching peak plasma levels approximately 2 days after administration in healthy subjects. The absorption process for subcutaneously administered drugs is generally slower compared to intravenous routes, leading to a gradual increase in drug concentration in the plasma. Distribution: The apparent volume of distribution for Rozanolixizumab-noli is approximately 6.6 liters, indicating that the drug primarily remains within the vascular compartment and interstitial spaces. This distribution is typical for monoclonal antibodies, which due to their large size, do not extensively distribute into cellular components or fat tissues. Metabolism and Elimination: Rozanolixizumab-noli is not metabolized by liver enzymes such as cytochrome P450. Instead, it undergoes catabolism by standard proteolytic pathways into small peptides and amino acids, which are typical for antibodies. The clearance mechanism is primarily through degradation rather than renal or hepatic elimination. The apparent clearance rate is approximately 0.89 L/day.
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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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.