Rystiggo (rozanolixizumab-noli)
- Medicine Name: Rystiggo
- Generic Name: Rozanolixizumab-noli
- Dosage Form & Strength: 280 mg/2 mL (140 mg/mL) in a single-dose vial for injection.
- Manufactured By: UCB, Inc.
- Treatment of Generalized Myasthenia Gravis (gMG).
- Specifically for adult patients who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive.
- Administered as a subcutaneous infusion.
- Dosage varies based on the patient’s weight.
- It should only be used under the guidance of a qualified healthcare professional.
Recommended Dosage:
- Evaluate the need to administer age-appropriate vaccines according to immunization guidelines before initiating a new treatment cycle with Rystiggo.
- The recommended dosage is administered as a subcutaneous infusion once weekly for 6 weeks, based on the patient’s body weight:
- Less than 50 kg: 420 mg in 3 mL
- 50 kg to less than 100 kg: 560 mg in 4 mL
- 100 kg and above 840 mg in 6 mL
- 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.
- Infections: Delay administration of Rystiggo to patients with an active infection. Monitor for signs and symptoms of infection and consider withholding Rystiggo until the infection has resolved.
- Aseptic Meningitis: Serious events of aseptic meningitis have been reported. Monitor for symptoms and initiate treatment according to the standard of care.
What documents are required to import Rystiggo to India?
Rystiggo (rozanolixizumab-noli) injections can be imported by patients or government hospitals on the name of the patients only.
The following documentation is required to import the product:
- A valid prescription from a qualified doctor.
- Patients diagnostic reports
- Patient ID proof (issued by the government of India)
How does the order be confirmed?
The order will be confirmed only after the receipt of:
- A valid prescription from the Doctor
- Import permit, if applicable
Is BEYFORTUS available in India?
Rystiggo (rozanolixizumab-noli) is a (prescription drug, prescription medication, or prescription medicine) pharmaceutical drug that legally requires a medical prescription to be dispensed.
IPN (Indian Pharma Network) assists in the importation of cancer medications on a named patient supply (NPS). The facilitator is the Indian Pharma Network, which provides input.
Patients, doctors, and hospitals in Mumbai, Kolkata, Hyderabad, Chennai, Ahmedabad, Delhi, Bangalore, Srinagar, Jammu, Jaipur, Chandigarh, Ludhiana, Noida, Gurgaon, Lucknow, and Pune, among other locations in India, can access Rystiggo. Only after receiving a valid doctor’s prescription and import permission will the order be confirmed.
After completing the legal requirements (if applicable), IPN (Indian Pharma Network) can facilitate the supply of Rystiggo (prescription drugs) to all areas throughout the world and in India.
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What is the Generic Name for the trade name drug Rystiggo?
Rozanolixizumab-noli is a Generic Name for the trade name drug Beyfortus®.
Is it approved by the FDA?
Yes, Rystiggo was approved by the FDA in June 2023.
What is the use of Rystiggo?
Rystiggo is approved to treat adult patients with the anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibodies that have generalized myasthenia gravis (gMG).
What is the mechanism of action of rozanolixizumab?
Rozanolixizumab, a humanized monoclonal antibody administered subcutaneously, specifically targets the IgG-binding domain of FcRn. Rozanolixizumab inhibits IgG recycling, accelerates lysosomal breakdown, and lowers IgG levels by preventing IgG binding to FcRn.
Who is the manufacturer of Rystiggo?
UCB, a Belgian biopharmaceutical company, has announced that its Rystiggo (rozanolixizumab) medication has been approved by the US Food and Drug Administration (FDA).
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