Rozanolixizumab-Noli: uses, dosing, side effects & brands
Rozanolixizumab-Noli is a medicine sold in the U.S. under one brand, for myasthenia gravis. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
Key facts
- Treats
- Myasthenia Gravis
- Available as
- Injectable
- Sold as
- Rystiggo
- Prescription?
- Prescription only
- Generic available?
- Not in our catalog
How rozanolixizumab-noli is dosed
From the FDA label for Rystiggo (application BLA761286). Other rozanolixizumab-noli products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
Evaluate the need to administer age-appropriate vaccines according to immunization guidelines before initiation of a new treatment cycle with RYSTIGGO. ( 2.1 ) For subcutaneous infusion only. ( 2.2 ) The recommended dosage is administered as a subcutaneous infusion once weekly for 6 weeks. ( 2.2 ) Body 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 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. ( 2.2 ) 2.1 Recommended Vaccination Because RYSTIGGO causes transient reduction in IgG levels, immunization with live-attenuated or live vaccines is not recommended during treatment with RYSTIGGO. Evaluate the need to administer age-appropriate immunizations according to immunization guidelines before initiation of a new treatment cycle with RYSTIGGO [see Dosage and Administration (2.2) and Warnings and Precautions (5.1) ] . 2.2 Recommended Dosage The recommended dosage of RYSTIGGO is based on body weight, as shown below in Table 1. Table 1: Recommended Dose Based on Body Weight Body 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 Administer the…
Rozanolixizumab-Noli side effects
The following clinically significant adverse reactions are discussed in greater detail in other sections of the labeling: Infections [see Warnings and Precautions (5.1) ] Aseptic Meningitis [see Warnings and Precautions (5.2) ] Hypersensitivity Reactions [see Warnings and Precautions (5.3) ] The most common adverse reactions (≥10%) in patients with gMG are headache, infections, diarrhea, pyrexia, hypersensitivity reactions, and nausea. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact UCB, Inc. at 1-844-599-2273 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In clinical studies, the safety of RYSTIGGO has been evaluated in 196 patients who received at least one dose of RYSTIGGO, including 88 patients exposed to at least 5 treatment cycles and 9 patients exposed to at least 10 treatment cycles. In a placebo-controlled study (Study 1) in patients with gMG, 133 patients received RYSTIGGO [see Clinical Studies (14) ] . Of these 133 patients, approximately 56% were female, 68% were White, 12% were Asian, and 6% were of Hispanic or Latino ethnicity. The mean age at study entry was 52.5…
Who shouldn’t take rozanolixizumab-noli
None. None. ( 4 )
Rozanolixizumab-Noli drug interactions
Closely monitor for reduced effectiveness of medications that bind to the human neonatal Fc receptor. When concomitant long-term use of such medications is essential for patient care, consider discontinuing RYSTIGGO and using alternate therapies. ( 7.1 ) 7.1 Effect of RYSTIGGO on Other Drugs Concomitant use of RYSTIGGO with medications that bind to the human neonatal Fc receptor (FcRn) (e.g., immunoglobulin products, monoclonal antibodies, or antibody derivatives containing the human Fc domain of the IgG subclass) may lower systemic exposures and reduce effectiveness of such medications. Closely monitor for reduced effectiveness of medications that bind to the human neonatal Fc receptor. When concomitant long-term use of such medications is essential for patient care, consider discontinuing RYSTIGGO and using alternative therapies.
Every rozanolixizumab-noli product we track (1)
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
Only one: Rystiggo.
What people report to the FDA about rozanolixizumab-noli
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 2 reports naming rozanolixizumab-noli, and the FDA flagged 100% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:
- asthenia1 reports
- blood potassium decreased1 reports
- burning sensation1 reports
- dysphonia1 reports
- dyspnoea1 reports
- headache1 reports
- infusion related reaction1 reports
- loss of consciousness1 reports
Read these as a signal, not a rate. A report does not mean rozanolixizumab-noli caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label section above.
Source: openFDA drug/event (FAERS), retrieved July 26, 2026.
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Frequently asked questions
What is rozanolixizumab-noli?
Rystiggo (Rozanolixizumab-Noli) is a medication used to treat Myasthenia Gravis.
Can you take rozanolixizumab-noli with other medicines?
It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run rozanolixizumab-noli against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What forms does rozanolixizumab-noli come in?
Across the brands we track, rozanolixizumab-noli is currently marketed as injectable, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Is there a generic rozanolixizumab-noli?
We do not currently list a generic-labelled rozanolixizumab-noli product. That does not always mean none exists — it means none appears under a generic name in the FDA data we track. Ask your pharmacist.
Cite this page
- APA
- pharmaranks. (2026, July 24). Rozanolixizumab-Noli: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/rozanolixizumab-noli
- MLA
- “Rozanolixizumab-Noli: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/rozanolixizumab-noli.
We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Read the full FDA label for rozanolixizumab-noli on DailyMed (NIH) ↗.