rystiggo
Pharmaranks rates Rystiggo 3.5/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Rystiggo (Rozanolixizumab-Noli) is a medication used to treat Myasthenia Gravis.
Rozanolixizumab-Noli · by Ucb Inc
Based on 1 source · Recall-safety score from FDA recall history — this product's own recalls and its manufacturer's record. Not an efficacy or quality rating. methodology →
Key facts
- Active ingredient
- Rozanolixizumab-Noli
- Form
- Injectable
- Strength
- ROZANOLIXIZUMAB-NOLI 280MG/2ML(140MG/ML)
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- May treat
- myasthenia gravis
- Manufacturer
- Ucb Inc
- FDA application
- BLA761286
What is Rystiggo?
From the FDA label:Rozanolixizumab-noli, a neonatal Fc receptor blocker, is a recombinant, humanized IgG4P monoclonal antibody, expressed in a genetically engineered Chinese hamster ovary DG44 cell line. Rozanolixizumab-noli has an approximate molecular weight of 148 kDa. RYSTIGGO 140 mg/mL (2 mL, 3 mL, 4 mL, and 6 mL vials) RYSTIGGO (rozanolixizumab-noli) injection is a sterile, preservative-free, clear to slightly opalescent, colorless to pale brownish yellow solution for subcutaneous infusion. Each single-dose vial contains 280 mg, 420 mg, 560 mg, or 840 mg of rozanolixizumab-noli at a concentration of 140 mg/mL with a pH of 5.6. Each mL also contains histidine (1.05 mg), L-histidine hydrochloride monohydrate (4.87 mg), polysorbate 80 (0.30 mg), proline (28.78 mg), and water for injection, USP.
How to use
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…
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…
Warnings
Important safety information
Infections: Delay administration of RYSTIGGO to patients with an active infection. Monitor for signs and symptoms of infection in patients treated with RYSTIGGO. If serious infection occurs, administer appropriate treatment and consider withholding RYSTIGGO until the infection has resolved. ( 5.1 ) Aseptic Meningitis: Serious events of aseptic meningitis have been reported. Monitor for symptoms; diagnostic workup and treatment should be initiated according to the standard of care. ( 5.2 ) Hypersensitivity Reactions: Angioedema and rash have occurred. If a hypersensitivity reaction occurs, discontinue the infusion and institute appropriate therapy. ( 5.3 ) 5.1 Infections RYSTIGGO may increase the risk of infection [see Adverse Reactions (6.1) ] . Delay RYSTIGGO administration in patients with an active infection until the infection is resolved. During treatment with RYSTIGGO, monitor for clinical signs and symptoms of infection. If serious infection occurs, administer appropriate treatment and consider withholding RYSTIGGO until the infection has resolved. Immunization Immunization with vaccines during RYSTIGGO 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 RYSTIGGO causes a reduction in IgG levels, vaccination with live-attenuated or live vaccines is not recommended during treatment with RYSTIGGO. Evaluate the need to administer age-appropriate vaccines according to immunization guidelines before initiation of a new treatment cycle with RYSTIGGO. 5.2 Aseptic Meningitis Serious adverse reactions of aseptic meningitis (also called drug-induced aseptic meningitis) have been reported in patients treated with RYSTIGGO [see Adverse Reactions (6.1) ] . If symptoms consistent with aseptic meningitis develop, diagnostic workup and treatment should be initiated according to the standard of care. 5.3 Hypersensitivity Reactions Hypersensitivity reactions, including angioedema and rash, were observed in patients treated with RYSTIGGO [see Adverse Reactions (6.1) ] . Management of hypersensitivity reactions depend on the type and severity of the reaction. Monitor patients during treatment with RYSTIGGO and for 15 minutes after the administration is complete for clinical signs and symptoms of hypersensitivity reactions [see Dosage and Administration (2.3) ] . If a hypersensitivity reaction occurs, the healthcare professional should institute appropriate measures if needed or the patient should seek medical attention.
Who should not take Rystiggo
None. None. ( 4 )
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.
May treat (source: NIH RxClass)
Dosage forms
Injectable
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
Same active ingredient, far cheaper. Is there a generic? →
Request a 90-day supply
Bulk fills usually lower the per-dose price vs monthly refills.
Use copay cards
Manufacturer copay cards & patient-assistance programs — especially for brand drugs.
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Frequently asked questions
- What does Rystiggo treat?
- Rystiggo (Rozanolixizumab-Noli) may be used to treat myasthenia gravis, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- How is Rystiggo rated?
- pharmaranks gives Rystiggo a composite score of 3.5 out of 5, currently based on 1 weighted source (FDA regulatory recall-safety data weighted highest). See our methodology at /how-we-rate.
- Is there a coupon or discount for Rystiggo?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Rystiggo. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Rystiggo?
- Rystiggo is marketed by Ucb Inc. You can see Ucb Inc's full profile, rating, and other products on pharmaranks.
- Is Rystiggo a brand-name or generic drug?
- Rystiggo is a brand-name product with the active ingredient Rozanolixizumab-Noli.
- Is Rystiggo available over the counter?
- No. Rystiggo is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Rystiggo come in?
- Rystiggo is currently marketed as injectable, per the FDA's National Drug Code Directory.
- Is Rystiggo FDA-registered?
- Rystiggo is on record with the U.S. FDA under application number BLA761286. You can verify this on its official FDA label.
- Has Rystiggo been recalled by the FDA?
- Rystiggo has no FDA recalls recorded under its own application in the openFDA enforcement database. Its recall-safety score reflects its manufacturer's overall recall record. This is general reference, not medical advice — check the FDA recall database for the latest alerts.
- Is Rystiggo safe?
- There's no single safe-or-not verdict. pharmaranks gives Rystiggo a recall-safety score of 70/100, based on its FDA recall history (no recalls under its own FDA application) — not an efficacy or side-effect rating. Review its FDA-label side effects and warnings before use, and always consult a licensed professional.
- What are the side effects of Rystiggo?
- Rystiggo's side effects are taken directly from its FDA label. From the label: 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 mos… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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rystiggo
70/100