Frequently asked questions (FAQs)
About RYSTIGGO
RYSTIGGO is a prescription medicine used to treat adults with a disease called generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive or anti-muscle-specific tyrosine kinase (MuSK) antibody positive.
RYSTIGGO works by targeting and blocking an immune system protein called FcRn (neonatal Fc receptor). FcRn can extend the life of certain antibodies, including harmful anti-AChR and anti-MuSK antibodies whose presence interferes with signaling between nerves and muscles and may lead to gMG symptoms.
Learn more about how RYSTIGGO and FcRn interact.
RYSTIGGO is the first treatment that’s FDA approved to treat both anti-AChR and anti-MuSK antibody-positive gMG in adults.
Ask your doctor if RYSTIGGO is right for you. Our Doctor Discussion Guide can help you get the conversation started.
In a clinical trial, participants taking RYSTIGGO saw significant improvements in activities of daily living as measured by MG-ADL by the end of the 6-week treatment period.*
Individual results may vary, and not all people taking RYSTIGGO will experience improvements.
As determined by improvement from baseline on Day 43 of the study; -3.4 points in the RYSTIGGO-treated group (133 people) vs -0.8 in the placebo group (67 people).
Minimal Symptom Expression (MSE) is sometimes used as a treatment goal for gMG, and is defined as a total MG-ADL score of 0 or 1. People who reach MSE experience minimal symptoms as assessed by the MG-ADL scale.
In the clinical trial, over 25% of participants receiving RYSTIGGO achieved MSE.*
MSE was an exploratory outcome in the clinical trial, not a primary or secondary outcome. Therefore, caution must be used when interpreting as conclusions cannot be drawn. Results may vary.
26% (17 out of 66 people) in the 7 mg/kg group and 28% (19 out of 67 people) in the 10 mg/kg group, compared with 3% (2 out of 67 people) in the placebo group.
Getting started
RYSTIGGO is given as a subcutaneous infusion (under the surface of the skin).* Once prepared by a healthcare professional, an infusion may be completed in about 15 minutes.† Preparation and infusion time may vary by patient, dosage, and/or infusion provider.
In the lower left or right part of the abdomen below the navel. Do not receive RYSTIGGO in areas where the skin is tender, bruised, red, or hard, or contains tattoos, scars, or stretch marks. Your infusion provider will rotate infusion sites for subsequent administrations.
There are 3 recommended doses of RYSTIGGO, based on body weight.
You can receive RYSTIGGO at an infusion center, outpatient hospital clinic, or your doctor's office. You will be monitored while you receive RYSTIGGO, and for 15 minutes after your infusion is complete. If a hypersensitivity reaction is observed, your provider will stop RYSTIGGO administration and begin appropriate care.
You may be able to receive RYSTIGGO at home with nurse assistance. Eligibility will be assessed by your doctor and may be based on your insurance coverage.
Your doctor can provide more information about the infusion process and help locate an infusion center in your area. You can also use our Find an Infusion Center tool.
You will receive 6 doses in total, spaced 1 week apart. This 6-week period is called a treatment cycle. Every cycle is followed by a break in your RYSTIGGO treatment.
Because everyone responds to RYSTIGGO differently, the length of your break may vary and will be based on individual treatment needs and medical evaluation. Your doctor may adjust your break following any future RYSTIGGO treatments.*
In a long-term study, the minimum length between the start of treatment cycles was 9 weeks (63 days). The safety of starting later cycles sooner than 63 days from the start of the previous cycle has not been established.
Inform your doctor immediately if an infusion is missed. In most cases, RYSTIGGO may be administered up to 4 days after the scheduled infusion time. Afterward, resume the original dosing schedule until the treatment cycle is completed.
ONWARD provides personalized rare disease support, including guidance from a medically trained ONWARD Care Coordinator,* help reviewing insurance coverage and potential financial assistance options, and other services designed to help you start and stay on your prescribed RYSTIGGO treatment.
ONWARD is for adults who are anti-AChR or anti-MuSK antibody positive and prescribed a UCB medicine for the treatment of gMG. Designated caregivers can also benefit from ONWARD support.
For more information and to enroll, please visit ucbONWARD.com or call 1-844-ONWARD-1 (1-844-669-2731). Your healthcare provider can also begin the enrollment process on your behalf.
ONWARD Care Coordinators do not provide medical advice and will refer you to your healthcare professional for any questions related to your treatment plan.
The safety of RYSTIGGO
RYSTIGGO may cause serious side effects, including:
- Infection: RYSTIGGO may increase the risk of infection. In clinical studies, the most common infections were upper respiratory tract infections, COVID-19, urinary tract infections, and herpes simplex infections. Your healthcare provider should check you for infections before starting and during treatment with RYSTIGGO. Tell your healthcare provider if you have any history of infections. Tell your healthcare provider right away if you have signs or symptoms of an infection during treatment with RYSTIGGO. Some of the signs and symptoms may include fever, chills, frequent and/or painful urination, cough, runny nose, wheezing, shortness of breath, fatigue, sore throat, excess phlegm, nasal discharge, back pain, and/or chest pain.
- Aseptic Meningitis: RYSTIGGO could cause aseptic meningitis. Tell your healthcare provider right away if you develop any signs or symptoms of meningitis during treatment with RYSTIGGO such as severe headache, neck stiffness, drowsiness, fever, sensitivity to light, painful eye movements, nausea, and vomiting.
- Hypersensitivity Reactions: RYSTIGGO can cause swelling and rash. Your healthcare provider should monitor you during and after treatment and discontinue RYSTIGGO if needed. Tell your healthcare provider immediately about any undesirable reactions you experience after administration.
Please review the Important Safety Information for RYSTIGGO.
In the clinical trial, the most common side effects (reported in at least 10% of people receiving RYSTIGGO) were headache, infections, diarrhea, fever, hypersensitivity reactions, and nausea.
These are not all the possible side effects of RYSTIGGO. For more information, ask your healthcare provider or pharmacist. Tell your healthcare provider about any side effect that bothers you or that does not go away.
The use of vaccines during RYSTIGGO treatment has not been studied, and safety with live or live-attenuated vaccines is unknown. Administration of these vaccines is not recommended during RYSTIGGO treatment.
RYSTIGGO does not have a pre-treatment vaccination requirement. Your doctor will evaluate the need to give appropriate vaccines, based on vaccination guidelines, before a new RYSTIGGO treatment cycle begins.
Before taking RYSTIGGO, tell your healthcare provider if you are pregnant or plan to become pregnant, or are breastfeeding or plan to breastfeed. There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to RYSTIGGO during pregnancy. Patients or their healthcare providers may contact UCBCares® at 1‑844‑599‑CARE (2273) or email ucbcares@ucb.com, so that information about the exposure of RYSTIGGO during pregnancy and/or breastfeeding can be collected.
There are limited data on RYSTIGGO use during pregnancy to assess the risk of birth defects, miscarriage, or adverse maternal or fetal outcomes. There are no data on the presence of RYSTIGGO in human milk, the effects on breastfed infants, or the effects on milk production. Based on animal data, RYSTIGGO may cause fetal harm.