FAQs
Answers to common questions you may have about RYSTIGGO
FAQs
Answers to common questions you may have about RYSTIGGO
RYSTIGGO is a prescription medicine used to treat adults with generalized myasthenia gravis (gMG) who are anti-AChR (acetylcholine receptor) or anti-MuSK (muscle-specific tyrosine kinase) antibody positive.
RYSTIGGO works by targeting and blocking an immune system protein called FcRn (neonatal Fc receptor), an underlying cause of gMG. 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.
RYSTIGGO is different than other targeted treatments for gMG. It’s the first treatment that is FDA-approved to treat both anti-AChR and anti-MuSK antibody-positive gMG in adults.
Ask your healthcare provider if RYSTIGGO is right for you. Our Doctor Discussion Guide can help you get the conversation started.
In the RYSTIGGO clinical trial, RYSTIGGO was shown to significantly improve activities of daily living by the end of the
6-week treatment period; -3.4 points in the RYSTIGGO group (133 people) vs -0.8 for placebo (67 people).*
Improvements were seen in some participants as early as 1 week after the first dose.† Individual results may vary,
and not all people taking RYSTIGGO will experience improvements.
*As determined by improvement from baseline in the Myasthenia Gravis Activities of Daily Living score on Day 43 of the study.
†35% (23 out of 66 people) of the 7 mg/kg RYSTIGGO group and 38% (25 out of 66) of the 10 mg/kg RYSTIGGO group, compared to 24% (16 out of 67) of the placebo group.
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, infusion provider, and/or provider location.
*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.
†Infusion time may vary.
Most people will receive RYSTIGGO at an infusion center or their 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 during your infusion, your provider will stop RYSTIGGO administration and institute appropriate supportive measures.
Some people may be able to receive RYSTIGGO at home with nurse assistance. Eligibility for at-home infusions will be assessed by your doctor and may be based on your insurance coverage.
Your healthcare provider 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.
People receiving treatment may require repeated cycles to manage their gMG symptoms. The frequency of your RYSTIGGO treatment cycles and the length of your breaks will be based on individual treatment experience and medical evaluation.*
*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. Afterwards, resume the original dosing schedule until the full 6-week treatment cycle is completed.
In the RYSTIGGO 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 receiving RYSTIGGO, tell your doctor if you are pregnant or plan to become pregnant, or are breastfeeding or plan to breastfeed. 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.
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.