BIOLOGICS
Rystiggo (rozanolixizumab) is a prescription medicine approved by the U.S. Food and Drug Administration (FDA) to treat adults with generalized myasthenia gravis (gMG).
Rystiggo works by blocking a protein called FcRn. This receptor helps keep certain antibodies, called IgG, in the blood. By blocking FcRn, Rystiggo lowers the level of IgG in your body. In gMG, some of these antibodies attack the place where nerves and muscles connect. Rystiggo lowers the level of harmful antibodies in your body. This helps stop them from attacking your muscles, which may improve muscle strength.
Doctors prescribe Rystiggo for people with gMG who test positive for anti-acetylcholine receptor or anti-muscle-specific tyrosine kinase antibodies. The medication is given as an under-the-skin infusion once a week for six weeks. It can only be prepared and given by a healthcare provider.
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In clinical studies of adults with gMG who were anti-acetylcholine receptor or anti-MuSK antibody positive, the most common side effects affected about 10 percent to 44 percent of people who took Rystiggo. These side effects were more common than in people who took a placebo (inactive treatment).
These side effects were reported in 20 percent to 44 percent of study participants:
These side effects were reported in 10 percent to 20 percent of study participants:
Rystiggo can cause serious side effects that need medical attention right away. These include:
Get medical help right away if you think you are having a serious reaction.
UCB, the manufacturer of Rystiggo, offers financial assistance through its Onward support program. Eligible people with commercial insurance may pay as little as $0 per dose.
The Onward program also provides help with insurance verification and information about financial assistance options. To learn more, visit the company’s website or call 844-669-2731.
Talk with your doctor about whether you need any age-appropriate vaccines before starting a new cycle of Rystiggo. Because Rystiggo lowers IgG levels, live vaccines are not recommended during treatment.
Tell your doctor if you have any allergies to rozanolixizumab-noli or any ingredients in Rystiggo, about all medicines you take, including prescription drugs, over-the-counter medicines, and supplements, and if you have had any recent infections.
If you miss a scheduled dose, Rystiggo may be given up to four days after the scheduled time. After the four-day window has passed, you should skip the missed dose and go back to your original dosing schedule until the treatment cycle is completed. If you miss a dose and are unsure what to do, contact your doctor or pharmacist.
If you are pregnant, planning to become pregnant, or breastfeeding while taking Rystiggo, talk with your doctor.
These answers are fact-checked by our editorial staff.
How effective is Rystiggo?
In a study of adults with gMG who were anti-acetylcholine receptor or anti-MuSK antibody positive, people treated once a week for six weeks had greater improvement by day 43 than those given a placebo. The Myasthenia Gravis Activities of Daily Living scale is based on what people report about how gMG symptoms affect everyday tasks. Scores on this scale improved by 3.4 points with Rystiggo versus 0.8 points with placebo. On the Quantitative Myasthenia Gravis scale, scores improved by 5.4 to 6.7 points with Rystiggo versus 1.9 points with placebo. Lower scores on both scales mean fewer symptoms and less muscle weakness.
How long does Rystiggo take to work for generalized myasthenia gravis?
In the main study, improvement was measured at day 43 after starting treatment. Rystiggo was given once a week for six weeks during that study period. Available information does not say exactly when people may first notice improvement.
Should I take Rystiggo if I have an infection or need vaccines for generalized myasthenia gravis?
Rystiggo should be delayed if you have an active infection, and people taking it should be monitored for signs and symptoms of infection during treatment. If a serious infection happens, treatment may be withheld until the infection has resolved. Live or live-attenuated vaccines are not recommended during treatment, and age-appropriate vaccines should be reviewed before starting a new treatment cycle with Rystiggo.
How often is Rystiggo taken for generalized myasthenia gravis?
Rystiggo is given as an under-the-skin infusion once a week for six weeks. Future treatment cycles depend on how you respond to the drug. It is not known whether it is safe to start another cycle less than 63 days after the last one began.
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