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CD19-DIRECTED CYTOLYTIC ANTIBODY
Uplizna (inebilizumab-cdon) is a prescription medication approved by the U.S. Food and Drug Administration (FDA) for treating adults with generalized myasthenia gravis.
Uplizna works by targeting CD19, a marker found on certain B cells, which are a kind of immune cell. B cells produce antibodies, but in myasthenia gravis these antibodies attack your own body and sometimes the connection between nerves and muscles. Uplizna leads to the breakdown of those B cells. By reducing the number of these B cells, Uplizna may help reduce that immune attack, which may help improve muscle strength and daily function.
The medication is given as an intravenous infusion, which means it is delivered into a vein by a healthcare professional. Treatment starts with two infusions given two weeks apart. After that, it is given once every six months. Doctors will decide how long patients will continue on.
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In clinical studies of Uplizna for generalized myasthenia gravis in adults who are anti-acetylcholine receptor (AChR) or anti-muscle specific tyrosine kinase (MuSK) antibody positive, the most common side effects occurred in about 7 percent to 15 percent of people. These side effects were reported more often in people who received Uplizna than in those who received placebo.
Uplizna can cause serious side effects that require immediate medical attention. These include:
Get medical help right away if you think you are having a serious reaction.
Amgen, the manufacturer of Uplizna, offers the Amgen Commercial Co-Pay Program. Eligible commercially insured people may pay as little as $0 out-of-pocket for Uplizna and infusion costs.
The Amgen By Your Side program also offers personalized, nonmedical support from a Patient Access Liaison (PAL), including help understanding insurance coverage criteria, the approval process, and cost assistance options. To learn more, visit AmgenByYourSide.com, or call 833-842-8477.
Before starting Uplizna, your doctor will test or check for:
Before starting Uplizna, talk with your doctor about vaccines. You should get any required vaccines at least four weeks before you start Uplizna, and live or live-attenuated vaccines are not recommended during treatment and after stopping until B cells recover.
Tell your doctor if you have any allergies to inebilizumab-cdon or any ingredients in Uplizna.
Tell your doctor about all medicines you take, including prescription drugs, over-the-counter medicines, and supplements.
Let your doctor know if you have had recent infections.
Do not take Uplizna if you have had a life-threatening reaction to Uplizna, have an active hepatitis B infection, or have active TB or untreated inactive (latent) TB.
Uplizna is also FDA approved to treat neuromyelitis optica spectrum disorder (NMOSD) and immunoglobulin G4-related disease (IgG4-RD).
If you are pregnant, planning to become pregnant, or breastfeeding while taking Uplizna, talk with your doctor about the potential risks. Those who can become pregnant should use effective birth control during treatment and for six months after the last infusion.
These answers are fact-checked by our editorial staff.
How effective is Uplizna?
In a study of adults with generalized myasthenia gravis who were anti-acetylcholine receptor or anti-muscle specific tyrosine kinase antibody positive, people taking Uplizna had a greater improvement in daily function scores at week 26 than those taking placebo. The average Myasthenia Gravis Activities of Daily Living (MG-ADL) score improved by 4.2 points with Uplizna compared with 2.2 points with placebo, a difference of 1.9 points. Muscle weakness scores also improved more with Uplizna: The average Quantitative Myasthenia Gravis (QMG) score improved by 4.8 points compared with 2.3 points with placebo, a difference of 2.5 points. These results show that Uplizna improved symptoms more than placebo over 26 weeks, but it does not mean it works the same way for everyone.
How long does Uplizna take to work for myasthenia gravis?
The study measured the results at week 26. There isn't any information on the exact earliest time people with myasthenia gravis started to feel improvement in this study.
How often is Uplizna taken for myasthenia gravis?
For generalized myasthenia gravis, Uplizna is given as an intravenous infusion. The starting treatment is 300 milligrams, followed two weeks later by a second 300-milligram infusion. After that, starting six months from the first infusion, it is given as a single 300-milligram infusion every six months. Each infusion takes about 90 minutes, and monitoring continues for at least one hour afterward.
Can Uplizna be used with other medicines for myasthenia gravis?
In the study of generalized myasthenia gravis, people were on stable doses of corticosteroids, certain nonsteroidal immunosuppressive therapies, or both. Uplizna taken before or after other medicines that weaken the immune system may increase the risk of infection.
On MGteam, people share their experiences with myasthenia gravis, get advice, and find support from others who understand.
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