Use: Lumvoa is a prescription medicine used to treat Thyroid Eye Disease (TED), no matter if you’ve had TED for months or years.
What is the most important information I should know about Lumvoa?
Infusion reactions can happen during or soon after your infusion of Lumvoa. Tell your doctor or nurse right away if you have any of these symptoms during or after your treatment with Lumvoa:
High blood pressure
Feeling hot
Chills
Headache
Tiredness
Lumvoa may worsen inflammatory bowel disease (IBD), such as Crohn’s disease or ulcerative colitis. Tell your doctor right away if you have worsening IBD symptoms, which may include diarrhea with stomach pain or cramps, blood in your stools, sudden urgency to have a bowel movement, or feeling like you need to have a bowel movement even when there’s little or no stool to pass.
Lumvoa may cause an increase in your blood sugar. Before starting treatment with Lumvoa, tell your doctor if you have high blood sugar or if you have diabetes. It is important for you to take your treatments and follow an appropriate diet for glucose control as prescribed by your doctor.
Lumvoa may cause severe hearing problems including hearing loss, which in some cases may be permanent. Tell your doctor if you have any signs or symptoms of hearing problems or changes in hearing.
Before receiving Lumvoa, tell your doctor if you:
Have inflammatory bowel disease (Crohn’s disease or ulcerative colitis).
Have diabetes or know your blood sugar is high.
Are pregnant or plan to become pregnant. Lumvoa may harm your unborn baby. Tell your doctor if you become pregnant or suspect you are pregnant during treatment with Lumvoa. Women who are able to become pregnant should use an effective form of birth control (contraception) prior to starting treatment, during treatment, and for 6 months after the final dose of Lumvoa.
Are breastfeeding or plan to breastfeed. It is not known if Lumvoa passes into your breast milk. Talk to your doctor about the best ways to feed your baby during treatment with Lumvoa.
All the medicines you take, including prescription and over-the-counter medicines, vitamins, and dietary and herbal supplements. Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.
What are the possible side effects of Lumvoa?
The most common side effects of Lumvoa include muscle cramps or spasms, headache, hearing problems, high blood sugar, tiredness, diarrhea, ear discomfort, infusion reactions, nausea, cold-like symptoms, increases in a blood enzyme called creatine phosphokinase, dry skin, and high blood pressure.
This is not a complete list of all possible side effects. Tell your doctor or treatment team about any side effect you may have. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/safety/medwatch, or call 1-800-FDA-1088.
Lumvoa (500 mg) is an injection for infusion.
Please see accompanying Full Prescribing Information.
