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Effective October 7, 2019
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Effective October 7, 2019
Rasuvo is a single-dose auto-injector containing a prescription medicine, methotrexate. Methotrexate is used to:
Rasuvo should not be used for the treatment of cancer.
Rasuvo should not be used for the treatment of children with psoriasis.
Rasuvo is available in doses of 7.5, 10, 12.5, 15, 17.5, 20, 22.5, 25, and 30 mg. Your doctor will prescribe a different way to take methotrexate if you need to take methotrexate by mouth or in some other way.
Organ system toxicity. People who use methotrexate for the treatment of cancer, psoriasis, or rheumatoid arthritis, have an increased risk of death from organ toxicity. Types of organ toxicity can include: gastrointestinal, nerve, bone marrow, lung, liver, kidneys, immune system, and skin.
Your doctor will do blood tests and other types of tests before you take and while you are taking Rasuvo to check for signs and symptoms of organ toxicity. Call your doctor right away if you have any of the following symptoms of organ toxicity: vomiting, neck stiffness, diarrhea, paralysis, mouth sores, irritability, fever, sleepiness, confusion, problems with coordination, weakness, dry cough, temporary blindness, trouble breathing, seizures, severe skin rash, headache, and back pain.
Women who are pregnant are at increased risk for death of the baby and for birth defects in the baby. Women who are pregnant or who plan to become pregnant must not take Rasuvo. A pregnancy test should be performed before starting Rasuvo. Contraception should be used by both females and males while taking Rasuvo. Pregnancy should be avoided if either partner is receiving Rasuvo:
Common side effects of Rasuvo include: nausea, stomach pain, indigestion (dyspepsia), mouth sores, and rash.
Do not take Rasuvo if you:
Before you take Rasuvo, tell your doctor if you have any other medical conditions. Tell your doctor about all of the medicines you take, including prescription medicines, over-the-counter medicines, vitamins, and herbal supplements.
Rasuvo may affect how other medicines work, and other medicines may affect how Rasuvo works, causing side effects. Ask your doctor or pharmacist for a list of medicines if you are not sure.
Tell your doctor if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of Rasuvo. For more information, ask your doctor or pharmacist.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.