Generic Name: methotrexate
Trade Name: Rasuvo®, Otrexup®
For which conditions is Rasuvo approved for? Rasuvo is approved to treat adults with severe, active rheumatoid arthritis (RA) and for children with active polyarticular juvenile idiopathic arthritis (pJIA). Rasuvo is approved for use after other medicines, including non-steroidal anti-inflammatory drugs, have been used and did not work well. Rasuvo is not be used for the treatment of cancer. OTREXUP IS NOT FDA APPROVED FOR USE IN CANCER.
What is the mechanism of action? Rasuvo inhibits the activity in the body of a folic acid called dihydrofolic acid reductase. In doing so, it is thought that Rasuvo helps control tissue damage in RA by affecting immune function.
How is Rasuvo typically given (administered)? You’ll take Rasuvo as injection with a single-dose, prefilled auto-injector.
How are patients typically monitored? During treatment with Rasuvo, your doctor will check your blood counts and the function of your gastrointestinal system, immune system, liver, nervous system, lungs, and kidneys as well the health your skin.
What are some of the side effects (occur in 10% to 29% of patients) of treatment with Rasuvo?
- Problems with liver function
This is not a complete list of side effects. Some patients may experience other side effects that are not listed here. Patients may wish to discuss with their physician the other less common side effects of this drug, some of which may be serious.
Some side effects may require medical attention. Other side effects do not require medical attention and may go away during treatment. Patients should check with their physician about any side effects that continue or are bothersome.
What can patients do to help alleviate or prevent discomfort and side effects?
- Tell your doctor about any other medical conditions you have.
- Tell your doctor about all of the medicines you take, including prescription, over-the-counter medicines, vitamins, and herbal supplements.
- Keep a list of all the medicines you take to show your doctor and pharmacist when you get a new medicine.
- Take Rasuvo exactly as your doctor tells you to take it. This includes carefully following your doctor’s instructions for injecting Rasuvo.
- Do not drink alcohol while you are taking Rasuvo. Drinking alcohol can increase your chances of getting serious side effects.
- Individuals with the following conditions should not take Rasuvo: alcohol problems; liver problems; problems fighting infection; people who have (or think they have) a blood disorder, such as low levels of white blood cells, red blood cells (anemia), or platelets; allergy to methotrexate or any of the ingredients in Rasuvo (sodium chloride, sodium hydroxide and water for injection, sometimes hydrochloric acid).
Are there any special precautions patients should be aware of before starting treatment?
- You should avoid certain vaccinations while you’re taking Rasuvo. Talk to your doctor before you or members of your household receive any vaccines.
- Be aware that Rasuvo can cause dizziness and tiredness. Until you know how Rasuvo affects you, do not drive a car, operate machinery, or do anything that requires you to be alert.
- Women should avoid becoming pregnant during treatment with Rasuvo. Rasuvo carries an increased risk for death of the baby and birth defects. Women should take a pregnancy test before starting Rasuvo.
- Both men and women should use effective birth control during treatment with Rasuvo. Men should continue to use birth control for at least three months after finishing treatment. Women should continue to use birth control for at least one menstrual cycle after finishing treatment.
- Women should not breast feed while taking Rasuvo. Rasuvo can pass into your breast milk and may harm your baby. If you are breastfeeding and planning treatment with Rasuvo, talk to your doctor about the best way to feed your baby during treatment.
When should patients notify their physician?
Call your doctor right away if you have the following symptoms of problems with your organs:
- Mouth sores
- Neck stiffness
- Problems with coordination
- Dry cough
- Temporary blindness
- Back pain
- Trouble breathing
- Severe skin rash
What is a package insert?
A package insert is required by the FDA and contains a summary of the essential scientific information needed for the safe and effective use of the drug for healthcare providers and consumers. A package insert typically includes information regarding specific indications, administration schedules, dosing, side effects, contraindications, results from some clinical trials, chemical structure, pharmacokinetics and metabolism of the specific drug. By carefully reviewing the package insert, you will get the most complete and current information about how to safely use this drug. If you do not have the package insert for the drug you are using, your pharmacist or physician may be able to provide you with a copy.
Important Limitations of Use
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