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Otrexup (methotrexate) injection, for subcutaneous use, is now approved.
OTREXUP is indicated in:
Did you know:
Subcutaneously injected methotrexate may deliver better blood levels than oral methotrexate.1 An innovation in technology now makes it easier to get the benefits of subcutaneous methotrexate.2
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. For more information, go to www.otrexup.com or call 1-855-Otrexup (1-855-687-3987).
Indications and Important Safety Information Including Boxed Warning
Otrexup is a single-dose auto-injector containing a prescription medicine, methotrexate. Methotrexate is used to:
- Treat certain adults with severe, active rheumatoid arthritis, and children with active polyarticular juvenile idiopathic arthritis (pJIA), after treatment with other medicines including non-steroidal anti-inflammatory (NSAIDS) have been used and did not work well.
- Control the symptoms of severe, resistant, disabling psoriasis in adults when other types of treatment have been used and did not work well.
Otrexup should not be used for the treatment of cancer.
Otrexup should not be used for the treatment of children with psoriasis.
This product includes the following Black Box Warning:
Otrexup can cause serious side effects that can lead to death, including:
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, bone marrow, liver, immune system, nerve, lung, kidneys, and skin.
Your doctor will do blood tests and other types of tests before you take and while you are taking Otrexup 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, diarrhea, mouth sores, fever, confusion, weakness, temporary blindness, seizures, headache, back pain, neck stiffness, paralysis, irritability, sleepiness, problems with coordination, dry cough, trouble breathing, and severe skin rash.
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 Otrexup. A pregnancy test should be performed before starting Otrexup.
Contraception should be used by both females and males while taking Otrexup. Pregnancy should be avoided if either partner is receiving Otrexup:
- For a minimum of 3 months after treatment with Otrexup for males.
- During and for at least 1 menstrual cycle after treatment with Otrexup for females.
What are the possible side effects of Otrexup?
Otrexup may cause serious side effects, including:
- Fertility problems. Methotrexate, the active ingredient in Otrexup, may affect your ability to have a baby. Males may have a decreased sperm count, and females may have changes to their menstrual cycle. This can happen while taking Otrexup and for a short period of time after you stop.
- Certain cancers. Some people who have taken methotrexate have had a certain type of cancer called Non-Hodgkin’s lymphoma and other tumors. Your doctor may tell you to stop taking Otrexup if this happens.
- Tissue and bone problems. Taking Methotrexate while having radiation therapy may increase the risk of your tissue or bone not receiving enough blood. This may lead to death of the tissue or bone.
Common side effects of Otrexup include: nausea, stomach pain, indigestion (dyspepsia), mouth sores, and rash.
Who should not take Otrexup?
Do not take Otrexup if you:
- Are pregnant or planning to become pregnant
- Are breastfeeding; Otrexup can pass into your breast milk and may harm your baby
- Have alcohol problems (alcoholism)
- Have liver problems
- Have problems fighting infection (immunodeficiency syndrome)
- Have been told you have (or think you have) a blood disorder such as low levels of white blood cells, red blood cells (anemia), or platelets
- Have had an allergy to methotrexate or any of the ingredients in Otrexup
What should I tell my doctor before taking Otrexup?
Before you take Otrexup, 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.
Otrexup may affect how other medicines work, and other medicines may affect how Otrexup 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 Otrexup. 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.
For more information, go to www.otrexup.com or call 1-855-Otrexup (1-855-687-3987).
- Otrexup [package insert]. Ewing, NJ: Antares Pharma Inc.; 2013.
- Kivitz A, McLain D, Hill J, et al. “Nearly pain-free self-administration of methotrexate using an investigational auto-injector: Results of a phase-2 clinical trial in rheumatoid arthritis patients with mild-to-severe functional limitations.” Poster presented at: American College of Rheumatology Annual Meeting: October 26-30, 2013; San Diego, California. Poster 1337.