Are you getting the most out
NOW APPROVED: Otrexup (methotrexate) injection for subcutaneous use only.
Otrexup is the FIRST subcutaneous (SC) methotrexate (MTX) for self-administration delivered once weekly via auto injector, and is indicated for the management of patients with severe, active rheumatoid arthritis (RA) and polyarticular juvenile idiopathic arthritis (pJIA), who are intolerant of or had an inadequate response to first-line therapy and the symptomatic control of severe, recalcitrant, disabling psoriasis in adults who are not adequately responsive to other forms of therapy.
Stay tuned for exciting updates! Otrexup will be available to you in January 2014.
Important Safety Information and Boxed Warning
Otrexup™ (methotrexate) injection, for subcutaneous use
Otrexup is a single-dose auto-injector containing a prescription medicine, methotrexate. Methotrexate is used to:
- treat certain adults with severe, active rheumatoid arthritis (RA), 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.
Methotrexate includes the following boxed 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 birth defects. 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:
See “What is the most important information I should know about Otrexup?”
- 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.
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, 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.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. For more information, go to www.Otrexup.com or call 1-855-Otrexup (1-855-687-3987).
For full Prescribing Information, including boxed warning for MTX, please click here
About Antares Pharma
Antares Pharma is a specialty pharmaceutical company focused on the development and commercialization of self-administered parenteral pharmaceutical products and topical, gel-based medicines. Our proprietary subcutaneous self-administration technology platforms include pressure-assisted auto injectors, needle-free injectors, and multi-use pen injectors.
Antares Corporate Headquarters is located in Ewing, New Jersey, and our Parenteral Products Group is located in Minneapolis, Minnesota.
For more information, please visit AntaresPharma.com.