- 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 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, and 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.
- 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.
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 you 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). About Antares Pharma Antares Pharma focuses on self-administered parenteral pharmaceutical products and topical gel-based medicines. The Company has received marketing approval from the U.S. Food and Drug Administration for OTREXUP ™ (methotrexate) injection for the treatment of adults with severe active rheumatoid arthritis, children with active polyarticular juvenile idiopathic arthritis and adults with severe recalcitrant psoriasis. Antares Pharma is also developing VIBEX ® QS T for testosterone replacement therapy. The Company's technology platforms include VIBEX ® disposable Medi-Jet ™, disposable multi-use pen injectors and Vision ™ reusable needle-free injectors marketed as Tjet ® and Zomajet ® by Teva Pharmaceutical Industries, Ltd (Teva) and Ferring Pharmaceuticals (Ferring), respectively. Antares Pharma has a multi-product deal with Teva that includes Tev-Tropin ® [somatropin (rDNA origin) for injection] human growth hormone (hGH), VIBEX ® epinephrine and several other products. Antares Pharma’s partnership with Ferring includes Zomacton ® hGH (somatropin) injection. In the U.S. Antares has received FDA approval for Gelnique 3% ™ (oxybutynin) gel, a treatment for overactive bladder that is marketed by Actavis. Elestrin ® (estradiol gel) is FDA approved for the treatment of moderate-to-severe vasomotor symptoms associated with menopause, and is marketed in the U.S. by Meda Pharma. Antares Pharma has two facilities in the U.S. The Parenteral Products Group located in Minneapolis, Minnesota directs the manufacturing and marketing of the Company’s reusable needle-free injection devices and related disposables, and develops its disposable pressure-assisted Medi-Jet and pen injector systems. The Company’s corporate office and Product Development and Commercial Groups are located in Ewing, New Jersey. Forward-Looking Statement This press release contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements are indicated by the words “may,” “will,” “plans,” “intends,” “believes,” “expects,” “anticipates,” “potential,” “could,” “would,” “should,” and similar expressions and include statements regarding our expectations regarding the utility of OTREXUP ™ in rheumatoid arthritis. Such forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that may cause actual results to differ materially from those anticipated by the forward-looking statements. These risks and uncertainties include, among others, difficulties or delays in the commercial launch of OTREXUP ™, market acceptance by physicians and patients of new products, delays in product development and changes or delays in the regulatory process for existing or new product candidates. Additional information concerning these and other factors that may cause actual results to differ materially from those anticipated in the forward-looking statements is contained in the "Risk Factors" section of the Company's Annual Report on Form 10-K for the year ended December 31, 2012, and in the Company's other periodic reports and filings with the Securities and Exchange Commission. The Company cautions investors not to place undue reliance on the forward-looking statements contained in this press release. All forward-looking statements are based on information currently available to the Company on the date hereof, and the Company undertakes no obligation to revise or update these forward-looking statements to reflect events or circumstances after the date of this press release, except as required by law.