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IMPORTANT SAFETY INFORMATION:
XATMEP® (methotrexate) Oral Solution, 2.5 mg/mL
Warning: Severe toxic reactions, including embryo-fetal toxicity
- Methotrexate can cause the following severe or fatal adverse reactions.
- Monitor closely and modify dose or discontinue methotrexate as appropriate.
- Bone marrow suppression (5.1)
- Serious infections (5.2)
- Renal toxicity and increased toxicity with renal impairment (5.3)
- Gastrointestinal toxicity (5.4)
- Hepatic toxicity (5.5)
- Pulmonary toxicity (5.6)
- Hypersensitivity and dermatologic reactions (5.7)
- Methotrexate can cause embryo-fetal toxicity, including fetal death. Use in pJIA is contraindicated in pregnancy. Consider the benefits and risks of XATMEP and risks to the fetus when prescribing XATMEP to a pregnant patient with a neoplastic disease. Advise females and males of reproductive potential to use effective contraception during and after treatment with XATMEP (4, 5.9, 8.1, and 8.3).
XATMEP is a folate analog metabolic inhibitor indicated for the:
- Treatment of pediatric patients with acute lymphoblastic leukemia (ALL) as part of a multi-phase, combination chemotherapy maintenance regimen.
- Management of pediatric patients with active polyarticular juvenile idiopathic arthritis (pJIA) who have had an insufficient therapeutic response to, or are intolerant of, an adequate trial of first-line therapy including full dose non-steroidal anti-inflammatory agents (NSAIDs).
The recommended Xatmep dose is to be taken once weekly. Daily use has resulted in fatal toxicity.
Xatmep Oral Solution should not be used if hypersensitive or allergic to methotrexate or any of the ingredients in Xatmep.
Xatmep Oral Solution should not be used during pregnancy in patients with pJIA.
Take Xatmep exactly as your doctor tells you.
An accurate dosing device should always be used. Ask your pharmacist for an accurate dosing device. A household teaspoon is not an accurate dosing device.
Ask your doctor about the risks to the fetus if you or your partner is taking Xatmep for the treatment of ALL.
Pregnancy should be avoided if either partner is taking Xatmep. Contraception should be used by both females and males while either is taking Xatmep and for 6 months after the last dose taken by females and 3 months after the last dose taken by males.
Xatmep Oral Solution should not be used when nursing.
Methotrexate may affect the ability to have children. Methotrexate may affect menstrual cycles and sperm count.
Discuss vaccinations and immunizations with your doctor prior to receiving them, as they may not be as effective, or should be avoided during methotrexate therapy.
Xatmep may cause severe side effects, including organ toxicity. Organ toxicity may include: bone marrow, kidneys, gastrointestinal, liver, lung, skin, soft tissue and bone. Secondary malignancies may occur. Your doctor will monitor you for signs and symptoms of toxicity during treatment.
Other side effects of methotrexate include:
- mouth sores
- abdominal distress
- decreased resistance to infection
- leukopenia (decrease in white blood cells)
These are not all the possible side effects of Xatmep. Your doctor or your patient’s doctor is the best source of advice about side effects.
Call your doctor immediately if you or your patient has any side effects that concern you or do not go away.
Tell your doctor about any other medications, including prescription and over-the-counter medications, supplements, vitamins, or herbal remedies you are taking. Make sure to visit your doctor regularly.
Ask your doctor about proper storage and disposal of dispensing bottles and dosing devices. Keep this and all medications out of reach of children.
This Important Safety Information does not include all the information needed to use XATMEP safely and effectively. Visit XATMEP.com for Full Prescribing Information.
To report SUSPECTED ADVERSE REACTIONS, contact Azurity Pharmaceuticals, Inc. at 1-855-379-0383, or FDA at 1-800-FDA-1088 or www.fda.gov/MedWatch.- - - - - - - - -