IMPORTANT SAFETY INFORMATION
This information should not take the place of talking to your doctor about your condition and treatment.
WARNING: SEVERE TOXIC REACTIONS, INCLUDING EMBRYO-FETAL TOXICITY
Methotrexate can cause the following severe or fatal adverse reactions.
- Bone marrow suppression [see Warnings and Precautions (5.1)]
- Serious infections [see Warnings and Precautions (5.2) ]
- Renal toxicity and increased toxicity with renal impairment [see Warnings and Precautions (5.3)]
- Gastrointestinal toxicity [see Warnings and Precautions (5.4)]
- Hepatic toxicity [see Warnings and Precautions (5.5)]
- Pulmonary toxicity [see Warnings and Precautions (5.6)]
- Hypersensitivity and dermatologic reactions [see Warnings and Precautions (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 [see Contraindications (4), Warnings and Precautions (5.9), Use in Specific Populations (8.1, 8.3)].
Monitor closely and modify dose or discontinue methotrexate as appropriate.
INDICATIONXatmep is a folate analog metabolic inhibitor indicated for the:
- 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).
- treatment of pediatric patients with acute lymphoblastic leukemia (ALL) as part of a multi-phase, combination chemotherapy maintenance regimen.
- mouth sores
- abdominal distress
- decreased resistance to infection
- leukopenia (decrease in white blood cells)
ADDITIONAL IMPORTANT SAFETY INFORMATION
The recommended Xatmep dose is to be taken once weekly. Daily use has resulted in fatal toxicity.
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.
Xatmep includes a Boxed Warning for severe toxicity, including embryo-fetal toxicity and fetal death.
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 or when nursing.
Ask your doctor about the risks to the fetus you or your partners taking Xatmep for the treatment of pJIA.
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 last dose taken by males.
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:
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.
Keep this and all medications out of the reach of children.
Ask your doctor or pharmacist about proper storage and disposal of dispensing bottles and dosing devices.
See full Prescribing Information for further information, including Boxed Warning.
To report SUSPECTED ADVERSE REACTIONS, contact Silvergate Pharmaceuticals at 1-855-379-0383, or FDA at 1-800-FDA-1088 or www.fda.gov/MedWatch.