Xatmep Generic Name & Formulations
Legal Class
Rx
General Description
Methotrexate 2.5mg/mL; oral soln.
Pharmacological Class
Folate analogue inhibitor.
How Supplied
Oral soln—120mL
Manufacturer
Generic Availability
NO
Xatmep Indications
Indications
Active polyarticular juvenile idiopathic arthritis (pJIA) in patients with insufficient response to, or are intolerant of, an adequate trial of first-line therapy including full dose NSAIDs.
Xatmep Dosage and Administration
Adult
Not applicable.
Children
For oral use only; use other methotrexate formulation if dosing via other routes required. Use accurate measuring device. Individualize. Initially 10mg/m2 once weekly; adjust dose gradually to achieve optimal response; usual max: 20mg/m2 per week. Folate supplementation may reduce mouth sores.
Xatmep Contraindications
Contraindications
Pregnancy in patients with non-malignant diseases.
Xatmep Boxed Warnings
Boxed Warning
Severe toxic reactions. Embryo-fetal toxicity.
Xatmep Warnings/Precautions
Warnings/Precautions
Be fully familiar with this drug's toxicity before use. Discontinue if secondary malignant lymphomas occur. Obtain baseline and monitor CBCs for bone marrow suppression, and hepatic, renal and pulmonary function; adjust dose, interrupt, or discontinue if needed. During therapy, monitor hematology at least monthly, renal and hepatic function every 1–2 months, more often during dose changes or when predisposed to toxicity (eg, dehydration). Increased risk of serious infections (eg, bacterial, fungal, viral) including opportunistic infections; monitor and treat promptly. Peptic ulcer disease. Ulcerative colitis. Avoid in chronic liver disease. Increased risk of hepatotoxicity with alcoholism, obesity, diabetes, hyperlipidemia, previous significant exposure to liver toxins, history of liver disease, family history of liver disease, persistent abnormal liver tests, treatment duration, advanced age. Discontinue if anaphylaxis, other serious hypersensitivity or severe dermatologic reactions occur. Evacuate significant third-space accumulations prior to administration. Embryo-fetal toxicity. Exclude pregnancy in females of reproductive potential; use effective contraception during therapy and for 6 months after final dose and for at least 3 months after final dose for men. Nursing mothers: not recommended.
Xatmep Pharmacokinetics
See Literature
Xatmep Interactions
Interactions
Avoid concomitant live virus vaccines, nitrous oxide. Severe hematologic and GI toxicity with concomitant NSAIDs, salicylates; caution. May be potentiated by penicillins (monitor) or probenecid (consider alternative). May potentiate theophylline. Increased bone marrow suppression with trimethoprim/sulfamethoxazole; monitor. Increased hepatotoxicity with concomitant other hepatotoxins (eg, azathioprine, retinoids, sulfasalazine); monitor. Increased risk of soft tissue necrosis and osteonecrosis with radiation therapy.
Xatmep Adverse Reactions
Adverse Reactions
Ulcerative stomatitis, leukopenia, nausea, abdominal distress, elevated liver function tests, malaise, fatigue, chills, fever, dizziness, decreased resistance to infection; bone marrow suppression, infections, renal toxicity, GI toxicity, hepatotoxicity, pulmonary toxicity, hypersensitivity, dermatologic reactions, secondary malignancies, infertility.
Xatmep Clinical Trials
See Literature
Xatmep Note
Not Applicable
Xatmep Patient Counseling
See Literature
Xatmep Generic Name & Formulations
Legal Class
Rx
General Description
Methotrexate 2.5mg/mL; oral soln.
Pharmacological Class
Folate analogue inhibitor.
How Supplied
Oral soln—120mL
Manufacturer
Generic Availability
NO
Xatmep Indications
Indications
Treatment of pediatrics with acute lymphoblastic leukemia (ALL) as part of a multi-phase, combination chemotherapy maintenance regimen.
Xatmep Dosage and Administration
Adult
Not applicable.
Children
For oral use only; use other methotrexate formulation if dosing via other routes required. Use accurate measuring device. Initially 20mg/m2 once weekly; adjust subsequent dosing based on ANC and platelet count.
Xatmep Contraindications
Contraindications
Pregnancy in patients with non-malignant diseases.
Xatmep Boxed Warnings
Boxed Warning
Severe toxic reactions. Embryo-fetal toxicity.
Xatmep Warnings/Precautions
Warnings/Precautions
Be fully familiar with this drug's toxicity before use. Discontinue if secondary malignant lymphomas occur. Obtain baseline and monitor CBCs for bone marrow suppression, and hepatic, renal and pulmonary function; adjust dose, interrupt, or discontinue if needed. During therapy, monitor hematology at least monthly, renal and hepatic function every 1–2 months, more often during dose changes or when predisposed to toxicity (eg, dehydration). Increased risk of serious infections (eg, bacterial, fungal, viral) including opportunistic infections; monitor and treat promptly. Peptic ulcer disease. Ulcerative colitis. Avoid in chronic liver disease. Increased risk of hepatotoxicity with alcoholism, obesity, diabetes, hyperlipidemia, previous significant exposure to liver toxins, history of liver disease, family history of liver disease, persistent abnormal liver tests, treatment duration, advanced age. Discontinue if anaphylaxis, other serious hypersensitivity or severe dermatologic reactions occur. Evacuate significant third-space accumulations prior to administration. Embryo-fetal toxicity. Exclude pregnancy in females of reproductive potential; use effective contraception during therapy and for 6 months after final dose and for at least 3 months after final dose for men. Nursing mothers: not recommended.
Xatmep Pharmacokinetics
See Literature
Xatmep Interactions
Interactions
Avoid concomitant live virus vaccines, nitrous oxide. Severe hematologic and GI toxicity with concomitant NSAIDs, salicylates; caution. May be potentiated by penicillins (monitor) or probenecid (consider alternative). May potentiate theophylline. Increased bone marrow suppression with trimethoprim/sulfamethoxazole; monitor. Increased hepatotoxicity with concomitant other hepatotoxins (eg, azathioprine, retinoids, sulfasalazine); monitor. Increased risk of soft tissue necrosis and osteonecrosis with radiation therapy.
Xatmep Adverse Reactions
Adverse Reactions
Ulcerative stomatitis, leukopenia, nausea, abdominal distress, elevated liver function tests, malaise, fatigue, chills, fever, dizziness, decreased resistance to infection; bone marrow suppression, infections, renal toxicity, GI toxicity, hepatotoxicity, pulmonary toxicity, hypersensitivity, dermatologic reactions, secondary malignancies, infertility.
Xatmep Clinical Trials
See Literature
Xatmep Note
Not Applicable
Xatmep Patient Counseling
See Literature