Arthritis/rheumatic disorders:
Indications for: XATMEP
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.
Adult Dosage:
Not applicable.
Children Dosage:
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:
Pregnancy in patients with non-malignant diseases.
Boxed Warning:
Severe toxic reactions. Embryo-fetal toxicity.
XATMEP 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 Classification:
Folate analogue inhibitor.
XATMEP 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.
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.
Generic Drug Availability:
NO
How Supplied:
Oral soln—120mL
Leukemias, lymphomas, and other hematologic cancers:
Indications for: XATMEP
Treatment of pediatrics with acute lymphoblastic leukemia (ALL) as part of a multi-phase, combination chemotherapy maintenance regimen.
Adult Dosage:
Not applicable.
Children Dosage:
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:
Pregnancy in patients with non-malignant diseases.
Boxed Warning:
Severe toxic reactions. Embryo-fetal toxicity.
XATMEP 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 Classification:
Folate analogue inhibitor.
XATMEP 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.
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.
Generic Drug Availability:
NO
How Supplied:
Oral soln—120mL
