Xatmep 2.5 mg/mL
Methotrexate · SOLUTION · Azurity Pharmaceuticals, Inc.
Xatmep is a solution containing methotrexate at 2.5 mg/mL, taken oral. Manufactured by Azurity Pharmaceuticals, Inc..
Key Facts
- Brand Name
- Xatmep
- Generic Name
- Methotrexate
- NDC Code (Product)
52652-2001- Manufacturer
- Azurity Pharmaceuticals, Inc.
- Strength
- 2.5 mg/mL
- Dosage Form
- SOLUTION
- Route
- ORAL
- Marketing Status
- Application #
- NDA208400
- Marketing Start
- 05/01/2017
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE XATMEP is a folate analog metabolic inhibitor indicated for the: Treatment of pediatric patients with acute lymphoblastic leukemia (ALL) as a component of a combination chemotherapy maintenance regimen ( 1.1 ). Management of pediatric patients with active polyarticular juvenile idiopathic arthritis (pJIA) who are intolerant of or had an inadequate response to first-line therapy ( 1.2 ). 1.1 Acute Lymphoblastic Leukemia XATMEP is indicated for the treatment of pediatric patients with acute lymphoblastic leukemia (ALL) as part of a multi-phase, combination chemotherapy maintenance regimen. 1.2 Polyarticular Juvenile Idiopathic Arthritis XATMEP is indicated in 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).
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Use another formulation of methotrexate for patients requiring dosing via routes of administration other than oral ( 2.1 ). Measure with an accurate measuring device ( 2.1 ). Recommended Dosage: ALL: 20 mg/m 2 one time weekly ( 2.2 ). pJIA: Starting dose of 10 mg/m 2 one time weekly ( 2.3 ). 2.1 Important Administration Information XATMEP is intended for oral use only. Use another formulation of methotrexate for alternative dosing in patients who require dosing via other routes of administration. Instruct patients and caregivers that the recommended dose should be taken weekly, as directed, and that mistaken daily use of the recommended dose has led to fatal toxicity [see Warnings and Precautions ( 5.15 ), Overdosage ( 10 )]. It is important that XATMEP be measured with an accurate measuring device [see Warnings and Precautions ( 5.15 ), Patient Counseling Information ( 17 )] . A household teaspoon is not an accurate measuring device. A pharmacist can provide an appropriate device and can provide instructions for measuring the correct dose. 2.2 Acute Lymphoblastic Leukemia The recommended starting dose of XATMEP, in multi-agent combination chemotherapy m…
Contraindications
4 CONTRAINDICATIONS XATMEP is contraindicated in the following: Pregnancy in patients with non-malignant diseases. XATMEP can cause embryo-fetal toxicity and fetal death when administered during pregnancy [see Warnings and Precautions ( 5.9 ), Use in Specific Populations ( 8.1 )] . Patients with severe hypersensitivity to methotrexate [see Warnings and Precautions ( 5.7 ), Adverse Reactions ( 6.1 , 6.2 )] . Pregnancy (patients with pJIA) ( 4 ). Severe hypersensitivity to methotrexate ( 4 ).
Drug Interactions
7 DRUG INTERACTIONS Oral Antibiotics: May increase hematologic and gastrointestinal toxicity. Monitor patients accordingly ( 7.1 ). Nitrous Oxide: May increase the risk of toxicity ( 7.1 ). NSAIDs, Aspirin, and Steroids: May elevate and prolong serum methotrexate levels and increase gastrointestinal toxicity. Monitor patients accordingly ( 7.1 ). 7.1 Effect of Other Drugs on XATMEP Oral Antibiotics Penicillins may reduce the renal clearance of methotrexate; increased serum concentrations of methotrexate with concomitant hematologic and gastrointestinal toxicity have been observed with methotrexate. Monitor patients accordingly [see Warnings and Precautions ( 5.1 , 5.4 )] . Trimethoprim/sulfamethoxazole has been reported to increase bone marrow suppression in patients receiving methotrexate. Monitor patients accordingly [see Warnings and Precautions ( 5.1 )] . Hepatotoxins The potential for increased hepatotoxicity when methotrexate is administered with other hepatotoxic agents has not been evaluated; however, hepatotoxicity has been reported in such cases. Monitor patients receiving XATMEP with other potential hepatotoxins (e.g., azathioprine, retinoids, and sulfasalazine) for poss…
Adverse Reactions
6 ADVERSE REACTIONS The following adverse reactions are discussed in more detail in other sections of the labeling. 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 )] Secondary Malignancies [see Warnings and Precautions ( 5.8 )] Ineffective Immunization and Risks Associated with Live Vaccines [see Warnings and Precautions ( 5.10 )] Infertility [see Warnings and Precautions ( 5.11 )] Increased Toxicity Due to Third‑Space Accumulation [see Warnings and Precautions ( 5.12 )] Soft Tissue and Bone Toxicity with Radiation Therapy [see Warnings and Precautions ( 5.13 )] Most common adverse reactions are: ulcerative stomatitis, leukopenia, nausea, abdominal distress, and elevated liver function tests. Other frequently reported adverse reactions are malaise, fatigue, …
Frequently Asked Questions
What is Xatmep used for?
Xatmep contains Methotrexate. It is a solution taken oral. Consult your doctor for specific uses.
Is Xatmep a controlled substance?
Xatmep is not classified as a controlled substance by the DEA.
What is the generic name for Xatmep?
The generic name for Xatmep is Methotrexate. There are 11 other brand versions of Methotrexate.
What is the NDC code for Xatmep 2.5 mg/mL?
The NDC (National Drug Code) for Xatmep 2.5 mg/mL is 52652-2001, listed by Azurity Pharmaceuticals, Inc..