Rx Item-Xatmep (Methotrexate Sodium) 4oz Oral 2.5 Mg/Ml By Silvergate Pharma

solution , clear , yellow
yellow to orange
XATMEP- methotrexate solution
Silvergate Pharmaceuticals, Inc.

For: Acute Lymphoblastic Leukemia, Juvenile Idiopathic Arthritis

Xatmep (methotrexate) is a folate analog metabolic inhibitor in an oral solution formulation indicated for the treatment of pediatric patients with acute lymphoblastic leukemia (ALL) and for the management of pediatric patients with active polyarticular juvenile idiopathic arthritis. 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.

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Bone marrow suppression [see Warnings and Precautions (5.1)]
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Serious infections [see Warnings and Precautions (5.2)]
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Renal toxicity and increased toxicity with renal impairment [see Warnings and Precautions (5.3)]
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Gastrointestinal toxicity [see Warnings and Precautions (5.4)]
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Hepatic toxicity [see Warnings and Precautions (5.5)]
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Pulmonary toxicity [see Warnings and Precautions (5.6)]
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Hypersensitivity and dermatologic reactions [see Warnings and Precautions (5.7)]
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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)].
1 INDICATIONS AND USAGE

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).

2 DOSAGE AND ADMINISTRATION

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 (5.5), Overdosage (10)].

It is important that XATMEP be measured with an accurate measuring device [see Warnings and Precautions (5.5), 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.

XATMEP (METHOTREXATE SODIUM)
XATMEP (METHOTREXATE SODIUM) ORAL 2.5 MG/ML by Silvergate Pharma item No.:RX678714 NDC No. 52652200101 UPC No.:352652200117 NDC No. 52652-2001-01 52652-2001-1 5265220011 52652200101 UPC/GTIN No.3-52

XATMEP (METHOTREXATE SODIUM)
XATMEP (METHOTREXATE SODIUM) ORAL 2.5 MG/ML by Silvergate Pharma

XATMEP (METHOTREXATE SODIUM)
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XATMEP (METHOTREXATE SODIUM)
XATMEP (METHOTREXATE SODIUM) ORAL 2.5 MG/ML by Silvergate Pharma item No.:RX678714 NDC No. 52652200101 UPC No.:352652200117 NDC No. 52652-2001-01 52652-2001-1 5265220011 52652200101 UPC/GTIN No.3-52

XATMEP (METHOTREXATE SODIUM)
XATMEP (METHOTREXATE SODIUM) ORAL 2.5 MG/ML by Silvergate Pharma