Xatmep

XATMEP- methotrexate solution
Silvergate Pharmaceuticals, Inc.

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.

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)].

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 ( 5.15), 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 maintenance regimens, is 20 mg/m2 given one time weekly. After initiating XATMEP, continuation of appropriate dosing requires periodic monitoring of absolute neutrophil count (ANC) and platelet count to assure sufficient drug exposure (that is to maintain ANC at a desirable level) and to adjust for excessive hematological toxicity.

2.3 Polyarticular Juvenile Idiopathic Arthritis

The recommended starting dose of XATMEP is 10 mg/m2 given one time weekly.

Dosages should be tailored to the individual patient and adjusted gradually to achieve an optimal response. Although there is experience with doses up to 30 mg/m2 /week in pediatric patients, doses greater than 20 mg/m2 /week may result in a significant increase in the incidence and severity of serious toxic reactions, especially bone marrow suppression. Doses between 20 and 30 mg/m2 /week (0.65 to 1 mg/kg/week) may have better absorption and fewer gastrointestinal side effects if methotrexate is administered by an alternative route using another formulation.

Therapeutic response usually begins within 3 to 6 weeks and the patient may continue to improve for another 12 weeks or more.

Certain side effects such as mouth sores may be reduced by folate supplementation with methotrexate in pJIA.

2.4 Evaluations Prior to Starting Methotrexate

Assess hematologic, hepatic, and renal function before beginning, as well as periodically during and before reinstituting, therapy with XATMEP [see Warnings and Precautions (5.1, 5.3, 5.5, 5.7, 5.14)]. Exclude pregnancy in females of reproductive potential before starting XATMEP [see Contraindications (4), Warnings and Precautions ( 5.9), Use in Specific Populations (8.1, 8.3)].

2.5 Handling Information

XATMEP is a cytotoxic drug. Follow applicable special handling and disposal procedures.1

3 DOSAGE FORMS AND STRENGTHS

XATMEP is a clear yellow to orange oral solution that contains 2.5 mg of methotrexate per milliliter.

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)].

5 WARNINGS AND PRECAUTIONS

5.1 Bone Marrow Suppression

XATMEP suppresses hematopoiesis and can cause severe and life-threatening pancytopenia, anemia, leukopenia, neutropenia, and thrombocytopenia.

Obtain blood counts at baseline and periodically during treatment. Monitor patients for possible clinical complications of bone marrow suppression. Provide supportive care and modify dose or discontinue XATMEP as needed.

5.2 Serious Infections

Patients treated with XATMEP are at increased risk for developing life-threatening or fatal bacterial, fungal, or viral infections including opportunistic infections such as Pneumocystis jiroveci pneumonia, invasive fungal infections, hepatitis B reactivation, tuberculosis primary infection or reactivation, and disseminated Herpes zoster and cytomegalovirus infections.

Monitor patients for the signs and symptoms of infection during and after treatment with XATMEP and treat promptly. Consider dose modification or discontinuation of XATMEP in patients who develop serious infections [see Warnings and Precautions (5.1)].

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