Xatmep

What is Xatmep?

Xatmep (methotrexate) is a folate analog metabolic inhibitor used for the treatment of:

• pediatric patients with acute lymphoblastic leukemia (ALL)
• pediatric patients with active polyarticular juvenile idiopathic arthritis (pJIA)

Methotrexate

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What are the uses of this medicine?

Xatmep (methotrexate) is used for:

• Treatment of pediatric patients with acute lymphoblastic leukemia (ALL) as part of a multi-phase, combination chemotherapy maintenance regimen.
• 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).

How does this medicine work?

• Methotrexate acts by inhibition of folate metabolism, blocking dihydrofolic acid reductase, thereby inhibiting synthesis of purines and pyrimidines and decreasing DNA and RNA synthesis.
• The mechanism of action in pJIA is unknown; it may affect immune function.
• Methotrexate is considered a disease modifying antirheumatic drug (DMARD) and used widely in rheumatoid arthritis and other autoimmune diseases.

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

• pregnant women with non-malignant disease
• severe hypersensitivity to methotrexate

What drug interactions can this medicine cause?

Avoid coadministration with:

• Oral Antibiotics
• Nitrous Oxide
• NSAIDs, Aspirin, and Steroids

Is this medicine FDA approved?

• Methotrexate was approved for use in cancer in the United States in 1955, for psoriasis in 1972 and rheumatoid arthritis in 1988 and is still widely used for these indications.

How should this medicine be used?

Recommended dosage: Acute Lymphoblastic Leukemia:

• 20 mg/m2 one time weekly.

Polyarticular Juvenile Idiopathic Arthritis:

• Starting dose of 10 mg/m2 one time weekly.

Administration:

• 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.
• The recommended dose should be taken weekly, as directed, and that mistaken daily use of the recommended dose has led to fatal toxicity.
• 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.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Oral solution: 2.5 mg/mL

This medicine is available in fallowing brand namesː

• Xatmep

What side effects can this medication cause?

The most common side effects of this medicine include:

• ulcerative stomatitis
• leukopenia
• nausea
• abdominal distress
• elevated liver function tests

Other side effects may include:

• malaise
• fatigue
• chills and fever
• dizziness
• decreased resistance to infection

What special precautions should I follow?

• 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.
• Patients treated with Xatmep are at increased risk for developing life-threatening or fatal bacterial, fungal, or viral 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.
• Xatmep can cause renal damage including acute renal failure. Monitor renal function to decrease the risk of renal injury and mitigate renal toxicity. Consider administration of glucarpidase.
• Xatmep can cause diarrhea, vomiting, stomatitis, hemorrhagic enteritis, and fatal intestinal perforation. Patients with peptic ulcer disease or ulcerative colitis are at a greater risk of developing severe gastrointestinal adverse reactions. Interrupt or discontinue Xatmep and institute appropriate supportive care as needed.
• Xatmep can cause severe and potentially irreversible hepatotoxicity including fibrosis, cirrhosis, and fatal liver failure. Avoid use of Xatmep in patients with chronic liver disease.
• Methotrexate-induced pulmonary toxicity including acute or chronic interstitial pneumonitis and irreversible or fatal cases can occur at all dose levels. Monitor patients for signs of pulmonary toxicity and interrupt or discontinue Xatmep as appropriate.
• Severe, including fatal, dermatologic reactions, such as toxic epidermal necrolysis, Stevens-Johnson syndrome, exfoliative dermatitis, skin necrosis, erythema multiforme, can occur with methotrexate. Discontinue Xatmep if severe dermatologic reactions occur.
• Secondary malignancies can occur. In case of immunosuppression-associated lymphoma, discontinue methotrexate before starting treatment for lymphoma.
• Based on published reports and methotrexate’s mechanism of action, methotrexate can cause embryo-fetal toxicity and fetal death when administered to a pregnant woman. Advise females of reproductive potential to use effective contraception during therapy and for 6 months after the final dose. Advise males of reproductive potential to use effective contraception during and for at least 3 months after the final methotrexate dose.
• Immunizations may be ineffective. Immunization with live virus vaccines is not recommended.
• Methotrexate may cause impairment of fertility, oligospermia and menstrual dysfunction.
• Concomitant radiation therapy increases the risk of soft tissue necrosis and osteonecrosis associated with methotrexate.
• Advise patients to measure Xatmep with an accurate milliliter measuring device. Inform patients that a household teaspoon is not an accurate measuring device and could lead to overdosage, which can result in serious adverse reactions.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• leukopenia
• thrombocytopenia
• anemia
• pancytopenia
• bone marrow suppression
• mucositis
• stomatitis
• oral ulceration
• nausea
• vomiting
• gastrointestinal ulceration
• gastrointestinal bleeding

Management of overdosage:

• Leucovorin and levoleucovorin are indicated to diminish the toxicity and counteract the effect of inadvertently administered overdosages of methotrexate.
• Glucarpidase is indicated for the treatment of toxic methotrexate concentrations in patients with delayed methotrexate clearance due to impaired renal function.
• Hydration and urinary alkalinization may be necessary to prevent the precipitation of methotrexate.
• Neither hemodialysis nor peritoneal dialysis has been shown to improve methotrexate elimination.
• Clearance of methotrexate has been reported with acute, intermittent hemodialysis using a high-flux dialyzer.

Can this medicine be used in pregnancy?

• Based on published reports and methotrexate’s mechanism of action, methotrexate is a teratogen that can cause embryo-fetal toxicity and fetal death when administered to a pregnant woman.
• In pregnant women with non-malignant disease, Xatmep is contraindicated.

Can this medicine be used in children?

• Safety and effectiveness of Xatmep in pediatric patients have been established.

What are the active and inactive ingredients in this medicine?

Active ingredient:

• METHOTREXATE

Inactive ingredients:

• WATER
• SODIUM CITRATE, UNSPECIFIED FORM
• CITRIC ACID MONOHYDRATE
• METHYLPARABEN SODIUM
• PROPYLPARABEN SODIUM
• SUCRALOSE
• SODIUM HYDROXIDE
• HYDROCHLORIC ACID

Who manufactures and distributes this medicine?

Manufactured for:

• Azurity Pharmaceuticals, Inc.
• Wilmington, MA USA

What should I know about storage and disposal of this medication?

• Store Xatmep refrigerated (2°C to 8°C/36°F to 46°F) tightly closed in the original container prior to dispensing.
• Once dispensed, patients may store Xatmep either refrigerated (2°C to 8°C/36°F to 46°F) or at room temperature (20°C to 25°C/68°F to 77°F) with excursions permitted to 15°C to 30°C/59°F to 86°F.
• If stored at room temperature, discard after 60 days.
• Avoid freezing and excessive heat.

• Dailymed label info on Xatmep
• FDA Xatmep

Xatmep Resources
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