Xatmep

Last updated on RxList: 11/5/2020
Xatmep Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Xatmep?

Xatmep (methotrexate) oral solution 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; and for management of pediatric patients with active polyarticular juvenile idiopathic arthritis (pJIA) who are intolerant of or had an inadequate response to first-line therapy.

What Are Side Effects of Xatmep?

Common side effects of Xatmep include:

  • ulcerative stomatitis,
  • low white blood cell count (leukopenia),
  • nausea,
  • abdominal distress,
  • elevated liver function tests,
  • feeling unwell (malaise),
  • fatigue,
  • chills and fever,
  • dizziness and decreased resistance to infection.

Dosage for Xatmep

The recommended dosage of Xatmep to treat ALL is 20 mg/m2 one time weekly. The recommended dosage of Xatmep to treat pJIA is a starting dose of 10 mg/m2 one time weekly.

What Drugs, Substances, or Supplements Interact with Xatmep?

Xatmep may interact with oral antibiotics, hepatotoxins (e.g., azathioprine, retinoids, and sulfasalazine), probenecid, and theophylline. Tell your doctor all medications and supplements you use.

Xatmep During Pregnancy and Breastfeeding

Xatmep is not recommended for use during pregnancy; it may harm a fetus. Small amounts of Xatmep are believed to pass into breast milk. Because of the potential for adverse effects on nursing infants, breastfeeding while using Xatmep is not recommended.

Additional Information

Our Xatmep (methotrexate) Oral Solution Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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Xatmep Consumer Information

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Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning in your eyes, skin pain, red or purple skin rash that spreads and causes blistering and peeling).

Methotrexate can cause serious or fatal side effects. Call your doctor at once if you have:

  • sudden chest pain, wheezing, dry cough, cough with mucus, chest pain, feeling short of breath;
  • fever, chills, swollen lymph glands, night sweats, weight loss;
  • blisters or ulcers in your mouth, red or swollen gums, trouble swallowing;
  • vomiting, diarrhea, blood in your urine or stools;
  • skin changes such as redness, warmth, swelling, or oozing;
  • low blood cell counts--fever, chills, tiredness, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath;
  • kidney problems--little or no urination, swelling in your feet or ankles;
  • liver problems--swelling around your midsection, right-sided upper stomach pain, nausea, loss of appetite, dark urine, jaundice (yellowing of the skin or eyes);
  • nerve problems--confusion, weakness, drowsiness, coordination problems, feeling irritable, headache, neck stiffness, vision problems, loss of movement in any part of your body, seizure; or
  • signs of tumor cell breakdown--tiredness, weakness, muscle cramps, nausea, vomiting, diarrhea, fast or slow heart rate, tingling in your hands and feet or around your mouth.

Common side effects may include:

  • fever, chills, tiredness, not feeling well;
  • low blood cell counts;
  • mouth sores;
  • nausea, stomach pain;
  • abnormal liver function tests;
  • hair loss;
  • burning skin lesions; or
  • being more sensitive to light.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Xatmep (Methotrexate Oral Solution)

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Xatmep Professional Information

SIDE EFFECTS

The following adverse reactions are discussed in more detail in other sections of the labeling.

  • Bone Marrow Suppression [see WARNINGS AND PRECAUTIONS]
  • Serious Infections [see WARNINGS AND PRECAUTIONS]
  • Renal Toxicity and Increased Toxicity with Renal Impairment [see WARNINGS AND PRECAUTIONS]
  • Gastrointestinal Toxicity [see WARNINGS AND PRECAUTIONS]
  • Hepatic Toxicity [see WARNINGS AND PRECAUTIONS]
  • Pulmonary Toxicity [see WARNINGS AND PRECAUTIONS]
  • Hypersensitivity and Dermatologic Reactions [see WARNINGS AND PRECAUTIONS]
  • Secondary Malignancies [see WARNINGS AND PRECAUTIONS]
  • Ineffective Immunization and Risks Associated with Live Vaccines [see WARNINGS AND PRECAUTIONS]
  • Infertility [see WARNINGS AND PRECAUTIONS]
  • Increased Toxicity Due to Third–Space Accumulation [see WARNINGS AND PRECAUTIONS]
  • Soft Tissue and Bone Toxicity with Radiation Therapy [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug, and may not reflect the rates observed in practice.

The most frequently reported adverse reactions include ulcerative stomatitis, leukopenia, nausea, and abdominal distress. Other frequently reported adverse reactions are malaise, fatigue, chills, fever, dizziness, and decreased resistance to infection. Folate deficiency states may increase methotrexate toxicity.

Polyarticular Juvenile Idiopathic Arthritis

The approximate incidences of adverse reactions reported in pediatric patients with JIA treated with oral, weekly doses of methotrexate (5 to 20 mg/m2/week or 0.1 to 0.65 mg/kg/week) were as follows (virtually all patients were receiving concomitant nonsteroidal anti-inflammatory drugs, and some also were taking low doses of corticosteroids): elevated liver function tests, 14%; gastrointestinal reactions (e.g., nausea, vomiting, diarrhea), 11%; stomatitis, 2%; leukopenia, 2%; headache, 1.2%; alopecia, 0.5%; dizziness, 0.2%; and rash, 0.2%. Although there is experience with dosing up to 30 mg/m2/week in JIA, the published data for doses above 20 mg/m2/week are too limited to provide reliable estimates of adverse reaction rates.

Postmarketing Experience

Additional adverse reactions which have been identified during postmarketing use of methotrexate are listed below by organ system.

Blood And Lymphatic System Disorders: Suppressed hematopoiesis causing anemia, aplastic anemia, pancytopenia, leukopenia, neutropenia, thrombocytopenia, lymphadenopathy, lymphoproliferative disorders (including reversible), hypogammaglobulinemia

Cardiovascular Thromboembolic events (including arterial thrombosis, cerebral thrombosis, deep vein thrombosis, retinal vein thrombosis, thrombophlebitis, and pulmonary embolus), pericarditis, pericardial effusion, hypotension

Eye Disorders: Optic neuropathy, transient blindness, blurred vision, ocular irritation, conjunctivitis, xerophthalmia

Gastrointestinal Disorders: Gingivitis, pharyngitis, stomatitis, anorexia, nausea, vomiting, diarrhea, hematemesis, melena, gastrointestinal ulceration and bleeding, enteritis, pancreatitis

Hepatobiliary Disorders: Hepatotoxicity, acute hepatitis, chronic fibrosis and cirrhosis, decreased serum albumin, liver enzyme elevations

Immune System Disorders: Vasculitis, lymphomas, and anaphylactoid reactions

Infections: Fatal opportunistic infections (most commonly Pneumocystis jiroveci pneumonia). There have also been reports of other infections, pneumonia, sepsis, nocardiosis, histoplasmosis, cryptococcosis, Herpes zoster, Herpes simplex hepatitis, and disseminated Herpes simplex

Metabolism: Hyperglycemia and tumor lysis syndrome

Musculoskeletal System: Stress fracture, soft tissue necrosis, osteonecrosis, arthralgia, myalgia, osteoporosis

Nervous System Disorders: Headaches, drowsiness, blurred vision, transient blindness, speech impairment (including dysarthria and aphasia), hemiparesis, paresis and convulsions have also occurred following administration of methotrexate.

Following low doses, there have been reports of transient subtle cognitive dysfunction, mood alteration, unusual cranial sensations, leukoencephalopathy, or encephalopathy.

Renal Disorders: Azotemia, hematuria, proteinuria, cystitis

Reproductive Disorders: Defective oogenesis or spermatogenesis, menstrual dysfunction, loss of libido, impotence, vaginal discharge, gynecomastia

Respiratory Disorders: Pulmonary fibrosis, respiratory failure, chronic interstitial obstructive pulmonary disease, pleuritic pain and thickening alveolitis

Skin Disorders: Erythematous rashes, pruritus, urticaria, photosensitivity, pigmentary changes, alopecia, ecchymosis, telangiectasia, acne, furunculosis, erythema multiforme, toxic epidermal necrolysis, Stevens-Johnson syndrome, skin necrosis, skin ulceration, accelerated nodulosis, and exfoliative dermatitis.

Read the entire FDA prescribing information for Xatmep (Methotrexate Oral Solution)

© Xatmep Patient Information is supplied by Cerner Multum, Inc. and Xatmep Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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