View eligibility restrictions.
Designed for kids, Xatmep® helps save time and effort by eliminating the need to modify other forms of methotrexate
NO
Crushing1
Methotrexate tablets should not be chewed or crushed before a patient takes it3
NO
Compounding1
Compounded drugs are not FDA-approved for safety, effectiveness, or quality4
NO
Injections1
Injectable methotrexate has not been approved to be given orally5
Xatmep® is a folate analog metabolic inhibitor indicated for the treatment of pediatric patients with acute lymphoblastic leukemia (ALL) as part of a multi-phase, combination chemotherapy maintenance regimen.
20 mg/m2 given one (1) time weekly.
Instruct patients/caregivers that the recommended dose should be taken one (1) time weekly, as directed. Mistaken daily use has resulted in fatal toxicity.1
Advise patients/caregivers to ask their pharmacist for an accurate (mL) dosing device. Tell patients/caregivers that a household teaspoon is not an accurate dosing device.1
Xatmep® is a folate analog metabolic inhibitor indicated for 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).
10 mg/m2 given one (1) time weekly.
Instruct patients/caregivers that the recommended dose should be taken one (1) time weekly, as directed. Mistaken daily use has resulted in fatal toxicity.1
Advise patients/caregivers to ask their pharmacist for an accurate (mL) dosing device. Tell patients/caregivers that a household teaspoon is not an accurate dosing device.1
Ready-to-use, simple to administer
Sweet-tasting oral liquid formulation
Accessible at most pharmacies within 24 hours6
Widely covered by Medicaid nationwide7
Available for as little as $5 for commercially insured patients, with no cards, no coupons, and no calls required*
*View eligibility restrictions.
Azurity Solutions is a comprehensive support platform providing guidance to help patients access their prescribed Azurity medications.
*View eligibility restrictions.
See Full Prescribing Information for complete boxed warning.
Methotrexate can cause the following severe or fatal adverse reactions.
Monitor closely and modify dose or discontinue methotrexate as appropriate.
XATMEP is a folate analog metabolic inhibitor indicated for the:
XATMEP is contraindicated in pregnant patients with non-malignant disease and in patients with severe hypersensitivity to methotrexate.
XATMEP suppresses hematopoiesis and can cause severe and life-threatening pancytopenia, anemia, leukopenia, neutropenia, and thrombocytopenia. Obtain blood counts at baseline and periodically; monitor patients for complications of bone marrow suppression.
Patients treated with XATMEP are at increased risk for developing life-threatening or fatal bacterial, fungal, or viral infections, including Pneumocystis jiroveci pneumonia, invasive fungal infections, hepatitis B reactivation, tuberculosis (primary or reactivation), disseminated Herpes zoster and cytomegalovirus infections.
XATMEP can cause renal damage, including acute renal failure. Monitor renal function. Consider administration of glucarpidase in patients with toxic plasma methotrexate concentrations (> 1 micromole/liter) and delayed clearance due to impaired renal function.
XATMEP can cause diarrhea, stomatitis, vomiting, hemorrhagic enteritis, and fatal intestinal perforation. Patients with peptic ulcer disease and ulcerative colitis are at increased risk for severe gastrointestinal adverse reactions. Unexpected severe and fatal gastrointestinal toxicity can occur with concomitant use of NSAIDs.
Hepatic toxicity: severe and potentially irreversible hepatotoxicity, including fibrosis, cirrhosis, and fatal liver failure can occur. Avoid use of XATMEP in patients with chronic liver disease.
Pulmonary toxicity: acute or chronic interstitial pneumonitis and irreversible or fatal cases can occur at all dose levels.
Hypersensitivity: Severe, including fatal, dermatologic reactions such as toxic epidermal necrolysis, Stevens-Johnson syndrome, exfoliative dermatitis, skin necrosis, erythema multiforme can occur. Anaphylaxis or other serious hypersensitivity reactions can occur. Discontinue methotrexate and institute appropriate therapy. Radiation dermatitis and sunburn may be “recalled.”
Secondary malignancies can occur at all dose levels. Lymphoproliferative disease has been reported with low-dose oral methotrexate which regressed when methotrexate was withdrawn.
Methotrexate can cause embryo-fetal toxicity and fetal death when administered during pregnancy. In pregnant women with non-malignant disease, methotrexate is contraindicated. Consider the risks and benefits of XATMEP and risks to the fetus when.
Adverse Reactions: See Full Prescribing Information for additional Adverse Reactions (6).
Most common adverse reactions are ulcerative stomatitis, leukopenia, nausea, and abdominal distress.
Other frequently reported reactions are malaise, fatigue, chills and fever, dizziness, and decreased resistance to infection.
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 non-steroidal 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.
Penicillins may reduce the clearance of methotrexate; increased serum concentrations of methotrexate with concomitant hematologic and gastrointestinal toxicity have been observed with methotrexate. Monitor patients accordingly.
Trimethoprim/sulfamethoxazole has been reported to increase bone marrow suppression in patients receiving methotrexate. Monitor patients accordingly.
Hepatotoxins: May increase hepatotoxicity. Monitor patients receiving concomitant hepatotoxins for signs of hepatotoxicity.
Probenecid may reduce renal elimination of methotrexate; consider alternative drugs.
Nitrous oxide as an anesthetic potentiates the effect of methotrexate resulting in the potential for increased toxicity.
NSAIDs, Aspirin, and Steroids: Concomitant administration of some NSAIDS with high dose methotrexate therapy has been reported to elevate and prolong serum methotrexate levels, resulting in deaths from severe hematologic and gastrointestinal toxicity.
Methotrexate may decrease theophylline clearance. Monitor theophylline levels.
See Full Prescribing Information for Additional Information (8).
Methotrexate can cause embryo-fetal toxicity and fetal death when administered to a pregnant woman.
Advise women not to breastfeed during XATMEP therapy.
Inform caregivers and patients of the need for proper storage and disposal of dispensing bottles and dosing devices. Keep this and all medications out of reach of children.
This Important Safety Information does not include all the information needed to use XATMEP safely and effectively. Visit XATMEP.com for Full Prescribing Information.
To report SUSPECTED ADVERSE REACTIONS, contact Azurity Pharmaceuticals, Inc. at 1-800-461-7449, or FDA at 1-800-FDA-1088 or www.fda.gov/MedWatch.
References: 1. Xatmep [package insert]. Wilmington, MA: Azurity Pharmaceuticals, Inc.; 2020. 2. US Food and Drug Administration. Drugs@FDA: FDA-Approved Drugs. Search results for methotrexate. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=BasicSearch.process. Accessed October 30, 2024. 3. METHOTREXATE TABLETS [Prescribing Information]. New York, NY: Pfizer Inc.; 2024 4. FDA. Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503A of the Federal Food, Drug, and Cosmetic Act. 2018. Available at: https://www.fda.gov/media/98973/download. Accessed November 5, 2024. 5. METHOTREXATE- methotrexate injection, solution [Prescribing Information]. Lake Forest, IL: Hospira, Inc.; 2022 6. Data on file, Azurity Pharmaceuticals, Inc. September 2024. 7. Data on file, Azurity Pharmaceuticals, Inc. August 2024.
Product labeling and imagery are for representation purposes only and may reflect either name.
The Information contained herein, including product information, is intended only for residents of the United States.
© 2024 Azurity Pharmaceuticals, Inc. All Rights Reserved. All Trademarks referred to are the property of their respective owners. PP-XAT-US-0057
See Full Prescribing Information for complete boxed warning.
Methotrexate can cause the following severe or fatal adverse reactions.
Monitor closely and modify dose or discontinue methotrexate as appropriate.
XATMEP is a folate analog metabolic inhibitor indicated for the:
XATMEP is contraindicated in pregnant patients with non-malignant disease and in patients with severe hypersensitivity to methotrexate.
XATMEP suppresses hematopoiesis and can cause severe and life-threatening pancytopenia, anemia, leukopenia, neutropenia, and thrombocytopenia. Obtain blood counts at baseline and periodically; monitor patients for complications of bone marrow suppression.
Patients treated with XATMEP are at increased risk for developing life-threatening or fatal bacterial, fungal, or viral infections, including Pneumocystis jiroveci pneumonia, invasive fungal infections, hepatitis B reactivation, tuberculosis (primary or reactivation), disseminated Herpes zoster and cytomegalovirus infections.
XATMEP can cause renal damage, including acute renal failure. Monitor renal function. Consider administration of glucarpidase in patients with toxic plasma methotrexate concentrations (> 1 micromole/liter) and delayed clearance due to impaired renal function.
XATMEP can cause diarrhea, stomatitis, vomiting, hemorrhagic enteritis, and fatal intestinal perforation. Patients with peptic ulcer disease and ulcerative colitis are at increased risk for severe gastrointestinal adverse reactions. Unexpected severe and fatal gastrointestinal toxicity can occur with concomitant use of NSAIDs.
Hepatic toxicity: severe and potentially irreversible hepatotoxicity, including fibrosis, cirrhosis, and fatal liver failure can occur. Avoid use of XATMEP in patients with chronic liver disease.
Pulmonary toxicity: acute or chronic interstitial pneumonitis and irreversible or fatal cases can occur at all dose levels.
Hypersensitivity: Severe, including fatal, dermatologic reactions such as toxic epidermal necrolysis, Stevens-Johnson syndrome, exfoliative dermatitis, skin necrosis, erythema multiforme can occur. Anaphylaxis or other serious hypersensitivity reactions can occur. Discontinue methotrexate and institute appropriate therapy. Radiation dermatitis and sunburn may be “recalled.”
Secondary malignancies can occur at all dose levels. Lymphoproliferative disease has been reported with low-dose oral methotrexate which regressed when methotrexate was withdrawn.
Methotrexate can cause embryo-fetal toxicity and fetal death when administered during pregnancy. In pregnant women with non-malignant disease, methotrexate is contraindicated. Consider the risks and benefits of XATMEP and risks to the fetus when.
Adverse Reactions: See Full Prescribing Information for additional Adverse Reactions (6).
Most common adverse reactions are ulcerative stomatitis, leukopenia, nausea, and abdominal distress.
Other frequently reported reactions are malaise, fatigue, chills and fever, dizziness, and decreased resistance to infection.
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 non-steroidal 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.
Penicillins may reduce the clearance of methotrexate; increased serum concentrations of methotrexate with concomitant hematologic and gastrointestinal toxicity have been observed with methotrexate. Monitor patients accordingly.
Trimethoprim/sulfamethoxazole has been reported to increase bone marrow suppression in patients receiving methotrexate. Monitor patients accordingly.
Hepatotoxins: May increase hepatotoxicity. Monitor patients receiving concomitant hepatotoxins for signs of hepatotoxicity.
Probenecid may reduce renal elimination of methotrexate; consider alternative drugs.
Nitrous oxide as an anesthetic potentiates the effect of methotrexate resulting in the potential for increased toxicity.
NSAIDs, Aspirin, and Steroids: Concomitant administration of some NSAIDS with high dose methotrexate therapy has been reported to elevate and prolong serum methotrexate levels, resulting in deaths from severe hematologic and gastrointestinal toxicity.
Methotrexate may decrease theophylline clearance. Monitor theophylline levels.
See Full Prescribing Information for Additional Information (8).
Methotrexate can cause embryo-fetal toxicity and fetal death when administered to a pregnant woman.
Advise women not to breastfeed during XATMEP therapy.
Inform caregivers and patients of the need for proper storage and disposal of dispensing bottles and dosing devices. Keep this and all medications out of reach of children.
This Important Safety Information does not include all the information needed to use XATMEP safely and effectively. Visit XATMEP.com for Full Prescribing Information.
To report SUSPECTED ADVERSE REACTIONS, contact Azurity Pharmaceuticals, Inc. at 1-800-461-7449, or FDA at 1-800-FDA-1088 or www.fda.gov/MedWatch.
References: 1. Xatmep [package insert]. Wilmington, MA: Azurity Pharmaceuticals, Inc.; 2020. 2. US Food and Drug Administration. Drugs@FDA: FDA-Approved Drugs. Search results for methotrexate. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=BasicSearch.process. Accessed October 30, 2024. 3. METHOTREXATE TABLETS [Prescribing Information]. New York, NY: Pfizer Inc.; 2024 4. FDA. Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503A of the Federal Food, Drug, and Cosmetic Act. 2018. Available at: https://www.fda.gov/media/98973/download. Accessed November 5, 2024. 5. METHOTREXATE- methotrexate injection, solution [Prescribing Information]. Lake Forest, IL: Hospira, Inc.; 2022 6. Data on file, Azurity Pharmaceuticals, Inc. September 2024. 7. Data on file, Azurity Pharmaceuticals, Inc. August 2024.
See Full Prescribing Information for complete boxed warning.
Methotrexate can cause the following severe or fatal adverse reactions.
Monitor closely and modify dose or discontinue methotrexate as appropriate.
XATMEP is a folate analog metabolic inhibitor indicated for the:
XATMEP is contraindicated in pregnant patients with non-malignant disease and in patients with severe hypersensitivity to methotrexate.
XATMEP suppresses hematopoiesis and can cause severe and life-threatening pancytopenia, anemia, leukopenia, neutropenia, and thrombocytopenia. Obtain blood counts at baseline and periodically; monitor patients for complications of bone marrow suppression.
Patients treated with XATMEP are at increased risk for developing life-threatening or fatal bacterial, fungal, or viral infections, including Pneumocystis jiroveci pneumonia, invasive fungal infections, hepatitis B reactivation, tuberculosis (primary or reactivation), disseminated Herpes zoster and cytomegalovirus infections.
XATMEP can cause renal damage, including acute renal failure. Monitor renal function. Consider administration of glucarpidase in patients with toxic plasma methotrexate concentrations (> 1 micromole/liter) and delayed clearance due to impaired renal function.
XATMEP can cause diarrhea, stomatitis, vomiting, hemorrhagic enteritis, and fatal intestinal perforation. Patients with peptic ulcer disease and ulcerative colitis are at increased risk for severe gastrointestinal adverse reactions. Unexpected severe and fatal gastrointestinal toxicity can occur with concomitant use of NSAIDs.
Hepatic toxicity: severe and potentially irreversible hepatotoxicity, including fibrosis, cirrhosis, and fatal liver failure can occur. Avoid use of XATMEP in patients with chronic liver disease.
Pulmonary toxicity: acute or chronic interstitial pneumonitis and irreversible or fatal cases can occur at all dose levels.
Hypersensitivity: Severe, including fatal, dermatologic reactions such as toxic epidermal necrolysis, Stevens-Johnson syndrome, exfoliative dermatitis, skin necrosis, erythema multiforme can occur. Anaphylaxis or other serious hypersensitivity reactions can occur. Discontinue methotrexate and institute appropriate therapy. Radiation dermatitis and sunburn may be “recalled.”
Secondary malignancies can occur at all dose levels. Lymphoproliferative disease has been reported with low-dose oral methotrexate which regressed when methotrexate was withdrawn.
Methotrexate can cause embryo-fetal toxicity and fetal death when administered during pregnancy. In pregnant women with non-malignant disease, methotrexate is contraindicated. Consider the risks and benefits of XATMEP and risks to the fetus when.
Adverse Reactions: See Full Prescribing Information for additional Adverse Reactions (6).
Most common adverse reactions are ulcerative stomatitis, leukopenia, nausea, and abdominal distress.
Other frequently reported reactions are malaise, fatigue, chills and fever, dizziness, and decreased resistance to infection.
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 non-steroidal 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.
Penicillins may reduce the clearance of methotrexate; increased serum concentrations of methotrexate with concomitant hematologic and gastrointestinal toxicity have been observed with methotrexate. Monitor patients accordingly.
Trimethoprim/sulfamethoxazole has been reported to increase bone marrow suppression in patients receiving methotrexate. Monitor patients accordingly.
Hepatotoxins: May increase hepatotoxicity. Monitor patients receiving concomitant hepatotoxins for signs of hepatotoxicity.
Probenecid may reduce renal elimination of methotrexate; consider alternative drugs.
Nitrous oxide as an anesthetic potentiates the effect of methotrexate resulting in the potential for increased toxicity.
NSAIDs, Aspirin, and Steroids: Concomitant administration of some NSAIDS with high dose methotrexate therapy has been reported to elevate and prolong serum methotrexate levels, resulting in deaths from severe hematologic and gastrointestinal toxicity.
Methotrexate may decrease theophylline clearance. Monitor theophylline levels.
See Full Prescribing Information for Additional Information (8).
Methotrexate can cause embryo-fetal toxicity and fetal death when administered to a pregnant woman.
Advise women not to breastfeed during XATMEP therapy.
Inform caregivers and patients of the need for proper storage and disposal of dispensing bottles and dosing devices. Keep this and all medications out of reach of children.
This Important Safety Information does not include all the information needed to use XATMEP safely and effectively. Visit XATMEP.com for Full Prescribing Information.
To report SUSPECTED ADVERSE REACTIONS, contact Azurity Pharmaceuticals, Inc. at 1-800-461-7449, or FDA at 1-800-FDA-1088 or www.fda.gov/MedWatch.
References: 1. Xatmep [package insert]. Wilmington, MA: Azurity Pharmaceuticals, Inc.; 2020. 2. US Food and Drug Administration. Drugs@FDA: FDA-Approved Drugs. Search results for methotrexate. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=BasicSearch.process. Accessed October 30, 2024. 3. METHOTREXATE TABLETS [Prescribing Information]. New York, NY: Pfizer Inc.; 2024 4. FDA. Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503A of the Federal Food, Drug, and Cosmetic Act. 2018. Available at: https://www.fda.gov/media/98973/download. Accessed November 5, 2024. 5. METHOTREXATE- methotrexate injection, solution [Prescribing Information]. Lake Forest, IL: Hospira, Inc.; 2022 6. Data on file, Azurity Pharmaceuticals, Inc. September 2024. 7. Data on file, Azurity Pharmaceuticals, Inc. August 2024.
