Designedfor kids1
XATMEP is available
for as little as $5
View eligibility restrictions.
Ready-to-use Xatmep® (methotrexate) may help pediatric patients who can't swallow pills or have a fear of needles
- Available in 2 sizes: 60 mL and 120 mL
- Shelf-stable* for up to 60 days
- Ready-to-use oral liquid formulation
- Has a permanent J-Code: J8612
- Developed specifically for kids
*Patients may store Xatmep® either refrigerated (2°C-8°C/36°F-46°F) or at room temperature (20°C-25°C/68°F-77°F); excursions permitted to 15°C-30°C/59°F-86°F. If stored at room temperature, discard after 60 days. Avoid freezing and excessive heat.1
Benefits of Oral Liquid Xatmep®
FDA-Approved unlike compounded drugs
Convenient with no preparation time or shaking needed
Eliminates need for administration of injectable methotrexate orally, which is not approved4
Sweet taste may help enhance palatability
Ready-to-use formulation may help improve adherence
69% of commercially insured eligible patients paid $5 or less2
Eliminates need for crushing tablets and exposure to hazardous methotrexate dust3
No artificial flavors or dyes
Consistent potency and stability from the first mL to the last
BSA-based dosing empowers a precise, personalized methotrexate dose
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Did you know that 50% to 88% of children† are not adherent to prescription medication?5
†with a chronic illness that required prescription medication
Simpler therapeutic regimens may be associated with better adherence6
Xatmep® is simple to give
Just measure the dose and administer‡
Xatmep® is simple to swallow
A sweet taste, without artificial flavors or dyes
Xatmep® is simple to get
Accessible at most pharmacies within 24 hours7
‡Advise caregivers/patients to ask for an accurate (mL) dosing device. Inform caregivers/patients that a household teaspoon is not an accurate dosing device.1
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.
IMPORTANT SAFETY INFORMATION
XATMEP® (methotrexate) Oral Solution, 2.5 mg/mL
WARNING: SEVERE TOXIC REACTIONS, INCLUDING EMBRYO-FETAL TOXICITY
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.
- Bone marrow suppression (5.1)
- Serious infections (5.2)
- Renal toxicity and increased toxicity with renal impairment (5.3)
- Gastrointestinal toxicity (5.4)
- Hepatic toxicity (5.5)
- Pulmonary toxicity (5.6)
- Hypersensitivity and dermatologic reactions (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 (4, 5.9, 8.1, and 8.3).
INDICATIONS:
XATMEP is a folate analog metabolic inhibitor indicated for the:
- Treatment of pediatric patients with acute lymphoblastic leukemia (ALL) as partof a multi-phase, combination chemotherapy maintenance regimen.
- Management of pediatric patients with active polyarticular juvenile idiopathicarthritis (pJIA) who have had an insufficient therapeutic response to, or areintolerant of, an adequate trial of first-line therapy including full dose non-steroidal anti-inflammatory agents (NSAIDs).
ADDITIONAL IMPORTANT SAFETY INFORMATION:
Contraindications:
XATMEP is contraindicated in pregnant patients with non-malignant disease and in patients with severe hypersensitivity to methotrexate.
Warnings and Precautions:
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.
Drug Interactions:
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.
Use in Specific Populations:
See Full Prescribing Information for Additional Information (8).
Pregnancy
Methotrexate can cause embryo-fetal toxicity and fetal death when administered to a pregnant woman.
Lactation
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. Data on file. Azurity Pharmaceuticals, Inc. 3. NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings, 2016. Accessed August 13, 2024. https://www.cdc.gov/niosh/docs/2016-161/default.html. 4. METHOTREXATE- methotrexate injection, solution [Prescribing Information]. Lake Forest, IL: Hospira, Inc.; 2022. 5. MacGrady ME, Hommel KA. Medication adherence and health care utilization in pediatric chronic illness: a systematic review. Pediatrics. 2013;132(4):730-740. 6. Matsui D. Pediatr Drugs. 2007;9(5):283-288. 7. Data on file, Azurity Pharmaceuticals, Inc. September 2024.
