Dosing and Administration HCP pJIA

Xatmep Offers Convenient Dosing and Administration

Ready-to-use methotrexate oral solution
  • Xatmep is convenient to dispense.
  • Requires no time to prepare versus cutting or crushing methotrexate tablets or compounding tablets into a liquid formulation.

FDA-Approved Dosing and Administration — For Oral Use Only

For Polyarticular Juvenile Idiopathic Arthritis (pJIA)

Recommended starting dose 10 mg/m2 one time weekly.
Instruct patients/caregivers that the recommended dose should be taken weekly, as directed. Mistaken daily use has resulted in fatal toxicity.
Accurate dosing 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.
Dosing adjustments Dosages should be tailored to the individual and adjusted gradually to achieve an optimal response. Although there is experience with doses up to 30 mg/m2/week in pediatric patients, doses > than 20 mg/m2 may result in a significant increase in the incidence and severity of serious toxic reactions, especially bone marrow suppression. Doses between 20 – 30 mg/m2/week may have better absorption and fewer GI side effects if methotrexate is administered by an alternative route using a different formulation.
Storage Store refrigerated (2°C – 8°C/36°F – 46°F) in a tightly closed container. 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° – 86°F. If stored at room temperature, discard after 60 days. Avoid freezing and excessive heat.
Oral solution ensures consistent potency and stability
  • Same potency from first to last dose.
  • Same formulation at hospital and home.
  • Store refrigerated (2°C – 8°C/36°F – 46°F) in a tightly closed container. 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° – 86°F. If stored at room temperature, discard after 60 days. Avoid freezing and excessive heat.
  • No shaking necessary prior to administration.