Available for as little as $5.

View eligibility restrictions.

Common Questions About Xatmep

    • Xatmep is convenient to administer and requires no time to prepare
    • Same potency from first to last dose
    • Same formulation at hospital and home
    • No shaking necessary prior to administration
  • Xatmep is given to children with ALL as part of a combination chemotherapy regimen that includes several different medications.

  • Xatmep is given to children with pJIA who have not benefited sufficiently from, or are intolerant of, first-line therapy that includes full-dose nonsteroidal anti-inflammatory agents (NSAIDs).

  • Xatmep is a ready-to-use oral liquid, eliminating the need to split or crush tablets and offering an alternative to injections. Xatmep is the first and only FDA-approved pediatric oral liquid methotrexate.

Xatmep Dosing and Storage

  • Xatmep comes as a liquid formulation to be taken orally one (1) time weekly. Mistaken daily use has resulted in fatal toxicity.

  • The recommended starting dose of Xatmep is:

    • 20 mg/m2 given one (1) time weekly for ALL
    • 10 mg/m2 given one (1) time weekly for pJIA

    Do not change the dose of Xatmep unless your doctor tells you to do so.Xatmep should be taken at the time and frequency specified by your child’s doctor.

    • Always carefully measure the prescribed dose of Xatmep before you or the patient takes it
    • Ask your pharmacist for an accurate (mL) dosing device for administering Xatmep
    • A household teaspoon is NOT an accurate dosing device
    • Make sure the entire prescribed dose of Xatmep is swallowed
    • If you or the patient misses a dose of Xatmep, contact your doctor. Use the normal dose of Xatmep; do not use more Xatmep than your doctor has prescribed
    • If you have questions about Xatmep, ask your doctor or your pharmacist
    • Please consult your doctor before making any changes to the Xatmep dose
  • Patients may store Xatmep either refrigerated (2°C-8°C/36°F-46°F) in a tightly closed container 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.

Patient Support

  • Yes, Azurity offers additional income-based financial help for eligible Xatmep patients who do not have insurance.

  • Azurity Solutions is a comprehensive patient support program designed to help you access your child’s prescribed Azurity medications. This program includes resources for co-pay support and patient assistance, as well as resources for your healthcare provider’s office to use on your behalf.

  • Azurity offers a co-pay assistance program for eligible Xatmep patients with commercial insurance. It applies automatic savings at the pharmacy to reduce your out-of-pocket cost. Eligible patients may pay as little as $5 for Xatmep with these co-pay savings.*


    *Eligibility Restrictions, Terms, and Conditions

    By participating in this savings program, participants understand and agree that the information provided, as well as non-personally identifiable information obtained from the pharmacy, will be shared with the manufacturer and with any companies working with the manufacturer. Participants also affirm that they will not submit, and have not had submitted on their behalf, a claim for reimbursement or coverage for items purchased with this card under Medicaid, Medicare, TRICARE, or any other federal or state government healthcare program, or where prohibited by state law.

    • Offer applies to out‐of‐pocket expenses (co‐pay) greater than $5. Out‐of‐pocket expenses greater than $5 will be covered up to $230 per prescription. If your total out‐of‐pocket cost exceeds $230, you will be responsible for a $5 co‐pay plus any additional amount over $230. If your co‐pay is already $5 or less, this offer does not apply.
    • Offer applies only to Xatmep® patients and associated refills.
    • This offer is not valid for prescriptions paid in part or in full by any federally or state‐funded program, including but not limited to Medicaid, Medicare, Department of Veterans Affairs, Department of Defense, or TRICARE, and where prohibited by law.
    • This savings program cannot be combined with any other coupon, certificate, voucher, or similar offer.
    • Offer good only in the USA at participating retail pharmacies and cannot be redeemed at government‐subsidized clinics. Void where taxed, restricted, or prohibited by law.
    • Offer not extended to clubs, groups, or organizations.
    • Participation in this program must comply with all applicable laws and contractual or other obligations as a pharmacy provider.
    • This is not an insurance program.
    • Participating patients and pharmacists understand and agree to comply with the Terms and Conditions of this offer as set forth herein.
    • Any step‐edits or prior authorizations required by the insurance plan still apply.
    • Azurity Pharmaceuticals, Inc. reserves the right to modify or cancel this program at any time.
    • eVoucherRx™ and Voucher on Demand™ are not extended on prescriptions for patients:
      • who are cash‐paying customers.
      • using institution-based pharmacies to fill their prescriptions, or who are recipients of federal or state government health care.
      • who are filling their prescriptions at nonparticipating pharmacies.

    eVoucherRx™ is a trademark of RelayHealth.

    Voucher on Demand™ is a trademark of eRx Network, LLC.

IMPORTANT SAFETY INFORMATION:

XATMEP® (methotrexate) Oral Solution, 2.5 mg/mL

Warning: Severe toxic reactions, including embryo-fetal toxicity

  • 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).

See Full Prescribing Information for complete boxed warning.

Indications:

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.
  • 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).

The recommended Xatmep dose is to be taken once weekly. Daily use has resulted in fatal toxicity.

Xatmep Oral Solution should not be used if hypersensitive or allergic to methotrexate or any of the ingredients in Xatmep.

Xatmep Oral Solution should not be used during pregnancy in patients with pJIA.

Take Xatmep exactly as your doctor tells you.

An accurate dosing device should always be used. Ask your pharmacist for an accurate dosing device. A household teaspoon is not an accurate dosing device.

Ask your doctor about the risks to the fetus if you or your partner is taking Xatmep for the treatment of ALL.

Pregnancy should be avoided if either partner is taking Xatmep. Contraception should be used by both females and males while either is taking Xatmep and for 6 months after the last dose taken by females and 3 months after the last dose taken by males.

Xatmep Oral Solution should not be used when nursing.

Methotrexate may affect the ability to have children. Methotrexate may affect menstrual cycles and sperm count.

Discuss vaccinations and immunizations with your doctor prior to receiving them, as they may not be as effective, or should be avoided during methotrexate therapy.

Xatmep may cause severe side effects, including organ toxicity. Organ toxicity may include: bone marrow, kidneys, gastrointestinal, liver, lung, skin, soft tissue and bone. Secondary malignancies may occur. Your doctor will monitor you for signs and symptoms of toxicity during treatment.

Other side effects of methotrexate include:

  • mouth sores
  • diarrhea
  • Nausea
  • vomiting
  • abdominal distress
  • fatigue
  • chills
  • fever
  • dizziness
  • decreased resistance to infection
  • leukopenia (decrease in white blood cells)
  • malaise

These are not all the possible side effects of Xatmep. Your doctor or your patient’s doctor is the best source of advice about side effects.

Call your doctor immediately if you or your patient has any side effects that concern you or do not go away.

Tell your doctor about any other medications, including prescription and over-the-counter medications, supplements, vitamins, or herbal remedies you are taking. Make sure to visit your doctor regularly.

Ask your doctor about 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 1-855-379-0383, or FDA at 1-800-FDA-1088 or www.fda.gov/MedWatch.

- - - - - - - - -

FDA-5

IMPORTANT SAFETY INFORMATION:

XATMEP® (methotrexate) Oral Solution, 2.5 mg/mL

Warning: Severe toxic reactions, including embryo-fetal toxicity

  • 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).

See Full Prescribing Information for complete boxed warning.

Indications:

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.
  • 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).

The recommended Xatmep dose is to be taken once weekly. Daily use has resulted in fatal toxicity.

Xatmep Oral Solution should not be used if hypersensitive or allergic to methotrexate or any of the ingredients in Xatmep.

Xatmep Oral Solution should not be used during pregnancy in patients with pJIA.

Take Xatmep exactly as your doctor tells you.

An accurate dosing device should always be used. Ask your pharmacist for an accurate dosing device. A household teaspoon is not an accurate dosing device.

Ask your doctor about the risks to the fetus if you or your partner is taking Xatmep for the treatment of ALL.

Pregnancy should be avoided if either partner is taking Xatmep. Contraception should be used by both females and males while either is taking Xatmep and for 6 months after the last dose taken by females and 3 months after the last dose taken by males.

Xatmep Oral Solution should not be used when nursing.

Methotrexate may affect the ability to have children. Methotrexate may affect menstrual cycles and sperm count.

Discuss vaccinations and immunizations with your doctor prior to receiving them, as they may not be as effective, or should be avoided during methotrexate therapy.

Xatmep may cause severe side effects, including organ toxicity. Organ toxicity may include: bone marrow, kidneys, gastrointestinal, liver, lung, skin, soft tissue and bone. Secondary malignancies may occur. Your doctor will monitor you for signs and symptoms of toxicity during treatment.

Other side effects of methotrexate include:

  • mouth sores
  • diarrhea
  • Nausea
  • vomiting
  • abdominal distress
  • fatigue
  • chills
  • fever
  • dizziness
  • decreased resistance to infection
  • leukopenia (decrease in white blood cells)
  • malaise

These are not all the possible side effects of Xatmep. Your doctor or your patient’s doctor is the best source of advice about side effects.

Call your doctor immediately if you or your patient has any side effects that concern you or do not go away.

Tell your doctor about any other medications, including prescription and over-the-counter medications, supplements, vitamins, or herbal remedies you are taking. Make sure to visit your doctor regularly.

Ask your doctor about 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 1-855-379-0383, or FDA at 1-800-FDA-1088 or www.fda.gov/MedWatch.

- - - - - - - - -

FDA-5

IMPORTANT SAFETY INFORMATION:

XATMEP® (methotrexate) Oral Solution, 2.5 mg/mL

Warning: Severe toxic reactions, including embryo-fetal toxicity

  • 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).

See Full Prescribing Information for complete boxed warning.

Indications:

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.
  • 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).

The recommended Xatmep dose is to be taken once weekly. Daily use has resulted in fatal toxicity.

Xatmep Oral Solution should not be used if hypersensitive or allergic to methotrexate or any of the ingredients in Xatmep.

Xatmep Oral Solution should not be used during pregnancy in patients with pJIA.

Take Xatmep exactly as your doctor tells you.

An accurate dosing device should always be used. Ask your pharmacist for an accurate dosing device. A household teaspoon is not an accurate dosing device.

Ask your doctor about the risks to the fetus if you or your partner is taking Xatmep for the treatment of ALL.

Pregnancy should be avoided if either partner is taking Xatmep. Contraception should be used by both females and males while either is taking Xatmep and for 6 months after the last dose taken by females and 3 months after the last dose taken by males.

Xatmep Oral Solution should not be used when nursing.

Methotrexate may affect the ability to have children. Methotrexate may affect menstrual cycles and sperm count.

Discuss vaccinations and immunizations with your doctor prior to receiving them, as they may not be as effective, or should be avoided during methotrexate therapy.

Xatmep may cause severe side effects, including organ toxicity. Organ toxicity may include: bone marrow, kidneys, gastrointestinal, liver, lung, skin, soft tissue and bone. Secondary malignancies may occur. Your doctor will monitor you for signs and symptoms of toxicity during treatment.

Other side effects of methotrexate include:

  • mouth sores
  • diarrhea
  • Nausea
  • vomiting
  • abdominal distress
  • fatigue
  • chills
  • fever
  • dizziness
  • decreased resistance to infection
  • leukopenia (decrease in white blood cells)
  • malaise

These are not all the possible side effects of Xatmep. Your doctor or your patient’s doctor is the best source of advice about side effects.

Call your doctor immediately if you or your patient has any side effects that concern you or do not go away.

Tell your doctor about any other medications, including prescription and over-the-counter medications, supplements, vitamins, or herbal remedies you are taking. Make sure to visit your doctor regularly.

Ask your doctor about 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 1-855-379-0383, or FDA at 1-800-FDA-1088 or www.fda.gov/MedWatch.

- - - - - - - - -

FDA-5