Designed for kids.

Xatmep is available for as little as $5.

View eligibility restrictions.

Actor Portryal

XATMEP is 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

See Full Prescribing Information for complete boxed warning.

  • Methotrexate can cause severe or fatal toxicities. Monitor closely and modify dose or discontinue for the following toxicities: bone marrow suppression (5.1), infection (5.2), renal (5.3), gastrointestinal (5.4), hepatic (5.5), pulmonary (5.6), hypersensitivity and dermatologic (5.7).
  • Methotrexate can cause embryo-fetal toxicity and fetal death. Use in polyarticular juvenile idiopathic arthritis is contraindicated in pregnancy (4). Consider the benefits and risks of XATMEP and risks to the fetus when prescribing XATMEP to a pregnant patient with a neoplastic disease. Advise patients to use effective contraception during and after treatment with XATMEP (5.9, 8.1, 8.3).

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).

A calibrated measuring device is recommended to measure and deliver the prescribed dose accurately. A household teaspoon or tablespoon is not an adequate measuring device. Ask your pharmacist or doctor for assistance in the selection of a measuring device.
The recommended dose should be taken one time weekly, as directed. Mistaken daily use of the recommended dose has led to fatal toxicity.

ADDITIONAL IMPORTANT SAFETY INFORMATION:

Do not take XATMEP if you are pregnant and are being treated for any disease other than cancer or have had severe allergic reactions to methotrexate in the past.

What is the most important information I should know about XATMEP?

XATMEP may cause serious side effects that may be severe and lead to death, including:

  • Bone Marrow Suppression. XATMEP can affect your bone marrow and cause decreased red blood cell counts, white blood cell counts, and platelet counts, and a condition where your bone marrow cannot produce these blood cells. Your healthcare provider will check your blood cell counts before you start and during treatment with Xatmep. Your healthcare provider will watch you closely for infections during treatment with XATMEP.
    Call your healthcare provider right away if you develop new onset fever, symptoms of infection, easy bruising, or persistent bleeding.
  • Serious Infections. People who receive treatment with XATMEP have an increased risk of developing serious infections that can be life-threatening or lead to death. These infections include:
    • bacterial infections
    • fungal infections
    • viral infections
    • certain infections that happen because your immune system is weakened: hepatitis B infection that comes back (reactivation), tuberculosis (TB) infection that is new or that comes back (reactivation), shingles (herpes zoster), cytomegalovirus infections

    Your healthcare provider will closely watch you for signs and symptoms of infection during treatment with XATMEP. Your healthcare provider may hold or stop your treatment with XATMEP if you develop a serious infection.

  • Kidney Problems. XATMEP can cause kidney damage including sudden kidney failure. Your healthcare provider will check your kidney function during treatment and will hold or stop Xatmep treatment as needed for severe kidney damage.
    Call your healthcare provider right away if you have signs or symptoms of kidney problems such as being unable to pass urine, a change in how much urine is passed, blood in the urine, or a big weight gain.
  • Stomach and Intestine Problems. XATMEP can cause diarrhea, vomiting, mouth sores, stomach and intestinal inflammation with severe bleeding, and tears in the intestinal wall (perforation), and can lead to death. People who have stomach ulcers (peptic ulcer disease) or ulcerative colitis (UC) have a higher risk of developing severe stomach and intestine problems with XATMEP. Your healthcare provider may hold or stop your treatment with Xatmep if any of these severe stomach and intestinal problems happen, and treat you as needed.
    Call your healthcare provider if you develop diarrhea, vomiting, inflammation, or sores in your mouth.
  • Liver Problems. XATMEP can cause severe liver problems including liver scarring (fibrosis, cirrhosis), and liver failure that may not get better (possibly irreversible) and can cause death. Your healthcare provider will do tests to monitor your liver function before you start and during treatment with XATMEP, and may hold or stop your treatment with XATMEP if needed. The risk of liver problems is increased with heavy use of alcohol. Avoid drinking alcohol during Xatmep treatment.
    Tell your healthcare provider if you develop any signs or symptoms of liver problems during treatment with XATMEP, including:
    • tiredness
    • easy bleeding or bruising
    • loss of appetite
    • nausea
    • difficulty thinking clearly
    • swelling in your legs, feet, or ankles
    • weight loss
    • itchy skin
    • yellowing of your skin or the white part of your eyes
    • weakness
  • Lung Problems. Lung problems can happen suddenly (acute) with Xatmep or they can develop over a long period of time (chronic). Lung problems may not get better (possibly irreversible) and can cause death in anyone taking XATMEP. Your healthcare provider will monitor you for lung problems during treatment with XATMEP. Your healthcare provider may hold or stop your treatment with XATMEP if needed.
    Call your healthcare provider if you develop symptoms of a lung problem, including cough, fever, and trouble breathing.
  • Severe allergic reactions. Severe allergic reactions can happen with XATMEP. Do not receive Xatmep if you have had a severe allergic reaction to methotrexate in the past.
    Get medical help right away if you develop any of the signs or symptoms of a severe allergic reaction to XATMEP, including:
    • skin rash, itching, and hives
    • swelling of the face, lips, tongue, or throat, or trouble swallowing
    • dizziness or lightheadedness
    • trouble breathing
    • wheezing
    • throat tightness
    • runny or stuffy nose
    • fast heart rate
    • chest pain
    • feeling faint
  • Secondary Malignancies. New cancer may develop while you are taking XATMEP. Your healthcare provider may hold or stop your treatment with XATMEP if needed.
  • Embryo-Fetal Toxicity. XATMEP can cause harm to an unborn baby, including birth defects or the death of an unborn baby.
    • Females who can become pregnant: Your healthcare provider should do a pregnancy test before you start taking XATMEP to see if you are pregnant. If you are being treated for a medical condition other than cancer, do not receive or take Xatmep if you are pregnant. If you are taking Xatmep to treat your cancer, you and your healthcare provider will decide if you will receive or take Xatmep if you are pregnant. Use effective birth control during treatment and for 6 months after your final dose of Xatmep.
      Tell your healthcare provider right away if you become pregnant or think you are pregnant during treatment with XATMEP.
    • Males of reproductive potential: Use effective birth control during treatment and for 3 months after your final dose of XATMEP.
      Tell your healthcare provider right away if your female partner becomes pregnant during treatment with XATMEP.
  • Ineffective Immunization and Risks Associated with Live Vaccines. Avoid receiving vaccines during treatment with XATMEP because they may not be effective and live virus vaccines may cause infection.
  • Infertility. XATMEP may cause impairment of fertility, low sperm count (oligospermia), and menstrual dysfunction.

Before taking XATMEP, tell your healthcare provider about all your medical conditions, including if you:

  • have kidney problems or are receiving dialysis treatments
  • have liver problems
  • have fluid in your stomach area (ascites)
  • have lung problems or fluid in your lungs
  • have stomach ulcers (peptic ulcer disease)
  • have ulcerative colitis
  • have recently received or are scheduled to receive a vaccine. You should not receive live vaccines during treatment with XATMEP
  • plan to get radiation. There may be more chance of harm to tissue and bone.
  • are breastfeeding or plan to breastfeed. Methotrexate may pass into your breast milk. Do not breastfeed during treatment with XATMEP

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking certain medicines can affect the amount of methotrexate in your blood and can increase your risk for serious side effects.

The most common side effects of XATMEP include:

  • inflammation and sores in your digestive tract
  • low white blood cell count
  • nausea
  • stomach pain
  • elevated liver function tests

Other frequently reported adverse reactions are malaise, fatigue, chills and fever, dizziness, and decreased resistance to infection

Store XATMEP either refrigerated (2°C to 8°C/36°F to 46°F) or at room temperature (20°C to 25°C/68°F to 77°F) with excursions permitted to 15°C to 30°C/59°F to 86°F. If stored at room temperature, discard after 60 days.

The Important Safety Information does not include all the information needed to use XATMEP safely and effectively. Please talk to your healthcare provider and see the complete Prescribing Information for XATMEP.

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.

- - - - - - - - -

PT-XAT-1.0
FULL IMPORTANT SAFETY INFORMATION +

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 severe or fatal toxicities. Monitor closely and modify dose or discontinue for the following toxicities: bone marrow suppression (5.1), infection (5.2), renal (5.3), gastrointestinal (5.4), hepatic (5.5), pulmonary (5.6), hypersensitivity and dermatologic (5.7).
  • Methotrexate can cause embryo-fetal toxicity and fetal death. Use in polyarticular juvenile idiopathic arthritis is contraindicated in pregnancy (4). Consider the benefits and risks of XATMEP and risks to the fetus when prescribing XATMEP to a pregnant patient with a neoplastic disease. Advise patients to use effective contraception during and after treatment with XATMEP (5.9, 8.1, 8.3).

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).

A calibrated measuring device is recommended to measure and deliver the prescribed dose accurately. A household teaspoon or tablespoon is not an adequate measuring device. Ask your pharmacist or doctor for assistance in the selection of a measuring device.
The recommended dose should be taken one time weekly, as directed. Mistaken daily use of the recommended dose has led to fatal toxicity.

ADDITIONAL IMPORTANT SAFETY INFORMATION:

Do not take XATMEP if you are pregnant and are being treated for any disease other than cancer or have had severe allergic reactions to methotrexate in the past.

What is the most important information I should know about XATMEP?

XATMEP may cause serious side effects that may be severe and lead to death, including:

  • Bone Marrow Suppression. XATMEP can affect your bone marrow and cause decreased red blood cell counts, white blood cell counts, and platelet counts, and a condition where your bone marrow cannot produce these blood cells. Your healthcare provider will check your blood cell counts before you start and during treatment with Xatmep. Your healthcare provider will watch you closely for infections during treatment with XATMEP.
    Call your healthcare provider right away if you develop new onset fever, symptoms of infection, easy bruising, or persistent bleeding.
  • Serious Infections. People who receive treatment with XATMEP have an increased risk of developing serious infections that can be life-threatening or lead to death. These infections include:
    • bacterial infections
    • fungal infections
    • viral infections
    • certain infections that happen because your immune system is weakened: hepatitis B infection that comes back (reactivation), tuberculosis (TB) infection that is new or that comes back (reactivation), shingles (herpes zoster), cytomegalovirus infections

    Your healthcare provider will closely watch you for signs and symptoms of infection during treatment with XATMEP. Your healthcare provider may hold or stop your treatment with XATMEP if you develop a serious infection.

  • Kidney Problems. XATMEP can cause kidney damage including sudden kidney failure. Your healthcare provider will check your kidney function during treatment and will hold or stop Xatmep treatment as needed for severe kidney damage.
    Call your healthcare provider right away if you have signs or symptoms of kidney problems such as being unable to pass urine, a change in how much urine is passed, blood in the urine, or a big weight gain.
  • Stomach and Intestine Problems. XATMEP can cause diarrhea, vomiting, mouth sores, stomach and intestinal inflammation with severe bleeding, and tears in the intestinal wall (perforation), and can lead to death. People who have stomach ulcers (peptic ulcer disease) or ulcerative colitis (UC) have a higher risk of developing severe stomach and intestine problems with XATMEP. Your healthcare provider may hold or stop your treatment with Xatmep if any of these severe stomach and intestinal problems happen, and treat you as needed.
    Call your healthcare provider if you develop diarrhea, vomiting, inflammation, or sores in your mouth.
  • Liver Problems. XATMEP can cause severe liver problems including liver scarring (fibrosis, cirrhosis), and liver failure that may not get better (possibly irreversible) and can cause death. Your healthcare provider will do tests to monitor your liver function before you start and during treatment with XATMEP, and may hold or stop your treatment with XATMEP if needed. The risk of liver problems is increased with heavy use of alcohol. Avoid drinking alcohol during Xatmep treatment.
    Tell your healthcare provider if you develop any signs or symptoms of liver problems during treatment with XATMEP, including:
    • tiredness
    • easy bleeding or bruising
    • loss of appetite
    • nausea
    • difficulty thinking clearly
    • swelling in your legs, feet, or ankles
    • weight loss
    • itchy skin
    • yellowing of your skin or the white part of your eyes
    • weakness
  • Lung Problems. Lung problems can happen suddenly (acute) with Xatmep or they can develop over a long period of time (chronic). Lung problems may not get better (possibly irreversible) and can cause death in anyone taking XATMEP. Your healthcare provider will monitor you for lung problems during treatment with XATMEP. Your healthcare provider may hold or stop your treatment with XATMEP if needed.
    Call your healthcare provider if you develop symptoms of a lung problem, including cough, fever, and trouble breathing.
  • Severe allergic reactions. Severe allergic reactions can happen with XATMEP. Do not receive Xatmep if you have had a severe allergic reaction to methotrexate in the past.
    Get medical help right away if you develop any of the signs or symptoms of a severe allergic reaction to XATMEP, including:
    • skin rash, itching, and hives
    • swelling of the face, lips, tongue, or throat, or trouble swallowing
    • dizziness or lightheadedness
    • trouble breathing
    • wheezing
    • throat tightness
    • runny or stuffy nose
    • fast heart rate
    • chest pain
    • feeling faint
  • Secondary Malignancies. New cancer may develop while you are taking XATMEP. Your healthcare provider may hold or stop your treatment with XATMEP if needed.
  • Embryo-Fetal Toxicity. XATMEP can cause harm to an unborn baby, including birth defects or the death of an unborn baby.
    • Females who can become pregnant: Your healthcare provider should do a pregnancy test before you start taking XATMEP to see if you are pregnant. If you are being treated for a medical condition other than cancer, do not receive or take Xatmep if you are pregnant. If you are taking Xatmep to treat your cancer, you and your healthcare provider will decide if you will receive or take Xatmep if you are pregnant. Use effective birth control during treatment and for 6 months after your final dose of Xatmep.
      Tell your healthcare provider right away if you become pregnant or think you are pregnant during treatment with XATMEP.
    • Males of reproductive potential: Use effective birth control during treatment and for 3 months after your final dose of XATMEP.
      Tell your healthcare provider right away if your female partner becomes pregnant during treatment with XATMEP.
  • Ineffective Immunization and Risks Associated with Live Vaccines. Avoid receiving vaccines during treatment with XATMEP because they may not be effective and live virus vaccines may cause infection.
  • Infertility. XATMEP may cause impairment of fertility, low sperm count (oligospermia), and menstrual dysfunction.

Before taking XATMEP, tell your healthcare provider about all your medical conditions, including if you:

  • have kidney problems or are receiving dialysis treatments
  • have liver problems
  • have fluid in your stomach area (ascites)
  • have lung problems or fluid in your lungs
  • have stomach ulcers (peptic ulcer disease)
  • have ulcerative colitis
  • have recently received or are scheduled to receive a vaccine. You should not receive live vaccines during treatment with XATMEP
  • plan to get radiation. There may be more chance of harm to tissue and bone.
  • are breastfeeding or plan to breastfeed. Methotrexate may pass into your breast milk. Do not breastfeed during treatment with XATMEP

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking certain medicines can affect the amount of methotrexate in your blood and can increase your risk for serious side effects.

The most common side effects of XATMEP include:

  • inflammation and sores in your digestive tract
  • low white blood cell count
  • nausea
  • stomach pain
  • elevated liver function tests

Other frequently reported adverse reactions are malaise, fatigue, chills and fever, dizziness, and decreased resistance to infection

Store XATMEP either refrigerated (2°C to 8°C/36°F to 46°F) or at room temperature (20°C to 25°C/68°F to 77°F) with excursions permitted to 15°C to 30°C/59°F to 86°F. If stored at room temperature, discard after 60 days.

The Important Safety Information does not include all the information needed to use XATMEP safely and effectively. Please talk to your healthcare provider and see the complete Prescribing Information for XATMEP.

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.

- - - - - - - - -

PT-XAT-1.0

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 severe or fatal toxicities. Monitor closely and modify dose or discontinue for the following toxicities: bone marrow suppression (5.1), infection (5.2), renal (5.3), gastrointestinal (5.4), hepatic (5.5), pulmonary (5.6), hypersensitivity and dermatologic (5.7).
  • Methotrexate can cause embryo-fetal toxicity and fetal death. Use in polyarticular juvenile idiopathic arthritis is contraindicated in pregnancy (4). Consider the benefits and risks of XATMEP and risks to the fetus when prescribing XATMEP to a pregnant patient with a neoplastic disease. Advise patients to use effective contraception during and after treatment with XATMEP (5.9, 8.1, 8.3).

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).

A calibrated measuring device is recommended to measure and deliver the prescribed dose accurately. A household teaspoon or tablespoon is not an adequate measuring device. Ask your pharmacist or doctor for assistance in the selection of a measuring device.
The recommended dose should be taken one time weekly, as directed. Mistaken daily use of the recommended dose has led to fatal toxicity.

ADDITIONAL IMPORTANT SAFETY INFORMATION:

Do not take XATMEP if you are pregnant and are being treated for any disease other than cancer or have had severe allergic reactions to methotrexate in the past.

What is the most important information I should know about XATMEP?

XATMEP may cause serious side effects that may be severe and lead to death, including:

  • Bone Marrow Suppression. XATMEP can affect your bone marrow and cause decreased red blood cell counts, white blood cell counts, and platelet counts, and a condition where your bone marrow cannot produce these blood cells. Your healthcare provider will check your blood cell counts before you start and during treatment with Xatmep. Your healthcare provider will watch you closely for infections during treatment with XATMEP.
    Call your healthcare provider right away if you develop new onset fever, symptoms of infection, easy bruising, or persistent bleeding.
  • Serious Infections. People who receive treatment with XATMEP have an increased risk of developing serious infections that can be life-threatening or lead to death. These infections include:
    • bacterial infections
    • fungal infections
    • viral infections
    • certain infections that happen because your immune system is weakened: hepatitis B infection that comes back (reactivation), tuberculosis (TB) infection that is new or that comes back (reactivation), shingles (herpes zoster), cytomegalovirus infections

    Your healthcare provider will closely watch you for signs and symptoms of infection during treatment with XATMEP. Your healthcare provider may hold or stop your treatment with XATMEP if you develop a serious infection.

  • Kidney Problems. XATMEP can cause kidney damage including sudden kidney failure. Your healthcare provider will check your kidney function during treatment and will hold or stop Xatmep treatment as needed for severe kidney damage.
    Call your healthcare provider right away if you have signs or symptoms of kidney problems such as being unable to pass urine, a change in how much urine is passed, blood in the urine, or a big weight gain.
  • Stomach and Intestine Problems. XATMEP can cause diarrhea, vomiting, mouth sores, stomach and intestinal inflammation with severe bleeding, and tears in the intestinal wall (perforation), and can lead to death. People who have stomach ulcers (peptic ulcer disease) or ulcerative colitis (UC) have a higher risk of developing severe stomach and intestine problems with XATMEP. Your healthcare provider may hold or stop your treatment with Xatmep if any of these severe stomach and intestinal problems happen, and treat you as needed.
    Call your healthcare provider if you develop diarrhea, vomiting, inflammation, or sores in your mouth.
  • Liver Problems. XATMEP can cause severe liver problems including liver scarring (fibrosis, cirrhosis), and liver failure that may not get better (possibly irreversible) and can cause death. Your healthcare provider will do tests to monitor your liver function before you start and during treatment with XATMEP, and may hold or stop your treatment with XATMEP if needed. The risk of liver problems is increased with heavy use of alcohol. Avoid drinking alcohol during Xatmep treatment.
    Tell your healthcare provider if you develop any signs or symptoms of liver problems during treatment with XATMEP, including:
    • tiredness
    • easy bleeding or bruising
    • loss of appetite
    • nausea
    • difficulty thinking clearly
    • swelling in your legs, feet, or ankles
    • weight loss
    • itchy skin
    • yellowing of your skin or the white part of your eyes
    • weakness
  • Lung Problems. Lung problems can happen suddenly (acute) with Xatmep or they can develop over a long period of time (chronic). Lung problems may not get better (possibly irreversible) and can cause death in anyone taking XATMEP. Your healthcare provider will monitor you for lung problems during treatment with XATMEP. Your healthcare provider may hold or stop your treatment with XATMEP if needed.
    Call your healthcare provider if you develop symptoms of a lung problem, including cough, fever, and trouble breathing.
  • Severe allergic reactions. Severe allergic reactions can happen with XATMEP. Do not receive Xatmep if you have had a severe allergic reaction to methotrexate in the past.
    Get medical help right away if you develop any of the signs or symptoms of a severe allergic reaction to XATMEP, including:
    • skin rash, itching, and hives
    • swelling of the face, lips, tongue, or throat, or trouble swallowing
    • dizziness or lightheadedness
    • trouble breathing
    • wheezing
    • throat tightness
    • runny or stuffy nose
    • fast heart rate
    • chest pain
    • feeling faint
  • Secondary Malignancies. New cancer may develop while you are taking XATMEP. Your healthcare provider may hold or stop your treatment with XATMEP if needed.
  • Embryo-Fetal Toxicity. XATMEP can cause harm to an unborn baby, including birth defects or the death of an unborn baby.
    • Females who can become pregnant: Your healthcare provider should do a pregnancy test before you start taking XATMEP to see if you are pregnant. If you are being treated for a medical condition other than cancer, do not receive or take Xatmep if you are pregnant. If you are taking Xatmep to treat your cancer, you and your healthcare provider will decide if you will receive or take Xatmep if you are pregnant. Use effective birth control during treatment and for 6 months after your final dose of Xatmep.
      Tell your healthcare provider right away if you become pregnant or think you are pregnant during treatment with XATMEP.
    • Males of reproductive potential: Use effective birth control during treatment and for 3 months after your final dose of XATMEP.
      Tell your healthcare provider right away if your female partner becomes pregnant during treatment with XATMEP.
  • Ineffective Immunization and Risks Associated with Live Vaccines. Avoid receiving vaccines during treatment with XATMEP because they may not be effective and live virus vaccines may cause infection.
  • Infertility. XATMEP may cause impairment of fertility, low sperm count (oligospermia), and menstrual dysfunction.

Before taking XATMEP, tell your healthcare provider about all your medical conditions, including if you:

  • have kidney problems or are receiving dialysis treatments
  • have liver problems
  • have fluid in your stomach area (ascites)
  • have lung problems or fluid in your lungs
  • have stomach ulcers (peptic ulcer disease)
  • have ulcerative colitis
  • have recently received or are scheduled to receive a vaccine. You should not receive live vaccines during treatment with XATMEP
  • plan to get radiation. There may be more chance of harm to tissue and bone.
  • are breastfeeding or plan to breastfeed. Methotrexate may pass into your breast milk. Do not breastfeed during treatment with XATMEP

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking certain medicines can affect the amount of methotrexate in your blood and can increase your risk for serious side effects.

The most common side effects of XATMEP include:

  • inflammation and sores in your digestive tract
  • low white blood cell count
  • nausea
  • stomach pain
  • elevated liver function tests

Other frequently reported adverse reactions are malaise, fatigue, chills and fever, dizziness, and decreased resistance to infection

Store XATMEP either refrigerated (2°C to 8°C/36°F to 46°F) or at room temperature (20°C to 25°C/68°F to 77°F) with excursions permitted to 15°C to 30°C/59°F to 86°F. If stored at room temperature, discard after 60 days.

The Important Safety Information does not include all the information needed to use XATMEP safely and effectively. Please talk to your healthcare provider and see the complete Prescribing Information for XATMEP.

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.

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