IMPORTANT SAFETY INFORMATION:

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

Indications:

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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