Xatmep

The active ingredient in Xatmep is methotrexate. When used for cancer, the high dose works by slowing the growth of cancer cells in the body. At low doses for pJIA, it suppresses the immune system and reduces inflammation.

Follow all directions given to you by your doctor and read all documents provided, including the full Prescribing Information, FDA-Approved Product Labeling, Instructions for Use, and Medication Guide before using Xatmep. However, the following is a synopsis of the general guidelines for the use of Xatmep:

• For pJIA, this medication is typically taken weekly, not daily. Contact your doctor or pharmacist if you miss a dose.
• Always use an accurate measuring device when administering Xatmep.
• Your child may need to have lab tests done before and while taking this medication.
• Before getting any vaccine, let your care provider know your child is taking methotrexate. Avoid getting any live virus vaccines while on this medication.
• Your child may also be prescribed folic acid (folate) while on this medication to help reduce side effects.
• If your child is using this medication to treat cancer, check their temperature often, and let your doctor know if it goes above 100.4 F.
• Do not drink alcohol while taking this medication.
• This medication can make you more sensitive to the sun, increasing your risk of sunburns and skin cancer. Take care to limit time in the sun during peak hours, and always wear sunscreen.

The most common side effects of methotrexate seen in clinical trials as compared to placebo include:

• Mouth sores or ulcers.
• Nausea/ vomiting/ diarrhea.
• Stomach upset.
• Dizziness.
• Fever/ chills.
• Hair loss.
• Low white blood cell count or platelet levels.
• Elevated liver function tests.
• Menstrual dysfunction.

Some individuals may experience serious side effects while using Xatmep. These side effects are life-threatening and may require immediate medical attention. If you experience any of the following, contact your healthcare provider or seek emergency medical help:

• A serious infection where your temperature is above 100.4, with or without chills, muscle aches, fast heart rate, or cough.
• Signs of low platelets include blood in the urine or stool, unexplained bruising, cuts that take longer to stop bleeding, or nosebleeds.
• Signs of lung disease such as shortness of breath, fever, or a cough.
• Signs of serious liver problems include nausea, vomiting, fatigue, stomach pain, pale-coloured stool, loss of appetite, yellowing of the eyes/ skin, or dark-coloured urine.
• Severe headache, confusion, vision changes, seizure, or difficulty talking.
• Severe dermatologic reactions such as toxic epidermal necrolysis, Stevens-Johnson syndrome, exfoliative dermatitis, skin necrosis, or erythema multiforme. Symptoms include painful blisters, peeling skin, a sore throat, or body aches.
• Signs of an allergic reaction include skin rash (hives), tightness in the chest, or swelling of the mouth, lips, or tongue.
• Signs of a secondary malignancy, such as immunosuppression-associated lymphoma.

These are not all of the possible side effects of Xatmep. You should always seek medical advice from your healthcare provider for any questions or concerns about your medical condition or treatment. Read all patient information, medication guides, or drug information sheets that come with this medication. You can also report adverse effects to the Food and Drug Administration at www.fda.gov/medwatch or 1-800-FDA-1088.

Before starting Xatmep, it is crucial to discuss any existing health conditions with your healthcare provider. You should be sure that your healthcare provider is aware of all your medical conditions, including whether your child:

• Has kidney problems.
• Has a history of alcohol abuse, cirrhosis, or liver failure.
• Ulcerative colitis or peptic ulcer disease.
• Is pregnant or planning to become pregnant in the near future.
• Is currently breastfeeding.
• Has any of: bone marrow hypoplasia, leucopenia, thrombocytopenia, or significant anemia.

• Known or suspected hypersensitivity to methotrexate or any inactive ingredient in the formulation.
• Pregnancy (if using it for a non-cancerous condition).

For pJIA, symptoms start to improve after 3-6 weeks, while for cancer treatment, it begins working immediately.

When Xatmep is taken with other prescription drugs, over-the-counter medications, vitamins, and supplements, it may change how they work or increase the frequency or severity of side effects. Make sure that you tell your healthcare professional about anything that you are taking to avoid any negative drug interactions, including:

• Nitrous oxide anesthesia increases the toxicity of methotrexate and should be avoided while you are on this drug.
• Use of non-steroidal anti-inflammatory drugs (NSAIDs), including ibuprofen and naproxen, while on methotrexate is not recommended due to gastrointestinal toxicity.
• Methotrexate should be used with caution with other Disease-Modifying Antirheumatic drugs (DMARDs) such as penicillamine, hydroxychloroquine, or sulfasalazine.
• L-asparaginase prevents the action of methotrexate, and should not be taken at the same time.
• Use of methotrexate with diuretics may induce bone marrow suppression.
• Methotrexate in combination with leflunomide may increase the risk of pancytopenia.
• Certain medications may increase the toxicity of methotrexate, including sulfonylureas, aminobenzoic acid, salicylates, phenylbutazone, phenytoin, proton pump inhibitors such as omeprazole or pantoprazole, sulfonamides, penicillins, and tetracycline.
• You should not receive packed red blood cells while on this medication.
• Concurrent use of azathioprine may increase your risk of liver damage.

Brand name Xatmep is available as a 2.5mg/mL oral solution.

It should be kept in the fridge, protected from light, and away from the reach of children or pets. It can be kept at room temperature, but must be discarded after 60 days in this case.

It is manufactured by Azurity Pharmaceuticals.

No, but it is available as a tablet from several manufacturers of generic drugs.

Barring any serious side effects as noted above, Xatmep should not be discontinued unless under the advice of a physician.

No, methotrexate is toxic to a growing fetus and can lead to fetal death and birth defects. Any person of childbearing potential on methotrexate should initiate a trusted form of contraception before starting methotrexate. Males with partners of childbearing potential should also ensure their partners are on an appropriate birth control. You or your partner should continue using birth control for 6 months after the last dose for females or 3 months after the last dose for males. Notify your doctor if you are already pregnant, become pregnant, or if you have any plans to become pregnant.

Methotrexate is not recommended in nursing patients due to the risk of serious adverse reactions in nursing infants. Talk to your doctor if you are already breastfeeding or if you have any plans to breastfeed. They will know or recommend what is best for you.