Trexall - Methotrexate Tablets

What is this medication?

METHOTREXATE (METH oh TREX ate) treats autoimmune conditions, such as arthritis and psoriasis. It works by decreasing inflammation, which can reduce pain and prevent long-term injury to the joints and skin. It may also be used to treat some types of cancer. It works by slowing down the growth of cancer cells.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Rheumatrex, Trexall

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Dehydration
• Diabetes
• Fluid in the stomach area or lungs
• Frequently drink alcohol
• Having surgery, including dental surgery
• High cholesterol
• Immune system problems
• Inflammatory bowel disease, such as ulcerative colitis
• Kidney disease
• Liver disease
• Low blood cell levels (white cells, red cells, and platelets)
• Lung disease
• Recent or ongoing radiation
• Recent or upcoming vaccine
• Stomach ulcers, other stomach or intestine problems
• An unusual or allergic reaction to methotrexate, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breastfeeding

How should I use this medication?

Take this medication by mouth with water. Take it as directed on the prescription label. Do not take extra. Keep taking this medication until your care team tells you to stop.

Know why you are taking this medication and how you should take it. To treat conditions such as arthritis and psoriasis, this medication is taken ONCE A WEEK as a single dose or divided into 3 smaller doses taken 12 hours apart (do not take more than 3 doses 12 hours apart each week). This medication is NEVER taken daily to treat conditions other than cancer. Taking this medication more often than directed can cause serious side effects, even death. Talk to your care team about why you are taking this medication, how often you will take it, and what your dose is. Ask your care team to put the reason you take this medication on the prescription.

If you take this medication ONCE A WEEK, choose a day of the week before you start. Ask your pharmacist to include the day of the week on the label. Avoid "Monday", which could be misread as "Morning".

Handling this medication may be harmful. Talk to your care team about how to handle this medication. Special instructions may apply.

Talk to your care team about the use of this medication in children. While it may be prescribed for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, talk with your care team. Do not take double or extra doses.

What may interact with this medication?

Do not take this medication with any of the following:

• Acitretin
• Live virus vaccines
• Probenecid

This medication may also interact with the following:

• Alcohol
• Aspirin and aspirin-like medications
• Certain antibiotics, such as penicillin, neomycin, sulfamethoxazole; trimethoprim
• Certain medications for stomach problems, such as lansoprazole, omeprazole, pantoprazole
• Clozapine
• Cyclosporine
• Dapsone
• Folic acid
• Foscarnet
• NSAIDs, medications for pain and inflammation, such as ibuprofen or naproxen
• Phenytoin
• Pyrimethamine
• Steroid medications, such as prednisone or cortisone
• Tacrolimus
• Theophylline

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress. It may be some time before you see the benefit from this medication.

You may need blood work done while you are taking this medication.

If your care team has also prescribed folic acid, they may instruct you to skip your folic acid dose on the day you take methotrexate.

This medication can make you more sensitive to the sun. Keep out of the sun. If you cannot avoid being in the sun, wear protective clothing and sunscreen. Do not use sun lamps, tanning beds, or tanning booths.

Check with your care team if you have severe diarrhea, nausea, and vomiting, or if you sweat a lot. The loss of too much body fluid may make it dangerous for you to take this medication.

This medication may increase your risk of getting an infection. Call your care team for advice if you get a fever, chills, sore throat, or other symptoms of a cold or flu. Do not treat yourself. Try to avoid being around people who are sick.

Talk to your care team about your risk of cancer. You may be more at risk for certain types of cancers if you take this medication.

Talk to your care team if you or your partner may be pregnant. Serious birth defects can occur if you take this medication during pregnancy and for 6 months after the last dose. You will need a negative pregnancy test before starting this medication. Contraception is recommended while taking this medication and for 6 months after the last dose. Your care team can help you find the option that works for you.

If your partner can get pregnant, use a condom during sex while taking this medication and for 3 months after the last dose.

Do not breastfeed while taking this medication and for 1 week after the last dose.

This medication may cause infertility. Talk to your care team if you are concerned about your fertility.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Dry cough, shortness of breath or trouble breathing
• Infection—fever, chills, cough, sore throat, wounds that don't heal, pain or trouble when passing urine, general feeling of discomfort or being unwell
• Kidney injury—decrease in the amount of urine, swelling of the ankles, hands, or feet
• Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue
• Low red blood cell level—unusual weakness or fatigue, dizziness, headache, trouble breathing
• Pain, tingling, or numbness in the hands or feet, muscle weakness, change in vision, confusion or trouble speaking, loss of balance or coordination, trouble walking, seizures
• Redness, blistering, peeling, or loosening of the skin, including inside the mouth
• Stomach bleeding—bloody or black, tar-like stools, vomiting blood or brown material that looks like coffee grounds
• Stomach pain that is severe, does not away, or gets worse
• Unusual bruising or bleeding

Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):

• Diarrhea
• Dizziness
• Hair loss
• Nausea
• Pain, redness, or swelling with sores inside the mouth or throat
• Skin reactions on sun-exposed areas
• Vomiting

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Protect from light. Keep the container tightly closed. Get rid of any unused medication after the expiration date.

To get rid of medications that are no longer needed or have expired:

• Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, ask your pharmacist or care team how to get rid of this medication safely.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.