RediTrex (PF)

Methotrexate is used to control severe psoriasis or rheumatoid arthritis that has not responded to other treatments. It may also be used to control juvenile rheumatoid arthritis. Methotrexate belongs to a class of drugs known as antimetabolites. It works by suppressing the immune system.

Early treatment of rheumatoid arthritis with more aggressive therapy such as methotrexate helps to reduce further joint damage and to preserve joint function.

Read the Patient Information Leaflet and Instructions for Use if available from your pharmacist before you start using methotrexate and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

If you are using this medication at home, learn all preparation and usage instructions from your health care professional and the product package.

Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid. Methotrexate should be yellow in color. If your product has a seal, do not use it if the seal is broken.

Inject this medication under the skin as directed by your doctor, usually once a week. Do not rub the area after injection.

Before injecting each dose, clean the injection site with rubbing alcohol. Change the injection site each time to lessen injury under the skin. Ask your doctor or pharmacist where you may inject this medication. Do not inject into skin that is red, swollen, or bruised, or into areas with scars/stretch marks.

Learn how to store and discard medical supplies safely.

The dosage is based on your medical condition and response to treatment.

Use this medication regularly to get the most benefit from it. To help you remember, use it on the same day each week.

Do not increase your dose or use this drug more often or for longer than prescribed. Your condition will not improve any faster, and your risk of side effects will increase.

It may take up to several months before you get the full benefit of this drug.

Tell your doctor if your condition does not improve or if it worsens.

See also Warning section.

Nausea, vomiting, stomach pain, drowsiness, or dizziness may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Temporary hair loss may occur. Normal hair growth should return after treatment has ended.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: mouth sores, diarrhea, signs of anemia (such as unusual tiredness, pale skin), signs of liver problems (such as dark urine, persistent nausea/vomiting, stomach/abdominal pain, yellowing eyes/skin), easy bruising/bleeding, black stools, enlarged glands/lymph nodes, bone pain, unusual pain and discoloration of the skin, signs of kidney problems (such as change in the amount of urine), dry cough, muscle weakness.

Get medical help right away if you have any very serious side effects, including: irregular heartbeat, vision changes, weakness on one side of the body, severe headache, neck stiffness, mental/mood changes, seizures.

This medication may lower your ability to fight infections. This may make you more likely to get a serious (rarely fatal) infection or make any infection you have worse. Tell your doctor right away if you have any signs of infection (such as fever, chills, persistent sore throat, cough).

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

See also Warning section.

Before using methotrexate, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, kidney disease, lung disease (such as pulmonary fibrosis), alcohol use, suppressed immune system, blood cell/bone marrow disorders, certain stomach/intestinal diseases (such as peptic ulcer, ulcerative colitis), any active infection (including chickenpox or recent exposure to it), folic acid deficiency.

Methotrexate can make you more likely to get infections or may worsen any current infections. Therefore, wash your hands well to prevent the spread of infection. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Consult your doctor if you have been exposed to an infection or for more details.

Do not have immunizations/vaccinations without the consent of your doctor. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).

To lower the chance of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.

This drug may make you dizzy or drowsy. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Avoid alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Children may be more sensitive to the side effects of this drug, especially seizures.

This medication may make you more sensitive to the sun. Limit your time in the sun. Avoid tanning booths and sunlamps. Use sunscreen and wear protective clothing when outdoors. Tell your doctor right away if you get sunburned or have skin blisters/redness.

This medication can affect fertility in both males and females. Ask your doctor for more details.

Methotrexate must not be used during pregnancy. It may harm an unborn baby. Your doctor should do a pregnancy test before you start this medication. You should not become pregnant while using methotrexate. Women of childbearing age should ask about reliable forms of birth control while using this medication and for 6 months after the last dose. Men with female partners of childbearing age should ask about reliable forms of birth control while using this medication and for 3 months after the last dose. If you or your partner become pregnant, or think you are pregnant, talk to your doctor right away about the risks and benefits of this medication Methotrexate passes into breast milk and may harm a nursing infant. Breast-feeding is not recommended while using this drug and for at least 1 week after the end of treatment. Consult your doctor before breast-feeding.

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

See also Warning section.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include: acitretin, asparaginase, chloramphenicol, leflunomide, other drugs that can cause kidney problems (such as cisplatin), other drugs that can cause liver problems (such as azathioprine, sulfasalazine, retinoids such as isotretinoin), penicillins, phenytoin, probenecid, procarbazine, pyrimethamine, sulfa medications, tetracyclines.

Certain drugs that reduce stomach acid (proton pump inhibitors-PPIs such as esomeprazole, omeprazole, pantoprazole) may increase the amount of methotrexate in your blood. This effect may increase the risk of side effects, especially with high-dose methotrexate treatment. Ask your doctor or pharmacist for details and ways to lessen the risk of side effects.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include severe nausea and vomiting, and bloody stools.

For the best possible benefit, it is important to receive each scheduled dose of this medication as directed. If you miss a dose, contact your doctor or pharmacist right away to establish a new dosing schedule. Do not double the dose to catch up.

Do not share this medication with others.

Laboratory and/or medical tests (such as complete blood cell counts, liver and kidney function tests, pregnancy test, chest X-ray) should be performed before you start treatment, periodically to monitor your progress, or to check for side effects. Consult your doctor for more details.