Trexall-Generic (methotrexate) Tablets & Injection

Methotrexate {aka Trexal}

Patient Education - English

• Generic Name: methotrexate (injection)

• Pronounced: meth oh TREX ate

• Brand Name: Methotrexate Sodium, Preservative Free

What is the most important information I should know about methotrexate injection?

Methotrexate injection can cause serious or life-threatening side effects on your liver, lungs, kidneys, and bone marrow (immune system). To check for harmful effects, your blood will need to be tested on a regular basis. Your kidney or liver function may also need to be tested, and you may need an occasional liver biopsy or chest x-ray. Do not miss any scheduled appointments.

You may not be able to receive methotrexate injection if you have liver disease (especially if caused by alcoholism), a blood cell or bone marrow disorder, or if you are breast-feeding a baby. Your doctor will decide if this treatment is right for you.

Methotrexate can cause birth defects in an unborn baby. You should not use methotrexate to treat psoriasis or rheumatoid arthritis if you are pregnant. Use an effective form of birth control, whether you are a man or a woman. Tell your doctor if you or your sexual partner become pregnant during treatment.

There are many other medicines that can interact with methotrexate injection. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor. Keep a list with you of all the medicines you use and show this list to any doctor or other healthcare provider who treats you.

What is methotrexate injection?

Methotrexate injection interferes with the growth of certain cells of the body, especially cells that reproduce quickly, such as cancer cells, bone marrow cells, and skin cells.

Methotrexate injection is used to treat leukemia and certain types of cancer of the breast, skin, head and neck, or lung. Methotrexate injection is also used to treat severe psoriasis and rheumatoid arthritis.

Methotrexate injection is usually given after other medications have been tried without successful treatment of symptoms.

Methotrexate injection may also be used for other purposes not listed in this medication guide.

What should I discuss with my healthcare provider before receiving methotrexate injection?

You should not use this medication if you are allergic to methotrexate. Do not use methotrexate injection to treat psoriasis or rheumatoid arthritis if you have:

• liver disease;
• alcoholism or cirrhosis of the liver;
• a blood cell disorder such as anemia (lack of red blood cells) or leukopenia (lack of white blood cells);
• a weak immune system or bone marrow disorder; or
• if you are breast-feeding a baby.

Methotrexate injection is sometimes used to treat cancer even when patients do have one of the conditions listed above. Your doctor will decide if this treatment is right for you.

Before receiving methotrexate injection, tell your doctor if you are allergic to any drugs, or if you have:

• kidney or liver disease;
• lung disease or pneumonia;
• stomach ulcers, ulcerative colitis;
• any type of infection; or
• if you are receiving radiation treatments.

FDA pregnancy category X. Methotrexate injection can cause birth defects in an unborn baby. Do not use methotrexate injection to treat psoriasis or rheumatoid arthritis if you are pregnant. Tell your doctor right away if you become pregnant during treatment.

Use birth control to prevent pregnancy while you are receiving methotrexate injection, whether you are a man or a woman. Methotrexate injection use by either parent may cause birth defects.

If you are a man, use a condom to keep from causing a pregnancy while you are receiving methotrexate injection. Continue using condoms for at least 90 days after your treatment ends.

If you are a woman, use an effective form of birth control while you are receiving methotrexate injection, and for at least one cycle of ovulation after your treatment ends.

How is methotrexate injection given?

Methotrexate is given as an injection into a muscle or through a needle placed into a vein. Methotrexate may also be injected directly into a joint, or into the area around your spinal cord. You will receive this injection in a clinic or hospital setting.

To be sure this medication is not causing harmful effects, your blood will need to be tested on a regular basis. Your kidney or liver function may also need to be tested, and you may need an occasional liver biopsy or chest x-ray. Do not miss any scheduled appointments.

What happens if I miss a dose?

Call your doctor if you miss an appointment for your methotrexate injection.

What happens if I overdose?

Seek emergency medical attention if you think you have received too much of this medicine. An overdose of methotrexate injection can be fatal.

Overdose symptoms may include headache, confusion, nausea, vomiting, or seizure (convulsions).

What should I avoid while receiving methotrexate injection?

Avoid exposure to sunlight or artificial UV rays (sunlamps, tanning beds, or PUVA treatment), especially if you have psoriasis. Methotrexate injection can make your skin more sensitive to sunlight and your psoriasis may worsen.

What are the possible side effects of methotrexate injection?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

• diarrhea, vomiting, white patches or sores inside your mouth or on your lips;
• weight loss, night sweats, swollen glands;
• fever, chills, flu symptoms, cough with yellow or green mucus;
• dry cough without mucus;
• stabbing chest pain, feeling short of breath;
• pale skin, easy bruising or bleeding;
• sudden numbness or weakness on one side of the body, confusion, neck stiffness, headache, back pain, seizure (convulsions);
• black, bloody, or tarry stools;
• urinating less than usual or not at all;
• dry mouth, increased thirst, drowsiness, restless feeling, confusion, nausea, vomiting, increased urination, muscle pain or weakness, fast heart rate, feeling light-headed, fainting;
• fever, sore throat, and headache with a severe blistering, peeling, and red skin rash; or
• the first sign of any skin rash, no matter how mild.

Less serious side effects may include:

• nausea, vomiting, upset stomach;
• dizziness; or
• tired feeling.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect methotrexate injection?

Many drugs can interact with methotrexate injection. Below is just a partial list. Tell your doctor if you are using:

• any other cancer medications, especially cisplatin (Platinol);
• phenytoin (Dilantin);
• diabetes medication you take by mouth;
• retinol, tretinoin (Retin-A), isotretinoin (Accutane);
• theophylline (Elixophyllin, Slo-Bid, Theobid, Theo-Dur);
• vitamin or mineral supplements containing folic acid;
• an NSAID (non-steroidal anti-inflammatory drug) such as ibuprofen (Motrin, Advil), naproxen (Aleve, Naprosyn), diclofenac (Voltaren), etodolac (Lodine), indomethacin (Indocin), ketoprofen (Orudis), and others;
• salicylates such as aspirin, Disalcid, Doan's Pills, Dolobid, Salflex, Tricosal, and others;
• a sulfa drug such as Azulfidine, Bactrim, or Septra;
• an antibiotic such as chloramphenicol (Chloromycetin), tetracycline, penicillin, ampicillin (Principen), amoxicillin (Amoxil, Trimox), or an antibiotic given by injection;
• medicines used to treat ulcerative colitis, such as mesalamine (Pentasa) or sulfasalazine (Azulfidine);
• medicines used to prevent organ transplant rejection, such as azathioprine (Imuran), sirolimus (Rapamune) or tacrolimus (Prograf); or
• antiviral medicines such as adefovir (Hepsera), cidofovir (Vistide), or foscarnet (Foscavir).

This list is not complete and there may be other drugs that can interact with methotrexate injection. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?

Your doctor or pharmacist can provide more information about methotrexate injection.

The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.