April 23, 2017
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Trexall

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Trexall




PATIENT INFORMATION

Trexall®
(methotrexate) Tablets

Read the Patient Instructions that come with Trexall before you start using it and each time you get a refill. There may be new information. This leaflet does not take the place of talking with your doctor about your condition.

What is the most important information I should know about Trexall?

  • Trexall can cause serious side effects that may be life threatening (see “What are the possible or reasonably likely side effects of Trexall?”). Most side effects can be found by medical tests before they become serious. Your doctor may do regular tests to check how Trexall is affecting your body. It is important that you stay under a doctor's care while taking Trexall. Call your doctor right away to report any side effects or symptoms you get.
  • Trexall can cause birth defects or death of an unborn child. Therefore, if you are pregnant or your sexual partner is pregnant, or plans to become pregnant, do not take Trexall. Neither you nor your partner should become pregnant while taking Trexall. Women should wait at least 1 menstrual cycle after stopping treatment with Trexall before getting pregnant. Men should wait at least 3 months after stopping treatment with Trexall before getting their partner pregnant. Women who can become pregnant should have a pregnancy test before starting Trexall. During treatment with Trexall men whose partners and women who are able to get pregnant should us e effective birth control.

What is Trexall?

Trexall is a prescription medicine used in treating certain cancers, severe rheumatoid arthritis including polyarticular juvenile rheumatoid arthritis, and severe psoriasis.

Who should not take Trexall?

Do not take Trexall if:

  • you are pregnant or planning to become pregnant. Trexall can cause birth defects or death to your unborn child. See “What is the most important information I should know about Trexall?”
  • you are breastfeeding. Trexall can harm your baby. You will need to decide either to breastfeed or to take Trexall, but not both.
  • you have any conditions that weaken your immune system (immunodeficiency conditions).
  • your bone marrow does not make enough blood cells, or if you have low white blood cell counts, low platelet counts, or serious anemia.
  • you drink alcohol or have liver problems from alcohol abuse.
  • you have chronic liver disease.
  • you are allergic to methotrexate or any of the ingredients in Trexall. See the end of this leaflet for a complete list of ingredients in Trexall.

Before using Trexall tell your doctor:

  • about all your medical problems including if you:
    • have kidney problems or are getting dialysis treatments
    • have liver problems
    • have fluid in your stomach area (ascites)
    • have lung problems or fluid in your lungs (pleural effusion)
  • about all the medicines you take including prescription and nonprescription medicines, vitamins and herbal supplements. Trexall and certain other medicines can affect each other and cause serious side effects. Do not start or change any medicines unless you have talked to your doctorand your doctor has told you it is safe. Know all the medicines that you take and keep a list of them with you at all times to show doctors and pharmacists.

How should I take Trexall?

  • Take Trexall exactly as prescribed by your doctor. Your dose of Trexall and when you take it will depend on the condition that is being treated. Do not take more Trexall than prescribed. Do not change your dose of Trexall unless your doctor has told you to. For treatment of severe psoriasis, and severe rheumatoid arthritis including juvenile rheumatoid arthritis, Trexall should be taken weekly, not every day. This weekly dose is taken either at one time or in several doses.
  • If you miss a dose of Trexall call your doctor to ask if you should take the dose or not.
  • If you take too much Trexall call your doctor or go to your nearest emergency room right away. You will need to take a medicine called an antidote as soon as possible.
  • Call your doctor right away for further instructions if you get dehydrated (lose a large amount of body fluids). This can happen if you are sick and have a fever, vomiting, or diarrhea. Dehydration can also happen when you sweat a lot with activities or exercise and don't drink enough fluids.
  • Stop taking Trexall if you get diarrhea, or if you get sores in your mouth. Call your doctor right away. If you keep taking Trexall with these symptoms, you could get serious bleeding or tearing of your digestive tract.
  • Your doctor should do regular tests to monitor how Trexall is affecting your body. Check with your doctor after having any blood tests before taking Trexall again. Your doctor will tell you if it is safe to take more Trexall.
  • Certain side effects such as mouth sores may be reduced by folate supplementation with Trexall.

What should I avoid while taking Trexall?

Do not:

  • get pregnant or try to become pregnant. See “What is the most important information I should know about Trexall?”
  • breastfeed. See “Who should not take Trexall?”
  • drink alcohol. Alcohol drinks, including beer and wine, may increase some of the side effects with Trexall, including the chance of liver damage.
  • take certain live virus vaccines .

What are the possible or reasonably likely side effects of Trexall?

Trexall can cause serious and life-threatening problems including (see ”What is the most important information I should know about Trexall?):

  • birth defects and death of an unborn child
  • serious anemia, lower white cells, red cells, and platelets in your blood
  • liver damage
  • kidney damage
  • lung disease
  • cancer of the lymph system (lymphoma)
  • severe skin reactions and rashes
  • opportunistic infections such as Pneumocystis carini pneumonia
  • soft tissue and bone damage if you are getting radiation therapy at the same time you are taking Trexall

The most common side effects of Trexall include:

  • mouth sores
  • low white blood cells
  • nausea, upset stomach
  • feeling poorly
  • tiredness, chills, fever, dizziness
  • higher chance for getting infections
  • diarrhea
  • vomiting
  • hair loss
  • easy bruising

Stop taking Trexall and call your doctor right away if you get diarrhea, mouth sores, a fever, dehydration, cough, bleeding, shortness of breath, any signs of infection, or a skin rash. If you have any questions about these or other side effects, talk to your doctor. These are not all the side effects of Trexall. Ask your doctor or pharmacist for more information.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store Trexall?

  • Store Trexall at room temperature between 68° to 77° F (20° to 25° C).
  • Keep Trexall away from light.
  • Keep Trexall and all medicines out of the reach of children.

General information about Trexall

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Trexall for a condition for which it was not prescribed. Do not give Trexall to other people, even if they have the same symptoms that you have. It may harm them.

This leaflet summarizes the most important information about Trexall. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about Trexall that is written for healthcare professionals.

For additional information, please contact Teva Pharmaceuticals USA, Inc. at: 888-838-2872.

What are the ingredients in Trexall?

Active Ingredient: methotrexate sodium

Inactive Ingredients : anhydrous lactose, crospovidone, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized corn starch, sodium carbonate monohydrate, talc and titanium dioxide.

The 5 mg also contains: D&C yellow no. 10 aluminum lake, FD&C blue no. 1 aluminum lake and FD&C yellow no. 6 aluminum lake.

The 7.5 mg also contains: FD&C blue no.1 aluminum lake.

The 10 mg also contains: FD&C red no. 40 aluminum lake.

The 15 mg also contains: FD&C blue no. 2 aluminum lake and FD&C red no. 40 aluminum lake.

Last reviewed on RxList: 1/3/2017
This monograph has been modified to include the generic and brand name in many instances.

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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