Trexall

Methotrexate may be taken with or without food. For rheumatoid arthritis and psoriasis, the dose of methotrexate is given weekly, by injection or orally. The oral dose is 7.5 to 20 mg once weekly. For psoriasis, the starting oral dose is a single 7.5 mg dose weekly or 2.5 mg every 12 hours for three doses, once weekly. The final dose ranges between 10 and 25 mg weekly orally or by injection.

Trexall® (methotrexate tablets USP) (formerly Amethopterin) is an antimetabolite used in the treatment of certain neoplastic diseases, severe psoriasis, and adult rheumatoid arthritis. Chemically methotrexate, USP is N-[4[[(2,4-diamino-6-pteridinyl) methyl] methyl-amino]benzoyl]-L-glutamic acid. The structural formula is:

Trexall (methotrexate tablets USP), for oral administration, is available in 5 mg, 7.5 mg, 10 mg and 15 mg strengths.

Each tablet contains methotrexate sodium in an amount equivalent to the labeled amount of methotrexate, USP, and contains the following 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.

Before taking methotrexate, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to methotrexate or any of its ingredients
• have low blood folate levels
• are pregnant or breastfeeding
• are having surgery, including dental surgery

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Call your doctor for instructions if you miss a dose of methotrexate.

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

Stop using methotrexate and call your doctor at once if you have:

• dry cough, shortness of breath;

• diarrhea, vomiting, white patches or sores inside your mouth or on your lips;

• blood in your urine or stools;

• swelling, rapid weight gain, little or no urinating;

• seizure (convulsions);

• fever, chills, body aches, flu symptoms;

• pale skin, easy bruising, unusual bleeding, weakness, feeling light-headed or short of breath;

• liver problems--nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or

• severe skin reaction--fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Older adults may be more likely to have side effects from this medicine.

Common side effects may include:

• changes in your menstrual periods

• vomiting, upset stomach;

• headache, dizziness, tired feeling; or

• blurred vision.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

• It is used to treat rheumatoid arthritis.
• It is used to treat cancer.
• It is used to treat psoriasis.
• It may be given to you for other reasons. Talk with the doctor.

• Tell all of your health care providers that you take Trexall. This includes your doctors, nurses, pharmacists, and dentists.
• Avoid driving and doing other tasks or actions that call for you to be alert until you see how this medicine affects you.
• Talk with your doctor before getting any vaccines. Use with Trexall may either raise the chance of an infection or make the vaccine not work as well.
• You may have more chance of getting an infection. Wash hands often. Stay away from people with infections, colds, or flu.
• You may bleed more easily. Be careful and avoid injury. Use a soft toothbrush and an electric razor.
• Avoid drinking alcohol while taking this medicine.
• You may get sunburned more easily. Avoid sun, sunlamps, and tanning beds. Use sunscreen and wear clothing and eyewear that protects you from the sun. Keep protecting yourself from sunburn for as long as you were told by your doctor.
• Tell your doctor if you have too much sweat, fluid loss, throwing up, loose stools (diarrhea), not hungry, or more thirst.
• Patients with cancer who take Trexall (methotrexate tablets) may be at a greater risk of getting a bad health problem called tumor lysis syndrome (TLS). Sometimes, this has been deadly. Call your doctor right away if you have a fast heartbeat or a heartbeat that does not feel normal; any passing out; trouble passing urine; muscle weakness or cramps; upset stomach, throwing up, loose stools, or not able to eat; or feel sluggish.
• A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away, and sometimes death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.
• If you are 65 or older, use this medicine with care. You could have more side effects.
• This medicine may affect fertility. Fertility problems may lead to not being able to get pregnant or father a child. Talk with the doctor.
• If you are a man and have sex with a female who could get pregnant, protect her from pregnancy during care and for 3 months after care ends. Use birth control that you can trust.
• A pregnancy test will be done to show that you are NOT pregnant before starting Trexall. If you get pregnant while taking this medicine, call your doctor right away.
• Use birth control that you can trust to prevent pregnancy during care and for some time after care ends. Talk with your doctor to see how long to use birth control after you stop Trexall.
• If you are a woman and you miss a period, have unprotected sex, or think that your birth control has not worked, call your doctor right away.

Trexall® (methotrexate tablets USP) (formerly Amethopterin) is an antimetabolite used in the treatment of certain neoplastic diseases, severe psoriasis, and adult rheumatoid arthritis. Chemically methotrexate, USP is N-[4[[(2,4-diamino-6-pteridinyl) methyl] methyl-amino]benzoyl]-L-glutamic acid. The structural formula is:

C20H22N8O5 Molecular Weight: 454.45

Trexall (methotrexate tablets USP), for oral administration, is available in 5 mg, 7.5 mg, 10 mg and 15 mg strengths.

Each tablet contains methotrexate sodium in an amount equivalent to the labeled amount of methotrexate, USP, and contains the following 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.

Neoplastic Diseases

Methotrexate is indicated in the treatment of gestational choriocarcinoma, chorioadenoma destruens and hydatidiform mole.

Methotrexate is used in maintenance therapy in combination with other chemotherapeutic agents.

Methotrexate is used alone or in combination with other anticancer agents in the treatment of breast cancer, epidermoid cancers of the head and neck, advanced mycosis fungoides (cutaneous T cell lymphoma), and lung cancer, particularly squamous cell and small cell types. Methotrexate is also used in combination with other chemotherapeutic agents in the treatment of advanced stage non-Hodgkin’s lymphomas.

Psoriasis

Methotrexate is indicated in the symptomatic control of severe, recalcitrant, disabling psoriasis that is not adequately responsive to other forms of therapy, but only when the diagnosis has been established, as by biopsy and/or after dermatologic consultation. It is important to ensure that a psoriasis “flare” is not due to an undiagnosed concomitant disease affecting immune responses.

Rheumatoid Arthritis including Polyarticular-Course Juvenile Rheumatoid Arthritis

Methotrexate is indicated in the management of selected adults with severe, active, rheumatoid arthritis (ACR criteria), or children with active polyarticular-course juvenile rheumatoid arthritis, who have had an insufficient therapeutic response to, or are intolerant of, an adequate trial of first-line therapy including full dose non-steroidal anti-inflammatory agents (NSAIDs).

Aspirin, NSAIDs, and/or low dose steroids may be continued, although the possibility of increased toxicity with concomitant use of NSAIDs including salicylates has not been fully explored. (See PRECAUTIONS, Drug Interactions.) Steroids may be reduced gradually in patients who respond to methotrexate. Combined use of methotrexate with gold, penicillamine, hydroxychloroquine, sulfasalazine, or cytotoxic agents, has not been studied and may increase the incidence of adverse effects. Rest and physiotherapy as indicated should be continued.

Methotrexate can cause fetal death or teratogenic effects when administered to a pregnant woman. Methotrexate is contraindicated in pregnant women with psoriasis or rheumatoid arthritis and should be used in the treatment of neoplastic diseases only when the potential benefit outweighs the risk to the fetus. Women of childbearing potential should not be started on methotrexate until pregnancy is excluded and should be fully counseled on the serious risk to the fetus (See PRECAUTIONS) should they become pregnant while undergoing treatment. Pregnancy should be avoided if either partner is receiving methotrexate; during and for a minimum of three months after therapy for male patients, and during and for at least one ovulatory cycle after therapy for female patients. (See Boxed WARNINGS.)

Because of the potential for serious adverse reactions from methotrexate in breast fed infants, it is contraindicated in nursing mothers.

Patients with psoriasis or rheumatoid arthritis with alcoholism, alcoholic liver disease or other chronic liver disease should not receive methotrexate.

Patients with psoriasis or rheumatoid arthritis who have overt or laboratory evidence of immunodeficiency syndromes should not receive methotrexate.

Patients with psoriasis or rheumatoid arthritis who have preexisting blood dyscrasias, such as bone marrow hypoplasia, leukopenia, thrombocytopenia or significant anemia, should not receive methotrexate.

Patients with a known hypersensitivity to methotrexate should not receive the drug.

Teva Select Brands, North Wales, PA 19454

Division of Teva Pharmaceuticals USA, Inc.

Rev. A 7/2016

This Patient Information has been approved by the U.S. Food and Drug Administration. Iss. 7/2016

Trexall® (methotrexate tablets USP) 5 mg 30s Label Text

NDC 51285-366-01

Trexall®

(methotrexate tablets USP)

5 mg

PHARMACIST: Please Dispense

With Attached Patient

Information Leaflet.

Rx only

30 TABLETS

TEVA

Applies to methotrexate: oral tablet

Other dosage forms:

• injectable, powder for solution, solution

Along with its needed effects, methotrexate (the active ingredient contained in Trexall) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking methotrexate:

• Black, tarry stools
• blood in the urine or stools
• bloody vomit
• diarrhea
• joint pain
• reddening of the skin
• sores in the mouth or lips
• stomach pain
• swelling of the feet or lower legs

• Back pain
• blurred vision
• confusion
• convulsions (seizures)
• cough or hoarseness
• dark urine
• dizziness
• drowsiness
• fever or chills
• headache
• lower back or side pain
• painful or difficult urination
• pinpoint red spots on the skin
• shortness of breath
• unusual bleeding or bruising
• unusual tiredness or weakness
• yellow eyes or skin

Some side effects of methotrexate may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Hair loss, temporary
• loss of appetite
• nausea or vomiting

• Acne
• boils on skin
• pale skin
• skin rash or itching