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methotrexate

Pronunciation

Generic Name: methotrexate (injection) (meth oh TREX ate)
Brand Name: Methotrexate Sodium, Preservative Free, Otrexup, Rasuvo

What is methotrexate injection?

Methotrexate 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 purposes not listed in this medication guide.

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

Methotrexate can be toxic to your organs, such as your stomach, liver, lungs, kidneys, nerves, skin, and bone marrow (immune system). Your blood and urine will need to be tested often, and you may need an occasional liver biopsy or chest x-ray.

Methotrexate can harm an unborn baby or cause birth defects. Do not use if you are pregnant.

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Some medicines can cause unwanted or dangerous effects when used with methotrexate, especially a nonsteroidal anti-inflammatory drug (NSAID) for pain, arthritis, fever, or swelling. This includes aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib (Celebrex), diclofenac, indomethacin, meloxicam, and others.

Call your doctor right away if you have a serious side effect: signs of stomach bleeding--diarrhea, bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds; lung problems--sudden chest pain or discomfort, wheezing, dry cough or hack; signs of infection--sudden weakness or ill feeling, fever, chills, sore throat, mouth sores, red or swollen gums, trouble swallowing; or severe skin reaction--red or purple skin rash that spreads and causes blistering and peeling.

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

You should not use methotrexate if you are allergic to it. Methotrexate injection should not be used to treat psoriasis or rheumatoid arthritis if you have:

  • chronic liver disease;

  • alcoholism or cirrhosis of the liver;

  • a blood cell disorder such as low red or white blood cell counts, or low levels of platelets in your blood;

  • a weak immune system or bone marrow disorder; or

  • if you are pregnant or breast-feeding.

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.

To make sure methotrexate is safe for you, tell your doctor if you have:

  • kidney disease;

  • liver disease;

  • lung disease or pneumonia;

  • stomach ulcer, ulcerative colitis;

  • any type of infection; or

  • if you are receiving phototherapy or radiation treatments.

FDA pregnancy category X. This medication can harm an unborn baby or cause birth defects. Do not use methotrexate if you are pregnant. You may need to have a negative pregnancy test before starting this treatment. Tell your doctor right away if you become pregnant during treatment.

This medication may affect fertility (your ability to have children), whether you are a man or a woman. However, both men and women should use birth control to prevent pregnancy while receiving this medicine. Methotrexate use by either parent may cause birth defects.

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

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

Methotrexate can pass into breast milk and may harm a nursing baby. Do not breast-feed while you are using methotrexate.

How is methotrexate injection given?

Your doctor will perform blood tests to make sure you do not have conditions that would prevent you from safely using methotrexate.

Methotrexate is injected under your skin, into a muscle, or into a vein through an IV. Methotrexate may also be injected directly into a joint, or into the area around your spinal cord. A healthcare provider will give you this injection.

You may be shown how to use injections at home. Do not self-inject this medicine if you do not understand how to give the injection and properly dispose of used needles, IV tubing, and other items used to inject the medicine. Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Otrexup or Rasuvo (methotrexate injected under the skin) is for use only 1 time each week. Do not use Otrexup or Rasuvo every day.

This medication comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions. It is very important not to inject too much methotrexate when you are using this medication at home.

Do not use this medicine if it has changed colors or has lumps or particles in it. Call your pharmacist for new medication.

Use a disposable needle and syringe only once. Follow any state or local laws about throwing away used needles and syringes. Use a puncture-proof "sharps" disposal container (ask your pharmacist where to get one and how to throw it away). Keep this container out of the reach of children and pets.

Use a disposable needle only once, then throw away in a puncture-proof container (ask your pharmacist where you can get one and how to dispose of it). Keep this container out of the reach of children and pets.

Methotrexate can be toxic to your organs, such as your stomach, liver, lungs, kidneys, nerves, skin, and bone marrow (immune system). To check for harmful effects, your blood will need to be tested often. Your kidney or liver function may also need to be tested, and you may need an occasional liver biopsy or chest x-ray. Visit your doctor regularly.

Store at room temperature away from moisture, heat, and light. Do not freeze.

What happens if I miss a dose?

Call your doctor for instructions if you miss an appointment for your methotrexate injection, or if you forget to use the medicine at home.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of methotrexate injection can be fatal.

What should I avoid while receiving methotrexate injection?

Do not drink alcohol. Serious side effects can occur when alcohol is combined with methotrexate.

Do not receive a "live" vaccine while using methotrexate, or you could develop a serious infection. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.

This medicine can pass into body fluids (including urine, feces, vomit, semen, vaginal fluid). For at least 48 hours after you receive a dose, avoid allowing your body fluids to come into contact with your hands or other surfaces. Patients and caregivers should wear rubber gloves while cleaning up body fluids, handling contaminated trash or laundry or changing diapers. Wash hands before and after removing gloves. Wash soiled clothing and linens separately from other laundry.

Body fluids should not be handled by a woman who is pregnant or who may become pregnant. Use condoms during sexual activity to avoid exposure to body fluids.

Methotrexate may impair your thinking or reactions. Avoid driving or operating machinery until you know how this medicine will affect you.

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.

Methotrexate injection side effects

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

Call your doctor at once if you have:

  • nerve problems--confusion, weakness, coordination problems, drowsiness, feeling irritable, back pain, headache, neck stiffness, seizure (convulsions), vision problems, loss of movement in any part of your body;

  • signs of stomach bleeding--diarrhea, bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;

  • lung problems--sudden chest pain or tightness, wheezing, trouble breathing, dry cough or hack;

  • signs of infection--sudden weakness or ill feeling, fever, chills, sore throat, cough with mucus, vomiting, weight loss, night sweats, swollen glands, mouth sores, red or swollen gums, trouble swallowing;

  • kidney problems--swelling, rapid weight gain, little or no urinating; 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.

Common side effects may include:

  • nausea, vomiting, stomach pain or discomfort, diarrhea;

  • blisters or ulcers in your mouth, red or swollen gums, trouble swallowing;

  • mild skin rash;

  • headache, dizziness;

  • runny or stuffy nose, sore throat, wheezing, trouble breathing;

  • abnormal liver function tests;

  • easy bruising or bleeding;

  • temporary hair loss;

  • occasional headache, blurred vision; or

  • burning sensation of psoriasis skin lesions.

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.

See also: Side effects (in more detail)

Methotrexate dosing information

Usual Adult Dose for Acute Lymphoblastic Leukemia:

Induction: 3.3 mg/m2/day orally or IM (in combination with prednisone 60 mg/m2).

Maintenance (during remission): 15 mg/m2 IM or orally twice a week.
Alternate remission dosing: 2.5 mg/kg IV every 14 days.

Usual Adult Dose for Choriocarcinoma:

15 to 30 mg IM or orally daily for 5 days. Repeat courses 3 to 5 times with a rest period of greater than or equal to 1 week between courses, until any manifesting toxic symptoms subside.

Effectiveness of therapy is ordinarily evaluated by 24 hour quantitative analysis of urinary chorionic gonadotropin (hCG), which generally will return to normal or less than 50 intl units/24 hours usually after the third or fourth course and usually followed by a complete resolution of measurable lesions in 4 to 6 weeks. One to two courses of methotrexate after normalization of hCG is usually recommended.

Usual Adult Dose for Trophoblastic Disease:

15 to 30 mg IM or orally daily for 5 days. Repeat courses 3 to 5 times with a rest period of greater than or equal to 1 week between courses, until any manifesting toxic symptoms subside.

Effectiveness of therapy is ordinarily evaluated by 24 hour quantitative analysis of urinary chorionic gonadotropin (hCG), which generally will return to normal or less than 50 intl units/24 hours usually after the third or fourth course and usually followed by a complete resolution of measurable lesions in 4 to 6 weeks. One to two courses of methotrexate after normalization of hCG is usually recommended.

Usual Adult Dose for Lymphoma:

For Burkitt's tumor in Stages I-II: 10 to 25 mg orally once a day for 4 to 8 days

Malignant lymphoma in Stage III: 0.625 to 2.5 mg/kg orally daily as a part of combination chemotherapy.

Treatment in all stages usually consists of several courses of the drug interposed with 7 to 10 day rest periods.

Usual Adult Dose for Meningeal Leukemia:

12 mg/m2 intrathecally every 2 to 5 days until the cell count of the CSF returns to normal. At this point, one additional dose is advisable. Administration at intervals of less than 1 week may result in increased subacute toxicity.

Usual Adult Dose for Mycosis Fungoides:

2.5 to 10 mg PO daily or 50 mg IM once a week or 25 mg IM twice a week.

Usual Adult Dose for Osteosarcoma:

Initial Dose: 12 g/m2 intravenously as a 4 hour infusion (in combination with other chemotherapeutic agents). If this dose is not adequate to achieve a peak serum concentration of 1000 micromolar at the end of the infusion, the dose may be increased to 15 g/m2.

Treatments may occur at 4, 5, 6, 7, 11, 12, 15, 16, 29, 30, 44, and 45 weeks after surgery.

If the patient is vomiting or unable to tolerate oral medication, leucovorin should be added to this regimen at the same dose and schedule as the methotrexate.

Usual Adult Dose for Psoriasis:

Single Dose: 10 to 25 mg/week orally, subcutaneously, IM, or IV until adequate response is achieved.
Divided Dose: 2.5 mg orally, IM, or IV every 12 hours for 3 doses once a week.
Maximum weekly dose: 30 mg.

Usual Adult Dose for Rheumatoid Arthritis:

Single dose: 7.5 mg orally weekly.
Divided dose: 2.5 mg orally every 12 hours for 3 doses once a week.
Maximum weekly dose: 20 mg

Patients may be switched from oral methotrexate to weekly subcutaneous injections taking into account the increased bioavailability relative to the oral formulation.

Usual Adult Dose for Neoplastic Diseases:

I.V.: Range is wide from 30-40 mg/m2/week to 100-12,000 mg/m2 with leucovorin rescue

Usual Pediatric Dose for Acute Lymphocytic Leukemia:

100 mg/m2 over 1 hour followed by a 35 hour infusion delivering 900 mg/m2/day.

Usual Pediatric Dose for Dermatomyositis:

15 to 20 mg/m2 orally once weekly.

Usual Pediatric Dose for Meningeal Leukemia:

less than 4 months: 3 mg/dose intrathecally.
greater than or equal to 4 months less than 1 year: 6 mg/dose intrathecally.
greater than or equal to 1 year less than 2 years: 8 mg/dose intrathecally.
greater than or equal to 2 years less than 3 years: 10 mg/dose intrathecally.
greater than or equal to 3 years: 12 mg/dose intrathecally.

The dose may be administered every 2 to 5 days until CSF counts return to normal followed by a dose administered once weekly for 2 weeks and monthly thereafter. Administration at intervals of less than 1 week may result in increased subacute toxicity.

Usual Pediatric Dose for Neoplastic Diseases:

7.5 to 30 mg/m2 IM or orally every 2 weeks.
Alternate dosing: 10 to 18,000 mg/m2 IV bolus or continuous infusion over 6 to 42 hours.

Usual Pediatric Dose for Rheumatoid Arthritis:

5 to 15 mg/m2 IM or orally once weekly.

Subcutaneous injection for Polyarticular Juvenile Idiopathic Arthritis: 10 mg/m2 subcutaneously once weekly.

Usual Pediatric Dose for Solid Tumors:

less than 12 years: 12000 mg/m2 IV.
greater than or equal to 12 years: 8000 mg/m2 IV.
Maximum dose: 18 grams.

What other drugs will affect methotrexate injection?

Many drugs can interact with methotrexate. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your medications and any you start or stop using during treatment with methotrexate.

Where can I get more information?

  • Your doctor or pharmacist can provide more information about methotrexate injection.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. 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.

Copyright 1996-2012 Cerner Multum, Inc. Version: 3.04. Revision Date: 2014-08-15, 2:50:48 PM.

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