Xatmep 2.5 mg/mL oral solution

The photos shown are samples only

Generic name:
Methotrexate - oral

Pronunciation
(METH-oh-TREX-ate)

Brand name(s)
Rheumatrex , Jylamvo , Trexall , Xatmep

Methotrexate has rarely caused serious (sometimes fatal) side effects. This medication should be used only to treat cancer or severe diseases caused by an overactive immune system (such as psoriasis, rheumatoid arthritis).

Methotrexate has caused birth defects and death in unborn babies. Women must avoid becoming pregnant while taking this medication. Pregnant women who have psoriasis or rheumatoid arthritis must not use methotrexate. (See also Precautions section.)

If you have kidney problems or excess body water (ascites, pleural effusion), you must be closely monitored and your dose may be adjusted or stopped by your doctor.

Methotrexate (usually at high dosages) has rarely caused severe (sometimes fatal) blood/bone marrow problems (decreasing your body's ability to fight infections) and stomach/intestinal disease (such as bleeding) when used at the same time as non-steroidal anti-inflammatory drugs (NSAIDs such as indomethacin, ketoprofen). NSAIDs should not be used with high-dose methotrexate. Caution is advised if you also take aspirin. NSAIDs/aspirin may be used with low-dose methotrexate such as for the treatment of rheumatoid arthritis if directed by your doctor. If your doctor has told you to take low-dose aspirin to prevent heart attack or stroke (usually 81-162 milligrams a day), you should keep taking the aspirin unless your doctor tells you not to. Ask your doctor or pharmacist for more details on the safe use of these drugs (such as close monitoring by your doctor, keeping the same doses of NSAIDs).

In rare instances, this drug may also cause liver problems when it is used for long periods of time. If you are using methotrexate long term, a liver biopsy is usually recommended.

Methotrexate use has rarely caused serious (sometimes fatal) side effects, such as lung problems, lung infections (Pneumocystis jiroveci pneumonia), skin reactions, diarrhea, and mouth sores (ulcerative stomatitis). (See also Side Effects section.)

Lumps (tumors/abnormal growths) may very rarely appear during methotrexate use. The drug must be stopped and treatment may be needed. Tell your doctor right away if new lumps/growths occur.

When used to treat tumors, methotrexate sometimes causes side effects due to the rapid destruction of cancer cells (tumor lysis syndrome). To lower your risk, drink plenty of fluids unless your doctor directs you otherwise. Also, your doctor may prescribe an additional medication. Tell your doctor right away if you have symptoms such as irregular heartbeat, low back/side pain, signs of kidney problems (such as pink/bloody urine, change in the amount of urine, painful urination), or muscle spasms/weakness.

When this medication is used with radiation treatment, it may rarely increase the risk of tissue and bone damage. Discuss the risks and benefits of your treatment with your doctor.

Uses

Methotrexate is used to treat certain types of cancer (such as acute lymphoblastic leukemia, non-Hodgkin's lymphoma), severe psoriasis that has not responded to other treatments, or rheumatoid arthritis. It may also be used to treat a certain type of arthritis in children (polyarticular juvenile idiopathic arthritis - pJIA). Methotrexate belongs to a class of drugs known as antimetabolites. It works by slowing or stopping the growth of cancer cells and blocking the immune system from attacking healthy tissue.

Early treatment of rheumatoid arthritis with methotrexate helps to reduce further joint damage and to preserve joint function.

Other uses

This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.

This medication may also be used for lupus and psoriatic arthritis.

How to use

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

Methotrexate is a strong medication. The dosage and how often you take this medication are based on your medical condition and response to treatment. There are many different dosing schedules for this medication (especially for cancer treatment). Taking this medication the wrong way may cause serious side effects, including death. It is very important that you follow your doctor's instructions carefully. Take this medication by mouth as directed by your doctor.

For the treatment of psoriasis or rheumatoid arthritis, take this medication by mouth as directed by your doctor, usually once a week. It may take up to several months before you get the full benefit of this drug.

If you are using the liquid form of this medication, carefully measure the dose using a special measuring device/spoon. Do not use a household spoon because you may not get the correct dose.

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.

Since this drug can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from the tablets.

Drink plenty of fluids while taking this medication unless your doctor tells you otherwise. Doing so helps your kidneys to remove the drug from your body and avoid some of the side effects.

Side effects

See also Warning section.

Before taking 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
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 make current infections worse. Stay away from anyone who has an infection that may easily spread (such as chickenpox, COVID-19, measles, flu). Talk to your doctor if you have been exposed to an infection or for more details.

Tell your health care professional that you are using methotrexate before having any immunizations/vaccinations. 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).

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 order a pregnancy test before you start this medication. You should not become pregnant while using methotrexate. Women using this medication should ask about reliable forms of birth control during treatment and for 6 months after the last dose. Men using this medication should ask about reliable forms of birth control during treatment 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. Breastfeeding is not recommended while using this medication and for at least 1 week after the last dose. Consult your doctor before breastfeeding.

Drug interactions