Otrexup (PF) 10 mg/0.4 mL subcutaneous auto-injector

Generic name:
Methotrexate - subcutaneous injection

Pronunciation
(METH-oh-TREX-ate)

Brand name(s)
Otrexup , Rasuvo

Methotrexate has rarely caused serious (sometimes fatal) side effects. This medication should be used only to treat 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 using 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.

Methotrexate is used to treat 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 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.

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, psoriatic arthritis, and Crohn's disease.

Read the Patient Information Leaflet and Instructions for Use if available from your pharmacist before you start using methotrexate and each time you get a refill. Ask your health care professional how to prepare and use this medication. If you have any questions, ask your doctor or pharmacist.

Inject this medication under the skin as directed by your doctor, usually once a week. The injection is given in the thighs or abdomen. Some brands may also be given in the upper arms. The dosage is based on your medical condition and response to treatment.

Before using, check this product for particles or discoloration. If either is present, do not use the liquid. Before injecting each dose, clean the skin you are going to inject into (the injection site) with rubbing alcohol. Change the injection site each time to lessen injury under the skin. Do not inject into skin that is red, swollen, or bruised, or into areas with scars/stretch marks. To lessen bruising, do not rub the injection site after a shot. Learn how to store and discard medical supplies safely.

Use this medication regularly to get the most benefit from it. To help you remember, use it on the same day each week. Mark your calendar with a reminder.

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.

It may take up to several months before you get the full benefit of this drug.

Tell your doctor if your condition does not get better or if it gets worse.

See also Warning section.

Nausea, vomiting, stomach pain, drowsiness, or dizziness may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Temporary hair loss may occur. Normal hair growth should return after treatment has ended.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including:

• mouth sores
• diarrhea
• signs of anemia (such as unusual tiredness, pale skin)
• signs of liver problems (such as nausea/vomiting that doesn't stop, dark urine, stomach/abdominal pain, yellowing eyes/skin)
• easy bruising/bleeding
• black stools
• enlarged glands/lymph nodes
• bone pain
• unusual pain and discoloration of the skin
• signs of kidney problems (such as change in the amount of urine)
• dry cough
• muscle weakness

Get medical help right away if you have any very serious side effects, including:

• irregular heartbeat
• vision changes
• weakness on one side of the body
• severe headache
• neck stiffness
• mental/mood changes
• seizures

This medication may lower your ability to fight infections. This may make you more likely to get a serious (rarely fatal) infection or make any infection you have worse. Tell your doctor right away if you have any signs of infection (such as sore throat that doesn't go away, fever, chills, cough).

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

See also Warning section.

Before using 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
• certain 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).

Children may be more sensitive to the side effects of this drug, especially seizures.

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 some time 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.

See also Warning section.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include:

• acitretin
• asparaginase
• chloramphenicol
• leflunomide
• other drugs that can cause kidney problems (such as cisplatin)
• other drugs that can cause liver problems (such as azathioprine, sulfasalazine, retinoids such as isotretinoin)
• penicillins
• phenytoin
• probenecid
• procarbazine
• pyrimethamine
• sulfa medications
• tetracyclines

Certain drugs that reduce stomach acid (proton pump inhibitors-PPIs such as esomeprazole, omeprazole, pantoprazole) may increase the amount of methotrexate in your blood. This effect may increase the risk of side effects, especially with high-dose methotrexate treatment. Ask your doctor or pharmacist for details and ways to lessen the risk of side effects.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669. Symptoms of overdose may include severe nausea and vomiting, and bloody stools.

Do not share this medication with others.

Lab and/or medical tests (such as complete blood cell counts, liver/kidney function, pregnancy test, chest X-ray) should be done before you start using this medication and while you are using it. Keep all medical and lab appointments. Consult your doctor for more details.

It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule. Do not double the dose to catch up.

Store at room temperature away from light. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.