Methotrexate Sodium - Methotrexate Injection

What is this medication?

METHOTREXATE (METH oh TREX ate) treats inflammatory conditions such as arthritis and psoriasis. It works by decreasing inflammation, which can reduce pain and prevent long-term injury to the joints and skin. It may also be used to treat some types of cancer. It works by slowing down the growth of cancer cells.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Fluid in the stomach area or lungs
• If you often drink alcohol
• Infection or immune system problems
• Kidney disease
• Liver disease
• Low blood counts (white cells, platelets, or red blood cells)
• Lung disease
• Recent or ongoing radiation
• Recent or upcoming vaccine
• Stomach ulcers
• Ulcerative colitis
• An unusual or allergic reaction to methotrexate, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

How should I use this medication?

This medication is for infusion into a vein or for injection into muscle or into the spinal fluid (whichever applies). It is usually given in a hospital or clinic setting.

In rare cases, you might get this medication at home. You will be taught how to give this medication. Use exactly as directed. Take your medication at regular intervals. Do not take your medication more often than directed.

If this medication is used for arthritis or psoriasis, it should be taken weekly, NOT daily.

It is important that you put your used needles and syringes in a special sharps container. Do not put them in a trash can. If you do not have a sharps container, call your pharmacist or care team to get one.

Talk to your care team about the use of this medication in children. While this medication may be prescribed for children as young as 2 years for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

It is important not to miss your dose. Call your care team if you are unable to keep an appointment. If you give yourself the medication, and you miss a dose, talk with your care team. Do not take double or extra doses.

What may interact with this medication?

Do not take this medication with any of the following:

• Acitretin

This medication may also interact with the following:

• Aspirin or aspirin-like medications including salicylates
• Azathioprine
• Certain antibiotics like chloramphenicol, penicillin, tetracycline
• Certain medications that treat or prevent blood clots like warfarin, apixaban, dabigatran, and rivaroxaban
• Certain medications for stomach problems like esomeprazole, omeprazole, pantoprazole
• Cyclosporine
• Dapsone
• Diuretics
• Folic acid
• Gold
• Hydroxychloroquine
• Live virus vaccines
• Medications for infection like acyclovir, adefovir, amphotericin B, bacitracin, cidofovir, foscarnet, ganciclovir, gentamicin, pentamidine, vancomycin
• Mercaptopurine
• NSAIDs, medications for pain and inflammation, like ibuprofen or naproxen
• Pamidronate
• Pemetrexed
• Penicillamine
• Phenylbutazone
• Phenytoin
• Probenecid
• Pyrimethamine
• Retinoids such as isotretinoin and tretinoin
• Steroid medications like prednisone or cortisone
• Sulfonamides like sulfasalazine and trimethoprim/sulfamethoxazole
• Theophylline
• Zoledronic acid

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

This medication may make you feel generally unwell. This is not uncommon as chemotherapy can affect healthy cells as well as cancer cells. Report any side effects. Continue your course of treatment even though you feel ill unless your care team tells you to stop.

Your condition will be monitored carefully while you are receiving this medication.

Avoid alcoholic drinks.

This medication can cause serious side effects. To reduce the risk, your care team may give you other medications to take before receiving this one. Be sure to follow the directions from your care team.

This medication can make you more sensitive to the sun. Keep out of the sun. If you cannot avoid being in the sun, wear protective clothing and use sunscreen. Do not use sun lamps or tanning beds/booths.

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medication affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells.

You may need blood work while you are taking this medication.

Call your care team for advice if you get a fever, chills or sore throat, or other symptoms of a cold or flu. Do not treat yourself. This medication decreases your body's ability to fight infections. Try to avoid being around people who are sick.

This medication may increase your risk to bruise or bleed. Call your care team if you notice any unusual bleeding.

Be careful brushing or flossing your teeth or using a toothpick because you may get an infection or bleed more easily. If you have any dental work done, tell your dentist you are receiving this medication

Check with your care team if you get an attack of severe diarrhea, nausea and vomiting, or if you sweat a lot. The loss of too much body fluid can make it dangerous for you to take this medication.

Talk to your care team about your risk of cancer. You may be more at risk for certain types of cancers if you take this medication.

Do not become pregnant while taking this medication or for 6 months after stopping it. Women should inform their care team if they wish to become pregnant or think they might be pregnant. Men should not father a child while taking this medication and for 3 months after stopping it. There is potential for serious harm to an unborn child. Talk to your care team for more information. Do not breast-feed an infant while taking this medication or for 1 week after stopping it.

This medication may make it more difficult to get pregnant or father a child. Talk to your care team if you are concerned about your fertility.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Blood clot—pain, swelling, or warmth in the leg, shortness of breath, chest pain
• Dry cough, shortness of breath or trouble breathing
• Infection—fever, chills, cough, sore throat, wounds that don't heal, pain or trouble when passing urine, general feeling of discomfort or being unwell
• Kidney injury—decrease in the amount of urine, swelling of the ankles, hands, or feet
• Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing of the skin or eyes, unusual weakness or fatigue
• Low red blood cell count—unusual weakness or fatigue, dizziness, headache, trouble breathing
• Redness, blistering, peeling, or loosening of the skin, including inside the mouth
• Seizures
• Unusual bruising or bleeding

Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome):

• Diarrhea
• Dizziness
• Hair loss
• Nausea
• Pain, redness, or swelling with sores inside the mouth or throat
• Vomiting

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

This medication is given in a hospital or clinic. It will not be stored at home.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.