Methotrexate (Injection, Subcutaneous)

Generic name: Methotrexate

Usage of Methotrexate (Injection, Subcutaneous)

Methotrexate injection is used alone or together with other medicines to treat several types of cancer, such as breast, head and neck, lung, blood, bone, lymph node, and uterus cancers.

Methotrexate is also used to treat severe rheumatoid arthritis in adults and polyarticular juvenile idiopathic arthritis in children who had other treatments that did not work well. It is also used to control symptoms of severe psoriasis in adults who have not been helped by other treatments.

Methotrexate belongs to the group of medicines known as antineoplastics (cancer medicines). It blocks an enzyme that is needed by cells to live. This interferes with the growth of cancer cells, which are eventually destroyed by the body. For patients with arthritis or psoriasis, methotrexate may work by improving the immune system.

This medicine is available only with your doctor's prescription.

Methotrexate (Injection, Subcutaneous) side effects

Along with its needed effects, a medicine 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 or nurse immediately if any of the following side effects occur:

More common

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

Less common

Back pain

bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, or warmth at the injection site

blurred vision

confusion

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

seizures

trouble breathing

unusual bleeding or bruising

unusual tiredness or weakness

yellow eyes or skin

Some side effects 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:

More common

Hair loss, temporary

loss of appetite

nausea or vomiting

Less common

Acne

boils on skin

pale skin

skin rash or itching

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Before taking Methotrexate (Injection, Subcutaneous)

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of methotrexate injection for the treatment of cancer and juvenile idiopathic arthritis in children. However, safety and efficacy have not been established in children with psoriasis.

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of Otrexup™ or Reditrex® for the treatment of juvenile idiopathic arthritis in children. However, safety and efficacy have not been established in children with cancer and psoriasis.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of methotrexate injection in the elderly. However, elderly patients are more likely to have bone marrow, liver, or kidney problems, which may require caution and an adjustment in the dose in patients receiving methotrexate injection.

Breast Feeding

Studies in women breastfeeding have demonstrated harmful infant effects. An alternative to this medication should be prescribed or you should stop breastfeeding while using this medicine.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Measles Virus Vaccine, Live

Mumps Virus Vaccine, Live

Rotavirus Vaccine, Live

Rubella Virus Vaccine, Live

Varicella Virus Vaccine, Live

Zoster Vaccine, Live

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Abacavir

Acarbose

Aceclofenac

Acemetacin

Acetazolamide

Acetohexamide

Adalimumab

Adenovirus Vaccine

Adenovirus Vaccine, Live

Albendazole

Allopurinol

Alprazolam

Ambrisentan

Amiodarone

Amoxicillin

Ampicillin

Amtolmetin Guacil

Anidulafungin

Apixaban

Asparaginase

Aspirin

Atomoxetine

Atovaquone

Azacitidine

Azanidazole

Azithromycin

Bacampicillin

Bacillus of Calmette and Guerin Vaccine, Live

Balofloxacin

Balsalazide

Balsalazide Disodium

Beet Root

Bentiromide

Benznidazole

Bexarotene

Bicalutamide

Bortezomib

Bosentan

Bromfenac

Bufexamac

Bumetanide

Caspofungin

Cefaclor

Cefadroxil

Cefatrizine

Cefdinir

Cefditoren

Cefetamet

Cefixime

Cefpodoxime

Cefprozil

Cefteram Pivoxil

Ceftibuten

Cefuroxime

Celecoxib

Cephalexin

Cephradine

Chenodiol

Chloral Hydrate

Chlorpropamide

Chlortetracycline

Chlorthalidone

Chlorzoxazone

Cholera Vaccine, Live

Choline Salicylate

Cinoxacin

Ciprofloxacin

Citalopram

Clarithromycin

Clindamycin

Clofarabine

Clomipramine

Clonixin

Clopidogrel

Cloxacillin

Cyclosporine

Cyproheptadine

Dabigatran Etexilate

Dactinomycin

Danazol

Dantrolene

Dapsone

Darolutamide

Darunavir

Deferasirox

Delamanid

Demeclocycline

Dengue Tetravalent Vaccine, Live

Dexibuprofen

Dexketoprofen

Dexlansoprazole

Dexmethylphenidate

Diclofenac

Dicloxacillin

Diflunisal

Dipyrone

Dirithromycin

Disulfiram

Divalproex Sodium

Doxifluridine

Doxycycline

Dronedarone

Droxicam

Duloxetine

Ebola Zaire Vaccine, Live

Edoxaban

Efavirenz

Elexacaftor

Enalapril

Enalaprilat

Enasidenib

Encorafenib

Entecavir

Epoprostenol

Eravacycline

Erlotinib

Erythromycin

Escitalopram

Esomeprazole

Ethambutol

Etodolac

Etofenamate

Etravirine

Febuxostat

Felbamate

Felbinac

FenBufen

Fenoprofen

Fepradinol

Feprazone

Flecainide

Floctafenine

Floxacillin

Fluconazole

Flufenamic Acid

Flumequine

Fluorouracil

Flurbiprofen

Flutamide

Folic Acid

Foscarnet

Fosfomycin

Fosphenytoin

Framycetin

Fulvestrant

Furosemide

Fusidic Acid

Ganciclovir

Gemcitabine

Gemtuzumab Ozogamicin

Gliclazide

Glimepiride

Glipizide

Gliquidone

Glyburide

Golimumab

Griseofulvin

Hydrochlorothiazide

HydroxyChloroquine

Hydroxyurea

Ibuprofen

Ibuprofen Lysine

Imatinib

Indapamide

Indomethacin

Infliximab

Influenza Virus Vaccine, Live

Interferon Beta-1a

Interferon Beta-1b

Isoniazid

Itraconazole

Ixabepilone

Josamycin

Kanamycin

Ketoconazole

Ketoprofen

Ketorolac

Labetalol

Lamotrigine

Lansoprazole

Lapatinib

Leflunomide

Leniolisib

Levetiracetam

Levofloxacin

Linezolid

Lornoxicam

Loxoprofen

Lumiracoxib

Lymecycline

Mafenide

Meclocycline

Meclofenamate

Mefenamic Acid

Mefloquine

Meloxicam

Memantine

Mepartricin

Mercaptopurine

Mesalamine

Methacycline

Methazolamide

Methicillin

Methimazole

Metolazone

Metronidazole

Micafungin

Midostaurin

Milnacipran

Minocycline

Miokamycin

Momelotinib

Morniflumate

Moxifloxacin

Nabumetone

Nafcillin

Nalidixic Acid

Naproxen

Nefazodone

Neomycin

Nepafenac

Nevirapine

Niacin

Niflumic Acid

Nilutamide

Nimesulide

Nimesulide Beta Cyclodextrin

Nimorazole

Nitisinone

Nitrofurantoin

Nitrous Oxide

Nortriptyline

Oleandomycin

Olsalazine

Olsalazine Sodium

Omadacycline

Omeprazole

Ondansetron

Orlistat

Ornidazole

Oxacillin

Oxandrolone

Oxaprozin

Oxyphenbutazone

Oxytetracycline

Pantoprazole

Parecoxib

Paromomycin

Paroxetine

Pazopanib

Pazufloxacin

Pefloxacin

Peginterferon Alfa-2a

Pemetrexed

Penicillin G

Penicillin V

Pexidartinib

Phenylbutazone

Phenytoin

Piketoprofen

Pipemidic Acid

Piperacillin

Piroxicam

Pirprofen

Pivampicillin

Poliovirus Vaccine, Live

Posaconazole

Pristinamycin

Probenecid

Proglumetacin

Proguanil

Propionic Acid

Propylthiouracil

Propyphenazone

Proquazone

Pyrimethamine

Rabeprazole

Raltegravir

Ramipril

Ribavirin

Rifabutin

Rifampin

Rifapentine

Rifaximin

Riluzole

Ritonavir

Rivaroxaban

Rokitamycin

Rolitetracycline

Rosoxacin

Rufloxacin

Salicylic Acid

Salsalate

Sapropterin

Sarecycline

Secnidazole

Silver Sulfadiazine

Simeprevir

Sirolimus

Smallpox Monkeypox Vaccine, Live Non-Replicating

Smallpox Vaccine

Sodium Salicylate

Sorafenib

Spiramycin

Sulfacetamide

Sulfacytine

Sulfadiazine

Sulfamethizole

Sulfamethoxazole

Sulfapyridine

Sulfasalazine

Sulfisoxazole

Sulindac

Sultamicillin

Sunitinib

Tafamidis

Tamoxifen

Tedizolid Phosphate

Tegafur

Teicoplanin

Temocillin

Tenoxicam

Terbinafine

Teriflunomide

Testosterone

Tetracycline

Tiaprofenic Acid

Ticarcillin

Tigecycline

Tipranavir

Tizanidine

Tolazamide

Tolbutamide

Tolcapone

Tolfenamic Acid

Tolmetin

Tolvaptan

Torsemide

Tramadol

Triamterene

Trimethoprim

Trofinetide

Typhoid Vaccine, Live

Valdecoxib

Valproic Acid

Venlafaxine

Vincristine

Voriconazole

Warfarin

Yellow Fever Vaccine

Zafirlukast

Zidovudine

Zolpidem

Zonisamide

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Eltrombopag

Etoricoxib

Procarbazine

Rofecoxib

Rolapitant

Theophylline

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

Cola

How to use Methotrexate (Injection, Subcutaneous)

A nurse or other trained health professional will give you this medicine in a hospital or cancer treatment center. This medicine is given as a shot under your skin, into a muscle, into a vein, or into your spine (back or neck).

If you are using the Otrexup™ or Rasuvo® or Reditrex® injection at home:

The medicine comes with a patient information leaflet. Read and follow the instructions carefully. Ask your doctor if you have any questions.

The medicine is given as a shot under your skin, usually on the stomach or thigh.

Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas. This will help prevent skin problems from the injection.

If the medicine in the syringe has changed color, or if you see particles in it, do not use it.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For injection dosage form (solution):

For polyarticular juvenile idiopathic arthritis (pJIA):

Children—Dose is based on body size and must be determined by your doctor. The starting dose is 10 milligrams (mg) per meter squared (m2) once per week. Your doctor may adjust your dose as needed.

For psoriasis:

Adults—At first, 10 to 25 milligrams (mg) once per week. Your doctor may adjust your dose as needed. However, the dose is usually not more than 30 mg once per week.

Children—Use and dose must be determined by your doctor.

For rheumatoid arthritis:

Adults—At first, 7.5 milligrams (mg) once per week. Your doctor may adjust your dose as needed.

Children—Use and dose must be determined by your doctor.

Missed Dose

This medicine needs to be given on a fixed schedule. If you miss a dose or forget to use your medicine, call your doctor or pharmacist for instructions.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Put used syringe in a puncture-resistant disposable container.

Warnings

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly and to check for unwanted effects. Blood tests and chest x-rays may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. The medicine may also cause birth defects if it is used by the father when his sexual partner becomes pregnant. If you are a woman who can bear children, your doctor may give you a pregnancy test before you start using this medicine to make sure you are not pregnant. Female patients should use an effective form of birth control during treatment and for at least 6 months after the last dose. Male patients who have female partners should use an effective form of birth control during treatment and for at least 3 months after the last dose. Tell your doctor right away if pregnancy occurs while you are using this medicine.

Talk with your doctor before using this medicine if you plan to have children. Some men and women who use this medicine have become infertile (unable to have children).

Limit alcohol use with this medicine. Alcohol may increase the risk for liver problems.

This medicine may cause organ system toxicity. Call your doctor right away if you have the following symptoms: a fever, confusion, diarrhea, dry cough, irritability, neck stiffness, seizures, severe skin rash, sleepiness, trouble breathing, weakness, vomiting, or problems with coordination.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.

This medicine may cause serious nerve problems. Check with your doctor right away if you have seizures, confusion, tingling or numbness in your hands, feet, or lips, trouble seeing, or headache.

Methotrexate can lower the number of white blood cells in your blood, which increases the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:

If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.

Check with your doctor immediately if you notice any unusual bleeding or bruising, black, tarry stools, blood in the urine or stools, or pinpoint red spots on your skin.

Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.

Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.

Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters.

Avoid contact sports or other situations where bruising or injury could occur.

While you are being treated with methotrexate, and after you stop treatment with it, do not have any immunizations (vaccines) without your doctor's approval. Methotrexate may lower your body's resistance and the vaccine may not work as well or you might get the infection the vaccine is meant to prevent. In addition, you should not be around other persons living in your household who receive live virus vaccines because there is a chance they could pass the virus on to you. Some examples of live vaccines include measles, mumps, influenza (nasal flu vaccine), poliovirus (oral form), rotavirus, and rubella. Do not get close to them and do not stay in the same room with them for very long. If you have questions about this, talk to your doctor.

Check with your doctor right away if you have cough, fever, or trouble breathing. These could be symptoms of a serious lung or breathing problems (eg, acute or chronic interstitial pneumonitis).

Tell your doctor right away if you have a change in how much or how often you urinate, rapid weight gain, swelling in the legs, ankles, or feet, or trouble breathing. These could be symptoms of a serious kidney problem.

Serious skin reactions (eg, toxic epidermal necrolysis, Stevens-Johnson syndrome, exfoliative dermatitis, skin necrosis, or erythema multiforme) can occur with this medicine. Check with your doctor right away if you have blistering, peeling, or loosening of the skin, blue-green to black skin discoloration, cough, cracks in the skin, diarrhea, itching, joint or muscle pain, loss of heat from the body, red irritated eyes, red skin lesions, often with a purple center, sore throat, sores, ulcers, or white spots in the mouth or on the lips, fever or chills, or unusual tiredness or weakness while you are using this medicine.

This medicine may make your skin more sensitive to sunlight. Use a sunscreen when you are outdoors. Avoid sunlamps and tanning beds.

This medicine may make you dizzy or tired. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.

This medicine may increase your risk of having a lymphoma (cancer of the lymph system). Discuss these possible effects with your doctor.

This medicine may cause a serious reaction called tumor lysis syndrome. Tell your doctor right away if you have a change in urine amount, joint pain, stiffness, or swelling, lower back, side, or stomach pain, rapid weight gain, swelling of the feet or lower legs, or unusual tiredness or weakness.

Using this medicine with radiation therapy may increase risk of tissue or bone problems, such as tissue or bone not receiving enough blood. Tell your doctor if you are receiving other treatments, including radiation therapy, while using this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

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