Methotrexate (Injection Route, Subcutaneous Route)

Description and Brand Names

US Brand Name

Otrexup
Rasuvo
RediTrex

Descriptions

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.

This product is available in the following dosage forms:

Solution
Powder for Solution

Before Using

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.

Breastfeeding
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.

Drug Interactions
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, Live
Albendazole
Allopurinol
Alprazolam
Ambrisentan
Amiodarone
Amoxicillin
Ampicillin
Amtolmetin Guacil
Anidulafungin
Apixaban
Asciminib
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
Busulfan
Capecitabine
Capmatinib
Captopril
Carbamazepine
Caspofungin
Cefaclor
Cefadroxil
Cefatrizine
Cefdinir
Cefditoren
Cefetamet
Cefixime
Cefpodoxime
Cefprozil
Cefteram Pivoxil
Ceftibuten
Ceftobiprole Medocaril
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
Danicopan
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
Eltrombopag
Enalapril
Enalaprilat
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
Pivmecillinam
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
Vadadustat
Valdecoxib
Valproic Acid
Venlafaxine
Vincristine
Voclosporin
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.

Etoricoxib
Procarbazine
Rofecoxib
Rolapitant
Theophylline
Other Interactions
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
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

Alcohol abuse, or history of or
Anemia or
Leukopenia (low white blood cells) or
Liver disease, severe or
Thrombocytopenia (low platelet blood level) or
Weak immune system—Should not be used in patients with these conditions.
Ascites (extra fluid in the stomach area) or
Kidney disease or
Pleural effusion (extra fluid in the lung)—Use with caution. The effects may be increased because of slower removal of the medicine from the body.
Diabetes or
Liver disease or
Obesity or
Peptic ulcers or
Ulcerative colitis (inflammation of the colon)—Use with caution. May cause side effects to become worse.
Infection (bacteria, fungus, virus)—Use with caution. May decrease your ability to fight an infection.

Proper Use

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.

Precautions

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.