Description
Methotrexate injection is used in combination with other cancer medicines to treat acute lymphoblastic leukemia (ALL), breast cancer, and osteosarcoma (bone cancer). This medicine is also used to treat non-Hodgkin lymphoma. It is also used to prevent and treat meningeal leukemia, a type of cancer that spreads to the meninges (covering of the brain and spinal cord).
Methotrexate injection is also used to treat squamous cell cancer of the head and neck. This medicine is also used in combination with other cancer medicines to treat gestational trophoblastic neoplasia (tumors in the uterus).
Methotrexate injection is also used to treat rheumatoid arthritis and severe psoriasis (a skin disease). It is also used in children to treat polyarticular juvenile idiopathic arthritis.
This medicine is to be given by or under the direct supervision of your doctor.
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 in children to treat ALL, non-Hodgkin lymphoma, osteosarcoma, and polyarticular juvenile idiopathic arthritis, and to treat and prevent meningeal leukemia. However, safety and efficacy have not been established in children with other conditions.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of methotrexate injection in the elderly.
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.
- Bacillus of Calmette and Guerin Vaccine, Live
- Dengue Tetravalent Vaccine, Live
- Measles Virus Vaccine, Live
- Mumps Virus Vaccine, Live
- Rubella Virus Vaccine, Live
- Smallpox Monkeypox Vaccine
- Typhoid Vaccine
- Varicella Virus Vaccine, Live
- Yellow Fever Vaccine
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 Type 4, Live
- Adenovirus Vaccine Type 7, Live
- Albendazole
- Allopurinol
- Alprazolam
- Ambrisentan
- Amiodarone
- Amoxicillin
- Ampicillin
- Amtolmetin Guacil
- Anidulafungin
- Apalutamide
- Apixaban
- Asciminib
- Asparaginase
- Aspirin
- Atomoxetine
- Atovaquone
- Azacitidine
- Azithromycin
- Bacampicillin
- Balsalazide
- Balsalazide Disodium
- Beet Root
- Bentiromide
- Bexarotene
- Bicalutamide
- Bortezomib
- Bosentan
- Bromfenac
- Bufexamac
- Bumetanide
- Busulfan
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
- 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
- Ethanol
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 use disorder, or history of or
- Brain or nerve problems (eg, seizures), history of or
- Stomach ulcers (eg, peptic ulcer disease) or
- Surgery or
- Ulcerative colitis—Use with caution. May make these conditions worse.
- Ascites (extra fluid in the stomach area) or
- Kidney disease or
- Liver 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.
- Infection (bacteria, fungus, virus)—Use with caution. May decrease your ability to fight an infection.
Proper Use
A doctor or other trained health professional will give you this medicine in a hospital. This medicine is given through a needle placed into your spinal cord.
This medicine comes with a patient information insert. Read and follow the instructions in the insert carefully. Ask your doctor if you have any questions.
For patients with rheumatoid arthritis, psoriasis, or polyarticular juvenile idiopathic arthritis: Your doctor may give you folic acid or folinic acid supplement to help reduce the unwanted effects of this medicine.
For patients with cancer: Do not take folic acid or folinic acid supplement unless directed by your doctor.
Missed Dose
Call your doctor or pharmacist for instructions.
Precautions
It is very important that your doctor checks your progress at regular visits to make sure that this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.
Receiving this medicine while you are pregnant can harm your unborn baby. It may also cause birth defects if it is used by the father when his sexual partner becomes pregnant. If you are female and able to get pregnant, your doctor may do tests to make sure you are not pregnant before receiving this medicine. Female patients should use an effective form of birth control during treatment and for 6 months after the last dose. Male patients who have female partners should use an effective form of birth control during treatment and for 3 months after the last dose. If you think you have become pregnant while receiving the medicine for conditions other than cancer, tell your doctor right away.
This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Check with your doctor right away if you have chest tightness, cough, difficulty swallowing, dizziness, fast heartbeat, hives, itching, skin rash, puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue, trouble breathing, or unusual tiredness or weakness.
This medicine contains benzyl alcohol, which may cause serious reactions (eg, gasping syndrome) to newborn or premature babies. Discuss this with your doctor if you are concerned.
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.
This medicine may cause serious infections. Check with your doctor right away if you have cough or hoarseness, fever or chills, lower back or side pain, or painful or difficult urination.
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.
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.
Check with your doctor right away if you have stomach pain, black, tarry stools, constipation, diarrhea, loss of appetite, nausea, pain in the back of the throat or chest when swallowing, or vomiting blood or material that looks like coffee grounds. These may be symptoms of stomach or bowel problems.
This medicine may cause lung or breathing problems (eg, acute or chronic interstitial pneumonitis). Check with your doctor right away if you have chest pain, chills, cough, fever, general feeling of discomfort or illness, thickening of bronchial secretions, or trouble breathing.
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 sunscreen when you are outdoors. Avoid sunlamps and tanning beds.
This medicine may increase your risk for secondary cancer. Talk to your doctor if you have concerns about this.
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.
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.
Some men and women who use this medicine have become infertile (unable to have children). Talk with your doctor before using this medicine if you plan to have children.
Using this medicine with radiation treatment may increase the risk of tissue or bone problems, including 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.
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
- bleeding gums
- blood in the urine or stools
- pinpoint red spots on the skin
- unusual bleeding or bruising
Less common
- Chest pain
- chills
- cough
- fever
- painful or difficult urination
- sore throat
- sores, ulcers, or white spots on the lips or in the mouth
- swollen glands
- trouble breathing
- unusual tiredness or weakness
Incidence not known
- Agitation
- anxiety
- back pain
- blindness
- blistering, peeling, or loosening of the skin
- bloating
- blue or pale skin
- blurred vision
- changes in skin color
- changes in vision
- chest pain, possibly moving to the left arm, neck, or shoulder
- chest discomfort or tightness
- coma
- confusion
- constipation
- dark urine
- decrease in height
- decreased urine output
- depression
- diarrhea
- difficulty swallowing
- dizziness
- double vision
- drowsiness
- dry mouth
- eye pain
- fast heartbeat
- flushed, dry skin
- hallucinations
- headache
- heartburn
- hives, itching, skin rash
- increased hunger
- increased thirst
- increased urination
- indigestion
- irritability
- joint or muscle pain
- lethargy
- light-colored stools
- loss of appetite
- mood alteration
- muscle twitching
- nausea
- pain, redness, or swelling in the arm or leg
- pain in the back, ribs, arms, or legs
- pains in the chest, groin, or legs, especially calves of legs
- pains in the stomach, side, or abdomen, possibly radiating to the back
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- rapid weight gain
- red irritated eyes
- red skin lesion, often with a purple center
- seizures
- stiff neck
- stomach pain, cramping, or burning
- stupor
- sudden loss of coordination
- sudden onset of slurred speech
- sudden vision changes
- sweating
- swelling of the face, ankles, or hands
- swollen, painful, or tender lymph glands in the neck, armpit, or groin
- unexplained weight loss
- upper right abdominal or stomach pain
- vomiting
- vomiting of material that looks like coffee grounds, severe and continuing
- 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
- Swelling or inflammation of the mouth
Less common
- Loss or thinning of the hair
Incidence not known
- Blemishes on the skin
- burning, dry or itching eyes
- decreased interest in sexual intercourse
- discharge, excessive tearing
- dryness of the eyes
- inability to have or keep an erection
- increased sensitivity of the skin to sunlight
- loss in sexual ability, desire, drive, or performance
- pimples
- raised, dark red, wart-like spots on skin, especially when used on the face
- redness, pain, swelling of the eye, eyelid, or inner lining of eyelid
- redness or other discoloration of skin
- severe sunburn
- swelling of the breasts or breast soreness in both females and males
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.
DRG-80010346
