Consumer Information for: METHOTREXATE INJECTION BP

Consumer Information

Information about the product including what the product is used for, dosage, warnings, proper use and side effects. This summary will not tell you everything about the product. Contact your healthcare professional if you have any questions about the product.


What the medication is used for

Methotrexate Injection BP (without preservative) and Methotrexate Injection BP (with preservative) belongs to a group of medicines known as antimetabolites. It is used in high doses to treat certain types of cancers, including breast cancer, Non-Hodgkin's lymphoma and leukemia. At lower doses, it may also be used to treat severe psoriasis and severe rheumatoid arthritis.

What it does

Methotrexate Injection BP (without preservative) and Methotrexate Injection BP (with preservative) work by blocking an enzyme needed by body cells to live. This interferes with the growth of some cells, such as skin cells in psoriasis that are growing rapidly. In rheumatoid arthritis, Methotrexate Injection BP (without preservative) and Methotrexate Injection BP (with preservative) act on the inflammatory cells that cause joint swelling. Methotrexate Injection BP (without preservative) and Methotrexate Injection BP (with preservative) therapy are used to control psoriasis and rheumatoid arthritis but it will not cure them. In cancer, Methotrexate Injection BP (without preservative) and Methotrexate Injection BP (with preservative) work by blocking an enzyme process in cancer cells so that they cannot grow. Some normal cells in the body may be affected as well

When it should not be used

Do not take Methotrexate Injection BP (without preservative) or Methotrexate Injection BP (with preservative) if you:

  • Are allergic to any component of the drug
  • Have severe kidney problems
  • Are on dialysis
  • Are pregnant. Methotrexate Injection BP (without preservative) and Methotrexate Injection BP (with preservative) can cause harm to your unborn baby. Women of childbearing potential should not be started on Methotrexate Injection BP (without preservative) and Methotrexate Injection BP (with preservative) until pregnancy is excluded.
  • Are breast-feeding.
  • Have psoriasis or rheumatoid arthritis and the following:
    • alcoholism (drink excessive alcohol)
    • chronic liver disease
    • immunodeficiency (resistance to infectious diseases is reduced)
    • blood disorders
  • Are going to receive a general anesthetic called nitrous oxide. It is also known as laughing gas.

Methotrexate formulations and diluents containing preservatives must not be used for intrathecal (injected into the spinal canal/fluid), intracerebroventricular (injected into the ventricle) or high-dose therapy.

Methotrexate Injection BP formulations with preservative (benzyl alcohol) should not be used in neonates (children less than one month of age).

What the medicinal ingredient is

Methotrexate (meth-o-TREX-ate).

What the non-medicinal ingredients are
  1. Methotrexate Injection BP 25 mg/mL (without preservative) formulation contains: Sodium chloride, sodium hydroxide, Hydrochloric acid and water for injection.
  2. Methotrexate Injection BP 25 mg/mL (with preservative) formulation contains: Sodium chloride, benzyl alcohol, sodium hydroxide, Hydrochloric acid and water for injection.

What dosage form it comes in

(1) Methotrexate Injection BP 25 mg/mL (without preservative) formulation in the following presentations: 25 mg/mL Methotrexate – 50 mg/2 mL as Single use vial

25 mg/mL Methotrexate – 500 mg/20 mL as Single use vial
25 mg/mL Methotrexate – 1 g/40 mL as Single use vial

Note: 2 mL vials are available in a pack of 10 vials, 20 mL and 40 mL vials are available in a pack of single vials

(2) Methotrexate Injection BP 25 mg/mL (with preservative) formulation in the following presentations:
25 mg/mL Methotrexate – 50 mg/2 mL as Multidose vial
25 mg/mL Methotrexate – 500 mg/20 mL as Multidose vial

Note: 2 mL vials are available in a pack of 10 vials; 20 mL vials are available in a pack of single vials

Warnings and precautions

Serious Warnings and Precautions

Methotrexate Injection BP (without preservative) and Methotrexate Injection BP (with preservative) should be prescribed by a doctor who is experienced with the use of antimetabolite therapy.

  • Methotrexate Injection BP (with preservative) formulations which contain benzyl alcohol must not be used for intrathecal,
    • intracerebroventricular, or high-dose treatment.
  • Methotrexate Injection BP (with preservative) formulations which contain benzyl alcohol must not be used in neonates.
  • Methotrexate Injection BP (without preservative) and Methotrexate Injection BP (with preservative) can cause serious toxic reactions which may result in death.
  • Methotrexate Injection BP (without preservative) and Methotrexate Injection BP (with preservative) can cause birth defect (deformed babies) or death of an unborn baby when used in pregnant women. Pregnant women with psoriasis or rheumatoid arthritis should not take Methotrexate Injection BP (without preservative) or Methotrexate Injection BP (with preservative).

Before you use Methotrexate Injection BP (without preservative) or Methotrexate Injection BP (with preservative); talk to your doctor or pharmacist if you have any of the following conditions:

  • have or have had any unusual or allergic reaction to Methotrexate Injection BP (without preservative) or Methotrexate Injection BP (with preservative).
  • are pregnant or planning to become pregnant. Methotrexate can cause birth defects (deformed babies) or death of an unborn baby. Both male and female patients must use effective birth control methods all the time while taking Methotrexate Injection BP (without preservative) or Methotrexate Injection BP (with preservative) and a few months after the last dose of the drug. Methotrexate may cause sterility (infertility), which could be permanent. Be sure to discuss this with your doctor before taking Methotrexate Injection BP (without preservative) or Methotrexate Injection BP (with preservative). Tell your doctor right away if you think you have become pregnant while taking Methotrexate Injection BP (without preservative) or Methotrexate Injection BP (with preservative).
  • are breast-feeding or plan to breast-feed. Methotrexate may cause serious side effects. Do not breastfeed while you are taking the drug.
  • have kidney problems
  • have kidney disease
  • are dehydrated or have a lot of vomiting, diarrhea, or sweating.
  • have or have had liver problems, including hepatitis B or hepatitis C infection
  • have lung problems
  • have problem with your immune system, or infections
  • have gastrointestinal problems such as vomiting, diarrhea, mouth sores or inflammation, ulcer, or colitis (ulcer of the intestines)
  • have a skin disease
  • have a neurologic disorder
  • drink alcohol

Methotrexate Injection BP (without preservative) and Methotrexate Injection BP (with preservative) increase sensitivity to sunlight. Avoid sun exposure and do not use a sunlamp while taking this drug.

Methotrexate can cause sudden bleeding in the lungs. This is called Pulmonary alveolar haemorrhage. If you suddenly spit or cough up blood you must go to the hospital right away. You will need emergency care. This occurs in patients with some existing health problems. Some examples are rheumatic disorder (such as pain in your joints) or vasculitis such as swelling in an artery or vein

Precautions While Using This Medicine

  • Do not take Methotrexate Injection BP (without preservative) or Methotrexate Injection BP (with preservative) more than the dose prescribed. Methotrexate can cause serious toxic reactions which may result in death.
  • Do not drink alcohol.
  • Do not drive a car or operate machinery until you know how Methotrexate Injection BP (without preservative) or Methotrexate Injection BP (with preservative) affect you since the drug may cause dizziness and fatigue.
  • Drink extra fluid to prevent kidney problems.
  • Have regular blood tests to reduce the risk of infection or bleeding. Methotrexate can lower the number of white blood cells and there is an increased risk of infection or bleeding.
  • Talk to your doctor if you need a vaccination. Live vaccines may cause severe infections. Live vaccines or contact with any individual who has had a live vaccination should be avoided, since your ability to fight an infection (immune system) is decreased while taking Methotrexate Injection BP (without preservative) or Methotrexate Injection BP (with preservative).

Interactions with this medication

Talk to your healthcare professional about all the medicines you take or have recently taken, including any drugs, vitamins, minerals, natural supplements or alternative medicines. Methotrexate Injection BP (without preservative) and Methotrexate Injection BP (with preservative) may interact with the following drugs:

Do not take Methotrexate Injection BP (without preservative) or Methotrexate Injection BP (with preservative) if you are going to receive a general anesthetic called nitrous oxide. It is also known as laughing gas. When used together, they can cause

  • Myelosuppression (a condition in which the bone marrow cannot make enough blood cells),
  • Mouth sores,
  • Inflammation of the mouth,
  • Inflammation of the kidneys
  • Damage to the nervous system.
  • Non-steroidal anti-inflammatory drugs (NSAIDs) and salicylate (acetylsalicylic acid or ASA)
  • Disease Modifying Antirheumatic drugs (DMARDs), such as gold, penicillamine, hydroxychloroquine, or sulfasalazine
  • Drugs that may cause harm to the liver (leflunomide, azathioprine, sulfasalazine, retinoid)
  • Phenylbutazone
  • Phenytoin (to treat seizures)
  • Probenecid
  • Amphotericine B (may cause harm to kidneys)
  • Certain antibiotics such as penicillins, tetracycline, vancomycin, nystatin, neomycin, trimethoprim/ sulfamethoxazole, ciprofloxacin, pristinamycin, chloramphenicol
  • Theophylline
  • Mercaptopurine
  • Folic acid or folinic acid
  • Cytarabine and other chemotherapy agents
  • Radiotherapy
  • L-asparaginase, a drug used to treat cancer
  • Proton pump inhibitors (PPI). They are, drugs used to treat acid-related stomach problems. Some PPIs are omeprazole, esomeprazole, and pantoprazole.
  • Pyrimethamine, an anti-parasitic drug
  • Nitrous oxide, an inhaled gas used to prevent pain during medical procedures
  • Amiodarone, a drug used to treat abnormal heart rhythms
  • Sulfonylureas, drugs used to lower blood sugar levels, aminobenzoic acid, sulfonamides, also known as “sulfa drugs”
  • Packed red blood cells, used for blood transfusions
  • PUVA therapy, a type of ultraviolet light treatment for severe skin conditions
  • Triamterene, a drug used to reduce blood pressure and decrease swelling
Proper use of this medication

Take Methotrexate Injection BP (without preservative) and Methotrexate Injection BP (with preservative) only as directed by your doctor. Do not take more or less of it, and do not take it more often than your doctor ordered. The exact amount of medicine you need has been carefully worked out. Taking too much may increase the chance of side effects, while taking too little may not improve your condition. You should check with your doctor if you are not certain how to take the medication.

  • In most cases, Methotrexate Injection BP (without preservative) and Methotrexate Injection BP (with preservative) are taken once weekly; the prescribed dose is taken on a single day of the week.
  • In some cases, your healthcare professional may instruct you to take Methotrexate Injection BP (without preservative) or Methotrexate Injection BP (with preservative) every 12 hours for 3 doses; you should only do this once a week, and should not take more than 3 doses each week.
  • It should never be taken every day of the week when used to treat psoriasis or rheumatoid arthritis. As well, in most cases of cancer, Methotrexate Injection BP (without preservative) and Methotrexate Injection BP (with preservative) should not be taken every day of the week.
  • Taking Methotrexate Injection BP (without preservative) or Methotrexate Injection BP (with preservative) daily, or in a dose larger than prescribed can result in serious complications, often requiring hospitalization, and sometimes resulting in death. Taking even small doses of Methotrexate Injection BP (without preservative) or Methotrexate Injection BP (with preservative) daily for less than a week can result in serious consequences, including death.
    •
  • Select a day of the week when you are most likely to remember to take Methotrexate Injection BP (without preservative) or Methotrexate Injection BP (with preservative), and take it on that same day each week.
  • Each time you refill your prescription, check to see whether the dose you need to take has changed.

Methotrexate Injection BP (without preservative) and Methotrexate Injection BP (with preservative) are often given together with certain other medicines. If you are using a combination of medicines, make sure that you take each one at the proper time and do not mix them. Ask your doctor or pharmacist to help you plan a way to remember to take your medicines at the right times.

While you are using Methotrexate Injection BP (without preservative) or Methotrexate Injection BP (with preservative), your doctor may want you to drink extra fluids so that you will pass more urine. This will help the drug to pass from the body, and will prevent kidney problems and keep your kidneys working well.

If you vomit shortly after taking a dose of Methotrexate Injection BP (without preservative) or Methotrexate Injection BP (with preservative), check with your doctor. You will be told whether to take the dose again or to wait until the next scheduled dose.

Usual Dose

The dose of Methotrexate Injection BP (without preservative) and Methotrexate Injection BP (with preservative) will be different for different patients. The dose that is used may depend on a number of things, including what the medicine is being used for, the patient's size, and whether or not other medicines are also being taken. If you are taking or receiving

Methotrexate Injection BP (without preservative) or Methotrexate Injection BP (with preservative) at home, follow your doctor's orders or the directions on the label. If you have any questions about the proper dose of Methotrexate Injection BP (without preservative) or Methotrexate Injection BP (with preservative), ask your doctor. The doctor may decrease your dose if you have problems with your kidneys.

Overdose

If you think you have taken too much Methotrexate Injection BP (without preservative) or Methotrexate Injection BP (with preservative), contact your healthcare professional, hospital emergency department or regional poison control centre immediately, even if there are no symptoms.
  • Do this even if you have no signs of discomfort.

Missed Dose

  • If you missed a scheduled dose, contact your doctor for instruction.
Side effects and what to do about them

Along with their needed effects, medicines like Methotrexate Injection BP (without preservative) and Methotrexate Injection BP (with preservative) can sometimes cause unwanted effects. Also, because of the way these medicines act on the body, there is a chance that they might cause other unwanted effects that may not occur until months or years after the medicine is used. These delayed effects may include certain types of cancer, such as leukemia. Discuss these possible effects with your doctor.

Methotrexate Injection BP (without preservative) and Methotrexate Injection BP (with preservative) commonly cause nausea and vomiting. Even if you begin to feel ill, do not stop using this medicine without first checking with your doctor. Ask your doctor for ways to lessen these effects.

The most common side effects include:

  • Upset stomach, stomach pain, vomiting, nausea, loss of appetite, dizziness, chills and fever, diarrhea or sores on lips or mouth
  • A fall in the number of white blood cells. This may reduce your resistance to infection and increase your chances of cold sores, blood poisoning or swelling of blood vessels
  • Tiredness (fatigue)

Less common side effects are:

  • Headaches, hair loss, mood changes, confusion, ringing in the ears, sore eyes, skin rashes, increased sensitivity to sunlight or unexplained weight loss
  • A fall in the number of other blood cells. This may increase your chances of bruising, bleeding or tiredness
  • Damage to the lungs
  • Harm to the unborn baby
  • Convulsions

Rarely, Methotrexate Injection BP (without preservative) and Methotrexate Injection BP (with preservative) can cause other side effects including:

  • Liver damage, kidney damage, pain or difficulty urinating, lower back or side pain, blood in urine or stools, dark urine
  • Fits, blurred vision, short term blindness
  • Drowsiness, weakness
  • Hoarseness
  • Bloody vomit, black, tarry stools or pin-point red spots on the skin
  • Reddening or whitening of the skin, acne, boils, itching yellow skin or eyes
  • Impotence or loss of interest in sex, decreased fertility, abortion
  • Diabetes, thinning of the bones, painful muscles and joints
  • Low blood pressure
  • Gastrointestinal ulcers

More rarely, it can cause:

  • Skin rash and other skin disorders
  • Cancer of lymph glands, sudden death
  • Severe allergic reactions
  • Leukoencephalopathy
  • Damage to heart

Methotrexate Injection BP (without preservative) and Methotrexate Injection BP (with preservative) can cause abnormal test results. Your doctor will decide when to perform tests and will interpret the results. This includes blood and urine tests to check how your kidneys are working

Serious side effects, how often they happen and what to do about them
Symptom / effect Talk with your doctor, nurse, or pharmacist only if severe Talk with your doctor, nurse, or pharmacist in all cases Stop taking drug and talk with your doctor or pharmacist
Common
Diarrhea, vomiting, abdominal pain, or mouth ulcers     ✔
Sore throat, fever, chills, or swelling of glands   ✔  
Inflammation of the lungs: Persistent dry, non-productive cough, shortness of breath and fever.   ✔  
Less common
Chest pain, cough, shortness of breath or fever     ✔
Unusual bleeding or bruising     ✔
Severe headaches     ✔
Rare
Signs of severe allergic reaction: Skin rash, itching, chest tightness, wheezing, dizziness, hives, faintness, rapid heartbeat, shortness of breath, and/or a swollen face, lips or tongue     ✔
Pain or difficulty urinating, lower back or side pain, blood in urine or stools, dark urine   ✔  
Yellow colour of eyes or skin     ✔
Renal Failure/ kidney damage (inability of the kidneys to work properly): swelling of the hands, ankles or feet. Nausea, vomiting. Blood in the urine. Changes in frequency or amount of urine.     ✔
Gastrointestinal Related: Severe abdominal pain, tenderness, chills, fever, nausea, vomiting, extreme thirst, difficulty passing urine or bowel movement     ✔
Unknown
Central Nervous System Related: Behaviour changes, decreased consciousness, headache, weakness, numbness, vision loss or double vision, seizures, vomiting, loss of memory.     ✔
DRESS (allergic reactions): Fever, rash, hives, swelling of eyes, lips or tongue     ✔
Pulmonary alveolar haemorrhage: suddenly spit or cough up blood     ✔

This is not a complete list of side effects. For any unexpected effects while taking Methotrexate Injection BP (without preservative) and Methotrexate Injection BP (with preservative), contact your doctor or pharmacist.

How to store
  • Keep out of the reach and sight of children.
  • Store Methotrexate Injection BP (without preservative) and Methotrexate Injection BP (with preservative) vials between 15-25 °C and away from direct light. Avoid freezing and any unused solution should be discarded.
  • Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.
Reporting side effects

You can report any suspected side effects associated with the use of health products to Health Canada by:

NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice

More information

If you want more information about Methotrexate Injection BP (without preservative) and Methotrexate Injection BP (with preservative):

  • Talk to your healthcare professional
  • Find the full product monograph that is prepared for healthcare professionals and includes this Consumer Information by visiting the Health Canada website (https://healthproducts.canada.ca/dpd-bdpp/index-eng.jsp); or by calling the sponsor Accord Healthcare Inc. at 1-866-296-0354.

This leaflet was prepared by:

Accord Healthcare Inc.
3535 Boul. St. Charles Suite 704
Kirkland, Québec
H9H 5B9
Canada

Last revised: October 30, 2019

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