Lederle Leucovorin - Consumer Medicine Information
|Condition:||Anemia, Megaloblastic, Colorectal Cancer, Folic Acid Antagonist Overdose, Methotrexate Overdosage, Methotrexate Rescue, Pneumocystis Pneumonia, Pneumocystis Pneumonia Prophylaxis, Toxoplasmosis, Prophylaxis, Toxoplasmosis|
|Ingredients:||leucovorin calcium (also known as calcium folinate), lactose, magnesium stearate, microcrystalline cellulose, sodium starch glycolate and starch pregelatinized 1500|
calcium folinate tablets
About This Medication
What the Medication is Used For
The medication is used -
- To diminish the toxicity and counteract the effect of impaired METHOTREXATE elimination.
- To treat the megaloblastic anemias due to folate deficiency, as in sprue, nutritional deficiency, megaloblastic anemias of pregnancy and infancy.
What It Does
LEUCOVORIN is a reduced form of folic acid. LEUCOVORIN limits METHOTREXATE action on normal cells by competing with METHOTREXATE for the same transport processes into the cell. LEUCOVORIN rescues bone marrow and gastrointestinal cells from METHOTREXATE but has no apparent effect on pre-existing METHOTREXATE nephrotoxicity.
When It Should not be Used
Do not take LEUCOVORIN
- if you are allergic (hypersensitive) to calcium folinate or any of the other ingredients of LEUCOVORIN OR
- If you have megaloblasic anaemia due to Vitamin B12 deficiency
What the Medicinal Ingredient Is
LEUCOVORIN Calcium (also known as calcium folinate).
What the Important Nonmedicinal Ingredients Are
Non-medicinal ingredients are: Lactose, Magnesium Stearate, Microcrystalline Cellulose, Sodium Starch Glycolate and Starch Pregelatinized 1500.
What Dosage Forms It Comes In
Tablet: 5 mg LEUCOVORIN as LEUCOVORIN calcium
Warnings and Precautions
In very rare cases sloughing of the skin, rarely leading to death, has been reported in patients receiving Leucovorin along with other medications known to have similar side-effects.
Leucovorin should only be used under the direct supervision of a clinician experienced in the use of cancer chemotherapeutic agents.
BEFORE you use LEUCOVORIN talk to your doctor or pharmacist if:
- You have symptoms of gastrointestinal disorders.
- You are taking cytotoxic drugs (hydroxycarbamide cytarabine, mercaptopurine, thioguanine).
- You are epileptic and are being treated with phenobarbital, primidone, phenytoin and succinimides.
- If you are Pregnant or Nursing.
Interactions With This Medication
LEUCOVORIN can interfere with the breakdown or metabolism of certain drugs. In particular, you should inform your doctor if you are taking any of the following:
- Cytotoxic drugs - 5-fluorouracil (5FU), Methotrexate (High doses of LEUCOVORIN may reduce the efficacy of Methotrexate. LEUCOVORIN may enhance the toxicity of fluorouracil.)
- Folic acid antagonists – cotrimxazole, pyrimethamine
- Anti-epileptic substances - phenobarbital, primidone, phenytoin and succinimides.
Proper Use of This Medication
Take your dose as prescribed by the physician.
If you take too much LEUCOVORIN (Overdose):
- Immediately call your doctor or go to the nearest hospital emergency department
- Do this even if you have no signs of discomfort
- Always take the labelled medicine bottle with you, even if it is empty
Side Effects and What to Do About Them
Undesirable effects have been rarely reported.
Allergic sensitization, including anaphylactoid/anaphylactic reactions (including shock) and urticaria, has been reported following administration of folinic acid.
Serious Side Effects, how Often They Happen and What to Do About Them
|Symptom / effect||Talk with|
your doctor or
|Uncommon||- Allergic reactions|
- Any skin disorders
|Rare||- Seizures /syncope (Fainting / Dizziness)||T|
|Very Rare||- Anaphylactoid / anaphylactic reactions (including shock)||T|
|Frequency undetermined||- Allergic reactions, urticaria|
- Palmar-Planta Erythrodysaesthesia (Hand and Foot Syndrome)
- Mucositis (mouth ulcers)
- Stomatitis (mouth ulcers)
- Chelitis (swelling of the lip)
- Hyperammonemia (excess ammonia in the blood)
This is not a complete list of side effects. For any unexpected effects while taking LEUCOVORIN, contact your doctor or pharmacist.
How to Store It
Tablets should be stored at 15-30°C. Protect from light.
Reporting Suspected Side Effects
You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:
- Report online at www.healthcanada.gc.ca/medeffect
- Call toll-free at 1-866-234-2345
- Complete a Canada Vigilance Reporting Form and:
- Fax toll-free to 1-866-678-6789, or
- Mail to:
Canada Vigilance Program
Postal Locator 0701D
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect Canada Web site at www.healthcanada.gc.ca/medeffect.
NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.
This document plus the full product monograph, prepared for health professionals can be obtained by contacting the sponsor, Pfizer Canada Inc., at: 1-800-463-6001 or at www.pfizer.ca