Patient Medication Information: uses, side effects, how to take - Leucovorin Calcium Injection (Teva Canada)

Serious warnings and precautions box

You will receive LEUCOVORIN CALCIUM INJECTION:
- as a shot into your muscle (intramuscularly) or as a shot or infusion (drip) into your vein (intravenously). It must not be given into the fluid-filled space between the thin layers of tissue that cover the brain and spinal cord (intrathecally). Deaths have happened in people getting this medicine into the spine.
- with 5-fluorouracil only under the care of a healthcare professional experienced in the use of anti-cancer medicines.
If you are receiving leucovorin with fluorouracil (an anticancer medicine), your healthcare professional will monitor you for side effects like diarrhea or painful sores that may make it hard for you to eat, drink, or swallow (stomatitis/mucositis). These are early signs of severe and potentially life-threatening side effects. Talk to your healthcare professional right away if you experience any of these side effects.
Deaths from the following side effects have happened in people getting leucovorin:
- Severe problems with the digestive system (gastrointestinal toxicity): These include diarrhea and mucositis (ulcers (open sores) and swelling of lining of the bowels and mouth).
- Severe drop in blood cell counts (myelosuppression, a condition in which the bone marrow cannot make enough blood cells).
- Severe skin reactions: These include Stevens-Johnson syndrome (SJS) and Toxic
  Epidermal Necrolysis (TEN). These are more likely to occur if you are taking other medicines known to cause these skin reactions.

For more information on these and other serious side effects, see the Serious side effects and what to do about them table, below.

Leucovorin may lower the effects of anti-epileptic medications such as phenobarbital,

What LEUCOVORIN CALCIUM INJECTION is used for:

to lower the toxic effects of:
- a group of medicines called folic acid antagonists. It is also used to treat an overdose of these medicines
- methotrexate (a medicine often used to treat cancer)
to treat some kinds of anemia (low level of red blood cells in the body)
- due to low level of folate (an essential B vitamin) in the body such as in poor food intake or absorption (sprue, nutritional deficiency); or
- occurring during pregnancy and infancy.
before treatment with fluorouracil to improve survival time in the palliative treatment of patients with advanced colorectal cancer.

How LEUCOVORIN CALCIUM INJECTION works:

LEUCOVORIN CALCIUM INJECTION belongs to a class of medicines called folic acid analogs. It:

lowers the harmful effects of methotrexate by competing with methotrexate and limiting how much methotrexate enters your cells
treats anemia by supplying folic acid that is needed to produce red blood cell
increases the effects of 5-fluorouracil (a medicine used to treat cancer)

The ingredients in LEUCOVORIN CALCIUM INJECTION are:

Medicinal ingredients: Leucovorin Calcium (also known as calcium folinate).

Non-medicinal ingredients: Sodium chloride and Water for injection. Sodium hydroxide and Hydrochloric acid may be added to adjust pH.

LEUCOVORIN CALCIUM INJECTION comes in the following dosage forms:

Solution: 10 mg / mL

Do not receive LEUCOVORIN CALCIUM INJECTION if:

you have a type of anemia caused by too little Vitamin B₁₂
you are allergic (hypersensitive) to calcium folinate or any of the other ingredients of
LEUCOVORIN CALCIUM INJECTION (See What are the ingredients in LEUCOVORIN CALCIUM INJECTION)?
primidone and phenytoin. If you are taking anti-epileptic medications, you may be at an increased risk of having seizures more often

LEUCOVORIN CALCIUM INJECTION must NOT be injected into the fluid-filled space between the thin layers of tissue that cover the brain and spinal cord (intrathecally).

To help avoid side effects and ensure proper use, talk to your healthcare professional before you receive LEUCOVORIN CALCIUM INJECTION. Talk about any health conditions or problems you may have, including if you:

are currently taking methotrexate and:
- have aciduria (urine pH less than 7)
- have or have ever had a build-up of fluid in the chest cavity or the belly area
- are dehydrated (feeling thirsty, dark yellow urine, dizzy, lightheaded, tired, dry mouth and peeing less than 4 times a day)
- have stomach or bowel issues such as a blockage
- you have trouble with your kidneys
have diarrhoea
are pregnant, plan to become pregnant, or are breast-feeding.

Other warnings you should know about:

Older people with colorectal cancer. You could have more side effects. Deaths from severe bowel problems, diarrhea, and dehydration have happened in older people getting leucovorin with fluorouracil.
Lab and blood tests: Your healthcare professional will do blood tests before you receive
LEUCOVORIN CALCIUM INJECTION and/or during treatment to monitor your progress or check for side effects. These tests may check:
- the level of blood cells in your body.
- that your liver or kidneys are working properly.
- the level calcium and other essential minerals—like sodium and potassium
  (electrolyte) in your blood.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

Serious drug interactions:

Serious Drug Interactions with LEUCOVORIN CALCIUM INJECTION include:

If you are receiving leucovorin with fluorouracil (an anticancer medicine):
- your healthcare professional will monitor you for side effects like diarrhea or painful sores that may make it hard for you to eat, drink, or swallow (stomatitis/mucositis). These are early signs of severe and potentially life-threatening side effects. Talk to your healthcare professional right away if you experience any of these side effects. See the Serious side effects and what to do about them table, below
- you may experience increased side effects from fluorouracil
Leucovorin may lower the effects of anti-epileptic medications such as phenobarbital, primidone and phenytoin. If you are taking anti-epileptic medications you may be at an increased risk of having seizures more often
Leucovorin must not be mixed in the same infusion as 5-fluorouracil because a precipitate may form

The following may interact with LEUCOVORIN CALCIUM INJECTION:

medicines used to treat epilepsy - phenobarbital, primidone, and phenytoin. Your healthcare professional may check blood levels of these medicines and change your dose to prevent increased convulsions (fits).
a group of medicines called folic acid antagonists. These include:
- methotrexate (a medicine often used to treat cancer). High doses of leucovorin may lower how well methotrexate works
- trimethoprim or co-trimoxazole (an antibiotic)
- pyrimethamine (a medicine used to treat malaria)
anti-cancer medicines, such as 5-fluorouracil (5FU). Leucovorin may increase the harmful effect of fluorouracil

How you will receive LEUCOVORIN CALCIUM INJECTION:

in a healthcare setting under the care of your healthcare professional
as an injection into the muscle or as an injection or an infusion (drip) into your vein

Usual dose:

Your healthcare professional will work out the right dose of LEUCOVORIN CALCIUM INJECTION for you.

Overdose:

If you think you, or a person you are caring for, have taken too much LEUCOVORIN CALCIUM INJECTION, contact a healthcare professional, hospital emergency department, regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no signs or symptoms.

Possible side effects from using LEUCOVORIN CALCIUM INJECTION?

These are not all the possible side effects you may have when receiving LEUCOVORIN CALCIUM INJECTION. If you experience any side effects not listed here, tell your healthcare professional.

Side effects may include:

nausea, vomiting
red, swollen lips
dizziness
fever

Serious side effects and what to do about them

Frequency/Side Effect/Symptom	Talk to your healthcare professional		Stop taking drug and get immediate medical help
	Only if severe	In all cases
Very Common
Gastrointestinal toxicity (Severe problems with the digestive system): Diarrhea: persistent or severe Stomatitis (swelling and redness of the lining of your mouth): painful sores that may make it hard for you to eat, drink, or swallow Mucositis (ulcers (open sores) and swelling of lining of the bowels and mouth): red, shiny, or swollen mouth and gums, sores in the mouth or on the gums or tongue, blood in the mouth, pain in the mouth or throat, difficulty swallowing or talking, mild burning, or pain when eating		√
Common
Palmar-plantar erythrodysesthesia (Hand and Foot syndrome): red or swollen palms, thick calluses and blisters of the hands and soles of the feet, tingling or burning, tightness of the skin		√
Unknown
Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN)(severe skin reactions): redness, blistering and/or peeling of the skin and/or inside the lips, mouth, eyes, nasal passages or genitals, accompanied by fever, chills, tiredness, headache and cough, body aches or swollen glands, raised red or purple skin patches, possibly with blister or			√

crust in the center, swollen lips, mild itching or burning
Allergic reactions: difficulty swallowing or breathing, wheezing, drop in blood pressure, feeling sick to your stomach and throwing up, hives or rash, swelling of the face, lips, tongue or throat, low blood pressure, confusion, reduced alertness, cold, moist skin, fast breathing, fast heartbeat		√
Seizures (fit): uncontrollable shaking with or without loss of consciousness		√
Bone marrow suppression (severe drop in blood cells): bleeding, bruising, chills, fatigue, fever, infections, weakness, shortness of breath or other signs of infection		√
Syncope (fainting): a temporary loss of consciousness due to a sudden drop in blood pressure	√
Hyperammonemia (high ammonia levels in the blood): confusion, irritability, refusal to eat meat or high protein products	√

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.

Reporting side effects

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

Visiting the Web page on Adverse Reaction Reporting (canada.ca/drug-device-reporting)
for information on how to report online, by mail or by fax; or
Calling toll-free at 1-866-234-2345.

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.

Storage:

LEUCOVORIN CALCIUM INJECTION will be stored by your healthcare professional. It should be kept:

refrigerated (2^oC to 8^oC)
protected from light and freezing
out of reach and sight of children.

If you want more information about LEUCOVORIN CALCIUM INJECTION:

Talk to your healthcare professional
Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website http://www.tevacanada.com; or by calling 1-800-268-4127 ext. 3; or email druginfo@tevacanada.com.

Date of authorization: 2025-05-13

Rx or OTC	Prescription (Rx)?
DIN	02087316
Schedule(s)	PRESCRIPTION
Active ingredient(s)	Leucovorin (leucovorin calcium) 10 MG
Dosage form(s)	Solution
Route(s) of administration	Intramuscular, Intravenous
Drug class (WHO ATC)	V Various drug classes V03 All other therapeutic products V03A All other therapeutic products V03AF Detoxifying agents for antineoplastic treatment V03AF03 Calcium folinate
Company	TEVA CANADA LIMITED
Current status	Marketed
Current status date	May 16, 2014

Leucovorin Calcium Injection (Teva Canada): Uses, Side Effects and Dosage