Pronunciation:

loo-koe-VOR-in

Dosage Forms:

• Tablet
• Powder for Solution
• Solution
• Injectable

Classifications:

Therapeutic—

Methotrexate Rescue

Uses of This Medicine:

Leucovorin is used as an antidote to the harmful effects of methotrexate (a cancer medicine) that is given in high doses. It is used also to prevent or treat certain kinds of anemia. Leucovorin acts the same way in the body as folic acid, which may be low in these patients.

Leucovorin is also used along with fluorouracil (a cancer medicine) to treat cancer of the colon (bowel).

Leucovorin is available only with a prescription.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in the product labeling, leucovorin is used in certain patients with the following medical conditions:

• Ewing's sarcoma (type of cancer found in the bone)
• Gestational trophoblastic tumors (tumors in the uterus or womb)
• Head and neck cancer
• Non-Hodgkin's lymphoma (cancer of the lymph system)

Before Using This Medicine:

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.

Children—

In children with seizures, leucovorin may increase the number of seizures that occur.

Older adults—

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of leucovorin in the elderly with use in other age groups.

Pregnancy—

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

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. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

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:

• Kidney disease—Levels of methotrexate may be increased because of its slower removal from the body, so the dose of leucovorin may not be enough to block the unwanted effects of methotrexate

• Nausea and vomiting—Not enough leucovorin may be absorbed into the body to block the unwanted effects of methotrexate

Proper Use of This Medicine:

It is very important that you take leucovorin exactly as directed , especially when it is being taken to counteract the harmful effects of cancer medicine. Do not miss any doses. Also, it is best to take the doses at evenly spaced times day and night. For example, if you are to take 4 doses a day, the doses should be spaced about 6 hours apart. If this interferes with your sleep or other daily activities, or if you need help in planning the best times to take your medicine, check with your health care professional.

Do not stop taking leucovorin without checking with your doctor. It is very important that you get exactly the right amount.

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 use as an antidote to methotrexate:
  • For oral (tablets) or injection dosage forms:
    • Adults, teenagers, and children—Dose is based on body size and must be determined by your doctor.
• For use as an antidote to other medicines:
  • For oral (tablets) or injection dosage forms:
    • Adults, teenagers, and children—Dose may range from 0.4 milligrams (mg) to 15 mg a day and must be determined by your doctor.
• For certain kinds of anemia:
  • For oral (tablets) or injection dosage forms:
    • Adults, teenagers, and children—Up to 1 mg a day.
• For colon cancer:
  • For injection dosage forms:
    • Adults and teenagers—Dose is based on body size and must be determined by your doctor.
    • Children—Dose must be determined by your doctor.

Missed dose—

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.

Side Effects of This Medicine:

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 immediately if any of the following side effects occur:

Rare

Skin rash, hives, or itching

wheezing

Check with your doctor as soon as possible if any of the following side effects occur:

Rare

(reported with use in treatment of cancer)

Convulsions (seizures)

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.