Pronunciation:

lee-voe-loo-koe-VOE-rin

Brand Names:

• Fusilev

Dosage Forms:

• Powder for Solution
• Solution

Classifications:

Therapeutic—

Methotrexate Rescue

Uses of This Medicine:

Levoleucovorin injection is used as an antidote to the harmful effects of methotrexate (a cancer medicine) that is given in high doses in patients with bone cancer (osteosarcoma). It is also used to treat overdosage of certain medicines. This medicine acts the same way in the body as folic acid (vitamin B9).

Levoleucovorin injection is also used in combination with 5-fluorouracil (Adrucil®) to relieve and prevent symptoms of patients with advanced metastatic (cancer that has already spread) cancer of the colon and rectum.

This medicine is to be given only by or under the direct supervision of a doctor.

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—

Appropriate studies have not been performed on the relationship of age to the effects of levoleucovorin injection in children younger than 6 years of age. Safety and efficacy have not been established.

Older adults—

Appropriate studies on the relationship of age to the effects of levoleucovorin injection have not been performed in geriatric patients with bone cancer. However, no geriatric-specific problems have been documented to date.

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of Fusilev® in elderly patients with advanced colorectal cancer.

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. 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 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.

• Capecitabine
• Doxifluridine
• Fluorouracil
• Tegafur

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:

• Ascites (fluid in the stomach) or
• Dehydration or
• Kidney disease, severe or
• Pleural effusion (fluid around the lungs)—Levels of methotrexate may be increased because of its slower removal from the body. The dose of levoleucovorin may not be enough to block the unwanted effects of methotrexate.

• Blood problems (e.g., anemia caused by lack of vitamin B12)—Should not be used in patients with these conditions.

Proper Use of This Medicine:

A nurse or other trained health professional will give you this medicine. This medicine is given through a needle placed in one of your veins.

Precautions While Using This Medicine:

It is very important that your doctor check your closely to make sure that this medicine is working properly. Blood and urine tests will be needed to check for unwanted effects.

Do not take other medicines unless they have been discussed with your doctor. This includes 5-fluorouracil (Adrucil®) and combination of trimethoprim and sulfamethoxazole (Bactrim®, Septra®). Using any of these medicines together with levoleucovorin increases your risk of serious side effects. .

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 or nurse immediately if any of the following side effects occur:

More common

Cloudy urine

decrease in urine output or decrease in urine-concentrating ability

difficult or labored breathing

fever

general feeling of discomfort or illness

lack or loss of strength

shortness of breath

stomach cramps, tenderness, or pain

tightness in the chest

unusual tiredness or weakness

watery or bloody diarrhea

wheezing

Incidence not known

Feeling unusually cold

shivering

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

Acid or sour stomach

bad, unusual, or unpleasant (after) taste

belching

blistering, crusting, irritation, itching, reddening, or swelling of the skin

burning, tingling, numbness, or pain in the hands, arms, feet, or legs

change in taste

cracked, dry, or scaly skin

decreased appetite

diarrhea

hair loss or thinning of the hair

heartburn

indigestion

loss of appetite

mood or mental changes

nausea

sensation of pins and needles

stabbing pain

stomach discomfort or upset

swelling or inflammation of the mouth

vomiting

weight loss

Incidence not known

Rash

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.