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levoleucovorin (Intravenous route)

lee-voe-loo-koe-VOE-rin

Commonly used brand name(s)

In the U.S.

  • Fusilev

Available Dosage Forms:

  • Powder for Solution

Therapeutic Class: Methotrexate Rescue

Uses For levoleucovorin

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. levoleucovorin acts the same way in the body as folic acid (vitamin B9).

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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.

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

Before Using levoleucovorin

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 levoleucovorin, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to levoleucovorin 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.

Pediatric

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.

Geriatric

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.

Interactions with 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 levoleucovorin, 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 levoleucovorin with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Tegafur

Using levoleucovorin 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
  • Fluorouracil

Interactions with Food/Tobacco/Alcohol

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 levoleucovorin. 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 levoleucovorin

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

Precautions While Using levoleucovorin

It is very important that your doctor check your closely to make sure that levoleucovorin 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. .

levoleucovorin Side Effects

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.

See also: Side effects (in more detail)

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