sargramostim (Intravenous route)

sar-GRA-moe-stim

Commonly used brand name(s):

In the U.S.

• Leukine

Available Dosage Forms:

• Powder for Solution
• Solution

Therapeutic Class: Hematopoietic

Pharmacologic Class: Colony Stimulating Factor

Uses For sargramostim

Sargramostim is a synthetic (man-made) version of a substance that is naturally produced in your body called a colony stimulating factor. It helps the bone marrow to make new white blood cells .

When certain cancer medicines are used to fight cancer cells, they also affect the white blood cells that fight infections. Sargramostim is used to prevent or reduce the risk of infection while you are being treated with cancer medicines. sargramostim is also used to help the bone marrow recover after a bone marrow transplantation, and for a process called peripheral blood progenitor cell collection in cancer patients .

sargramostim is available only with your doctor's prescription .

Before Using sargramostim

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 sargramostim, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to sargramostim 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 performed to date have not demonstrated pediatrics-specific problems that would limit the usefulness of sargramostim in children. However, safety and efficacy have not been established in babies younger than 4months of age .

Geriatric

Appropriate studies performed to date have not demonstrated geriatrics-specific problems that would limit the usefulness of sargramostim in the elderly .

Interactions with Medicines

Using sargramostim 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.

• Vincristine
• Vincristine Liposome

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 sargramostim. Make sure you tell your doctor if you have any other medical problems, especially:

• Bone marrow hyperplasia—Should not be used. Will result to higher risk of serious side effect in patients with this condition .

• Congestive heart failure or
• Edema (fluid retention) or
• Heart disease or
• Heart rhythm problems, history of or
• Hypoxia (decreased oxygen in the tissues) or
• Kidney disease or
• Liver disease or
• Lung disease or breathing problems or
• Pericardial effusion (fluid around the heart) or
• Pleural effusion (fluid around the lungs)—Use with caution. May make these conditions worse .

Proper Use of sargramostim

A nurse or other trained health professional may give you sargramostim. Your doctor will prescribe your exact dose and tell you how often it should be given. sargramostim is given through a needle placed in one of your veins .

Precautions While Using sargramostim

It is very important that your doctor check your progress at regular visits to make sure that sargramostim is working properly. Blood tests may be needed to check for unwanted effects .

Tell your doctor about all the other medicines you are using, especially if you are being treated for cancer. sargramostim should not be given at the same time as chemotherapy or radiotherapy or within 24 hours before or after you receive your cancer treatment .

sargramostim 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 immediately if any of the following side effects occur:

• Abdominal pain
• black, tarry stools
• bloating or swelling of face, arms, hands, lower legs, or feet
• blood in eye
• bloody nose
• bloody stools
• blurred vision
• body aches or pain
• bone pain
• chest pain
• cloudy urine
• congestion
• cough
• decrease in urine output or decrease in urine-concentrating ability
• difficult or labored breathing
• drowsiness
• dry mouth
• dryness or soreness of throat
• eye pain
• fast, pounding, or irregular heartbeat or pulse
• fatigue
• fever
• flushed, dry skin
• fruit-like breath odor
• hoarseness
• increased hunger
• increased thirst
• increased urination
• irregular heartbeat
• large amount of cholesterol in the blood
• loss of appetite
• mood or mental changes
• muscle spasms [tetany] or twitching seizures
• nausea or vomiting
• rapid weight gain
• redness in whites of eyes
• runny nose
• shortness of breath
• sweating
• tender, swollen glands in neck
• tightness in chest
• tingling of hands or feet
• trouble in swallowing
• troubled breathing
• trembling
• unusual tiredness or weakness
• unusual weight gain or loss
• voice changes
• vomiting of blood or material that looks like coffee grounds
• wheezing
• yellow eyes or skin

Get emergency help immediately if any of the following symptoms of overdose occur:

• General feeling of discomfort or illness
• headache
• rash

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:

• Chills
• diarrhea
• difficulty in moving
• fear or nervousness
• itching skin
• lack or loss of strength
• muscle pain or stiffness
• pain in joints
• sleeplessness
• trouble sleeping
• unable to sleep

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.

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