Pronunciation:

sar-GRA-moe-stim

Brand Names:

• Leukine

Dosage Forms:

• Powder for Solution

Classifications:

Therapeutic—

Hematopoietic

Pharmacologic—

Colony Stimulating Factor

Uses of This Medicine:

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

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. It is also used to help the bone marrow recover faster after a bone marrow transplant or after a peripheral blood progenitor cell collection in cancer patients having stem cell transplant. This medicine is also used to improve survival in cancer patients who have been exposed to radiation.

This medicine is available only with your doctor's prescription

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 sargramostim injection in children younger than 2 years of age. Safety and efficacy have not been established, except for use in children exposed to radiation.

Older adults—

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

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 taking 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 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.

• Alclometasone
• Aldosterone
• Amcinonide
• Beclomethasone
• Betamethasone
• Budesonide
• Ciclesonide
• Clobetasol
• Clobetasone
• Clocortolone
• Cortisone
• Deflazacort
• Desonide
• Desoximetasone
• Dexamethasone
• Diflorasone
• Diflucortolone
• Difluprednate
• Flucloronide
• Fludrocortisone
• Flumethasone
• Flunisolide
• Fluocinolone
• Fluocinonide
• Fluocortin
• Fluocortolone
• Fluorometholone
• Flurandrenolide
• Fluticasone
• Halcinonide
• Halobetasol
• Hydrocortisone
• Loteprednol
• Medrysone
• Methylprednisolone
• Mometasone
• Paramethasone
• Prednicarbate
• Prednisolone
• Prednisone
• Rimexolone
• Triamcinolone
• Vincristine
• Vincristine Sulfate Liposome

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:

• 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 This Medicine:

A nurse or other trained health professional may give you this medicine. It is given through a needle placed into one of your veins or as a shot under your skin (usually in the stomach, thigh, or outer part of the upper arm). .

You may be taught how to give this medicine at home. Make sure you understand all of the instructions before giving yourself an injection. Do not use more medicine or use it more often than your doctor tells you to.

This medicine should come with a patient information leaflet. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.

This medicine is available in a powder form. You must mix the powder with another liquid before using it.

To use this medicine as a shot under your skin:

• You will be shown the body areas where this shot can be given. Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas. This will help prevent skin problems from the injections. Do not inject into areas where the skin is tender, bruised, red, hard, or has scars or stretch marks.
• Check the mixed liquid inside the vial. It should be clear and colorless. Do not use it if it is cloudy, discolored, or has particles in it. Do not shake.
• Use a new needle and syringe each time you inject your medicine.

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 injection dosage form (powder for solution):
  • To increase white blood cell count:
    • Adults and children 2 years of age and older—Dose is based on body weight and must be determined by your doctor. The dose is usually 250 micrograms per square meter (mcg/m2) injected under the skin once a day. Your doctor may adjust your dose as needed.
    • Children younger than 2 years of age—Use and dose must be determined by your doctor.
  • To increase survival in patients who have been exposed to radiation:
    • Adults and children weighing more than 40 kilograms (kg)—Dose is based on body weight and must be determined by your doctor. The dose is usually 7 micrograms per kilogram (mcg/kg) injected under the skin once a day.
    • Children weighing 15 kg to 40 kg—Dose is based on body weight and must be determined by your doctor. The dose is usually 10 mcg/kg injected under the skin once a day.
    • Children weighing less than 15 kg—Dose is based on body weight and must be determined by your doctor. The dose is usually 12 mcg/kg injected under the skin once a day.

Missed dose—

This medicine needs to be given on a fixed schedule. If you miss a dose or forget to use your medicine, call your doctor or pharmacist for instructions.

Storage—

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store in the refrigerator. Do not freeze.

Keep this medicine in its original container. The mixed liquid has different storage directions based on what kind of liquid it was mixed with.

Throw away used needles in a hard, closed container where the needles cannot poke through. Keep this container away from children and pets.

Precautions While Using This Medicine:

It is very important that your doctor check you and your child's progress at regular visits to make sure that this medicine is working properly. Blood tests are 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. This medicine should not be given at the same time as chemotherapy (cancer medicines) or radiation treatment or within 24 hours before or after you receive your cancer treatment.

This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Call your doctor right away if you or your child have a rash, itching, swelling of the face, tongue, or throat, trouble breathing, or chest pain after you receive the medicine.

This medicine may cause infusion-related reactions, which can be life-threatening and requires immediate medical attention. Tell your doctor right away if you start to have a fever, chills or shaking, dizziness, trouble breathing, itching or rash, lightheadedness or fainting after receiving this medicine.

This medicine may cause a condition called capillary leak syndrome. It can cause fluid to leak from the blood vessels into your body's tissues. Call your doctor right away if you have swelling or puffiness, urinating less often, trouble breathing, feeling of fullness, dizziness, or feeling faint.

This medicine may cause heart rhythm problems. Tell your doctor right away if you or your child gets dizzy or lightheaded, have fast or irregular heart beats, or feels like fainting.

This medicine may increase your risk of having cancer and the number of white blood cells in the blood. Talk to your doctor if you have concerns.

This medicine contains benzyl alcohol, which can be harmful to infants and unborn babies.

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:

More common

Black, tarry stools

bloating or swelling of the face, arms, hands, lower legs, or feet

blood in the eye

bloody nose

blurred vision

body aches or pain

bone pain

chest pain or tightness

cloudy urine

cough

decrease in urine output or decrease in urine-concentrating ability

difficult or labored breathing

drowsiness

dry mouth

dryness or soreness of the throat

eye pain

fast, pounding, or irregular heartbeat or pulse

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

nausea

rapid weight gain

redness in whites of eyes

stomach pain

stuffy or runny nose

sweating

tender, swollen glands in the neck

tingling of the hands or feet

trouble with swallowing

trembling

twitching

unusual tiredness or weakness

unusual weight gain or loss

voice changes

vomiting

vomiting of blood or material that looks like coffee grounds

yellow eyes or skin

Incidence not known

Chills

confusion

dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

general feeling of illness

headache

pain in the chest, groin, or legs, especially the calves

severe, sudden headache

slurred speech

sudden loss of coordination

sudden, severe weakness or numbness in the arm or leg

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

Diarrhea

difficulty in moving

fear or nervousness

itching skin

lack or loss of strength

muscle pain or stiffness

pain in the joints

trouble sleeping

Incidence not known

Bleeding, blistering, burning, coldness, discoloration of skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site

feeling of warmth

redness of the face, neck, arms, and occasionally, upper chest

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.