Sargramostim

WHY is this medicine prescribed?

Sargramostin is used to decrease the chance of infection in people who have acute myelogenous leukemia (AML; a type of cancer of the white blood cells) and are receiving chemotherapy medications that may decrease the number of neutrophils (a type of blood cell needed to fight infection). Sargramostin is also used in people who are undergoing blood stem cell transplants, in people who are undergoing bone marrow transplants, and to prepare the blood for leukapheresis (a treatment in which certain blood cells are removed from the body and then returned to the body following chemotherapy). Sargramostim is also used in people who have not responded after receiving a blood marrow transplant. Sargramostin is in a class of medications called colony-stimulating factors. It works by helping the body make more neutrophils and certain other blood cells.

Are there OTHER USES for this medicine?

Sargramostim is also sometimes used to treat certain types of myelodysplastic syndrome (a group of conditions in which the bone marrow produces blood cells that are misshapen and does not produce enough healthy blood cells) and aplastic anemia (a condition in which the bone marrow does not produce enough new blood cells). Sargramostim is also sometimes used to decrease the chance of infection in people who have human immunodeficiency virus (HIV). Talk to your doctor about the risks of using this medication for your condition.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Sargramostim comes as a solution (liquid) or a powder to be mixed with liquid to inject subcutaneously (under the skin) or intravenously (into a vein). It is infused (injected slowly) over a period of 2 to 24 hours once daily. It also may be injected subcutaneously once daily. The length of your treatment depends on the condition that you have and how well your body responds to the medication.

If you are using sargramostim to decrease the risk of infection during chemotherapy, you will receive the medication at least 4 days after you receive your last dose of each chemotherapy cycle. You will continue to receive the medication every day until your blood cell counts return to normal or for up to 6 weeks. If you are using sargramostim to prepare your blood for leukapheresis, you will receive the medication once daily until the last leukapheresis. If you are using sargramostim because you are undergoing blood stem cell transplant, you will receive the medication beginning on the day of the blood cell transplant and continue for at least 3 days. If you are using sargramostim to decrease the risk of infection during a bone marrow transplant, you will receive the medication at least 24 hours after you receive chemotherapy and again 2 to 4 hours after the bone marrow is infused. If you are using sargramostim because you are not responding to a bone marrow transplant, you will receive the medication once a day for 14 days. Do not stop using sargramostim without talking to your doctor.

Sargramostim may be given to you by a nurse or other healthcare provider, or you may be told to inject the medication at home. If you will be injecting sargramostim, inject the medication at about the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use sargramostim exactly as directed. Do not use more or less of it or use it more often than prescribed by your doctor.

If you will be injecting sargramostim yourself, a healthcare provider will show you how to inject the medication. Be sure that you understand these directions. Ask your healthcare provider if you have any questions about where on your body you should inject sargramostim, how to give the injection, what type of syringe to use, or how to dispose of used needles and syringes after you inject the medication.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

What SPECIAL PRECAUTIONS should I follow?

Before using sargramostim injection,

• tell your doctor and pharmacist if you are allergic to sargramostim, yeast, any other medications, or any of the ingredients in sargramostim injection. Ask your pharmacist for a list of the ingredients.

• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention betamethasone (Celestone), dexamethasone (Decadron), lithium (Lithobid), methylprednisolone (Medrol), and prednisone. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

• tell your doctor if you are being treated or if you have ever been treated with radiation therapy or if you have or ever had cancer, edema (swelling of stomach, feet, ankles, or lower legs), any type of heart disease, heart failure, an irregular heartbeat, lung, kidney, or liver disease.

• tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while using sargramostim, call your doctor.

• you should know that sargramostim decreases the risk of infection, but does not prevent all infections that may develop during or after chemotherapy. Call your doctor immediately if you develop signs of infection such as fever, chills, sore throat, or ongoing cough and congestion.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What SIDE EFFECTS can this medicine cause?

Sargramostim may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• redness, swelling, bruising, itching or a lump in the area where the medication was injected
• bone, joint, or muscle pain
• headache
• nausea
• vomiting
• diarrhea
• stomach pain
• mouth sores
• loss of appetite
• hair loss

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately or get emergency medical treatment:

• shortness of breath or fast breathing
• difficulty breathing
• wheezing
• dizziness
• sweating
• hives
• rash
• itching
• swelling around the mouth, face, eyes, stomach, feet, ankles, or lower legs
• sudden weight gain
• chest pain
• fast or irregular heartbeat
• fainting
• unusual bruising or purple markings under the skin
• unusual bleeding
• nosebleeds
• unusual tiredness or weakness
• decreased urination

Sargramostim may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the container it came in, away from sunlight, closed, and out of reach of children. Store sargramostim in the refrigerator. Do not freeze or shake sargramostim. Opened sargramostim vials may be refrigerated for up to 20 days. Dispose of opened vials after 20 days.

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include the following:

• shortness of breath
• unusual tiredness or weakness
• fever
• fast or irregular heartbeat
• nausea
• headache
• rash

What OTHER INFORMATION should I know?

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to sargramostim.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.