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Important Safety Information

Who should not take Neulasta®?

Do not take Neulasta® if you have had a serious allergic reaction to pegfilgrastim (Neulasta®) or to filgrastim (Neupogen®).

What should I tell my health care provider before taking Neulasta®? Tell your healthcare provider if you:

  • Have sickle cell trait or sickle cell disease
  • Have had severe skin reactions to acrylic adhesives
  • Are allergic to latex
  • Have any other medical problems
  • Are pregnant or plan to become pregnant
  • Are breastfeeding or plan to breastfeed

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

What are possible serious side effects of Neulasta®?

  • Spleen Rupture. Your spleen may become enlarged and can rupture while taking Neulasta. A ruptured spleen can cause death. Call your doctor right away if you have pain in the left upper stomach area or left shoulder tip area. This pain could mean your spleen is enlarged or ruptured.
  • A serious lung problem called acute respiratory distress syndrome (ARDS). Call your health care provider or get emergency medical help right away if you get any of these symptoms of ARDS: fever, shortness of breath, trouble breathing, or a fast rate of breathing.
  • Serious Allergic Reactions. Get emergency medical help right away if you get any of these symptoms of a serious allergic reaction with Neulasta: shortness of breath, wheezing, dizziness, swelling around the mouth or eyes, fast pulse, sweating, and hives. If you have an allergic reaction during the delivery of Neulasta, remove the On-body Injector for Neulasta by grabbing the edge of the adhesive pad and peeling off the On-body Injector for Neulasta. Get emergency medical help right away.
  • Sickle Cell Crises. Severe sickle cell crises, and sometimes death, can happen in people with sickle cell trait or disease who receive filgrastim, a medicine similar to Neulasta.

The most common side effect of Neulasta is pain in the bones and in your arms and legs.

Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of Neulasta. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

For more information about Neulasta, talk with your healthcare provider or pharmacist; go to www.neulasta.com, or call 1-844-696-3852 (1-844-MYNEULASTA).

Please see the Neulasta Patient Information for additional information.

Indication

Neulasta® (pegfilgrastim) is a prescription medication used to help reduce the chance of infection due to a low white blood cell count, in people with certain types of cancer (non-myeloid), who receive anti-cancer medicines (chemotherapy) that can cause fever and low blood cell count.

It is not known if Neulasta is safe and effective in children.

Chemotherapy Glossary

Absolute neutrophil count (ANC)—ANC refers to the total number of neutrophils present in the blood. Neutrophils are particularly important because they defend our bodies against certain types of infection.1

Bacteria—Microscopic (can only be seen with a microscope) organisms (living things) that live in and around most living and nonliving things. Some types of bacteria help our bodies stay in balance, while other types can multiply within the body and cause infection. Bacteria are the most common causes of infections in people with cancer. Some examples of bacterial infection include food poisoning, pneumonia, and strep throat.1

Chemotherapy (chemo)—Drugs to destroy cancer cells. A person on chemotherapy may take one drug or a combination of drugs. Most often these drugs are given by vein using intravenous (IV) infusion. Some can be taken by mouth or given as a shot, among other methods of delivery.2

Co-insurance—Some insurance coverage requires you to pay a percentage of the cost of covered medical services, usually 20–30 percent. Your portion of the cost is the co-insurance.3

Colony-stimulating factors—Also called CSFs, colony-stimulating factors are drugs that promote the production of various white blood cells. An example of a CSF is Neulasta® (pegfilgrastim).1

Complete blood count (CBC)—The CBC is a test that determines the number of red blood cells, white blood cells, and platelets in the blood.2

Co-payment—Also called co-pay, a flat fee for specified medical services required by some insurers. For example, your insurance provider may require you to pay a $10 co-payment for a doctor visit or a $50 co-payment for a hospital stay.3

Deductible—The amount you must pay each year for your medical expenses before your insurance policy starts paying. Deductibles are common in fee-for-service coverage and PPOs.3

Febrile neutropenia—Having a low white blood cell count (neutropenia) and a fever (a neutropenic fever). Febrile neutropenia is often a sign of a serious infection.4

Infection—An invasion of microorganisms such as bacteria or viruses that have the ability to multiply and cause disease.1

Lymphoma—Cancer that begins in cells of the lymphatic system (part of the immune system that produces and stores cells that fight infection and disease).6

Myelosuppressive chemotherapy—Sometimes called strong chemotherapy, a type of chemotherapy that can lower the number of blood cells in your body. Often, people just use the word myelosuppressive to mean chemotherapy that lowers your number of white blood cells.5

Neutropenia—A lower-than-normal number of neutrophils (infection-fighting white blood cells) in the blood. It is a common side effect of some chemotherapy treatments. Doctors check the number of neutrophils when they measure the white blood cell count, to monitor the risk of infection.2

Neutropenic diet—A diet designed to help people with weakened immune systems lower their risk of infection.

Neutropenic fever—Having a low white blood cell count with a fever may be a sign of serious infection.

Neutrophil—The most common type of white blood cell. Neutrophils help the body fight infection. A low white blood cell count usually indicates that the neutrophil count is low. It is easier to get an infection and harder to recover from an infection when the number of neutrophils in the bloodstream is low.1

Neutrophil count—The number of a specific kind of infection-fighting white blood cells called neutrophils in the blood. A low white blood cell count usually indicates that the neutrophil count is low. It is easier to get an infection and harder to recover from an infection when the number of neutrophils in the bloodstream is low.1

Oncologist—A doctor who specializes in the treatment of cancer.7

Placebo—A "dummy" treatment used in some clinical trials. In these studies, a group of patients who are given a placebo treatment are compared to another group of patients who are given the actual treatment. The difference in results between the actual treatment group and the placebo group are considered the result of giving the medicine.8

Platelets—A type of cell made in the bone marrow. The main function of platelets is to aid in clotting the blood following an injury.2

Side effect—Any undesired actions or effects of a drug or treatment. For example, common side effects of chemotherapy include fatigue, nausea, vomiting, and loss of appetite.2

Thrombocytopenia—A condition resulting from an abnormally low number of platelets (thrombocytes) circulating in the blood. Bleeding and/or bruising may occur if the platelet count is especially low.2

White blood cell (WBC)—A white blood cell is one of the three main types of blood cells. They are produced in the bone marrow and released into the blood. White blood cells are responsible for fighting infection. There are several kinds of white blood cells, including monocytes, lymphocytes, neutrophils, eosinophils, and basophils.1

References

  1. Infections in people with cancer. American Cancer Society website. Updated November 6, 2013. http://www.cancer.org/
    treatment/treatmentsandsideeffects/physicalsideeffects/infectionsinpeoplewithcancer/
    infectionsinpeoplewithcancer/infections-in-people-with-cancer-precautions-to-take. Accessed April 2, 2014.
  2. Chemotherapy and you. National Cancer Institute website. Update May 2007. NIH Publication No. 11-7156. Available at: http://www.cancer.gov/cancertopics/chemotherapy-and-you.pdf. Accessed May 15, 2014.
  3. New York State Department of Financial Services. Insurance Help: Health Insurance—Glossary of Terms. http://www.dfs.ny.gov/consumer/inshelp/c_hterm.htm. Accessed March 10, 2014.
  4. National Cancer Institute. Dictionary of Cancer Terms: Febrile neutropenia. http://www.cancer.gov/dictionary?expand=F. Accessed May 7, 2014.
  5. Chemotherapy principles: an in-depth discussion. American Cancer Society website. Updated February 7, 2013. http://www.cancer.org/acs/groups/cid/documents/webcontent/002995-pdf.pdf. Accessed May 15, 2014.
  6. Dictionary of cancer terms—definition of lymphoma. National Cancer Institute website. www.cancer.gov/dictionary?CdrID=45368. Accessed May 8, 2014.
  7. Dictionary of cancer terms—definition of oncologist. National Cancer Institute website. www.cancer.gov/dictionary?CdrID=46260. Accessed May 7, 2014.
  8. Dictionary of cancer terms—definition of placebo. National Cancer Institute website. www.cancer.gov/dictionary?CdrID=46688. Accessed May 7, 2014.