Nivestym

Nivestym, a man-made version of a certain natural substance made in your body, is a prescription medication used to prevent infections in patients receiving chemotherapy, undergoing bone marrow transplants or have low neutrophil counts caused by other conditions.

Nivestym belongs to a group of drugs called colony stimulating factors which work by stimulating the growth of neutrophils, a type of white blood cell important in the body's fight against infection.

This medication comes in injectable forms to be given directly into a vein (IV) or under the skin (subcutaneously) by a healthcare professional. It can be also given at home by you or your caregiver.

Common side effects include aching in the bones and muscles, nausea and fever. Nivestym can also cause dizziness. Do not drive or operate heavy machinery until you know how Nivestym affects you.

Nivestym is a man-made form of granulocyte colony-stimulating factor (G-CSF). G-CSF is a substance produced by the body. It stimulates the growth of neutrophils, a type of white blood cell important in the body's fight against infection.

Nivestym is a prescription medication used to prevent infections in patients receiving chemotherapy, undergoing bone marrow transplants or have low white blood cell (neutrophil) counts caused by other conditions.

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

Serious side effects have been reported with Nivestym. See the “Nivestym Precautions” section.

The most common side effects of Nivestym include aching in the bones and muscles.

This is not a complete list of Nivestym side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effects that bother you or that do not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

No drug interactions have been evaluated by the manufacturer. However, you should tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Not all drug interactions are known or reported and new drug interactions are continually being reported.

Serious side effects have been reported with Nivestym including the following:

• Spleen rupture. Your spleen may become enlarged and can rupture. Tell your healthcare provider right away you have pain in the left upper stomach area or your left shoulder.
• A serious lung problem. Tell your healthcare provider right away if you have the following symptoms:
  • Shortness of breath with or without fever
  • Trouble breathing
  • Fast rate of breathing
• Serious allergic reactions. Tell your healthcare provider right away if you have the following symptoms:
  • Rash all over your body
  • Shortness of breath
  • Wheezing
  • Dizziness
  • Swelling around your mouth or eyes
  • Fast heart rate
  • Sweating
• Sickle cell crises. This may occur if you already have a sickle cell disorder. It could lead to death. Tell your healthcare provider right away if you have symptoms of sickle cell crisis such as pain or difficulty breathing.
• Kidney injury. Tell your healthcare provider right away if you have the following symptoms:
  • Swelling of your face or ankles
  • Blood in your urine or dark colored urine
  • You urinate less than usual
• Capillary leak syndrome. Nivestym can cause fluid to leak from blood vessles into your body’s tissues. This can quickly cause symptoms that may become life threatening. Get emergency help right away if you develop any of the following symptoms:
  • Swelling or puffiness and are urinating less than usual
  • Trouble breathing
  • Swelling of your stomach area and feeling of fullness
  • Dizziness or feeling faint
  • General feeling of tiredness
• Decreased platelet count. Your healthcare provider will check your blood during treatment. Tell your healthcare provider if you have any unusual bleeding or bruising during treatment. This could be a sign of decreased ability of your blood to clot.
• Increased white blood cell count. Your healthcare provider will check your blood during treatment.
• Inflammation of your blood vessels. Tell your healthcare provider if you develop purple spots or redness of your skin.
• Inflammation of the aorta (large blood vessel which moves blood from the heart to the body). Tell your healthcare provider right away if you have the following symptoms:
  • Fever
  • Stomach pain
  • Feeling tired
  • Back pain

Nivestym can cause dizziness. Do not drive or operate heavy machinery until you know how Nivestym affects you.

Do not take Nivestym if you:

• are allergic to Nivestym or to any of its ingredients
• A history of serious allergic reactions to human granulocyte colony-stimulating factors such as filgrastim or pegfilgrastim products

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Nivestym, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Nivestym, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Nivestym or to any of its ingredients
• have a sickle cell disorder
• have kidney problems
• are receiving radiation therapy
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

There are no well-controlled studies that have been done in pregnant women. Nivestym should be used during pregnancy only if the possible benefit outweighs the possible risk to the unborn baby.

Tell your doctor if you are breastfeeding or plan to breastfeed.

Studies have shown that filgrastim products have been detected in human breast milk. Because of the possibility for adverse reactions in nursing infants from Nivestym, a choice should be made whether to stop nursing or to stop use of this medication. The importance of the drug to the mother should be considered.

• Nivestym injections can be given by a healthcare provider by intravenous (IV) infusion or under your skin (subcutaneous injection). Your healthcare provider may decide subcutaneous injections can be given at home by you or your caregiver. If Nivestym is given at home, see the detailed "Instructions For Use" that comes with your Nivestym for information on how to prepare and inject a dose of Nivestym.
• You and your caregiver should be shown how to prepare and inject Nivestym before you use it, by your healthcare provider.
• You should not try to inject a dose of Nivestym less than 0.3 mL (180 mcg) from a Nivestym prefilled syringe. A dose less than 0.3 mL cannot be accurately measured using the Nivestym prefilled syringe.
• Your healthcare provider will tell you how much Nivestym to inject and when to inject it. Do not change your dose or stop Nivestym unless your healthcare provider tells you to.
• If you are receiving Nivestym because you are also receiving chemotherapy, your dose of Nivestym should be injected at least 24 hours before or 24 hours after your dose of chemotherapy.
• If you miss a dose of Nivestym, talk to your healthcare provider about when you should give your next dose.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the condition for which you are being treated.

• Patients with cancer receiving myelosuppressive chemotherapy or induction and/or consolidation chemotherapy for AML.
  • Recommended starting dose is 5 mcg/kg/day subcutaneous injection, short intravenous infusion (15 to 30 minutes), or continuous intravenous infusion. 
• Patients with cancer undergoing bone marrow transplantation.
  • 10 mcg/kg/day given as an intravenous infusion no longer than 24 hours. 
• Patients undergoing autologous peripheral blood progenitor cell collection and therapy.
  • 10 mcg/kg/day subcutaneous injection. 
  • Administer for at least 4 days before first leukapheresis procedure and continue until last leukapheresis. 
• Patients with congenital neutropenia.
  • Recommended starting dose is 6 mcg/kg subcutaneous injection twice daily.
• Patients with cyclic or idiopathic neutropenia.
  • Recommended starting dose is 5 mcg/kg subcutaneous injection daily.
• Direct administration of less than 0.3 mL (180 mcg) using Nivestym prefilled syringe is not recommended due to potential for dosing errors.

If you take too much Nivestym, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If Nivestym is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

• Store Nivestym in the refrigerator between 36°F to 46°F (2°C to 8°C).
• Do not freeze.
• Keep Nivestym in the original carton to protect from light or physical damage.
• Do not shake Nivestym.
• Take Nivestym out of the refrigerator 30 minutes before use and allow it to reach room temperature before preparing an injection.
• Throw away any Nivestym that has been left at room temperature for longer than 24 hours.
• Throw away any unused Nivestym left in vials or prefilled syringes.
• Keep this and all medicines out of the reach of children.