Neulasta

What is Neulasta?

Neulasta 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.

Acute Radiation Syndrome: The effectiveness of Neulasta for this use was only studied in animals, because it could not be studied in people.

Description

Pegfilgrastim is a covalent conjugate of recombinant methionyl human G-CSF (filgrastim) and monomethoxypolyethylene glycol. Filgrastim is a water-soluble 175 amino acid protein with a molecular weight of approximately 19 kilodaltons (kD). Filgrastim is obtained from the bacterial fermentation of a strain of E coli transformed with a genetically engineered plasmid containing the human G-CSF gene. To produce pegfilgrastim, a 20 kD monomethoxypolyethylene glycol molecule is covalently bound to the N-terminal methionyl residue of filgrastim. The average molecular weight of pegfilgrastim is approximately 39 kD.

Neulasta is provided in two presentations:

• Neulasta for manual subcutaneous injection is supplied in 0.6 mL prefilled syringes. The prefilled syringe does not bear graduation marks and is designed to deliver the entire contents of the syringe (6 mg/0.6 mL).
• On-body injector (OBI) for Neulasta is supplied with a prefilled syringe containing 0.64 mL of Neulasta in solution that delivers 0.6 mL of Neulasta in solution when used with the OBI for Neulasta. The syringe does not bear graduation marks and is only to be used with the OBI for Neulasta.

The delivered 0.6 mL dose from either the prefilled syringe for manual subcutaneous injection or the OBI for Neulasta contains 6 mg pegfilgrastim (based on protein weight) in a sterile, clear, colorless, preservative-free solution (pH 4.0) containing acetate (0.35 mg), polysorbate 20 (0.02 mg), sodium (0.02 mg), and sorbitol (30 mg) in Water for Injection, USP.

Mechanism of Action

Pegfilgrastim is a colony-stimulating factor that acts on hematopoietic cells by binding to specific cell surface receptors, thereby stimulating proliferation, differentiation, commitment, and end cell functional activation.

Who should not take Neulasta?

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

What should I tell my healthcare provider before taking Neulasta?

Before you receive Neulasta, tell your healthcare provider about all of your medical conditions, including if you:

• have a sickle cell disorder.
• have kidney problems.
• are allergic to latex. The needle cap on the prefilled syringe contains dry natural rubber (derived from latex). You should not give Neulasta using the prefilled syringe if you have latex allergies.
• are pregnant or plan to become pregnant. It is not known if Neulasta will harm your unborn baby.
• are breastfeeding or plan to breastfeed. It is not known if Neulasta passes into your breast milk.

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

How should I take Neulasta?

• Neulasta is given as an injection under your skin (subcutaneous injection) by a healthcare provider. If your healthcare provider decides that the subcutaneous injections can be given at home by you or your caregiver, follow the detailed “Instructions for Use” that comes with your Neulasta for information on how to prepare and inject a dose of Neulasta.
• You and your caregiver will be shown how to prepare and inject Neulasta before you use it.
• You should not inject a dose of Neulasta to children weighing less than 45 kg from a Neulasta prefilled syringe. A dose less than 0.6 mL (6 mg) cannot be accurately measured using the Neulasta prefilled syringe.
• If you are receiving Neulasta because you are also receiving chemotherapy, the last dose of Neulasta should be injected at least 14 days before and 24 hours after your dose of chemotherapy.
• If you miss a dose of Neulasta, talk to your healthcare provider about when you should give your next dose.

What are possible side effects of Neulasta?

Neulasta may cause serious side effects, including:

• Spleen rupture. Your spleen may become enlarged and can rupture. A ruptured spleen can cause death. Call your healthcare provider right away if you have pain in the left upper stomach area or your left shoulder.
• A serious lung problem called Acute Respiratory Distress Syndrome (ARDS). Call your healthcare provider or get emergency help right away if you have shortness of breath with or without a fever, trouble breathing, or a fast rate of breathing.
• Serious allergic reactions. Neulasta can cause serious allergic reactions. These reactions can cause:
  • a rash over your whole body,
  • shortness of breath,
  • wheezing,
  • dizziness,
  • swelling around your mouth or eyes,
  • fast heart rate,
  • sweating.

If you have any of these symptoms, stop using Neulasta and call your healthcare provider or get emergency medical help right away.

• Sickle cell crises. You may have a serious sickle cell crisis, which could lead to death, if you have a sickle cell disorder and receive Neulasta. Call your healthcare provider right away if you have symptoms of sickle cell crisis such as pain or difficulty breathing.
• Kidney injury (glomerulonephritis). Neulasta can cause kidney injury. Call your healthcare provider right away if you develop any of the following symptoms:
  • swelling of your face or ankles
  • blood in your urine or dark colored urine
  • you urinate less than usual
• Increased white blood cell count (leukocytosis). Your healthcare provider will check your blood during treatment with Neulasta.
• Capillary Leak Syndrome. Neulasta can cause fluid to leak from blood vessels into your body’s tissues. This condition is called “Capillary Leak Syndrome” (CLS). CLS can quickly cause you to have symptoms that may become life-threatening. Get emergency medical 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 (abdomen) and feeling of fullness
  • dizziness or feeling faint
  • a general feeling of tiredness
• Inflammation of the aorta (aortitis). Inflammation of the aorta (the large blood vessel which transports blood from the heart to the body) has been reported in patients who received Neulasta. Symptoms may include:
  • fever,
  • abdominal pain,
  • feeling tired,
  • back pain.

Call your healthcare provider if you experience these symptoms.

The most common side effects of Neulasta are pain in the bones, arms, and legs.

These are not all the possible side effects of Neulasta. Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

General information about the safe and effective use of Neulasta

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Neulasta for a condition for which it was not prescribed. Do not give Neulasta to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about Neulasta that is written for health professionals.

How should I store Neulasta?

• Store Neulasta in the refrigerator between 36ºF to 46ºF (2ºC to 8ºC).
• Do not freeze.
• Keep the prefilled syringe in the original carton to protect from light or physical damage.
• Do not shake the prefilled syringe.
• Take Neulasta out of the refrigerator 30 minutes before use and allow it to reach room temperature before preparing an injection.
• Throw away (dispose of) any Neulasta that has been left at room temperature, 68ºF to 77ºF (20ºC to 25ºC), for more than 48 hours.

Keep the Neulasta prefilled syringe out of the reach of children.

What are the ingredients in Neulasta?

Active ingredient: pegfilgrastim

Inactive ingredients: acetate, polysorbate 20, sodium and sorbitol in water for injection.

Label

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