Pegfilgrastim

What is Pegfilgrastim?

• Pegfilgrastim is a leukocyte growth factor 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).

What are the uses of this medicine?

• Pegfilgrastim is a prescription medicine 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.

How does this medicine work?

• Pegfilgrastim 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.
• Pegfilgrastim is a form of filgrastim that has polyethylene glycol (PEG) attached to it.
• This form stays in the body longer than does filgrastim, so it doesn’t need to be given as often.
• 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 Use this medicine ?

This medicine cannot be used in patients who:

• have had a serious allergic reaction to pegfilgrastim or filgrastim.

What drug interactions can this medicine cause?

• Tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.
• Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

Is this medicine FDA approved?

• Pegfilgrastim was approved for medical use in the United States in January 2002, in the European Union in August 2002, and in Australia in September 2002.

How should this medicine be used?

Recommended dosage: Patients with cancer receiving myelosuppressive chemotherapy:

• 6 mg administered subcutaneously once per chemotherapy cycle.
• Do not administer between 14 days before and 24 hours after administration of cytotoxic chemotherapy.
• Use weight based dosing for pediatric patients weighing less than 45 kg.

Patients acutely exposed to myelosuppressive doses of radiation:

• Two doses, 6 mg each, administered subcutaneously one week apart.
• Administer the first dose as soon as possible after suspected or confirmed exposure to myelosuppressive doses of radiation, and a second dose one week after.
• Use weight based dosing for pediatric patients weighing less than 45 kg.

Administration:

• Pegfilgrastim injection products come as a solution (liquid) in prefilled injection syringes to inject subcutaneously (under the skin), and in a prefilled automatic injection device (on-body injector) to apply to the skin.
• If you are using a pegfilgrastim injection product to decrease the risk of infection during chemotherapy, it is usually given as a single dose for each chemotherapy cycle, no sooner than 24 hours after the last dose of chemotherapy of the cycle is given and more than 14 days before beginning the next chemotherapy cycle.
• If you are using pegfilgrastim injection because you have been exposed to harmful amounts of radiation, it is usually given as 2 single doses, 1 week apart.
• Your healthcare provider should place the on-body injector for Pegfilgrastim on an area of your skin that does not have swelling, redness, cuts, wounds, or abrasions.
• Pegfilgrastim 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 Pegfilgrastim for information on how to prepare and inject a dose of Pegfilgrastim.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Injection: 6 mg/0.6 mL solution in a single-dose prefilled syringe for manual use only. (3)
• Injection: 6 mg/0.6 mL solution in a single-dose prefilled syringe co-packaged with the on-body injector for Pegfilgrastim.

This medicine is available in fallowing brand namesː

• Fulphila
• Neulasta
• Nyvepria
• Udenyca
• Ziextenzo

What side effects can this medication cause?

The most common side effects of this medicine include:

• pain in your bones, and in your arms, and legs

Pegfilgrastim may cause serious side effects, including:

• Spleen rupture
• Acute Respiratory Distress Syndrome
• Serious allergic reactions
• Sickle cell crises
• glomerulonephritis
• leukocytosis
• thrombocytopenia
• Capillary Leak Syndrome
• Myelodysplastic syndrome and acute myeloid leukemia
• aortitis

What special precautions should I follow?

• Splenic rupture, including fatal cases, can occur following the administration of Pegfilgrastim. Evaluate patients who report left upper abdominal or shoulder pain for an enlarged spleen or splenic rupture.
• Acute respiratory distress syndrome (ARDS) can occur in patients receiving Pegfilgrastim. Evaluate patients who develop fever, lung infiltrates, or respiratory distress. Discontinue Pegfilgrastim in patients with ARDS.
• Serious allergic reactions, including anaphylaxis, can occur in patients receiving Pegfilgrastim. Permanently discontinue Pegfilgrastim in patients with serious allergic reactions.
• The on-body injector for Pegfilgrastim uses acrylic adhesive. For patients who have reactions to acrylic adhesives, use of this product may result in a significant reaction.
• Severe and sometimes fatal sickle cell crises can occur in patients with sickle cell disorders receiving pegfilgrastim products. Discontinue Pegfilgrastim if sickle cell crisis occurs.
• Glomerulonephritis has occurred in patients receiving Pegfilgrastim. Evaluate and consider dose-reduction or interruption of Pegfilgrastim if causality is likely.
• Thrombocytopenia has been reported in patients receiving pegfilgrastim. Monitor platelet counts.
• MDS and AML have been associated with the use of Pegfilgrastim in conjunction with chemotherapy and/or radiotherapy in patients with breast and lung cancer. Monitor patients with breast and lung cancer using Pegfilgrastim in conjunction with chemotherapy and/or radiotherapy for signs and symptoms of MDS/AML.
• Missed or partial doses have been reported in patients receiving Pegfilgrastim via the on-body injector (OBI) due to the device not performing as intended. Instruct patients to notify their healthcare provider if they suspect the on-body injector may not have performed as intended.
• Aortitis has been reported in patients receiving Pegfilgrastim. Discontinue Pegfilgrastim if aortitis is suspected.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• leukocytosis
• bone pain
• edema
• dyspnea
• pleural effusion

Management of overdosage:

• In the event of overdose, the patient should be monitored for adverse reactions.

Can this medicine be used in pregnancy?

• Available data with Pegfilgrastim use in pregnant women are insufficient to establish whether there is a drug associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.

Can this medicine be used in children?

• The safety and effectiveness of Pegfilgrastim have been established in pediatric patients.

What are the active and inactive ingredients in this medicine?

• Active ingredient: pegfilgrastim
• Inactive ingredients: acetate, polysorbate 20, sodium and sorbitol in water for injection.

Who manufactures and distributes this medicine?

Manufactured by:

• Amgen Inc., One Amgen Center Drive, Thousand Oaks, California

What should I know about storage and disposal of this medication?

• Store Pegfilgrastim in the refrigerator between 36°F to 46°F (2°C to 8°C).
• 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 Pegfilgrastim out of the refrigerator 30 minutes before use and allow it to reach room temperature before preparing an injection.
• Throw away (dispose of) any Pegfilgrastim that has been left at room temperature, 68°F to 77°F (20°C to 25°C), for more than 48 hours.

Hematologic Agents Eculizumab, Emapalumab, Emicizumab, Lanadelumab, Ravulizumab

Hematologic Growth Factors

• Granulocyte colony stimulating factors
  • Filgrastim, Pegfilgrastim

• Granulocyte-Macrophage Colony Stimulating Factors
  • Sargramostim

• Erythropoiesis stimulating agents
  • Epoetin, Darbepoetin, Peginesatide

Thrombopoietin receptor agonists and Thrombopoiesis Stimulators

• • Avatrombopag, Eltrombopag, Fostamatinib, Lusutrombopag, Romiplostim, Oprelvekin (IL-11)

• Dailymed label info on Pegfilgrastim
• FDA Pegfilgrastim

Pegfilgrastim Resources
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