pegfilgrastim (Rx)

Brand and Other Names:Neulasta, Fulphila, more...pegfilgrastim-jmdb, Udenyca, pegfilgrastim-cbqv, Ziextenzo, pegfilgrastim-bmez, pegfilgrastim-apgf, Nyvepria
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

prefilled syringe, single-dose

  • 6mg/0.6mL (Neulasta, Fulphila, Udenyca, Ziextenzo)

prefilled syringe, single-dose copackaged with the on-body injector (OBI)

  • 6mg/0.6mL (Neulasta Onpro kit)

Biosimilar to Neulasta

  • Fulphila (pegfilgrastim-jmdb)
  • Udenyca (pegfilgrastim-cbqv)
  • Ziextenzo (pegfilgrastim-bmez)

Prevention of Chemotherapy-induced Neutropenia

Indicated to decrease incidence of infection, as manifested by febrile neutropenia, for patients with nonmyeloid malignancies receiving myelosuppressive anticancer drugs associated with a clinically significant incidence of febrile neutropenia

6mg SC once per chemotherapy cycle

Hematopoietic Subsyndrome of Acute Radiation Syndrome

Neulasta only

Indicated to increase survival in patients acutely exposed to myelosuppressive doses of radiation

2 doses (6 mg each) SC 1 week apart

Administer the first dose as soon as possible after suspected or confirmed exposure to radiation levels >2 gray (Gy)

Dosage Modifications

Renal impairment: No dosage adjustment necessary; renal dysfunction has no effect on the pharmacokinetics of pegfilgrastim

Dosing Considerations

Hematopoietic subsyndrome of acute radiation syndrome

  • Obtain a baseline complete blood cell (CBC) count
  • Do not delay administration of pegfilgrastim if a CBC count is not readily available
  • Estimate a patient’s absorbed radiation dose (eg, level of radiation exposure) based on information from public health authorities, biodosimetry if available, or clinical findings (eg, time to onset of vomiting, lymphocyte depletion kinetics)

Limitation of use

  • Not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation

Dosage Forms & Strengths

prefilled syringe, single-dose

  • 6mg/0.6mL (Neulasta, Fulphila, Udenyca, Ziextenzo)

prefilled syringe, single-dose copackaged with the on-body injector (OBI)

  • 6mg/0.6mL (Neulasta Onpro kit)

Biosimilar to Neulasta

  • Fulphila (pegfilgrastim-jmdb)
  • Udenyca (pegfilgrastim-cbqv)
  • Ziextenzo (pegfilgrastim-bmez)

Prevention of Chemotherapy Induced Neutropenia

Indicated to decrease incidence of infection, as manifested by febrile neutropenia, for patients with nonmyeloid malignancies receiving myelosuppressive anticancer drugs associated with a clinically significant incidence of febrile neutropenia

Weight ≥45 kg: 6 mg SC once per chemotherapy cycle

Weight <45 kg

  • Prefilled syringe is not designed to allow for direct administration of doses <0.6 mL (6 mg) since the syringe does not bear graduation marks, which are necessary to accurately measure; use of the prefilled syringe for doses <0.6 mL is not recommended due to the potential for dosing errors
  • <10 kg: 0.1 mg/kg (0.01 mL/kg) SC once per chemotherapy cycle
  • 10-20 kg: 1.5 mg (0.15 mL) SC once per chemotherapy cycle
  • 21-30 kg: 2.5 mg (0.25 mL) SC once per chemotherapy cycle
  • 31-44 kg: 4 mg (0.4 mL) SC once per chemotherapy cycle

Hematopoietic Subsyndrome of Acute Radiation Syndrome

Neulasta only

Indicated to increase survival in patients acutely exposed to myelosuppressive doses of radiation

Administer the first dose SC as soon as possible after suspected or confirmed exposure to radiation levels >2 gray (Gy)

Administer the second dose SC 1 week after first dose

Weight ≥45 kg: 6 mg SC once per chemotherapy cycle

Weight <45 kg

  • Prefilled syringe is not designed to allow for direct administration of doses <0.6 mL (6 mg) since the syringe does not bear graduation marks, which are necessary to accurately measure; use of the prefilled syringe for doses <0.6 mL is not recommended due to the potential for dosing errors
  • <10 kg: 0.1 mg/kg (0.01 mL/kg)
  • 10-20 kg: 1.5 mg (0.15 mL)
  • 21-30 kg: 2.5 mg (0.25 mL)
  • 31-44 kg: 4 mg (0.4 mL)

Dosage Modifications

Renal impairment: No dosage adjustment necessary; renal dysfunction has no effect on the pharmacokinetics of pegfilgrastim

Dosing Considerations

Direct administration of the prefilled syringe to patients requiring <6 mg (0.6 mL) is not recommended owing to potential for dosing errors

Hematopoietic subsyndrome of acute radiation syndrome

  • Obtain a baseline complete blood cell (CBC) count
  • Do not delay administration of pegfilgrastim if a CBC count is not readily available
  • Estimate a patient’s absorbed radiation dose (eg, level of radiation exposure) based on information from public health authorities, biodosimetry if available, or clinical findings (eg, time to onset of vomiting, lymphocyte depletion kinetics)

Limitation of use

  • Not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation
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Adverse Effects

>10%

Bone pain (31%)

1-10%

Pain in extremity (9%)

<1%

Leukocytosis (WBC counts >100 x 10^9/L)

Postmarketing Reports

Gastrointestinal disorders: Splenic rupture and splenomegaly, glomerulonephritis

Blood and lymphatic system disorder: Sickle cell crisis, leukocytosis, capillary leak syndrome

Hypersensitivity Reactions: Allergic reactions/hypersensitivity, including anaphylaxis, skin rash, and urticaria, generalized erythema and flushing, cutaneous vasculitis to skin, and subcutaneous tissue disorders

Respiratory, thoracic, and mediastinal disorders: Acute respiratory distress syndrome (ARDS), alveolar hemorrhage

General disorders and administration site conditions: Application site reactions (application site hemorrhage, pain, discomfort, bruise, and erythema)

Skin and subcutaneous tissue disorders: Sweet syndrome (acute febrile neutrophilic dermatosis), cutaneous vasculitis, aortitis

Thrombocytopenia

Contact dermatitis and local skin reactions such as rash, pruritus, and urticaria with on-body injector (possibly indicating a hypersensitivity reaction to adhesive)

Myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML) in patients with breast and lung cancer receiving chemotherapy and/or radiotherapy

Injection site reactions

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Warnings

Contraindications

History of serious allergic reactions to pegfilgrastim or filgrastim

Cautions

Rare cases of splenic rupture may occur; evaluate if patient experiences left upper abdominal and/or shoulder tip pain

ARDS reported; evaluate symptoms, including fever, pulmonary infiltrates, or respiratory distress; discontinue if ARDS occurs

Serious allergic reactions (eg, anaphylaxis) can occur; majority of reported events occurred upon initial exposure; allergic reactions, including anaphylaxis, can recur within days after the discontinuation of initial antiallergic treatment; permanently discontinue treatment in patients with serious allergic reactions (see Contraindications)

Severe and sometimes fatal sickle cell crises can occur in patients with sickle cell disorders; discontinue therapy if sickle cell crisis occurs

Capillary leak syndrome may occur; may vary in frequency and severity; closely monitor patients who develop symptoms and provide standard symptomatic treatment, which may include a need for intensive care

Glomerulonephritis reported; if suspected, evaluate for cause; if causality likely, consider dose reduction or interruption of therapy

Leukocytosis observed; monitoring CBC count during therapy recommended; higher counts reported

Pegfilgrastim may potentially act as growth factor for any tumor type, including myeloid malignancies and myelodysplasia

Missed or partial doses reported in patients receiving drug via OBI due to device not performing as intended; in event of missed or partial dose, patients may be at increased risk of events such as neutropenia, febrile neutropenia and/or infection than if dose had been correctly delivered; instruct patients using OBI to notify their healthcare professional immediately in order to determine need for replacement dose if they suspect that device may not have performed as intended

Aortitis reported; it may occur as early as the first week after start of therapy; manifestations may include generalized signs and symptoms such as fever, abdominal pain, malaise, back pain, and increased inflammatory markers (eg, C-reactive protein and white blood cell count); consider aortitis in patients who develop these signs and symptoms without known etiology; discontinue if aortitis is suspected

Increased hematopoietic activity of bone marrow in response to growth factor therapy has been associated with transient positive bone imaging changes; this should be considered when interpreting bone imaging results

Thrombocytopenia reported; monitor platelet counts

Myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML) associated with use of pegfilgrastim products in conjunction with chemotherapy and/or radiotherapy in patients with breast and lung cancer; monitor patients for signs and symptoms of MDS/AML in these settings

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Pregnancy & Lactation

Pregnancy

Insufficient data available on use in pregnant women to establish whether there is a drug associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes

Data from published studies in pregnant women exposed to filgrastim products have not established an association of filgrastim product use during pregnancy with major birth defects, miscarriage, or adverse maternal or fetal outcomes

In animal studies, no evidence of reproductive/developmental toxicity occurred in offspring of pregnant rats that received cumulative doses of pegfilgrastim approximately 10 times recommended human dose (based on body surface area); in pregnant rabbits, increased embryolethality and spontaneous abortions occurred at 4 times the maximum recommended human dose simultaneously with signs of maternal toxicity

Lactation

Unknown whether pegfilgrastim is secreted in human milk

Other recombinant G-CSF products are poorly secreted in breast milk, and G-CSF is not orally absorbed by neonates

Caution should be exercised when administered to a nursing female

Pregnancy Categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

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Pharmacology

Mechanism of Action

Recombinant PEG-conjugated human G-CSF; acts on hematopoietic cells by binding to specific cell surface receptors, thereby stimulating proliferation, differentiation, commitment, and end-cell functional activation

Absorption

AUC (100 mcg/kg): 47.9 mcg·hr/mL (0-5 years); 22 mcg·hr/mL (6-11 years); 29.3 mcg·hr/mL (12-21 years)

Excretion

Neutrophil receptor binding is an important component of the clearance of pegfilgrastim, and serum clearance is directly related to the number of neutrophils and body weight

Patients with higher body weights experienced higher systemic exposure to pegfilgrastim after receiving a dose normalized for body weight

Half-life: 15-80 hr (adults); 30.1 hr (0-5 years); 20.2 hr (6-11 years); 21.2 hr (12-21 years)

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Administration

SC Administration (Prefilled Syringe)

SC use only

Prior to use‚ allow prefilled syringe to reach room temperature for a minimum of 30 min

Do not administer between 14 days before and 24 hr after administration of cytotoxic chemotherapy

Visually inspect prefilled syringe for particulate matter and discoloration prior to administration, whenever solution and container permit; do not administer if discoloration or particulates are observed

Needle cap contains dry natural rubber (derived from latex); avoid in patients with latex allergies

Patients weighing <45 kg

  • Prefilled syringe is not designed to allow for direct administration of doses <0.6 mL (6 mg)
  • Syringe does not bear graduation marks; thus, direct administration to patients requiring dosing of <0.6 mL (6 mg) is not recommended owing to the potential for dosing errors

SC Administration (Onpro kit)

A healthcare provider must fill the OBI with Neulasta using prefilled syringe and then apply the OBI to the skin (abdomen or back of arm); use the back of the arm if there is a caregiver available to monitor the status of the OBI for Neulasta

Approximately 27 hr after the OBI for Neulasta is applied to the patient’s skin, Neulasta will be delivered over ~45 min

Initiate the same day as the cytotoxic chemotherapy, as long as the OBI delivers Neulasta no less than 24 hr after administration of cytotoxic chemotherapy

Use only prefilled syringe copackaged in kit; prefilled syringe also contains additional solution to compensate for liquid loss during delivery through the OBI for Neulasta

Do not use the OBI to deliver any other drug product; OBI for Neulasta should be applied to intact, nonirritated skin on the arm or abdomen

Storage

Prefilled syringe

  • Refrigerate at 2-8°C (36-46°F) in the carton to protect from light; do not shake
  • Discard syringes stored at room temperature for >72 hr
  • Avoid freezing; if frozen, thaw in the refrigerator before administration
  • Discard syringe if frozen more than once

Onpro kit

  • Refrigerate at 2-8°C (36-46°F) until ready to use
  • Because OBI for Neulasta is at room temperature during the period of use, Neulasta Onpro kit should not be held at room temperature <12 hr prior to use
  • Discard kit if stored at room temperature for >12 hr
  • Do not use OBI for Neulasta if its packaging has been previously opened
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Images

BRAND FORM. UNIT PRICE PILL IMAGE
Neulasta Onpro subcutaneous
-
6 mg/0.6 mL syringe
Neulasta subcutaneous
-
6 mg/0.6 mL solution

Copyright © 2010 First DataBank, Inc.

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Patient Handout

Patient Education
pegfilgrastim subcutaneous

PEGFILGRASTIM - INJECTION

(PEG-fil-GRA-stim)

COMMON BRAND NAME(S): Fulphila, Neulasta, Nyvepria, Udenyca, Ziextenzo

USES: Pegfilgrastim is a man-made version of a certain natural substance made in your body. It is used to help your body make more white blood cells. White blood cells are important to help you fight off infections. Pegfilgrastim is given to people whose ability to make white blood cells is reduced due to chemotherapy. Some brands may also be used to increase white blood cells after exposure to large amounts of radiation.This monograph is about the following pegfilgrastim products: pegfilgrastim, pegfilgrastim-apgf, pegfilgrastim-cbqv, pegfilgrastim-jmdb, and pegfilgrastim-bmez.

HOW TO USE: Read the Patient Information Leaflet and Instructions for Use if available from your pharmacist before you start using pegfilgrastim and each time you get a refill. If you have any questions, ask your doctor or pharmacist.This medication is given by injection under the skin as directed by your doctor. For use during chemotherapy, it is usually given once during each chemotherapy cycle. However, it should not be given within 14 days before or 24 hours after chemotherapy. Ask your doctor for specific directions about when to use this medication. For use after radiation exposure, pegfilgrastim is usually given for 2 doses, one week apart.The dosage and schedule are based on your medical condition and response to treatment. Children's dosage is also based on weight.If you are using this medication at home, learn all preparation and usage instructions from your health care professional and the product package. Before use, take the medication out of the refrigerator. Let it warm up to room temperature, usually for at least 30 minutes. Do not heat this medication any other way, such as by heating in the microwave or placing in hot water. Do not shake this medication. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid.Before injecting each dose, clean the injection site with rubbing alcohol. Change where you inject each time to lessen injury under the skin. Do not inject pegfilgrastim into skin that is bruised, tender, red, hard, or that has scars, moles, or stretch marks.Learn how to store and discard medical supplies safely.

SIDE EFFECTS: Aching or pain in the bones and muscles may occur. Taking a non-aspirin pain reliever such as acetaminophen may help relieve pain. Ask your doctor or pharmacist for more details. Redness, swelling, itching, or bruising at the injection site may also occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor right away if you have any serious side effects, including: pink/bloody urine, easy bleeding/bruising, fever, fast heartbeat, purple or red spots on your skin, back pain.Get medical help right away if you have any very serious side effects, including: breathing problems (such as trouble breathing, shortness of breath, fast breathing), unusual decrease in urination, unusual tiredness, swelling/puffiness of the body.Rarely, serious (possibly fatal) damage to the spleen may occur. Get medical help right away if you develop stomach/abdominal pain or shoulder pain.Rarely, this medication may increase the risk of developing a certain bone marrow disorder (myelodysplastic syndrome-MDS) or blood cancer (acute myeloid leukemia-AML) in people with breast or lung cancer who are receiving chemotherapy/radiation. Ask your doctor for more details.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using pegfilgrastim, tell your doctor or pharmacist if you are allergic to it; or to any pegfilgrastim or filgrastim products; or if you have any other allergies. This product may contain inactive ingredients (such as dry natural rubber/latex in the needle cover on the prefilled syringe), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: sickle cell disease, spleen problems.Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.This medication may pass into breast milk. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Pegfilgrastim is very similar to filgrastim. Do not use a filgrastim product while using a pegfilgrastim product.This medication may interfere with certain lab tests (such as bone imaging tests), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.

OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

NOTES: Do not share this medication with others.Lab and/or medical tests (such as complete blood count, kidney function) should be done while you are using this medication. Keep all medical and lab appointments. Consult your doctor for more details.

MISSED DOSE: It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule. Do not double the dose to catch up.

STORAGE: Store this medication in the refrigerator. Keep the medication in the original package to protect from light. Do not freeze or shake. If this medication is taken out of the refrigerator, use or discard it within the time directed in your product package. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Information last revised August 2021. Copyright(c) 2021 First Databank, Inc.

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

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Formulary

FormularyPatient Discounts

Adding plans allows you to compare formulary status to other drugs in the same class.

To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

Adding plans allows you to:

  • View the formulary and any restrictions for each plan.
  • Manage and view all your plans together – even plans in different states.
  • Compare formulary status to other drugs in the same class.
  • Access your plan list on any device – mobile or desktop.

The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC NOT COVERED – Drugs that are not covered by the plan.
Code Definition
PA Prior Authorization
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
QL Quantity Limits
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST Step Therapy
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR Other Restrictions
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.