pegfilgrastim

[peg″-fil-gras´tim]

a long-acting colony-stimulating factor produced by recombinant technology and used as an adjunct in patients with bone marrow suppression caused by antineoplastic therapy.

pegfilgrastim

Neulasta

Pharmacologic class: Granulocytic colony stimulating factor

Action

Binds to specific cell-surface receptors on hematopoietic cells, stimulating their proliferation and differentiation in bone marrow

Availability

Injection: 6 mg/0.6 ml in prefilled syringes

Indications and dosages

➣ To reduce risk of infection in non-myeloid cancer patients who are receiving myelosuppressive drugs

Adults: 6 mg subcutaneously as a single dose once per chemotherapy cycle

Contraindications

• Hypersensitivity to drug, Escherichia coli-derived proteins, filgrastim, or other drug components

Precautions

Use cautiously in:

• myeloid cancers, sickle cell disease

• patients undergoing chemotherapy or radiation

• pregnant or breastfeeding patients

• children (safety and efficacy not established).

Administration

• Inspect solution for particles; discard if particles or discoloration appear.

• Don't give 14 days before to 24 hours after administration of cytotoxic chemotherapy.

Adverse reactions

CNS: headache, weakness, fatigue, dizziness, insomnia

CV: peripheral edema

GI: nausea, vomiting, diarrhea, abdominal pain, dyspepsia, stomatitis, splenic rupture

Hematologic: leukocytosis, granulo-cytopenia

Musculoskeletal: bone pain, myalgia, joint pain

Respiratory: adult respiratory distress syndrome (ARDS) in septic patients

Skin: alopecia, mucositis

Other: taste perversion, allergic reaction, increased pain, fever, neutropenic fever, aggravation of sickle cell disease

Interactions

Drug-drug. Lithium: potentiation of neutrophil release

Drug-diagnostic tests. Alkaline phosphatase, lactate dehydrogenase, uric acid: increased levels

Patient monitoring

☞ Assess for signs and symptoms of impending splenic rupture, such as left upper abdominal quadrant or shoulder pain and splenic enlargement.

• Monitor vital signs and temperature.

☞ Watch for signs and symptoms of sepsis, ARDS, and neutropenic fever.

• Monitor CBC, uric acid level, and liver function tests.

Patient teaching

• Teach patient or caregiver how to administer injection and dispose of syringes at home, if appropriate.

☞ Teach patient to recognize and immediately report respiratory distress or signs and symptoms of splenic rupture.

• Caution patient to avoid driving and other hazardous activities until he knows how drug affects concentration and alertness.

• Advise patient to minimize GI upset by eating small, frequent servings of food and drinking plenty of fluids.

• Instruct patient to have follow-up laboratory tests as needed.

• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs and tests mentioned above.

Mentioned in

Neulasta

References in periodicals archive

(NASDAQ: BYSI), a global biopharmaceutical company focused on the development of innovative cancer therapies, today announced the results of its head-to-head clinical trial for Study BPI-2358-105, accepted as an abstract titled, 'Quality of Life (QoL) in Advanced NSCLC Patients Treated with Docetaxel and with Either Plinabulin or Pegfilgrastim for the Prevention of Neutropenia.'

BeyondSpring's Plinabulin Demonstrates Superior Quality of Life over Pegfilgrastim in a Head-to-Head Comparison Trial for the Prevention of Neutropenia

Pegfilgrastim biosimilar is an existing medical product that fights low white blood cell levels.

Pegfilgrastim Biosimilar Market Value Share, Analysis and Segments 2018-2028

Integrated data derived from the two Phase 3 clinical trials, demonstrated that in Cycle 1, the mean DSN[+ or -]SD was 0.24[+ or -]0.581 days for Rolontis (n=314) and 0.36[+ or -]0.789 days for pegfilgrastim (n=329), demonstrating non-inferiority (p

Spectrum Pharmaceuticals Presents Integrated Results from Two Phase 3 Rolontis Trials Being Presented at the ASCO Annual Meeting

Sandoz, a Novartis division and a company involved in biosimilars, announced yesterday that it has resubmitted its Biologics License Application (BLA) for a proposed biosimilar Pegfilgrastim to the US Food and Drug Administration (FDA) to address an FDA complete response letter received in June 2016.

Sandoz resubmits Pegfilgrastim Biologics License Application to the US Food and Drug Administration

Pelmeg, a pegfilgrastim biosimilar, is a pegylated version of granulocyte-colony stimulating factor (G-CSF) that stimulates the bone marrow to produce more neutrophils, reducing the incidence of febrile neutropenia.

The Mundipharma network wins EC and CHMP approval for Pelmeg for reduction of neutropenia and febrile neutropenia during cytotoxic chemotherapy

With a non-US market worth of USD 603m and originator patents already expired, pegfilgrastim biosimilars offer an exciting market opportunity.

Mundipharma Acquires Biosimilars Development Company Cinfa Biotech

Patients with febrile neutropenia given prophylactic filgrastim or sargramostim should continue with G-CSF therapy; however, as pegfilgrastim is long acting patients given prophylactic pegfilgrastim should not be treated with additional G-CSF (66).

Supportive care in hemato-oncology: a review in light of the latest guidelines / Hemato-Onkolojide Destek Tedaviler: Son Kilavuzlar Istginda Gozden Gecirme

Amgen's Neulasta, or pegfilgrastim, is a drug currently being used to fight chemotherapy induced neutropenia in cancer patients.

PEG-ging peptides: peptides seem so promising as drug candidates. Their small size, however, makes delivery difficult and gives them an extremely short half-life--the kidneys or reticuloendothelial system often clears them only minutes after being administered. They are also susceptible to degradation by proteolytic enzymes. Linking them to polyethylene glycol (PEG) can solve these problems

Introduction: Pegfilgrastim is administered in multiple clinical settings.

Effective CD34+ stem cell mobilization with low-dose pegfilgrastim

When needed, new-line growth factors such as pegfilgrastim (a form of recombinant granulocyte colony-stimulating factor) are expensive, with the upper limit of Medicare reimbursement totaling $2,508 a cycle (based on January 2004 CMS data).

Newer regimens for colorectal cancer prolong life but lead to soaring costs

In its 2002 financial outlook, Amgen did not include the regulatory approvals of Aranesp(TM) in the oncology setting and pegfilgrastim, a long-acting version of NEUPOGEN(R), because the company cannot predict the timing of regulatory actions.

AMGEN EXPECTS ACCELERATED GROWTH IN 2002 FINANCIAL RESULTS