pegfilgrastim


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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.

pegfilgrastim

(peg-fil-gra-stim) ,

Neulasta

(trade name)

Classification

Therapeutic: colony stimulating factors
Pregnancy Category: C

Indications

To decrease the incidence of infection (febrile neutropenia) in patients with nonmyeloid malignancies receiving myelosuppressive antineoplastics associated with a high risk of febrile neutropenia.

Action

Filgrastim is a glycoprotein that binds to and stimulates neutrophils to divide and differentiate. Also activates mature neutrophils. Binding to a polyethylene glycol molecule prolongs its effects.

Therapeutic effects

Decreased incidence of infection in patients who are neutropenic from chemotherapy.

Pharmacokinetics

Absorption: Well absorbed following subcut administration.
Distribution: Unknown.
Metabolism and Excretion: Unknown.
Half-life: 15–80 hr.

Time/action profile

ROUTEONSETPEAKDURATION
Subcutunknownunknownunknown

Contraindications/Precautions

Contraindicated in: Hypersensitivity to filgrastim or Escherichia coli-derived proteins.
Use Cautiously in: Patients with sickle cell disease (↑ risk of sickle cell crisis);Concurrent use of lithium;Malignancy with myeloid characteristics; Obstetric / Lactation: Pregnancy or lactation; Pediatric: 6 mg fixed dose should not be used in infants, children, and adolescents weighing <45 kg.

Adverse Reactions/Side Effects

Respiratory

  • adult respiratory distress syndrome (ards) (life-threatening)

Gastrointestinal

  • splenic rupture (life-threatening)

Hematologic

  • sickle cell crisis (life-threatening)
  • leukocytosis

Musculoskeletal

  • medullary bone pain (most frequent)

Miscellaneous

  • allergic reaction including anaphylaxis (life-threatening)

Interactions

Drug-Drug interaction

Simultaneous use with antineoplastics may have adverse effects on rapidly proliferating neutrophils; avoid use for 24 hr before and 24 hr following chemotherapy.Lithium may potentiate the release of neutrophils; concurrent use should be undertaken cautiously.

Route/Dosage

Subcutaneous (Adults and Children >45 kg) 6 mg per chemotherapy cycle.

Availability

Solution for injection: 6 mg/0.6 mL in prefilled syringes

Nursing implications

Nursing assessment

  • Assess patient for bone pain throughout therapy. Pain is usually mild to moderate and controllable with nonopioid analgesics, but may require opioid analgesics.
  • Assess patient periodically for signs of ARDS (fever, lung infiltration, respiratory distress). If ARDS occurs, treat condition and discontinue pegfilgrastim and/or withold until symptoms resolve.
  • Lab Test Considerations: Obtain CBC and platelet count before chemotherapy. Monitor hematocrit and platelet count regularly.
    • May cause elevated LDH, alkaline phosphatase, and uric acid.

Potential Nursing Diagnoses

Risk for infection (Indications)
Acute pain (Side Effects)

Implementation

  • Do not confuse Neulasta (pegfilgrastim) with Lunesta (eszopiclone) or Neumega (oprelvekin).
  • Pegfilgrastim should not be administered between 14 and 24 days after administration of cytotoxic chemotherapy.
    • Keep patients with sickle cell disease receiving pegfilgrastim well hydrated and monitor for sickle cell crisis.
  • Subcutaneous: Administer subcut once per chemotherapy cycle. Do not administer solutions that are discolored or contain particulate matter. Do not shake. Store refrigerated; may be allowed to reach room temperature for a maximum of 48 hr, but protect from light.
    • Supplied in prefilled syringes. Following administration, activate UltraSafe Needle Guard to prevent needle sticks by placing hands behind needle, grasping guard with one hand, and sliding guard forward until needle is completely covered and guard clicks into place. If audible click is not heard, guard may not be completely activated. Dispose of by placing entire prefilled syringe with guard activated into puncture-proof container.

Patient/Family Teaching

  • Advise patient to notify health care professional immediately if signs of allergic reaction (shortness of breath, hives, rash, pruritus, laryngeal edema) or signs of splenic rupture (left upper abdominal or shoulder tip pain) occur.
  • Emphasize the importance of compliance with therapy and regular monitoring of blood counts.
  • Home Care Issues: Instruct patient on correct disposal technique for home administration. Caution patient not to reuse needle, syringe, or drug product. Provide patient with a puncture-proof container for disposal of prefilled syringe.

Evaluation/Desired Outcomes

  • Decreased incidence of infection in patients who receive bone marrow–depressing antineoplastics.

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.
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References in periodicals archive ?
Pharmaceuticals company Sandoz reported on Friday that it has presented encouraging data from its Phase I study of biosimilar pegfilgrastim in healthy volunteers during the 2017 San Antonio Breast Cancer Symposium.
Primary vs secondary prophylaxis with pegfilgrastim for the reduction of febrile neutropenia risk in patients receiving chemotherapy for non-Hodgkin's lymphoma: cost-effectiveness analyses.
Myeloid growth factors currently used for the prophylaxis of febrile neutropenia and maintenance of scheduled dose delivery include filgrastim, pegfilgrastim (category 1), and sargramostim (category 2B).
49) La seguridad y eficacia de nuevos factores de crecimiento como el pegfilgrastim se deben comparar con las del filgrastim en ninos pequenos.
Introduction: Pegfilgrastim is administered in multiple clinical settings.
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).
Leukine is similar to Roche's filgrastim and pegfilgrastim, the two drugs Amgen purchased that fight the immune-suppressing effects of cancer treatment.
Contract award notice: Conclusion of non-exclusive discount agreements pursuant to section 130a (8) sgb v on medicines containing the active substance pegfilgrastim (atc code l03aa13) within the framework of a so-called open-house model
Pegfilgrastim is a long-acting formulation of oncology medicine filgrastim (granulocyte colony-stimulating factor, or G-CSF).
Many Key Biologics Losing Protection by 2020 Top 10 biologics total $79Bn sales globally Global Top 10 Biologics sales US Non US expiry date EU expiry by region Sales US date Adalimumab (Humira) 66% 34% 2016 2018 Insulin Glargine (Lantus) 77% 23% Expired Expired Etanercept (Enbrel) 66% 34% 2028 (extended) Expired Infliximab (Remicade) 57% 43% 2018 Expired Rituximab (Mabthera) 55% 45% 2018 Expired Bevacizumab (Avastin) 48% 52% 2020 2019 Trastuzumab (Herceptin) 41% 59% 2019 Expired Insulin Aspart (Novorapid) 78% 22% Expired Expired Glatiramer Acetate (Copaxone) 84% 16% Expired 2017 Pegfilgrastim (Neulasta) 84% 16% 2015 2017 Source: QuintilesIMS, MIDAS, MAT Q4 2015.
The Hyderabad-based firm, which launched pegfilgrastim, rituximab and darbepoetin in India, is reportedly working on trastuzumab and bevacizumab, among others.
Neulasta is our registered trademark for pegfilgrastim, a pegylated protein based on the Filgrastim molecule.