Neulasta


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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.

Neulasta

A brand name for PEGFILGASTRIM.
References in periodicals archive ?
As such, it is indicated in the exact same way as subcutaneous (pre-filled syringe) Neulasta.
A comprehensive analytical, biofunctional, preclinical and clinical comparability programme has demonstrated a high degree of similarity between Pelmeg and Neulasta. The Pelmeg confirmed biosimilarity to Neulasta in sensitive clinical study settings, demonstrated pharmacokinetic comparability to Neulasta at the clinical dose of 6 mg as well as pharmacodynamic comparability to Neulasta at the clinical dose of 6 mg and at the reduced dose of 3 mg, added the network.
--Generic (Biosimilar) Neulasta launches on schedule; generic Advair is delayed but launches by 2019.
The top drugs that year were Regeneron Pharmaceuticals Inc's chemotherapy drug Eylea, Roche Holding AG's cancer and rheumatoid arthritis treatment Rituxan and Amgen Inc's Neulasta, which helps reduce the risk of infection during cancer treatment.
The announcement sees the Mundipharma network (including NAPP Pharmaceuticals in the UK) gain immediate access to Pelmeg (B12019), a biosimilar to Neulasta (pegfilgrastim), which received CHMP recommendation for approval on 20 September 2018.
TUESDAY, June 5, 2018 (HealthDay News) -- The first biosimilar drug to Neulasta has been approved by the U.S.
The 50-50joint venture was launched in 1984 to fund the global development of Epogen (epoetin alfa) and, over time, was expanded to include Neupogen (filgrastim), Neulasta (pegfilgrastim), Aranesp (darbepoetin alfa), Nplate (romiplostim) and brodalumab.
For instance, many patients receiving chemotherapy receive a Neulasta shot after chemo to help keep the white counts from plummeting.
Neupogen (filgrastim) and Neulasta (prefilgrastim) are used to treat neutropenia, which promotes leukocytopoiesis; they were developed by Memorial Sloan Kettering Cancer Center (MSK) from 1970 and are FDA approved and sold by Amgen.
Its products include Prolia for osteoporosis, Enbrel for rheumatoid arthritis and skin disorders, and Neulasta and Neupogen for fighting infection in cancer patients.
Neupogen and Neulasta, two products that stimulate production of white blood cells had sales of $4.84 billion in 2010.
Neulasta and NEUPOGEN sales increased 12 percent to $1,021 million in the fourth quarter of 2011 versus $914 million in the fourth quarter of 2010, primarily driven by an increase in the average net sales price, and to a lesser extent, favorable changes in wholesaler inventories.