tbo-filgrastim

tbo-filgrastim

(tbo fil-gras-tim) ,

Granix

(trade name)

Classification

Therapeutic: colony stimulating factors
Pregnancy Category: C

Indications

To reduce the duration/severity of neutropenia in patients with non-myeloid malignancies who have received myelosuppressive antineoplastics associated with significant febrile neutropenia.

Action

Binds to granulocyte-colony stimulating factor (G-CSF) receptors and stimulates proliferation of neutrophils.

Therapeutic effects

Increased neutrophil counts.

Pharmacokinetics

Absorption: 33% absorbed following subcutaneous administration.
Distribution: Recombinant G-CSF products are poorly secreted in breast milk.
Metabolism and Excretion: Unknown.
Half-life: 3.2–3.5 hr.

Time/action profile (increase in neutrophil count)

ROUTEONSETPEAKDURATION
Subcutwithin 3 days3–5 days16–18 days

Contraindications/Precautions

Contraindicated in: Hypersensitivity, including previous hypersensitivity to filgrastim or pegfilgrastim.
Use Cautiously in: Sickle cell disease; Obstetric: Use only if potential benefit justifies potential fetal risk; Lactation: Use cautiously; Pediatric: Safety and effectiveness not established.

Adverse Reactions/Side Effects

Respiratory

  • acute respiratory distress syndrome (life-threatening)

Gastrointestinal

  • splenic rupture (life-threatening)

Dermatologic

  • rash
  • urticaria

Hematologic

  • sickle-cell crisis (life-threatening)
  • leukocytosis

Musculoskeletal

  • bone pain (most frequent)

Miscellaneous

  • Allergic reactions including anaphylaxis and angioneurotic edema
  • potential for tumor growth stimulation

Interactions

Drug-Drug interaction

Use cautiously with lithium ; may have additive effects on neutrophil release.

Route/Dosage

Subcutaneous (Adults and Children >18 yr) 5 mcg/kg per day; given no earlier than 24 hr following myelosuppressive chemotherapy; continue until expected neutrophil nadir is passed and neutrophil recovery has occurred.

Availability

Soluion for subcutaneous injection: 300 mcg/0.5 mL single-use prefilled syringe, 480 mcg/0.8 mL single-use prefilled syringe

Nursing implications

Nursing assessment

  • Assess for bone pain. Occurs commonly and may require treatment with acetaminophen or NSAIDs.
  • Monitor for signs of enlarged spleen or splenic rupture (upper abdominal pain, left shoulder pain, left upper quadrant pain).
  • Assess for acute respiratory distress syndrome (dyspnea with or without fever, fever, lung infiltrates, respiratory distress). May require discontinuation of tbo-filgrastim.
  • Monitor for signs and symptoms of allergic reactions (rash, urticaria, shortness of breath, wheezing, dizziness, swelling around mouth or eyes, fast heart rate, sweating). Administration of antihistamines, steroids, bronchodilators, and/or epinephrine may reduce severity of reactions. Permanently discontinue tbo-filgrastim if severe reactions occur.
  • Lab Test Considerations: Monitor CBC prior to chemotherapy and twice weekly until recovery.

Potential Nursing Diagnoses

Risk for infection (Indications)
Acute pain (Adverse Reactions)

Implementation

  • Tbo-filgrastim should be administered by a health care professional.
  • Administer no earlier than 24 hr after chemotherapy.
    • Solution should be clear; do not administer solution that is discolored or contains particulate matter. Refrigerate; do not freeze. Do not shake. Syringe is for 1-time use only.
  • Subcutaneous: Inject into abdomen (except for 2 inch area around navel), front of middle thigh, upper outer area of buttocks, upper back portion of upper arm. Rotate site daily. Avoid area that is tender, red, bruised, hard, or has scars or stretch marks. Pinch skin gently and administer at 45° angle. Follow manufacturer's instructions for use of safety needle guard device.

Patient/Family Teaching

  • Explain purpose of injection to patient. Advise patient to read Patient Information sheet prior to administration.
  • Advise patient to notify health care professional immediately if signs and symptoms of rupture or enlargement of the spleen, acute respiratory distress syndrome, infection (fever, redness, swelling) or allergic reactions occur.
  • Discuss potential risks and benefits with patients with sickle cell disease prior to administration.
  • Advise patient to notify health care professional if bone pain becomes bothersome.
  • Advise patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult with health care professional before taking other medications.
  • Advise female patient to notify health care professional if pregnancy is planned or suspected or if breastfeeding.

Evaluation/Desired Outcomes

  • Decreased incidence of infection in patients who receive bone marrow-depressing antineoplastics.
References in periodicals archive ?
- The US Food and Drug Administration has approved Granix (tbo-filgrastim) Injection for a new vial presentation and indication in pediatric patients 1 month and older, Israeli drugmaker Teva Pharmaceutical Industries Ltd.
Food and Drug Administration (FDA) has approved GRANIX (tbo-filgrastim) Injection for a new vial presentation and indication in pediatric patients 1 month and older.
Teva received approval for tbo-filgrastim, brand name Granix, through the BLA route and is not considered a biosimilar in the US.
has announced two significant additions to its global oncology biologic portfolio with the recent launches of Lonquex (lipegfilgrastim) and Granix (tbo-filgrastim) Injection, and an update on the review status of balugrastim by the Food and Drug Administration.
Bradway maintained on the firm's conference call that Teva's product - called Tbo-filgrastim - is not officially a biosimilar and therefore "won't be a product that has the same label as Neupogen".
has won approval for tbo-filgrastim (XM02 filgrastim), the first new granulocyte colony-stimulating factor (G-CSF) to be approved in the United States in more than 10 years.
Food and Drug Administration (FDA) for tbo-filgrastim (XM02 filgrastim), the first new granulocyte colony-stimulating factor (G-CSF) to be approved in the US in over a decade.
Tbo-filgrastim is a short-acting recombinant type of G-CSF, indicated to decrease the duration of severe neutropenia in patients who suffer from certain kind of cancer (non-myeloid malignancies) who are on chemotherapy that affects the bone marrow.
Michael Hayden, President of Global R&D and Chief Scientific Officer for Teva Pharmaceutical Industries Ltd, stated : "As a company dedicated to bringing needed medicines to patients, we are delighted with the approval of tbo-filgrastim which offers physicians and their patients undergoing chemotherapy a new supportive care treatment option".
Food and Drug Administration today approved Sicor Biotech s tbo-filgrastim to reduce the time certain patients receiving cancer chemotherapy experience severe neutropenia, a decrease in infection-fighting white blood cells called neutrophils.
Tbo-filgrastim is intended for use in adults who have cancers other than blood or bone marrow cancers (non-myeloid malignancies) and are taking chemotherapy drugs that cause a substantial decrease in the production of neutrophils in the bone marrow.
Tbo-filgrastim stimulates the bone marrow to increase the production of neutrophils.