tbo fil-GRAS-tim

Therapeutic Classification: colony-stimulating factors

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

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

• Increased neutrophil counts.

Absorption: 33% absorbed following subcutaneous administration.

Distribution: Recombinant G-CSF products are poorly secreted in breast milk.

Metabolism/Excretion: Unknown.

Half-life: 3.2–3.5 hr.

(increase in neutrophil count)

Contraindicated in:

• Hypersensitivity, including previous hypersensitivity to filgrastim or pegfilgrastim.

Use Cautiously in:

• Sickle cell disease
• OB: Use only if potential benefit justifies potential fetal risk
• Lactation: Use cautiously
• Pedi: Safety and effectiveness not established.

Resp: ACUTE RESPIRATORY DISTRESS SYNDROME.

GI: SPLENIC RUPTURE.

Derm: rash, urticaria.

Hemat: SICKLE-CELL CRISIS, leukocytosis.

MS: bone pain.

Misc: Allergic reactions including anaphylaxis and angioneurotic edema, potential for tumor growth stimulation.

Drug-Drug:

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

• SC (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.

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

• 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.

• Monitor CBC prior to chemotherapy and twice weekly until recovery.

• 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.
• SC: Inject into abdomen (except for 2 inch area around navel), front of middle thigh, upper outer area of buttocks, or 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.

• Explain purpose of injection to patient. Advise patient to read Patient Information sheet prior to administration and with each Rx refill in case of changes. Instruct patient and/or caregiver in injection technique and care and disposal of equipment.
• 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.

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

Granix

Category C

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

NDC Code^*

• 63459- Cephalon, Inc.
  • 63459-910- GRANIX
    • 63459-910-11- 1 BLISTER PACK in 1 CARTON (63459-910-11) > 1 SYRINGE, GLASS in 1 BLISTER PACK (63459-910-12) >.5 mL in 1 SYRINGE, GLASS (63459-910-01)

• 63459- Cephalon, Inc.
  • 63459-910- GRANIX
    • 63459-910-15- 10 BLISTER PACK in 1 CARTON (63459-910-15) > 1 SYRINGE, GLASS in 1 BLISTER PACK (63459-910-12) >.5 mL in 1 SYRINGE, GLASS (63459-910-01)

• 63459- Cephalon, Inc.
  • 63459-910- GRANIX
    • 63459-910-17- 1 SYRINGE, GLASS in 1 CARTON (63459-910-17) >.5 mL in 1 SYRINGE, GLASS (63459-910-18)

• 63459- Cephalon, Inc.
  • 63459-910- GRANIX
    • 63459-910-36- 5 SYRINGE, GLASS in 1 CARTON (63459-910-36) >.5 mL in 1 SYRINGE, GLASS (63459-910-18)

• 63459- Cephalon, Inc.
  • 63459-912- GRANIX
    • 63459-912-11- 1 BLISTER PACK in 1 CARTON (63459-912-11) > 1 SYRINGE, GLASS in 1 BLISTER PACK (63459-912-12) >.8 mL in 1 SYRINGE, GLASS (63459-912-01)

• 63459- Cephalon, Inc.
  • 63459-912- GRANIX
    • 63459-912-15- 10 BLISTER PACK in 1 CARTON (63459-912-15) > 1 SYRINGE, GLASS in 1 BLISTER PACK (63459-912-12) >.8 mL in 1 SYRINGE, GLASS (63459-912-01)

• 63459- Cephalon, Inc.
  • 63459-912- GRANIX
    • 63459-912-17- 1 SYRINGE, GLASS in 1 CARTON (63459-912-17) >.8 mL in 1 SYRINGE, GLASS (63459-912-18)

• 63459- Cephalon, Inc.
  • 63459-912- GRANIX
    • 63459-912-36- 5 SYRINGE, GLASS in 1 CARTON (63459-912-36) >.8 mL in 1 SYRINGE, GLASS (63459-912-18)

• 63459- Cephalon, Inc.
  • 63459-918- GRANIX
    • 63459-918-59- 10 VIAL in 1 CARTON (63459-918-59) > 1 mL in 1 VIAL (63459-918-53)

• 63459- Cephalon, Inc.
  • 63459-920- GRANIX
    • 63459-920-59- 10 VIAL in 1 CARTON (63459-920-59) > 1.6 mL in 1 VIAL (63459-920-53)