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

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.

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

• 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.

Granix

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

• Increased neutrophil counts.

Therapeutic Classification: colony-stimulating factors

Category C

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)

• 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.

tbo fil-GRAS-tim

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)