Ziextenzo

Pegfilgrastim (6mg)
Price: ₹15,500 - ₹18,000 per auto-injector
Mfr: Novartis India Ltd. (Sandoz) | Form: Pre-filled Syringe (SureClick auto-injector)

📋 Clinical Overview

Pegfilgrastim is a covalent conjugate of recombinant human granulocyte colony-stimulating factor (G-CSF) and a 20 kDa polyethylene glycol (PEG) molecule. It is a long-acting, pegylated form of filgrastim designed to stimulate the production, maturation, and activation of neutrophils. The 6mg dose is a single, fixed-dose subcutaneous injection, primarily used to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anticancer drugs associated with a clinically significant incidence of febrile neutropenia.

💊 Dosage & Administration

Adult: 6 mg administered subcutaneously as a single injection per chemotherapy cycle. Administer approximately 24 hours after completion of chemotherapy. Do not administer between 14 days before and 24 hours after chemotherapy.

Note: For subcutaneous use only. Administer in the abdomen (except 2-inch area around navel), front of middle thighs, back of upper arms, or upper outer area of buttocks. Rotate injection sites. Use pre-filled syringe or auto-injector. Allow to reach room temperature for 30 minutes before injection. Do not shake. Inspect for particulate matter or discoloration. Discard any unused portion.

⚠️ Contraindications

  • History of serious allergic reactions (e.g., anaphylaxis) to Pegfilgrastim, Filgrastim, or any component of the formulation.
  • Simultaneous administration with chemotherapy or radiotherapy (contraindicated 14 days before and 24 hours after cytotoxic chemotherapy).

🔬 Mechanism of Action

Pegfilgrastim binds to specific cell surface receptors on hematopoietic cells, predominantly committed progenitor cells of the neutrophil-granulocyte lineage. This binding activates intracellular signaling pathways (primarily JAK/STAT and MAPK), leading to proliferation, differentiation, commitment, and enhanced functional activity (including phagocytosis and antibody-dependent cellular cytotoxicity) of neutrophils. The pegylation reduces renal clearance, prolonging its half-life and duration of action.

🤕 Side Effects

  • Bone pain (moderate to severe in some patients)
  • Headache
  • Myalgia (muscle pain)
  • Arthralgia (joint pain)
  • Pain in extremities
  • Fatigue
  • Nausea
  • Diarrhea
  • Constipation
  • Injection site reactions (erythema, pain, swelling)

🤰 Special Populations

Pregnancy: Category C. Animal studies have shown fetal toxicity. There are no adequate and well-controlled studies in pregnant women. Use only if the potential benefit justifies the potential risk to the fetus.

Driving: Pegfilgrastim may cause fatigue, dizziness, or headache. Patients should be cautioned about driving or operating machinery if they experience these effects.

🔄 Drug Interactions

LithiumMay potentiate the release of neutrophils; monitor for excessive neutrophilia.Moderate
Chemotherapeutic Agents (e.g., 5-FU, Anthracyclines, Alkylating agents)Concurrent administration can increase sensitivity of myeloid cells to chemotherapy; STRICT timing must be followed (not 14 days before to 24 hours after).High
CorticosteroidsTheoretical potential for increased bone pain; clinical significance unknown.Low

🔁 Alternatives to Ziextenzo

Same composition (Pegfilgrastim (6mg)), different brands:

Fulphila Pegasta Peg-grafeel Pegmine Pegfil