Introduction

The Filgram 30 MU (Filgrastim) PFS is a recombinant human granulocyte colony-stimulating factor (G-CSF) designed to stimulate neutrophil production, reducing the risk of infection in patients undergoing myelosuppressive chemotherapy or bone marrow transplantation. Manufactured by Eskayef Pharmaceuticals Ltd., a pioneer in biopharmaceutical innovation, and supplied globally by Onco Solution, this prefilled syringe (PFS) ensures precise dosing, convenience, and safety for patients with neutropenia. By enhancing bone marrow function, the Filgram 30 MU (Filgrastim) PFS plays a critical role in oncology and hematology, improving outcomes for patients with cancer, congenital neutropenia, and those undergoing stem cell mobilization.

Key Benefits

• Neutrophil Stimulation: Boosts white blood cell production, reducing infection risks during chemotherapy.
• Versatile Applications: Effective for chemotherapy-induced neutropenia, AML, bone marrow transplantation, and congenital/cyclic neutropenia.
• Convenient Administration: Prefilled syringe ensures accurate dosing and ease of use for IV/SC delivery.
• Global Accessibility: Supplied by Onco Solution, ensuring reliable access to life-saving therapies.

Indications

The Filgram 30 MU (Filgrastim) PFS is indicated for:

1. Chemotherapy-Induced Neutropenia: Reduces febrile neutropenia incidence in nonmyeloid malignancies.
2. Acute Myeloid Leukemia (AML): Accelerates neutrophil recovery post-induction/consolidation chemotherapy.
3. Bone Marrow Transplantation (BMT): Shortens neutropenia duration post-myeloablative chemotherapy.
4. Stem Cell Mobilization: Enhances peripheral blood progenitor cell collection for autologous transplants.
5. Chronic Neutropenia: Manages severe congenital, cyclic, or idiopathic neutropenia to prevent infections.

Pharmacology

• Mechanism of Action: Filgrastim, the active ingredient in Filgram 30 MU (Filgrastim) PFS, binds to G-CSF receptors on hematopoietic cells, stimulating neutrophil proliferation, differentiation, and functional activation.
• Key Effects:
  • Increases phagocytic activity and antibody-dependent cellular toxicity.
  • Reduces chemotherapy-induced nadir duration and infection-related complications.
• Non-Species Specific: Compatible across species with minimal impact on non-neutrophil lineages.

Dosage & Administration

Standard Dosing

• Chemotherapy Patients (Nonmyeloid/AML): 5 mcg/kg/day via subcutaneous (SC) injection, short IV infusion (15–30 mins), or continuous IV infusion.
• Bone Marrow Transplant (BMT): 10 mcg/kg/day as a 24-hour IV infusion.
• Stem Cell Mobilization: 10 mcg/kg/day SC for ≥4 days pre-leukapheresis.
• Chronic Neutropenia:
  • Congenital: 6 mcg/kg SC twice daily.
  • Cyclic/Idiopathic: 5 mcg/kg SC daily.

Renal/Hepatic Adjustments

• No specific dosing adjustments required; monitor for toxicity in severe impairment.

Contraindications

• Hypersensitivity to filgrastim, pegfilgrastim, or any component of the formulation.

Adverse Reactions

Common Side Effects:

• General: Bone pain (20–30%), headache (15%), fever (10%).
• Hematologic: Leukocytosis (WBC >100,000/mm³ in <5% of cases).
• Gastrointestinal: Nausea, diarrhea (5–10%).

Serious Risks:

• Splenic Rupture: Monitor for left upper quadrant pain or shoulder tip pain.
• ARDS: Discontinue if respiratory distress or lung infiltrates develop.
• Sickle Cell Crisis: Fatalities reported in susceptible patients.
• Anaphylaxis: Rare but severe; discontinue permanently if occurs.

Warnings & Precautions

1. Splenic Enlargement: Regular palpation for splenomegaly in long-term users.
2. Capillary Leak Syndrome: Monitor for edema, hypotension, or hypoalbuminemia.
3. Myelodysplastic Syndrome (MDS)/AML Risk: Monitor blood counts in congenital neutropenia patients.
4. Glomerulonephritis: Discontinue if renal function declines abruptly.

Use in Pregnancy & Lactation

• Pregnancy Category C: Limited human data; use only if benefits outweigh fetal risks.
• Lactation: Avoid breastfeeding; excretion in milk is unknown.

Pediatric Useq

• Safety & Efficacy: Established in children ≥1 year for chemotherapy-induced neutropenia.
• Dosing: Weight-based protocols similar to adults; pharmacokinetics align across age groups.

Overdosage

• Symptoms: Excessive leukocytosis (WBC >100,000/mm³), bone pain.
• Management: Discontinue temporarily; resume at reduced dose after WBC normalization.

Drug Interactions

• Lithium: May potentiate neutrophil release; monitor WBC closely.
• Chemotherapy: Administer ≥24 hours after cytotoxic therapy to avoid progenitor cell damage.

Storage & Handling

• Temperature: Refrigerate at 2°C–8°C; do not freeze or shake.
• Protection: Keep in original packaging to avoid light exposure.
• Shelf Life: 24 months unopened; discard unused portions.

Packaging

• Filgram 30 MU (300 mcg) PFS: Each prefilled syringe contains 0.5 mL sterile solution (300 mcg filgrastim).

Why Choose Filgram 30 MU (Filgrastim) PFS?

• Proven Efficacy: Clinically validated to reduce infection risks and accelerate recovery in diverse patient groups.
• Trusted Manufacturer: Produced by Eskayef Pharmaceuticals Ltd., a leader in WHO-GMP-certified biopharmaceuticals.
• Global Reach: Distributed by Onco Solution, ensuring affordable access across Asia, Africa, and Europe.

Conclusion

The Filgram 30 MU (Filgrastim) PFS is a cornerstone of supportive cancer care, offering targeted neutrophil stimulation to mitigate life-threatening infections. By integrating this therapy, healthcare providers align with Eskayef Pharmaceuticals Ltd.’s commitment to innovation and Onco Solution’s mission to democratize access to advanced therapies.