Product Details

Introduction

Filgram 30 MU (Filgrastim) PFS is a premium biopharmaceutical product manufactured by Eskayef Pharmaceuticals Ltd., one of Bangladesh’s leading pharmaceutical companies. Available through Makkaa Pharma, this pre-filled syringe formulation delivers recombinant human granulocyte colony-stimulating factor (G-CSF) to effectively manage neutropenia in various clinical scenarios.

Understanding Filgram

Filgram contains Filgrastim, a glycoprotein produced through advanced recombinant DNA technology. This specialized therapeutic protein regulates neutrophil production within the bone marrow, affecting neutrophil progenitor proliferation and differentiation while enhancing phagocytic activity. As a biological response modifier, Filgrastim plays a crucial role in supporting patients through challenging treatments that compromise immune function.

Therapeutic Applications

Filgram 30 MU is indicated for multiple clinical situations where neutrophil count management is essential:

1. Cancer Patients Receiving Myelosuppressive Chemotherapy: Helps prevent and manage chemotherapy-induced neutropenia, reducing infection risk during treatment cycles
2. Acute Myeloid Leukemia Patients: Supports those undergoing induction or consolidation chemotherapy
3. Bone Marrow Transplant Recipients: Assists in neutrophil recovery following transplantation procedures
4. Severe Neutropenia Management: Effective for patients with congenital, cyclic, or idiopathic neutropenia
5. Peripheral Blood Progenitor Cell Collection: Facilitates stem cell mobilization for autologous transplantation
6. HIV-Associated Neutropenia: Helps maintain neutrophil counts in patients with persistent neutropenia due to HIV infection

Pharmacological Profile

Filgrastim works through a specific mechanism of action that targets neutrophil production and function:

Mechanism of Action: Filgrastim binds to cell surface receptors on hematopoietic cells, stimulating granulocyte development while enhancing their migration and cytotoxicity capabilities.

Pharmacodynamics: Administration of Filgram causes marked increases in peripheral blood neutrophil counts within 24 hours, with minor increases in monocytes. These elevations are dose-dependent within recommended dosage ranges.

Response Timeline: Following discontinuation of Filgram therapy, circulating neutrophil counts typically decrease by 50% within 1-2 days and return to baseline levels within 1-7 days, demonstrating the predictable and manageable nature of the therapy.

Dosage Guidelines

Filgram 30 MU dosing varies based on the specific clinical indication:

For Chemotherapy-Induced Neutropenia:

• 5 mcg/kg daily as a single subcutaneous injection
• Alternative administration options include continuous IV or SC infusion, or daily IV infusion over 15-30 minutes

For Bone Marrow Transplantation:

• 10 mcg/kg daily via IV infusion over 30 minutes or 4 hours
• Continuous IV or SC infusion over 24 hours is also an option
• Dosage adjustments based on individual response

For Peripheral Blood Progenitor Cell Mobilization:

• 10 mcg/kg daily as a single injection or continuous infusion for 4-7 days
• When administered after myelosuppressive chemotherapy: 5 mcg/kg daily from the first day after chemotherapy completion

For Congenital Neutropenia:

• 12 mcg/kg daily in single or divided doses, adjusted according to response

For Cyclic or Idiopathic Neutropenia:

• 5 mcg/kg daily in single or divided doses, adjusted according to response

For HIV-Associated Neutropenia:

• Initial dose: 1 mcg/kg daily
• May be increased to maximum 4 mcg/kg daily until normal neutrophil count is achieved
• Maintenance: 300 mcg daily

Quality Assurance

Filgram 30 MU PFS exemplifies Eskayef Pharmaceuticals’ commitment to biopharmaceutical excellence. Each pre-filled syringe undergoes stringent quality control measures to ensure sterility, potency, and safety. The pre-filled syringe format offers convenience and precise dosing for healthcare providers and patients alike.

Safety Considerations

Healthcare professionals should be aware of important safety considerations when prescribing Filgram:

• Complete blood count monitoring is recommended twice weekly during treatment to avoid adverse effects from excessive neutrophil levels
• Filgram should not be administered within 24 hours before or after chemotherapy
• Potential exists for growth factor effects on any tumor type, requiring appropriate clinical monitoring
• Patients with autoimmune conditions may require special monitoring

Potential Side Effects

Common side effects associated with Filgram therapy include:

• Musculoskeletal pain and bone pain
• Hypersensitivity reactions
• Splenic enlargement and hepatomegaly
• Hematological effects (thrombocytopenia, anemia)
• Headache and epistaxis
• Gastrointestinal symptoms (nausea, vomiting, diarrhea)
• Urinary abnormalities
• Transient decreases in blood glucose and elevated uric acid levels

Storage Requirements

To maintain product integrity and efficacy, Filgram 30 MU PFS must be:

• Refrigerated at 2-8°C
• Protected from freezing
• Handled according to standard protocols for biological products

Pharmaceutical Compatibility

For clinical situations requiring dilution:

• Dilution of Filgram to concentrations below 5 mcg/ml is not recommended
• Compatible with 5% dextrose solution when dilution is necessary
• Standard aseptic techniques should be employed during preparation

Global Availability

Makkaa Pharma ensures reliable worldwide delivery of Filgram 30 MU PFS within 3 to 7 working days. This commitment to rapid delivery acknowledges the time-sensitive nature of neutropenia management and the critical importance of continuity in treatment protocols for cancer patients and others requiring G-CSF therapy.

Expert Support

Makkaa Pharma’s dedicated team provides comprehensive support for healthcare professionals using Filgram, including:

• Detailed product information
• Guidance on proper storage and administration
• Assistance with ordering and delivery logistics
• Educational resources for optimal clinical utilization

Manufacturer Information

Eskayef Pharmaceuticals Limited has been at the forefront of pharmaceutical innovation since 1990, when Transcom Group acquired the Bangladesh operation of SK&F, USA. With over three decades of experience, Eskayef has established itself as a premier manufacturer of world-class medicines, including advanced biopharmaceuticals like Filgram.

For more information about Filgram 30 MU (Filgrastim) PFS or to place an order, visit www.makkaapharma.com or contact our dedicated customer service team today.