**Important Disclaimer:** This summary is for educational and informational purposes only and should not, under any circumstances, replace direct consultation with a qualified physician or pharmacist. Always refer to the product's internal leaflet or consult a healthcare professional before use.
**Drug Name:** Accofil 30 MIU/0.5ML 5 prefilled syringes
**Manufacturer:**
Accofil is manufactured by **Accord Healthcare**.
**Main Commentary Body:**
Accofil is a biosimilar medicine containing the active substance filgrastim. Filgrastim is a recombinant human granulocyte colony-stimulating factor (G-CSF), a protein that stimulates the production, maturation, and activation of neutrophils (a type of white blood cell) in the bone marrow. It is primarily used to increase the number of white blood cells in patients who have low counts due to various medical conditions or treatments.
* **Indications and Usage:**
Accofil is used to stimulate the production of white blood cells (neutrophils) in several clinical situations:
* **Chemotherapy-induced neutropenia:** To reduce the duration of neutropenia (low neutrophil count) and the incidence of febrile neutropenia (fever associated with low neutrophils) in patients receiving cytotoxic chemotherapy for non-myeloid malignancies.
* **Bone marrow transplantation:** To reduce the duration of neutropenia in patients undergoing myeloablative therapy followed by bone marrow transplantation.
* **Mobilization of peripheral blood progenitor cells (PBPCs):** To mobilize PBPCs into the peripheral blood for collection (apheresis) and subsequent autologous (from the patient) or allogeneic (from a donor) transplantation.
* **Severe chronic neutropenia (SCN):** For long-term treatment of patients with congenital, cyclic, or idiopathic neutropenia to increase neutrophil counts and reduce the incidence and duration of infection-related events.
* **HIV infection:** For the treatment of persistent neutropenia in patients with advanced HIV infection to reduce the risk of bacterial infections when other treatments are not appropriate.
* **Characteristics:**
Filgrastim, the active ingredient in Accofil, is a cytokine that regulates the production and release of functional neutrophils from the bone marrow. It binds to specific receptors on myeloid progenitor cells, stimulating their proliferation, differentiation, and maturation into neutrophils. It also enhances the functional activity of mature neutrophils, such as phagocytosis and chemotaxis.
* **Dosage and Administration:**
Accofil is administered by subcutaneous injection (under the skin) or by intravenous infusion (into a vein). The prefilled syringes are designed for single use. The dosage and administration schedule depend on the specific indication and the patient's condition.
* **Subcutaneous Injection:** The preferred route for most indications. Patients may be trained to self-administer after initial instruction.
* **Intravenous Infusion:** May be used for certain indications, diluted in 5% glucose solution.
* **Typical Doses (examples, exact dose depends on indication and body weight):**
* **Chemotherapy-induced neutropenia:** 0.5 MIU (5 micrograms)/kg/day.
* **Bone marrow transplantation:** 1.0 MIU (10 micrograms)/kg/day.
* **PBPC mobilization:** 1.0 MIU (10 micrograms)/kg/day (for autologous) or 1.0 MIU (10 micrograms)/kg/day (for donors).
* **Frequency:** Usually once daily.
* **Duration:** Treatment continues until the neutrophil count recovers to an acceptable level.
* **Contraindications:**
Accofil should not be used in individuals with:
* Hypersensitivity to filgrastim or any of the excipients.
* Patients with severe congenital neutropenia (Kostmann's syndrome) with cytogenetic abnormalities (as there is a risk of myelodysplastic syndrome/leukemia).
* **Warnings and Precautions:**
* **Splenic Rupture:** Cases of splenic rupture have been reported, some fatal. Patients reporting left upper abdominal pain or shoulder tip pain should be evaluated for splenic enlargement or rupture.
* **Acute Respiratory Distress Syndrome (ARDS):** ARDS has been reported. Patients developing fever, lung infiltrates, or respiratory distress should be evaluated and treatment discontinued.
* **Allergic Reactions:** Allergic reactions, including anaphylaxis, have occurred. Discontinue immediately if a serious allergic reaction occurs.
* **Sickle Cell Disease:** Use with caution in patients with sickle cell trait or sickle cell disease, as severe sickle cell crises have been reported.
* **Myelodysplastic Syndrome (MDS) / Acute Myeloid Leukemia (AML):** Use in patients with MDS or AML is not recommended outside of clinical trials due to the potential for G-CSF to promote tumor growth.
* **Thrombocytopenia:** Platelet counts should be regularly monitored, especially during PBPC mobilization.
* **Aortitis:** Aortitis (inflammation of the aorta) has been reported.
* **Capillary Leak Syndrome:** Capillary leak syndrome has been reported, which can be life-threatening.
* **Immunogenicity:** The potential for immunogenicity (development of antibodies) exists, but is generally low.
* **Bone Pain:** Bone pain is a common side effect.
* **Nutrient Absorption and Metabolism (Pharmacokinetics):**
* **Absorption:** Following subcutaneous administration, filgrastim is well absorbed, with peak serum concentrations occurring within 3-5 hours.
* **Distribution:** The volume of distribution is approximately 150 mL/kg.
* **Metabolism and Excretion:** Filgrastim is primarily eliminated by renal excretion and degradation by neutrophils. The elimination half-life is approximately 3.5 hours after subcutaneous administration. The half-life can be prolonged in patients with severe renal or hepatic impairment.
* **Side Effects:**
Like all medicines, Accofil can cause side effects, although not everybody gets them.
* **Very Common (may affect more than 1 in 10 people):** Bone pain, musculoskeletal pain, nausea, vomiting, fatigue, alopecia (hair loss), increased lactate dehydrogenase (LDH), increased uric acid.
* **Common (may affect up to 1 in 10 people):** Diarrhea, constipation, headache, decreased appetite, cough, dyspnea (shortness of breath), epistaxis (nosebleed), rash, enlarged spleen, thrombocytopenia (low platelet count), leukocytosis (high white blood cell count), anemia, injection site reactions.
* **Uncommon (may affect up to 1 in 100 people):** Splenic rupture, ARDS, allergic reactions (including anaphylaxis), sickle cell crisis, Sweet's syndrome (acute febrile neutrophilic dermatosis), vasculitis, aortitis, capillary leak syndrome, liver enzyme abnormalities.
* **Rare (may affect up to 1 in 1,000 people):** Cutaneous vasculitis, glomerulonephritis.
* **Drug Interactions:**
No formal drug interaction studies have been performed with Accofil.
* **Chemotherapy:** Accofil should not be used within 24 hours before or after administration of cytotoxic chemotherapy, as rapidly dividing myeloid cells are sensitive to cytotoxic agents.
* **Lithium:** Lithium may potentiate the myelostimulatory effect of filgrastim.
* **Other Haematopoietic Growth Factors:** Avoid concomitant use with other haematopoietic growth factors.
* **Patient Counseling:**
* Follow your doctor's instructions precisely regarding dosage, administration, and duration of treatment.
* If you are self-administering, ensure you receive proper training from a healthcare professional.
* Report any unusual pain, especially in the left upper abdomen or shoulder tip, to your doctor immediately, as this could be a sign of splenic enlargement or rupture.
* Report any signs of allergic reaction (e.g., rash, itching, swelling, difficulty breathing) immediately.
* Keep all appointments for blood tests, as regular monitoring of blood counts is essential.
* Store Accofil in the refrigerator (2°C to 8°C). Do not freeze. Protect from light.
* Do not shake the syringe vigorously.
* Do not use if the solution is cloudy, discolored, or contains particles.
* Keep out of the sight and reach of children.
**Sources:**
1. European Medicines Agency (EMA) - Accofil (Filgrastim) EPAR Product Information: [https://bit.ly/ema-accofil](https://www.ema.europa.eu/en/documents/product-information/accofil-epar-product-information_en.pdf)
2. Medicines.org.uk - Accofil 30 MIU/0.5 ml solution for injection in pre-filled syringe: [https://bit.ly/accofil-uk](https://www.medicines.org.uk/emc/product/5800/smpc)
3. National Cancer Institute - Filgrastim: [https://bit.ly/nci-filgrastim](https://www.cancer.gov/publications/dictionaries/cancer-drug/def/filgrastim)
Comments
Post a Comment