Zarzio
Generic Name
Filgrastim biosimilar
Manufacturer
Sandoz (Novartis Group)
Country
Switzerland
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| zarzio 300 mcg injection | ৳ 4,200.00 | N/A |
Description
Overview of the medicine
Zarzio is a biosimilar to filgrastim, a recombinant human granulocyte colony-stimulating factor (G-CSF). It stimulates the production, maturation, and activation of neutrophils, a type of white blood cell, in the bone marrow. It is primarily used to prevent or treat neutropenia (low neutrophil count) in various clinical settings, including cancer patients undergoing chemotherapy and bone marrow transplantation.
Uses & Indications
Dosage
Adults
Chemotherapy-induced neutropenia: 0.5 MU/kg/day (5 mcg/kg/day) by subcutaneous injection or intravenous infusion. Begin at least 24 hours after chemotherapy. Bone marrow transplantation: 1.0 MU/kg/day (10 mcg/kg/day) by intravenous infusion over 30 minutes or 24 hours, or by continuous subcutaneous infusion.
Elderly
Same dosage as adults, no specific dosage adjustment required.
Renal_impairment
No specific dose adjustment recommended for mild to moderate renal impairment. Data for severe impairment is limited; dose reduction may be considered if needed.
How to Take
Administer by subcutaneous injection or intravenous infusion. Subcutaneous injection is generally preferred for self-administration and outpatient use. Intravenous infusion is usually reserved for the initial daily doses in BMT or for specific clinical situations.
Mechanism of Action
Zarzio binds to specific G-CSF receptors on hematopoietic stem cells and progenitor cells, stimulating their proliferation, differentiation, and maturation into neutrophils. It also enhances the functional activity of mature neutrophils, including phagocytosis and cytokine production.
Pharmacokinetics
Onset
Increase in neutrophil count within 24 hours.
Excretion
Primarily renal.
Half life
Approximately 3.5 hours after subcutaneous administration; slightly longer after intravenous administration.
Absorption
Rapid absorption after subcutaneous administration, reaching peak serum concentrations within 3-5 hours.
Metabolism
Primarily metabolized by neutrophils and renal clearance.
Side Effects
Contraindications
- Known hypersensitivity to filgrastim or any of the excipients.
- Patients with severe congenital neutropenia (Kostmann's syndrome) with cytogenetic abnormalities.
- Use in patients with chronic myeloid leukaemia or myelodysplastic syndromes is contraindicated.
Drug Interactions
Lithium
May potentiate the myeloproliferative effect of Zarzio, requiring close monitoring of neutrophil counts.
5-Fluorouracil
Co-administration with 5-fluorouracil may lead to increased neutropenia.
Myelosuppressive antineoplastic drugs
Do not use Zarzio 24 hours before and 24 hours after cytotoxic chemotherapy due to the sensitivity of rapidly dividing myeloid cells.
Storage
Store in a refrigerator (2°C - 8°C). Do not freeze. Keep the pre-filled syringe in the outer carton to protect from light. May be stored at room temperature (not above 25°C) for a single period of up to 72 hours.
Overdose
Symptoms of overdose are generally not severe. Discontinuation of therapy typically leads to a decrease in circulating neutrophils. The effects are usually reversible after drug cessation. Management is supportive.
Pregnancy & Lactation
Pregnancy: Use only if the potential benefit outweighs the potential risk to the fetus. Lactation: Unknown if excreted in human milk; caution should be exercised. Consult a doctor.
Side Effects
Contraindications
- Known hypersensitivity to filgrastim or any of the excipients.
- Patients with severe congenital neutropenia (Kostmann's syndrome) with cytogenetic abnormalities.
- Use in patients with chronic myeloid leukaemia or myelodysplastic syndromes is contraindicated.
Drug Interactions
Lithium
May potentiate the myeloproliferative effect of Zarzio, requiring close monitoring of neutrophil counts.
5-Fluorouracil
Co-administration with 5-fluorouracil may lead to increased neutropenia.
Myelosuppressive antineoplastic drugs
Do not use Zarzio 24 hours before and 24 hours after cytotoxic chemotherapy due to the sensitivity of rapidly dividing myeloid cells.
Storage
Store in a refrigerator (2°C - 8°C). Do not freeze. Keep the pre-filled syringe in the outer carton to protect from light. May be stored at room temperature (not above 25°C) for a single period of up to 72 hours.
Overdose
Symptoms of overdose are generally not severe. Discontinuation of therapy typically leads to a decrease in circulating neutrophils. The effects are usually reversible after drug cessation. Management is supportive.
Pregnancy & Lactation
Pregnancy: Use only if the potential benefit outweighs the potential risk to the fetus. Lactation: Unknown if excreted in human milk; caution should be exercised. Consult a doctor.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 2-3 years when stored correctly, check product specific expiry date.
Availability
Hospitals, specialized pharmacies
Approval Status
Approved by EMA, FDA
Patent Status
Patent expired for originator, biosimilar available
WHO Essential Medicine
YesClinical Trials
Zarzio has undergone extensive clinical trials demonstrating its comparability to the originator product (Neupogen) in terms of efficacy and safety, particularly in chemotherapy-induced neutropenia and PBPC mobilization. These studies confirmed its biosimilarity.
Lab Monitoring
- Complete Blood Count (CBC) with differential, especially neutrophil count, regularly during treatment. Platelet count and hemoglobin levels should also be monitored.
- Splenic size by physical examination or ultrasound, particularly in patients with severe chronic neutropenia.
Doctor Notes
- Ensure proper patient training for self-administration and proper disposal of used syringes.
- Monitor CBC with differential prior to and regularly during treatment; adjust dosage as per neutrophil response.
- Educate patients on symptoms of splenic enlargement or rupture (e.g., left upper abdominal or shoulder tip pain) and to seek immediate medical attention if they occur.
Patient Guidelines
- Follow your doctor's instructions carefully regarding dosage and administration.
- Do not shake the syringe vigorously as it may inactivate the medication.
- Store in the refrigerator (2°C - 8°C) and protect from light. Do not freeze.
Missed Dose Advice
If a dose is missed, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not double the dose to make up for a missed one. Contact your doctor or nurse for advice.
Driving Precautions
Zarzio is not known to affect the ability to drive or use machines. However, if you experience dizziness or fatigue, do not drive or operate machinery.
Lifestyle Advice
- Maintain good hygiene to reduce infection risk, especially during periods of neutropenia.
- Report any signs of infection (fever, chills, sore throat) immediately to your healthcare provider.
- Avoid contact sports or activities that could cause injury to your abdomen if your spleen is enlarged.
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