Nipotin
Generic Name
Epoetin Alfa
Manufacturer
Square Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| nipotin 10000 iu injection | ৳ 4,200.00 | N/A |
Description
Overview of the medicine
Nipotin 10000 IU Injection contains Epoetin Alfa, a recombinant human erythropoietin, used to stimulate red blood cell production in patients with anemia due to chronic kidney disease, chemotherapy, or certain other conditions.
Uses & Indications
Dosage
Adults
Initial dose typically 50-150 IU/kg three times a week (for CKD or chemotherapy-induced anemia), adjusted based on hemoglobin response and target levels (e.g., 10-11 g/dL).
Elderly
No specific dose adjustments required for elderly patients, but monitoring for comorbidities and adverse effects is crucial.
Renal_impairment
Primary indication for CKD anemia. Dosage is individualized and adjusted to maintain target hemoglobin levels. Start with 50 IU/kg three times weekly, then adjust.
How to Take
Nipotin injection can be administered either intravenously (IV) or subcutaneously (SC). Subcutaneous administration is generally preferred for chronic treatment due to convenience. Do not shake the syringe.
Mechanism of Action
Epoetin Alfa stimulates erythropoiesis by binding to erythropoietin receptors on progenitor cells in the bone marrow, leading to increased red blood cell production and maturation.
Pharmacokinetics
Onset
Reticulocytosis typically observed within 7-10 days. A clinically significant increase in hemoglobin usually occurs over 2-6 weeks.
Excretion
Renal excretion of intact Epoetin Alfa is minor. The degradation products are likely excreted renally.
Half life
Intravenous (IV) half-life: 4-13 hours. Subcutaneous (SC) half-life: 16-67 hours.
Absorption
Bioavailability varies with administration route; subcutaneous (SC) administration leads to slower absorption and lower peak concentrations than intravenous (IV). SC bioavailability is typically 30-40%.
Metabolism
Primarily cleared by erythropoietin receptors, which internalize and degrade the molecule. Minimal hepatic metabolism.
Side Effects
Contraindications
- Uncontrolled hypertension.
- Pure red cell aplasia (PRCA) that began after treatment with any erythropoietin protein product.
- Known hypersensitivity to Epoetin Alfa or any components of the formulation.
Drug Interactions
Cyclosporine
Epoetin Alfa may decrease cyclosporine blood levels; monitor cyclosporine levels if co-administered.
Iron supplements
Adequate iron stores are essential for Epoetin effectiveness; oral or IV iron supplements are often co-administered.
Storage
Store in a refrigerator at 2°C to 8°C. Do not freeze. Protect from light. Do not shake.
Overdose
Overdose of Epoetin Alfa can lead to polycythemia (excessive red blood cells), which may require phlebotomy (blood removal) to reduce hematocrit levels or withholding therapy.
Pregnancy & Lactation
Pregnancy Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is unknown whether Epoetin Alfa is excreted in human milk; caution should be exercised when administered to a nursing mother.
Side Effects
Contraindications
- Uncontrolled hypertension.
- Pure red cell aplasia (PRCA) that began after treatment with any erythropoietin protein product.
- Known hypersensitivity to Epoetin Alfa or any components of the formulation.
Drug Interactions
Cyclosporine
Epoetin Alfa may decrease cyclosporine blood levels; monitor cyclosporine levels if co-administered.
Iron supplements
Adequate iron stores are essential for Epoetin effectiveness; oral or IV iron supplements are often co-administered.
Storage
Store in a refrigerator at 2°C to 8°C. Do not freeze. Protect from light. Do not shake.
Overdose
Overdose of Epoetin Alfa can lead to polycythemia (excessive red blood cells), which may require phlebotomy (blood removal) to reduce hematocrit levels or withholding therapy.
Pregnancy & Lactation
Pregnancy Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is unknown whether Epoetin Alfa is excreted in human milk; caution should be exercised when administered to a nursing mother.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 24 months from the date of manufacture when stored under recommended conditions.
Availability
Hospitals, Clinics, Pharmacies
Approval Status
Approved
Patent Status
Off-patent
WHO Essential Medicine
YesClinical Trials
Extensive clinical trials have demonstrated the efficacy and safety of Epoetin Alfa in treating anemia associated with chronic kidney disease and chemotherapy. Ongoing research includes studies on biosimilars and specific patient populations.
Lab Monitoring
- Hemoglobin and hematocrit levels (regularly, at least weekly initially, then monthly).
- Iron stores (serum ferritin, transferrin saturation) before and during treatment.
- Blood pressure (regularly).
- Renal function tests (creatinine, BUN) in CKD patients.
Doctor Notes
- Emphasize the importance of not exceeding a target hemoglobin of 11 g/dL to mitigate cardiovascular and thromboembolic risks.
- Ensure patients have adequate iron stores before and during Epoetin Alfa therapy. Iron supplementation is often necessary.
- Educate patients on the symptoms of hypertension and potential thromboembolic events, advising them to seek immediate medical attention if these occur.
Patient Guidelines
- Do not shake the syringe or vial, as this can denature the protein.
- Store the medication in the refrigerator (2-8°C) and protect from light. Do not freeze.
- Report any unusual symptoms such as severe headache, sudden vision changes, swelling, or signs of a blood clot (e.g., leg pain, shortness of breath) immediately to your doctor.
- Ensure adequate iron intake as advised by your doctor to maximize treatment effectiveness.
Missed Dose Advice
If a dose of Nipotin is missed, administer it as soon as you remember. If it is almost time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not double the dose to catch up.
Driving Precautions
Nipotin is not known to directly impair the ability to drive or operate machinery. However, patients should be aware of potential side effects like headache or fatigue and exercise caution.
Lifestyle Advice
- Maintain a healthy and balanced diet, focusing on foods rich in iron, if appropriate.
- Engage in regular, moderate exercise as tolerated, after consulting your physician.
- Avoid smoking, as it can worsen cardiovascular risks.
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