Indications of Nipotin 5000 Injection

Erythropoietin is used to treat anemia associated with chronic renal failure in both dialysis and non-dialysis patients.

Anemia in patients with non-myeloid malignancies who are experiencing anemia as a result of concurrent treatment.

To decrease the need for allogeneic blood transfusions, anemic patients (hemoglobin >10 to 13 g/dL) are scheduled for elective, noncardiac, nonvascular surgery.

In HIV-positive patients, anemia is linked to zidovudine medication.

Pharmacology of Nipotin 5000 Injection

Erythropoietin (EPO) is a glycoprotein hormone that regulates the production of red blood cells in mammals. Recombinant human erythropoietin (r-HuEPO) is a pure glycoprotein made from mammalian cells that have had the human erythropoietin gene introduced into them.

Dosage & Administration of Nipotin 5000 Injection

Treatment of anemia in chronic renal failure: Erythropoietin is administered to maintain hemoglobin concentration between 11 to 12 g/dl and hematocrit of 33-36 % in adults.

Starting dose:

• Adult: Usually 50 to 100 lU/kg three times in a week (TIW) by IV or Subcutaneous route.
• Pediatric: 50 lU/kg TIW by IV or Subcutaneous route.

Dose adjustment: Dose should be increased if hematocrit doses not increase by 5 to 6 points after 8 weeks therapy, and hematocrit is below suggested target range. Dose should be reduced when hematocrit approaches 36% or hematocrit increases >4 points in any 2-week period.

Maintenance dose: Maintenance dose must be individualized for each patient. In patients undergoing dialysis, the median maintenance dose is 75 lU/kg TIW, with a range from 12.5 to 525 lU/kg TIW as directed by the physician. In CRF patients not on dialysis, maintenance dose is 75 to 150 lU/kg/week.

Contraindications

Erythropoietin is contraindicated in patients with:

• Uncontrolled hypertension
• Known hypersensitivity to mammalian cell-derived products
• A history of hypersensitivity to Erythropoietin or any component of the preparation.

Side Effects of Nipotin 5000 Injection

General: Headache, dizziness, fever, malaise, arthralgia and occasionally hyperkalemia. Cardiovascular: Hypertension is the most common side effect, palpitations. Gastrointestinal: Nausea, vomiting, anorexia and diarrhea may occur occasionally. Allergic reactions.

Pregnancy & Lactation

Pregnancy Category C. Since there are no controlled studies of erythropoietin in pregnant women, and because animal reproduction studies are not always predictive of human responses, erythropoietin should be used during pregnancy only if clearly needed. It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when erythropoietin is administered to a nursing woman.

Precautions & Warnings

Erythropoietin should be used with caution in those patients with controlled hypertension, ischaemic vascular disease, history of seizures, or suspected allergy to the product.

Iron evaluation: Prior to and during Erythropoietin therapy, the patient’s iron stores, including transferrin saturation and serum ferritin, should be evaluated. Transferrin saturation should be at least 20%, and ferritin should be at least 100 ng/ml. Virtually all patients will require supplemental Iron to increase or maintain transferrin saturation to levels that will adequately support erythropoiesis.

Therapeutic Class

Drugs for Haemolytic Hypoplastic & Renal Anemia

Storage Conditions

Erythropoietin should be stored at 2°C to 8°C. Protect from light. Do not freeze & avoid shaking.

Pharmaceutical Name of Nipotin 5000 Injection

Aristopharma Ltd

Generic of Nipotin 5000 Injection

Erythropoietin