Erythropoietin is a glycoprotein hormone produced primarily by the kidney in response to hypoxia and is the key regulator of red blood cell (RBC) production. Erythropoietin is involved in all phases of erythroid development, and has its principal effect at the level of erythroid precursors. After erythropoietin binds to its cell surface receptor, it activates signal transduction pathways that interfere with apoptosis and stimulates erythroid cell proliferation. Recombinant human erythropoietion is structurally and functionally identical to the endogenous erythropoietin and is manufactured by recombinant DNA technology. Patients with chronic renal failure cannot produce sufficient amount of endogenous erythropoietin that leads to anemia. In that case, exogenous erythropoietin (rch) stimulates erythropoiesis to recover the signs and symptoms of anemia.
Nipotin 2000 Injection: Each 0.2 ml Pre-filled Syringe contains Erythropoietin concentrated solution (rDNA) BP 2000 IU.
Nipotin 3000 Injection: Each 0.3 ml Pre-filled Syringe contains Erythropoietin concentrated solution (rDNA) BP 3000 IU.
Nipotin 4000 Injection: Each 0.4 ml Pre-filled Syringe contains Erythropoietin concentrated solution (rDNA) BP 4000 IU.
Nipotin 5000 Injection: Each 0.5 ml Pre-filled Syringe contains Erythropoietin concentrated solution (rDNA) BP 5000 IU.
Nipotin 10000 Injection: Each 1 ml Pre-filled Syringe contains Erythropoietin concentrated solution (rDNA) BP 10000 IU.
Nipotin is indicated in the following conditions:
Treatment of anemia due to-
-Chronic Kidney Disease (CKD) in patients on dialysis and not on dialysis.
-The effects of concomitant myelosuppressive chemotherapy and upon initiation, there is a minimum of two additional months of planned chemotherapy.
-Zidovudine treated HIV-infected patients
Reduction of RBC transfusions in patients undergoing surgery.
Treatment of anemia in chronic renal failure:
Nipotin should be administered intravenously or subcutaneously in patients with renal insufficiency or chronic renal failure. In patients maintained on hemodialysis, Nipotin should always be administered after completion of dialysis.
For patients with CKD on dyalysis: The recommended starting dose of Nipotin (rch) is 50-100 IU/kg, three times per week administered over 1-5 minutes. For hemodialysis patient, intravenous route of administration is preferred.
For patients with CKD not on dialysis: The recommended starting dose of Nipotin (rch) is 50-100 IU/kg, three times per week, administered as I.V. or S.C. injection over 1-5 minutes.
Further dose increments should depend upon the initial response (proposed rate < 20 g/l per month). Because of the length of time required for erythropoiesis - several days for erythroid progenitors to mature and be released into the circulation - a clinically significant increase in haematocrit is usually not observed in less than 2 weeks and may require up to 6 weeks in some patients. If required, dose increments in steps of 25 IU/kg in intervals of four weeks are recommended. If the rate of haemoglobin (Hb) rise exceeds 20 g/l per month at 50 IU/kg, three times per week, downward dosage adjustments should be made in the amount administered in each dose and by omitting one of the weekly doses. Similar downward dose adjustments should be made if the Hb level exceeds 120 g/l. Maximum dose should generally not exceed 200 IU/kg 3 times per week. When a target haemoglobin concentration of 100-120 g/l has been achieved, maintenance dose should be individualized for each patient. In patients undergoing dialysis, the median maintenance dose is 75 IU/Kg, three times a week, with a range from 12.5 to 525 IU/kg three times a week as directed by the physician. In CRF patients not on dialysis, maintenance dose is 75 to 150 IU/kg per week.
Erythropoietin should not be used in patients with-
-Pure red cell aplasia that begins after treatment with Erythropoietin or other Erythropoietin protein drugs.
-Serious allergic reactions to Erythropoietin.
-Use of the multi-dose vials in neonates, infants, pregnant women, and nursing mothers.
Myocardial infarction, stroke, and thromboembolism: Using erythropoietin to target a hemoglobin level of greater than 1.1 g/l increases the risk of serious adverse cardiovascular reactions and has not been shown to provide additional benefit. Use caution in patients with coexistent cardiovascular disease and stroke.
Increased mortality and/or increased risk of tumor progression or recurrence in patients with cancer, hypertension: Control hypertension prior to initiating and during treatment with erythropoietin.
Seizures: erythropoietin increases the risk for seizures in patients with CKD. Increase monitoring of these patients for changes in seizure frequency or premonitory symptoms.
Pure red cell aplasia (PRCA): If severe anemia and low reticulocyte count develop during erythropoietin treatment, withhold erythropoietin and evaluate for pure red cell aplasia (PRCA).
The most common side effects during treatment with erythropoietin are myocardial infarction, stroke, and thromboembolism, increased mortality and/or increased risk of tumor progression or recurrence in patients with cancer, hypertension, seizures, serious allergic reactions etc.
There are no known clinically significant medicine interactions, but the effect of erythropoietin (rch) may be potentiated by the simultaneous therapeutic administration of a haematinic agent. Drugs that decrease erythropoiesis may decrease the response to erythropoietin (rch).
Pregnant woman: There are no controlled studies of erythropoietin in pregnant women. Therefore, erythropoietin should be used during pregnancy only if erythropoietin is clearly needed.
Nursing mothers: 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.
Nipotin 2000 Injection: Each pack contains 1 pre-filled syringe of recombinant erythropoietin 2000 IU/0.2 ml in blister pack.
Nipotin 3000 Injection: Each pack contains 1 pre-filled syringe of recombinant erythropoietin 3000 IU/0.3 ml in blister pack.
Nipotin 4000 Injection: Each pack contains 1 pre-filled syringe of recombinant erythropoietin 4000 IU/0.4 ml in blister pack.
Nipotin 5000 Injection: Each pack contains 1 pre-filled syringe of recombinant erythropoietin 5000 IU/0.5 ml in blister pack.
Nipotin 10000 Injection: Each pack contains 1 pre-filled syringe of recombinant erythropoietin 10000 IU/1 ml in blister pack.
Aristopharma Ltd. is one of the top 10 pharmaceutical companies in Bangladesh. The company started its journey in 1986 with the honest promise to provide quality medicines at affordable prices to the countrymen.
© 2023. Aristopharma Ltd. All rights reserved.