Initer
Rx2000 IU • IV/SC Injection
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Other strengths and forms by Healthcare Pharmaceuticals Ltd.
Indications & Uses
Dosage Reference
Reference Information Only
Dosages shown are general references from official sources. Always consult your doctor or pharmacist for personalized dosing.
Adults:
Dosage evaluation of iron stores and nutritional factors
Check the iron status of every patient before and during treatment, and keep iron repletion maintained. Correct or rule out other causes of anemia before starting Erythropoietin alfa (for example vitamin deficiency, metabolic or chronic inflammatory conditions, bleeding, etc.).
For all patients with CKD, monitor hemoglobin at least weekly when starting or adjusting therapy, until it is stable, and then at least monthly. When adjusting the dose, consider the hemoglobin rate of rise, the rate of decline, ESA responsiveness and hemoglobin variability. A single hemoglobin excursion may not need a dose change. Don't increase the dose more often than once every 4 weeks. Decreases can be made more often, but avoid frequent dose adjustments. When hemoglobin rises rapidly (e.g., more than 1 g/dL in any 2-week period), reduce the dose of Erythropoietin alfa by 25% or more as needed to slow the response. For patients who do not respond adequately, meaning the hemoglobin has not increased by more than 1 g/dL after 4 weeks of therapy, increase the dose by 25%. Over a 12-week escalation period without adequate response, raising the Erythropoietin alfa dose further is unlikely to improve the response and may increase risks. Use the lowest dose that will maintain a hemoglobin level sufficient to reduce the need for RBC transfusions. Evaluate other causes of anemia, and discontinue Erythropoietin alfa if responsiveness does not improve.
For patients with CKD on dialysis, start Erythropoietin alfa when the hemoglobin level is less than 10 g/dL. If the level approaches or exceeds 11 g/dL, reduce or interrupt the dose. The recommended starting dose for adults is 50 to 100 units/kg, 3 times weekly, intravenously or subcutaneously. For pediatric patients the recommended starting dose is 50 units/kg, 3 times weekly, intravenously or subcutaneously. The intravenous route is recommended for patients on hemodialysis.
For patients with CKD not on dialysis, consider starting Erythropoietin alfa only when the hemoglobin level is less than 10 g/dL and the following apply: the rate of hemoglobin decline indicates the likelihood of needing an RBC transfusion, and reducing the risk of alloimmunization and/or other RBC transfusion-related risks is a goal. Once the hemoglobin level exceeds 10 g/dL, reduce or interrupt the dose, and use the lowest dose sufficient to reduce the need for RBC transfusions. The recommended starting dose for adults is 50 to 100 units/kg, 3 times weekly, intravenously or subcutaneously.
Zidovudine-treated HIV-infected patients
The recommended starting dose in adults is 100 units/kg as an intravenous or subcutaneous injection 3 times per week. If hemoglobin does not increase after 8 weeks of therapy, increase the dose by approximately 50 to 100 units/kg at 4- to 8-week intervals, until hemoglobin reaches the level needed to avoid RBC transfusions or the dose reaches 300 units/kg. Withhold Erythropoietin alfa if hemoglobin exceeds 12 g/dL. Resume therapy at a dose 25% below the previous dose when hemoglobin declines to less than 11 g/dL. Discontinue Erythropoietin alfa if hemoglobin has not increased at a dose of 300 units/kg for 8 weeks.
Patients on cancer chemotherapy
Start Erythropoietin alfa only when the hemoglobin is less than 10 g/dL and a minimum of two additional months of chemotherapy is planned. Use the lowest dose necessary to avoid RBC transfusions. Adults receive 150 units/kg subcutaneously 3 times per week, or 40,000 units subcutaneously weekly, until the chemotherapy course is completed. Pediatric patients (5 to 18 years) receive 600 units/kg intravenously weekly until the chemotherapy course is completed.
Prevention of anemia of prematurity
Erythropoietin alfa is given subcutaneously at a dose of 3x250 IU/kg b.w. per week. Treatment should start as early as possible, preferably by day 3 of life. Premature infants who have received a transfusion before starting Erythropoietin alfa are not likely to benefit as much as infants who have not had a transfusion. The treatment should last for 6 weeks.
Side Effects
In clinical studies, these adverse reactions were seen in 5% of patients treated with Erythropoietin Alfa. Patients with CKD had hypertension, arthralgia, muscle spasm, pyrexia, dizziness, medical device malfunction, vascular occlusion and upper respiratory tract infection. For HIV-infected patients treated with zidovudine, the reactions were pyrexia, cough, rash and injection site irritation. Cancer patients on chemotherapy had nausea, vomiting, myalgia, arthralgia, stomatitis, cough, weight decrease, leukopenia, bone pain, rash, hyperglycemia, headache, depression, dysphagia, hypokalemia and thrombosis. Surgery patients had nausea, vomiting, pruritus, headache, injection site pain, chills, deep vein thrombosis, cough and hypertension. Premature infants very commonly (>10%) show a fall in serum ferritin values.
Cautions & Contraindications
Contraindications
Erythropoietin alfa should not be given to people whose blood pressure is uncontrolled, or to anyone who has had a serious allergic reaction to it. It must also not be used in patients who develop Pure Red Cell Aplasia (PRCA) after treatment with any erythropoietin. Those patients should not receive Erythropoietin alfa or any other erythropoietin.
Pregnancy & Breastfeeding
There are no adequate and well-controlled studies of Erythropoietin alfa in pregnant women. Studies in animals have shown reproductive toxicity. Because of this, the advice is as follows.
In patients with chronic renal failure, Erythropoietin alfa should be used in pregnancy only if the potential benefit outweighs the potential risk to the foetus. In pregnant or breastfeeding surgical patients who are taking part in an autologous blood predonation programme, Erythropoietin alfa is not recommended.
It is not known whether exogenous Erythropoietin alfa passes into human milk, so it should be used with caution in nursing women. Whether to continue or stop breastfeeding, or to continue or stop therapy with Erythropoietin alfa, should be decided by weighing the benefit of breastfeeding to the child against the benefit of the therapy to the woman.
⚠️ Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
Overdose
Erythropoietin Alfa has a very wide therapeutic margin. Even so, an overdose can push haemoglobin above the level you want. The doctor manages this by stopping Erythropoietin Alfa or lowering the dose, and/or by phlebotomy, as the clinical situation calls for. Severe hypertension has been seen in cases of overdose with ESAs.
⚠️ In an emergency call 999 or go to the nearest hospital emergency department.
Storage
Keep Erythropoietin Alfa at 2ºC to 8ºC, and hold it within that range until it is given to the patient. Don't freeze it and don't shake it. Leave it in its original package so the light stays off it.
Drug Interactions
Common questions about Initer 2000 IU
What is Initer 2000 IU IV/SC Injection?
Initer 2000 IU IV/SC Injection is a medicine that contains Erythropoietin Alfa. It is made by Healthcare Pharmaceuticals Ltd. It belongs to the Drugs for Haemolytic Hypoplastic & Renal Anemia group of medicines.
What is Initer used for?
Initer is used for: Anemia, Cancer.
What are the side effects of Initer?
In clinical studies, these adverse reactions were seen in 5% of patients treated with Erythropoietin Alfa. Patients with CKD had hypertension, arthralgia, muscle spasm, pyrexia, dizziness, medical device malfunction, vascular occlusion and upper respiratory tract infection.
Can I take Initer during pregnancy or while breastfeeding?
There are no adequate and well-controlled studies of Erythropoietin alfa in pregnant women. Studies in animals have shown reproductive toxicity. Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
What happens if I take too much Initer?
Erythropoietin Alfa has a very wide therapeutic margin. Even so, an overdose can push haemoglobin above the level you want. In an emergency call 999 or go to the nearest hospital emergency department.
How should I store Initer?
Keep Erythropoietin Alfa at 2ºC to 8ºC, and hold it within that range until it is given to the patient. Don't freeze it and don't shake it.
Can I take other medicines with Initer?
Some medicines can interact with Erythropoietin Alfa, for example: Ferrous Sulphate. Tell your doctor or pharmacist about every medicine you take.
Do I need a prescription for Initer?
Initer is a prescription (Rx) medicine. Take it as your doctor advises.