Epoetin 4000 I.U. ( Recombinant Erythropoietin ) Vial

Epoetin 2000 & 4000 I.U. SEDICOComposition:
Each 1 ml of the solution contains:
Recombinant erythropoietin................2000 or 4000 units.
Indications:

Treatment of anemia of chronic renal failure patients, including those on dialysis and those who are not.
‎Treatment of anemia in HIV patients treated on Zidovudine. ‎
Treatment of anemia in Cancer patients on chemotherapy ‎
Reduction of allergenic blood transfusion in surgery patients

Dosage and administration:
Chronic renal failure patients :
‎Doses over the range of 50-100 units / Kg three times weekly have been shown to be safe and effective. The dose should be reduced as the hematocrit approaches 36% or increased by more than 4 points in any two week period. The dose must be individualized to maintain the hematocrit within the suggested target range.
Zidovudine-treated HIV infected Patients :
‎ The recommended starting dose is 100 units / Kg as an IV OR S.C injection three times weekly. If the hematocrit exceeds 40% the dose should be discontinued until the hematocrit drops to 36%.
Cancer patients on chemotherapy:
‎ The recommended starting dose is 150 units / Kg S.C Three times weekly. Dose adjustments may be required if the response is not satisfactory, the dose can be increased up to 300 units / Kg three times weekly. If the hematocrit exceeds 40% the dose should be discontinued until the hematocrit drops to 36%.
Surgery patients :
‎ The recommended dose is 300 units / Kg / day S.S for 10 days before surgery, on the day of surgery, and for four days after surgery.
Contraindications:
- Uncontrolled hypertension.
- Known hypersensitivity to mammalian cell - derived products.
- Known hypersensitivity to human albumin.

Use during pregnancy:
There are no adequate & well-controlled studies in pregnant women. This drug should be used during pregnancy only if potential benefit justifies the potential risk to the fetus.

Use during lactation:
It is not known whether the drug is excreted in lactating mother's milk.
Because many drugs are excreted in lactating mother's milk, caution should be exercised when this drug is administered to a nursing women .

Drug-Drug interactions:
No evidence of interaction with other drug was observed in the course of clinical trials .

Side effect :
The drug is generally well-tolerated, but the following side effects occurred in chronic renal failure patients, but may be attributed to the disease & not the drug necessarily:
Hypertension, headache, arthralgia , nausea, edema , fatigue , diarrhea , vomiting , chest pain & skin reaction.
Thrombotic events : myocardial infarction , cerebro-vascular accident , transient ischemic attack .

Precautions:
In the absence of clinical data a precaution should be taken on patients with a known history of seizures or underlying hematologic disease (Sickle cell anemia , myelodyplastic syndrome or hypercoagulable disorder)
Erythropoiesis - stimulating agents ( ESAs ) shortened overall survival and / or time to tumor progression in clinical studies in patients with breast, non-small cell lung, head and neck, lymphoid and cervical cancers when dosed to target a hemoglobin of 12 g / dl .

Dosage:
Chronic renal failure patients:
Doses over the range of 50 to 100 units / Kg three times weekly have been shown to be safe and effective .
The dose should be reduced as the hematocrit approaches 36% or increases by more than 4 % during 2-weeks from starting of the remedy .
The dose must be individualized to maintain the hematocrit within the suggested target range .

Zidovudine-treated HIV-infected patients:
The recommended starting dose is 100 units/kg as an I.V. or S.C. injection three times weekly and the dose may be increased every 4-8 weeks by 50 to 100 units /kg three times weekly .
If the hematocrit exceeds 40 % the dose should be discontinued until the hematocrit drops to 36%

Cancer patients on chemotherapy :
The recommended starting dose is 150 units/kg S.C. three times weekly .
Dose adjustment : If the response is not satisfactory , the dose can be increased up to 300 units/kg three times weekly . If the hematocrit exceeds 40% the dose should be with held until the hematocrit falls to 36% .

Surgery patients:
The recommended dose is 300 units / kg / day S.C. for 10 days before surgery , on the day of surgery , and for 4 days after surgery.

Storage:
- Store at 2 to 8° C.
- Do not freeze or shake .
- Keep out of reach of Children.

Presentation:
Box of 1 Vial 1 ml 2000 I.U.
Box of 1 Vial 1 ml 4000 I.U.

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