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Hemax

Hemax

epoetin alfa

Manufacturer:

Bio Sidus

Distributor:

BJC Healthcare
Concise Prescribing Info
Contents
r-Hu-erythropoietin α (epoetin α)
Indications/Uses
Anemia of chronic renal failure in adult & ped patients on dialysis (end-stage renal failure) including in those not requiring dialysis; in HIV-infected patients on zidovudine-induced anaemia; cancer patients w/ metastases of non-myeloid malignancies on chemotherapy-induced anaemia; preterm infants w/ body wt between 750-1,500 g at birth & gestational age <34 wk.
Dosage/Direction for Use
Anemia in chronic renal failure patients Adult Initially 50-100 IU/kg 3x a wk IV or SC. Correct dose according to Hb level increase after 4 wk of treatment: ≥1 g/dL increase: Maintain same dose, <1 g/dL increase: May increase dose by approx 25%. Maintenance dose: Individualised dose. Ped patients Initial dose: Same as adult dose. Maintenance dose: Childn weighing >30 kg 30-100 IU/kg 3x wkly, 10-30 kg 60-150 IU/kg 3x wkly, <10 kg 75-150 IU/kg 3x wkly. Anemia in HIV-infected patients (zidovudine-induced) Initially 100 IU/kg 3x wkly for 8 wk. May be escalated by 50 IU/kg increases to max 300 IU 3x wkly if no satisfactory response is obtained. Anemia in cancer patients on chemotherapy Adult Initially 150 U/kg/dose 3x a wk SC. May be increased by 50 U/kg/dose each time up to max 300 U/kg 3x wkly if no response after 4 wk. Reduce dose by 25% if Hb level reaches 12 g/dL or increases >1 g/dL w/in 2 wk. Single wkly administration: Initially 40,000 IU SC once a wk. May be increased to 60,000 IU if Hb did not increase 1 g/dL in 4 wk (free of transfusions). Reduce dose by 25% if Hb increase >1 g/dL in 2 wk. Ped patient 6 mth to 18 yr 25-300 IU/kg IV or SC 3-7x wkly. Anemia of prematurity 250 IU/kg 3x a wk SC. Start treatment as soon as possible & should last for 6 wk.
Contraindications
Hypersensitivity to human albumin & products derived from mammalian cells. Uncontrolled arterial HTN, epoetin-related pure red cell aplasia. Pregnancy & lactation.
Special Precautions
Discontinue treatment in case pure RBC aplasia (PRCA) occurs. Not indicated for HIV-infected patients w/ anaemia of other aetiology (Fe or folate deficiency, haemolysis, GI haemorrhage); in patients receiving hormone therapy, biological products or RT w/o concomitant bone marrow suppressive chemotherapy, & chemotherapy when anticipated outcome is to cure. Not to be administered as emergency transfusion substitute in patients requiring immediate correction of severe anaemia. Increased risk of HTN, lack of efficacy & PRCA; mortality & occurrence of serious CV events; tumor progression or recurrence in patients w/ breast, head & neck, lymphoid, & cervical cancer, & NSCLC. Increased DVT in patients on erythropoiesis stimulating agents (ESA) not receiving prophylactic anticoagulation. History & exacerbation of porphyria. Patients w/ pre-existing risk factors for thrombotic vascular events (TVEs) including obesity & prior history of TVEs eg, DVT, pulmonary embolism & cancer patients. Ab-mediated PRCA in chronic renal failure patients w/ long term use & in patients w/ hepatitis C w/ concomitant interferon & ribavirin use. Fe deficiency, underlying infections, inflammatory processes or neoplasia, occult blood loss, underlying haematologic diseases (thalassaemia, myelodysplasia), haemolysis, Al overload, vit deficiencies (vit B12 or folic acid), cystic fibrosis, PRCA, bone marrow fibrosis & suppression from uremia, hyperparathyroidism/osteitis fibrosa cystica, erythrocyte enzyme abnormalities. Food indigestion; increased K level. Use lowest dose needed to avoid RBC transfusion & Hb should not be >12 g/dL. Obtain reticulocyte count in chronic renal failure patients developing sudden lack of efficacy w/ decrease Hb & need for transfusion. Perform anti-erythropoietin Abs & bone marrow testing in case reticulocyte index <20,000 µL or <0.5% w/ normal platelets & WBCs. Consider prophylactic anticoagulation when ESA including epoetin is indicated to reduce number of allogeneic transfusions. Fe supplementation in patients w/ not enough Fe stores due to frequent transfusions. Not to be used during pregnancy & lactation.
Adverse Reactions
Arterial HTN, headaches, oedema, low back pain, polycythemia, thrombotic complications, fever, hyperkalemia, breathing difficulties, tachycardia, seizures, arthralgias; skin rash, urticaria.
Drug Interactions
Increased BP w/ antihypertensives. Concomitant use w/ heparin; Fe supplements.
MIMS Class
Haematopoietic Agents / Supportive Care Therapy
ATC Classification
B03XA01 - erythropoietin ; Belongs to the class of other antianemic preparations. Used in the treatment of anemia.
Presentation/Packing
Form
Hemax powd for inj 10,000 IU
Packing/Price
1's;25 × 1's
Form
Hemax powd for inj 2,000 IU
Packing/Price
1's;25 × 1's
Form
Hemax powd for inj 3,000 IU
Packing/Price
1's;25 × 1's
Form
Hemax powd for inj 4,000 IU
Packing/Price
1's;25 × 1's
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