Epoetin Alfa Recombinant - @- Erythropoiesis Stimulating Agent - Hemotopietic Agents
Indication:
Anemia in cancer patients on chemotherapy
Adverse Reaction:
Adverse reactions-
CNS- asthenia 12% dizziness 4% parathesia 10%
GI - diarrhea 20% nausea 15% vomiting 15%
Respiratory - shortness of breath 12% upper respiratory tract infection 10%
Miscellaneous - edema 15% fatigue 12% pyrexia 27% trunk pain 2%
Contra-Indications:
Uncontrolled hypertension
Special Precautions/Warnings-
Increased mortality , serious cardiovascular and thromboembolic reactions-
Cancer patients- an increased incidence of thrombotic events has been observed in patients treated with cancer with erythropoetic agents
Chronic renal failure- patients with CRF experienced greater risk of death ansd serious
CV reactions when administered ESAs to target higher versus lower haemoglobin levels.
Surgery patients - an increased risk incidence of deep vein thrombosis in patients receiving epoetin alfa undrgoing surgical orthopedic procedures has been observed
Chronic renal procedures- seizures have occurred in patients with CRF participitating
in epoetin alfa clinical trials
Hematologic effects - exacerbation of porphyria has been observed rarely in patients with
CRF treated with epotin alfa. Use epoetin alfa with caution in patients with known porphyria
Bone marrow fibrosis - bone marrow is a known complications of CRF in humans and may be related to secondary hyperparathyroidism
Iron evaluation- during epoetin alfa therapy, absolute or funtional iron deficiency may develop. Proir to and during epoetin alfa therapy evaluate patients iron status, including transferrin saturation ( serum iron divided by iron binding capacity ) and serum ferritin.
Chronic renal failure- Diet- reinforce the importance of compliance with dietary and dialysis prescriptions
Hypersensitivity reactions- there have been rare reports of potentially serious allergic
reactions, including urticaria, with associated respiratory symptoms or circumoral edema
or urticaria alone.
Renal function impairment- in adult patients with CRF not on dialysis closely monitor renal function and fluid electrolyte balance.
Pregnancy- only use epoetin alfa during pregnancy if the potential benefit justifies the
potential risk to the fetus.
Lactation- excercise caution when epoetin alfa is administered to a breast feeding woman.
Children- excercise caution while administering epoetin alfa to children.
Elderly- individualize dose selection and adjustment for an elderly patient to acheive
and maintain hematocrit target.
Monitoring- take special care and closely monitor and aggresively control blood
pressure in patients treated with epoetin alfa , particularly in patients with a underlying
history of hypertension or CV disease, or who are in preoperative period
Dosages/ Overdosage Etc:
Indication-
Anemia in cancer patients on chemotherapy
Dosage-
Maximum dose
Children-
60,000 units once weekly for the treatment of anemia in cancer patients on
chemotherapy
Adults-
initial dose - 150units/kg subcutaneously 3 times a week or 40.000 units subcutaneously
weekly
Patient Information:
1. Inform patients of the increased risks of mortality, serious CV reactions, thromboembolic
reactions, and increased risk of tumor progressionor recurrence
2.Inform patients of the possible adverse reactions of epoetin alfa and of the signs and
symptoms of allergic drug reaction, and advice them of appropiate actions.
3. If home use is precscibed for dialysis patients, throughly instruct them the importance of
proper disposal and caution them against the reuse of needles , syringes, or drug product.
4. A puncture resistent container for the disposal of used syringes and needles should be
aviailable to the patient. Provide guidance on the disposal of full container
5. In some women, menses have resumed following eportin alfa therapy. Discuss the
possibilty of pregnancy and the need for contraception evaluation
6. Caution patients to avoid potentially hazardous activities such as driving, or
operating heavy machinery, during this period.
Pregnancy and lactation:
Pregnancy-
Only use epoetin alfa during pregnancy if the potential benefit justifies the
potential risk to the fetus.
Lactation-
Excercise caution when epoetin alfa is administered to a breast feeding woman.
Children-
Excercise caution while administering epoetin alfa to children.
Elderly-
Individualize dose selection and adjustment for an elderly patient to acheive
and maintain hematocrit target.