Epoetin IV/SC Injection

Indications

Epoetin is classified as an erythropoiesis-stimulating agent (ESA) and is indicated for the following conditions:

• Anemia Treatment:
  • Anemia associated with Chronic Kidney Disease (CKD), for both dialysis and non-dialysis patients.
  • Anemia resulting from Zidovudine treatment in individuals with HIV.
  • Anemia due to the side effects of myelosuppressive chemotherapy, with at least two additional months of planned chemotherapy following initiation.
• Surgical Use:
  • Reducing the need for allogeneic red blood cell (RBC) transfusions in patients undergoing elective, non-cardiac, non-vascular surgeries.
• Infant Care:
  • Prevention of anemia of prematurity in infants weighing between 750 to 1500 grams and born before 34 weeks of gestational age.

Consult a registered physician for medication use.

Description

Epoetin is a recombinant form of human erythropoietin (EPO), produced in Chinese hamster ovary cells. It shares a 165-amino-acid sequence identical to that of human urinary EPO and is functionally indistinguishable from it. The molecular weight of erythropoietin is approximately 30,400 daltons.

Dosage Guidelines

Iron Status Evaluation:

Before and during Epoetin treatment, assess iron levels in all patients to ensure iron repletion. Address other potential causes of anemia, such as vitamin deficiencies or chronic inflammatory conditions, prior to starting Erythropoietin alfa.

Patients with CKD:

• Monitoring: For CKD patients, monitor hemoglobin levels weekly upon initiating or adjusting therapy until stability is achieved, then at least monthly. Adjust therapy based on hemoglobin changes, responsiveness to ESA, and variability. Avoid increasing the dose more frequently than every four weeks; decreases can be made more often.
• Rapid Response Management: If hemoglobin rises quickly (over 1 g/dL in any two-week span), reduce the Erythropoietin alfa dose by at least 25%. If no adequate response is noted (less than 1 g/dL increase after four weeks), consider increasing the dose by 25%. For those who do not respond adequately after a 12-week escalation, further increases are unlikely to be beneficial and may pose additional risks. Always use the lowest effective dose to maintain sufficient hemoglobin levels to minimize RBC transfusions.
• Dialysis Patients: Begin Erythropoietin alfa treatment when hemoglobin is below 10 g/dL. If hemoglobin approaches or exceeds 11 g/dL, reduce or pause Erythropoietin alfa dosing. The typical starting dose for adults is 50 to 100 units/kg administered three times weekly, either intravenously or subcutaneously. For pediatric patients, a starting dose of 50 units/kg three times weekly is recommended, with intravenous administration preferred for hemodialysis patients.
• Non-Dialysis Patients: Initiate Erythropoietin alfa for non-dialysis CKD patients when hemoglobin is less than 10 g/dL, considering the rate of hemoglobin decline and the goal of minimizing RBC transfusions. If hemoglobin exceeds 10 g/dL, adjust the Erythropoietin alfa dose downwards.

Zidovudine-Treated HIV Patients:

The recommended starting dose for adults is 100 units/kg administered intravenously or subcutaneously three times weekly. If there is no increase in hemoglobin after eight weeks, adjust the dose by 50 to 100 units/kg every four to eight weeks until the desired level is reached, or a maximum of 300 units/kg.

Cancer Patients Undergoing Chemotherapy:

Erythropoietin alfa should be initiated in cancer patients receiving chemotherapy only when hemoglobin is less than 10 g/dL, with a minimum of two additional months of planned treatment. Use the lowest effective dose to prevent RBC transfusions:

• Adults: 150 units/kg subcutaneously three times weekly or 40,000 units weekly until chemotherapy is complete.
• Pediatric Patients (5 to 18 years): 600 units/kg intravenously weekly until the chemotherapy course is finished.

Prevention of Anemia of Prematurity:

Administer Erythropoietin alfa subcutaneously at a dosage of 3 x 250 IU/kg body weight weekly, starting as early as day 3 of life. Infants who received a transfusion prior to treatment initiation may not benefit as much from this therapy, which should continue for six weeks.

Consult a registered physician for medication use.

Administration

Preparation and Administration Guidelines:

• Avoid shaking; do not use Erythropoietin alfa that has been shaken or frozen.
• Protect the syringe from light.
• Visually inspect parenteral drug products for any particulate matter or discoloration prior to administration. Discard any syringes that show any abnormalities.

Consult a registered physician for medication use.

Drug Interactions

Currently, there are no significant known drug interactions. However, the effect of Epoetin may be enhanced by administering a haematinic agent, such as ferrous sulfate, in cases of deficiency.

Contraindications

• Uncontrolled hypertension.
• Severe allergic reactions to Erythropoietin alfa.
• Patients who develop Pure Red Cell Aplasia (PRCA) following treatment with any erythropoietin should not receive Erythropoietin alfa or any other erythropoietin.

Side Effects

In clinical studies, common adverse reactions (5% of patients) included:

• CKD Patients: Hypertension, muscle spasms, arthralgia, fever, dizziness, vascular occlusion, and respiratory infections.
• HIV Patients on Zidovudine: Fever, cough, rash, and injection site irritation.
• Cancer Patients on Chemotherapy: Nausea, vomiting, myalgia, arthralgia, cough, weight loss, leukopenia, and others.
• Surgical Patients: Nausea, vomiting, pruritus, headache, and hypertension.
• Premature Infants: A significant decrease in serum ferritin values is often observed.

Pregnancy and Lactation

Due to a lack of well-controlled studies in pregnant women and evidence of reproductive toxicity in animals, Erythropoietin alfa should be used during pregnancy only when the potential benefits outweigh the risks to the fetus. It is not recommended for pregnant or lactating patients involved in autologous blood donation programs.

The excretion of Erythropoietin alfa in human milk is unknown. Caution is advised when administering Erythropoietin alfa to nursing women, and the decision to continue breastfeeding or the therapy should be made considering the benefits to both the child and the mother.

Overdose Effects

Epoetin has a broad therapeutic margin. Overdosing may lead to elevated hemoglobin levels, which can be managed by reducing or discontinuing Epoetin and, if necessary, by phlebotomy. Severe hypertension has been reported following ESA overdose.

Therapeutic Class

Medications for Haemolytic Hypoplastic & Renal Anemia

Storage Conditions

Store Epoetin at temperatures between 2ºC and 8ºC. Avoid freezing and shaking. Keep in the original packaging to protect from light until administration.