Eprex

e·po·e·tin al·fa (

-p

-t

)

A recombinant preparation of human erythropoietin used to treat some forms of anemia.

epoetin alfa

Epogen, Eprex (CA) (UK), Procrit

Pharmacologic class: Recombinant human erythropoietin

Therapeutic class: Biological response modifier

Pregnancy risk category C

FDA Boxed Warning

• Use lowest dosage that will gradually increase hemoglobin to lowest level sufficient to avoid need for red blood cell (RBC) transfusion.
• Drug may increase risk of death and serious cardiovascular events when given to target hemoglobin above 12 g/dL.
• Drug may shorten time to tumor progression in patients with advanced head and neck cancer receiving radiation therapy when given to target hemoglobin above 12 g/dL. It may shorten overall survival and increase deaths from disease progression at 4 months in patients with metastatic breast cancer receiving chemotherapy when given to target hemoglobin above 12 g/dL and may increase risk of death when given to target hemoglobin of 12 g/dL in patients with active cancer receiving neither chemotherapy nor radiation therapy. Drug isn't indicated for these patients.
• When drug is given preoperatively to reduce allogeneic RBC transfusions, higher incidence of deep vein thrombosis occurred in patients not receiving prophylactic anticoagulation.

Action

Binds to erythropoietin, stimulating mitotic activity of erythroid progenitor cells in bone marrow and causing release of reticulocytes from bone marrow into bloodstream, where they become mature RBCs

Availability

Injection: 2,000 units/ml, 3,000 units/ml, 4,000 units/ml, 10,000 units/ml; 10,000 units/ml and 20,000 units/ml in multidose vials

⊘Indications and dosages

➣ Anemia associated with chronic renal failure

Adults: Initially, 50 to 100 units/kg I.V. or subcutaneously three times weekly. May be increased after 8 weeks if hematocrit is still below target range.

➣ Anemia caused by zidovudine therapy in patients with human immunodeficiency virus infection

Adults: 100 units/kg I.V. or subcutaneously three times weekly for 8 weeks or until hematocrit level is adequate. If desired response isn't reached after 8 weeks, dosage may be increased by 50 to 100 units/kg I.V. or subcutaneously three times weekly; after 4 to 8 weeks, dosage may be further increased, as prescribed, to a maximum dosage of 300 units/kg I.V. or subcutaneously three times weekly.

➣ Anemia associated with cancer chemotherapy

Adults: 150 units/kg subcutaneously three times weekly for 8 weeks or until hematocrit level is adequate. If desired response isn't reached after 8 weeks, dosage may be increased to a maximum of 300 units/kg subcutaneously three times weekly.

➣ To reduce need for blood transfusion in surgical patients

Adults: 300 units/kg subcutaneously daily for 10 days before surgery, on day of surgery, and for 4 days after surgery; or 600 units/kg subcutaneously weekly starting 3 weeks before surgery, followed by additional dose on day of surgery

➣ Anemia in children with chronic renal failure who are on dialysis

Children ages 1 month to 16 years: 50 units/kg I.V. or subcutaneously three times weekly. Maintenance dosage is individualized to maintain hematocrit within target range.

Contraindications

• Hypersensitivity to drug, human albumin, or products derived from mammal cells
• Uncontrolled hypertension

Precautions

Use cautiously in:
• renal insufficiency
• pregnant or breastfeeding patients
• children.

Administration

• For I.V. use, give single dose by direct I.V. injection over at least 1 minute, and follow with saline flush.
• If patient is on hemodialysis, administer drug into venous return line of dialysis tubing after patient completes dialysis session.
• Know that supplemental iron may be needed to support erythropoiesis and avoid iron depletion.
☞ Avoid using multidose vials in premature infants because of benzyl alcohol content.

Route	Onset	Peak	Duration
I.V.	Immediate	Immediate	Unknown
Subcut.	Unknown	5-24 hr	Unknown

Adverse reactions

CNS: headache, paresthesia, fatigue, dizziness, asthenia, seizures

CV: hypertension, increased clotting of arteriovenous grafts

GI: nausea, vomiting, diarrhea

Metabolic: hyperuricemia, hyperphosphatemia, hyperkalemia

Musculoskeletal: joint pain

Respiratory: cough, dyspnea

Skin: rash, urticaria

Other: fever, edema, injection site pain

Interactions

Drug-diagnostic tests. Blood urea nitrogen, creatinine, phosphate, potassium, uric acid: increased levels

Patient monitoring

• Monitor vital signs and cardiovascular status, especially for hypertension and edema.
• Assess arteriovenous graft for patency, because drug may increase clotting at graft.
• Monitor electrolyte and uric acid levels. Watch closely for hyperuricemia, hyperkalemia, and hyperphosphatemia.
• Check temperature for fever.
• Monitor neurologic status for signs and symptoms of impending seizure.
• Evaluate nutritional status and hydration in light of GI adverse effects.

Patient teaching

☞ Instruct patient to monitor weight and blood pressure regularly and to immediately report hypertension, sudden weight gain, or swelling.
• Caution patient to avoid driving and other hazardous activities until he knows how drug affects concentration, motor skills, and alertness.
• Tell patient to minimize GI upset by eating small, frequent servings of food and drinking plenty of fluids.
• Advise female patient to discuss pregnancy or breastfeeding with prescriber before starting drug.
• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the tests mentioned above.