Procrit


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Procrit

 [pro´krit]
trademark for a preparation of epoetin alfa, used to treat anemia from various causes.

epoetin alfa

Epogen, Eprex (CA) (UK), Procrit

Pharmacologic class: Recombinant human erythropoietin

Therapeutic class: Biological response modifier

Pregnancy risk category C

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 kidney disease (CKD) in patients on dialysis or not on dialysis

Adults: Initially, 50 to 100 units/kg I.V. or subcutaneously three times weekly. Don't increase dosage more frequently than once q 4 weeks. May decrease dosage more frequently but avoid frequent dosage adjustments.

Anemia in children with chronic CKD who are on dialysis

Children ages 1 month to 16 years: Initially, 50 units/kg I.V. or subcutaneously three times weekly. Don't increase dosage more frequently than once q 4 weeks. May decrease dosage more frequently but avoid frequent dosage adjustments.

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 due to effects of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy

Adults: 150 units/kg subcutaneously three times weekly until completion of a chemotherapy course, or 40,000 units subcutaneously weekly until completion of a chemotherapy course Children ages 5 to 18: 600 units/kg I.V. weekly until completion of a chemotherapy course

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

Contraindications

• Serious allergic reactions
• Uncontrolled hypertension
• Pure red cell aplasia that begins after treatment
• Use of multidose vials in neonates, infants, and pregnant and breastfeeding patients

Precautions

Use cautiously in:
• renal insufficiency, CV disease
• pregnant or breastfeeding patients
• children younger than age 1 month (safety and efficacy not established).

Administration

• Don't shake drug and don't use if it has been shaken or frozen.
• Don't dilute or mix with other drug solutions. However, preservative-free epoetin alfa from single-use vials may be admixed in a syringe with bacteriostatic 0.9% sodium chloride injection with benzyl alcohol 0.9% (bacteriostatic saline) in a 1:1 ratio using aseptic technique at time of administration; keep in mind that risks are associated with benzyl alcohol use in some patients.
• Don't reenter preservative-free vials.
• For patients with CKD on dialysis, start drug when hemoglobin level is less than 10 g/dl. If hemoglobin level approaches or exceeds 11 g/dl, reduce dosage or interrupt dosing.
• For patients with CKD not on dialysis, consider starting drug only when hemoglobin level is less than 10 g/dl and the following considerations apply: Rate of hemoglobin decline indicates the likelihood of requiring an RBC transfusion and reducing the risk of alloimmunization or other RBC transfusion-related risks is a goal. If hemoglobin level exceeds 10 g/dl, reduce dosage or interrupt dosing and use lowest dosage sufficient to reduce the need for RBC transfusions.
• Be aware that in patients undergoing surgery, deep venous thrombosis prophylaxis is strongly recommended during epoetin alfa therapy.
• 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 neonates, infants, and pregnant and breastfeeding patients because of benzyl alcohol content, which has been associated with serious adverse events and death, including "gasping syndrome."

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

• Tell patient who will self-administer drug to follow exact directions for injection and needle disposal.

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.

Procrit

(prō′krĭt′)
A trademark for the drug epoetin alfa.

ProCrit®

Epoetin alpha Hematology Recombinant erythropoietin, used to treat anemias–eg, Hct 10–13 g/dL, anemia of chronic renal failure, perioperative transfusion, to ↓ blood transfusions in anemic Pts scheduled for elective noncardiac, nonvascular surgery, anemia linked to AZT-treatment of HIV Pts; anemia of prematurity Side effects Possibly HTN, hypersensitivity, thrombotic/vascular events. See Erythropoietin.
References in periodicals archive ?
Procrit is marketed and distributed by Ortho Biotech LP of Bridgewater, NJ, a subsidiary of Johnson & Johnson.
These new statements address the risks that the drugs Aranesp, Epogen and Procrit pose to patients with cancer and patients with kidney failure.
The warning also applies to Johnson & Johnson's Procrit.
In March, the Food and Drug Administration (FDA) issued a warning about the use of Aranesp, Epogen, and Procrit in all patients.
Food and Drug Administration (FDA) recently announced new warnings for some drugs used to treat anemia, including Procrit and Epogen (epoetin alfa), as well as Aranesp (darbepoetin alfa).
For 16 weeks, they gave Procrit, a brand of epoetin alfa, in a weekly injection to 58 volunteers who had less than 11.
FDA and Ortho Biotech warned of counterfeit Procrit, which may be dangerous because some has been found to contain bacteria, or have no active ingredient.
The committee has recommended the approval based on its evaluation of evidence showing comparable efficacy and safety of biosimilar epoetin alfa as against Epogen and Procrit.
The red blood cell counts can be enhanced by the periodic use of Aranesp or Procrit.
The medication guide is part of a Risk Evaluation and Mitigation Strategy (REMS) focusing specifically on erythropoiesis-stimulating agents (ESAs), including Procrit (epoetin alfa), Aranesp (darbepoetin alfa) and Epogen (epoetin alfa).
8 billion, as cheaper generics wrested away two-thirds of Risperdal sales and demand for anemia drugs Procrit and Eprex continued to wither due to safety concerns.