Procrit (erythropoietin)
PROCRIT (erythropoietin) – an erythropoiesis-stimulating agent (ESA) commonly used to treat certain types of anemia, and for reduction of the need for allogenic RBC transfusions. The mechanism by which Procrit stimulates erythropoiesis is the same mechanism as seen with endogenous erythropoietin.
FDA approved uses: Procrit is indicated for –
• Treatment of anemia due to Chronic Kidney Disease (CKD) in patients on dialysis and not on dialysis.
• Treatment of anemia caused by Zidovudine in HIV-infected patients.
• Treatment of anemia caused by the effects of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum two months of planned additional chemotherapy.
• Reduction of allogenic red blood cell (RBC) transfusions in patients undergoing elective, noncardiac, nonvascular surgery.
Important limitations of use – Procrit has not been shown to improve quality of life, fatigue, or patient well-being. Procrit is not indicated for use: In patients with cancer receiving hormonal agents, biologic products, or radiotherapy, unless also receiving concomitant myelosuppressive chemotherapy; In patients with cancer receiving myelosuppressive chemotherapy when the anticipated outcome is cure; In patients scheduled for surgery who are willing to donate autologous blood; In patients undergoing cardiac or vascular surgery.
Available dosage forms: Single-dose vial: 2000, 3000, 4000, 10,000, and 40,000 Units/1 mL; Multidose vial containing benzyl alcohol: 20,000 Units/2 mL and 20,000 Units/1 mL.
Usual dosage: CKD Patients – Initial dose: 50 to 100 Units/kg 3 times weekly (adults) and 50 Units/kg 3 times weekly (children on dialysis). Individualize maintenance dose. Intravenous route recommended for patients on hemodialysis; Zidovudine-treated HIV-infected Patients – 100 Units/kg 3 times weekly; Cancer Patients on Chemotherapy – 40,000 Units weekly or 150 Units/kg 3 times weekly (adults); 600 Units/kg intravenously weekly (children ≥ 5 years); Surgery Patients – 300 Units/kg per day daily for 15 days or 600 Units/kg weekly.
Contraindications: Do not administer to patients with uncontrolled hypertension, pure red cell aplasia (PRCA) that begins after treatment with Procrit or other erythropoiesis stimulating agents, and patients with serious allergic reactions to Procrit. Also do not use multi-dose vials in neonates, infants, pregnant women, and nursing mothers.
Special Warnings: Increased Mortality, Myocardial Infarction, Stroke, and Thromboembolism – Using ESAs to target a hemoglobin level of greater than 11 g/dL increases the risk of serious adverse cardiovascular reactions and has not been shown to provide additional benefit. Use caution in patients with coexistent cardiovascular disease and stroke. Increased Mortality and/or Increased Risk of Tumor Progression or Recurrence in Patients With Cancer has been reported. Hypertension – Control hypertension prior to initiating and during treatment with PROCRIT. Seizures – PROCRIT increases the risk for seizures in patients with CKD. Increase monitoring of these patients for changes in seizure frequency or premonitory symptoms.
Adverse reactions (side effects) of these medications: The most common side effects of Procrit include hypertension, arthralgia, muscle spasm, pyrexia, dizziness, medical device malfunction, vascular occlusion, cough, rash injection site irritation, and upper respiratory tract infection. Adverse reactions seen in clinical trials of cancer patients on chemotherapy include: nausea, vomiting, myalgia, arthralgia, stomatitis, cough, weight decrease, leukopenia, bone pain, rash, hyperglycemia, insomnia, headache, depression, dysphagia, hypokalemia, and thrombosis.
Common drug interactions: The manufacturer states that no formal drug interaction studies have been conducted with Procrit.
Special instructions for patients: Read the Medication Guide that comes with Procrit and discuss any questions or concerns with your healthcare provider before starting and at regular intervals while receiving Procrit. Undergo regular blood pressure monitoring, adhere to anti-hypertensive regimen and follow recommended dietary restrictions. Contact healthcare provider for newly developed neurologic symptoms or if you experience a change in seizure frequency.
Full prescribing information may be found at the manufacturer‘s official website Procrit.com or at the U.S. Food and Drug Administration’s website at Procrit Info at Drugs@FDA