PROCRIT- erythropoietin injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Erythropoietin (UNII: 64FS3BFH5W) (Erythropoietin - UNII:64FS3BFH5W)

Available from:

Physicians Total Care, Inc.

INN (International Name):

Erythropoietin

Composition:

Erythropoietin 10000 [iU] in 1 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

PROCRIT is indicated for the treatment of anemia due to chronic kidney disease (CKD), including patients on dialysis and not on dialysis to decrease the need for red blood cell (RBC) transfusion. PROCRIT is indicated for the treatment of anemia due to zidovudine administered at ≤ 4200 mg/week in HIV-infected patients with endogenous serum erythropoietin levels of ≤ 500 mUnits/mL. PROCRIT is indicated for the treatment of anemia in patients with non-myeloid malignancies where anemia is due to the effect of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy. PROCRIT is indicated to reduce the need for allogeneic RBC transfusions among patients with perioperative hemoglobin > 10 to ≤ 13 g/dL who are at high risk for perioperative blood loss from elective, noncardiac, nonvascular surgery. PROCRIT is not indicated for patients who are willing to donate autologous blood pre-operatively. PROCRIT has not been shown to improve quality of

Product summary:

Store at 36°F to 46°F (2°C to 8°C). Do not freeze. Do not shake. Protect from light; store PROCRIT in the carton until use. Do not use PROCRIT that has been shaken or frozen. Single-dose, Preservative-free Vial: Each 1 mL of solution contains 10,000 Units (NDC 54868-2523-1) of epoetin alfa. Each strength is supplied in cartons, each carton containing 6 single-dose vials. Single-dose, Preservative-free Vial (in phosphate-buffered formulation): Each 1 mL of solution contains 40,000 Units (NDC 54868-5802-0) of epoetin alfa and is supplied in dispensing packs containing 4 single-dose vials. Multidose, Preserved Vial: 1 mL (20,000 Units/mL). Each 1 mL of solution contains 20,000 Units (NDC 54868-5673-1) of epoetin alfa and is supplied in dispensing packs containing 4 multidose vials.

Authorization status:

Biologic Licensing Application

Patient Information leaflet

PROCRIT - ERYTHROPOIETIN INJECTION, SOLUTION
Physicians Total Care, Inc.
----------
MEDICATION GUIDE
PROCRIT® (PRO'–KRIT)
(epoetin alfa)
Read this Medication Guide:
•
before you start PROCRIT.
•
if you are told by your healthcare provider that there is new
information about PROCRIT.
•
if you are told by your healthcare provider that you may inject
PROCRIT at home, read this
Medication Guide each time you receive a new supply of medicine.
This Medication Guide does not take the place of talking to your
healthcare provider about your medical
condition or your treatment. Talk with your healthcare provider
regularly about the use of PROCRIT and
ask if there is new information about PROCRIT.
What is the most important information I should know about PROCRIT?
Using PROCRIT can lead to death or other serious side effects.
For patients with cancer:
Your healthcare provider has received special training through the ESA
APPRISE Oncology Program in
order to prescribe PROCRIT. Before you can begin to receive PROCRIT,
you must sign the patient-
healthcare provider acknowledgment form. When you sign this form, you
are stating that your healthcare
provider talked with you about the risks of taking PROCRIT.
These risks include that your tumor may grow faster and you may die
sooner if you choose to take
PROCRIT.
You should talk with your healthcare provider about:
•
Why PROCRIT treatment is being prescribed for you.
•
What are the chances you will get red blood cell transfusions if you
do not take PROCRIT.
•
What are the chances you will get red blood cell transfusions even if
you take PROCRIT.
•
How taking PROCRIT may affect the success of your cancer treatment.
After you have finished your chemotherapy course, PROCRIT treatment
should be stopped.
For all patients who take PROCRIT, including patients with cancer or
chronic kidney disease:
•
If you decide to take PROCRIT, your healthcare provider should
prescribe the smallest dose of
PROCRIT that is needed to reduce your chance of getting red blood cell
transfu

Summary of Product characteristics

PROCRIT - ERYTHROPOIETIN INJECTION, SOLUTION
PHYSICIANS TOTAL CARE, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
PROCRIT SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR PROCRIT.
PROCRIT
(EPOETIN ALFA)
INJECTION, FOR INTRAVENOUS OR SUBCUTANEOUS USE
INITIAL U.S. APPROVAL: 1989
WARNING: ESAS INCREASE THE RISK OF DEATH, MYOCARDIAL INFARCTION,
STROKE, VENOUS
THROMBOEMBOLISM, THROMBOSIS OF VASCULAR ACCESS AND TUMOR PROGRESSION
OR
RECURRENCE
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
_CHRONIC KIDNEY DISEASE:_
IN CONTROLLED TRIALS, PATIENTS EXPERIENCED GREATER RISKS FOR DEATH,
SERIOUS ADVERSE CARDIOVASCULAR
REACTIONS, AND STROKE WHEN ADMINISTERED ERYTHROPOIESIS-STIMULATING
AGENTS (ESAS) TO TARGET A
HEMOGLOBIN LEVEL OF GREATER THAN 11 G/DL (5.1).
NO TRIAL HAS IDENTIFIED A HEMOGLOBIN TARGET LEVEL, ESA DOSE, OR DOSING
STRATEGY THAT DOES NOT INCREASE
THESE RISKS.
USE THE LOWEST PROCRIT DOSE SUFFICIENT TO REDUCE THE NEED FOR RED
BLOOD CELL (RBC) TRANSFUSIONS (5.1).
_CANCER:_
ESAS SHORTENED OVERALL SURVIVAL AND/OR INCREASED THE RISK OF TUMOR
PROGRESSION OR RECURRENCE IN
CLINICAL STUDIES OF PATIENTS WITH BREAST, NON-SMALL CELL LUNG, HEAD
AND NECK, LYMPHOID, AND CERVICAL
CANCERS (TABLE 2, 5.3).
PRESCRIBERS AND HOSPITALS MUST ENROLL IN AND COMPLY WITH THE ESA
APPRISE ONCOLOGY PROGRAM TO
PRESCRIBE AND/OR DISPENSE PROCRIT TO PATIENTS WITH CANCER (5.2).
USE THE LOWEST DOSE TO AVOID RBC TRANSFUSIONS (2.4).
USE ESAS ONLY FOR ANEMIA FROM MYELOSUPPRESSIVE CHEMOTHERAPY (1.5).
ESAS ARE NOT INDICATED FOR PATIENTS RECEIVING MYELOSUPPRESSIVE
CHEMOTHERAPY WHEN THE ANTICIPATED
OUTCOME IS CURE (1.5).
DISCONTINUE FOLLOWING THE COMPLETION OF A CHEMOTHERAPY COURSE (2.4).
_PERISURGERY:_
DUE TO INCREASED RISK OF DEEP VENOUS THROMBOSIS (DVT), DVT PROPHYLAXIS
IS RECOMMENDED (5.1).
RECENT MAJOR CHANGES
Dosage and Administration: Surgery Patients (2.5)
05/2012
INDICATIONS AND USAGE
PROCRIT is an erythropoiesis-stimulating agent (ESA) indicated for