EPOGEN- epoetin alfa solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

EPOETIN (UNII: 64FS3BFH5W) (ERYTHROPOIETIN - UNII:64FS3BFH5W)

Available from:

Amgen Inc

INN (International Name):

ERYTHROPOIETIN

Composition:

ERYTHROPOIETIN 2000 [iU] in 1 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Epogen 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. Epogen is indicated for the treatment of anemia due to zidovudine administered at ≤ 4200 mg/week in patients with HIV-infection with endogenous serum erythropoietin levels of ≤ 500 mUnits/mL. Epogen 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. Epogen 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. Epogen is not indicated for patients who are willing to donate autologous blood pre-operatively. Epogen has not been shown to improve quality of

Product summary:

Epogen (epoetin alfa) injection is a sterile, clear, and colorless solution available as:  Preservative- f ree ,   s ingle- d ose v ial s (in citrate-buffered formulation) :  2,000 Units/mL (NDC 55513-126-10), 3,000 Units/mL (NDC 55513-267-10), 4,000 Units/mL (NDC 55513-148-10), or 10,000 Units/mL (NDC 55513-144-10)  supplied in dispensing packs containing ten 1 mL single-dose vials. Preserved,   m ulti ple - dose   v ial:  20,000 Units/2 mL (10,000 Units/mL) (NDC 55513-283-10) supplied in dispensing packs containing ten 2 mL multiple-dose vials. Preserved ,   m ulti ple- dose v ial: 20,000 Units/mL (NDC 55513-478-10) supplied in dispensing packs containing ten 1 mL multiple-dose vials. Store at 36o F to 46o F (2o C to 8o C). Do not freeze. Do not shake. Do not use Epogen that has been shaken or frozen. Store Epogen vials in the original carton until use to protect from light.

Authorization status:

Biologic Licensing Application

Patient Information leaflet

Amgen Inc
----------
MEDICATION GUIDE
Epogen® (Ee-po-jen)
(epoetin alfa)
Read this Medication Guide:
•
before you start Epogen.
•
if you are told by your healthcare provider that there is new
information about Epogen.
•
if you are told by your healthcare provider that you may inject Epogen
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
Epogen and ask if there is new information about Epogen.
What is the most important information I should know about Epogen?
Epogen may cause serious side effects that can lead to death,
including:
For people with cancer:
•
Your tumor may grow faster and you may die sooner if you choose to
take Epogen. Your
healthcare provider will talk with you about these risks.
For all people who take Epogen, including people with cancer or
chronic kidney disease:
•
Serious heart problems, such as heart attack or heart failure, and
stroke. You may die sooner if
you are treated with Epogen to increase red blood cells (RBCs) to near
the same level found in
healthy people.
•
Blood clots. Blood clots may happen at any time while taking Epogen.
If you are receiving
Epogen for any reason and you are going to have surgery, talk to your
healthcare provider
about whether or not you need to take a blood thinner to lessen the
chance of blood clots
during or following surgery. Blood clots can form in blood vessels
(veins), especially in your
leg (deep venous thrombosis or DVT). Pieces of a blood clot may travel
to the lungs and block
the blood circulation in the lungs (pulmonary embolus).
•
Call your healthcare provider or get medical help right away if you
have any of these
symptoms:
○ Chest pain
○ Trouble breathing or shortness of breath
○ Pain in your legs, with or without swelling
○ A cool or pale arm or leg
○ Sudden confusion, trouble speaking, or tro

Summary of Product characteristics

EPOGEN- EPOETIN ALFA SOLUTION
AMGEN INC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
EPOGEN SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR EPOGEN.
EPO G EN (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 (2.2).
USE THE LOWEST EPOGEN 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 (5.2).
USE THE LOWEST DOSE TO AVOID RBC TRANSFUSIONS (2.4).
USE ESAS ONLY FOR ANEMIA FROM MYELOSUPPRESSIVE CHEMOTHERAPY (1.3).
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, Patients with Chronic Kidney Disease
(2.2)
9/2017
• Warnings and Precautions, Increased Mortality and/or Increased
Risk of Tumor Progression or Recurrence in
Patients With Cancer (5.2)
7/2018
• Warnings and Precautions, Severe Cutaneous Reactions (5.8)
9/2017
• Warnings and Precautions, Risk of Serious A