ARANESP- darbepoetin alfa injection, solution ARANESP- darbepoetin alfa solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

DARBEPOETIN ALFA (UNII: 15UQ94PT4P) (DARBEPOETIN ALFA - UNII:15UQ94PT4P)

Available from:

Amgen Inc

INN (International Name):

DARBEPOETIN ALFA

Composition:

DARBEPOETIN ALFA 10 ug in 0.4 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Aranesp is indicated for the treatment of anemia due to chronic kidney disease (CKD), including patients on dialysis and patients not on dialysis. Aranesp 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. Aranesp has not been shown to improve quality of life, fatigue, or patient well-being. Aranesp 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 with cancer receiving myelosuppressive chemotherapy in whom the anemia can be managed by transfusion. •       As a substitute for RBC transfusions in patients who require immediate correction o

Product summary:

Store at 36ºF to 46ºF (2ºC to 8ºC). Do not freeze. Do not shake. Protect from light; store Aranesp in the carton until use. Do not use Aranesp that has been shaken or frozen. Aranesp is a clear, colorless solution available in the following packages: Single - dose Vial Single - dose Prefilled Syringe (SingleJect ® ) with a 27-gauge, ½-inch needle with an UltraSafe® Needle Guard that is manually activated to cover the needle during disposal

Authorization status:

Biologic Licensing Application

Patient Information leaflet

ARANESP- DARBEPOETIN ALFA SOLUTION
Amgen Inc
----------
MEDICATION GUIDE
Aranesp® (Air-uh-nesp)
(darbepoetin alfa)
Read this Medication Guide:
•
before you start Aranesp.
•
if you are told by your healthcare provider that there is new
information about Aranesp.
•
if you are told by your healthcare provider that you may inject
Aranesp 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
Aranesp and ask if there is new information about Aranesp.
What is the most important information I should know about Aranesp?
Aranesp 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 Aranesp. Your
healthcare provider will talk with you about these risks.
For all people who take Aranesp, 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 Aranesp 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 Aranesp.
If you are receiving
Aranesp 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

Summary of Product characteristics

ARANESP- DARBEPOETIN ALFA INJECTION, SOLUTION
ARANESP- DARBEPOETIN ALFA SOLUTION
AMGEN INC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ARANESP SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR ARANESP.
ARANESP (DARBEPOETIN ALFA) INJECTION, FOR INTRAVENOUS OR SUBCUTANEOUS
USE
INITIAL U.S. APPROVAL: 2001
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, ARANESP DOSE, OR
DOSING STRATEGY THAT DOES NOT
INCREASE THESE RISKS (2.2).
USE THE LOWEST ARANESP 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 (2.3).
USE ESAS ONLY FOR ANEMIA FROM MYELOSUPPRESSIVE CHEMOTHERAPY (1.2).
ESAS ARE NOT INDICATED FOR PATIENTS RECEIVING MYELOSUPPRESSIVE
CHEMOTHERAPY WHEN THE ANTICIPATED
OUTCOME IS CURE (1.3).
DISCONTINUE FOLLOWING THE COMPLETION OF A CHEMOTHERAPY COURSE (2.3).
RECENT MAJOR CHANGES
Warnings and Precautions, Increased Mortality and/or Increased Risk of
Tumor Progression or Recurrence in Patients
with Cancer (5.2) 1/2019
INDICATIONS AND USAGE
Aranesp is an erythropoiesis-stimulating agent (ESA) indicated for the
treatment of anemia due to:
Chronic Kidney Disease (CKD) in patients on dialysis and patients not
on dialysis (1.1).
The effects of concomitant myelosuppres