RETACRIT- epoetin alfa-epbx injection, solution

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

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

Dostopno od:

Vifor (International) Inc.

Pot uporabe:

INTRAVENOUS

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

RETACRIT 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. RETACRIT is indicated for the treatment of anemia due to zidovudine administered at ≤ 4,200 mg/week in patients with HIV-infection with endogenous serum erythropoietin levels of ≤ 500 mUnits/mL. RETACRIT 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. RETACRIT 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. RETACRIT is not indicated for patients who are willing to donate autologous blood pre-operatively. RETACRIT has not been shown to improv

Povzetek izdelek:

RETACRIT (epoetin alfa-epbx) injection is a sterile, clear, and colorless solution in single-dose and multiple-dose vials available as: NDC 59353-002-10 Carton containing 10 vials 2,000 Units/mL NDC 59353-002-01 1 mL Single-dose vial NDC 59353-003-10 Carton containing 10 vials 3,000 Units/mL NDC 59353-003-01 1 mL Single-dose vial NDC 59353-004-10 Carton containing 10 vials 4,000 Units/mL NDC 59353-004-01 1 mL Single-dose vial NDC 59353-010-10 Carton containing 10 vials 10,000 Units/mL NDC 59353-010-01 1 mL Single-dose vial NDC 59353-120-10 Carton containing 10 vials with a freeze strip indicator 20,000 Units/mL NDC 59353-120-01 1 mL Multiple-dose vial NDC 59353-220-10 Carton containing 10 vials with a freeze strip indicator 20,000 Units/ 2 mL (10,000 Units/mL) NDC 59353-220-01 2 mL Multiple-dose vial Store refrigerated at 2°C to 8°C (36°F to 46°F). Do not freeze. When exposed to freezing temperatures, the green area of the freeze strip indicator in the carton of the multiple-dose vials will show signs of cloudy or white discoloration. Do not shake. Do not use RETACRIT that has been shaken or frozen or if the green area of the freeze strip indicator is cloudy or white. Store RETACRIT vials in the original carton until use to protect from light. The vial stopper used for RETACRIT is not made with natural. rubber latex.

Status dovoljenje:

Biologic Licensing Application

Navodilo za uporabo

Vifor (International) Inc.
----------
This Medication Guide has been approved by the U.S. Food and
Drug Administration.
Revised: 8/2020
MEDICATION GUIDE
RETACRIT® (Ret-uh-krit)
(epoetin alfa-epbx)
Read this Medication Guide:
•
before you start RETACRIT.
•
if you are told by your healthcare provider that there is new
information about RETACRIT.
•
if you are told by your healthcare provider that you may inject
RETACRIT 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 RETACRIT
and ask if there is new information about RETACRIT.
What is the most important information I should know about RETACRIT?
RETACRIT 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 RETACRIT. Your
healthcare provider will talk with you about these risks.
For all people who take RETACRIT, 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 RETACRIT 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 RETACRIT.
If you are receiving
RETACRIT 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:
o
Chest pain
o
Trouble breathing or

Lastnosti izdelka

RETACRIT- EPOETIN ALFA-EPBX INJECTION, SOLUTION
VIFOR (INTERNATIONAL) INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
RETACRIT SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR RETACRIT.
RETACRIT (EPOETIN ALFA-EPBX) INJECTION, FOR INTRAVENOUS OR
SUBCUTANEOUS USE
INITIAL U.S. APPROVAL: 2018
RETACRIT (EPOETIN ALFA-EPBX) IS BIOSIMILAR TO EPOGEN/PROCRIT (EPOETIN
ALFA)
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:_
•
•
•
_CANCER:_
•
•
•
•
•
_PERISURGERY:_
•
RECENT MAJOR CHANGES
Dosage and Administration, Preparation and Administration (2.6)
4/2023
INDICATIONS AND USAGE
RETACRIT is an erythropoiesis-stimulating agent (ESA) indicated for:
•
•
Limitations of Use
®
*
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 RETACRIT DOSE SUFFICIENT TO REDUCE THE NEED FOR RED
BLOOD CELL
(RBC) TRANSFUSIONS (5.1).
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).
DUE TO INCREASED RISK OF DEEP VENOUS THROMBOSIS (DVT), DVT PROPHYLAXIS
IS
RECOMMEND