MIRCERA- methoxy polyethylene glycol-epoetin beta injection, solution

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

Methoxy polyethylene glycol-epoetin beta (UNII: LR3UXN0193) (Methoxy polyethylene glycol-epoetin beta - UNII:LR3UXN0193)

제공처:

Vifor (International) Inc.

INN (International Name):

Methoxy polyethylene glycol-epoetin beta

구성:

Methoxy polyethylene glycol-epoetin beta 30 ug in 0.3 mL

관리 경로:

INTRAVENOUS

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

Mircera is indicated for the treatment of anemia associated with chronic kidney disease (CKD) in: Limitations of Use Mircera is not indicated and is not recommended: Mircera has not been shown to improve symptoms, physical functioning, or health-related quality of life. Mircera is contraindicated in patients with: Risk Summary Available data from a small number of published case reports and postmarketing experience with Mircera use in pregnancy are insufficient to identify a drug associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Chronic kidney disease is associated with maternal and embryo-fetal risks (see Clinical Considerations) . In animal reproduction studies, administration of methoxy polyethylene glycol-epoetin beta to rats and rabbits during pregnancy and lactation adversely affected offspring at doses 17-fold and greater than the recommended human dose (see Data) . The estimated background risk of major birth defects and miscarriage for the indicated populatio

제품 요약:

Mircera (methoxy polyethylene glycol-epoetin beta) injection is available in single-dose prefilled syringes. The syringe plungers are designated with unique colors for each dosage strength. The prefilled syringes are supplied with a 27 gauge, ½ inch needle. To reduce the risk of accidental needlesticks after application, each prefilled syringe is equipped with a needle guard that covers the needle during disposal. Mircera is available in the following pack sizes: Single-Dose Prefilled Syringe with a Needle Guard. A 27 Gauge, ½ inch Needle is also provided: One Prefilled Syringe/Pack NDC number 30 mcg/0.3 mL NDC 59353-400-09 50 mcg/0.3 mL NDC 59353-401-09 75 mcg/0.3 mL NDC 59353-402-09 100 mcg/0.3 mL NDC 59353-403-09 120 mcg/0.3 mL NDC 59353-407-09 150 mcg/0.3 mL NDC 59353-404-09 200 mcg/0.3 mL NDC 59353-405-09 250 mcg/0.3 mL NDC 59353-406-09 360 mcg/0.6 mL NDC 59353-408-09 Store Mircera refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light. Do not freeze or shake. The end-user may store the product at room temperature up to 25°C (77°F) in the original carton up to 30 days. Discard after 30 days.

승인 상태:

Biologic Licensing Application

환자 정보 전단

MIRCERA- METHOXY POLYETHYLENE GLYCOL-EPOETIN BETA INJECTION, SOLUTION
Vifor (International) Inc.
----------
MEDICATION GUIDE
MIRCERA® (mir-SER-ah)
(methoxy polyethylene glycol-epoetin beta)
Read this Medication Guide:
•
before you start Mircera.
•
if you are told by your healthcare provider that there is new
information about Mircera.
•
if you are told by your healthcare provider that you may inject
Mircera 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 Mircera and
ask if there is new information about Mircera.
What is the most important information I should know about Mircera?
Mircera may cause serious side effects that can lead to death,
including:
For people with cancer:
•
Mircera is not for use to treat anemia that is caused by cancer
chemotherapy. If you have certain
cancers, your tumor may grow faster and you may die sooner if you take
Mircera.
For all people who take Mircera:
•
Serious heart problems, such as heart attack or heart failure, and
stroke. You may die sooner if you
are treated with Mircera 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 Mircera.
If you are receiving Mircera
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 shortness of breath
o
Pain in your legs, with

제품 특성 요약

MIRCERA- METHOXY POLYETHYLENE GLYCOL-EPOETIN BETA INJECTION, SOLUTION
VIFOR (INTERNATIONAL) INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
MIRCERA SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR MIRCERA.
MIRCERA (METHOXY POLYETHYLENE GLYCOL-EPOETIN BETA) INJECTION, FOR
INTRAVENOUS OR
SUBCUTANEOUS USE
INITIAL U.S. APPROVAL: 2007
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:_
•
•
RECENT MAJOR CHANGES
Dosage and Administration (2.2)
03/2023
INDICATIONS AND USAGE
Mircera is an erythropoiesis-stimulating agent (ESA) indicated for the
treatment of anemia associated with
chronic kidney disease (CKD) in:
•
•
Limitations of Use
Mircera is not indicated and is not recommended for use:
•
•
Mircera has not been shown to improve quality of life, fatigue, or
patient well-being.
DOSAGE AND ADMINISTRATION
In adult patients, Mircera is administered by subcutaneous or
intravenous injection (2.2).
•
®
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 (5.1).
USE THE LOWEST MIRCERA DOSE SUFFICIENT TO REDUCE THE NEED FOR RED
BLOOD CELL (RBC)
TRANSFUSIONS (5.1).
MIRCERA IS NOT INDICATED AND IS NOT RECOMMENDED FOR THE TREATMENT OF
ANEMIA DUE
TO CANCER CHEMOTHERAPY. A DOSE-RANGING STUDY OF MIRCERA WAS TERMINATED
EARLY
BECAUSE OF MORE DEATHS AMONG PATIENTS RECEIVING MIRCERA THAN ANOTHER
ESA (5.2).
ESAS SHORTENED OVERALL SURVIVAL AND/OR INCREASED THE RISK OF TUMOR
PROGRESSION OR
RECURRENCE IN CLINICAL STUDIES IN PATIENT