MIRCERA- methoxy polyethylene glycol-epoetin beta injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Genentech, Inc.

INN (International Name):

Methoxy polyethylene glycol-epoetin beta

Composition:

Methoxy polyethylene glycol-epoetin beta 50 ug in 0.3 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Mircera is indicated for the treatment of anemia associated with chronic kidney disease (CKD) in adult patients on dialysis and patients not on dialysis. Mircera is not indicated and is not recommended: - In the treatment of anemia due to cancer chemotherapy [see Warnings and Precautions (5.2)] - As a substitute for RBC transfusions in patients who require immediate correction of anemia [see Clinical Pharmacology (12.2)] Mircera has not been shown to improve symptoms, physical functioning or health-related quality of life. Mircera is contraindicated in patients with: - Uncontrolled hypertension [see Warnings and Precautions (5.3)] - Pure red cell aplasia (PRCA) that begins after treatment with Mircera or other erythropoietin protein drugs [see Warnings and Precautions (5.6)] - History of serious or severe allergic reactions to Mircera (e.g. anaphylactic reactions, angioedema, bronchospasm, skin rash, and urticaria). Risk Summary There are no adequate and well-controlled studies in pregnant women. Mircera

Product summary:

Mircera is available in single-use 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 Use Prefilled Syringe (PFS) with a Needle Guard. A 27 Gauge, ½ Inch Needle is also provided: The recommended storage temperature is at 2°C to 8°C (36°F to 46°F). Do not freeze or shake. Protect from light. Keep Mircera in the original package until use. Storage of prefilled syringes over the recommended temperature (2°C to 8°C), when necessary, is permissible only for temperatures up to 25°C (77°F) and for no more than 30 days.

Authorization status:

Biologic Licensing Application

Patient Information leaflet

Genentech, Inc.
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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.
•
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. 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 trouble understandin

Summary of Product characteristics

MIRCERA- METHOXY POLYETHYLENE GLYCOL-EPOETIN BETA INJECTION, SOLUTION
GENENTECH, INC.
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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)
SOLUTION FOR INJECTION: INTRAVENOUS [IV] OR SUBCUTANEOUS [SC] USE
INITIAL U.S. APPROVAL: 2007
WARNINGS: 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 (5.1).
USE THE LOWEST MIRCERA DOSE SUFFICIENT TO REDUCE THE NEED FOR RED
BLOOD CELL (RBC) TRANSFUSIONS (5.1).
_CANCER:_
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 PATIENTS WITH BREAST, NON-SMALL CELL LUNG, HEAD
AND NECK, LYMPHOID, AND CERVICAL
CANCERS (5.2).
RECENT MAJOR CHANGES
Boxed Warning
10/2014
Indications and Usage (1.2)
10/2014
Dosage and Administration (2.1, 2.2)
10/2014
Contraindications (4)
10/2014
Warnings and Precautions
(5.1, 5.2, 5.3, 5.4, 5.6, 5.7, 5.8, 5.9)
10/2014
INDICATIONS AND USAGE
Mircera is an erythropoiesis-stimulating agent (ESA) indicated for the
treatment of anemia associated with chronic kidney
disease (CKD in adult patients on dialysis and patients not on
dialysis (1.1