METHOXY POLYETHYLENE GLYCOL-EPOETIN BETA

Other

Brand names: Mircera

Intravenous

Mechanism of Action

12.1 Mechanism of Action Mircera is an erythropoietin receptor activator with greater activity in vivo as well as increased half-life, in contrast to erythropoietin. A primary growth factor for erythroid development, erythropoietin is produced in the kidney and released into the bloodstream in response to hypoxia. In responding to hypoxia, erythropoietin interacts with erythroid progenitor cells to increase red cell production. Production of endogenous erythropoietin is impaired in patients with CKD and erythropoietin deficiency is the primary cause of their anemia.

Indications

fatigue

physical functioning

or health-related quality of life.

Contraindications

• anaphylactic reactions
• angioedema
• bronchospasm
• skin rash
• and urticaria) [see Warnings and Precautions ( 5.7

FDA Warnings

5 WARNINGS AND PRECAUTIONS • Hypertension: Control hypertension prior to initiating and during treatment with Mircera ( 5
• Serious Allergic Reactions: Discontinue Mircera and manage reactions ( 5
3 g/dL), ESAs increased the risk of death, myocardial infarction, stroke, congestive heart failure, thrombosis of hemodialysis vascular access, and other thromboembolic events in the higher target groups
• Using ESAs to target a hemoglobin level of greater than 11 g/dL increases the risk of serious adverse cardiovascular reactions and has not been shown to provide additional benefit [see Clinical Studies ( 14 )]

Known Side Effects

7 documented side effects by frequency

Shortness of Breath

1-10%

Nausea

1-10%

Itching

1-10%

Vomiting

1-10%

Dizziness

0.1-1%

Rash

0.1-1%

Low Blood Pressure

0.1-1%

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Formulations

Dosage Forms

Tablet

Route

Intravenous