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Mircera

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Mircera

Mircera

SIDE EFFECTS

The following serious adverse reactions are discussed in greater detail in other sections of the labeling:

  • Increased mortality, serious cardiovascular and thromboembolic events [see Warnings and PRECAUTIONS]
  • Increased mortality and/or tumor progression [see Warnings and PRECAUTIONS]
  • Hypertension [see Warnings and PRECAUTIONS]
  • Seizures [see Warnings and PRECAUTIONS]
  • Pure red cell aplasia [see Warnings and PRECAUTIONS]

The most commonly reported adverse reactions were hypertension [see Warnings and PRECAUTIONS], diarrhea, nasopharyngitis, headache, and upper respiratory tract infection. The most common adverse reactions that led to treatment discontinuation in the Mircera (methoxy polyethylene glycol-epoetin beta) clinical studies were: hypertension, coronary artery disease, anemia, concomitant termination of other chronic renal failure therapy and septic shock.

Clinical Trials Experience

The data described below reflect exposure to Mircera (methoxy polyethylene glycol-epoetin beta) in 2737 patients, including 1451 exposed for 6 months and 1144 exposed for greater than one year. Mircera (methoxy polyethylene glycol-epoetin beta) was sLudied primarily in active-controlled studies (n=1789 received Mircera (methoxy polyethylene glycol-epoetin beta) , and n=948 received another ESA) and in long-term follow up studies. The population was 18 to 92 years of age, 58% male, and the percentage of Caucasian, Black (including African Americans), Asian and Hispanic patients were 73%, 20%, 5%, and 9%, respectively. Approximately 85% of the patients were receiving dialysis. Most patients received Mircera (methoxy polyethylene glycol-epoetin beta) using dosing regimens of once every two or four weeks, administered SC or IV.

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of Mircera (methoxy polyethylene glycol-epoetin beta) cannot be directly compared to rates in the clinical trials of other drugs and may not reflect the rates observed in practice.

Some of the adverse reactions reported are typically associated with CRF, or recognized complications of dialysis, and may not necessarily be attributable to Mircera (methoxy polyethylene glycol-epoetin beta) therapy. Adverse reaction rates did not importantly differ between patients receiving Mircera (methoxy polyethylene glycol-epoetin beta) or another ESA.

Table 3 summarizes the most frequent adverse reactions ( ≥ 5%) in patients treated with Mircera (methoxy polyethylene glycol-epoetin beta) .

Table 3: Adverse Reactions Occurring in ≥ 5% of CRF Patients

Adverse Reaction Patients Treated with Mircera
(n=1789)
VASCULAR
  Hypertension 13%
  Hypotension 5%
GASTROINTESTINAL
  Diarrhea 11%
  Vomiting 6%
  Constipation 5%
INFECTIONS AND INFESTATIONS
  Nasopharyngitis 11%
  Upper Respiratory Tract Infection 9%
  Urinary Tract Infection 5%
NERVOUS SYSTEM
  Headache 9%
MUSCULOSKELETAL AND CONNECTIVE TISSUE
  Muscle Spasms 8%
  Back Pain 6%
  Pain in Extremity 5%
INJURY, POISONING AND PROCEDURAL COMPLICATIONS
  Procedural Hypotension 8%
  Arteriovenous Fistula Thrombosis 5%
  Arteriovenous Fistula Site 5%
  Complication  
METABOLISM AND NUTRITION
  Fluid Overload 7%
RESPIRATORY, THORACIC AND MEDIASTINAL
  Cough 6%

In the controlled trials, the rates of serious adverse reactions did not importantly differ between patients receiving Mircera (methoxy polyethylene glycol-epoetin beta) and another ESA (38% vs. 42%) except for the occurrence of serious gastrointestinal hemorrhage (1.2% vs. 0.2%). Serious hemorrhagic adverse reactions of all types occurred among 5% and 4% of patients receiving Mircera (methoxy polyethylene glycol-epoetin beta) or another ESA, respectively.

Immunogeniciry

As with all therapeutic proteins, there is a potential for immunogenicity. Neutralizing antibodies to erythropoietin, in association with PRCA or severe anemia (with or without other cytopenias), have been reported in patients receiving other ESAs during post-marketing experience [see Warnings and PRECAUTIONS]. Compared to SC administration, the IV route of administration may lessen the risk for development of antibodies to Mircera (methoxy polyethylene glycol-epoetin beta) .

In 1789 patients treated with Mircera (methoxy polyethylene glycol-epoetin beta) in clinical studies, antibody testing using an enzyme-linked immunosorbent assay (ELISA) was conducted at baseline and during treatment. Antibody development was not detected in any of the patients.

The incidence of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection,

concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies to Mircera (methoxy polyethylene glycol-epoetin beta) with the incidence of antibodies to other ESAs may be misleading.

Read the Mircera (methoxy polyethylene glycol-epoetin beta) Side Effects Center for a complete guide to possible side effects

DRUG INTERACTIONS

No formal drug/drug interaction studies have been performed.

Last reviewed on RxList: 12/20/2007
This monograph has been modified to include the generic and brand name in many instances.

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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