Recommended Topic Related To:

Mircera

"The U.S. Food and Drug Administration today expanded the approved use of Stivarga (regorafenib) to treat patients with advanced gastrointestinal stromal tumors (GIST) that cannot be surgically removed and no longer respond to other FDA-approved t"...

Mircera

Mircera Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Mircera (methoxy polyethylene glycol-epoetin beta) is used to treat anemia (a lack of red blood cells in the body). This medication is not for treating anemia caused by cancer chemotherapy. It is a man-made form of a protein that is normally produced by the kidneys to help the body produce red blood cells. Common side effects include stuffy nose, sore throat, cough, headache, muscle aches, back pain, nausea, vomiting, diarrhea, constipation, and itching, redness, bruising, or swelling at the injection site.

The recommended starting dose of Mircera for the treatment of anemia in adult CRF (chronic renal failure) patients who are not currently treated with an ESA is 0.6 mcg/kg body weight administered as a single IV or SC injection once every two weeks. Other drugs may interact with Mircera. Tell your doctor all medications and supplements you use. During pregnancy, Mircera should be used only if prescribed. It may be harmful to a fetus. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is unknown if this drug passes into breast milk or if it could harm a nursing baby. Consult your doctor before breastfeeding.

Our Mircera (methoxy polyethylene glycol-epoetin beta) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Mircera in Detail - Patient Information: Side Effects

Contact your doctor if you feel weak, tired, or short of breath, or if your skin looks pale. These may be signs that your body has stopped responding to this medication.

Epoetin beta-methoxy polyethylene glycol can increase your risk of life-threatening heart or circulation problems, including heart attack or stroke. Seek emergency medical help if you have symptoms of heart or circulation problems, such as:

  • chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
  • feeling short of breath, even with mild exertion;
  • swelling, rapid weight gain;
  • sudden numbness or weakness, especially on one side of the body;
  • sudden headache, confusion, problems with vision, speech, or balance;
  • chest pain, sudden cough, wheezing, rapid breathing, fast heart rate; or
  • pain or swelling in one or both legs.

Get emergency medical help if you have any of these signs of an allergic reaction: hives or itchy skin rash; difficulty breathing; fast heart rate; swelling of your face, lips, tongue, or throat.

Stop using this medication and call your doctor at once if you have a serious side effect such as:

  • feeling like you might pass out;
  • seizure (convulsions);
  • pain or burning when you urinate; or
  • dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, chest pain, shortness of breath, uneven heartbeats, seizure).

Less serious side effects may include:

  • stuffy nose, sore throat, cough;
  • headache;
  • muscle aches, back pain;
  • nausea, vomiting, diarrhea, constipation; or
  • itching, redness, bruising, or swelling where you injected the medication.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect.

Read the entire detailed patient monograph for Mircera (Methoxy Polyethylene glycol-epoetin beta) »

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Mircera FDA Prescribing Information: Side Effects
(Adverse Reactions)

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 entire FDA prescribing information for Mircera (Methoxy Polyethylene glycol-epoetin beta) »

A A A

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.


Cancer

Get the latest treatment options.