Mircera

Mircera is a prescription medication used to treat anemia associated with chronic kidney disease, including patients on dialysis and patients not on dialysis. Anemia is a condition that develops when your blood lacks enough healthy red blood cells. Erythropoietin, a primary growth factor for red blood cell production, is produced in the kidney and released into the bloodstream. Production of this growth factor is impaired in patients with chronic renal failure (CRF).

Mircera belongs to a group of drugs called erythropoiesis-stimulating agent (ESA). ESAs work like the human protein erythropoietin, which stimulates bone marrow to make red blood cells.

Mircera comes as a solution designed for intravenous (IV) or subcutaneous (under the skin) administration.

Common side effects include headache, inflammation in the nose and throat, and high blood pressure.

Mircera is a prescription medicine used to treat anemia. People with anemia have a lower-than-normal number of RBCs. Mircera works like the human protein called erythropoietin to help your body make more RBCs. Mircera is used to reduce or avoid the need for RBC transfusions. 

Mircera may be used to treat anemia if it is caused by chronic kidney disease (CKD) in:

• adults who may or may not be on hemodialysis, and children ages 5 to 17 years on hemodialysis. 

• If your hemoglobin level stays too high or if your hemoglobin goes up too quickly, this may lead to serious health problems which may result in death. These serious health problems may happen if you take Mircera, even if you do not have an increase in your hemoglobin level.

Mircera is not used for the treatment of anemia: 

• that is caused by cancer chemotherapy 
• in place of emergency treatment for anemia (RBC transfusions).

Mircera has not been proven to improve the quality of life, fatigue, or well-being.

It is not known if Mircera is safe and effective in children:

• for subcutaneous use 
• below the age of 5 years
• receiving peritoneal dialysis or who are not yet treated with dialysis
• not already on an erythropoiesis-stimulating agent (ESA) therapy.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Mircera. See the “Mircera Precautions” section.

Common side effects of Mircera in children include:

• headache
• inflammation in the nose and throat
• high blood pressure
• vomiting
• lung inflammation
• stomach pain
• cough
• high potassium
• fever
• device related infection
• bleeding problems

Common side effects of Mircera in adults include:

• high blood pressure
• low blood pressure
• diarrhea
• vomiting
• constipation
• inflammation in the nose and throat
• upper airway tract infection
• urinary tract infection
• headache
• muscle spasms
• back pain
• pain in hands and feet
• cough
• fluid overload

This is not a complete list of Mircera side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effects that bother you or that do not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

No drug interactions have been studied by the manufacturer. However, you should tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Not all drug interactions are known or reported and new drug interactions are continually being reported.

Serious side effects have been reported with Mircera including the following: 

• increased death rate, heart attack, stroke, and blockage of blood vessels. Depending on the condition and disease state, serious side effects such as increased death rate, heart attack, stroke, blood vessel blockages were observed making it important to keep the dose of Mircera to its minimum.
• increased tumor progression or recurrence in patients with cancer. In patients undergoing chemotherapy, there was a decrease in overall survival.
• high blood pressure. Tell your healthcare provider right away if you have some or all of the following symptoms of high blood pressure.
  • shortness of breath during routine activity, such as climbing two flights of stairs
  • tiredness
  • chest pain
  • a racing heartbeat
  • severe headache
  • vision problems
• hypersensitivity (severe allergic reaction). Tell your healthcare provider about any signs or symptoms of hypersensitivity, which include the following:
  • chest pain
  • swelling of the face, eyes, lips, tongue, arms, or legs
  • difficulty breathing or swallowing
  • rash
• seizures. Tell your healthcare provider right away if you have some or all of the following symptoms of a seizure:
  • loss of consciousness followed by confusion
  • uncontrollable muscle spasms
  • sudden and rapid eye movements
  • biting tongue
  • clenching teeth
• severe skin reactions. Tell your healthcare provider right away if you have some or all of the following symptoms of severe skin reactions:
  • blistering
  • peeing skin
  • fever
  • body aches
  • rash
• dialysis management. Patients may require adjustments in their medications such as adding heparin to prevent blood from clotting.
• lack or loss of red blood cell response. There may be other causative factors for an inadequate response such as iron deficiency, infection, inflammation, and bleeding.
• low red blood cell production. Tell your doctor if you have any of these symptoms of anemia during treatment with Mircera:
  • feeling weak, tired, or you get tired easily
  • you look pale
  • you feel short of breath

Do not drive or operate heavy machinery until you know how Mircera affects you.

Do not take Mircera if you:

• are allergic to Mircera or to any of its ingredients
• have uncontrolled high blood pressure.
• completely stop producing healthy red blood cells after beginning treatment

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Mircera, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Mircera, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Mircera or to any of its ingredients
• have heart problems
• have or develop cancer
• have high blood pressure
• have had a seizure or stroke
• receive dialysis
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Mircera crosses into human milk. In rats, Mircera was present in maternal milk when given a dose three times greater than the dose recommended in humans. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Mircera.

Take Mircera exactly as prescribed.

If you or your caregiver has been trained to give Mircera shots (injections) at home:

• Be sure that you read, understand, and follow the “Instructions for Use” that come with Mircera.
• Take Mircera exactly as your healthcare provider tells you to. Do not change the dose of Mircera unless told to by your healthcare provider.
• Your healthcare provider will show you how much Mircera to use, how to inject it, how often it should be injected, and how to safely throw away the used prefilled syringes and needles.

 

During treatment with Mircera, continue to follow your healthcare provider’s instructions for diet, dialysis, and medicines, including medicines for high blood pressure.

 

Have your blood pressure checked as instructed by your healthcare provider.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your weight
• your height
• your age
• your gender

once all the other causes of anemia are ruled out, the smallest dose of Mircera should be used to minimize the need for red blood cell transfusion.

Talk to your healthcare provider if you need supplemental iron.

The recommended starting dose of Mircera for the treatment of low red blood cells in adults with chronic kidney disease but not on other red blood cell stimulating drugs is 0.6 mcg/kg body weight. Start by administering Mircera once every two weeks as a single injection until red blood cell levels stabilize and administer Mircera once every month thereafter. Being on dialysis will require you to target a lower level of red blood cells.

In pediatrics, the starting dose will depend on what drug they were previously on. Talk to your doctor to determine the right starting dose.

If you take too much Mircera, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

• Store Mircera prefilled syringes in the refrigerator at 36°F to 46°F (2°C to 8°C).

• Do not freeze or shake Mircera. 
• Keep Mircera in the original carton to protect from light. 
• Mircera prefilled syringes may be stored at room temperature up to 77°F (25°C) for no more than 30 days. Throw away (discard) Mircera after 30 days.
• Keep Mircera and all medicines out of the reach of children.

WARNINGS: ESAS INCREASE THE RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, THROMBOSIS OF VASCULAR ACCESS, AND TUMOR PROGRESSION OR RECURRENCE  

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.
• No trial has identified a hemoglobin target level, ESA dose, or dosing strategy that does not increase these risks.
• Use the lowest Mircera dose sufficient to reduce the need for red blood cell (RBC) transfusions.

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.
• ESAs have shown 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.