Mircera

Read the Medication Guide and Instructions for Use provided by your pharmacist before you start using methoxy polyethylene glycol-epoetin beta and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

For adults, inject this medication into a vein or under the skin as directed by your doctor, usually once every 2 or 4 weeks. Hemodialysis patients should receive this medication by injection into a vein. For children, inject this medication only into a vein as directed by the doctor, usually once every 4 weeks. The dosage is based on your medical condition, weight, lab tests, and response to treatment.

If you are using this medication at home, learn all preparation and usage instructions from your health care professional and the product package. Do not shake the medication and do not mix it with other medications. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid. Before injecting each dose, clean the injection site with rubbing alcohol. If you are injecting this medication under the skin, change the injection site each time to lessen injury under the skin.

Learn how to store and discard medical supplies safely.

Use this medication regularly to get the most benefit from it. To help you remember, it may help to mark your calendar with a reminder.

Do not increase your dose or use this drug more often or for longer than prescribed. Your condition will not improve any faster, and your risk of side effects will increase.

It may take 2 to 6 weeks before your red blood cell count increases. Tell your doctor if your symptoms do not get better or if they get worse.

Headache, body aches, diarrhea, or vomiting may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Methoxy polyethylene glycol-epoetin beta may sometimes cause or worsen high blood pressure, especially in patients with long-term kidney failure. This effect may be caused by the number of red blood cells increasing too quickly, usually within the first 3 months of starting treatment. If you have high blood pressure, it should be well controlled before beginning treatment with this medication. Your blood pressure should be checked often. Ask your doctor if you should learn how to check your own blood pressure. If high blood pressure develops or worsens, follow your doctor's instructions about diet changes and starting or adjusting your high blood pressure medication. Lowering high blood pressure helps prevent strokes, heart attacks, and further kidney problems. Keep all lab appointments to have your red blood cell count/hemoglobin level tested regularly to reduce the chance of this side effect.

Rarely, this medication may suddenly stop working well after a period of time because your body may make antibodies to it. A very serious anemia can result. Tell your doctor right away if symptoms of anemia return (such as increased tiredness, low energy, pale skin color, shortness of breath).

Tell your doctor right away if you have any serious side effects, including: symptoms of heart failure (such as shortness of breath, swelling ankles/feet, unusual tiredness, unusual/sudden weight gain).

Get medical help right away if you have any very serious side effects, including: seizures.

This medication may rarely cause serious (sometimes fatal) problems from blood clots (such as heart attack, stroke, blood clots in the legs or lungs). Get medical help right away if you have: shortness of breath/rapid breathing, chest/jaw/left arm pain, unusual sweating, confusion, sudden dizziness/fainting, pain/swelling/warmth in the groin/calf, sudden/severe headaches, trouble speaking, weakness on one side of the body, sudden vision changes, blood clots in your hemodialysis vascular access site.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing, fast heartbeat.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before using methoxy polyethylene glycol-epoetin beta, tell your doctor or pharmacist if you are allergic to it; or to other drugs that cause more red blood cells to be made (such as epoetin alfa, darbepoetin alfa); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: high blood pressure, heart disease (such as heart failure, past heart attack/stroke), seizure disorder, severe anemia caused by antibodies to past erythropoietin-type treatment (pure red cell aplasia).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Do not share this medication with others.

Lab and/or medical tests (such as blood pressure, complete blood count that includes hemoglobin level) should be done while you are using this medication. Keep all medical and lab appointments. Consult your doctor for more details.

Blood tests for your iron levels will also be done and you may be prescribed iron supplements to take. Your doctor may recommend that you eat a well-balanced diet rich in iron (such as raisins, figs, meat, eggs, vegetables, iron-fortified cereals). Follow your doctor's instructions and dietary recommendations.

If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule. Do not double the dose to catch up.

Store in the refrigerator. Do not freeze. This medication may also be stored at room temperature for up to 30 days. Protect it from light. Store the medication in the original carton until ready for use. Let the medication come to room temperature before using. After each dose, throw away any unused medication right away. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.