METHOXY POLYETHYLENE GLYCOL-EPOETIN BETA - INJECTION

METHOXY POLYETHYLENE GLYCOL-EPOETIN BETA - INJECTION

PHONETIC PRONUNCIATION:

COMMON BRAND NAME(S): Mircera

GENERIC NAME(S): methoxy polyethylene glycol-epoetin beta

Uses

USES: This medication is used to treat anemia (low red blood cell count) in people with long-term serious kidney disease (chronic kidney disease). It works by signaling the bone marrow to make more red blood cells. Methoxy polyethylene glycol-epoetin beta helps to reverse anemia. It also helps to reduce the need for blood transfusions. This medication is very similar to the natural substance in your body (erythropoietin) that prevents anemia.


How to use METHOXY POLYETHYLENE GLYCOL-EPOETIN BETA - INJECTION

HOW TO USE: 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. Inject this medication into a vein or under the skin as directed by your doctor, usually every 2 to 4 weeks. Hemodialysis patients should receive this medication by injection into a vein. 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 methoxy polyethylene glycol-epoetin beta under the skin, change the injection site each time to lessen injury under the skin. Learn how to store and discard medical supplies safely. The dosage is based on your medical condition, weight, and response to treatment. Blood tests should be done often to check how well this medication is working and to decide the correct dose for you. Consult your doctor for more details. 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.

Side Effects

SIDE EFFECTS: 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 your doctor has prescribed this medication because he or she 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.

Precautions

PRECAUTIONS: 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.

Interactions

DRUG INTERACTIONS: 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.

Overdose

OVERDOSE: 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.

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Faq for METHOXY POLYETHYLENE GLYCOL-EPOETIN BETA - INJECTION

Methoxy Polyethylene Glycol-Epoetin Beta (Mircera) Injection is used for the treatment of anemia in patients with chronic kidney disease, including those on dialysis and those not on dialysis.

Methoxy Polyethylene Glycol-Epoetin Beta is a synthetic erythropoietin (EPO) that works by stimulating the bone marrow to produce more red blood cells. It provides an extended half-life compared to other erythropoiesis-stimulating agents, allowing for less frequent dosing.

Common side effects include headache, high blood pressure, joint pain, flu-like symptoms, diarrhea, and swelling or redness at the injection site. Please consult your doctor if you experience any persistent or severe side effects.

Methoxy Polyethylene Glycol-Epoetin Beta (Mircera) Injection is given as an injection under the skin (subcutaneous) or into a vein (intravenous) by a healthcare professional. It should not be self-administered without proper medical instruction.

There is limited information available on the use of Methoxy Polyethylene Glycol-Epoetin Beta during pregnancy and breastfeeding. It is advisable to consult your doctor before using this medication if you are pregnant or breastfeeding.

The dosage and frequency of Methoxy Polyethylene Glycol-Epoetin Beta (Mircera) Injection will vary depending on your specific condition and response to treatment. It is usually administered once every two weeks or once every four weeks. Your doctor will determine the appropriate dosage schedule for you.

If you miss a scheduled dose, contact your healthcare provider as soon as possible to reschedule the missed dose. Do not double the dose to make up for the missed one.

It is important to inform your doctor about any other medications you are taking, as they may interact with Methoxy Polyethylene Glycol-Epoetin Beta. Regular blood tests may be required to monitor your response to treatment and adjust the dosage if needed.

Methoxy Polyethylene Glycol-Epoetin Beta is generally not recommended for use in children. The safety and effectiveness of this medication have not been established in pediatric populations.


Warning

WARNING: Discuss the risks and benefits of methoxy polyethylene glycol-epoetin beta with your doctor, as this medication may rarely cause very serious (possibly fatal) side effects, including blood clots, heart attack, stroke, or heart failure. It is very important to keep all lab appointments since your doctor will need to carefully check your red blood cell count and hemoglobin level. The lowest effective dose of this medication should be used. When used to treat anemia related to cancer, this medication may also increase the risk of death and/or cause the tumor to grow faster. This medication is not approved for the treatment of anemia related to cancer. Ask your doctor about the risks and benefits of this medication, as well as other effective and possibly safer treatments for anemia related to cancer.


Disclaimer

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.