Methoxy Polyethylene Glycol Epoetin Beta

Overview

Methoxy polyethylene glycol epoetin beta is a long-acting drug that is used in the treatment of anemia. Epoetin beta and methoxy polyethylene glycol are drugs that are used in combination to treat anemia associated with chronic kidney disease and reduce the need for transfusions. Methoxy polyethylene glycol epoetin beta is manufactured from erythropoietin. This drug stimulates erythropoiesis (red cell production). It produces red blood cells by interacting with the receptors on the cells of the bone marrow.

Methoxy polyethylene glycol epoetin beta is the first approved erythropoiesis-stimulating agent that is chemically modified and is on the World Health Organization's list of essential medicines. It was approved for use in 2007 in the United States, the European Union, and Switzerland.

How Does Methoxy Polyethylene Glycol Epoetin Beta Work?

Erythropoietin is a glycoprotein produced by the kidneys as a response to cellular hypoxia and stimulates the production of red blood cells in the bone marrow. Low levels of erythropoietin are constantly secreted in adequate quantities to compensate for red blood cell turnover. Erythropoietin is an essential factor for red cell production. However, erythropoietin production is impaired in chronic kidney disease, and this deficiency is the primary cause of anemia in patients with chronic kidney disease.

Methoxy polyethylene glycol epoetin beta is a chemically modified erythropoietin receptor activator. It is a long-acting receptor activator that stimulates erythropoiesis by interacting with the erythropoietin receptors that are present in the progenitor cells in the bone marrow.

Uses:

• Methoxy polyethylene glycol epoetin beta is a drug that stimulates erythropoiesis. It is used in the treatment of anemia in adult patients with chronic kidney disease. It can be used in patients on dialysis and not on dialysis treatment.

• Methoxy polyethylene glycol epoetin beta is also used in the treatment of anemia associated with chronic kidney disease in pediatric patients on hemodialysis.

Dosage:

Methoxy polyethylene glycol epoetin beta is available as 30 mcg (microgram), 50 mcg, 100 mcg, 120 mcg, 150 mcg, 200 mcg, or 250 mcg in 0.3 ml (milliliter) solution as single-dose prefilled syringes. It is also available as 360 mcg in 0.6 mL solution single-dose prefilled syringes.

• The recommended adult dose for patients with chronic kidney disease (CKD) who are not on erythropoietin stimulating agent (ESA) is 0.6 mcg/kg body weight. It is administered as a single subcutaneous or intravenous injection every two weeks. Once the hemoglobin level stabilizes, the drug is administered once a month using a dose that is twice that of the every-two-week dose. It is the same for patients on dialysis and not on dialysis.

• Methoxy polyethylene glycol epoetin beta is administered intravenously to pediatric patients between 5 to 17 years. It is administered once every four weeks in pediatric patients whose hemoglobin levels have been stabilized by ESA.

For Patients

What Does Anemia Mean?

Anemia is a condition in which sufficient healthy red blood cells are not present in the blood. This reduces the oxygen availability to the body tissues because not enough red blood cells are present to carry oxygen. Anemia can be caused by a lack of red blood cells, severe bleeding, or autoimmune disorders that destroy the red blood cells. Various forms of anemia can occur. It causes fatigue, weakness, paleness, irregular heartbeats, chest pain, shortness of breath, dizziness, and headaches.

How Does Chronic Kidney Disease Cause Anemia?

Erythropoietin is a glycoprotein that is essential for the production of red blood cells. The kidneys produce it as a response to cellular hypoxia and stimulate the production of red blood cells in the bone marrow. Low erythropoietin levels are constantly secreted in adequate quantities to compensate for red blood cell turnover. Erythropoietin is an essential factor for red cell production. However, erythropoietin production is impaired in chronic kidney disease, and this deficiency is the primary cause of anemia in patients with chronic kidney disease.

What Happens in Anemia?

Anemia is a condition in which the red blood cells and hemoglobin levels are low. The lack of red blood cells reduces the oxygen availability to the body tissues. This causes shortness of breath, dizziness, fatigue, tiredness, headaches, and an irregular heartbeat. If anemia is left untreated, it can increase the risk of complications in the heart or lungs.

Learn More About Methoxy Polyethylene Glycol Epoetin Beta

Facts to Know Before Methoxy Polyethylene Glycol Epoetin Beta:

Why and When to Switch to Methoxy Polyethylene Glycol Epoetin Beta?

Methoxy polyethylene glycol epoetin beta is used in the treatment of anemia associated with chronic kidney disease. Adult patients are directly treated with Methoxy polyethylene glycol epoetin beta or short-acting erythropoiesis-stimulating agents. Patients treated with short-acting ESAs up to three times a week can be switched to a once-monthly dose of Methoxy polyethylene glycol epoetin beta.

How Effective Is Methoxy Polyethylene Glycol Epoetin Beta?

Methoxy polyethylene glycol epoetin beta effectively reduces the anemia in about six weeks. It effectively corrects anemia in about 93 to 98 percent of the patients. It increases hemoglobin levels, reticulocyte count, and hematocrit levels in a dose-proportional manner. It causes beneficial effects such as decreased cardiac output, a lower resting heart rate, and left ventricular hypertrophy in patients with chronic renal failure.

Things to Inform the Doctor Before Starting Methoxy Polyethylene Glycol Epoetin Beta:

1. The presence of high blood pressure should be informed before starting this drug.

2. The presence of red cell aplasia should be informed.

3. It should be informed if a person is pregnant or planning to become pregnant. Pregnancy or pregnancy planning should be discussed with the doctor before starting this drug.

4. Breastfeeding mothers should discuss this with the doctor before starting this drug.

5. The presence of seizures should be informed.

6. A person should inform them if they are under dialysis treatment.

7. The history of cancer should be informed before starting this drug.

Starting Methoxy Polyethylene Glycol Epoetin Beta:

Methoxy polyethylene glycol epoetin beta is given intravenously (into a vein) or subcutaneously (under the skin) by a healthcare provider. Methoxy polyethylene glycol epoetin beta is not available for oral use. However, it is used as an intravenous drug in pediatric patients. It is usually given once every two weeks. The patient's blood pressure is monitored often while on Methoxy polyethylene glycol epoetin beta.

Things to Do While Under Methoxy Polyethylene Glycol Epoetin Beta:

1. It is important to follow the instructions given by the doctor while taking Methoxy polyethylene glycol epoetin beta.

2. The presence of any allergic reactions or severe skin reactions should be informed to the doctor.

3. The presence of symptoms like a severe headache, blurred vision, anxiety, and nose bleeding should be informed.

4. The presence of symptoms like chest pain, shortness of breath, sudden numbness, or weakness should be informed.

5. It is important to inform the doctor of missing an appointment.

Advice for Caregivers:

The patient's caregivers should inform the doctor if there are signs of allergic reactions like hives, breathing difficulties, abnormal swelling, or severe skin reactions.

Things to Do After Taking Methoxy Polyethylene Glycol Epoetin Beta:

It is important to inform the doctor if any noticeable changes are present after taking Methoxy polyethylene glycol epoetin beta. Any signs of allergic reactions like difficulty breathing, hives, swelling of the face, lips, or tongue, or other symptoms like severe headache, blurred vision, anxiety, nose bleeding, chest pain, shortness of breath, sudden numbness, or weakness should be informed immediately.

Diet Modifications:

The doctor's instructions about restrictions on food, beverages, or activity should be followed.

Diet modifications are not necessary unless specified by the doctor.

Look Out for the Side Effects:

On experiencing side effects, it is essential to inform the doctor to adjust the treatment accordingly. The patients should familiarize themselves with the common and rare side effects of Methoxy polyethylene glycol epoetin beta so that patients know what to look out for. Methoxy polyethylene glycol epoetin beta may cause other side effects not listed here.

The common side effects include

• Body aches.

• Blurred vision.

• Chills.

• Confusion.

• Cough.

• Dizziness.

• Ear congestion.

• Fever.

• Headache.

• Nasal congestion.

• Sore throat.

• Slow or rapid heart rate.

• Nervousness.

• Sneezing.

• Unusual tiredness.

The less common side effects include

• Bladder pain.

• Bloody or cloudy urine.

• Painful urination.

• Lower back pain.

• Sudden loss of coordination.

• Slurred speech.

• Sudden vision changes.

Staying on Methoxy Polyethylene Glycol Epoetin Beta:

Tips to Stay on Track:

Sticking to a proper dosage schedule is important, and the dosage should be noticed. If any side effects occur after taking Methoxy polyethylene glycol epoetin beta, it is essential to seek medical help. Skipping appointments or stopping the medication should only be done with the knowledge of the doctor. It should be confirmed with the healthcare provider if an appointment is missed.

Things to remember,

1) Sticking to the dosage schedule is essential because missing a dose will affect the treatment outcome.

2) It is essential to follow up regularly with the doctor and stick to the dosage schedule.

For Doctors

Indications:

• Methoxy polyethylene glycol epoetin beta is a drug that stimulates erythropoiesis. It is used in the treatment of anemia in adult patients with chronic kidney disease. It can be used in patients on dialysis and not on dialysis treatment.

• Methoxy polyethylene glycol epoetin beta is also used in the treatment of anemia associated with chronic kidney disease in pediatric patients on hemodialysis.

Mechanism of Action:

Erythropoietin is a glycoprotein produced by the kidneys as a response to cellular hypoxia and stimulates the production of red blood cells in the bone marrow. Low levels of erythropoietin are constantly secreted in adequate quantities to compensate for red blood cell turnover. Erythropoietin is an essential factor for red cell production. However, erythropoietin production is impaired in chronic kidney disease, and this deficiency is the primary cause of anemia in patients with chronic kidney disease.

Methoxy polyethylene glycol epoetin beta is a chemically modified erythropoietin receptor activator. It is a long-acting receptor activator that stimulates erythropoiesis by interacting with the erythropoietin receptors that are present in the progenitor cells in the bone marrow.

Pharmacodynamics:

Methoxy polyethylene glycol epoetin beta is a chemically modified erythropoietin receptor activator that stimulates erythropoiesis by interacting with the erythropoietin receptors present in the progenitor cells in the bone marrow. A single initial dose increases the hemoglobin levels in 7 to 15 days.

Pharmacokinetics:

Absorption:

The absolute bioavailability is 62 percent after subcutaneous administration. It reached the maximum serum concentrations at a median time of 72 hours.

Distribution:

The volume of distribution of Methoxy polyethylene glycol epoetin beta at a steady state was 61 mL/kg.

Metabolism:

Methoxy polyethylene glycol epoetin beta is not metabolized.

Elimination:

Following an intravenous administration of 0.4 mcg/kg body weight to CKD patients receiving dialysis, the terminal half-life was 119 hours. Following a subcutaneous administration of 0.8 mcg/kg body weight to CKD patients receiving dialysis, the terminal half-life was 124 hours.

What Are the Ingredients in Methoxy Polyethylene Glycol Epoetin Beta?

Methoxy polyethylene glycol epoetin beta contains ingredients like sodium dihydrogen phosphate monohydrate, mannitol, sodium sulfate, methionine, poloxamer 188, and water.

Warnings and Precautions:

1. Methoxy polyethylene glycol epoetin beta should not be used in patients with uncontrolled hypertension.

2. Methoxy polyethylene glycol epoetin beta should not be used in patients with red cell aplasia.

3. Methoxy polyethylene glycol epoetin beta is not recommended for the treatment of anemia associated with cancer chemotherapy.

4. Methoxy polyethylene glycol epoetin beta should not be used as a substitute for red blood cell transfusion when an emergency transfusion is required.

5. The lowest dose required to reduce the need for transfusions should be used.

6. This drug can increase the risk of heart attacks, stroke, or blood clots.

7. Methoxy polyethylene glycol epoetin beta should not be used in patients allergic to this drug.

Indications and Uses:

• Methoxy polyethylene glycol epoetin beta is a drug that stimulates erythropoiesis. It is used in the treatment of anemia in adult patients with chronic kidney disease. It can be used in patients on dialysis and not on dialysis treatment.

• Methoxy polyethylene glycol epoetin beta is also used in the treatment of anemia associated with chronic kidney disease in pediatric patients on hemodialysis.

Dosage Strength and Forms:

Methoxy polyethylene glycol epoetin beta is available as 30 mcg (microgram), 50 mcg, 100 mcg, 120 mcg, 150 mcg, 200 mcg, or 250 mcg in 0.3 ml (milliliter) solution as single-dose prefilled syringes. It is also available as 360 mcg in 0.6 mL solution single-dose prefilled syringes.

Dosage:

• The recommended adult dose for patients with chronic kidney disease (CKD) who are not on erythropoietin stimulating agent (ESA) is 0.6 mcg/kg body weight. It is administered as a single subcutaneous or intravenous injection every two weeks. Once the hemoglobin level stabilizes, the drug is administered once a month using a dose that is twice that of the every-two-week dose. It is the same for patients on dialysis and not on dialysis.

• Methoxy polyethylene glycol epoetin beta is administered intravenously to pediatric patients between five to 17 years. It is administered once every four weeks in pediatric patients whose hemoglobin levels have been stabilized by ESA.

Considerations for Administration:

1. Methoxy polyethylene glycol epoetin beta should not be administered to patients with high blood pressure.

2. Methoxy polyethylene glycol epoetin beta should not be administered to patients with red cell aplasia, should be informed.

3. It should not be given to patients with a history of seizures.

4. It should not be administered to patients with anemia due to cancer therapy.

5. Methoxy polyethylene glycol epoetin beta should not be used as a substitute for red blood cell transfusion when an emergency transfusion is required.

6. Methoxy polyethylene glycol epoetin beta should not be used in patients allergic to this drug.

Results from Clinical Trials:

Clinical studies conducted on CKD patients with anemia showed Methoxy polyethylene glycol epoetin beta reduces the need for red blood cell transfusions. It also improves the reticulocyte count and hemoglobin levels in about six weeks. It also reduces the occurrence of cardiovascular events. However, it does not improve the quality of life, fatigue, or well-being of the patient.

Drug Interactions:

Methoxy polyethylene glycol epoetin beta is known to interact with the following drugs:

• Aspirin.

• Metformin/Pioglitazone.

• Low-strength Aspirin.

• Amoxicillin/Clavulanic acid.

• Mycophenolate mofetil.

• Enoxaparin.

• Sulfamethoxazole/Trimethoprim.

• Ubiquinone.

• Glucose.

• Diltiazem.

• Folic acid.

• Insulin regular.

• Multivitamins with iron.

• Arginine.

• Levocarnitine.

• Insulin glargine.

• Metoprolol.

• Acetaminophen.

• Clopidogrel.

Common Adverse Effects:

The common adverse effects of Methoxy polyethylene glycol epoetin beta are hypertension, diarrhea, and nasopharyngitis.

Other Specifications:

• Hypersensitivity Reactions: Methoxy polyethylene glycol epoetin beta should not be used in patients allergic to this drug. It can cause severe allergic reactions and cutaneous reactions.

• Pregnancy: No data is available regarding the use of Methoxy polyethylene glycol epoetin beta in pregnant women. Hence, Methoxy polyethylene glycol epoetin beta is not recommended in pregnant women.

• Lactation: No data is available regarding the use of Methoxy polyethylene glycol epoetin beta in lactating mothers. Hence, Methoxy polyethylene glycol epoetin beta is not recommended in lactating mothers.

• Pediatric Use: Methoxy polyethylene glycol epoetin beta is safe and effective in pediatric populations between the age of five to 17 years.

• Geriatric Use: There is no difference in the safety and efficacy of Methoxy polyethylene glycol epoetin beta in younger and older patients.

• Dialysis Management: Adjustments in dialysis may be required for the patients while receiving Methoxy polyethylene glycol epoetin beta.