Methoxy polyethylene glycol-epoetin beta (Injection)

Methoxy polyethylene glycol-epoetin beta (Injection) is used to treat anemia in adults with chronic kidney disease (CKD) who may or may not be on dialysis, and in children with CKD who are on dialysis. This medicine is not used to treat anemia caused by cancer medicines.

Methoxy polyethylene glycol-epoetin beta (Injection) helps the bone marrow make red blood cells. If the body does not make enough red blood cells, severe anemia can happen. This often occurs in people with chronic kidney failure whose kidneys are not functioning properly.

This medicine is available only with your doctor's prescription.

It is very important that your doctor checks your or your child's progress regularly while you or your child are using this medicine. Blood tests are needed to check for unwanted effects. You may also need to monitor your blood pressure at home. If you notice any changes to your normal blood pressure, call your doctor right away.

This medicine may increase your risk of having a heart attack, stroke, congestive heart failure, and blood clotting problems. Check with your doctor right away if you start having dizziness, fainting spells, severe tiredness, chest pain, trouble breathing, sudden or severe headache, or problems with vision, speech, or walking.

This medicine may also increase your risk of having serious heart and blood vessel problems such as a heart attack, congestive heart failure, or stroke. Check with your doctor right away if you start having dizziness, fainting spells, severe tiredness, chest pain, trouble with breathing, sudden or severe headache, or problems with vision, speech, or walking.

When used in patients with certain types of cancer (e.g., breast, cervix, lymphoid, lung, head, or neck cancer), this medicine has shortened survival time and worsened the tumor or cancer in some patients. If you are concerned about this, talk with your doctor.

This medicine may cause convulsions (seizures), especially during the first few months of treatment. Talk with your doctor if you have concerns about this.

This medicine may cause serious allergic reactions, including anaphylaxis and angioedema, which can be life-threatening and require immediate medical attention. Call your doctor right away if you have a rash, itching, swelling of the face, tongue, or throat, trouble breathing, or chest pain after you receive the medicine.

Serious skin reactions (e.g., erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis) can occur with this medicine. Check with your doctor right away if you have blistering, peeling, or loosening of the skin, chills, cough, diarrhea, itching, joint or muscle pain, red irritated eyes, red skin lesions, often with a purple center, sore throat, sores, ulcers, or white spots in the mouth or on the lips, or unusual tiredness or weakness.

Make sure any doctor or dentist who treats you knows that you are using this medicine. You may need to stop using this medicine several days before having surgery. Your doctor may want you to take a blood thinner (e.g., warfarin) to prevent blood clots during or after surgery.

In deciding to use a medicine, you and your doctor need to consider the risks and benefits. For this medicine, you should think about the following:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, let your health care professional know if you have any other allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Studies have not shown any specific problems in children aged 5 to 17 that would limit the usefulness of methoxy polyethylene glycol-epoetin beta (Injection) when given through a needle placed into a vein. Safety and effectiveness have not been established in children younger than 5 years old or when given as a shot under the skin in children.

Geriatric

Studies have not shown any specific problems in the elderly that would limit the usefulness of methoxy polyethylene glycol-epoetin beta (Injection). However, older patients are more likely to have kidney, liver, or heart issues, which may require caution or a dose adjustment when receiving this medicine.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication while breastfeeding. Weigh the possible benefits against the potential risks before taking this medication during breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines may be used together even if an interaction might happen. In these situations, your doctor may want to change the dose or take other precautions. Inform your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used around the time of eating food or certain types of food because interactions may happen. Using alcohol or tobacco with certain medicines may also cause interactions. Discuss with your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Other medical issues may affect the use of this medicine. Make sure to tell your doctor if you have any other medical problems, especially:

• Bleeding problems or
• Chronic inflammatory or metabolic conditions or
• Iron or vitamin deficiency or
• Chronic inflammatory conditions—These should be corrected before using this medicine.

• History of blood clots or
• Congestive heart failure or
• History of heart attack or
• Heart bypass surgery or
• Heart or blood vessel disease or
• History of stroke—These may increase the chance of side effects.

• Cancer—May cause some tumors to progress or return.

• Controlled hypertension (high blood pressure) or
• History of seizures—Use with caution. May worsen these conditions.

• Uncontrolled hypertension (high blood pressure) or
• Pure red cell aplasia (bone marrow disease)—Should not be used in patients with these conditions.

• Patients receiving dialysis—May need a higher dose of blood thinner (e.g., heparin) to prevent excessive clotting.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may happen, if they do, they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

• Blurred vision
• body aches or pain
• chills
• confusion
• cough
• difficulty with breathing
• dizziness
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• ear congestion
• fever
• headache
• loss of voice
• nasal congestion
• nervousness
• pounding in the ears
• runny nose
• slow or fast heartbeat
• sneezing
• sore throat
• sweating
• unusual tiredness or weakness

Less common

• Bladder pain
• bloody or cloudy urine
• difficult, burning, or painful urination
• frequent urge to urinate
• lower back or side pain
• pains in the chest, groin, or legs, especially the calves of the legs
• severe headaches of sudden onset
• sudden loss of coordination
• sudden onset of slurred speech
• sudden vision changes

Incidence not known

• Blistering, peeling, or loosening of the skin
• chest tightness
• confusion
• decreased urine output
• diarrhea
• difficulty with speaking
• difficulty with swallowing
• dilated neck veins
• double vision
• extreme tiredness or weakness
• fast, pounding, or irregular heartbeat or pulse
• hives or welts, itching, or skin rash
• inability to move the arms, legs, or facial muscles
• inability to speak
• irregular breathing
• joint or muscle pain
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals
• pain or discomfort in the arms, jaw, back, or neck
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• red skin lesions, often with a purple center
• red, irritated eyes
• redness of the skin
• seizures
• severe, sudden headache
• slow or slurred speech
• sores, ulcers, or white spots in the mouth or on the lips
• sudden, severe weakness or numbness in the arm or leg
• sweating
• swelling of the face, fingers, feet, or lower legs
• vision changes
• vomiting
• weight gain

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Back pain
• muscle spasms

Less common

• Difficulty having a bowel movement

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

In the U.S.

• Mircera

Available Dosage Forms:

• Solution

Therapeutic Class: Hematopoietic

Pharmacologic Class: Erythropoietic

Find detailed information on biosimilars for this medication.

This medicine is usually given by your doctor. However, medicines given by injection are sometimes used at home. If you will be using this medicine at home, your doctor will teach you how the injections are to be given. Be sure you understand exactly how the medicine is to be injected.

This medicine comes with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

This medicine may be given as a shot under your skin (usually in the upper arms, thighs, or stomach) or into a vein. If your doctor tells you to inject it a certain way, follow your doctor's instructions.

If you are giving this medicine at home:

• Use a new needle and unopened syringe each time you inject your medicine.
• Do not use more medicine or use it more often than your doctor tells you to.
• You will be shown the body areas where this shot can be given. Use a different body area each time you give yourself a shot. Do not inject into moles or areas that are tender, red, bruised, hard, or has scars, stretch marks, not intact, or that could be irritated by a belt or waistband. Keep track of where you give each shot to make sure you rotate body areas. This will help prevent skin problems from the injections.
• Check the liquid in the prefilled syringe. It must be clear or colorless to slightly yellow. Do not use it if the solution in the prefilled syringe becomes cloudy, discolored, or has particles in it. Do not shake.
• Do not save any leftover medicine from an open syringe. Use each syringe only 1 time.

People with kidney problems need to be on a special diet. Also, people with high blood pressure (which may be caused by kidney disease or by Mircera® treatment) may need to be on a special diet or take medicine to keep their blood pressure under control. After their anemia has been corrected, some people feel so much better that they want to eat more than before. To keep your kidney disease or your high blood pressure from getting worse, it is very important that you follow your special diet and you take your medicines regularly, even if you are feeling better.

In addition to Mircera®, your body needs iron and vitamins to make red blood cells. Your doctor may direct you to take iron or vitamin supplements. Be sure to follow your doctor's orders carefully.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For injection dosage form (prefilled syringe): For patients with chronic kidney disease not on dialysis: Adults—Dose is based on body weight and must be determined by your doctor. The dose is usually 1.2 microgram (mcg) per kilogram (kg) of body weight injected under the skin once every month. Some patients may receive a starting dose of 0.6 microgram (mcg) per kilogram (kg) of body weight injected into a vein or under the skin once every 2 weeks. Your doctor may adjust the dose as needed. Children—Use and dose must be determined by your doctor. For patients with chronic kidney disease on dialysis: Adults—Dose is based on body weight and must be determined by your doctor. The starting dose is 0.6 microgram (mcg) per kilogram (kg) of body weight injected into a vein or under the skin once every 2 weeks. Your doctor may adjust the dose as needed. Children 5 to 17 years of age—Dose is based on your child's hemoglobin level or whether he or she is receiving epoetin alfa or darbepoetin alfa and must be determined by your doctor. The dose may be 48 mcg (from epoetin) or 145.5 mcg (from darbepoetin) given through a needle placed into your child's vein once every 4 weeks. Children younger than 5 years of age—Use and dose must be determined by your doctor.

Missed Dose

Call your doctor or pharmacist for instructions.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store in the refrigerator. Do not freeze.

If you store this medicine at home, keep it in the original package until you are ready to use it. Protect it from direct light. You may store it at room temperature for up to 30 days. Throw away any unused medicine after 30 days.

Throw away used needles and syringes in a hard, closed container where the needles cannot poke through. Keep this container away from children and pets.