Pronunciation:

peg-in-ES-a-tide

Warnings:

Erythropoiesis-stimulating agents (ESAs) increase the risks for death, myocardial infarction, stroke, and other serious cardiovascular events. In clinical studies, patients with chronic kidney disease (CKD) had a greater risk for death, serious adverse cardiovascular reactions, and stroke when administered ESAs to target Hb levels of 11 g/dL or higher. No trial has identified a Hb target level, ESA dose, or dosing strategy that does not increase these risks. Therefore, in patients with CKD, use the lowest sufficient dose to reduce the need for RBC transfusion .

Classifications:

Pharmacologic—

Erythropoietic

Uses of This Medicine:

Peginesatide injection is used to treat anemia in patients with chronic kidney disease (CKD) who are on dialysis.

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

Peginesatide was voluntarily withdrawn from the U.S. market on February 24, 2013 due to safety concerns for serious allergic reactions.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

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

Children—

Appropriate studies have not been performed on the relationship of age to the effects of peginesatide injection in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of peginesatide injection in the elderly.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

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

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

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

• Bleeding problems or
• Inflammatory or metabolic conditions, chronic or
• Vitamin deficiency—Should be corrected first before using this medicine.

• Blood clots, history of or
• Congestive heart failure or
• Heart attack, history of or
• Heart bypass surgery or
• Heart or blood vessel disease or
• Orthopedic procedure (bone or muscle surgery) or
• Stroke, history of—The chance of side effects may be increased.

• Hypertension (high blood pressure), controlled or
• Seizures, history of—Use with caution. May make these conditions worse.

• Hypertension (high blood pressure), uncontrolled—Should not be used in patients with this condition.

Proper Use of This Medicine:

Peginesatide injection is usually given by a doctor. However, medicines given by injection are sometimes used at home. If you will be using peginesatide 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 is available in 3 forms. You may use a single-use vial (glass container), single-use prefilled syringe, or multiple-use vials.

This medicine may be given as a shot under your skin 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, unopened vial, or 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.
• Throw away used needles and syringes in a hard, closed container that the needles cannot poke through (puncture-resistant). Keep this container away from children and pets.

You might not use all of the medicine in each vial or syringe. Use single-use vial or syringe only one time. Do not save an open single-use vial or syringe. If the medicine in the vial or syringe has changed color, or if you see particles in it, do not use it.

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:
  • For anemia from chronic kidney failure:
    • Adults—Dose is based on body weight and must be determined by your doctor. The starting dose is 0.04 milligram (mg) per kilogram (kg) of body weight injected into a vein or under the skin once a month. Your doctor may adjust the dose as needed.
    • Children—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.

Store unused portions of the medicine in multiple use vials in the refrigerator and throw away the medicine 28 days after its first use. Protect the medicine from light. Keep your medicine in the original package until you are ready to use it.

Precautions While Using This Medicine:

It is very important that your doctor check your blood regularly while you are using this medicine. 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 cause serious types of allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash, itching, swelling of the face, tongue, and throat, trouble with breathing, or chest pain after you receive the medicine.

This medicine may increase your risk of having 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 with breathing, sudden or severe headache, or problems with vision, speech, or walking.

Peginesatide sometimes causes convulsions (seizures), especially during the first few months of treatment. Talk with your doctor if you have concerns about this.

Many 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 peginesatide treatment) may need to be on a special diet or to 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 take your medicines regularly, even if you are feeling better.

In addition to peginesatide, 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.

Side Effects of This Medicine:

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

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

More common

Abdominal or stomach pain

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

irregular heartbeat

loss of voice

nasal congestion

nausea or vomiting

nervousness

numbness or tingling in the hands, feet, or lips

pounding in the ears

runny nose

shortness of breath

slow or fast heartbeat

sneezing

sore throat

sweating

unusual tiredness or weakness

weakness or heaviness of the legs

Incidence not known

Back pain

chest tightness

chills

difficulty with swallowing

flushing

hives

itching

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

seizures

skin rash

trouble breathing

weakness

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

Diarrhea

difficulty with moving

muscle pain or stiffness

muscle spasms

pain in the arms or legs

pain in the joints

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.