Peginesatide (Injection)

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Peginesatide was voluntarily withdrawn from the U.S. market on February 24, 2013 due to safety concerns for serious allergic reactions.

It is very important that your doctor checks your blood regularly while you are taking this medicine. You may also need to monitor your blood pressure at home. If you notice any changes in your normal blood pressure, call your doctor right away.

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

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 feeling dizziness, fainting, severe tiredness, chest pain, trouble breathing, sudden or severe headache, or have 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 any concerns about this.

Many people with kidney problems need to follow a special diet. Additionally, people with high blood pressure (which may be caused by kidney disease or by peginesatide treatment) may need to follow 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 prevent your kidney disease or high blood pressure from getting worse, it is very important to 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 advise you to take iron or vitamin supplements. Be sure to follow your doctor's instructions carefully.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the benefits it will provide. This is a decision you and your doctor will make together. 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 inform your healthcare 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.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of peginesatide (Injection) in children. Safety and effectiveness have not been established.

Geriatric

Appropriate studies performed to date have not shown any geriatric-specific problems that would limit the usefulness of peginesatide (Injection) in older adults.

Breast Feeding

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

Interactions with Food/Tobacco/Alcohol

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

Other Medical Problems

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

• Bleeding problems or
• Chronic inflammatory or metabolic conditions or
• Vitamin deficiency—Should be corrected first before using this medicine.

• History of blood clots or
• Congestive heart failure or
• History of heart attack or
• History of heart bypass surgery or
• Heart or blood vessel disease or
• History of orthopedic procedure (bone or muscle surgery) or
• History of stroke—The chance of side effects may be increased.

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

• Uncontrolled hypertension (high blood pressure)—Should not be used in patients with this condition.

Along with its intended effects, a medicine may cause some unwanted effects. Not all of these side effects will happen, but if they do, you might need medical help.

Check with your doctor right away if you experience any of the following side effects:

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 require medical attention. These side effects might go away during treatment as your body gets used to the medicine. Your health care professional may also have suggestions to help prevent or lessen some of these side effects. Talk to your health care professional if any of the following side effects continue, become 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 happen in some patients. If you notice any other effects, consult your healthcare professional.

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

Pharmacologic Class: Erythropoietic

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.