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peginesatide injection

WARNINGS:

This medication has been withdrawn from the market as of February 23, 2013 due to serious (possibly fatal) allergic reactions occurring within 30 minutes after the first dose of peginesatide.

This medication may also rarely cause other very serious (possibly fatal) side effects, including blood clots. See also Side Effects section.

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Uses

This medication is used to treat anemia (low red blood cell count) in people with long-term serious kidney disease (chronic renal failure) on dialysis. Peginesatide helps to reverse anemia. It also helps to reduce the need for blood transfusions. It works by causing the bone marrow to make more red blood cells. This medication is very similar to the natural substance in your body (erythropoietin) that prevents anemia.

How to use peginesatide injection

Read the Medication Guide provided by your pharmacist before you start using peginesatide and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

This medication is given by injection under the skin or into a vein as directed by your doctor, usually once every month. Hemodialysis patients should receive this medication by injection into a vein. Peritoneal dialysis patients should receive this medication by injection under the skin.

If you are injecting this medication under the skin, do not inject into skin that is tender, red, bruised, hard, or with scars or stretch marks.

The dosage is based on your medical condition, response to treatment, weight, and laboratory tests. Blood tests should be performed frequently to check how well this medication is working and to determine the correct dose for you. Consult your doctor for more details.

If you are using this medication at home, learn all preparation and usage instructions from your health care professional and the product package. This medication is normally clear and colorless to slightly yellow. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid. Learn how to store and discard medical supplies safely. Do not reuse the syringes or needles.

Do not increase your dose or use this drug more often or for longer than prescribed. Use this medication regularly to get the most benefit from it. To help you remember, use it on the same day each month. It may help to mark your calendar with a reminder.

Tell your doctor if your condition does not improve or if it worsens.

Side Effects

Headache, nausea, vomiting, diarrhea, and body aches may occur. If any of these effects persist or worsen, 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.

Peginesatide 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 adequately controlled before beginning treatment with this medication. Your blood pressure should be checked frequently. Ask your doctor if you should learn how to monitor 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 laboratory appointments to have your blood count (hemoglobin) tested regularly to reduce the chance of this side effect.

Tell your doctor right away if you have any serious side effects, including: muscle spasm/weakness, seizures, confusion, loss of consciousness.

This medication may rarely cause blood clots. Get medical help right away if you have any very serious side effects, including: pain/redness/swelling/weakness of the arms or legs, calf pain/swelling that is warm to the touch, new/worsening shortness of breath, sudden vision changes, slurred speech, weakness on one side of the body, sudden severe headache, chest/jaw/left arm pain, fainting, blood clots in your hemodialysis vascular access site.

Rarely, this medication may suddenly stop working well after a period of time because your body may make antibodies that reduce the effectiveness of peginesatide, and a very serious anemia can result. Tell your doctor right away if symptoms of anemia return (such as increased tiredness, low energy, pale skin, shortness of breath).

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.

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.

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

Before using peginesatide, tell your doctor or pharmacist if you are allergic to it; 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: uncontrolled high blood pressure, bleeding/clotting problems, blood vessel problems (such as stroke), heart problems (such as angina, heart failure), seizure disorder, certain vitamin deficiencies (such as folic acid, vitamin B12).

Infrequently, patients with long-term kidney failure on dialysis may be at increased risk of seizures during the first 3 months of treatment with this medication, possibly caused by the number of red blood cells increasing too quickly. Therefore, these patients should use caution and avoid activities such as driving or using machinery during this period. Limit alcoholic beverages because alcohol may also increase the risk of seizures.

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. In some women of child-bearing age, menstrual periods have resumed during treatment with a similar drug (epoetin alfa). If this occurs with peginesatide treatment, it may be possible to get pregnant while using this medication. Discuss the need for birth control with your doctor.

It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.

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

If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Notes

Do not share this medication with others.

Laboratory and/or medical tests (such as complete blood count that includes hemoglobin, reticulocyte count) must be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

Blood tests for your iron levels will be performed and you may be prescribed iron supplements. Your doctor may recommend that you eat a well-balanced diet rich in iron (including foods such as raisins, figs, meat, eggs, vegetables, iron-fortified cereals). Follow your doctor's instructions and dietary recommendations.

Missed Dose

For the best possible benefit, it is important to receive each scheduled dose of this medication as directed. If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

Storage

Store in the refrigerator between 36-46 degrees F (2-8 degrees C) away from light. Do not freeze. Brief storage up to 77 degrees F (25 degrees C) is permitted for up to 30 days. Store in the original carton until ready for use. Do not store in the bathroom. Keep all medications away from children and pets.

For the single-use vials, discard any unused portion immediately. For the multi-use vials, store opened vials in the refrigerator and discard any unused medication after 28 days.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Information last revised March 2013. Copyright(c) 2013 First Databank, Inc.

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Selected from data included with permission and copyrighted by First Databank, Inc. This copyrighted material has been downloaded from a licensed data provider and is not for distribution, expect as may be authorized by the applicable terms of use.

CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment.

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