Omontys

The Food and Drug Administration has alerted healthcare providers and patients that Affymax and Takeda are instituting a voluntary recall of Omontys (peginesatide). This recall is due to reports of serious allergic reaction, some cases resulting in death. If you have been given Omontys (peginesatide) for home use, stop using it and return it to your healthcare provider. Affymax and Takeda voluntarily recalled their product in February 2013.

This medication comes in an injectable form to be given once a month, either directly into a vein through your hemodialysis vascular access (IV), or just under your skin.

Common side effects of peginesatide include shortness of breath, diarrhea, nausea, and vomiting.

Peginesatide is a prescription medicine used to treat anemia (low red blood cells) in adults with chronic kidney disease (CKD) who are on dialysis.

This medication may be prescribed for other uses. Ask your healthcare provider or pharmacist for more information.

Peginesatide may cause serious side effects, including:

• See "Overview" and "Drug Precautions" sections.
• serious allergic reactions
• high blood pressure
• antibodies to peginesatide

The most common side effects of peginesatide include:

• shortness of breath
• diarrhea
• nausea
• vomiting
• cough
• problems with hemodialysis access
• headache
• muscle spasm
• joint, back, leg, or arm pain
• low blood pressure (hypotension)
• fever
• increase in blood potassium level
• upper respiratory infection

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

This is not a complete list of peginesatide side effects. Ask your healthcare provider or pharmacist for more information.

You may report side effects to FDA at 1-800-FDA-1088.

No significant drug interactions have been identified, however, you should tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Not all drug interactions are known or reported and new drug interactions are continually being reported.

Using peginesatide or other erythropoiesis-stimulating agents (ESAs) can lead to serious side effects including death.

• If you decide to take peginesatide, your healthcare provider should prescribe the smallest dose of peginesatide that is needed to reduce your chance of needing red blood cell transfusions.
• You may get serious heart problems such as heart attack, stroke, heart failure, and may die sooner if you are treated with peginesatide to reach a normal or near-normal hemoglobin level.
• You may get blood clots while receiving peginesatide. If you are receiving peginesatide and you are going to have surgery, talk to your healthcare provider about whether or not you need to take a blood thinner to lessen the chance of blood clots during or following surgery. Clots can form in blood vessels (veins), especially in your leg (deep venous thrombosis or DVT). Pieces of a blood clot may travel to the lungs and block the blood circulation in the lungs (pulmonary embolus).

Call your healthcare provider or get medical help right away if you have any of these symptoms of blood clots:

• Chest pain
• Trouble breathing or shortness of breath
• Pain in the legs, with or without swelling
• A cool or pale arm or leg
• Sudden confusion, trouble speaking, or understanding others’ speech
• Sudden numbness or weakness of the face, arm, or leg, especially on one side of your body
• Sudden trouble seeing
• Sudden trouble walking, dizziness, loss of balance or coordination
• Loss of consciousness (fainting)
• Hemodialysis vascular access stops working.

Peginesatide should not be used for the treatment of anemia:

• if you have chronic kidney disease (CKD) and are NOT on dialysis,
• if you are receiving treatment for cancer and your anemia is NOT caused by CKD,
• in place of emergency treatment for anemia (red blood cell transfusions).

Peginesatide has not been proven to improve the quality of life, fatigue, or well-being.

It is not known if peginesatide is safe and effective in children.

Do not use peginesatide if you:

• have high blood pressure that is not controlled (uncontrolled hypertension).
• have had a serious allergic reaction to peginesatide.

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of peginesatide there are no specific foods that you must exclude from your diet when receiving peginesatide.

Before using peginesatide tell your healthcare provider if you:

• have heart disease
• have or develop cancer
• have high blood pressure
• have any history of stroke, blood clot or seizure (convulsion)
• have blood disorders (such as sickle cell anemia or clotting disorders)
• have any other medical conditions
• are pregnant or breastfeeding

Tell your healthcare provider about all of the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your healthcare provider if you are pregnant or plan to become pregnant. It is not known if peginesatide will harm your unborn baby.

Tell your healthcare provider if you are breastfeeding or plan to breastfeed. It is not known if peginesatide passes into your breast milk.

Peginesatide comes in an injectable form. It may be given by your healthcare provider through your hemodialysis vascular access (IV) or under your skin.

Your healthcare provider may decide you or your caregiver can give the injections at home. Follow the "Instructions for Use" that come with peginesatide.

Your healthcare provider will show you or your caregiver how much peginesatide to use, how to inject it, and how to safely dispose of the used containers, needles and syringes.

Take peginesatide exactly as your healthcare provider tells you to. Do not change the dose of peginesatide unless told to do so by your healthcare provider.

If you miss a dose of peginesatide, tell your healthcare provider right away.

Peginesatide is usually administered by a healthcare provider in a medical setting making it unlikely for an overdose to occur. However, if overdose is suspected, contact your healthcare provider or seek emergency medical attention.

In some cases, peginesatide is given by injection at home. If you or your caregiver inject more than the prescribed amount of peginesatide, call you healthcare provider right away for instructions on what to do.

• Single Use Vials and Single Use Pre-filled Syringes: sorbitol, sodium phosphate monobasic (dihydrate), sodium phosphate dibasic, polysorbate 20, and sodium hydroxide in Water for Injection.
• Multiple Use Vials: sorbitol, phenol, L-methionine, glacial acetic acid, and sodium hydroxide in Water for Injection.

• Keep peginesatide in the original package.
• Protect peginesatide from light.
• Store peginesatide in the refrigerator between 36 °F to 46 °F (2 °C to 8 °C).
• If a refrigerator is not available, peginesatide vials and pre-filled syringes can be stored at 77 °F or less (25 °C or less) for up to 30 days.
• Throw away multiple use vials of peginesatide no later than 28 days from the first day that you put a needle into the vial.
• Peginesatide single use vials and pre-filled syringes should be used only one time. Dispose of the single use vial and the pre-filled syringe after use even if there is medicine left in the container.

Keep peginesatide and all medicines out of the reach of children.

WARNING: ESAs INCREASE THE RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, THROMBOSIS OF VASCULAR ACCESS AND TUMOR PROGRESSION OR RECURRENCE

Chronic Kidney Disease:

• In controlled trials, patients experienced greater risks for death, serious adverse cardiovascular reactions, and stroke when administered erythropoiesis-stimulating agents (ESAs) to target a hemoglobin level of greater than 11 g/dL.
• No trial has identified a hemoglobin target level, ESA dose, or dosing strategy that does not increase these risks.
• Use the lowest peginesatide dose sufficient to reduce the need for red blood cell (RBC) transfusions [see Warnings and Precautions.