Peginesatide solution for injection

What is this medication?

PEGINESATIDE helps your body make more red blood cells. This medicine is used to treat anemia caused by chronic kidney disease.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Omontys

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• blood clotting disorder or history of blood clots
• cancer
• heart disease
• hemoglobin level of 11 g/dl or greater
• high blood pressure
• low levels of iron, folate, or vitamin B12
• seizures
• an unusual or allergic reaction to peginesatide, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medication?

This medicine is for injection into a vein or under the skin. It is usually given by a health care professional in a hospital or clinic setting.

If you get this medicine at home, you will be taught how to prepare and give this medicine. Use exactly as directed. Take your medicine at regular intervals. Do not take your medicine more often than directed.

It is important that you put your used needles and syringes in a special sharps container. Do not put them in a trash can. If you do not have a sharps container, call your pharmacist or healthcare provider to get one.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

It is important not to miss your dose. Call your doctor or health care professional if you are unable to keep an appointment. If you give yourself the medicine and you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medication?

This medicine may interact with the following medications:

• epoetin alfa
• darbepoetin alfa

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your prescriber or health care professional for regular checks on your progress and for the needed blood tests and blood pressure measurements. It is especially important for the doctor to make sure your hemoglobin level is in the desired range to limit the risk of potential side effects and to give you the best benefit. Keep all appointments for any recommended tests. Check your blood pressure as directed. Ask your doctor what your blood pressure should be and when you should contact him or her.

As your body makes more red blood cells, you may need to take iron, folic acid, or vitamin B supplements. Ask your doctor or health care provider which products are right for you. If you have kidney disease continue dietary restrictions, even though this medication can make you feel better. Talk with your doctor or health care professional about the foods you eat and the vitamins that you take.

What side effects may I notice from receiving this medication?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
• breathing problems
• changes in vision
• chest pain
• confusion, trouble speaking or understanding
• feeling faint or light-headed, falls
• high blood pressure
• pain, swelling, warmth of the leg
• severe headache
• sudden numbness or weakness of face, arm or leg
• trouble walking, dizziness, loss of balance or coordination
• seizures (convulsions)
• unusually weak or tired

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• cough
• diarrhea
• joint pain
• muscle pain
• nausea
• vomiting

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children.

If you are using this medicine at home, you will be instructed on how to store this medicine. Throw away any unused medicine after the expiration date on the label.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.