Uses of Darbepoetin Alfa Vials:

• It is used to treat anemia.

What do I need to tell my doctor BEFORE I take Darbepoetin Alfa Vials?

• If you have an allergy to darbepoetin alfa or any other part of this medicine (darbepoetin alfa vials).
• If you are allergic to this medicine (darbepoetin alfa vials); any part of this medicine (darbepoetin alfa vials); or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you have high blood pressure.
• If you have a kind of anemia called Pure Red Cell Aplasia (PRCA).
• If you have cancer, talk with your doctor.

This is not a list of all drugs or health problems that interact with this medicine (darbepoetin alfa vials).

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine (darbepoetin alfa vials) with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Darbepoetin Alfa Vials?

• Tell all of your health care providers that you take this medicine (darbepoetin alfa vials). This includes your doctors, nurses, pharmacists, and dentists.
• If you will be having surgery, talk with your doctor. You may need to take another drug to keep you from getting blood clots while you get this medicine (darbepoetin alfa vials).
• High blood pressure has happened with this medicine (darbepoetin alfa vials). Have your blood pressure checked as you have been told by your doctor.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• Tell your doctor if you are pregnant, plan on getting pregnant, or are breast-feeding. You will need to talk about the benefits and risks to you and the baby.

How is this medicine (Darbepoetin Alfa Vials) best taken?

Use this medicine (darbepoetin alfa vials) as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• It is given as a shot into the fatty part of the skin.
• It may be given as a shot into a vein during dialysis.
• If you will be giving yourself the shot, your doctor or nurse will teach you how to give the shot.
• Keep using this medicine (darbepoetin alfa vials) as you have been told by your doctor or other health care provider, even if you feel well.
• Do not shake.
• Do not use if it has been shaken.
• Do not use if it has been frozen.
• Wash your hands before and after use.
• Do not use if the solution is cloudy, leaking, or has particles.
• Do not use if solution changes color.
• Do not give into red or irritated skin.
• Throw away any part left over after the dose is given.
• Throw away needles in a needle/sharp disposal box. Do not reuse needles or other items. When the box is full, follow all local rules for getting rid of it. Talk with a doctor or pharmacist if you have any questions.

What do I do if I miss a dose?

• Call your doctor to find out what to do.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of high blood pressure like very bad headache or dizziness, passing out, or change in eyesight.
• A fast heartbeat.
• Shortness of breath, a big weight gain, or swelling in the arms or legs.
• Weakness on 1 side of the body, trouble speaking or thinking, change in balance, drooping on one side of the face, or blurred eyesight.
• Feeling confused.
• Cool or pale arm or leg.
• Trouble walking.
• Dizziness or passing out.
• Sweating a lot.
• Seizures.
• Feeling very tired or weak.
• Pale skin.
• Call your doctor right away if you have signs of a blood clot like chest pain or pressure; coughing up blood; shortness of breath; swelling, warmth, numbness, change of color, or pain in a leg or arm; or trouble speaking or swallowing.
• A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away, and sometimes death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.

What are some other side effects of Darbepoetin Alfa Vials?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Stomach pain.
• Cough.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If OVERDOSE is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Darbepoetin Alfa Vials?

• Store in a refrigerator. Do not freeze.
• Store in the original container to protect from light.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Consumer Information Use and Disclaimer

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• This medicine comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time this medicine (darbepoetin alfa vials) is refilled. If you have any questions about this medicine (darbepoetin alfa vials), please talk with the doctor, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.