Retacrit

Retacrit is a man-made form of a protein that helps your body produce red blood cells. This protein may be reduced when you have kidney failure or use certain medications. When fewer red blood cells are produced, you can develop a condition called anemia.

Retacrit is used to treat anemia caused by chemotherapy or chronic kidney disease, or anemia caused by taking zidovudine to treat HIV (human immunodeficiency virus).

Retacrit is also used to reduce the need for red blood cell transfusions in people having certain types of surgery.

Retacrit may also be used for purposes not listed in this medication guide.

Retacrit can cause serious side effects, including heart attack or stroke. Retacrit may also speed up tumor growth, or shorten remission or survival time in some people. Talk with your doctor about the risks and benefits of using this medicine.

You should not use this medicine if you have uncontrolled high blood pressure, or if you have ever had pure red cell aplasia (PRCA, a type of anemia) caused by using Retacrit or darbthis medicine.

Call your doctor at once if you have signs of a blood clot: sudden numbness or weakness, problems with vision or speech, chest pain, trouble breathing, pain or cold feeling in an arm or leg.

You should not use this medication if you are allergic to Retacrit or darbthis medicine, or if:

• you have untreated or uncontrolled high blood pressure;

• you have had pure red cell aplasia (PRCA, a type of anemia) after using darbRetacrit or this medicine; or

• you use an Retacrit multi-dose vial and you are pregnant or breast-feeding.

Do not use Retacrit from a multi-dose vial when giving medicine to a baby. The multi-dose vial contains an ingredient that can cause serious side effects or death in very young infants or premature babies.

Retacrit may speed up tumor growth, or shorten remission or survival time in some people with certain types of cancer. Talk with your doctor about the risks and benefits of using this medicine.

Tell your doctor if you have ever had:

• heart disease, high blood pressure;

• a heart attack, or blood clot;

• a seizure disorder;

• phenylketonuria (PKU); or

• kidney disease (or if you are on dialysis).

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It may not be safe to breast-feed while using this medicine. Ask your doctor about any risk.

Do not use Retacrit from a multi-dose vial if you are pregnant or breast-feeding.

Retacrit is made from donated human plasma and may contain viruses or other infectious agents. Donated plasma is tested and treated to reduce the risk of contamination, but there is still a small possibility it could transmit disease. Ask your doctor about any possible risk.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Retacrit is injected under the skin, or as an infusion into a vein. A healthcare provider may teach you how to properly use the medication by yourself.

Read and carefully follow any Instructions for Use provided with your medicine. Do not use Retacrit if you don't understand all instructions for proper use. Ask your doctor or pharmacist if you have questions.

Prepare your injection only when you are ready to give it. Do not use if the medicine has changed colors or has particles in it. Call your pharmacist for new medicine.

Do not shake Retacrit or you may ruin it.

Call your doctor if you feel weak, tired, or light-headed. These may be signs that your body has stopped responding to Retacrit.

You may need frequent medical tests to be sure this medicine is not causing harmful effects. Your injections may be delayed based on the results.

You may be given other medications to help prevent serious side effects. Keep using these medicines for as long as your doctor has prescribed.

If you need surgery, tell the surgeon ahead of time that you are using Retacrit. You may need to use a medicine to prevent blood clots.

Retacrit is only part of a complete treatment program that may also include a special diet. Follow your doctor's instructions very closely.

Store in the refrigerator and protect from light. Do not freeze Retacrit, and throw away the medication if it has become frozen.

Each single-use vial (bottle) of this medicine is for one use only. Throw it away after one use, even if there is still medicine left inside. Throw away any leftover medicine in a multi-dose vial 21 days after the first use.

Use a needle and syringe only once and then place them in a puncture-proof "sharps" container. Follow state or local laws about how to dispose of this container. Keep it out of the reach of children and pets.

Avoid driving or hazardous activity until you know how Retacrit will affect you. Your reactions could be impaired.

Other drugs may affect Retacrit, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Applies to epoetin alfa: injectable solution

General

The most common adverse reaction was dose-dependent increase in blood pressure or aggravation of existing hypertension.[Ref]

Gastrointestinal

Very common (10% or more): Nausea (up to 56%), diarrhea (up to 30%), vomiting (up to 28%), stomatitis (10%)

Common (1% to 10%): Dysphagia

Frequency not reported: Vomiting[Ref]

Other

Very common (10% or more): Pyrexia (up to 42%)

Common (1% to 10%): Chills, influenza-like illness, peripheral edema, artificial kidney clotting during dialysis, edema[Ref]

Nervous system

Very common (10% or more): Headache (up to 34%)

Common (1% to 10%): Convulsion, dizziness

Frequency not reported: Cerebrovascular accident, transient ischemic attack[Ref]

Cardiovascular

Very common (10% or more): Hypertension (up to 33%), embolism and thrombosis (up to 15%)

Common (1% to 10%): Deep vein thrombosis, thrombosis

Uncommon (0.1% to 1%): Myocardial infarction

Frequency not reported: Blood pressure increased, aneurysm[Ref]

Respiratory

Very common (10% or more): Cough (up to 26%)

Common (1% to 10%): Respiratory tract congestion, upper respiratory tract infection, pulmonary embolism[Ref]

Dermatologic

Very common (10% or more): Rash (up to 25%), pruritus (up to 21%)

Common (1% to 10%): Urticaria

Uncommon (0.1% to 1%): Erythema

Frequency not reported: Angioedema

Postmarketing reports: Severe cutaneous reactions[Ref]

Musculoskeletal

Very common (10% or more): Arthralgia (up to 24%), pain in extremity (up to 15%), myalgia (up to 10%)

Common (1% to 10%): Bone pain, muscle spasm

Frequency not reported: Porphyria[Ref]

Local

Very common (10% or more): Injection site reaction (up to 18%), injection site pain (up to 13%)

Common (1% to 10%): Vascular access thrombosis[Ref]

Metabolic

Very common (10% or more): Hyperkalemia (up to 10%)

Common (1% to 10%): Weight decrease, hyperglycemia, hypokalemia[Ref]

Psychiatric

Common (1% to 10%): Insomnia, depression[Ref]

Hematologic

Common (1% to 10%): Leukopenia

Postmarketing reports: Erythropoietin antibody-mediated pure red cell aplasia, thrombocytopenia[Ref]

Immunologic

Frequency not reported: Anaphylactic reaction, hypersensitivity

Postmarketing reports: Serious allergic reaction[Ref]

Use Retacrit (epoetin alfa-epbx) 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.
• To gain the most benefit, do not miss doses.
• Keep using Retacrit (epoetin alfa-epbx) as you have been told by your doctor or other health care provider, even if you feel well.
• If you will be giving yourself the shot, your doctor or nurse will teach you how to give the shot.
• Follow how to use as you have been told by the doctor or read the package insert.
• Do not shake.
• Do not use if it has been shaken.
• 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 use if it has been frozen.
• Do not give into red or irritated skin.
• 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.

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:

• Irritation where the shot is given.
• Fever.
• Headache.
• Upset stomach or throwing up.
• Cough.
• Bone, joint, or muscle pain.
• Muscle spasm.
• Mouth irritation or mouth sores.
• Weight loss.
• Not able to sleep.

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-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.