Retacrit

Retacrit is a prescription medication used to treat anemia and reduce red blood cell transfusions that are immunologically incompatible.

Retacrit belongs to a group of drugs called erythropoiesis-stimulating agent (ESA), a substance that stimulates the production of red blood cells.

This medication is available in an injectable form to be given directly into a vein (IV) or under the skin (subcutaneously) and comes in single-dose vials.

Common side effects include joint pain, fever, and nausea. Retacrit can also cause dizziness. Do not drive or operate heavy machinery until you know how Retacrit affects you.

Retacrit is a prescription medicine used to treat anemia. People with anemia have a lower-than-normal number of RBCs. Retacrit works like the human protein called erythropoietin to help your body make more RBCs. Retacrit is used to reduce or avoid the need for RBC transfusions.

Retacrit may be used to treat anemia if it is caused by:

• Chronic kidney disease (you may or may not be on dialysis).
• Chemotherapy that will be used for at least two months after starting Retacrit.
• A medicine called zidovudine (AZT) used to treat HIV infection.

Retacrit may also be used to reduce the chance you will need RBC transfusions if you are scheduled for certain surgeries where a lot of blood loss is expected.

If your hemoglobin level stays too high or if your hemoglobin goes up too quickly, this may lead to serious health problems which may result in death. These serious health problems may happen if you take Retacrit, even if you do not have an increase in your hemoglobin level.

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

Retacrit should not be used for treatment of anemia:

• If you have cancer and you will not be receiving chemotherapy that may cause anemia.
• If you have a cancer that has a high chance of being cured. Talk with your healthcare provider about the kind of cancer you have.
• If your anemia caused by chemotherapy treatment can be managed by RBC transfusion.
• In place of emergency treatment for anemia (RBC transfusions).

Retacrit should not be used to reduce the chance you will need RBC transfusions if:

• You are scheduled for surgery on your heart or blood vessels.
• You are able and willing to donate blood prior to surgery.

It is not known if Retacrit is safe and effective in treating anemia in children less than 1 month old who have chronic kidney disease and in children less than 5 years old who have anemia caused by chemotherapy.

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

Serious side effects have been reported with Retacrit. See the “Retacrit Precautions” section.

• High blood pressure. High blood pressure is a common side effect of Retacrit in people with chronic kidney disease. Your blood pressure may go up or be difficult to control with blood pressure medicine while taking Retacrit. This can happen even if you have never had high blood pressure before. Your healthcare provider should check your blood pressure often. If your blood pressure does go up, your healthcare provider may prescribe new or more blood pressure medicine.
• Seizures. If you have any seizures while taking Retacrit, get medical help right away and tell your healthcare provider.
• Antibodies to Retacrit. Your body may make antibodies to Retacrit. These antibodies can block or lessen your body's ability to make RBCs and cause you to have severe anemia. Call your healthcare provider if you have unusual tiredness, lack of energy, dizziness, or fainting. You may need to stop taking Retacrit.
• Serious allergic reactions. Serious allergic reactions can cause a skin rash, itching, shortness of breath, wheezing, dizziness and fainting because of a drop in blood pressure, swelling around your mouth or eyes, fast pulse, or sweating. If you have a serious allergic reaction, stop using Retacrit and call your healthcare provider or get medical help right away.
• Severe skin reactions. Signs and symptoms of severe skin reactions with Retacrit may include: skin rash with itching, blisters, skin sores, peeling, or areas of skin coming off. If you have any signs or symptoms of a severe skin reaction, stop using Retacrit and call your healthcare provider or get medical help right away.

Common side effects of Retacrit include the following:

• joint, muscle, or bone pain
• fever
• cough
• dizziness
• high blood sugar
• low blood potassium levels
• chills
• redness and pain at injection site
• rash
• nausea
• vomiting
• low white blood cells
• trouble sleeping
• difficulty swallowing
• itching
• headache
• weight loss
• muscle spasm
• depression
• respiratory infection

This is not a complete list of Retacrit side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effects that bother you or that do not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

No drug interactions have been studied by the manufacturer. 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.

Serious side effects have been reported with Retacrit including the following:

For people with cancer:

• Your tumor may grow faster and you may die sooner if you choose to take Retacrit. Your healthcare provider will talk with you about these risks.

For all people who take Retacrit, including people with cancer or chronic kidney disease:

• Serious heart problems, such as heart attack or heart failure, and stroke. You may die sooner if you are treated with Retacrit to increase red blood cells (RBCs) to near the same level found in healthy people.
• Blood clots. Blood clots may happen at any time while taking Retacrit. If you are receiving Retacrit for any reason 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. Blood 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:
  • Chest pain
  • Trouble breathing or shortness of breath
  • Pain in your legs, with or without swelling
  • A cool or pale arm or leg
  • Sudden confusion, trouble speaking, or trouble understanding others' speech
  • Sudden numbness or weakness in your 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

Do not take Retacrit if you:

• Have cancer and have not been counseled by your healthcare provider about treatment with Retacrit.
• Have high blood pressure that is not controlled (uncontrolled hypertension).
• Have been told by your healthcare provider that you have or have ever had a type of anemia called Pure Red Cell Aplasia (PRCA) that starts after treatment with Retacrit or other erythropoietin protein medicines.
• Have had a serious allergic reaction to Retacrit or other epoetin alfa products.

Medications 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 Retacrit, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Retacrit, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Retacrit or to any of its ingredients
• have high blood pressure
• have a heart problem
• have had a seizure or stroke
• have phenylketonuria
• receive dialysis treatment
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed

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

Tell your doctor if you are pregnant or plan to become pregnant.

In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Retacrit crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Retacrit.

• If you or your caregiver has been trained to give Retacrit shots (injections) at home:
  • Be sure that you read, understand, and follow the "Instructions for Use" that come with Retacrit.
  • Take Retacrit exactly as your healthcare provider tells you to. Do not change the dose of Retacrit unless told to do so by your healthcare provider.
  • Your healthcare provider will show you how much Retacrit to use, how to inject it, how often it should be injected, and how to safely throw away the used vials, syringes, and needles.
  • If you miss a dose of Retacrit, call your healthcare provider right away and ask what to do.
  • If you take more than the prescribed dose of Retacrit, call your healthcare provider right away.
• During treatment with Retacrit, continue to follow your healthcare provider's instructions for diet and medicines.
• Have your blood pressure checked as instructed by your healthcare provider.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your weight
• your height
• your age 
• your gender

Patients with chronic kidney disease or patients taking zidovudine for HIV infection usually receive three shots weekly either intravenously or subcutaneously. 

The recommended dose for adults on cancer chemotherapy is 150 Units/kg subcutaneously three times weekly or 40,000 Units subcutaneously every week until completion of chemotherapy.

The recommended dose for pediatrics (5 to 17 years of age) on cancer chemotherapy is 600 Units/kg intravenously every week until completion of chemotherapy.

Surgery patients can take Retacrit in two regimens:

• 300 Units/kg per day subcutaneously for 10 days before, on the day of, and four days after the surgery.
• 600 Units/kg subcutaneously 21, 14, and 7 days before the surgery and on the day of the surgery.

Retacrit comes in 2,000 Units/mL, 3,000 Units/mL, 4,000 Units/mL, 10,000 Units/mL, and 40,000 Units/mL as a clear and colorless liquid in single-dose vials.

Talk to your healthcare provider if you need supplemental iron.

If you take too much Retacrit, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

• Store Retacrit in the refrigerator
• Do not shake or freeze
• Store in original carton to protect from light
• Keep this 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 RETACRIT dose sufficient to reduce the need for red blood cell (RBC) transfusions

Cancer:

• ESAs shortened overall survival and/or increased the risk of tumor progression or recurrence in clinical studies of patients with breast, non-small cell lung, head and neck, lymphoid, and cervical cancers
• to decrease these risks, as well as the risk of serious cardiovascular and thromboembolic reactions, use the lowest dose needed to avoid RBC transfusions
• use ESAs only for anemia from myelosuppressive chemotherapy
• ESAs are not indicated for patients receiving myelosuppressive chemotherapy when the anticipated outcome is cure
• discontinue following the completion of a chemotherapy course

Perisurgery:

• due to increased risk of deep venous thrombosis (DVT), DVT prophylaxis is recommended