(epoetin alfa-epbx)

Prescribing Information
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2 DOSAGE AND ADMINISTRATION

2 DOSAGE AND ADMINISTRATION

2.1 Important Dosing Information

Evaluation of Iron Stores and Nutritional Factors

Evaluate the iron status in all patients before and during treatment. Administer supplemental iron therapy when serum ferritin is less than 100 mcg/L or when serum transferrin saturation is less than 20%. The majority of patients with CKD will require supplemental iron during the course of ESA therapy.

Monitoring of Response to Therapy

Correct or exclude other causes of anemia (e.g., vitamin deficiency, metabolic or chronic inflammatory conditions, bleeding, etc.) before initiating RETACRIT. Following initiation of therapy and after each dose adjustment, monitor hemoglobin weekly until the hemoglobin level is stable and sufficient to minimize the need for RBC transfusion.

Selection of Formulation

In pregnant women, lactating women, neonates, and infants use only single-dose vials (the benzyl alcohol-free formulation) [see Contraindications (4) and Use in Specific Populations (8.1, 8.2, and 8.4)].

2.2 Patients with Chronic Kidney Disease

In controlled trials, patients experienced greater risks for death, serious adverse cardiovascular reactions, and stroke when administered 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. Individualize dosing and use the lowest dose of RETACRIT sufficient to reduce the need for RBC transfusions [see Warnings and Precautions (5.1)]. Physicians and patients should weigh the possible benefits of decreasing transfusions against the increased risks of death and other serious cardiovascular adverse reactions [see Boxed Warning and Clinical Studies (14)].

For all patients with CKD:

When initiating or adjusting therapy, monitor hemoglobin levels at least weekly until stable, then monitor at least monthly. When adjusting therapy consider hemoglobin rate of rise, rate of decline, ESA responsiveness and hemoglobin variability. A single hemoglobin excursion may not require a dosing change.

•
Do not increase the dose more frequently than once every 4 weeks. Decreases in dose can occur more frequently. Avoid frequent dose adjustments.
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If the hemoglobin rises rapidly (e.g., more than 1 g/dL in any 2-week period), reduce the dose of RETACRIT by 25% or more as needed to reduce rapid responses.
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For patients who do not respond adequately, if the hemoglobin has not increased by more than 1 g/dL after 4 weeks of therapy, increase the dose by 25%.
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For patients who do not respond adequately over a 12-week escalation period, increasing the RETACRIT dose further is unlikely to improve response and may increase risks. Use the lowest dose that will maintain a hemoglobin level sufficient to reduce the need for RBC transfusions. Evaluate other causes of anemia. Discontinue RETACRIT if responsiveness does not improve.

For adult patients with CKD on dialysis:

•
Initiate RETACRIT treatment when the hemoglobin level is less than 10 g/dL.
•
If the hemoglobin level approaches or exceeds 11 g/dL, reduce or interrupt the dose of RETACRIT.
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The recommended starting dose for adult patients is 50 to 100 Units/kg 3 times weekly intravenously or subcutaneously. The intravenous route is recommended for patients on hemodialysis.

For adult patients with CKD not on dialysis:

•
Consider initiating RETACRIT treatment only when the hemoglobin level is less than 10 g/dL and the following considerations apply:
o
The rate of hemoglobin decline indicates the likelihood of requiring a RBC transfusion
and,
o
Reducing the risk of alloimmunization and/or other RBC transfusion-related risks is a goal
•
If the hemoglobin level exceeds 10 g/dL, reduce or interrupt the dose of RETACRIT, and use the lowest dose of RETACRIT sufficient to reduce the need for RBC transfusions.
•
The recommended starting dose for adult patients is 50 to 100 Units/kg 3 times weekly intravenously or subcutaneously.

For pediatric patients with CKD:

•
Initiate RETACRIT treatment only when the hemoglobin level is less than 10 g/dL.
•
If the hemoglobin level approaches or exceeds 12 g/dL, reduce or interrupt the dose of RETACRIT.
•
The recommended starting dose for pediatric patients (ages 1 month or older) is 50 Units/kg 3 times weekly intravenously or subcutaneously.

When treating patients who have chronic kidney disease and cancer, physicians should refer to Warnings and Precautions (5.1 and 5.2).

2.3 Zidovudine-treated Patients with HIV Infection

Starting Dose

The recommended starting dose in adults is 100 Units/kg as an intravenous or subcutaneous injection 3 times per week.

Dose Adjustment

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If hemoglobin does not increase after 8 weeks of therapy, increase RETACRIT dose by approximately 50 to 100 Units/kg at 4- to 8-week intervals until hemoglobin reaches a level needed to avoid RBC transfusions or 300 Units/kg.
•
Withhold RETACRIT if hemoglobin exceeds 12 g/dL. Resume therapy at a dose 25% below the previous dose when hemoglobin declines to less than 11 g/dL.

Discontinue RETACRIT if an increase in hemoglobin is not achieved at a dose of 300 Units/kg for 8 weeks.

2.4 Patients on Cancer Chemotherapy

Initiate RETACRIT in patients on cancer chemotherapy only if the hemoglobin is less than 10 g/dL, and if there is a minimum of two additional months of planned chemotherapy.

Use the lowest dose of RETACRIT necessary to avoid RBC transfusions.

Recommended Starting Dose

Adults:

•
150 Units/kg subcutaneously 3 times per week until completion of a chemotherapy course or
•
40,000 Units subcutaneously weekly until completion of a chemotherapy course.

Pediatric Patients (5 to 18 years):

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600 Units/kg intravenously weekly until completion of a chemotherapy course.

Dose Reduction

Reduce dose by 25% if:

•
Hemoglobin increases greater than 1 g/dL in any 2-week period or
•
Hemoglobin reaches a level needed to avoid RBC transfusion.

Withhold dose if hemoglobin exceeds a level needed to avoid RBC transfusion. Reinitiate at a dose 25% below the previous dose when hemoglobin approaches a level where RBC transfusions may be required.

Dose Increase

After the initial 4 weeks of RETACRIT therapy, if hemoglobin increases by less than 1 g/dL and remains below 10 g/dL, increase dose to:

•
300 Units/kg three times per week in adults or
•
60,000 Units weekly in adults
•
900 Units/kg (maximum 60,000 Units) weekly in pediatric patients

After 8 weeks of therapy, if there is no response as measured by hemoglobin levels or if RBC transfusions are still required, discontinue RETACRIT.

2.5 Surgery Patients

The recommended RETACRIT regimens are:

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300 Units/kg per day subcutaneously for 15 days total: administered daily for 10 days before surgery, on the day of surgery, and for 4 days after surgery.
•
600 Units/kg subcutaneously in 4 doses administered 21, 14, and 7 days before surgery and on the day of surgery.

Deep venous thrombosis prophylaxis is recommended during RETACRIT therapy [see Warnings and Precautions (5.1)].

2.6 Preparation and Administration

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Do not shake. Do not use RETACRIT that has been shaken or frozen.
•
Protect vials from light.
•
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Do not use any vials exhibiting particulate matter or discoloration.
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Discard unused portions of RETACRIT in preservative-free vials. Do not re-enter preservative-free vials.
•
Store unused portions of RETACRIT in multiple-dose vials at 2°C to 8°C (36°F to 46°F). Discard 21 days after initial entry.
•
Do not dilute. Do not mix with other drug solutions.
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The vial stopper used for RETACRIT is not made with natural rubber latex.
Medication Guide

MEDICATION GUIDE

This Medication Guide has been approved by the U.S. Food and Drug Administration.     Revised: 6/2024

MEDICATION GUIDE
RETACRIT® (Ret-uh-krit)
(epoetin alfa-epbx)

Read this Medication Guide:

•
before you start RETACRIT.
•
if you are told by your healthcare provider that there is new information about RETACRIT.
•
if you are told by your healthcare provider that you may inject RETACRIT at home, read this Medication Guide each time you receive a new supply of medicine.

This Medication Guide does not take the place of talking to your healthcare provider about your medical condition or your treatment. Talk with your healthcare provider regularly about the use of RETACRIT and ask if there is new information about RETACRIT.

What is the most important information I should know about RETACRIT?

RETACRIT may cause serious side effects that can lead to death, including:

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

See "What are the possible side effects of RETACRIT?" below for more information.

If you decide to take RETACRIT, your healthcare provider should prescribe the smallest dose of RETACRIT that is necessary to reduce your chance of needing RBC transfusions.

What is RETACRIT?

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.
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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.
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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.

Who should not take RETACRIT?

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.

Do not give RETACRIT from multiple-dose vials to:

•
Pregnant or breastfeeding women
•
Babies

Before taking RETACRIT, tell your healthcare provider about all of your medical conditions, including if you:

•
Have heart disease.
•
Have high blood pressure.
•
Have had a seizure (convulsion) or stroke.
•
Have phenylketonuria. RETACRIT contains phenylalanine (a component of aspartame).
•
Receive dialysis treatment.
•
Are pregnant or plan to become pregnant. It is not known if RETACRIT may harm your unborn baby. Talk to your healthcare provider about possible pregnancy and birth control choices that are right for you.
•
Are breastfeeding or plan to breastfeed. It is not known if RETACRIT passes into breast milk.

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

How should I take RETACRIT?

•
If you or your caregiver has been trained to give RETACRIT shots (injections) at home:
o
Be sure that you read, understand, and follow the "Instructions for Use" that come with RETACRIT.
o
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.
o
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.
o
If you miss a dose of RETACRIT, call your healthcare provider right away and ask what to do.
o
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.

What are the possible side effects of RETACRIT?

RETACRIT may cause serious side effects, including:

•
See "What is the most important information I should know about RETACRIT?"
•
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.
•
Dangers of using RETACRIT from multiple-dose vials in newborns, infants, and pregnant or breastfeeding women. Do not use RETACRIT from multiple-dose vials in newborns, infants, pregnant or breastfeeding women because the RETACRIT in these vials contains benzyl alcohol. Benzyl alcohol has been shown to cause brain damage, other serious side effects, and death in newborn and premature babies. If you use RETACRIT from multiple-dose vials you should not breastfeed for at least 2 weeks after the last dose. RETACRIT that comes in single-dose vials does not contain benzyl alcohol. See "Who should not take RETACRIT?"

Common side effects of RETACRIT include:

•
joint, muscle, or bone pain
•
fever
•
cough
•
dizziness
•
high blood sugar
•
low potassium levels in the blood
•
chills
•
redness and pain at the RETACRIT injection site
•
rash
•
nausea
•
vomiting
•
blood vessel blockage
•
low white blood cells
•
trouble sleeping
•
difficulty swallowing
•
soreness of mouth
•
itching
•
headache
•
respiratory infection
•
weight decrease
•
depression
•
muscle spasm

These are not all of the possible side effects of RETACRIT. Your healthcare provider can give you a more complete list. Tell your healthcare provider about 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 FDA at 1-800-FDA-1088.

How should I store RETACRIT?

•
Do not shake RETACRIT.
•
Store RETACRIT vials in the carton it comes in to protect from light.
•
Store RETACRIT in the refrigerator between 36°F to 46°F (2°C to 8°C).
•
Do not freeze RETACRIT. Do not use the carton of RETACRIT multiple-dose vials if it that has been frozen or if the green area on the freeze strip indicator inside the RETACRIT carton looks white or cloudy.
•
Throw away multiple-dose vials of RETACRIT no later than 21 days from the first day that you put a needle into the vial.
•
Single-dose vials of RETACRIT should be used only one time. Throw the vial away after use even if there is medicine left in the vial.

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

General information about the safe and effective use of RETACRIT.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use RETACRIT for a condition for which it was not prescribed. Do not give RETACRIT to other people even if they have the same symptoms that you have. It may harm them. You can ask your healthcare provider or pharmacist for information about RETACRIT that is written for healthcare professionals.

What are the ingredients in RETACRIT?

Active Ingredient: epoetin alfa-epbx

Inactive Ingredients:

•
Multiple-dose vials contain benzyl alcohol.
•
All single-dose vials contain calcium chloride dehydrate, glycine, isoleucine, leucine, L-glutamic acid, phenylalanine, polysorbate 20, sodium chloride, sodium phosphate dibasic anhydrous, sodium phosphate monobasic monohydrate, and threonine, in water for injection. Sodium hydroxide and hydrochloric acid may be added to adjust the pH.
•
All multiple-dose vials contain benzyl alcohol, L-methionine, polysorbate 20, sodium phosphate dibasic anhydrous, sodium phosphate monobasic monohydrate, and sucrose, in water for injection. Sodium hydroxide and hydrochloric acid may be added to adjust the pH.

Manufactured by Hospira, Inc., a Pfizer Company, Lake Forest, IL 60045 USA
US License No. 1974
Distributed by Pfizer Labs, division of Pfizer Inc., New York, NY 10001 USA

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LAB-0827-9.0
For more information, go to www.pfizer.com or call 1-800-438-1985.

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