PROCRIT- erythropoietin injection, solution

United States - English - NLM (National Library of Medicine)

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Active ingredient:
Erythropoietin (UNII: 64FS3BFH5W) (Erythropoietin - UNII:64FS3BFH5W)
Available from:
Janssen Products, LP
INN (International Name):
Erythropoietin
Composition:
Erythropoietin 2000 [iU] in 1 mL
Administration route:
INTRAVENOUS
Prescription type:
PRESCRIPTION DRUG
Therapeutic indications:
PROCRIT is indicated for the treatment of anemia due to chronic kidney disease (CKD), including patients on dialysis and not on dialysis to decrease the need for red blood cell (RBC) transfusion. PROCRIT is indicated for the treatment of anemia due to zidovudine administered at ≤ 4200 mg/week in patients with HIV-infection with endogenous serum erythropoietin levels of ≤ 500 mUnits/mL. PROCRIT is indicated for the treatment of anemia in patients with non-myeloid malignancies where anemia is due to the effect of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy. PROCRIT is indicated to reduce the need for allogeneic RBC transfusions among patients with perioperative hemoglobin > 10 to ≤ 13 g/dL who are at high risk for perioperative blood loss from elective, noncardiac, nonvascular surgery. PROCRIT is not indicated for patients who are willing to donate autologous blood pre-operatively. PROCRIT has not been shown to improve quali
Product summary:
PROCRIT (epoetin alfa) injection is a sterile, clear, and colorless solution available as: Preservative-free, single-dose vials (in citrate-buffered formulation) : 2,000 Units/mL (NDC 59676-302-01), 3,000 Units/mL (NDC 59676-303-01), 4,000 Units/mL (NDC 59676-304-01), or 10,000 Units/mL (NDC 59676-310-01) supplied in cartons, each carton containing six 1 mL single-dose vials. Preservative-free, single-dose vials (in citrate-buffered formulation) : 10,000 Units/mL (NDC 59676-310-02) supplied in dispensing packs (tray) containing 25 single-dose 1 mL vials. Preservative-free, single-dose vials (in phosphate-buffered formulation) : 40,000 Units/mL (NDC 59676-340-01) supplied in dispensing packs containing four 1 mL single-dose vials. Preserved, multiple-dose vials : 20,000 Units/2mL (10,000 Units/mL) (NDC 59676-312-04) supplied in dispensing packs containing four 2 mL multiple-dose vials. Preserved, multiple-dose vials : 20,000 Units/mL (NDC 59676-320-04) supplied in dispensing packs containing four 1 mL multiple-dose vials. Store at 36°F to 46°F (2°C to 8°C). Do not freeze. Do not shake. Do not use PROCRIT that has been shaken or frozen. Store PROCRIT vials in the original carton until use to protect from light.
Authorization status:
Biologic Licensing Application
Authorization number:
59676-302-00, 59676-302-01, 59676-303-00, 59676-303-01, 59676-304-00, 59676-304-01, 59676-310-00, 59676-310-01, 59676-310-02, 59676-312-00, 59676-312-04, 59676-320-00, 59676-320-04, 59676-340-00, 59676-340-01

Janssen Products, LP

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This Medication Guide has been approved by the U.S. Food and Drug

Administration.

Revised 9/2017

MEDICATION GUIDE

PROCRIT® (PRO'–KRIT)

(epoetin alfa)

Read this Medication Guide:

before you start PROCRIT.

if you are told by your healthcare provider that there is new information about PROCRIT.

if you are told by your healthcare provider that you may inject PROCRIT 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 PROCRIT and ask

if there is new information about PROCRIT.

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

PROCRIT 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 PROCRIT. Your

healthcare provider will talk with you about these risks.

For all people who take PROCRIT, 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 PROCRIT 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 PROCRIT. If you are receiving

PROCRIT 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

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

If you decide to take PROCRIT, your healthcare provider should prescribe the smallest dose of PROCRIT

that is necessary to reduce your chance of needing RBC transfusions.

What is PROCRIT?

PROCRIT is a prescription medicine used to treat anemia. People with anemia have a lower-than-normal

number of RBCs. PROCRIT works like the human protein called erythropoietin to help your body make

more RBCs.

PROCRIT is used to reduce or avoid the need for RBC transfusions.

PROCRIT 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 PROCRIT.

A medicine called zidovudine (AZT) used to treat HIV infection.

PROCRIT 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

PROCRIT, even if you do not have an increase in your hemoglobin level.

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

PROCRIT 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).

PROCRIT 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 PROCRIT 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 PROCRIT?

Do not take PROCRIT if you:

Have cancer and have not been counseled by your healthcare provider about treatment with

PROCRIT.

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 PROCRIT or other erythropoietin

protein medicines.

Have had a serious allergic reaction to PROCRIT.

Do not give PROCRIT from multiple-dose vials to:

Pregnant or breastfeeding women

Babies

Before taking PROCRIT, 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.

Receive dialysis treatment.

Are pregnant or plan to become pregnant. It is not known if PROCRIT 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 PROCRIT 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 PROCRIT?

If you or your caregiver has been trained to give PROCRIT shots (injections) at home:

Be sure that you read, understand, and follow the "Instructions for Use" that come with

PROCRIT.

Take PROCRIT exactly as your healthcare provider tells you to. Do not change the dose of

PROCRIT unless told to do so by your healthcare provider.

Your healthcare provider will show you how much PROCRIT 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 PROCRIT, call your healthcare provider right away and ask what to do.

If you take more than the prescribed dose of PROCRIT, call your healthcare provider right

away.

During treatment with PROCRIT, 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 PROCRIT?

PROCRIT may cause serious side effects, including:

See "What is the most important information I should know about PROCRIT?"

High blood pressure. High blood pressure is a common side effect of PROCRIT in people with

chronic kidney disease. Your blood pressure may go up or be difficult to control with blood pressure

medicine while taking PROCRIT. 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 PROCRIT, get medical help right away and tell your

healthcare provider.

Antibodies to PROCRIT. Your body may make antibodies to PROCRIT. 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 PROCRIT.

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 PROCRIT

and call your healthcare provider or get medical help right away.

Severe skin reactions. Signs and symptoms of severe skin reactions with PROCRIT 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 PROCRIT and call your healthcare provider or get

medical help right away.

Dangers of using PROCRIT from multiple-dose vials in newborns, infants, and pregnant or

breastfeeding women. Do not use PROCRIT from multiple-dose vials in newborns, infants, pregnant

or breastfeeding women because the PROCRIT 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 PROCRIT from multiple-dose vials you should not breastfeed for at

least 2 weeks after the last dose. PROCRIT that comes in single-dose vials does not contain benzyl

alcohol. See "Who should not take PROCRIT?"

Common side effects of PROCRIT include:

joint, muscle, or bone pain

fever

cough

dizziness

high blood sugar

low potassium levels in

the blood

chills

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

redness and pain at the PROCRIT injection site

These are not all of the possible side effects of PROCRIT. 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 PROCRIT?

Do not shake PROCRIT.

Store PROCRIT vials in the carton it comes in to protect from light.

Store PROCRIT in the refrigerator between 36°F to 46°F (2°C to 8°C).

Do not freeze PROCRIT. Do not use PROCRIT that has been frozen.

Throw away multiple-dose vials of PROCRIT no later than 21 days from the first day that you put a

needle into the vial.

Single-dose vials of PROCRIT should be used only one time. Throw the vial away after use even if

there is medicine left in the vial.

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

General information about PROCRIT

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use

PROCRIT for a condition for which it was not prescribed. Do not give PROCRIT 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 PROCRIT that is written for healthcare professionals.

What are the ingredients in PROCRIT?

Active ingredient: epoetin alfa

Inactive ingredients:

Multiple-dose vials contain benzyl alcohol.

All vials contain albumin (human), citric acid, sodium chloride, sodium citrate and Water for

Injection.

Single-dose vials containing 40,000 Units of PROCRIT also contain sodium phosphate dibasic

anhydrate and sodium phosphate monobasic monohydrate.

Manufactured by:

Amgen Inc.

One Amgen Center Drive

Thousand Oaks, CA 91320-1799 U.S.A.

Manufactured for:

Janssen Products, LP

Horsham, Pennsylvania 19044

© 2000 Janssen Pharmaceutical Companies

For more information, go to the following website: www.PROCRIT.com or call 1-800-JANSSEN (1-800-

526-7736).

Revised: 5/2020

Document Id: 3e749d77-fc7c-4b60-b015-e19337b413bb

34391-3

Set id: 0c721ba4-ae19-417f-aae1-221ed1a0866a

Version: 28

Effective Time: 20200521

Janssen Products, LP

PROCRIT- erythropoietin injection, solution

Janssen Products, LP

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HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use PROCRIT safely and effectively. See full

prescribing information for PROCRIT.

PROCRIT (epoetin alfa) injection, for intravenous or subcutaneous use

Initial U.S. Approval: 1989

WARNING: ESAs INCREASE THE RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS

THROMBOEMBOLISM, THROMBOSIS OF VASCULAR ACCESS AND TUMOR PROGRESSION OR

RECURRENCE

See full prescribing information for complete boxed warning.

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 (5.1).

No trial has identified a hemoglobin target level, ESA dose, or dosing strategy that does not increase

these risks (2.2).

Use the lowest PROCRIT dose sufficient to reduce the need for red blood cell (RBC) transfusions (5.1).

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 (5.2).

Use the lowest dose to avoid RBC transfusions (2.4).

Use ESAs only for anemia from myelosuppressive chemotherapy (1.3).

ESAs are not indicated for patients receiving myelosuppressive chemotherapy when the anticipated

outcome is cure (1.5).

Discontinue following the completion of a chemotherapy course (2.4).

Perisurgery:

Due to increased risk of deep venous thrombosis (DVT), DVT prophylaxis is recommended (5.1).

RECENT MAJOR CHANGES

Dosage and Administration, Patients with Chronic Kidney Disease (2.2)

9/2017

Warnings and Precautions, Increased Mortality and/or Increased Risk of Tumor Progression or

Recurrence in Patients With Cancer (5.2)

7/2018

Warnings and Precautions, Severe Cutaneous Reactions (5.8)

9/2017

Warnings and Precautions, Risk of Serious Adverse Reactions Due to Benzyl Alcohol Preservative (5.9)

9/2017

INDICATIONS AND USAGE

PROCRIT is an erythropoiesis-stimulating agent (ESA) indicated for:

Treatment of anemia due to

Reduction of allogeneic RBC transfusions in patients undergoing elective, noncardiac, nonvascular surgery (1.4).

Limitations of Use

PROCRIT has not been shown to improve quality of life, fatigue, or patient well-being (1.5).

PROCRIT is not indicated for use:

In patients with cancer receiving hormonal agents, biologic products, or radiotherapy, unless also receiving concomitant

myelosuppressive chemotherapy (1.5).

®

Chronic Kidney Disease (CKD) in patients on dialysis and not on dialysis (1.1).

Zidovudine in patients with HIV-infection (1.2).

The effects of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two

additional months of planned chemotherapy (1.3).

In patients with cancer receiving myelosuppressive chemotherapy when the anticipated outcome is cure (1.5).

In patients with cancer receiving myelosuppressive chemotherapy in whom the anemia can be managed by transfusion

(1.5).

In patients scheduled for surgery who are willing to donate autologous blood (1.5).

In patients undergoing cardiac or vascular surgery (1.5).

As a substitute for RBC transfusions in patients who require immediate correction of anemia (1.5).

DOSAGE AND ADMINISTRATION

Evaluate iron status before and during treatment and maintain iron repletion. Correct or exclude other causes of anemia

before initiating treatment (2.1).

In pregnant women, lactating women, neonates, infants: Use only single-dose vials (2.1).

Patients with CKD: Initial dose: 50 to 100 Units/kg 3 times weekly (adults) and 50 Units/kg 3 times weekly (pediatric

patients). Individualize maintenance dose. Intravenous route recommended for patients on hemodialysis (2.2).

Patients on Zidovudine due to HIV-infection: 100 Units/kg 3 times weekly (2.3).

Patients with Cancer on Chemotherapy: 40,000 Units weekly or 150 Units/kg 3 times weekly (adults); 600 Units/kg

intravenously weekly (pediatric patients ≥ 5 years) (2.4).

Surgery Patients: 300 Units/kg per day daily for 15 days or 600 Units/kg weekly (2.5).

DOSAGE FORMS AND STRENGTHS

Inje ction

2,000 Units/mL, 3,000 Units/mL, 4,000 Units/mL, 10,000 Units/mL, and 40,000 Units/mL in single-dose vials (3)

20,000 Units/2 mL (10,000 Units/mL) and 20,000 Units/mL in multiple-dose vials containing benzyl alcohol (3)

CONTRAINDICATIONS

Uncontrolled hypertension (4)

Pure red cell aplasia (PRCA) that begins after treatment with PROCRIT or other erythropoietin protein drugs (4)

Serious allergic reactions to PROCRIT (4)

Use of the multiple-dose vials containing benzyl alcohol in neonates, infants, pregnant women, and lactating women (4)

WARNINGS AND PRECAUTIONS

Increased Mortality, Myocardial Infarction, Stroke, and Thromboembolism: Using ESAs to target a hemoglobin level of

greater than 11 g/dL increases the risk of serious adverse cardiovascular reactions and has not been shown to provide

additional benefit (5.1 and 14.1). Use caution in patients with coexistent cardiovascular disease and stroke (5.1).

Increased Mortality and/or Increased Risk of Tumor Progression or Recurrence in Patients With Cancer (5.2).

Hypertension: Control hypertension prior to initiating and during treatment with PROCRIT (5.3).

Seizures: PROCRIT increases the risk for seizures in patients with CKD (5.4). Increase monitoring of these patients for

changes in seizure frequency or premonitory symptoms (5.4).

PRCA: If severe anemia and low reticulocyte count develop during PROCRIT treatment, withhold PROCRIT and

evaluate for PRCA (5.6).

Serious Allergic Reactions: Discontinue PROCRIT and manage reactions (5.7).

Severe Cutaneous Reactions: Discontinue PROCRIT (5.8).

ADVERSE REACTIONS

Patients with CKD: Adverse reactions in ≥ 5% of PROCRIT-treated patients in clinical studies were hypertension,

arthralgia, muscle spasm, pyrexia, dizziness, medical device malfunction, vascular occlusion, and upper respiratory tract

infection (6.1).

Patients on Zidovudine due to HIV-infection: Adverse reactions in ≥ 5% of PROCRIT-treated patients in clinical studies

were pyrexia, cough, rash, and injection site irritation (6.1).

Patients with Cancer on Chemotherapy: Adverse reactions in ≥ 5% of PROCRIT-treated patients in clinical studies

were nausea, vomiting, myalgia, arthralgia, stomatitis, cough, weight decrease, leukopenia, bone pain, rash,

hyperglycemia, insomnia, headache, depression, dysphagia, hypokalemia, and thrombosis (6.1).

Surgery Patients: Adverse reactions in ≥ 5% of PROCRIT-treated patients in clinical studies were nausea, vomiting,

pruritus, headache, injection site pain, chills, deep vein thrombosis, cough, and hypertension (6.1).

To report SUSPECTED ADVERSE REACTIONS, contact Janssen Products, LP at 1-800-JANSSEN (1-800-526-

7736) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.

Revised: 7/2018

FULL PRESCRIBING INFORMATION: CONTENTS*

WARNING: ESAs INCREASE THE RISK OF DEATH, MYOCARDIAL INFARCTION,

STROKE, VENOUS THROMBOEMBOLISM, THROMBOSIS OF VASCULAR ACCESS

AND TUMOR PROGRESSION OR RECURRENCE

1 INDICATIONS AND USAGE

1.1 Anemia Due to Chronic Kidney Disease

1.2 Anemia Due to Zidovudine in Patients with HIV-infection

1.3 Anemia Due to Chemotherapy in Patients With Cancer

1.4 Reduction of Allogeneic Red Blood Cell Transfusions in Patients Undergoing Elective,

Noncardiac, Nonvascular Surgery

1.5 Limitations of Use

2 DOSAGE AND ADMINISTRATION

2.1 Important Dosing Information

2.2 Patients with Chronic Kidney Disease

2.3 Zidovudine-treated Patients with HIV-infection

2.4 Patients on Cancer Chemotherapy

2.5 Surgery Patients

2.6 Preparation and Administration

3 DOSAGE FORMS AND STRENGTHS

4 CONTRAINDICATIONS

5 WARNINGS AND PRECAUTIONS

5.1 Increased Mortality, Myocardial Infarction, Stroke, and Thromboembolism

5.2 Increased Mortality and/or Increased Risk of Tumor Progression or Recurrence in Patients With

Cancer

5.3 Hypertension

5.4 Seizures

5.5 Lack or Loss of Hemoglobin Response to PROCRIT

5.6 Pure Red Cell Aplasia

5.7 Serious Allergic Reactions

5.8 Severe Cutaneous Reactions

5.9 Risk of Serious Adverse Reactions Due to Benzyl Alcohol Preservative

5.10 Risk of Infectious Diseases Due to Albumin (Human) Content

5.11 Dialysis Management

6 ADVERSE REACTIONS

6.1 Clinical Trial Experience

6.2 Postmarketing Experience

6.3 Immunogenicity

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

8.2 Lactation

8.4 Pediatric Use

8.5 Geriatric Use

10 OVERDOSAGE

11 DESCRIPTION

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

12.2 Pharmacodynamics

12.3 Pharmacokinetics

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

14 CLINICAL STUDIES

14.1 Patients With Chronic Kidney Disease

14.2 Zidovudine-treated Patients With HIV-infection

14.3 Patients with Cancer on Chemotherapy

14.4 Surgery Patients

16 HOW SUPPLIED/STORAGE AND HANDLING

17 PATIENT COUNSELING INFORMATION

FULL PRESCRIBING INFORMATION

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 [see Warnings and

Precautions (5.1)].

No trial has identified a hemoglobin target level, ESA dose, or dosing strategy that does

not increase these risks [see Dosage and Administration (2.2)].

Use the lowest PROCRIT dose sufficient to reduce the need for red blood cell (RBC)

transfusions [see Warnings and Precautions (5.1)].

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 [see Warnings and Precautions (5.2)].

To decrease these risks, as well as the risk of serious cardiovascular and

thromboembolic reactions, use the lowest dose needed to avoid RBC transfusions [see

Dosage and Administration (2.4)].

Use ESAs only for anemia from myelosuppressive chemotherapy [see Indications and

Usage (1.3)].

ESAs are not indicated for patients receiving myelosuppressive chemotherapy when the

anticipated outcome is cure [see Indications and Usage (1.5)].

Discontinue following the completion of a chemotherapy course [see Dosage and

Administration (2.4)].

Perisurgery:

Due to increased risk of Deep Venous Thrombosis (DVT), DVT prophylaxis is

recommended [see Dosage and Administration (2.5), Warnings and Precautions (5.1)].

1 INDICATIONS AND USAGE

1.1 Anemia Due to Chronic Kidney Disease

PROCRIT is indicated for the treatment of anemia due to chronic kidney disease (CKD), including

patients on dialysis and not on dialysis to decrease the need for red blood cell (RBC) transfusion.

1.2 Anemia Due to Zidovudine in Patients with HIV-infection

Sections or subsections omitted from the full prescribing information are not listed.

PROCRIT is indicated for the treatment of anemia due to zidovudine administered at ≤ 4200 mg/week in

patients with HIV-infection with endogenous serum erythropoietin levels of ≤ 500 mUnits/mL.

1.3 Anemia Due to Chemotherapy in Patients With Cancer

PROCRIT is indicated for the treatment of anemia in patients with non-myeloid malignancies where

anemia is due to the effect of concomitant myelosuppressive chemotherapy, and upon initiation, there is

a minimum of two additional months of planned chemotherapy.

1.4 Reduction of Allogeneic Red Blood Cell Transfusions in Patients Undergoing Elective,

Noncardiac, Nonvascular Surgery

PROCRIT is indicated to reduce the need for allogeneic RBC transfusions among patients with

perioperative hemoglobin > 10 to ≤ 13 g/dL who are at high risk for perioperative blood loss from

elective, noncardiac, nonvascular surgery. PROCRIT is not indicated for patients who are willing to

donate autologous blood pre-operatively.

1.5 Limitations of Use

PROCRIT has not been shown to improve quality of life, fatigue, or patient well-being.

PROCRIT is not indicated for use:

In patients with cancer receiving hormonal agents, biologic products, or radiotherapy, unless also

receiving concomitant myelosuppressive chemotherapy.

In patients with cancer receiving myelosuppressive chemotherapy when the anticipated outcome is

cure.

In patients with cancer receiving myelosuppressive chemotherapy in whom the anemia can be

managed by transfusion.

In patients scheduled for surgery who are willing to donate autologous blood.

In patients undergoing cardiac or vascular surgery.

As a substitute for RBC transfusions in patients who require immediate correction of anemia.

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 PROCRIT. 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 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. Individualize dosing and use the lowest dose of

PROCRIT 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.

If the hemoglobin rises rapidly (e.g., more than 1 g/dL in any 2-week period), reduce the dose of

PROCRIT by 25% or more as needed to reduce rapid responses.

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%.

For patients who do not respond adequately over a 12-week escalation period, increasing the

PROCRIT 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 PROCRIT if responsiveness does not improve.

For adult patients with CKD on dialysis:

Initiate PROCRIT 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 PROCRIT.

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 PROCRIT treatment only when the hemoglobin level is less than 10 g/dL and the

following considerations apply:

The rate of hemoglobin decline indicates the likelihood of requiring a RBC transfusion and,

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 PROCRIT, and use the

lowest dose of PROCRIT 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 PROCRIT 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 PROCRIT.

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

If hemoglobin does not increase after 8 weeks of therapy, increase PROCRIT 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 PROCRIT 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 PROCRIT 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 PROCRIT 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 PROCRIT 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):

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 PROCRIT 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 PROCRIT.

2.5 Surgery Patients

The recommended PROCRIT regimens are:

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 PROCRIT therapy [see Warnings and

Precautions (5.1)].

2.6 Preparation and Administration

Do not shake. Do not use PROCRIT 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.

Discard unused portions of PROCRIT in preservative-free vials. Do not re-enter preservative-free

vials.

Store unused portions of PROCRIT in multiple-dose vials at 36°F to 46°F (2°C to 8°C). Discard 21

days after initial entry.

Do not dilute. Do not mix with other drug solutions except for admixing as described below:

Preservative-free PROCRIT from single-dose vials may be admixed in a syringe with bacteriostatic

0.9% sodium chloride injection, USP, with benzyl alcohol 0.9% (bacteriostatic saline) in a 1:1 ratio

using aseptic technique at the time of administration. Do not mix PROCRIT with bacteriostatic saline

when administering to pregnant women, lactating women, neonates, and infants [see Use in Specific

Populations (8.1, 8.2, 8.4)].

3 DOSAGE FORMS AND STRENGTHS

Injection:

2,000 Units/mL, 3,000 Units/mL, 4,000 Units/mL, 10,000 Units/mL, and 40,000 Units/mL of

PROCRIT as a clear and colorless liquid in single-dose vials

20,000 Units/2 mL (10,000 Units/mL) and 20,000 Units/mL of PROCRIT as a clear and colorless

liquid in multiple-dose vials (contains benzyl alcohol)

4 CONTRAINDICATIONS

PROCRIT is contraindicated in patients with:

Uncontrolled hypertension [see Warnings and Precautions (5.3)]

Pure red cell aplasia (PRCA) that begins after treatment with PROCRIT or other erythropoietin

protein drugs [see Warnings and Precautions (5.6)]

Serious allergic reactions to PROCRIT [see Warnings and Precautions (5.7)]

PROCRIT from multiple-dose vials contains benzyl alcohol and is contraindicated in:

Neonates, infants, pregnant women, and lactating women [see Warnings and Precautions (5.9), Use in

Specific Populations (8.1, 8.2, 8.4)].

5 WARNINGS AND PRECAUTIONS

5.1 Increased Mortality, Myocardial Infarction, Stroke, and Thromboembolism

In controlled clinical trials of patients with CKD comparing higher hemoglobin targets (13 – 14

g/dL) to lower targets (9 – 11.3 g/dL), PROCRIT and other ESAs increased the risk of death,

myocardial infarction, stroke, congestive heart failure, thrombosis of hemodialysis vascular access,

and other thromboembolic events in the higher target groups.

Using ESAs to target a hemoglobin level of greater than 11 g/dL increases the risk of serious

adverse cardiovascular reactions and has not been shown to provide additional benefit [see Clinical

Studies (14.1)]. Use caution in patients with coexistent cardiovascular disease and stroke [see Dosage

and Administration (2.2)]. Patients with CKD and an insufficient hemoglobin response to ESA

therapy may be at even greater risk for cardiovascular reactions and mortality than other patients. A

rate of hemoglobin rise of greater than 1 g/dL over 2 weeks may contribute to these risks.

In controlled clinical trials of patients with cancer, PROCRIT and other ESAs increased the risks

for death and serious adverse cardiovascular reactions. These adverse reactions included

myocardial infarction and stroke.

In controlled clinical trials, ESAs increased the risk of death in patients undergoing coronary artery

bypass graft surgery (CABG) and the risk of deep venous thrombosis (DVT) in patients undergoing

orthopedic procedures.

The design and overall results of the 3 large trials comparing higher and lower hemoglobin targets are

shown in Table 1.

Table 1: Randomized Controlled Trials Showing Adverse

Cardiovascular Outcomes in Patients With CKD

Normal

Hematocrit Study

(NHS)

(N=1265)

CHOIR

(N=1432)

TREAT

(N=4038)

Time Period of

T rial

1993 to 1996

2003 to 2006

2004 to 2009

Population

CKD patients on

hemodialysis with

coexisting CHF or

CAD, hematocrit

30 ± 3% on

epoetin alfa

CKD patients not

on dialysis with

hemoglobin < 11

g/dL not

previously

administered

epoetin alfa

CKD patients not

on dialysis with

type II diabetes,

hemoglobin ≤ 11

g/dL

Hemoglobin

Target;

Higher vs. Lower

(g/dL)

14.0 vs. 10.0

13.5 vs. 11.3

13.0 vs. ≥ 9.0

Median (Q1, Q3)

Achieved

Hemoglobin level

(g/dL)

12.6 (11.6, 13.3)

vs. 10.3 (10.0,

10.7)

13.0 (12.2, 13.4)

vs. 11.4 (11.1,

11.6)

12.5 (12.0, 12.8)

vs. 10.6 (9.9, 11.3)

Primary Endpoint

All-cause

mortality or non-

fatal MI

All-cause

mortality, MI,

hospitalization for

CHF, or stroke

All-cause

mortality, MI,

myocardial

ischemia, heart

failure, and stroke

Hazard Ratio or

Relative Risk

(95% CI)

1.28 (1.06 – 1.56)

1.34 (1.03 – 1.74)

1.05 (0.94 – 1.17)

Advers e

Outcome for

Higher Target

Group

All-cause

mortality

All-cause

mortality

Stroke

Hazard Ratio or

Relative Risk

(95% CI)

1.27 (1.04 – 1.54)

1.48 (0.97 – 2.27)

1.92 (1.38 – 2.68)

Patients with Chronic Kidney Disease

Normal Hematocrit Study (NHS): A prospective, randomized, open-label study of 1265 patients with

chronic kidney disease on dialysis with documented evidence of congestive heart failure or ischemic

heart disease was designed to test the hypothesis that a higher target hematocrit (Hct) would result in

improved outcomes compared with a lower target Hct. In this study, patients were randomized to epoetin

alfa treatment targeted to a maintenance hemoglobin of either 14 ± 1 g/dL or 10 ± 1 g/dL. The trial was

terminated early with adverse safety findings of higher mortality in the high hematocrit target group.

Higher mortality (35% vs. 29%) was observed for the patients randomized to a target hemoglobin of 14

g/dL than for the patients randomized to a target hemoglobin of 10 g/dL. For all-cause mortality, the

HR=1.27; 95% CI (1.04, 1.54); p=0.018. The incidence of nonfatal myocardial infarction, vascular

access thrombosis, and other thrombotic events was also higher in the group randomized to a target

hemoglobin of 14 g/dL.

CHOIR: A randomized, prospective trial, 1432 patients with anemia due to CKD who were not

undergoing dialysis and who had not previously received epoetin alfa therapy were randomized to

epoetin alfa treatment targeting a maintenance hemoglobin concentration of either 13.5 g/dL or 11.3

g/dL. The trial was terminated early with adverse safety findings. A major cardiovascular event (death,

myocardial infarction, stroke, or hospitalization for congestive heart failure) occurred in 125 of the 715

patients (18%) in the higher hemoglobin group compared to 97 of the 717 patients (14%) in the lower

hemoglobin group [hazard ratio (HR) 1.34, 95% CI: 1.03, 1.74; p=0.03].

TREAT: A randomized, double-blind, placebo-controlled, prospective trial of 4038 patients with: CKD

not on dialysis (eGFR of 20 – 60 mL/min), anemia (hemoglobin levels ≤ 11 g/dL), and type 2 diabetes

mellitus, patients were randomized to receive either darbepoetin alfa treatment or a matching placebo.

Placebo group patients also received darbepoetin alfa when their hemoglobin levels were below 9

g/dL. The trial objectives were to demonstrate the benefit of darbepoetin alfa treatment of the anemia to

a target hemoglobin level of 13 g/dL, when compared to a "placebo" group, by reducing the occurrence

of either of two primary endpoints: (1) a composite cardiovascular endpoint of all-cause mortality or a

specified cardiovascular event (myocardial ischemia, CHF, MI, and CVA) or (2) a composite renal

endpoint of all-cause mortality or progression to end stage renal disease. The overall risks for each of

the two primary endpoints (the cardiovascular composite and the renal composite) were not reduced

with darbepoetin alfa treatment (see Table 1), but the risk of stroke was increased nearly two-fold in the

darbepoetin alfa -treated group versus the placebo group: annualized stroke rate 2.1% vs. 1.1%,

respectively, HR 1.92; 95% CI: 1.38, 2.68; p < 0.001. The relative risk of stroke was particularly high

in patients with a prior stroke: annualized stroke rate 5.2% in the darbepoetin alfa-treated group and

1.9% in the placebo group, HR 3.07; 95% CI: 1.44, 6.54. Also, among darbepoetin alfa-treated subjects

with a past history of cancer, there were more deaths due to all causes and more deaths adjudicated as

due to cancer, in comparison with the control group.

Patients with Cancer

An increased incidence of thromboembolic reactions, some serious and life-threatening, occurred in

patients with cancer treated with ESAs.

In a randomized, placebo-controlled study (Study 2 in Table 2 [see Warnings and Precautions (5.2)]) of

939 women with metastatic breast cancer receiving chemotherapy, patients received either weekly

epoetin alfa or placebo for up to a year. This study was designed to show that survival was superior

when epoetin alfa was administered to prevent anemia (maintain hemoglobin levels between 12 and 14

g/dL or hematocrit between 36% and 42%). This study was terminated prematurely when interim results

demonstrated a higher mortality at 4 months (8.7% vs. 3.4%) and a higher rate of fatal thrombotic

reactions (1.1% vs. 0.2%) in the first 4 months of the study among patients treated with epoetin alfa.

Based on Kaplan-Meier estimates, at the time of study termination, the 12-month survival was lower in

the epoetin alfa group than in the placebo group (70% vs. 76%; HR 1.37, 95% CI: 1.07, 1.75; p=0.012).

Patients Having Surgery

An increased incidence of deep venous thrombosis (DVT) in patients receiving epoetin alfa undergoing

surgical orthopedic procedures was demonstrated [see Adverse Reactions (6.1)]. In a randomized,

controlled study, 680 adult patients, not receiving prophylactic anticoagulation and undergoing spinal

surgery, were randomized to 4 doses of 600 Units/kg epoetin alfa (7, 14, and 21 days before surgery,

and the day of surgery) and standard of care (SOC) treatment (n=340) or to SOC treatment alone (n=340).

A higher incidence of DVTs, determined by either color flow duplex imaging or by clinical symptoms,

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