PROCRIT- erythropoietin injection, solution

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

ERYTHROPOIETIN (UNII: 64FS3BFH5W) (ERYTHROPOIETIN - UNII:64FS3BFH5W)

Disponível em:

Janssen Products, LP

DCI (Denominação Comum Internacional):

Erythropoietin

Composição:

Erythropoietin 2000 [iU] in 1 mL

Via de administração:

INTRAVENOUS

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

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

Resumo do produto:

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.

Status de autorização:

Biologic Licensing Application

Folheto informativo - Bula

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
•

Características técnicas

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 Precaut