HERZUMA- trastuzumab kit HERZUMA- trastuzumab injection, powder, lyophilized, for solution

Страна: Соединенные Штаты

Язык: английский

Источник: NLM (National Library of Medicine)

Активный ингредиент:

TRASTUZUMAB (UNII: P188ANX8CK) (TRASTUZUMAB - UNII:P188ANX8CK)

Доступна с:

Cephalon, Inc.

Тип рецепта:

PRESCRIPTION DRUG

Терапевтические показания :

HERZUMA is indicated for adjuvant treatment of HER2 overexpressing node positive or node negative (ER/PR negative or with one high risk feature [see Clinical Studies (14.1)] ) breast cancer - as part of a treatment regimen consisting of doxorubicin, cyclophosphamide, and either paclitaxel or docetaxel - as part of a treatment regimen with docetaxel and carboplatin - as a single agent following multi-modality anthracycline based therapy. Select patients for therapy based on an FDA-approved companion diagnostic for a trastuzumab product [see Dosage and Administration (2.1)] . HERZUMA is indicated: - In combination with paclitaxel for first-line treatment of HER2-overexpressing metastatic breast cancer - As a single agent for treatment of HER2-overexpressing breast cancer in patients who have received one or more chemotherapy regimens for metastatic disease. Select patients for therapy based on an FDA-approved companion diagnostic for a trastuzumab product [see Dosage and Administration (2.1)] . HERZUMA is indi

Обзор продуктов:

420 mg Multiple-dose vial NDC 63459-305-47 HERZUMA (trastuzumab-pkrb) for injection 420 mg/vial is supplied in a multiple-dose vial as a white to pale yellow lyophilized sterile powder, under vacuum. Each carton contains one multiple-dose vial (420 mg/vial) of HERZUMA and one vial (20 mL) of Bacteriostatic Water for Injection (BWFI), USP, containing 1.1% benzyl alcohol as a preservative. 150 mg Single-dose vial NDC 63459-303-43 HERZUMA (trastuzumab-pkrb) for Injection 150 mg/vial is supplied in a single-dose vial as a white to pale yellow lyophilized sterile powder, under vacuum. Each carton contains one single-dose vial (150 mg/vial) of HERZUMA. Store HERZUMA vials in the refrigerator at 2°C to 8°C (36°F to 46°F) until time of reconstitution.

Статус Авторизация:

Biologic Licensing Application

Характеристики продукта

HERZUMA- TRASTUZUMAB
HERZUMA- TRASTUZUMAB INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
CEPHALON, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
HERZUMA SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR HERZUMA.
HERZUMA (TRASTUZUMAB-PKRB) FOR INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 2018
HERZUMA (TRASTUZUMAB-PKRB) IS BIOSIMILAR TO HERCEPTIN (TRASTUZUMAB).
WARNING: CARDIOMYOPATHY, INFUSION REACTIONS, EMBRYO-FETAL TOXICITY,
AND
PULMONARY TOXICITY
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_
CARDIOMYOPATHY: TRASTUZUMAB PRODUCTS CAN RESULT IN SUBCLINICAL AND
CLINICAL CARDIAC
FAILURE MANIFESTING AS CHF, AND DECREASED LVEF, WITH GREATEST RISK
WHEN ADMINISTERED
CONCURRENTLY WITH ANTHRACYCLINES. EVALUATE CARDIAC FUNCTION PRIOR TO
AND DURING
TREATMENT. DISCONTINUE HERZUMA FOR CARDIOMYOPATHY. (2.3, 5.1)
INFUSION REACTIONS, PULMONARY TOXICITY: DISCONTINUE HERZUMA FOR
ANAPHYLAXIS,
ANGIOEDEMA, INTERSTITIAL PNEUMONITIS, OR ACUTE RESPIRATORY DISTRESS
SYNDROME. (5.2,
5.4)
EMBRYO-FETAL TOXICITY: EXPOSURE TO TRASTUZUMAB PRODUCTS DURING
PREGNANCY CAN RESULT
IN OLIGOHYDRAMNIOS, IN SOME CASES COMPLICATED BY PULMONARY HYPOPLASIA
AND NEONATAL
DEATH. ADVISE PATIENTS OF THESE RISKS AND THE NEED FOR EFFECTIVE
CONTRACEPTION. (5.3,
8.1, 8.3)
RECENT MAJOR CHANGES
Indications and Usage, Adjuvant Breast Cancer (1.1)
05/2019
Indications and Usage, Metastatic Gastric Cancer (1.3)
05/2019
Dosage and Administration (2)
05/2019
Warnings and Precautions, Cardiomyopathy (5.1)
05/2019
INDICATIONS AND USAGE
HERZUMA is a HER2/neu receptor antagonist indicated for:
the treatment of HER2-overexpressing breast cancer. (1.1, 1.2)
the treatment of HER2-overexpressing metastatic gastric or
gastroesophageal junction
adenocarcinoma. (1.3)
Select patients for therapy based on an FDA-approved companion
diagnostic for a trastuzumab product.
(1, 2.1)
DOSAGE AND ADMINISTRATION
FOR INTRAVENOUS (IV) INFUSION ONLY. DO NOT ADMINISTER AS AN IV PUSH OR
BOLUS. (