PERJETA- pertuzumab injection, solution, concentrate

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

PERTUZUMAB (UNII: K16AIQ8CTM) (PERTUZUMAB - UNII:K16AIQ8CTM)

Available from:

Genentech, Inc.

INN (International Name):

Pertuzumab

Composition:

Pertuzumab 30 mg in 1 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

PERJETA is indicated for use in combination with trastuzumab and docetaxel for the treatment of patients with HER2-positive metastatic breast cancer who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease [see Dosage and Administration (2.2) and Clinical Studies (14.1)] . PERJETA is indicated for use in combination with trastuzumab and chemotherapy for - the neoadjuvant treatment of patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer (either greater than 2 cm in diameter or node positive) as part of a complete treatment regimen for early breast cancer [see Dosage and Administration (2.2) and Clinical Studies (14.2)] . - the adjuvant treatment of patients with HER2-positive early breast cancer at high risk of recurrence [see Dosage and Administration (2.2) and Clinical Studies (14.3)] . PERJETA is contraindicated in patients with known hypersensitivity to pertuzumab or to any of its excipients. Pregnancy Pharmacovigilance Program There is a pre

Product summary:

PERJETA injection is supplied as a 420 mg/14 mL (30 mg/mL) single-dose vial containing preservative-free solution. NDC 50242-145-01. Store vials in a refrigerator at 2°C to 8°C (36°F to 46°F) until time of use. Keep vial in the outer carton in order to protect from light. DO NOT FREEZE. DO NOT SHAKE.

Authorization status:

Biologic Licensing Application

Summary of Product characteristics

PERJETA- PERTUZUMAB INJECTION, SOLUTION, CONCENTRATE
GENENTECH, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
PERJETA SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR PERJETA.
PERJETA (PERTUZUMAB) INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 2012
WARNING: LEFT VENTRICULAR DYSFUNCTION AND EMBRYO-FETAL TOXICITY
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
LEFT VENTRICULAR DYSFUNCTION: PERJETA CAN RESULT IN SUBCLINICAL AND
CLINICAL CARDIAC
FAILURE MANIFESTING AS DECREASED LVEF AND CHF. EVALUATE CARDIAC
FUNCTION PRIOR TO
AND DURING TREATMENT. DISCONTINUE PERJETA TREATMENT FOR A CONFIRMED
CLINICALLY
SIGNIFICANT DECREASE IN LEFT VENTRICULAR FUNCTION. (2.3, 5.1, 6.1)
EMBRYO-FETAL TOXICITY: EXPOSURE TO PERJETA CAN RESULT IN EMBRYO-FETAL
DEATH AND
BIRTH DEFECTS. ADVISE PATIENTS OF THESE RISKS AND THE NEED FOR
EFFECTIVE
CONTRACEPTION. (5.2, 8.1, 8.3)
INDICATIONS AND USAGE
PERJETA is a HER2/neu receptor antagonist indicated for:
Use in combination with trastuzumab and docetaxel for treatment of
patients with HER2-positive
metastatic breast cancer (MBC) who have not received prior anti-HER2
therapy or chemotherapy for
metastatic disease. (1.1)
Use in combination with trastuzumab and chemotherapy as
neoadjuvant treatment of patients with HER2-positive, locally
advanced, inflammatory, or early stage
breast cancer (either greater than 2 cm in diameter or node positive)
as part of a complete
treatment regimen for early breast cancer. (1.2, 2.2, 14.2)
adjuvant treatment of patients with HER2-positive early breast cancer
at high risk of recurrence (1.2,
2.2, 14.3)
DOSAGE AND ADMINISTRATION
FOR INTRAVENOUS INFUSION ONLY. Do not administer as an intravenous
push or bolus. (2.4)
HER2 testing: Perform using FDA-approved tests by laboratories with
demonstrated proficiency. (2.1)
The initial PERJETA dose is 840 mg administered as a 60-minute
intravenous infusion, followed every 3
weeks thereafter by 420 mg administered as a 3