ZELBORAF- vemurafenib tablet, film coated

Страна: США

мова: англійська

Джерело: NLM (National Library of Medicine)

Активний інгредієнт:

VEMURAFENIB (UNII: 207SMY3FQT) (VEMURAFENIB - UNII:207SMY3FQT)

Доступна з:

Genentech, Inc.

ІПН (Міжнародна Ім'я):

Vemurafenib

Склад:

Vemurafenib 240 mg

Адміністрація маршрут:

ORAL

Тип рецепту:

PRESCRIPTION DRUG

Терапевтичні свідчення:

ZELBORAF® is indicated for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E mutation as detected by an FDA-approved test. Limitation of Use: ZELBORAF is not indicated for treatment of patients with wild-type BRAF melanoma [see Warnings and Precautions (5.2)] . ZELBORAF® is indicated for the treatment of patients with Erdheim-Chester Disease (ECD) with BRAF V600 mutation. None. Risk Summary Based on its mechanism of action, ZELBORAF can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1)] . There are no available data on the use of ZELBORAF in pregnant women to determine the drug-associated risk; however, placental transfer of vemurafenib to a fetus has been reported. Exposure to vemurafenib could not be achieved in animals at levels sufficient to fully address its potential toxicity in pregnant women. Advise pregnant women of the potential harm to a fetus. The estimated background risks of major birth defects and miscarriage for the indicated population(s) are unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Data Animal Data Vemurafenib showed no evidence of developmental toxicity in rat fetuses at doses up to 250 mg/kg/day (approximately 1.3 times the clinical exposure at 960 mg twice daily based on AUC) or rabbit fetuses at doses up to 450 mg/kg/day (approximately 0.6 times the clinical exposure at 960 mg twice daily based on AUC). Fetal drug levels were 3–5% of maternal levels, indicating that vemurafenib has the potential to be transmitted from the mother to the developing fetus. There is no information available regarding the presence of vemurafenib in human milk, effects on the breastfed infant, or effects on milk production. Because of the potential for serious adverse reactions in a breastfed infant, including malignancy, severe dermatologic reactions, QT prolongation, hepatotoxicity, photosensitivity, and ophthalmologic toxicity, [see Warnings and Precautions (5)] , advise women not to breastfeed during treatment with ZELBORAF and for 2 weeks after the final dose. Contraception Based on its mechanism of action, ZELBORAF can cause fetal harm when administered to a pregnant woman [see Use in Specific Populations (8.1)] . Advise females of reproductive potential to use effective contraception during treatment with ZELBORAF and for 2 weeks after the final dose. The safety and effectiveness of ZELBORAF in pediatric patients have not been established. Vemurafenib was studied in 6 adolescent patients 15 to 17 years of age with unresectable or metastatic melanoma with BRAF V600 mutation. A maximum tolerated dose was not reached with doses up to vemurafenib 960 mg twice daily. No new safety signals were observed. Vemurafenib steady-state exposure in these 6 adolescent patients was generally similar to that in adults. Clinical studies of ZELBORAF did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. No formal clinical study has been conducted to evaluate the effect of hepatic impairment on the pharmacokinetics of vemurafenib. No dose adjustment is recommended for patients with mild and moderate hepatic impairment based on a population pharmacokinetic analysis [see Clinical Pharmacology (12.3)]. The appropriate dose of ZELBORAF has not been established in patients with severe hepatic impairment. No formal clinical study has been conducted to evaluate the effect of renal impairment on the pharmacokinetics of vemurafenib. No dose adjustment is recommended for patients with mild and moderate renal impairment based on a population pharmacokinetic analysis [see Clinical Pharmacology (12.3)]. The appropriate dose of ZELBORAF has not been established in patients with severe renal impairment.

Огляд продуктів:

ZELBORAF (vemurafenib) is supplied as 240 mg film-coated tablets with VEM debossed on one side. The following packaging configurations are available: NDC 50242-090-01 single bottle of 120 count NDC 50242-090-02 single bottle of 112 count Storage and Stability: Store at room temperature 20°C–25°C (68°F–77°F); excursions permitted between 15°C and 30°C (59°F and 86°F), See USP Controlled Room Temperature. Store in the original container with the lid tightly closed. Disposal of unused/expired medicines: The release of pharmaceuticals in the environment should be minimized. Medicines should not be disposed of via wastewater and disposal through household waste should be avoided. Use established "collection systems," if available in your location.

Статус Авторизація:

New Drug Application

інформаційний буклет

Genentech, Inc.
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This Medication Guide has been approved by the U.S.
Food and Drug Administration
Revised: 11/2017
MEDICATION GUIDE
ZELBORAF® (ZEL-bor-raf)
(vemurafenib)
tablet
What is the most important information I should know about ZELBORAF?
ZELBORAF can cause serious side effects, including:
Risk of new cancers. ZELBORAF may cause certain types of skin cancer
called cutaneous squamous cell
carcinoma (cuSCC) and keratoacanthoma. New melanoma lesions have
occurred in people who take
ZELBORAF. ZELBORAF may also cause another type of cancer called
non-cutaneous squamous cell
carcinoma (non-cuSCC). Talk with your healthcare provider about your
risk for these cancers.
Check your skin and tell your healthcare provider right away about any
skin changes including a:
•
new wart
•
skin sore or reddish bump that bleeds or does not heal
•
change in size or color of a mole
Your healthcare provider should check your skin before you start
taking ZELBORAF, and every 2
months during treatment with ZELBORAF, to look for any new skin
cancers. Your healthcare provider
may continue to check your skin for 6 months after you stop taking
ZELBORAF.
Your healthcare provider should also check for cancers that may not
occur on the skin. Tell your
healthcare provider about any new symptoms that you get while taking
ZELBORAF.
Other blood cell cancers have happened in some people with
Erdheim-Chester Disease (ECD) including
those who take ZELBORAF. If you have other blood cell cancers and take
ZELBORAF for ECD, your
healthcare provider will monitor your blood cancer through routine
blood tests.
See "What are the possible side effects of ZELBORAF?" for more
information about side effects.
What is ZELBORAF?
ZELBORAF is a prescription medicine used to treat:
•
a type of skin cancer called melanoma that:
•
has spread to other parts of the body or cannot be removed by surgery,
and
•
has a certain type of abnormal "BRAF" gene.
ZELBORAF is not used to treat melanoma with a normal BRAF gene.
Your healthcare provider will per

Характеристики продукта

ZELBORAF- VEMURAFENIB TABLET, FILM COATED
GENENTECH, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ZELBORAF SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ZELBORAF.
ZELBORAF (VEMURAFENIB) TABLET FOR ORAL USE
INITIAL U.S. APPROVAL: 2011
INDICATIONS AND USAGE
ZELBORAF is a kinase inhibitor indicated for the treatment of patients
with unresectable or metastatic
melanoma with BRAF V600E mutation as detected by an FDA-approved test.
(1.1, 2.1)
ZELBORAF is indicated for the treatment of patients with Erdheim-
Chester Disease with BRAF V600
mutation. (1.2, 2.1)
Limitation of Use: ZELBORAF is not indicated for treatment of patients
with wild-type BRAF melanoma (2.1,
5.2)
DOSAGE AND ADMINISTRATION
Confirm the presence of BRAF V600E mutation in tumor specimens prior
to initiation of treatment with
ZELBORAF. (2.1)
Recommended dose: 960 mg orally twice daily taken approximately 12
hours apart with or without a
meal. (2.2)
DOSAGE FORMS AND STRENGTHS
Tablet: 240 mg (3)
CONTRAINDICATIONS
None (4)
WARNINGS AND PRECAUTIONS
New Primary Cutaneous Malignancies: Perform dermatologic evaluations
prior to initiation of therapy,
every 2 months while on therapy, and for up to 6 months following
discontinuation of ZELBORAF.
Manage with excision and continue treatment without dose adjustment.
(5.1)
New Non-Cutaneous Squamous Cell Carcinoma: Evaluate for symptoms or
clinical signs of new non-
cutaneous SCC before initiation of treatment and periodically during
treatment. (5.1)
Other Malignancies: Monitor patients receiving ZELBORAF closely for
signs or symptoms of other
malignancies (5.1).
Tumor Promotion in BRAF Wild-Type Melanoma: Increased cell
proliferation can occur with BRAF
inhibitors (5.2).
Serious Hypersensitivity Reactions including anaphylaxis and Drug
Reaction with Eosinophilia and
Systemic Symptoms (DRESS Syndrome): Discontinue ZELBORAF for severe
hypersensitivity reactions.
(5.3)
Severe Dermatologic Reactions, including Stevens-Johnson Synd