GAVRETO- pralsetinib capsule

Страна: США

мова: англійська

Джерело: NLM (National Library of Medicine)

Активний інгредієнт:

pralsetinib (UNII: 1WPE73O1WV) (pralsetinib - UNII:1WPE73O1WV)

Доступна з:

Blueprint Medicines Corporation

Адміністрація маршрут:

ORAL

Тип рецепту:

PRESCRIPTION DRUG

Терапевтичні свідчення:

GAVRETO is indicated for the treatment of adult patients with metastatic RET fusion-positive non-small cell lung cancer (NSCLC) as detected by an FDA approved test. This indication is approved under accelerated approval based on overall response rate and duration of response [see Clinical Studies (14.1)] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). GAVRETO is indicated for the treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic RET -mutant medullary thyroid cancer (MTC) who require systemic therapy. This indication is approved under accelerated approval based on overall response rate and duration of response [see Clinical Studies (14.2)] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). GAVRETO is indicated for the treatment of adult and pediatric patients 12 years of age and older wit

Огляд продуктів:

GAVRETO (pralsetinib) 100 mg, light blue, opaque, immediate release, hydroxypropyl methylcellulose (HPMC) hard capsule printed with "BLU-667" on the capsule shell body and "100 mg" on the capsule shell cap are supplied as follows: Store at 20°C to 25°C (68°F to 77°F); excursions are permitted from 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature] . Protect from moisture.

Статус Авторизація:

New Drug Application

Характеристики продукта

GAVRETO- PRALSETINIB CAPSULE
BLUEPRINT MEDICINES CORPORATION
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
GAVRETO SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR GAVRETO.
GAVRETO™ (PRALSETINIB) CAPSULES, FOR ORAL USE
INITIAL U.S. APPROVAL: 2020
RECENT MAJOR CHANGES
Indications and Usage , RET-Mutant Medullary Thyroid Cancer (1.2)
12/2020
Indications and Usage, RET Fusion-Positive Thyroid Cancer (1.3)
12/2020
Warnings and Precautions, Tumor Lysis Syndrome (5.5)
12/2020
INDICATIONS AND USAGE
GAVRETO is a kinase inhibitor indicated for treatment of:
Adult patients with metastatic rearranged during transfection (_RET_)
fusion-positive non-small cell lung cancer as
detected by an FDA approved test (NSCLC).
(1.1)
Adult and pediatric patients 12 years of age and older with advanced
or metastatic _RET_-mutant medullary thyroid cancer
(MTC) who require systemic therapy
(1.2)
Adult and pediatric patients 12 years of age and older with advanced
or metastatic _RET _fusion-positive thyroid cancer
who require systemic therapy and who are radioactive iodine-refractory
(if radioactive iodine is appropriate)
(1.3)
This indication is approved under accelerated approval based on
overall response rate and duration of response.
Continued approval for this indication may be contingent upon
verification and description of clinical benefit in confirmatory
trial(s )
DOSAGE AND ADMINISTRATION
Select patients for treatment with GAVRETO based on the presence of a
_RET_ gene fusion or gene mutation. (2.1, 14)
The recommended dosage in adults and pediatric patients 12 years and
older is 400 mg orally once daily on an empty
stomach (no food intake for at least 2 hours before and at least 1
hour after taking GAVRETO) (2.2)
DOSAGE FORMS AND STRENGTHS
Capsules: 100 mg. (3)
CONTRAINDICATIONS
None. (4)
WARNINGS AND PRECAUTIONS
Interstitial Lung Disease (ILD)/Pneumonitis: Withhold GAVRETO for
Grade 1 or 2 reactions until resolution and then
resume at a reduced dose.