Страна: Соединенные Штаты
Язык: английский
Источник: NLM (National Library of Medicine)
pralsetinib (UNII: 1WPE73O1WV) (pralsetinib - UNII:1WPE73O1WV)
Blueprint Medicines Corporation
ORAL
PRESCRIPTION DRUG
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
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.
New Drug Application
GAVRETO- PRALSETINIB CAPSULE BLUEPRINT MEDICINES CORPORATION ---------- 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. Прочитать полный документ