Duvelisib 15 MG Oral Capsule Copiktra
1 INDICATIONS AND USAGE COPIKTRA is a kinase inhibitor indicated for the treatment of adult patients with: Relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) after at least two prior therapies. ( 1.1 ). Relapsed or refractory follicular lymphoma (FL) after at least two prior systemic therapies. ( 1.2 ). This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. 1.1 Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) COPIKTRA is indicated for the treatment of adult patients with relapsed or refractory CLL or SLL after at least two prior therapies. 1.2 Follicular Lymphoma (FL) COPIKTRA is indicated for the treatment of adult patients with relapsed or refractory FL after at least two prior systemic therapies. This indication is approved under accelerated approval based on overall response rate (ORR) [see Clinical Studies ( 14.2 )]; continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
Verastem, Inc.
CAPSULE PINK duv 15 mg
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Duvelisib 25 MG Oral Capsule Copiktra
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16 HOW SUPPLIED/STORAGE AND HANDLING COPIKTRA (duvelisib) capsules are supplied as follows: Abbreviations: HDPE = high-density polyethylene; NDC = National Drug Code; no. = number capsule Strength Description Package Configuration NDC No. 25 mg white to off-white and Swedish orange opaque capsules marked with "duv 25 mg" in black ink 14-day (28ct) single blister pack 14-day (28ct) carton (1 x 28ct blister pack per carton) 28-day (56ct) carton (2 × 28ct blister packs per carton) 28-day (56ct) HDPE bottles 71779-125-04 71779-125-03 71779-125-02 71779-125-01 15 mg pink opaque capsules marked with “duv 15 mg” in black ink 14-day (28ct) single blister pack 28-day (56ct) carton (2 × 28ct blister packs per carton) 56-count HDPE bottles 71779-115-03 71779-115-02 71779-115-01 Store at 20° to 25°C (68° to 77°F), with excursions permitted at 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Retain in original package until dispensing. Dispense blister packs in original container.
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