For: Chronic Lymphocytic Leukemia, Follicular Lymphoma
Copiktra (duvelisib) is a first-in-class, oral, dual phosphoinositide-3-kinase (PI3K)-delta/PI3K-gamma inhibitor for the treatment relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) and relapsed or refractory follicular lymphoma (FL).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. These highlights do not include all the information needed to use COPIKTRA safely and effectively. See full prescribing information for COPIKTRA.
COPIKTRA (duvelisib), capsules for oral use
Initial U.S. Approval: 2018
WARNING: FATAL AND SERIOUS TOXICITIES: INFECTIONS, DIARRHEA OR COLITIS, CUTANEOUS REACTIONS, and PNEUMONITIS
See full prescribing information for complete boxed warning.
Fatal and/or serious infections occurred in 31% of COPIKTRA-treated patients. Monitor for signs and symptoms of infection. Withhold COPIKTRA if infection is suspected. (5.1)
Fatal and/or serious diarrhea or colitis occurred in 18% of COPIKTRA-treated patients. Monitor for the development of severe diarrhea or colitis. Withhold COPIKTRA. (5.2)
Fatal and/or serious cutaneous reactions occurred in 5% of COPIKTRA-treated patients. Withhold COPIKTRA. (5.3)
Fatal and/or serious pneumonitis occurred in 5% of COPIKTRA-treated patients. Monitor for pulmonary symptoms and interstitial infiltrates. Withhold COPIKTRA. (5.4)
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.
DOSAGE AND ADMINISTRATION
25 mg orally, twice daily. Modify dosage for toxicity. (2.1, 2.2)
DOSAGE FORMS AND STRENGTHS
Capsules: 25 mg, 15 mg. (3)
CONTRAINDICATIONS
None. (4)
WARNINGS AND PRECAUTIONS
Hepatotoxicity: Monitor hepatic function. (5.5)
Neutropenia: Monitor blood counts. (5.6)
Embryo-Fetal toxicity: COPIKTRA can cause fetal harm. Advise patients of potential risk to a fetus and to use effective contraception. (5.7)
ADVERSE REACTIONS
The most common adverse reactions (?20%) are diarrhea or colitis, neutropenia, rash, fatigue, pyrexia, cough, nausea, upper respiratory infection, pneumonia, musculoskeletal pain, and anemia. (6)
To report SUSPECTED ADVERSE REACTIONS, contact Verastem, Inc. (Verastem) at 877-7RXVSTM or 1-877-779-8786, or U.S. Food and Drug Administration (FDA) at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
CYP3A inducers: Avoid co-administration with strong CYP3A inducers. (7.1)
CYP3A inhibitors: Monitor for COPIKTRA toxicities when co-administered with strong or moderate CYP3A inhibitors. Reduce COPIKTRA dose to 15 mg twice daily when co-administered with strong CYP3A4 inhibitors. (7.1)
CYP3A substrates: Monitor for signs of toxicities when co-administering COPIKTRA with sensitive CYP3A substrates. (7.2)
USE IN SPECIFIC POPULATIONS
Lactation: Advise women not to breastfeed. (8.2)
See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.
Revised: 7/2019