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Rx Item-COPIKTRA DUVELISIB 25MG 2x28 Capsules by Verastim Inc

RX71779-0125-02Visit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop

Rx Item-COPIKTRA DUVELISIB 25MG 2x28 Capsules by Verastim Inc

$17957.58$17102.46

NDC No. 71779-0125-02 71779-125-02 7177912502 71779012502 UPC/GTIN No. 3-71779-12502-8 371779-125028 371779125028 MPN No.012502 Only Lic.-Physician, Pharmacy, Dentist, Drug Mfg, Dist., Gov, Hospital, Lic.Lab, Naturalist, Naturopath, NP, Optometrist, & Pharmacist, PA, Physical Therapist, Podiatrist, Research Co., Uni., VA, Vet & Wholesalers In Scope Of their Practice Can Order Rx Item.

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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

RX71779-0125-02
Rx Item-COPIKTRA DUVELISIB 25MG 2x28 Cap
RX71779-0125-02

Visit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.
Rx Item-COPIKTRA DUVELISIB 25MG 2x28 Cap
Visit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.

Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop
AmericanPharmaWholesale.com
Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop