KENGREAL (Page 4 of 4)

14.2 CHAMPION PCI and PLATFORM Trials

Two additional concurrent clinical trials of the effect of KENGREAL in patients undergoing percutaneous coronary intervention, CHAMPION PCI and CHAMPION PLATFORM were conducted and terminated early for futility. They were completed prior to the design and conduct of CHAMPION PHOENIX. The comparative characteristics and outcomes of each trial are shown in Table 4.

Table 4: Summary of the CHAMPION Trials
PCI PLATFORM PHOENIX
Subjects Randomized (% of planned enrollment) 8,846 (99%) 5,346 (84%) 11,145 (100%)
Primary Endpoint at 48 hours Death, MI, or IDR Death, MI, or IDR Death, MI, IDR, or ST
Outcome of primary analysis, OR (95% CI) 1.05 (0.88, 1.24) 0.87 (0.71, 1.07) 0.78 (0.66, 0.93)
Clopidogrel dose and time in clopidogrel arm 600 mg immediately before PCI 600 mg immediately after PCI 300 or 600 mg shortly before or shortly after PCI
Population enrolled(%) Stable angina 15% 5% 58%
UA/NSTEMI 74% 95% 26%
STEMI 11% Excluded 16%

16 HOW SUPPLIED/STORAGE AND HANDLING

KENGREAL is supplied as a sterile lyophilized powder in single-use 10 mL vials.

  • NDC # 10122-620-01: 10 mL vial containing 50 mg cangrelor
  • NDC # 10122-620-10: 10 count of 10 mL vials containing 50 mg cangrelor

Vials of KENGREAL should be stored at USP Controlled Room Temperature, [20°C to 25°C (68°F to 77°F) with excursions between 15°C and 30°C (59°F and 86°F) permitted].

KENGREAL® is a registered trademeark of Chiesi Farmaceutici S.p.A.

Distributed by:
Chiesi USA, Inc.
Cary, NC 27518

CTK-001-0720-01-SPL

Principal Display Panel
NDC 10122-620-10
Kengreal®
( cangrelor ) for injection
50 mg per vial
Rx Only 10 Single Use Vials

Kengreal (cangrelor) for injection 50 mg vial carton
(click image for full-size original)

KENGREAL cangrelor injection, powder, lyophilized, for solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:10122-620
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CANGRELOR (CANGRELOR) CANGRELOR 50 mg
Inactive Ingredients
Ingredient Name Strength
MANNITOL 158 mg
SORBITOL 52 mg
SODIUM HYDROXIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:10122-620-10 10 VIAL, SINGLE-USE in 1 CARTON contains a VIAL, SINGLE-USE (10122-620-01)
1 NDC:10122-620-01 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-USE This package is contained within the CARTON (10122-620-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA204958 07/08/2015
Labeler — Chiesi USA, Inc. (088084228)
Registrant — Chiesi USA, Inc. (088084228)

Revised: 09/2020 Chiesi USA, Inc.

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