asured from date of first intracranial response until intracranial disease progression (new lesions, intracranial target lesion diameter growth ≥20% from nadir, or unequivocal progression of intracranial non-target lesions) or death.
Table 6: Intracranial Objective Response in Patients with Measurable Brain Metastases in ALTA
Efficacy parameter IRC Assessment
90 mg once daily
(N=26) 90→180 mg once daily
(N=18)
CI = Confidence Interval; NE = Not Estimable
Intracranial Overall Response Rate, (95 % CI) 42% (23-63) 67% (41-87)
Complete Response, n (%) 2 (7.7%) 0
Partial Response, n (%) 9 (35%) 12 (67%)
Duration of Intracranial Response, median (months)
(range) NE
(1.9+ - 9.2+) 5.6
(1.9+ - 9.2+)
Among the 23 patients who exhibited an intracranial response, 78% of patients in the 90 mg arm and 68% of patients in the 90→180 mg arm maintained a response for at least 4 months.
16 HOW SUPPLIED/STORAGE AND HANDLING
30 mg tablets: round, white to off-white film-coated tablet with "U3" debossed on one side and plain on the other side; available in:
Bottles of 21 tablets NDC 76189-113-21
Bottles of 180 tablets NDC 76189-113-18
90 mg tablets: oval, white to off-white film-coated tablet with "U7" debossed on one side and plain on the other side; available in:
Bottles of 7 tablets NDC 76189-119-07
Bottles of 30 tablets NDC 76189-119-30
Store at controlled room temperature 20°C to 25°C (68°F to 77°F); excursion permitted between 15°C to 30°C (59°F to 86°F) (see USP).
17 PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information).
Inform patients of the following:
Interstitial Lung Disease (ILD)/Pneumonitis
Inform patients of the symptoms and risks of serious pulmonary adverse reactions such as ILD/pneumonitis. Advise patients to immediately report any new or worsening respiratory symptoms [see WARNINGS AND PRECAUTIONS (5.1)].
Hypertension
Advise patients of risks of hypertension and to promptly report signs or symptoms of hypertension [see WARNINGS AND PRECAUTIONS (5.2)].
Bradycardia
Advise patients to report any symptoms of bradycardia and to inform their healthcare provider about the use of heart and blood pressure medications [see WARNINGS AND PRECAUTIONS (5.3)].
Visual Disturbance
Advise patients to inform their healthcare provider of any new or worsening vision symptoms [see WARNINGS AND PRECAUTIONS (5.4)].
Creatine Phosphokinase (CPK) Elevation
Inform patients of the signs and symptoms of creatinine phosphokinase (CPK) elevation and the need for monitoring during treatment. Advise patients to inform their healthcare provider of any new or worsening symptoms of unexplained muscle pain, tenderness, or weakness [see WARNINGS AND PRECAUTIONS (5.5)].
Pancreatic Enzyme Elevation
Inform patients of the signs and symptoms of pancreatitis and the need to monitor for amylase and lipase elevations during treatment [see WARNINGS AND PRECAUTIONS (5.6)].
Hyperglycemia
Inform patients of the risks of new or worsening hyperglycemia and the need to periodically monitor glucose levels. Advise patients with diabetes mellitus or glucose intolerance that anti-hyperglycemic medications may need to be adjusted during treatment with ALUNBRIG [see WARNINGS AND PRECAUT |
