Treatment of Osteoporosis in Postmenopausal Women

The recommended dosage is one 70 mg effervescent tablet once weekly.

Treatment to Increase Bone Mass in Men With Osteoporosis

The recommended dosage is one 70 mg effervescent tablet once weekly.

Important Administration Instructions

Instruct patients to do the following to assure adequate drug absorption and to decrease the risk of esophageal adverse reactions:

i. Take BINOSTO upon arising for the day and at least 30 minutes before the first food, beverage, or medication of the day.
• Patients should not swallow the undissolved effervescent tablet, should not chew the effervescent tablet or allow the effervescent tablet to dissolve in their mouths because of the risk for oropharyngeal irritation [see Warnings and Precautions ( 5.1)].
Dissolve the effervescent tablet in 4 ounces room temperature plain water only (not mineral water or flavored water).

ii. Wait at least 5 minutes after the effervescence stops and then stir the buffered solution for approximately 10 seconds and ingest.
iii. Avoid lying down for at least 30 minutes after taking BINOSTO and until after their first food of the day.
iv. Do not take BINOSTO at bedtime or before arising for the day.
Failure to follow these instructions may increase the risk of esophageal adverse reactions [see Warnings and Precautions ( 5.1)].

Recommendations for Calcium and Vitamin D Supplementation

Instruct patients to take supplemental calcium and vitamin D if dietary intake is inadequate [see Warnings and Precautions ( 5.2)] . Patients at increased risk for vitamin D insufficiency (e.g., over the age of 70 years, nursing home-bound, or chronically ill) may need vitamin D supplementation. Patients with gastrointestinal malabsorption syndromes may require higher doses of vitamin D supplementation and measurement of 25-hydroxyvitamin D should be considered.

Administration Instructions for Missed Doses

If the once-weekly dose is missed, instruct patients to take one dose on the morning after they remember. They should not take 2 doses on the same day but should return to taking one dose once a week, as originally scheduled on their chosen day.