Usual Adult Dose for Osteoporosis

Treatment of Postmenopausal Osteoporosis:
Immediate release:

• Daily dosing: 5 mg orally once a day, or
• Weekly dosing: 35 mg orally once a week, or
• Monthly dosing: 75 mg orally on 2 consecutive days each month or 150 mg orally once a month

• See administration advice for important administration instructions; the dose should be obtained with 1 tablet.
• In post-menopausal women with osteoporosis, clinical trials have shown this drug reduces the incidence of vertebral fractures and a composite endpoint of nonvertebral osteoporosis-related fractures.
• In men with osteoporosis, this drug has been shown to increase bone mass.
• The optimal duration of use has not been determined; safety and efficacy for the treatment of osteoporosis are based on clinical data of 3 years duration; periodically re-evaluate need for continued treatment.

• Treatment of postmenopausal osteoporosis
• Treatment of osteoporosis in men
• Treatment of glucocorticoid-induced osteoporosis in men and women

Usual Adult Dose for Prevention of Osteoporosis

Prevention of Postmenopausal Osteoporosis:
Immediate-release:

• Daily dosing: 5 mg orally once a day, or
• Weekly dosing: 35 mg orally once a week, or
• Monthly dosing: 75 mg orally on 2 consecutive days each month or 150 mg orally once a month

• See administration advice for important administration instructions; the dose should be obtained with 1 tablet.
• Delayed release tablets are not indicated for the prevention of postmenopausal osteoporosis.
• Reevaluate bisphosphonate therapy periodically.

• Prevention of osteoporosis in postmenopausal women
• Prevention of glucocorticoid-induced osteoporosis in men and women who are either initiating or continuing systemic glucocorticoid treatment (daily dosage of greater than or equal to 7.5 mg of prednisone or equivalent) for chronic diseases

Usual Adult Dose for Paget's Disease

Initial dose: 30 mg orally once a day for 2 months

Retreatment:

• After completing a 2-month course of therapy, retreatment may be considered once patient has been off therapy for at least 2 months (i.e., if relapse occurs, or if treatment fails to normalize serum alkaline phosphatase)
• For retreatment, the dose and duration of therapy are the same as for initial treatment

• See administration advice for important administration instructions; the dose should be obtained with 1 tablet.
• There is no data available on more than 1 course of retreatment.

Renal Dose Adjustments

Mild to moderate renal dysfunction (CrCl 30 mL/min or more): No adjustment recommended
Severe renal dysfunction (CrCl less than 30 mL/min): Not recommended

Liver Dose Adjustments

No adjustment recommended

Precautions

CONTRAINDICATIONS:

• Abnormalities of the esophagus which delay esophageal emptying such as stricture or achalasia
• Inability to stand or sit upright for at least 30 minutes
• Hypocalcemia
• Hypersensitivity to the active substance or any product ingredients; angioedema, generalized rash, bullous skin reactions, Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported

Dialysis

Data not available

Other Comments

Administration advice
IMMEDIATE-RELEASE Tablets:

• Take 1 tablet orally 30 minutes before the first food or drink of day (other than water) and before taking any oral medications or supplements to maximize absorption and clinical benefit
• Swallow tablet whole with a full glass of plain water; avoid water with supplements, including mineral water, because they may have a higher concentration of calcium; do not chew or suck the tablet because of a potential for oropharyngeal ulceration
• Avoid laying down for 30 minutes after dosing; do not eat or drink anything except plain water, or take other medications for at least 30 minutes

• Take orally in the morning immediately following breakfast to avoid risk of abdominal pain
• Swallow whole while in an upright position and with at least 4 ounces of plain water; do not chew, cut, or crush tablets
• Avoid lying down for 30 minutes

• Weekly dose (35 mg tablet): Take tablet on the morning after remembered and return to 1 tablet once a week as originally scheduled or chose a new day; do not take 2 tablets on the same day
• Monthly dose (75 mg tablet): Do not take more than two 75 mg tablets within 7 days; if next scheduled dose is more than 7 days away: Take one tablet on the morning after remembered; if both tablets are missed, take 1 tablet in the morning after remembered and then the other tablet on the next consecutive morning; If next scheduled dose is within 7 days: Skip the missed dose and take next month's doses as scheduled
• Monthly dose (150 mg tablet): Do not take more than one 150 mg tablet within 7 days; if next scheduled dose is more than 7 days away: Take tablet on the morning after remembered; if next scheduled dose is within 7 days: Skip the missed dose and take next month's doses as scheduled

• Weekly dose: If once-weekly dose is missed, take one dose on the morning after remembering; resume next dose on its regular schedule; 2 doses should not be taken on the same day

• Patients treated with glucocorticoids should receive adequate amounts of calcium and vitamin D.
• Patients should take supplemental calcium and vitamin D if dietary intake is inadequate.
• Calcium supplements, antacids, magnesium-based supplements or laxatives, and iron preparations should be taken at a different time of the day as they interfere with the absorption of this drug.

• The optimal duration of use has not been determined; for patients at low-risk for fracture, consider drug discontinuation after 3 to 5 years.

• Hematologic: Blood calcium levels
• Musculoskeletal: Bone, joint, or muscle pain

• Patients should read the Medication Guide before starting therapy and each time the prescription is renewed.
• Instruct patients that the brands Atelvia and Actonel contain the same ingredient and should not be taken together.
• Patients should be advised to closely follow dosing instructions as clinical benefits may be compromised by failure to take the drug according to instructions; patients who cannot comply with dosing instructions due to mental disability should use this product under appropriate supervision.
• Consult a physician if symptoms of difficulty or pain upon swallowing, retrosternal pain or severe persistent or worsening heartburn develop before continuing taking this drug.