ACTONEL has an affinity for hydroxyapatite crystals in bone and acts as an antiresorptive agent. At the cellular level, ACTONEL inhibits osteoclasts. The osteoclasts adhere normally to the bone surface, but show evidence of reduced active resorption (for example, lack of ruffled border). Histomorphometry in rats, dogs, and minipigs showed that ACTONEL treatment reduces bone turnover (activation frequency, that is, the rate at which bone remodeling sites are activated) and bone resorption at remodeling sites.

ACTONEL is a bisphosphonate indicated for:

• Treatment and prevention of postmenopausal osteoporosis 
• Treatment to increase bone mass in men with osteoporosis 
• Treatment and prevention of glucocorticoid-induced osteoporosis 
• Treatment of Paget’s disease 

Limitations of Use
Optimal duration of use has not been determined. For patients at low-risk for fracture, consider drug discontinuation after 3 to 5 years of use. 

• Treatment of Postmenopausal Osteoporosis: 5 mg daily, 35 mg once-a-week, 75 mg two consecutive days each month, 150 mg once-a month 
• Prevention of Postmenopausal Osteoporosis: 5 mg daily, 35 mg once-a-week
• Men with Osteoporosis: 35 mg once-a-week
• Glucocorticoid-Induced Osteoporosis: 5 mg daily 
• Paget’s Disease: 30 mg daily for 2 months

Instruct patients to:

Swallow tablet whole with 6 to 8 ounces of plain water, at least 30 minutes before the first food, beverage, or medication of the day Avoid lying down for 30 minutes

Take supplemental calcium and vitamin D if dietary intake is inadequate 

Most common adverse reactions reported in greater than 10% of patients treated with ACTONEL and with a higher frequency than placebo are: back pain, arthralgia, abdominal pain, and dyspepsia. 

Hypersensitivity reactions (angioedema, generalized rash, bullous skin reactions, Stevens-Johnson syndrome, and toxic epidermal necrolysis), and eye inflammation (iritis, uveitis) have been reported rarely.

• 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 
• Known hypersensitivity to any component of this product 

Products Containing Same Active Ingredient: Patients receiving Atelvia should not be treated with ACTONEL.

• Upper Gastrointestinal Adverse Reactions can occur. Instruct patients to follow dosing instructions.
• Discontinue use if new or worsening symptoms occur 
• Hypocalcemia may worsen and must be corrected prior to use
• Osteonecrosis of the Jaw has been reported
• Severe Bone, Joint, Muscle Pain may occur. Discontinue use if severe symptoms develop
• Atypical Femur Fractures have been reported. Patients with new thigh or groin pain should be evaluated to rule out a femoral fracture