Treatment of Osteoporosis in Postmenopausal Women

FOSAMAX is indicated for the treatment of osteoporosis in postmenopausal women. In postmenopausal women, FOSAMAX increases bone mass and reduces the incidence of fractures, including those of the hip and spine (vertebral compression fractures). [See Clinical Studies]

Prevention of Osteoporosis in Postmenopausal Women

FOSAMAX is indicated for the prevention of postmenopausal osteoporosis [see Clinical Studies].

Treatment to Increase Bone Mass in Men with Osteoporosis

FOSAMAX is indicated for treatment to increase bone mass in men with osteoporosis [see Clinical Studies].

Treatment of Glucocorticoid-Induced Osteoporosis

FOSAMAX is indicated for the treatment of glucocorticoid-induced osteoporosis in men and women receiving glucocorticoids in a daily dosage equivalent to 7.5 mg or greater of prednisone and who have low bone mineral density [see Clinical Studies].

Treatment of Paget's Disease of Bone

FOSAMAX is indicated for the treatment of Paget's disease of bone in men and women. Treatment is indicated in patients with Paget's disease of bone who have alkaline phosphatase at least two times the upper limit of normal, or those who are symptomatic, or those at risk for future complications from their disease. [See Clinical Studies.]

Important Limitations of Use

The optimal duration of use has not been determined. The safety and effectiveness of FOSAMAX for the treatment of osteoporosis are based on clinical data of four years duration. All patients on bisphosphonate therapy should have the need for continued therapy re-evaluated on a periodic basis. Patients at low-risk for fracture should be considered for drug discontinuation after 3 to 5 years of use. Patients who discontinue therapy should have their risk for fracture re-evaluated periodically.

Although alendronate tablets 5 mg, 10 mg, 35 mg, and 40 mg are available in the marketplace, FOSAMAX is no longer marketed in the 5 mg, 10 mg, 35 mg, and 40 mg strengths.

Treatment of Osteoporosis in Postmenopausal Women

The recommended dosage is:

• one 70 mg tablet once weekly
  or
• one bottle of 70 mg oral solution once weekly
  or
• one 10 mg tablet once daily

Prevention of Osteoporosis in Postmenopausal Women

The recommended dosage is:

• one 35 mg tablet once weekly
  or
• one 5 mg tablet once daily

Treatment to Increase Bone Mass in Men with Osteoporosis

The recommended dosage is:

• one 70 mg tablet once weekly
  or
• one bottle of 70 mg oral solution once weekly
  or
• one 10 mg tablet once daily

Treatment of Glucocorticoid-Induced Osteoporosis

The recommended dosage is one 5 mg tablet once daily, except for postmenopausal women not receiving estrogen, for whom the recommended dosage is one 10 mg tablet once daily.

Treatment of Paget's Disease of Bone

The recommended treatment regimen is 40 mg once a day for six months.

Re-treatment of Paget's Disease

Re-treatment with FOSAMAX may be considered, following a six-month post-treatment evaluation period in patients who have relapsed, based on increases in serum alkaline phosphatase, which should be measured periodically. Re-treatment may also be considered in those who failed to normalize their serum alkaline phosphatase.

Important Administration Instructions

Instruct patients to do the following:

• Take FOSAMAX at least one-half hour before the first food, beverage, or medication of the day with plain water only [see PATIENT INFORMATION]. Other beverages (including mineral water), food, and some medications are likely to reduce the absorption of FOSAMAX [see DRUG INTERACTIONS]. Waiting less than 30 minutes, or taking FOSAMAX with food, beverages (other than plain water) or other medications will lessen the effect of FOSAMAX by decreasing its absorption into the body.
• Take FOSAMAX upon arising for the day. To facilitate delivery to the stomach and thus reduce the potential for esophageal irritation, a FOSAMAX tablet should be swallowed with a full glass of water (6-8 ounces). To facilitate gastric emptying FOSAMAX oral solution should be followed by at least 2 ounces (a quarter of a cup) of water. Patients should not lie down for at least 30 minutes and until after their first food of the day. FOSAMAX should not be taken at bedtime or before arising for the day. Failure to follow these instructions may increase the risk of esophageal adverse experiences [see WARNINGS AND PRECAUTIONS and PATIENT INFORMATION].

Recommendations for Calcium and Vitamin D Supplementation

Instruct patients to take supplemental calcium if dietary intake is inadequate [see WARNINGS AND PRECAUTIONS]. 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.

Patients treated with glucocorticoids should receive adequate amounts of calcium and vitamin D.

Administration Instructions for Missed Doses

If a once-weekly dose of Fosamax (tablet or oral solution) is missed, instruct patients to take one dose on the morning after they remember. They should not take two doses on the same day but should return to taking one dose once a week, as originally scheduled on their chosen day.

Dosage Forms And Strengths

• 70 mg tablets are white, oval, uncoated tablets with code 31 on one side and an outline of a bone image on the other.
• 70 mg oral solution is a clear, colorless solution with a raspberry flavor.

Storage And Handling

No. 3814 — FOSAMAX Tablets, 70 mg, are white, oval, uncoated tablets with code 31 on one side and an outline of a bone image on the other:

NDC 0006-0031-44 unit-of-use blister package of 4.

No. 3833 — FOSAMAX Oral Solution, 70 mg, is a clear, colorless solution with a raspberry flavor:

NDC 0006-3833-34 unit-of-use cartons of 4 single-dose bottles containing 75 mL each.

Storage

FOSAMAX Tablets

Store in a well-closed container at room temperature, 15-30°C (59-86°F).

FOSAMAX Oral Solution

Store at 25°C (77°F), excursions permitted to 15-30°C (59-86°F). [See USP Controlled Room Temperature.] Do not freeze.

Distributed by: Merck Sharp & Dohme Corp., a subsidiary of MERCK & CO., INC., Whitehouse Station, NJ 08889, USA. Manufactured by: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. Whitehouse Station, NJ 08889, USA. FOSAMAX Tablets, 70 mg, are also manufactured by: Merck Sharp & Dohme (Italia) S.p.A. Via Emilia, 21, 27100 - Pavia, Italy. Revised: 04/2013

Last reviewed on RxList: 5/6/2013
This monograph has been modified to include the generic and brand name in many instances.