Alendronate Sodium

ALENDRONATE SODIUM- alendronate sodium tablet
Virtus Pharmaceuticals

1 INDICATIONS AND USAGE

1.1 Treatment of Osteoporosis in Postmenopausal Women

Alendronate sodium tablets, USP are indicated for the treatment of osteoporosis in postmenopausal women. In postmenopausal women, alendronate sodium tablets, USP increase bone mass and reduces the incidence of fractures, including those of the hip and spine (vertebral compression fractures). [See Clinical Studies (14.1).]

1.2 Prevention of Osteoporosis in Postmenopausal Women

Alendronate sodium tablets, USP are indicated for the prevention of postmenopausal osteoporosis [see Clinical Studies (14.2) ].

1.3 Treatment to Increase Bone Mass in Men with Osteoporosis

Alendronate sodium tablets, USP are indicated for treatment to increase bone mass in men with osteoporosis [see Clinical Studies (14.3) ].

1.4 Treatment of Glucocorticoid-Induced Osteoporosis

Alendronate sodium tablets, USP are 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 (14.4) ].

1.5 Treatment of Paget’s Disease of Bone

Alendronate sodium tablets, USP are 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 (14.5).]

1.6 Important Limitations of Use

The optimal duration of use has not been determined. The safety and effectiveness of alendronate sodium tablets, USP 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.

2 DOSAGE AND ADMINISTRATION

2.1 Treatment of Osteoporosis in Postmenopausal Women

The recommended dosage is:

  • one 70 mg (alendronate) tablet once weekly

or

  • one 10 mg (alendronate) tablet once daily

2.2 Prevention of Osteoporosis in Postmenopausal Women

The recommended dosage is:

  • one 35 mg (alendronate) tablet once weekly

or

  • one 5 mg (alendronate) tablet once daily

2.3 Treatment to Increase Bone Mass in Men with Osteoporosis

The recommended dosage is:

  • one 70 mg tablet once weekly

or

  • one 10 mg tablet once daily

2.4 Treatment of Glucocorticoid-Induced Osteoporosis

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

2.5 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 alendronate sodium tablets 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.

2.6 Important Administration Instructions

Instruct patients to do the following:

  • Take alendronate sodium tablets at least one-half hour before the first food, beverage, or medication of the day with plain water only [see Patient Counseling Information (17.2) ]. Other beverages (including mineral water), food, and some medications are likely to reduce the absorption of alendronate sodium tablets [see Drug Interactions (7.1) ]. Waiting less than 30 minutes, or taking alendronate sodium tablets with food, beverages (other than plain water) or other medications will lessen the effect of alendronate sodium tablets by decreasing its absorption into the body
  • Take alendronate sodium tablets upon arising for the day. To facilitate delivery to the stomach and thus reduce the potential for esophageal irritation, an alendronate sodium tablet should be swallowed with a full glass of water (6-8 oz). Patients should not lie down for at least 30 minutes and until after their first food of the day. Alendronate sodium tablets 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 (5.1) and Patient Counseling Information (17.2)].

2.7 Recommendations for Calcium and Vitamin D Supplementation

Instruct patients to take supplemental calcium 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.

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

2.8 Administration Instructions for Missed Doses

If a once-weekly dose of alendronate sodium tablet 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.

3 DOSAGE FORMS AND STRENGTHS

  • 5 mg (alendronate) tablets are round, flat face beveled edged, white to off-white tablets; one side debossed “AP209”, the other side blank.
  • 10 mg (alendronate) tablets are modified oval, white to off-white tablets; one side debossed “AP208”, the other side blank.
  • 35 mg (alendronate) tablets are modified oval, white to off-white tablets; one side debossed “AP207”, the other side blank.
  • 70 mg (alendronate) tablets are modified oval, white to off-white tablets; one side debossed “AP205”, the other side blank.

4 CONTRAINDICATIONS

Alendronate sodium is contraindicated in patients with the following conditions:

  • Abnormalities of the esophagus which delay esophageal emptying such as stricture or achalasia [see Warnings and Precautions (5.1) ]
  • Inability to stand or sit upright for at least 30 minutes [see Dosage and Administration (2.6); Warnings and Precautions (5.1)]
  • Hypocalcemia [see Warnings and Precautions (5.2) ]
  • Hypersensitivity to any component of this product. Hypersensitivity reactions including urticaria and angioedema have been reported [see Adverse Reactions (6.2) ].

5 WARNINGS AND PRECAUTIONS

5.1 Upper Gastrointestinal Adverse Reactions

Alendronate sodium, like other bisphosphonates administered orally, may cause local irritation of the upper gastrointestinal mucosa. Because of these possible irritant effects and a potential for worsening of the underlying disease, caution should be used when alendronate sodium is given to patients with active upper gastrointestinal problems (such as known Barrett’s esophagus, dysphagia, other esophageal diseases, gastritis, duodenitis, or ulcers).

Esophageal adverse experiences, such as esophagitis, esophageal ulcers and esophageal erosions, occasionally with bleeding and rarely followed by esophageal stricture or perforation, have been reported in patients receiving treatment with oral bisphosphonates including alendronate sodium. In some cases these have been severe and required hospitalization. Physicians should therefore be alert to any signs or symptoms signaling a possible esophageal reaction and patients should be instructed to discontinue alendronate sodium and seek medical attention if they develop dysphagia, odynophagia, retrosternal pain or new or worsening heartburn.

The risk of severe esophageal adverse experiences appears to be greater in patients who lie down after taking oral bisphosphonates including alendronate sodium and/or who fail to swallow oral bisphosphonates including alendronate sodium with the recommended full glass (6-8 oz) of water, and/or who continue to take oral bisphosphonates including alendronate sodium after developing symptoms suggestive of esophageal irritation. Therefore, it is very important that the full dosing instructions are provided to, and understood by, the patient [see Dosage and Administration (2.6) ]. In patients who cannot comply with dosing instructions due to mental disability, therapy with alendronate sodium should be used under appropriate supervision.

There have been post-marketing reports of gastric and duodenal ulcers with oral bisphosphonate use, some severe and with complications, although no increased risk was observed in controlled clinical trials [see Adverse Reactions (6.2) ].

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