IBANDRONATE SODIUM

IBANDRONATE SODIUM- ibandronate sodium tablet
Alvogen Inc.

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1 INDICATIONS AND USAGE

1.1 Treatment and Prevention of Postmenopausal Osteoporosis

Ibandronate Sodium Tablets are indicated for the treatment and prevention of osteoporosis in postmenopausal women. Ibandronate sodium increases bone mineral density (BMD) and reduces the incidence of vertebral fractures.

1.2 Important Limitations of Use

The optimal duration of use has not been determined. The safety and effectiveness of Ibandronate Sodium Tablets for the treatment of osteoporosis are based on clinical data of three 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 Dosage Information

The dose of Ibandronate Sodium Tablet is one 150 mg tablet as ibandronic acid taken once monthly on the same date each month.

2.2 Important Administration Instructions

Instruct Patients to do the following:

• Take Ibandronate Sodium Tablets at least 60 minutes before the first food or drink (other than water) of the day or before taking any oral medication or supplementation, including calcium, antacids, or vitamins to maximize absorption and clinical benefit, (see DRUG INTERACTIONS [7.1]). Avoid the use of water with supplements including mineral water because they may have a higher concentration of calcium.

• Swallow Ibandronate Sodium Tablets whole with a full glass of plain water (6 to 8 oz) while standing or sitting in an upright position to reduce the potential for esophageal irritation. Avoid lying down for 60 minutes after taking Ibandronate Sodium Tablets (see WARNINGS AND PRECAUTIONS [5.1]). Do not chew or suck the tablet because of a potential for oropharyngeal ulceration.

• Do not eat, drink anything except plain water, or take other medications for at least 60 minutes after taking Ibandronate Sodium Tablet.

2.3 Recommendations for Calcium and Vitamin D Supplementation

Instruct patients to take supplemental calcium and vitamin D if their dietary intake is inadequate. Avoid the use of calcium supplements within 60 minutes of Ibandronate Sodium Tablet administration because co-administration of Ibandronate Sodium Tablet and calcium may interfere with the absorption of ibandronate sodium (see DRUG INTERACTIONS [7.1]).

2.4 Administration Instructions for Missed Once-Monthly Doses

If the once-monthly dose is missed, instruct patients to do the following:

• If the next scheduled Ibandronate Sodium Tablet day is more than 7 days away, take one Ibandronate Sodium Tablet 150 mg (ibandronate) in the morning following the date that it is remembered.

• If the next scheduled Ibandronate Sodium Tablet day is only 1 to 7 days away, wait until the subsequent month’s scheduled Ibandronate Sodium Tablet day to take their tablet.

For subsequent monthly doses for both of the above scenarios, instruct patients to return to their original schedule by taking one Ibandronate Sodium Tablet 150 mg (ibandronate) every month on their previous chosen day.

3 DOSAGE FORMS AND STRENGTHS

Ibandronate Sodium Tablets 150 mg (ibandronate): yellow colored capsule shaped film-coated tablets debossed with “ID” on one side and “150” on the other side.

4 CONTRAINDICATIONS

Ibandronate 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 60 minutes (see Dosage and Administration [2.2], and Warnings and Precautions [5.1])

• Hypocalcemia (see Warnings and Precautions [5.2])

• Known hypersensitivity to ibandronate sodium tablets or to any of its excipients. Cases of anaphylaxis have been reported. (see Adverse Reactions [6.2]).

5 WARNINGS AND PRECAUTIONS

5.1 Upper Gastrointestinal Adverse Reactions

Ibandronate 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 ibandronate 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. 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 ibandronate 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 and/or who fail to swallow it with the recommended full glass (6 to 8 oz) of water, and/or who continue to take oral bisphosphonates 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 [2.2]). In patients who cannot comply with dosing instructions due to mental disability, therapy with ibandronate 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.

5.2 Hypocalcemia and Mineral Metabolism

Hypocalcemia has been reported in patients taking ibandronate sodium. Treat hypocalcemia and other disturbances of bone and mineral metabolism before starting ibandronate sodium therapy. Instruct patients to take supplemental calcium and vitamin D if their dietary intake is inadequate (see DOSAGE AND ADMINISTRATION [2.3]).

5.3 Musculoskeletal Pain

Severe and occasionally incapacitating bone, joint, and/or muscle pain has been reported in patients taking ibandronate sodium and other bisphosphonates (see ADVERSE REACTIONS [6]). The time to onset of symptoms varied from one day to several months after starting the drug. Most patients had relief of symptoms after stopping. A subset had recurrence of symptoms when rechallenged with the same drug or another bisphosphonate. Consider discontinuing use if severe symptoms develop.

5.4 Jaw Osteonecrosis

Osteonecrosis of the jaw (ONJ), which can occur spontaneously, is generally associated with tooth extraction and/or local infection with delayed healing, and has been reported in patients taking bisphosphonates, including ibandronate sodium. Known risk factors for osteonecrosis of the jaw include invasive dental procedures (e.g., tooth extraction, dental implants, boney surgery), diagnosis of cancer, concomitant therapies (e.g., chemotherapy, corticosteroids, angiogenesis inhibitors), poor oral hygiene, and co-morbid disorders (e.g., periodontal and/or other pre-existing dental disease, anemia, coagulopathy, infection, ill-fitting dentures). The risk of ONJ may increase with duration of exposure to bisphosphonates.

For patients requiring invasive dental procedures, discontinuation of bisphosphonate treatment may reduce the risk for ONJ. Clinical judgment of the treating physician and/or oral surgeon should guide the management plan of each patient based on individual benefit/risk assessment.

Patients who develop osteonecrosis of the jaw while on bisphosphonate therapy should receive care by an oral surgeon. In these patients, extensive dental surgery to treat ONJ may exacerbate the condition. Discontinuation of bisphosphonate therapy should be considered based on individual benefit/risk assessment.

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