Ibandronate Sodium

IBANDRONATE SODIUM — ibandronate sodium tablet, film coated
Orchid Chemicals & Pharmaceuticals Limited

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 Tablets increases bone mineral density (BMD) and reduces the incidence of vertebral fractures.

1.2 Important Limitations of Use

The safety and effectiveness of Ibandronate Sodium Tablets for the treatment of osteoporosis are based on clinical data of three years duration. The optimal duration of use has not been determined. All patients on bisphosphonate therapy should have the need for continued therapy re-evaluated on a periodic basis.

2 DOSAGE AND ADMINISTRATION

2.1 Dose

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 Dosing Instructions

  • To maximize absorption and clinical benefit, Ibandronate Sodium Tablets should be taken 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 (see DRUG INTERACTIONS [7.1]).
  • To facilitate delivery to the stomach and thus reduce the potential for esophageal irritation, Ibandronate Sodium Tablets should be swallowed whole with a full glass of plain water (6 to 8 oz) while the patient is standing or sitting in an upright position. Patients should not lie down for 60 minutes after taking Ibandronate Sodium Tablets (see WARNINGS AND PRECAUTIONS [5.1]).
  • Patients should not eat, drink anything except water, or take other medications for at least 60 minutes after taking Ibandronate Sodium Tablets.
  • Plain water is the only drink that should be taken with Ibandronate Sodium Tablets. Note that some mineral waters may have a higher concentration of calcium and therefore should not be used.
  • Patients should not chew or suck the tablet because of a potential for oropharyngeal ulceration.
  • The Ibandronate Sodium 150 mg tablet as ibandronic acid should be taken on the same date each month (i.e., the patient’s Ibandronate Sodium Tablets day).
  • The patient must not take two 150 mg tablets within the same week.
  • If the once-monthly dose is missed, and the patient’s next scheduled Ibandronate Sodium Tablets day is more than 7 days away, the patient should be instructed to take one Ibandronate Sodium 150 mg tablet as ibandronic acid in the morning following the date that it is remembered. The patient should then return to taking one Ibandronate Sodium 150 mg tablet as ibandronic acid every month in the morning of their chosen day, according to their original schedule.
  • If the once-monthly dose is missed, and the patient’s next scheduled Ibandronate Sodium Tablets day is only 1 to 7 days away, the patient must wait until the subsequent month’s scheduled Ibandronate Sodium Tablets day to take their tablet. The patient should then return to taking one Ibandronate Sodium 150 mg tablet as ibandronic acid every month in the morning of their chosen day, according to their original schedule.

2.3 Recommendations for Calcium and Vitamin D Supplementation

Patients should receive supplemental calcium and vitamin D if dietary intake is inadequate (see DRUG INTERACTIONS [7.1]).

2.4 Use in Specific Populations

Ibandronate sodium is not recommended for use in patients with severe renal impairment (creatinine clearance of <30 mL/min).

No dose adjustment is necessary for patients with mild or moderate renal impairment.

No dose adjustment is necessary for the elderly, or for patients with hepatic impairment.

3 DOSAGE FORMS AND STRENGTHS

Tablets, 150 mg as ibandronic acid

4 CONTRAINDICATIONS

  • Abnormalities of the esophagus which delay esophageal emptying such as stricture or achalasia (see Upper Gastrointestinal Adverse reactions [5.1])
  • Inability to stand or sit upright for at least 60 minutes (see Dosing Instructions [2.2], Upper Gastrointestinal Adverse Reactions [5.1])
  • Hypocalcemia (see WARNINGS AND PRECAUTIONS [5.2])
  • Known hypersensitivity to ibandronate sodium or to any of its excipients (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

Treat hypocalcemia and other disturbances of bone and mineral metabolism before starting ibandronate sodium therapy. Adequate intake of calcium and vitamin D is important in all patients to prevent hypocalcemia (see DOSAGE AND ADMINISTRATION [2.3]). Hypocalcemia following dosing has been reported postmarketing.

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, primarily in the jaw, has been reported in patients treated with bisphosphonates. Most cases have been in cancer patients undergoing dental procedures, but some have occurred in patients with postmenopausal osteoporosis or other diagnoses. Known risk factors for osteonecrosis include a diagnosis of cancer, concomitant therapies (e.g., chemotherapy, radiotherapy, corticosteroids), and co-morbid disorders (e.g., anemia, coagulopathy, infection, pre-existing dental disease). Most reported cases have been in patients treated with bisphosphonates intravenously but some have been in patients treated orally (see ADVERSE REACTIONS [6.2]).

For patients who develop osteonecrosis of the jaw (ONJ) while on bisphosphonate therapy, dental surgery may exacerbate the condition. For patients requiring dental procedures, there are no data available to suggest whether discontinuation of bisphosphonate treatment reduces the risk of ONJ. Clinical judgment of the treating physician should guide the management plan of each patient based on individual benefit/risk assessment.

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