Usual Adult Dose for Osteoporosis

Oral:
150 mg orally once a month on the same day each month

IV Injection:
3 mg by IV injection over 15 to 30 seconds every three months.

Comments:

• The IV injection should not be administered more frequently than once every 3 months.
• Obtain serum creatinine prior administration of each IV injection.
• Perform a routine oral examination prior administration of IV injection

Usual Adult Dose for Prevention of Osteoporosis

Oral:
150 mg orally once a month on the same day each month

IV Injection:
3 mg by IV injection over 15 to 30 seconds every three months.

Comments:

• The IV injection should not be administered more frequently than once every 3 months.
• Obtain serum creatinine prior administration of each IV injection.
• Perform a routine oral examination prior administration of IV injection

Renal Dose Adjustments

Mild to moderate renal dysfunction (CrCl 30 mL/min or more): No adjustment recommended.
Severe renal dysfunction (CrCl less than 30 mL/min): Not recommended.

Liver Dose Adjustments

No adjustment recommended.

Precautions

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:
Oral:

• To maximize absorption, take this drug at least 60 minutes before the first food or drink (other than water) of the day, or before taking any other medication or supplements, including calcium, antacids, or vitamins.
• Avoid the use of water with supplements, including mineral water (they may have higher concentration of calcium).
• Swallow the tablets whole with a full glass of plain water (6 to 8 ounces) in upright position to reduce the potential for esophageal irritation.
• Avoid lying down for 60 minutes after taking this drug.
• Tablets should not be chewed or sucked because of a potential for oropharyngeal ulceration.
• Food, drink (except plain water), and other medications should not be taken for at least 60 minutes after taking this drug.

• This drug should be administered intravenously only by a health care professional.
• Care must be taken not to administer intra-arterially or paravenously as this could lead to tissue damage.
• Appropriate medical support and monitoring measures should be readily available when the injection is administered.
• If anaphylactic or other severe hypersensitivity/allergic reactions occur, discontinue the injection immediately and initiate appropriate treatment.
• Inspect the liquid in the vial for particulate matter and discoloration before administration; vial with particulate matter or discoloration should not be used.
• Discard any unused portion.
• Calcium-containing solutions or other intravenously administered drugs should not be mixed with this drug.

• Take supplemental calcium and vitamin D if dietary intake is inadequate.
• The use of calcium supplements within 60 minutes of administration of this drug should be avoided.

• If the next scheduled dose is more than 7 days away, take one tablet in the morning after remembering.
• If the next scheduled dose is only 1 to 7 days away, wait until the next month's scheduled day to take the tablet.
• Resume the next dose on its regular schedule.

• Administer the missed dose as soon as it can be re-scheduled.
• The next dose should be scheduled every 3 months from the date of the last injection.

• The optimal duration of use has not been determined.
• All patients on bisphosphonate therapy should be reevaluated for continued therapy on a periodic basis.
• Patients at low-risk for fracture should consider drug discontinuation after 3 to 5 years of use.
• Reevaluate risk for fractures periodically after discontinuing therapy.

• Metabolic: Serum calcium and symptoms of hypocalcemia

• Patients should read the Medication Guide that comes with this drug before start treatment and with each refill.
• Report any side effect that bothers or that does not go away.
• Failure to follow administration instructions for this drug may increase the risk of esophageal adverse reactions.
• Discontinue this drug and seek medical attention if dysphagia, odynophagia, retrosternal pain or new or worsening heartburn develop.