BFAD approves new once-weekly dose of alendronate for osteoporosis
October 19, 2001 | 12:00am
Eating out. Going to the movies. Shopping for groceries. From entertainment to household chores, many of us have a list of things we do once a week. Chances are, taking medicine is not one of them.
That might begin to change for some people as the result of a Bureau of Food and Drug Administration (BFAD) action announced recently by Merck Sharp & Dohme Philippines (MSD). A new dosage strength of alendronate sodium has been approved as a once-weekly tablet for the treatment of osteoporosis. Alendronate sodium is the first and only oral medication approved for the treatment of osteoporosis in a once-weekly dosing regimen.
The approval of alendronate sodium in a dosage form containing seven times the daily dosage strength was based on a clinical study that showed alendronate sodium taken once a week had an equivalent effect to the alendronate sodium taken once a day in increasing bone mineral density (BMD) in postmenopausal women.
A comparative study evaluating the therapeutic equivalence of alendronate once-weekly treatment and the daily formulation showed that the effect on bone mineral density (BMD) of alendronate was equivalent when administered daily or once weekly. Increases in BMD at the hip and total body were similar in the two treatment groups. To ensure adequate calcium and vitamin D intake, all patients in the study received calcium and vitamin D supplements.
In the clinical trial, the safety and tolerability profiles of alendronate sodium once-weekly and the once-daily regimen were similar. The most common gastrointestinal (GI) adverse experiences were abdominal pain, indigestion, acid regurgitation and nausea. There were no statistically significant differences between the two dosing regimens in upper GI adverse experiences that resulted in discontinuation from the study.
An additional analysis showed that there was no significant increase in the incidence of upper GI adverse events observed on the day of dosing between patients receiving alendronate once-weekly and those receiving the once-daily.
To assist patients in following the dosing regimen for the once-weekly dosing, a patient-friendly blister package containing a two-week supply has been developed. Patients can select a day of the week that works best for them to take the once-weekly dose of alendronate sodium.
Alendronate sodium, like other bisphosphonates, should be used with caution in people with certain stomach or digestive problems. Alendronate sodium should not be used if the patient has certain disorders of the esophagus that delay emptying or if the patient is unable to stand or sit upright for at least 30 minutes. In addition, alendronate sodium should not be used in patients with severe kidney disease or low levels of calcium in their blood, in patients who are allergic to alendronate sodium or in patients who are pregnant or nursing.
Some patients may develop severe digestive reactions including irritation, inflammation or ulceration of the esophagus. The risk of severe esophageal experiences appears to be greater in patients who fail to follow dosing instructions. Patients who experience heartburn, difficulty or pain when swallowing or chest pain should stop taking the drug and should consult their doctor.
Alendronate once-weekly is a new dosage formulation different from the once-daily dosage formulation of alendronate sodium. Alendronate sodium is a pharmaceutical drug product that can be bought only with a prescription from a physician. For additional information on osteoporosis and its treatment, consult your doctor. For other concerns, call the MSD Customer Call Center at 878-6338 or 1-800-1-888-6737 (for those outside Metro Manila).
That might begin to change for some people as the result of a Bureau of Food and Drug Administration (BFAD) action announced recently by Merck Sharp & Dohme Philippines (MSD). A new dosage strength of alendronate sodium has been approved as a once-weekly tablet for the treatment of osteoporosis. Alendronate sodium is the first and only oral medication approved for the treatment of osteoporosis in a once-weekly dosing regimen.
The approval of alendronate sodium in a dosage form containing seven times the daily dosage strength was based on a clinical study that showed alendronate sodium taken once a week had an equivalent effect to the alendronate sodium taken once a day in increasing bone mineral density (BMD) in postmenopausal women.
A comparative study evaluating the therapeutic equivalence of alendronate once-weekly treatment and the daily formulation showed that the effect on bone mineral density (BMD) of alendronate was equivalent when administered daily or once weekly. Increases in BMD at the hip and total body were similar in the two treatment groups. To ensure adequate calcium and vitamin D intake, all patients in the study received calcium and vitamin D supplements.
An additional analysis showed that there was no significant increase in the incidence of upper GI adverse events observed on the day of dosing between patients receiving alendronate once-weekly and those receiving the once-daily.
Alendronate sodium, like other bisphosphonates, should be used with caution in people with certain stomach or digestive problems. Alendronate sodium should not be used if the patient has certain disorders of the esophagus that delay emptying or if the patient is unable to stand or sit upright for at least 30 minutes. In addition, alendronate sodium should not be used in patients with severe kidney disease or low levels of calcium in their blood, in patients who are allergic to alendronate sodium or in patients who are pregnant or nursing.
Some patients may develop severe digestive reactions including irritation, inflammation or ulceration of the esophagus. The risk of severe esophageal experiences appears to be greater in patients who fail to follow dosing instructions. Patients who experience heartburn, difficulty or pain when swallowing or chest pain should stop taking the drug and should consult their doctor.
Alendronate once-weekly is a new dosage formulation different from the once-daily dosage formulation of alendronate sodium. Alendronate sodium is a pharmaceutical drug product that can be bought only with a prescription from a physician. For additional information on osteoporosis and its treatment, consult your doctor. For other concerns, call the MSD Customer Call Center at 878-6338 or 1-800-1-888-6737 (for those outside Metro Manila).
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