Source: European Medicines Agency (EU) Revision Year: 2021 Publisher: N.V. Organon, Kloosterstraat 6, 5349 AB Oss, The Netherlands
FOSAVANCE is indicated for the treatment of postmenopausal osteoporosis in women at risk of vitamin D insufficiency. It reduces the risk of vertebral and hip fractures.
The recommended dose is one tablet once weekly.
Patients should be instructed that if they miss a dose of FOSAVANCE they should take one tablet on the morning after they remember. They should not take two tablets on the same day but should return to taking one tablet once a week, as originally scheduled on their chosen day.
Due to the nature of the disease process in osteoporosis, FOSAVANCE is intended for long-term use.
The optimal duration of bisphosphonate treatment for osteoporosis has not been established. The need for continued treatment should be re-evaluated periodically based on the benefits and potential risks of FOSAVANCE on an individual patient basis, particularly after 5 or more years of use.
Patients should receive supplemental calcium if intake from diet is inadequate (see section 4.4). Additional supplementation with vitamin D should be considered on an individual basis taking into account any vitamin D intake from vitamins and dietary supplements.
FOSAVANCE 70 mg/2,800 IU tablets: The equivalence of intake of 2,800 IU of vitamin D3 weekly in FOSAVANCE to daily dosing of vitamin D 400 IU has not been studied.
FOSAVANCE 70 mg/5,600 IU tablets: The equivalence of intake of 5,600 IU of vitamin D3 weekly in FOSAVANCE to daily dosing of vitamin D 800 IU has not been studied.
In clinical studies there was no age-related difference in the efficacy or safety profiles of alendronate. Therefore no dose adjustment is necessary for the elderly.
FOSAVANCE is not recommended for patients with renal impairment where creatinine clearance is less than 35 ml/min, due to lack of experience. No dose adjustment is necessary for patients with a creatinine clearance greater than 35 ml/min.
The safety and efficacy of FOSAVANCE in children less than 18 years of age have not been established. This medicinal product should not be used in children less than 18 years of age because no data are available for the alendronic acid/colecalciferol combination. Currently available data for alendronic acid in the paediatric population is described in section 5.1.
Oral use.
To permit adequate absorption of alendronate:
FOSAVANCE must be taken with water only (not mineral water) at least 30 minutes before the first food, beverage, or medicinal product (including antacids, calcium supplements and vitamins) of the day. Other beverages (including mineral water), food and some medicinal products are likely to reduce the absorption of alendronate (see section 4.5 and section 4.8).
The following instructions should be followed exactly in order to minimise the risk of oesophageal irritation and related adverse reactions (see section 4.4):
Hypocalcaemia, hypophosphataemia and upper gastrointestinal adverse reactions, such as upset stomach, heartburn, oesophagitis, gastritis, or ulcer, may result from oral overdose.
No specific information is available on the treatment of overdose with alendronate. In case of overdose with FOSAVANCE, milk or antacids should be given to bind alendronate. Owing to the risk of oesophageal irritation, vomiting should not be induced and the patient should remain fully upright.
Vitamin D toxicity has not been documented during chronic therapy in generally healthy adults at a dose less than 10,000 IU/day. In a clinical study of healthy adults a 4,000 IU daily dose of vitamin D3 for up to five months was not associated with hypercalciuria or hypercalcaemia.
18 months.
Store in the original blister in order to protect from moisture and light.
FOSAVANCE 70 mg/2,800 IU tablets: Aluminium/aluminium blisters, in cartons containing 2, 4, 6 or 12 tablets.
FOSAVANCE 70 mg/5,600 IU tablets: Aluminium/aluminium blisters, in cartons containing 2, 4 or 12 tablets.
Not all pack sizes may be marketed.
No special requirements.
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
