Fosavance 70mg Tablet

FOSAVANCE 5600 is indicated in women for the treatment of post-menopausal osteoporosis to reduce the risk of fractures, including those of the hip and spine (vertebral compression fractures) and to help ensure vitamin D adequacy.

The recommended dosage is one 70 mg/5600 I.U. tablet once weekly. For most osteoporotic patients the appropriate dose is 70 mg/5600 I.U. once weekly.

FOSAVANCE 5600 must be taken at least 30 minutes before the first food, beverage, or medication of the day with plain water only. Other beverages (including mineral water), food, and some medications are likely to reduce the absorption of alendronate, an ingredient of FOSAVANCE 5600 (see u201cINTERACTIONSu201d).

To facilitate delivery to the stomach and thus reduce the potential for oesophageal irritation, FOSAVANCE 5600 should only be swallowed upon arising for the day with a full glass of water and patients should not lie down for at least 30 minutes and until after their first food of the day. FOSAVANCE 5600 should not be taken at bedtime or before arising for the day. Failure to follow these instructions may increase the risk of oesophageal adverse experiences (see u201cWARNINGS AND SPECIAL PRECAUTIONSu201d).

Patients should receive supplemental calcium and/or vitamin D if intake is inadequate (see u201cWARNINGS AND SPECIAL PRECAUTIONSu201d). Medical practitioners should consider the vitamin D intake from vitamins and dietary supplements. FOSAVANCE 5600 is intended to provide a weeku2019s supply of vitamin D based on a daily dose of 400 I.U. and 800 I.U. in a single, once-weekly dose, respectively.

No dosage adjustment is necessary for the elderly or for patients with mild-to-moderate renal insufficiency (creatinine clearance 35 to 60 ml/min) (see u201cCONTRAINDICATIONSu201d).

Abnormalities of the oesophagus which delay oesophageal emptying such as stricture or achalasia. Inability to stand or sit upright for at least 30 minutes. Hypersensitivity to any component of FOSAVANCE 5600. Hypocalcaemia (see u201cWARNINGS AND SPECIAL PRECAUTIONSu201d). Severe renal insufficiency (creatinine clearance < 35 ml/min). Pregnancy and lactation (see u201cPREGNANCY AND LACTATIONu201d). Paediatric age group.

Alendronate Sodium FOSAVANCE 5600 may cause local irritation of the upper gastrointestinal mucosa. Oesophageal adverse experiences, such as oesophagitis, oesophageal ulcers and oesophageal erosions, in some instances followed by oesophageal stricture or perforation, have been reported in patients receiving treatment with alendronate as contained in FOSAVANCE 5600. In some cases these have been severe and required hospitalisation. Medical practitioners should therefore be alert to any signs or symptoms signalling a possible oesophageal reaction and patients should be instructed to discontinue FOSAVANCE 5600, and seek medical attention if they develop dysphagia, odynophagia, retrosternal pain or new or worsening heartburn.

The risk of severe oesophageal adverse experiences appears to be greater in patients who lie down after taking FOSAVANCE 5600, and/or who fail to swallow it with a full glass of water, and/or who continue to take FOSAVANCE 5600 after developing symptoms suggestive of oesophageal irritation. Therefore, it is very important that the full dosing instructions are provided to, and understood by the patient (see u201cDOSAGE AND DIRECTIONS FOR USEu201d).

While no increased risk was observed in extensive clinical trials with alendronate as contained in FOSAVANCE 5600, there have been reports of gastric and duodenal ulcers, some severe and with complications. Because of possible irritant effects of alendronate, as contained in FOSAVANCE 5600 on the upper gastrointestinal mucosa and a potential for worsening of the underlying disease, caution should be used when FOSAVANCE 5600 is given to patients with active upper gastrointestinal problems, such as dysphagia, oesophageal diseases (including known Barrettu2019s oesophagus), gastritis, duodenitis or ulcers.

To facilitate delivery to the stomach and thus reduce the potential for oesophageal irritation patients should be instructed to swallow FOSAVANCE 5600 with a full glass of water, and not to lie down for at least 30 minutes, and until after their first food of the day. Patients should not chew or suck on the tablet because of a potential for oropharyngeal ulceration. Patients should be specifically instructed not to take FOSAVANCE 5600 at bedtime or before arising for the day. Patients should be informed that failure to follow these instructions may increase their risk of oesophageal problems. Patients should be instructed that if they develop symptoms of oesophageal disease (such as difficulty or pain upon swallowing, retrosternal pain or new or worsening heartburn) they should stop taking FOSAVANCE 5600 and consult their medical practitioner.

Since non-steroidal anti-inflammatory drug (NSAID) use is associated with gastrointestinal irritation, caution is advised with the concomitant use of FOSAVANCE 5600 and NSAIDs.

Localised osteonecrosis of the jaw, generally associated with tooth extraction and/or local infection (including osteomyelitis) with delayed healing, has been reported with oral bisphosphonates (see u201cSIDE EFFECTSu201d). Most reported cases of bisphosphonate-associated osteonecrosis of the jaw have been in cancer patients treated with intravenous bisphosphonates. Known risk factors for osteonecrosis of the jaw include a diagnosis of cancer, concomitant therapies (e.g. chemotherapy, radiotherapy, corticosteroids), poor oral hygiene and co-morbid disorders (e.g. periodontal and/or other pre-existing dental disease, anaemia, coagulopathy, infection and smoking). Patients who develop osteonecrosis of the jaw should receive appropriate care by a dental practitioner, and discontinuation of bisphosphonate therapy should be considered based on individual benefit/risk assessment. Dental surgery may exacerbate the condition.

For patients requiring invasive dental surgery (e.g. tooth extraction, dental implants), clinical judgement of the prescribing medical practitioner and treating dental practitioner should guide the management plan, including FOSAVANCE 5600 treatment, of each patient based on individual benefit/risk assessment.

Bone, joint, and/or muscle pain has been reported in patients taking bisphosphonates. In post-marketing experience, these symptoms have been severe and/or incapacitating (see u201cSIDE EFFECTSu201d). The time to onset of symptoms varied from one day to several months after starting treatment. Most patients had relief of symptoms after stopping treatment. A subset had recurrence of symptoms when rechallenged with the same medicine or another bisphosphonate.

Low-energy fractures of the subtrochanteric and proximal femoral shaft have been reported in long-term (usually longer than 3 years) bisphosphonate-treated patients. Some were stress fractures (some of which were reported as insufficiency fractures) occurring in the absence of apparent trauma. Some patients experienced prodromal pain in the affected area, often associated with imaging features of stress fracture, weeks to months before a complete fracture occurred. Approximately one third of these fractures were bilateral; therefore, the contra-lateral femur should be examined in patients who have sustained a femoral shaft stress fracture. Bisphosphonate therapy in patients with stress fractures should be discontinued.

Patients should be instructed that if they miss a dose of FOSAVANCE 5600, they should take 1 tablet on the morning after they remember. They should not take 2 tablets on the same day but should return to taking 1 tablet once a week, as originally scheduled on their chosen day.

Causes of osteoporosis other than oestrogen deficiency and aging should be considered.

Hypocalcaemia must be corrected before initiating therapy with FOSAVANCE 5600 (see u201cCONTRAINDICATIONSu201d). Other disorders affecting mineral metabolism (such as vitamin D deficiency) should also be effectively treated. In patients with these conditions serum calcium and symptoms of hypocalcaemia should be monitored during therapy with FOSAVANCE 5600.

Cholecalciferol Vitamin D 3 may increase the magnitude of hypercalcaemia and/or hypercalciuria when administered to patients with diseases associated with unregulated overproduction of calcitriol (e.g. leukaemia, lymphoma, sarcoidosis). Urine and serum calcium should be monitored in these patients.

Patients with malabsorption may not adequately absorb vitamin D 3.

Use in the Elderly In clinical studies, there was no age-related difference in the efficacy or safety profiles of FOSAVANCE 5600.

Alendronate Sodium If taken concomitantly it is likely that calcium supplements, antacids, and other oral medications will interfere with absorption of alendronate. Therefore, patients must wait at least 30 minutes after taking FOSAVANCE 5600 before taking any other oral medication. No other interactions of clinical significance are anticipated. A small number of post-menopausal women in the osteoporosis trials received oestrogen (intra-vaginal, transdermal or oral) while taking FOSAVANCE 5600. No adverse experiences attributable to their concomitant use were identified. Specific interaction studies were not performed. In post-menopausal osteoporosis studies, alendronate, an ingredient of FOSAVANCE 5600, was used with a wide range of commonly prescribed medicines without evidence of clinical adverse interactions.

Cholecalciferol Olestra, mineral oils, orlistat, and bile acid sequestrants (e.g. cholestyramine, colestipol) may impair the absorption of vitamin D. Anticonvulsants, cimetidine and thiazides, may increase the catabolism of vitamin D.

FOSAVANCE 5600 has not been studied in pregnant or breastfeeding women and should not be given to them (see u201cCONTRAINDICATIONSu201d).

Adverse reactions that have been reported with FOSAVANCE 5600 may affect the ability of patients to drive or operate machinery.

The following adverse experiences with alendronate, as contained in FOSAVANCE 5600 have been reported during clinical studies.

[Common ( u2265 1/100, < 1/10), Uncommon ( u2265 1/1 000, < 1/100), Rare ( u2265 1/10 000, < 1/1 000), Very rare (< 1/10 000 including isolated cases)]

Nervous system disorders Common: Headache Gastrointestinal disorders Common: Abdominal pain, dyspepsia, constipation, diarrhoea, flatulence, oesophageal ulcer*, dysphagia*, abdominal distension, acid regurgitation Uncommon: Nausea, gastritis, melaena Rare: Oropharyngeal ulceration*, gastric or duodenal ulcers, some severe and with complications. *(see u201cWARNINGS AND SPECIAL PRECAUTIONSu201d and u201cDOSAGE AND DIRECTIONS FOR USEu201d)

Skin and subcutaneous tissue disorders Uncommon: Rash, erythema Musculoskeletal, connective tissue and bone disorders Common: Musculoskeletal (bone, muscle or joint) pain. Laboratory Test Findings A decrease in serum calcium and phosphate may occur.

Post-Marketing Experience The following adverse experiences have been reported during post-marketing use of FOSAVANCE 5600: Immune system disorders: Hypersensitivity reactions including urticaria and angioedema. Metabolism and nutrition disorders: Symptomatic hypocalcaemia, generally in association with predisposing conditions (see u201cWARNINGS AND SPECIAL PRECAUTIONSu201d). Nervous system disorders: Dizziness, vertigo, dysgeusia. Eye disorders: Uveitis, scleritis, episcleritis. Gastrointestinal disorders: Vomiting, oesophagitis *, oesophageal erosions *, oesophageal stricture *, oesophageal perforations. *(See u201cWARNINGS AND SPECIAL PRECAUTIONSu201d and u201cDOSAGE AND DIRECTIONS FOR USEu201d). Musculoskeletal, connective tissue and bone disorders: Severe and/or incapacitating bone, joint, and/or muscle pain, (see u201cWARNINGS AND SPECIAL PRECAUTIONSu201d); localised osteonecrosis of the jaw, generally associated with tooth extraction and/or local infection, with delayed healing (see u201cWARNINGS AND SPECIAL PRECAUTIONSu201d), joint swelling, low-energy femoral shaft fracture. Skin and subcutaneous tissue disorders: Pruritus, rash with photosensitivity, alopecia, severe skin reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis.

General disorders and administration site conditions: Transient symptoms as in an acute-phase response (myalgia, malaise, asthenia and fever) have been reported with alendronate, usually in association with initiation of treatment, peripheral oedema.

Alendronate Sodium Hypocalcaemia, hypophosphatemia and upper gastrointestinal adverse events, such as upset stomach, heartburn, oesophagitis, gastritis or ulcer, may result from oral overdosage. Milk or antacids, should be given to bind alendronate. Due to the risk of oesophageal irritation, vomiting should not be induced and the patient should remain fully upright.

Cholecalciferol Vitamin D toxicity may occur with hypercalcaemia or hypercalciuria. This has not been documented during chronic therapy in generally healthy adults at a dose < 10 000 I.U./day.