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Drug Details

ACTONEL Once a Week

• Drug Class Description
  Bisphosphonates.
• Generic Name
  Risedronate sodium
• Presentation
  Film-coated tablet
• Description
  Each film-coated tablet contains 35 mg risedronate sodium (equivalent to 32.5 mg risedronic acid). Each film-coated tablet contains 35 mg risedronate sodium (equivalent to 32.5 mg risedronic acid). Excipients: Each film-coated tablet contains lactose.
• Indications
  

  Treatment of postmenopausal osteoporosis, to reduce the risk of vertebral fractures. Treatment of established postmenopausal osteoporosis, to reduce the risk of hip fractures. Treatment of osteoporosis in men at high risk of fractures

• Adult Dosage
  

  The recommended dose in adults is one 35 mg tablet orally once a week. The tablet should be taken on the same day each week.

  The absorption of risedronate sodium is affected by food, thus to ensure adequate absorption patients should take Actonel Once a Week 35 mg:

  • Before breakfast: At least 30 minutes before the first food, other medicinal product or drink (other than plain water) of the day.

  Patients should be instructed that if a dose is missed, one Actonel Once a Week 35 mg tablet should be taken on the day that the tablet is remembered. Patients should then return to taking one tablet once a week on the day the tablet is normally taken. Two tablets should not be taken on the same day.

  The tablet must be swallowed whole and not sucked or chewed. To aid delivery of the tablet to the stomach Actonel Once a Week 35 mg is to be taken while in an upright position with a glass of plain water (>120 ml). Patients should not lie down for 30 minutes after taking the tablet.

  Supplemental calcium and vitamin D should be considered if the dietary intake is inadequate.

• Child Dosage
  

  Safety and efficacy of Actonel Once a Week 35 mg have not been established in children and adolescents.

• Elderly Dosage
  

  No dosage adjustment is necessary since bioavailability, distribution and elimination were similar in elderly (>60 years of age) compared to younger subjects.

  This has also been shown in the very elderly, 75 years old and above postmenopausal population.

  Renal Impairment: No dosage adjustment is required for those patients with mild to moderate renal impairment. The use of risedronate sodium is contraindicated in patients with severe renal impairment (creatinine clearance lower than 30ml/min).

• Contra Indications
  
  • Hypersensitivity to risedronate sodium or to any of the excipients.
  • Hypocalcaemia .
  • Pregnancy and lactation.
  • Severe renal impairment (creatinine clearance <30ml/min).
• Special Precautions
  

  Foods, drinks (other than plain water) and medicinal products containing polyvalent cations (such as calcium, magnesium, iron and aluminium) interfere with the absorption of bisphosphonates and should not be taken at the same time as Actonel Once a Week 35 mg. In order to achieve the intended efficacy, strict adherence to dosing recommendations is necessary.

  Efficacy of bisphosphonates in the treatment of osteoporosis is related to the presence of low bone mineral density and/or prevalent fracture.

  High age or clinical risk factors for fracture alone are not sufficient reasons to initiate treatment of osteoporosis with a bisphosphonate.

  The evidence to support efficacy of bisphosphonates including risedronate in the very elderly (>80 years) is limited.

  Bisphosphonates have been associated with oesophagitis, gastritis, oesophageal ulcerations and gastroduodenal ulcerations. Thus, caution should be used:

  • In patients who have a history of oesophageal disorders which delay oesophageal transit or emptying e.g. stricture or achalasia
  • In patients who are unable to stay in the upright position for at least 30 minutes after taking the tablet.
  • If risedronate is given to patients with active or recent oesophageal or upper gastrointestinal problems.

  Prescribers should emphasise to patients the importance of paying attention to the dosing instructions and be alert to any signs and symptoms of possible oesophageal reaction. The patients should be instructed to seek timely medical attention if they develop symptoms of oesophageal irritation such as dysphagia, pain on swallowing, retrosternal pain or new/worsened heartburn.

  Hypocalcaemia should be treated before starting Actonel Once a Week 35 mg therapy. Other disturbances of bone and mineral metabolism (i.e. parathyroid dysfunction, hypovitaminosis D) should be treated at the time of starting Actonel Once a Week 35 mg therapy.

  Osteonecrosis of the jaw, generally associated with tooth extraction and/or local infection (including osteomyelitis) has been reported in patients with cancer receiving treatment regimens including primarily intravenously administered bisphophonates. Many of these patients were also receiving chemotherapy and corticosteroids. Osteonecrosis of the jaw has also been reported in patients with osteoporosis receiving oral bisphosphonates.

  A dental examination with appropriate preventive dentistry should be considered prior to treatment with bisphosphonates in patients with concomitant risk factors (e.g. cancer, chemotherapy, radiotherapy, corticosteroids, poor oral hygiene).

  While on treatment, these patients should avoid invasive dental procedures if possible. For patients who develop osteonecrosis of the jaw 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 osteonecrosis of the jaw.

  Clinical judgment of the treating physician should guide the management plan of each patient based on individual benefit /risk assessment.

  This medicine contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

• Interactions
  

  No formal interaction studies have been performed, however no clinically relevant interactions with other medicinal products were found during clinical trials.

  In the risedronate sodium Phase III osteoporosis studies with daily dosing, acetyl salicylic acid or NSAID use was reported by 33% and 45% of patients respectively. In the Phase III once a week study in postmenopausal women, acetyl salicylic acid or NSAID use was reported by 57% and 40% of patients respectively. Among regular acetyl salicylic acid or NSAID users (3 or more days per week) the incidence of upper gastrointestinal adverse events in risedronate sodium treated patients was similar to that in control patients.

  If considered appropriate risedronate sodium may be used concomitantly with oestrogen supplementation (for women only).

  Concomitant ingestion of medications containing polyvalent cations (e.g. calcium, magnesium, iron and aluminium) will interfere with the absorption of risedronate sodium.

  Risedronate sodium is not systemically metabolised, does not induce cytochrome P450 enzymes, and has low protein binding.

• Adverse Drug Reactions
  

  Risedronate sodium has been studied in phase III clinical trials involving more than 15,000 patients. The majority of undesirable effects observed in clinical trials were mild to moderate in severity and usually did not require cessation of therapy.

  Adverse experiences reported in phase III clinical trials in postmenopausal women with osteoporosis treated for up to 36 months with risedronate sodium 5mg/day (n=5020) or placebo (n=5048) and considered possibly or probably related to risedronate sodium are listed below using the following convention (incidences versus placebo are shown in brackets): very common (1/10); common (1/100; <1/10); uncommon (1/1,000; <1/100); rare (1/10,000; <1/1,000); very rare (<1/10,000).

  Nervous system disorders:

  Common: headache (1.8% vs. 1.4%)

  Eye disorders:

  Uncommon: iritis*

  Gastrointestinal disorders:

  Common: constipation (5.0% vs. 4.8%), dyspepsia (4.5% vs. 4.1%), nausea (4.3% vs. 4.0%), abdominal pain (3.5% vs. 3.3%), diarrhoea (3.0% vs. 2.7%)

  Uncommon: gastritis (0.9% vs. 0.7%), oesophagitis (0.9% vs. 0.9%), dysphagia (0.4% vs. 0.2%), duodenitis (0.2% vs. 0.1%), oesophageal ulcer (0.2% vs. 0.2%)

  Rare: glossitis (<0.1% vs. 0.1%), oesophageal stricture (<0.1% vs. 0.0%),

  Musculoskeletal and connective tissues disorders:

  Common: musculoskeletal pain (2.1% vs. 1.9%)

  Investigations:

  Rare: abnormal liver function tests*

  * No relevant incidences from Phase III osteoporosis studies; frequency based on adverse event/laboratory/rechallenge findings in earlier clinical trials.

  In a one-year, double-blind, multicentre study comparing risedronate sodium 5 mg daily (n= 480) and risedronate sodium 35 mg weekly (n=485) in postmenopausal women with osteoporosis, the overall safety and tolerability profiles were similar. The following additional adverse experiences considered possibly or probably drug related by investigators have been reported (incidence greater in risedronate 35 mg than in risedronate sodium 5 mg group): gastrointestinal disorder (1.6% vs. 1.0%) and pain (1.2% vs. 0.8%).

  In a 2-year study in men with osteoporosis, the overall safety and tolerability were similar between the treatment and the placebo groups. Adverse experiences were consistent with those previously observed in women.

  Laboratory findings: Early, transient, asymptomatic and mild decreases in serum calcium and phosphate levels have been observed in some patients.

  The following additional adverse reactions have been reported during post-marketing use (frequency unknown):

  Eye disorders:

  iritis, uveitis

  Muskuloskeletal and connective tissues disorders:

  osteonecrosis of the jaw

  Skin and subcutaneous tissue disorders:

  hypersensitivity and skin reactions, including angioedema, generalised rash, urticaria and bullous skin reactions, some severe including isolated reports of Stevens Johnson syndrome and toxic epidermal necrolysis.

  hair loss

  Immune system disorders:

  anaphylactic reaction

  Hepatobiliary disorders:

  serious hepatic disorders. In most of the reported cases the patients were also treated with other products known to cause hepatic disorders.