Risedronate Sodium (Sandoz Risedronate)

1. Health Canada Product Monograph — Risedronate Sodium

• Used for the treatment and prevention of osteoporosis in postmenopausal women, reducing the risk of spine and non-spine fragility fractures and increasing bone mineral density at the spine, hip, and wrist.
• Used for the treatment of osteoporosis in men, to improve bone mineral density.
• May be considered for postmenopausal women at risk of developing osteoporosis, based on factors such as family history, prior fracture, smoking, low bone mass, thin body frame, and early menopause.
• The optimal duration of use has not been established, and the ongoing need for therapy should be reassessed periodically with the prescriber.

• This product is not intended for use during pregnancy, and there are no studies of risedronate sodium in pregnant women, so it should be avoided if pregnancy is known or suspected.

• This product is not intended for use by nursing mothers; it is not known whether risedronate passes into human milk, though a small degree of transfer into milk was seen in animal studies, and because of the potential for serious effects in a nursing infant from bisphosphonates as a class, the decision to continue nursing or continue the medication should weigh its importance to the mother.

• No dose adjustment is needed based on age alone, and studies in osteoporosis patients found no meaningful differences in effectiveness or safety between older and younger patients; kidney function should still be considered, since the drug is not recommended in severe kidney impairment, which becomes more common with age.

• Not authorized for use in patients under 18 years of age, since no pediatric data are available.

• The recommended dose for treating or preventing postmenopausal osteoporosis, and for treating osteoporosis in men, is one 35 mg tablet taken once a week on the same day each week.
• The tablet must be swallowed whole while sitting or standing upright, with at least 120 mL of plain water, taken at least 30 minutes before the first food, drink other than plain water, or other medication of the day.
• Patients should remain upright and avoid lying down for at least 30 minutes after taking the tablet, and should not chew, cut, or crush it.
• If a weekly dose is missed, it should be taken on the day it is remembered, and the patient should then return to their original weekly schedule; two tablets should never be taken on the same day.
• Supplemental calcium and vitamin D should be taken if dietary intake is inadequate, and any medication containing calcium, magnesium, aluminum, or iron should be taken at a different time of day, since these can interfere with risedronate absorption.
• No dose adjustment is needed for mild-to-moderate kidney impairment, but the medication is not recommended in patients with severe kidney impairment due to limited clinical experience.

• Abdominal pain may occur.
• Indigestion (dyspepsia) may occur.
• Nausea may occur.
• Constipation may occur.
• Diarrhea may occur.
• Gas (flatulence) may occur.
• Stomach irritation (gastritis) may occur.
• Headache may occur.
• Weakness (asthenia) may occur.
• Skin rash or itching may occur.
• Joint pain (arthralgia) may occur.

Serious side effects require immediate discussion with the prescriber or emergency care.

• Osteonecrosis of the jaw, a serious bone-healing problem usually linked to invasive dental work, has been reported with bisphosphonate use.
• Unusual, low-trauma fractures of the thigh bone (atypical femoral fractures) have been reported, sometimes preceded by weeks or months of dull thigh or groin pain.
• Severe and occasionally disabling bone, joint, or muscle pain has been reported, which may recur if the same or another bisphosphonate is tried again.
• Irritation or ulceration of the esophagus, including difficulty swallowing and esophageal ulcers, can occur, especially if dosing instructions are not followed closely.
• Eye inflammation, including uveitis, iritis, scleritis, and episcleritis, has been reported and requires prompt evaluation by an eye specialist if it occurs.
• Severe allergic and skin reactions, including swelling of the face or throat, widespread rash, and blistering skin reactions, have been reported.
• A drop in blood calcium (hypocalcemia) can occur or worsen, particularly if calcium and vitamin D status are not corrected before starting treatment.
• Contact your doctor's office promptly for new hip, thigh, or groin pain, difficulty or pain swallowing, chest pain, severe or worsening bone or joint pain, jaw pain or swelling, or eye pain or redness.

• Use with caution in patients with a history of esophageal disorders, such as stricture, inflammation, or difficulty swallowing, since these patients need extra emphasis on correct dosing technique.
• Use with caution in patients with risk factors for osteonecrosis of the jaw, including cancer, chemotherapy, corticosteroid use, immunosuppression, poor oral hygiene, or diabetes; a dental check-up before starting treatment is advised for these patients.
• Use with caution in patients on long-term bisphosphonate therapy, who should be monitored for new thigh or groin pain suggesting an atypical fracture.
• Not recommended in patients with severe kidney impairment.
• Correct any hypocalcemia or other bone and mineral disorders before starting therapy.

• Contraindicated in patients hypersensitive to risedronate sodium or to any ingredient in the formulation, including the tablet container components.
• Contraindicated in patients with hypocalcemia (low blood calcium), which must be corrected before starting therapy.

• Antacids and calcium supplements containing polyvalent cations such as calcium, magnesium, aluminum, or iron interfere with risedronate absorption and must be taken at a different time of day.
• Concurrent NSAID or aspirin use is common in patients taking risedronate and may add to the risk of upper gastrointestinal irritation.
• Angiogenesis inhibitor medications used for cancer may raise the risk of osteonecrosis of the jaw when combined with risedronate, so a dental examination is advised before starting risedronate in these patients.
• Hormone replacement therapy has not shown a clinically significant interaction with risedronate and may be used together if considered appropriate.
• As a class, bisphosphonates are known to interfere with bone-imaging agents used in nuclear medicine scans, though this has not been specifically studied with risedronate.

• Food and beverages other than plain water substantially reduce risedronate absorption, so the tablet must be taken on a fully empty stomach, at least 30 minutes before the first food or drink of the day.

• Take first thing in the morning, at least 30 minutes before eating, drinking anything other than plain water, or taking any other medication, and remain upright without lying down for at least 30 minutes afterward.

• Store in a dry place at room temperature between 15 and 30 degrees C, and keep out of the reach and sight of children.

• This is a once-weekly tablet used to treat or prevent osteoporosis by slowing bone breakdown and helping preserve bone density.
• Take it first thing in the morning on an empty stomach with a full glass (at least 120 mL) of plain water only, while sitting or standing upright, then wait at least 30 minutes before eating, drinking anything else, lying down, or taking other medications.
• Common effects include stomach upset, indigestion, nausea, and joint pain.
• Contact your doctor's office promptly for new thigh, hip, or groin pain, difficulty or pain swallowing, chest pain, jaw pain or swelling, or eye pain or redness, since these can signal rare but serious complications.
• Take any calcium, magnesium, aluminum, or iron-containing products, including antacids and supplements, at a different time of day, since they can block absorption of this medication.
• Maintain good oral hygiene, keep up with routine dental check-ups, and let your dentist know you are taking this medication before any dental procedure.