Risedronate Sodium

Contraindications

4 CONTRAINDICATIONS Atelvia is contraindicated in patients with the following conditions: Abnormalities of the esophagus which delay esophageal emptying such as stricture or achalasia [ see Warnings and Precautions (5.2) ] Inability to stand or sit upright for at least 30 minutes [ see Dosage and Administration (2) , Warnings and Precautions (5.2) ] Hypocalcemia [ see Warnings and Precautions (5.3) ] Known hypersensitivity to any component of this product. Angioedema, generalized rash, bullous skin reactions, Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported [see Adverse Reactions (6.2) ] Abnormalities of the esophagus which delay esophageal emptying such as stricture or achalasia ( 4 , 5.2 ) Inability to stand or sit upright for at least 30 minutes ( 4 , 5.2 ) Hypocalcemia ( 4 , 5.3 ) Known hypersensitivity to any component of this product ( 4 , 6.2 )

Pregnancy & Breastfeeding

8.1 Pregnancy Risk Summary Available data on use of Atelvia in pregnant women are insufficient to inform drug-associated risk of adverse maternal or fetal outcomes. Discontinue Atelvia when pregnancy is recognized. In animal reproduction studies, daily oral administration of risedronate to pregnant rats during organogenesis decreased neonatal survival and body weight at doses approximately 5 and 26 times, respectively, the highest recommended human daily dose of 30 mg (based on body surface area, mg/m 2 ), the dose indicated for treatment of Paget’s disease. A low incidence of cleft palate was observed in fetuses of dams treated at doses approximately equal to the 30 mg human daily dose. Delayed skeletal ossification was observed in fetuses of dams treated at approximately 2.5 to 5 times the 30 mg human daily dose. Periparturient mortality due to maternal hypocalcemia occurred in dams and neonates upon daily oral administration of risedronate to pregnant rats during mating and/or gestation starting at doses equivalent to the 30 mg daily human dose. Bisphosphonates are incorporated into the bone matrix, from which they are gradually released over a period of weeks to years. The amount of bisphosphonate incorporated into adult bone available for release into the systemic circulation is directly related to the dose and duration of bisphosphonate use. Consequently, based on mechanism of action of bisphosphonates, there is a potential risk of fetal harm, predominantly skeletal, if a woman becomes pregnant after completing a course of bisphosphonate therapy. The impact of variables such as time between cessation of bisphosphonate therapy to conception, the particular bisphosphonate used, and the route of administration (intravenous versus oral) on this risk has not been studied. The estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. All pregnancies have a background risk of birth defects, loss, or other adverse outco