Alendronic acid

BINOSTO is a bisphosphonate indicated for: Treatment of osteoporosis in postmenopausal women ( 1.1 ) Treatment to increase bone mass in men with osteoporosis ( 1.2 ) Limitation of use: Optimal duration of use has not been determined. For patients at low-risk for fracture, consider drug discontinuation after 3 to 5 years of use ( 1.3 ) 1.1 Treatment of Osteoporosis in Postmenopausal Women BINOSTO effervescent tablet 70 mg is indicated for the treatment of osteoporosis in postmenopausal women. For the treatment of osteoporosis, alendronate sodium increases bone mass and reduces the incidence of fractures, including those of the hip and spine (vertebral compression fractures). …

• 70 mg BINOSTO effervescent tablet once weekly
• Instruct patients to: Dissolve one tablet of BINOSTO in approximately half a glass of plain room temperature water (4 oz)
• Wait at least 5 minutes after the effervescence stops, stir the solution for approximately 10 seconds and consume contents
• Swallow solution at least 30 minutes before the first food, beverage, or medication of the day
• Avoid lying down for at least 30 minutes after taking BINOSTO and until after the first food of the day
• Treatment of Osteoporosis in Postmenopausal Women The recommended dosage is one 70 mg effervescent tablet once weekly
• Treatment to Increase Bone Mass in Men With Osteoporosis The recommended dosage is one 70 mg effervescent tablet once weekly
• Important Administration Instructions Instruct patients to do the following to assure adequate drug absorption and to decrease the risk of esophageal adverse reactions: Take BINOSTO upon arising for the day and at least 30 minutes before the first food, beverage, or medication of the day
• Patients should not swallow the undissolved effervescent tablet, should not chew the effervescent tablet or allow the effervescent tablet to dissolve in their mouths because of the risk for oropharyngeal irritation [see Warnings and Precautions ]
• Dissolve the effervescent tablet in 4 ounces room temperature plain water only (not mineral water or flavored water)
• Wait at least 5 minutes after the effervescence stops and then stir the buffered solution for approximately 10 seconds and ingest. …

BINOSTO effervescent tablets are round, flat-faced, white to off-white tablets, 25 mm in diameter, with beveled edges, with "M" debossed on one side, containing 91.37 mg of alendronate sodium, which is equivalent to 70 mg of free alendronic acid. After dissolution the solution has a pH of 4.8-5.4. Effervescent tablets, 70 mg ( 3 )

• BINOSTO is not indicated for use
• In pediatric patients
• The safety and efficacy of alendronate sodium were examined in a randomized, double-blind, placebo-controlled two-year study of 139
• Pediatric patients, aged 4-18 years, with severe osteogenesis imperfecta (OI)
• One-hundred-and-nine patients were randomized to 5 mg alendronate sodium daily (weight less than 40 kg) or 10 mg alendronate sodium daily (weight greater than or equal to 40 kg) and 30 patients to placebo
• The mean baseline lumbar spine BMD Z-score of the patients was -4.5. …

Of the patients receiving alendronate sodium in the Fracture Intervention Trial (FIT), 71% (n=2302) were greater than or equal to 65 years of age and 17% (n=550) were greater than or equal to 75 years of age. Of the patients receiving alendronate sodium in the United States and Multinational osteoporosis treatment studies in women and osteoporosis studies in men, [see Clinical Studies (14.1) , (14.2) ] , 45% and 54%, respectively, were 65 years o …

• See FDA-approved patient labeling (Medication Guide)
• Instruct patients to read the Medication Guide before starting therapy with BINOSTO and to reread it each time the prescription is renewed
• Osteoporosis Recommendations, Including Calcium and Vitamin D Supplementation Instruct patients to take supplemental calcium and vitamin D, if daily dietary intake is inadequate
• Weight-bearing exercise should be considered along with the modification of certain behavioral factors, such as cigarette smoking and/or excessive alcohol consumption, if these factors exist. …

BINOSTO 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 (5.1) ] Inability to stand or sit upright for at least 30 minutes [see Dosage and Administration (2.3) ; Warnings and Precautions (5.1) ] Do not administer BINOSTO to patients at increased risk of aspiration Hypocalcemia [see Warnings and Precautions (5.2) ] Hypersensitivity to any component of this produ …

Calcium supplements, antacids or oral medications containing multivalent cations interfere with absorption of alendronate. ( 7.1 ) Use caution when co-prescribing aspirin/nonsteroidal anti- inflammatory drugs that may worsen gastrointestinal irritation. ( 7.2 , 7.3 ) 7.1 Calcium Supplements/Antacids Co-administration of BINOSTO and calcium, antacids, or oral medications containing multivalent cations will interfere with absorption of BINOSTO. Therefore, instruct patients to wait at least one-half hour after taking BINOSTO before taking any other oral medications. …

Upper Gastrointestinal Adverse Reactions can occur. Instruct patients to follow dosing instructions. Discontinue if new or worsening symptoms occur. ( 5.1 ) Hypocalcemia can worsen and must be corrected prior to use. ( 5.2 ) Severe Bone, Joint, Muscle Pain may occur. Discontinue use if severe symptoms develop. ( 5.3 ) Osteonecrosis of the Jaw has been reported. ( 5.4 ) Atypical Fractures Including Femoral Fractures have been reported. Patients with new thigh or groin pain should be evaluated to rule out a femoral fracture. Risk/benefit of continuing bisphosphonate therapy should be re-evaluated in these patients and interruption of bisphosphonate therapy should be considered. …

The following clinically significant adverse drug reactions are described elsewhere in the labeling: Upper Gastrointestinal Adverse Reactions [see Warnings and Precautions (5.1) ] Mineral Metabolism [see Warnings and Precautions (5.2) ] Musculoskeletal Pain [see Warnings and Precautions (5.3) ] Osteonecrosis of the Jaw [see Warnings and Precautions (5.4) ] Atypical Fractures Including Femoral Fractures [see Warnings and Precautions (5.5) ] Renal Impairment [see Warnings and Precautions (5.6) ] Patients sensitive to High Sodium Intake [see Warnings and Precautions (5.7) ] The most common adverse reactions (incidence greater than or equal to 3%) are abdominal pain, acid regurgitation, constipa …

8.1 Pregnancy Risk Summary Available data on the use of BINOSTO in pregnant women are insufficient to inform a drug-associated risk of adverse maternal or fetal outcomes. Discontinue BINOSTO when pregnancy is recognized. In animal reproduction studies, daily oral administration of alendronate to rats from before mating through the end of gestation or lactation showed decreased postimplantation survival and decreased pup body weight gain starting …

Significant lethality after single oral doses was seen in female rats and mice at 552 mg/kg (3256 mg/m 2 ) and 966 mg/kg (2898 mg/m 2 ), respectively. In males, these values were slightly higher, 626 and 1280 mg/kg, respectively. There was no lethality in dogs at oral doses up to 200 mg/kg (4000 mg/m 2 ). No specific information is available on the treatment of overdosage with BINOSTO. Hypocalcemia, hypophosphatemia, and upper gastrointestinal adverse events, such as upset stomach, heartburn, esophagitis, gastritis, or ulcer, may result from oral overdosage. …

Store at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F), [See USP Controlled Room Temperature.] Protect from moisture. Store tablets in original blister package until use.

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.