MANUFACTURER:
Mission Pharmacal Company
PHARMACOLOGICAL CLASS:
Bisphosphonate.
ACTIVE INGREDIENT(S):
Alendronate (as sodium) 70mg; effervescent tabs for oral soln; strawberry-flavor; contains 650mg sodium/tab.
INDICATION(S):
Treatment of postmenopausal osteoporosis. To increase bone mass in men with osteoporosis.
PHARMACOLOGY:
Alendronate binds to bone hydroxyapatite and specifically inhibits the activity of osteoclasts, the bone-resorbing cells. It reduces bone resorption with no direct effect on bone formation, although the latter process is ultimately reduced because bone resorption and formation are coupled during bone turnover.
CLINICAL TRIALS:
Binosto (alendronate sodium) effervescent tablet 70mg is bioequivalent to alendronate sodium tablet 70mg. The fracture reduction efficacy and bone mineral density changes attributed to Binosto are based on clinical trial data of alendronate sodium 10mg daily and alendronate sodium 70mg weekly.
LEGAL CLASSIFICATION:
Rx
ADULTS:
Dissolve one tab in 4oz plain (not mineral) water only; after effervescence stops, wait 5mins and stir soln for 10secs. Take in the AM at least 30 minutes before the first food, drink, or medication of the day. Do not lie down for at least 30 minutes and until after the first food of the day. 70mg once weekly.
CHILDREN:
Not recommended.
CONTRAINDICATION(S):
Esophagus abnormalities which delay esophageal emptying (eg, stricture, achalasia). Inability to stand or sit upright for at least 30 minutes. Increased risk of aspiration. Hypocalcemia.
WARNINGS/PRECAUTIONS:
Active upper GI disease; discontinue and reeva luate if signs/symptoms of esophageal reaction occur. Severe renal impairment (CrCl <35mL/min): not recommended. Correct preexisting hypocalcemia or other mineral metabolism disorders (eg, Vit. D deficiency) before starting. Monitor for hypocalcemia during therapy. Ensure adequate Vit. D and calcium intake. Sodium restriction (including heart failure, hypertension, or other cardiovascular diseases). Consider discontinuing therapy during invasive dental procedures (eg, tooth extraction, implants, boney surgery). History of bisphosphonate exposure: eva luate for atypical fractures if thigh/groin pain develops; consider withholding therapy until risk/benefit assessment. Reeva luate periodically. Pregnancy (Cat.C). Nursing mothers.
INTERACTION(S):
Calcium supplements, antacids, other multivalent cations reduce absorption (separate dosing by at least 30min). Increased upper GI events with aspirin-containing products and alendronate >10mg/day; caution with NSAIDs.
ADVERSE REACTION(S):
Abdominal pain, acid regurgitation, constipation, diarrhea, dyspepsia, musculoskeletal pain (may be severe), nausea; esophagitis, esophageal ulcers or erosions; jaw osteonecrosis, atypical femur fractures; rarely: gastric or duodenal ulcer.
HOW SUPPLIED:
Tabs—4, 12
LAST UPDATED:
10/29/2012
BINOSTO™ 是全球首个也是唯一一个可制成缓冲液来治疗骨质疏松症的泡腾片
瑞士 FREIENBACH 2012年10月23日电 /美通社/ -- EffRx Pharmaceuticals SA 欣然宣布，可作为缓冲口服液的 BINOSTO™ (阿仑膦酸钠) 泡腾片（70 mg）现在美国作为处方药出售。美国食品药品监督管理局 (U.S. Food and Drug Administration) 今年早些时候批准 BINOSTO 用于治疗绝经后女性骨质疏松症，以及提高男性骨质疏松症患者的骨量。
BINOSTO 带来了可轻松吞咽的缓冲溶液阿仑膦酸钠，它符合骨质疏松治疗的“黄金标准”并能降低骨折风险。特别对于那些不愿吞咽药片或吞咽片剂困难的患者而言，BINOSTO 是骨质疏松治疗领域的一个真正的突破。
EffRx 董事长兼首席执行官 Christer Rosén 表示：“我们很高兴能够让分销合作伙伴 Mission Pharmacal 在美国推出我们的首款产品 BINOSTO。我们正在步入新的业务阶段，而从 Mission 那得知美国医疗界非常看好 BINOSTO 时，我们备受鼓舞。有了这种令人振奋的新治疗选择，医师可高枕无忧，因为清楚他们为骨质疏松症患者采用的是已证实有效、可轻松服用的药物，并且能够降低髋关节和脊柱骨折的风险。”
对所有骨质疏松症患者而言，避免遭受危及生命的骨折的最佳预防方法就是遵照医嘱服用药物。但是研究表明，许多患者因吞咽片剂有困难便不再依从治疗，并停止服药。BINOSTO 一周仅需给药一次，再饮少量水便可，无药片粘在食道上的风险，有望长期提高患者的依从性和耐药性，从而降低致残骨折的风险。
EffRx Pharmaceuticals SA 还宣布，该公司将重获北美以外地区 BINOSTO/Steovess® (EX101) 的权利。此产品的开发和商业运作权利最初授给Nycomed （2011年被武田制药 (Takeda) 收购）。EffRx 将通过欧洲、俄罗斯、中东、非洲、拉美和亚太地区的合作伙伴进行 BINOSTO/Steovess® 的商业化运作。如需了解业务发展问题，请联系：Lorenzo Bosisio，电邮：lbosisio@effrx.com 。
BINOSTO/STEOVESS® 简介
BINOSTO 是一种含有70mg阿仑膦酸钠的草莓味泡腾片，可快速溶解于半杯（4盎司或125ml）室温水中并形成缓冲溶液，每周仅需给药一次。BINOSTO 现在美国出售，包装为一盒4片。
BINOSTO（原名为 EX101）由 EffRx 根据与默克公司 (Merck & Co, Inc.) 达成的一项协议开发，该协议授权 EffRx 在全球范围内享有所有 FOSAMAX®（阿仑膦酸钠） 泡腾片及相关专利的权利。这些专利已授予给 EffRx，直到2023年2月 BINOSTO 都归其独家所有。其他相关专利已申请，仍在审查待批。
BINOSTO 在欧盟以“STEOVESS®”而众所周知，并且2011年12月经成员国非集中审批程序 (DCP) 批准后颇受认可。STEOVESS® 在欧盟被用于治疗绝经后骨质疏松症。
BINOSTO® (alendronate sodium) Dosing
Dosing Instructions
To assure adequate drug absorption and to decrease the risk of esophageal adverse reactions, dosing instructions should be followed:
BINOSTO should only be taken upon arising for the day and must be taken at least 30 minutes before the first food, beverage, or medication of the day
Click on the arrow to see how to prepare BINOSTO.
Patients should not lie down for at least 30 minutes after taking BINOSTO and until after their first food of the day
BINOSTO should not be taken at bedtime or before arising for the day
Waiting less than 30 minutes, or taking BINOSTO with food, beverages (other than plain water) or other medications will lessen the effect of BINOSTO by decreasing its absorption into the body
Failure to follow these instructions may increase the risk of esophageal adverse reactions
Recommendations for Calcium and Vitamin D Supplementation
Patients should receive supplemental calcium and vitamin D, if dietary intake is inadequate. Patients at increased risk for vitamin D insufficiency (e.g., over the age of 70 years, nursing home-bound, or chronically ill) may need vitamin D supplementation. Patients with gastrointestinal malabsorption syndromes may require higher doses of vitamin D supplementation and measurement of 25-hydroxyvitamin D should be considered.
