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Ibandronate
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DRUG INFO
Ibandronate
Drug Name:
Ibandronate
Indication: For the treatment and prevention of osteoporosis in postmenopausal women. Also used to treat tumor induced hypercalemia.
Pharmacology: Ibandronate is a nitrogen-containing bisphosphonate that inhibits osteoclast-mediated bone resorption. Ibandronate is indicated for the treatment and prevention of osteoporosis in postmenopausal women.
Mechanism Of Action: The action of ibandronate on bone tissue is based partly on its affinity for hydroxyapatite, which is part of the mineral matrix of bone. Ibandronate also targets farnesyl pyrophosphate (FPP) synthase. Nitrogen-containing bisphosphonates (such as pamidronate, alendronate, risedronate, ibandronate and zoledronate) appear to act as analogues of isoprenoid diphosphate lipids, thereby inhibiting FPP synthase, an enzyme in the mevalonate pathway. Inhibition of this enzyme in osteoclasts prevents the biosynthesis of isoprenoid lipids (FPP and GGPP) that are essential for the post-translational farnesylation and geranylgeranylation of small GTPase signalling proteins. This activity inhibits osteoclast activity and reduces bone resorption and turnover. In postmenopausal women, it reduces the elevated rate of bone turnover, leading to, on average, a net gain in bone mass.
Drug Category: Antiresorptives; Bisphosphonates; Antihypocalcemic Agents; ATC:M05BA06
Brand Names/Synonyms: Boniva; Ibandronate; Ibandronate Sodium; Ibandronate Sodium Monohydrate; Ibandronic Acid; Ibandronic Acid [Ban:Inn]; None
Dosage Forms: LIQUID
Absorption: Poorly absorbed (oral absorption is about 1% of what IV absorption is)
Interactions: Interactions for Ibandronate:
Calcium Supplements/Antacids
Products containing calcium and other multivalent cations (such as aluminum, magnesium, iron) are likely to interfere with absorption of Ibandronate. Ibandronate should be taken at least 60 minutes before any oral medications containing multivalent cations (including antacids, supplements or vitamins).
H2 Blockers and Proton Pump Inhibitors (PPIs)
Of over 3500 patients enrolled in the Ibandronate osteoporosis Treatment and Prevention Studies, 15% used anti-peptic agents (primarily H2 blockers and PPIs). Among these patients, the incidence of upper gastrointestinal adverse experiences in the patients treated with Ibandronate was similar to that in placebo-treated patients. Similarly, of over 1600 patients enrolled in a study comparing once-monthly with daily dosing regimens of ibandronate, 14% of patients used anti-peptic agents. Among these patients, the incidence of upper gastrointestinal adverse experiences in the patients treated with Ibandronate 150 mg once monthly was similar to that in patients treated with Ibandronate 2.5 mg once daily.
Aspirin/Nonsteroidal Antiinflammatory Drugs (NSAIDs)
In the large, placebo-controlled osteoporosis Treatment Study, aspirin and nonsteroidal anti-inflammatory drugs were taken by 62% of the 2946 patients. Among aspirin or NSAID users, the incidence of upper gastrointestinal adverse events in patients treated with ibandronate 2.5 mg daily (28.9%) was similar to that in placebo-treated patients (30.7%). Similarly, in the 1-year monthly comparison study, aspirin and nonsteroidal anti-inflammatory drugs were taken by 39% of the 1602 patients. The incidence of upper gastrointestinal events in patients concomitantly taking aspirin or NSAIDs was similar in patients taking ibandronate 2.5 mg daily (21.7%) and 150 mg once monthly (22.0%). However, since aspirin, NSAIDs, and bisphosphonates are all associated with gastrointestinal irritation, caution should be exercised in the concomitant use of aspirin or NSAIDs with Ibandronate.
Drug/Laboratory Test Interactions
Bisphosphonates are known to interfere with the use of bone-imaging agents. Specific studies with ibandronate have not been performed.
Chemical IUPAC Name: morpholin-4-yl-[4-(trifluoromethyl)phenyl]-methanone
Chemical Formula: C9H23NO7P2
Half Life: 10-60 hours
Drug Type: Approved Drug
# Accession No: APRD00231
CAS Registry Number: 138926-19-9
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Ibandronate News
(When available)
Procter & Gamble alleges Boniva ads are misleading Jan 4, 2006
Reuters.uk, ROG.VX: Quote, Profile, Research) and GlaxoSmithKline (GSK.L: Quote, Profile, Research) of exaggerating the benefits of their Boniva osteoporosis treatment. ...
FDA Approves First IV Treatment for Postmenopausal Osteoporosis ... Jan 6, 2006
PR Newswire (press release), 6 /PRNewswire/ -- The US Food and Drug Administration (FDA) has approved Boniva(R) (ibandronate sodium) Injection, the first intravenous (IV) medication for ...
FDA Approves First IV Treatment for Postmenopausal Osteoporosis ... Jan 6, 2006
Market Wire (press release) NUTLEY, NJ and RESEARCH TRIANGLE PARK, NC -- (MARKET WIRE) -- 01/06/2006 -- The US Food and Drug Administration (FDA) has approved Boniva® (ibandronate sodium ...
Actonel makers sue GSK and Roche over Boniva ads Jan 5, 2006
Pharma Times (subscription), The two firms are upset about a promotional campaign run by GSK and Roche for their Boniva (ibandronate sodium) product, a bisphosphonate drug used to increase ...
Procter & Gamble Alleges Boniva Ads Are Misleading Jan 5, 2006
Indlaw.com, ...said they filed a lawsuit accusing drugmakers Roche Holding AG and GlaxoSmithKline Plc of exaggerating the benefits of their Boniva osteoporosis treatment. ...
P&G sues drug maker over Boniva ads Jan 4, 2006
Cincinnati Business Courier, Procter & Gamble Pharmaceuticals and Sanofi-Aventis, co-marketers of the osteoporosis drug Actonel, alleges that advertising for Boniva falsely claims ...
Roche, Glaxo hit with lawsuit over Boniva Jan 4, 2006
United Press International York, alleges Roche and GlaxoSmithKline falsely claimed in promotions aimed at both consumers and physicians that their osteoporosis treatment Boniva has been ...
FDA Approves Use of Boniva Injection Jan 6, 2006
Schaeffers Research, ...companies GlaxoSmithKline PLC and Roche Holding AG said on Friday that the Food and Drug Administration has approved the use of Boniva Injection, an ...
FDA OKs First IV Osteoporosis Drug Jan 13, 2006
WebMD The drug is a new form of Boniva, an osteoporosis medicine that is already approved in pill form. Boniva pills are available to ...
FDA approves first quarterly IV injection for postmenopausal ... Jan 9, 2006
Biotech Intelligence (press release), Drug Administration (FDA) has approved a new, quarterly intravenous (IV) injection of the potent and highly effective osteoporosis drug Boniva (ibandronic acid ...
FDA Approves First IV Treatment for Postmenopausal Osteoporosis ... Jan 9, 2006
DG News NUTLEY, NJ, and RESEARCH TRIANGLE PARK, NC -- January 9, 2006 -- The US Food and Drug Administration (FDA) has approved Boniva(R) (ibandronate sodium) Injection ...
Pharmaceutical companies sued over adverts Jan 11, 2006
Legalbrief (subscription), Britain's GlaxoSmithKline and Swiss drug-maker Roche over allegations that their marketing embellishes the benefits of newly-launched osteoporosis pill Boniva. ...
Synergetics Inks Agreements with Johnson & Johnson Unit and ... Jan 10, 2006
Financial News USA (press release), ...companies GlaxoSmithKline PLC (NYSE:GSK) and Roche Holding AG said on Friday that the Food and Drug Administration has approved the use of Boniva Injection, an ...
Companies say FDA approves IV version of postmenopausal ... Jan 9, 2006
Redlands Daily Facts, Boniva Injection, formally known as ibandronate sodium, becomes the first intravenous drug for the treatment of postmenopausal osteoporosis, Roche and ...
Roche and GlaxoSmithKline develop new injection for bone ... Jan 9, 2006
Kuwait News Agency, CEO Division Roche Pharma William M. Burns noted that the US approval of quarterly Boniva Injection represents an important new opportunity to bring the bone ...
PROCTER & GAMBLE PHARMACEUTICALS AND SANOFI-AVENTIS US LLC FILE ... Jan 4, 2006
PR Newswire (press release), The lawsuit alleges that Roche and GSK engaged in false and misleading advertising regarding their prescription osteoporosis medication, Boniva(R) (ibandronate ...
Rivals sue Glaxo and Roche Jan 5, 2006
Telegraph.co.uk, Roche face a lawsuit from rival pharmaceutical groups over allegations that their marketing embellishes the benefits of newly-launched osteoporosis pill Boniva ...
P&G sues rivals over ads touting osteoporosis drug Jan 5, 2006
Cincinnati Post, District of New York, seeks an injunction that would force Roche Pharmaceuticals and GlaxoSmithKline to halt the advertising campaign for its product, Boniva. ...
Osteoporosis drug backed Jan 8, 2006
Trade Arabia, Swiss drug maker Roche Holding and GlaxoSmithKline won US approval for long-lasting intravenous use of their osteoporosis drug Boniva, the companies said. ...
Procter & Gamble Pharmaceuticals and Sanofi-Aventis Us LLC File ... Jan 4, 2006
Yahoo! News (press release) ...alleges that Roche and GSK engaged in false and misleading advertising regarding their prescription osteoporosis medication, Boniva® (ibandronate sodium ...
Reports call drug lawsuit claims unfounded Jan 5, 2006
Cincinnati Business Courier, ...published reports. The suit against Roche Pharmaceuticals and GlaxoSmithKline centers on the osteoporosis drug Boniva. Filed Wednesday ...
Roche faces lawsuit over osteoporosis drug adverts Jan 5, 2006
Shanghai Daily, ...which is being sued in an advertising dispute in the United States, said yesterday it is confident it is accurately representing its osteoporosis drug Boniva. ...
Alcoa, Mills, Equity Inns Jan 7, 2006
Investor's Business Daily (subscription) Roche (RHHDY) and GlaxoSmithKline Plc (GSK) said the Food and Drug Administration has approved Boniva Injection, the first intravenous medication for the ...
New year brings lawsuits for pharma Jan 6, 2006
United Press International ...and GlaxoSmithKline in the US Federal District Court in the Southern District of New York alleging false advertising of their osteoporosis treatment Boniva. ...
Suit over osteo ads Jan 4, 2006
CNN/Money ...said they filed a lawsuit accusing drugmakers Roche and GlaxoSmithKline of exaggerating the benefits of their recently launched Boniva osteoporosis treatment. ...
UPDATE 1-Roche, Glaxo: US OKs new use for osteoporosis drug Jan 6, 2006
Reuters L: Quote, Profile, Research)(GSK.N: Quote, Profile, Research) won US approval for long-lasting intravenous use of their osteoporosis drug Boniva, the companies ...
Swiss company defends drug ad challenged by P&G Jan 5, 2006
The State, Holding AG, which is being sued in an advertising dispute by Procter & Gamble Co., said Thursday it is accurately representing its osteoporosis drug, Boniva. ...
Garden State Business Briefs Jan 5, 2006
Newark Star Ledger, ...yesterday filed a lawsuit in US District Court in New York against two rivals: Roche Pharmaceuticals and GlaxoSmithKline, which promote Boniva, a newer entrant ...
Swiss company defends drug ad challenged by P&G Jan 5, 2006
WWAY NewsChannel 3, The Swiss pharmaceutical company Roche (rohsh) Holding says the ads for Boniva (boh-NEE'-vuh) accurately and appropriately reflect research findings. ...
FDA Said to Approve IV Osteoperosis Drug Jan 6, 2006
Brocktown News, ...of the medication. In April, the FDA approved a once-a-month pill version of Boniva to battle the bone-weakening disease. The new ...
European Stocks May Rise, Led by BP, BHP, Commodity Producers Jan 8, 2006
Bloomberg ...and Roche Holding AG, the Swiss drugmaker, may advance after the US Food and Drug Administration approved their postmenopausal osteoporosis injection Boniva. ...
Swiss shares move higher in morning trade tracking Wall St; Adecco ... Jan 9, 2006
Forbes In the healthcare sector, Roche fell 1.20 sfr to 196.80 on profit-taking, with news that its and GlaxoSmithKline's osteoporosis treatment Boniva has received ...
AFX European summary - late Jan 4, 2006
Forbes ...against Roche Pharmaceuticals and GlaxoSmithKline PLC alleging false and misleading advertising regarding the prescription osteoporosis medication, Boniva. ...
European stocks - Factors to watch on Jan 9 Jan 8, 2006
Reuters.uk, ROCHE (ROG.VX: Quote, Profile, Research) The drug makers won US approval for long-lasting intravenous use of their osteoporosis drug Boniva, the companies said ...
Newspaper round-up Jan 5, 2006
Reuters.uk, ...a lawsuit from rival pharmaceutical companies after allegations were made that their marketing embellishes the benefits of their Boniva osteoporosis treatment. ...
Preventing bone loss is best protection Dec 13, 2005
Newsday, I was told that I have osteoporosis and I'm taking a prescription drug called Boniva. Is this the best way to protect bones? No. ...
Euroshares outlook - higher after Wall St gains, news still thin ... Jan 4, 2006
Forbes ...the US division of Sanofi-Aventis yesterday filed a lawsuit alleging false and misleading advertising regarding the prescription osteoporosis medication, Boniva ...
US Lawsuit Impact On Roche, GSK Seen Limited Jan 5, 2006
New Ratings 0715 GMT [Dow Jones] Procter & Gamble (PG) and Sanofi-Aventis (SNY) sue Roche (RHHBY) and GlaxoSmithKline (GSK) over terminology used in marketing Boniva. ...
(PRN) - NHP to Participate in the Deutsche Bank 2006 Real Estate ... Jan 6, 2006
Bolsamania.com, Auto Show ... [+. PRN) - FDA Approves First IV Treatment for Postmenopausal Osteoporosis - Boniva(R) Injection ... [+. PRN) - Lipper ...
On the Move: GSK, VW, France Telecom Jan 5, 2006
BusinessWeek ...and Procter & Gamble (PG ) have filed a lawsuit against Roche & the UK's GSK (GSK ) for making false and misleading claims about their osteoporosis drug, Boniva ...
... Go to the Article Jan 4, 2006
CancerWise ...loss. Bisphosphonates, a family of drugs used to prevent and treat osteoporosis, include Fosamax®, Actonel® and Boniva®. The ...
I'm shrinking Dec 25, 2005
Belleville News-Democrat, ...engage in weight-bearing exercise (walking, weightlifting, etc.), to consume plenty of calcium, and, when appropriate, to take a drug such as Boniva or Fosamax ...
New Pharmaceutical Treatment Options in the Elderly Dec 14, 2005
Medscape (subscription) Both drugs require only daily dosing: darifenacin at 7.5-15 mg and solifenacin succinate 5-10 mg. Ibandronate sodium (Boniva). Ibandronate ...
FDA approves first quarterly IV injection for postmenopausal ... Jan 9, 2006
Biotech Intelligence (press release), Drug Administration (FDA) has approved a new, quarterly intravenous (IV) injection of the potent and highly effective osteoporosis drug Boniva (ibandronic acid ...
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