Adult Dosing

Treatment/prevention of osteoporosis in postmenopausal women

• 150 mg PO once a month on the same date of each month

Pediatric Dosing

• Safety and effectiveness in pediatric patients <18 years of age have not been established

[Outline]

• Adult Dosing
• Pediatric Dosing

• Treatment/prevention of osteoporosis in postmenopausal women

Note:

• Patient on bisphosphonate therapy should periodically re-evaluate the need for continued therapy
• Consider discontinuation after 3-5 yrs of use in patients at low-risk for fracture; periodically assess risk for fracture in patients who discontinue therapy

• Hypersensitivity to any of the ingredients of the product
• Uncorrected hypocalcemia
• Inability to stand or sit upright for at least 60 minutes
• Esophageal abnormalities that delay esophageal emptying

• N/A

Renal Dose Adjustment (Based on CrCl)

• >30 mL/min: No adjustment indicated
• <30 mL/min: Use not recommended

Hepatic Dose Adjustment

• Hepatic impairment: Dose adjustments not defined

• May cause upper gastrointestinal disorders such as dysphagia, esophagitis, and esophageal or gastric ulcer
• Prior to initiating therapy, effectively treat hypocalcemia, hypovitaminosis D, and other disturbances of bone and mineral metabolism. Treat with supplemental calcium and vitamin D
• Upper GI effects such as dysphagia, esophagitis, and esophageal or gastric ulcers have been reported with therapy. Refer to dosing instructions to minimize the risk of these effects
• Therapy is not recommended for use in patients with severe renal impairment (creatinine clearance <30 mL/min)
• Therapy may cause osteonecrosis of the jaw
• Ibandronate therapy may lead to bone, joint, or muscle pain. Suspend therapy in such conditions
• Ibandronate should be taken at least 60 minutes before the first food or drink (other than water) of the day and before any oral medications containing multivalent cations (including antacids, supplements or vitamins). Tablets should be swallowed whole with a full glass of plain water (6 to 8 oz) while the patient is standing or sitting in an upright position. Patients should not lie down for 60 minutes after taking tablets. Patients receiving oral ibandronate should receive supplemental calcium and vitamin D if dietary intake is inadequate

Cautions: Use cautiously in

• Renal impairment
• Upper GI disease
• Invasive dental procedure

Pregnancy Category:C

Breastfeeding: Absorption of ibandronate by a breastfed infant is unlikely because it is poorly absorbed on oral administration. An alternate drug may be preferred, especially while nursing a newborn or preterm infant. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 5 January 2011). Manufacturer advises caution.

• CV: Hypertension, insomnia, depression
• EENT: Uveitis, scleritis, jaw osteonecrosis
• CNS: Headache, dizziness, fatigue
• GI: Dysphagia, esophagitis, esophageal ulcer, esophageal erosion, esophageal perforation, esophageal stricture, abdominal pain, dyspepsia, nausea, constipation, diarrhea, gastritis
• RESP: URTI
• METABOLIC: Hypocalcemia
• MUSC: Severe musculoskeletal pain, back pain, myalgia
• MISC: Anaphylaxis, atypical femur fracture, arthralgia, influenza, influenza like symptoms, rash, extremity pain

• Biphosphonate; inhibits resorption of bone by inhibiting ostoclast activity
• Metabolism: not metabolized; CYP450: none
• Renally excreted (50-60 % unchanged); minimal in feces
• Half life: 37-157 hrs

US Trade Name(s)

• Boniva

US Availability

ibandronate (generic)

• TABS: 150 mg

Boniva

• TABS: 150 mg

Canadian Trade Name(s)

• N/A

Canadian Availability

• N/A

UK Trade Name(s)

• Bondronat
• Bonviva

UK Availability

Bondronat

• TABS: 50 mg

Bonviva

• TABS: 150 mg

Australian Trade Name(s)

• Bondronat

Australian Availability

Bondronat

• TABS: 50 mg

[Outline]

Endocrine/Metabolic

Bisphosphonates

Pricing data from www.DrugStore.com in U.S.A.

• Boniva 150 MG TABS [Disp Pack] (GENENTECH)
  1 mg = $134.99
  3 mg = $387.98

Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.

Drug Name: Boniva 150 MG Oral Tablet

Ingredient(s): Ibandronate

Imprint: BNVA;150

Color(s): White

Shape: Oval

Size (mm): 14.00

Score: 1

Inactive Ingredient(s): lactose monohydrate / povidone / cellulose, microcrystalline / crospovidone / stearic acid / silicon dioxide / water / hypromellose / titanium dioxide / talc / polyethylene glycol 6000

Drug Label Author:
Hoffmann-La Roche Inc

DEA Schedule:
Non-Scheduled