Boniva 150 film coated tablet

Boniva (Genentech), manufactured drug form of Ibandronate sodium, 150mg/tablet ibandronate sodium film coated tablet, NDC 0004-0186

Available in:

NDC Product ID:

  • 0004-0186

Manufacturer:

Manufactured drug form

Manufactured form of:

Generic drug:

  • No

Label date:

  • Jan 1, 2011

Label link:

Label sections:

Section name Section URI Prominent warning Highlight text Section LOINC code
  • Recent Major Changes Section
  • No
  • 43683-2
  • 1 Indications And Usage
  • No
  • BONIVA is a bisphosphonate indicated for the treatment and prevention of postmenopausal osteoporosis. (1.1). The optimal duration of use has not been determined. Patients should have the need for continued therapy re-evaluated on a periodic basis.
  • 34067-9
  • 2 Dosage And Administration
  • No
  • One 150 mg tablet taken once monthly or one 2.5 mg tablet taken once daily (2.1) Dosing instructions (2.2) Swallow whole tablet with 6-8 oz of plain water only, at least 60 minutes before the first food, beverage, or medication of the day. Do not lie down for at least 60 minutes after taking BONIVA. Do not eat, drink (except for water), or take other medication for 60 minutes after taking BONIVA.
  • 34068-7
  • 3 Dosage Forms And Strengths
  • No
  • Tablets: 2.5 mg, 150 mg (3)
  • 43678-2
  • 4 Contraindications
  • No
  • Abnormalities of the esophagus which delay esophageal emptying such as stricture or achalasia (4, 5.1) Inability to stand or sit upright for at least 60 minutes (4, 5.1) Hypocalcemia (4) Hypersensitivity to BONIVA (4)
  • 34070-3
  • 5 Warnings And Precautions
  • No
  • Severe irritation of the upper gastrointestinal (GI) mucosa can occur. Dosing instructions should be followed and caution should be used in patients with active upper GI disease. Discontinue use if new or worsening symptoms occur. (5.1) Hypocalcemia may worsen during treatment. Correct hypocalcemia before use. (5.2) Severe bone, joint, and muscle pain may occur. Consider discontinuing use if symptoms develop. (5.3) Osteonecrosis of the jaw has been reported. (5.4) Atypical femur fractures have been reported. Patients with new thigh or groin pain should be evaluated to rule out a femoral fracture. (5.5)
  • 43685-7
  • 6 Adverse Reactions
  • No
  • The most common adverse reactions (>5%) are back pain, dyspepsia, pain in extremity, diarrhea, headache, and myalgia. (6) To report SUSPECTED ADVERSE REACTIONS, contact Genentech at 1-888-835-2555 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
  • 34084-4
  • 7 Drug Interactions
  • No
  • Calcium supplements, antacids and some oral medications may interfere with absorption of ibandronate. (7.1) Use caution when co-prescribing aspirin/nonsteroidal anti-inflammatory drugs that may worsen gastrointestinal irritation. (7.2)
  • 34073-7
  • 8 Use In Specific Populations
  • No
  • BONIVA is not recommended in patients with severe renal impairment (creatinine clearance <30 mL/min). (5.6, 8.6)
  • 43684-0
  • 10 Overdosage
  • No
  • 34088-5
View entire collection »

Discontinued:

  • No

Marketing start date:

  • Jul 15, 2002

Patents:

Patent expiry date:

  • Mar 17, 2012

FDA application number:

  • NDA021455

Color:

Shape:

Size:

  • 14 mm (0.55 in )

Scoring:

  • 1

Imprint:

  • BNVA;150

Therapeutic equivalents:

top ↑

Consumer product

Brand:

top ↑

You can help improve this topic by adding more facts here

Edit this topic
Edit and Show details

Add or delete facts, download data in JSON or RDF formats, and explore topic metadata.

Freebase Logo
What is Freebase?

Freebase is a huge collection of facts, built by people like you. Freebase connects facts in ways other sites can't, giving you new ways to explore millions of subjects.
You can help improve it!