Ibandronate

Ibandronate is a prescription medicine used for the treatment and prevention of osteoporosis in postmenopausal women.

• Ibandronate is available under the following different brand names: Boniva

Adult dosage

Tablet

• 150mg

Prefilled syringe

• 1 mg/1 mL (3 mL)

Osteoporosis

Adult dosage

• 150 mg orally every month OR
• 3 mg IV every 3 months administered over 15-30 seconds (Treatment only)

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

Common side effects of Ibandronate include:

• heartburn,
• stomach pain,
• diarrhea,
• back pain,
• bone pain,
• muscle or joint pain,
• pain in the arms or legs,
• headache,
• fever,
• chills,
• tiredness, and
• flu-like symptoms.

Serious side effects of Ibandronate include:

• chest pain,
• new or worsening heartburn,
• difficulty or pain when swallowing,
• pain or burning under the ribs or in the back,
• severe heartburn,
• burning pain in the upper stomach,
• coughing up blood,
• new or unusual pain in thigh or hip,
• jaw pain,
• numbness,
• swelling,
• severe joint, bone or muscle pain,
• muscle spasms or contractions, and
• numbness or tingly feeling (around the mouth or in the fingers and toes).

Rare side effects of Ibandronate include:

• none 

This is not a complete list of side effects and other serious side effects or health problems that may occur as a result of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Ibandronate has severe interactions with the following drug:
  • human parathyroid hormone, recombinant
• Ibandronate has serious interactions with no other drugs.
• Ibandronate has moderate interactions with at least 24 other drugs.
• Ibandronate has minor interactions with the following other drugs:
  • entecavir
  • food
  • foscarnet
  • magnesium chloride
  • magnesium citrate
  • magnesium hydroxide
  • magnesium oxide
  • magnesium sulfate
  • teriparatide

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions, concerns.

Contraindications

• Hypersensitivity; anaphylaxis reported, including fatalities
• Uncorrected hypocalcemia
• Inability to stand or sit upright for at least 60 min
• Esophagus abnormalities that delay emptying (eg, stricture, achalasia)

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Ibandronate?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Ibandronate?”

Cautions

• Potential for esophagitis, dysphagia & esophageal ulcers
• Severe esophageal risk is greater in patients who lie down after taking oral bisphosphonates and/or who fail to swallow it with the recommended full glass (6-8 oz) of water
• Do not continue to take oral bisphosphonates after developing symptoms suggestive of esophageal irritation
• Food decreases bioavailability
• Ensure adequate intake of calcium, vitamin D; correct hypocalcemia before use
• Osteonecrosis of the jaw can occur spontaneously and is generally associated with tooth extraction and/or local infection with delayed healing; known risk factors include invasive dental procedures (e.g., tooth extraction, dental implants, boney surgery), diagnosis of cancer, concomitant therapies (e.g., chemotherapy, corticosteroids, angiogenesis inhibitors), poor oral hygiene, and co-morbid disorders; risk of osteonecrosis of the jaw may increase with duration of exposure to bisphosphonates
• Risk of severe bone, joint, and/or muscle pain; consider discontinuing if symptoms develop
• Possible increased risk for atypical subtrochanteric and diaphyseal femur fractures; consider periodic reevaluation of the need for continued bisphosphonate therapy, particularly if treatment exceeds 5 years; patients with new thigh or groin pain should be evaluated to rule out a femoral fracture
• Not recommended in severe renal impairment (CrCl less than 30 mL/min)
• Avoid concomitant multivalent cation-containing drugs or food
• Esophageal cancer risk (July 21, 2011, FDA safety communication)
  • Conflicting findings exist from studies evaluating the risk of esophageal cancer with oral bisphosphonates
  • Esophagitis and other esophageal events have been reported, particularly in patients who do not follow the specific directions for use of oral bisphosphonates (eg, sit up or stand after administration, take with a full glass of water)
  • An ongoing review of data from published studies to evaluate whether the use of oral bisphosphonate drugs is associated with an increased risk of cancer of the esophagus is currently being conducted by the FDA
  • The FDA has not concluded that taking an oral bisphosphonate drug increases the risk of esophageal cancer
  • There are insufficient data to recommend endoscopic screening of asymptomatic patients
  • FDA will continue to evaluate all available data supporting the safety and effectiveness of bisphosphonate drugs and will update the public when more information becomes available
  • Instruct patients to contact their healthcare provider if they develop symptoms of esophagitis (e.g., swallowing difficulties, chest pain, new or worsening heartburn, trouble or pain when swallowing)

Pregnancy and Lactation

• Ibandronate is not indicated for use in women of reproductive potential; there are no data with ibandronate use in pregnant women to inform any drug-associated risks
• Lactation
  • Ibandronate is not indicated for use in women of reproductive potential; there is no information on the presence of ibandronate in human milk, effects of ibandronate on the breastfed infant, or effects of ibandronate on milk production; ibandronate is present in rat milk; clinical relevance of these data is unclear