BONIVA (ibandronate sodium)

BONIVA (ibandronate sodium)

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BONIVA (ibandronate sodium)

BONIVA (ibandronate sodium) is a nitrogen-containing bisphosphonate that inhibits osteoclast-mediated bone resorption. The chemical name for ibandronate sodium is 3-(N-methyl-N-pentyl) amino-1-hydroxypropane-1,1-diphosphonic acid, monosodium salt, monohydrate with the molecular formula C9H22NO7P2Na⋅H2O and a molecular weight of 359.24. Ibandronate sodium is a white- to off-white powder. It is freely soluble in water and practically insoluble in organic solvents

Indications and usage

BONIVA is a bisphosphonate indicated for the treatment and prevention of postmenopausal osteoporosis.

Limitations of Use

The optimal duration of use has not been determined. For patients at low-risk for fracture, consider drug discontinuation after 3 to 5 years of use.

Mechanism of Action

The action of ibandronate on bone tissue is based on its affinity for hydroxyapatite, which is part of the mineral matrix of bone. Ibandronate 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.

Dosage and administration

The dose of BONIVA is one 150 mg tablet taken once monthly on the same date each month.

Important Administration Instructions

  • Take BONIVA at least 60 minutes before the first food or drink (other than water) of the day or before taking any oral medication or supplementation, including calcium, antacids, or vitamins to maximize absorption and clinical benefit. Avoid the use of water with supplements including mineral water because they may have a higher concentration of calcium.
  • Swallow BONIVA tablets whole with a full glass of plain water (6 to 8 oz) while standing or sitting in an upright position to reduce the potential for esophageal irritation. Avoid lying down for 60 minutes after taking BONIVA. Do not chew or suck the tablet because of a potential for oropharyngeal ulceration.
  • Do not eat, drink anything except plain water, or take other medications for at least 60 minutes after taking BONIVA.

Recommendations for Calcium and Vitamin D Supplementation

Instruct patients to take supplemental calcium and vitamin D if their dietary intake is inadequate. Avoid the use of calcium supplements within 60 minutes of BONIVA administration because co-administration of BONIVA and calcium may interfere with the absorption of ibandronate sodium

Administration Instructions for Missed Once-Monthly

Doses If the once-monthly dose is missed, instruct patients to do the following:

  • If the next scheduled BONIVA day is more than 7 days away, take one BONIVA 150 mg tablet in the morning following the date that it is remembered.
  • If the next scheduled BONIVA day is only 1 to 7 days away, wait until the subsequent month’s scheduled BONIVA day to take their tablet.

Contraindications

  • Abnormalities of the esophagus which delay esophageal emptying such as stricture or achalasia
  • Inability to stand or sit upright for at least 60 minutes
  • Hypocalcemia
  • Hypersensitivity to BONIVA

Warnings and populations

  • Upper gastrointestinal Adverse Reactions can occur. Instruct patients to follow dosing instructions and discontinue use if new or worsening symptoms occur.
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  • Hypocalcemia may worsen during treatment. Correct hypocalcemia before use.
  • Severe Bone, Joint, and Muscle Pain may occur. Consider discontinuing use if symptoms develop.
  • Osteonecrosis of the Jaw has been reported.
  • Atypical Femur Fractures have been reported. Patients with new thigh or groin pain should be evaluated to rule out a femoral fracture

Adverse drug reactions

The most common adverse reactions (greater than 5%) are back pain, dyspepsia, pain in extremity, diarrhea, headache, and myalgia.

Drug interactions

Calcium Supplements/Antacids: Products containing calcium and other multivalent cations (such as aluminum, magnesium, iron) are likely to interfere with absorption of BONIVA. Therefore, instruct patients to take BONIVA at least 60 minutes before any oral medications, including medications containing multivalent cations (such as antacids, supplements or vitamins). Also, patients should wait at least 60 minutes after dosing before taking any other oral medications.

Aspirin/Nonsteroidal Anti-Inflammatory Drugs (NSAIDs): Because aspirin, NSAIDs, and bisphosphonates are all associated with gastrointestinal irritation, caution should be exercised in the concomitant use of aspirin or NSAIDs with BONIVA.

H2 Blockers: In healthy volunteers, co-administration with ranitidine resulted in a 20% increased bioavailability of ibandronate, which was not considered to be clinically relevant.

Drug/Laboratory Test Interactions: Bisphosphonates are known to interfere with the use of bone-imaging agents. Specific studies with ibandronate have not been performed.

Use in specific populations

Pregnancy: BONIVA is not indicated for use in women of reproductive potential. There are no data with BONIVA use in pregnant women to inform any drug-associated risks.

Lactation: BONIVA is not indicated for use in women of reproductive potential. There is no information on the presence of ibandronate in human milk, the effects of ibandronate on the breastfed infant, or the effects of ibandronate on milk production. Ibandronate is present in rat milk.The clinical relevance of these data is unclear.

Pediatric Use: Safety and effectiveness in pediatric patients have not been established.

Renal Impairment: BONIVA is not recommended for use in patients with severe renal impairment (creatinine clearance less than 30 mL/min).

Overdosage

No specific information is available on the treatment of overdosage of BONIVA. However, based on knowledge of this class of compounds, oral overdosage may result in hypocalcemia, hypophosphatemia, and upper gastrointestinal adverse events, such as upset stomach, dyspepsia, esophagitis, gastritis, or ulcer. Milk or antacids should be given to bind BONIVA. Due to the risk of esophageal irritation, vomiting should not be induced, and the patient should remain fully upright. Dialysis would not be beneficial.

Storage and Handling

Store at 25°C (77°F); excursions permitted between 15° and 30°C (59° and 86°F) [see USP Controlled Room Temperature].

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