Boniva (Ibandronate Sodium) - Drug Interactions, Contraindications, Overdosage

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. BONIVA should be taken 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 (see PATIENT COUNSELING INFORMATION [17.1]).

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 (see CLINICAL PHARMACOLOGY [12.3]).

Drug/Laboratory Test Interactions

Bisphosphonates are known to interfere with the use of bone-imaging agents. Specific studies with ibandronate have not been performed.

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.

CONTRAINDICATIONS

• Known hypersensitivity to BONIVA or to any of its excipients (see ADVERSE REACTIONS [6.2]).
• Hypocalcemia (see WARNINGS AND PRECAUTIONS [5.2])
• Inability to stand or sit upright for at least 60 minutes (see DOSAGE AND ADMINISTRATION [2.2], WARNINGS AND PRECAUTIONS [5.1])