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Trade Names:
Boniva
- Tablets 2.5 mg
- Tablets 150 mg
- Injection 1 mg/mL

Mechanism of Action

Pharmacology

Inhibits osteoclast activity and reduces bone resorption and turnover.

Pharmacokinetics

Absorption

Absorption from an oral dose is in the upper GI tract. Plasma level increase is dose related up to 50 mg orally and nonlinearly above that dose. After an oral dose, the time to C _max is 0.5 to 2 h. Compared with IV administration, oral bioavailability is 0.6%. When coadministered with food, bioavailability may be decreased 90%.

Distribution

Rapidly binds to bone or is excreted in the urine. Vd is at least 90 L. The amount removed from circulation via bone is estimated to be 40% to 50%.

Metabolism

No evidence of metabolism.

Elimination

Cl is 84 to 160 mL/min. The portion not removed from the circulation via bone absorption (approximately 50% to 60% of absorbed dose) is eliminated unchanged by the kidney. Unabsorbed drug is eliminated unchanged in the feces.

Special Populations

Increased exposure (AUC _∞ ) may occur.

Indications and Usage

Treatment (injection, tablets) and prevention (tablets) of osteoporosis in postmenopausal women.

Unlabeled Uses

Treatment of metastatic bone disease in breast cancer.

Contraindications

Inability to stand or sit upright for at least 60 min (tablets); uncorrected hypocalcemia (injection, tablets); hypersensitivity to any component of the product (injection, tablets).

Dosage and Administration

PO 2.5 mg once daily or one 150 mg tablet once monthly on the same date of each month. Take at least 60 min before the first food or drink (other than water) of the day or before taking any oral medication or supplement, including antacids, calcium, or vitamins.

IV 3 mg every 3 mo administered over 15 to 30 sec.

General Advice

• Tablets
• Two tablet strengths are available (2.5 mg tablet for once-daily administration and 150 mg tablet for once-monthly administration). Carefully check tablet to ensure proper dose is being administered.
• Do not administer tablets with any liquid other than plain water. Administration of ibandronate tablets with food, medication, juices, mineral water, coffee, or any other beverage will reduce ibandronate absorption and efficacy.

• Injection
• Injection must be administered IV by a health care provider.
• Administer injection using the enclosed needle.
• Prefilled syringes are for single use only; discard unused portion.
• Do not mix injection with calcium-containing solutions or other IV administered drugs.
• If a dose is missed, administer injection as soon as it can be rescheduled. Schedule subsequent injections every 3 mo from the date of last injection and not more frequently than once every 3 mo.
• Patient must receive supplemental calcium and vitamin D.

Storage/Stability

Store tablets and injection at controlled room temperature (59° to 86°F).

Drug Interactions

May interfere with oral absorption of ibandronate. Take ibandronate tablets at least 60 min before any oral medication containing multivalent cations.

Possible additive GI adverse reactions.

Laboratory Test Interactions

May interfere with bone-imaging agents.

Adverse Reactions

The overall safety and tolerability profiles of the oral and IV dosage forms are similar.

Cardiovascular

Hypertension (7%).

CNS

Headache (7%); asthenia, dizziness (4%); fatigue, insomnia, vertigo (3%); depression, nerve root lesion (2%).

Dermatologic

Rash (3%).

EENT

Nasopharyngitis (6%); pharyngitis (3%); ocular inflammation.

GI

Dyspepsia (12%); abdominal pain (8%); diarrhea (7%); nausea (5%); constipation, tooth disorder (4%); gastroenteritis, vomiting (3%); gastritis (2%); dysphagia, esophageal and gastric ulcer, esophagitis (postmarketing).

Genitourinary

UTI (6%); cystitis (3%).

Local

Redness, swelling (less than 2%).

Metabolic-Nutritional

Hypercholesterolemia (5%).

Musculoskeletal

Back pain (14%); arthralgia (10%); myalgia (6%); joint disorder, pain in extremity (4%); arthritis, localized osteoarthritis (3%); muscle cramp (2%); incapacitating bone, joint, or muscle pain (postmarketing).

Respiratory

Upper respiratory infection (34%); bronchitis (10%); pneumonia (6%).

Miscellaneous

Acute phase reaction (oral 4%; injection 10%); influenza, pain in extremities (8%); flu-like symptoms (5%); infection (4%); allergic reactions (3%).

Precautions

Pregnancy

Category C .

Lactation

Undetermined.

Children

Safety and efficacy not established.

Hypocalcemia, hypovitaminosis D, bone mineral disturbances

Treat effectively before starting therapy with ibandronate. Ibandronate injection may cause a transient decrease in serum calcium levels.

Osteonecrosis

Osteonecrosis, primarily in the jaw, has been reported in patients receiving bisphosphonates.

Renal function impairment

Not recommended for use in patients with severe renal function impairment (CrCl less than 30 mL/min).

Overdosage

Symptoms

Hypomagnesemia, hypophosphatemia, possible hypocalcemia, upper GI adverse reactions, including dyspepsia, esophagitis, gastritis, ulcer, or upset stomach.

Patient Information

• Advise patient to read patient information leaflet before starting therapy and with each refill.
• Instruct patient to take each tablet with plain water immediately upon arising for the day, at least 60 min before the first food, beverage, medication, or supplement (including calcium and vitamins) of the day, and to remain in a standing or sitting position for at least 60 min.
• Instruct patient to swallow tablet whole with a full glass (6 to 8 oz) of plain water. Caution patient not to chew or suck on tablet.
• Caution patient not to take the tablets with any liquid other than plain water. Advise patient that taking the tablets with food, other medications, juices, mineral water, coffee, or any other beverage will reduce the absorption of ibandronate and reduce its effectiveness.
• Advise patient taking once-monthly ibandronate 150 mg tablet to take the tablet on the same date each month.
• Advise patient taking ibandronate once a month that if the once-monthly dose is missed and the next scheduled dose is more than 7 days away, to take their ibandronate tablet in the morning after the date that it is remembered and then return to taking 1 ibandronate tablet in the morning of their chosen day, according to their original schedule.
• Advise patient taking ibandronate once a month that if the once-monthly dose is missed, and the next scheduled dose is only 1 to 7 days away, to skip the missed dose and take the next ibandronate tablet in the morning of the patient's chosen day, according to patient's original schedule.
• Caution patient using 150 mg tablet to never take 2 tablets within the same week.
• Instruct patient to discontinue therapy and seek medical care if any of the following occur: difficulty swallowing, new or worsening heartburn, pain behind breastbone.
• Advise patient regarding interventions that help prevent osteoporosis: calcium 1,500 mg/day (diet and supplements); vitamin D supplementation; weight-bearing exercise; reduction of cigarette smoking and alcohol consumption.