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Pronunciation: eye-BAN-droe-nate SOE-dee-um
- Tablets 150 mg
- Injection, solution 1 mg/mL
Inhibits osteoclast activity and reduces bone resorption and turnover.
Absorption from an oral dose is in the upper GI tract. T max is 0.5 to 2 h (oral). Compared with IV administration, oral bioavailability is 0.6%. Bioavailability decreased by 90% with food.
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%. Protein binding in human serum is approximately 86% (IV) or ranges from 85.7% to 99.5% (oral).
No evidence of metabolism.
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. Terminal half-life ranges from 37 to 157 h (150 mg tablet) or 4.6 to 25.5 h (IV).
Special PopulationsRenal Function Impairment
Patients with CrCl 40 to 70 mL/min had 55% higher AUC and patients with CrCl 30 mL/min had more than a 2-fold increase in exposure.Hepatic Function Impairment
No studies have been performed; ibandronate is not metabolized in the human liver.Elderly
Progressive age-related changes in renal function may alter the elimination of ibandronate in elderly patients.Children
Pharmacokinetics have not been studied in patients younger than 18 y of age.Gender
Bioavailability and pharmacokinetics are similar in men and women.Race
Pharmacokinetic differences because of race have not been studied.
Indications and Usage
Treatment (injection, tablets) and prevention (tablets) of osteoporosis in postmenopausal women.
Bone metastases; hypercalcemia of malignancy (injection).
Inability to stand or sit upright for at least 60 min (tablets); hypocalcemia; abnormalities of the esophagus that delay esophageal emptying, such as stricture or achalasia (oral); hypersensitivity to any component of the product.
Dosage and AdministrationAdults
PO One 150 mg tablet once monthly on the same date of each month. Should be taken with plain water 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.Adults
IV 3 mg every 3 mo, administered over 15 to 30 sec.
- If the once-monthly dose is missed and the patient's next scheduled ibandronate day is more than 7 days away, instruct the patient to take 1 ibandronate 150 mg tablet in the morning following the date that it is remembered. The patient then should return to taking 1 ibandronate 150 mg tablet every month in the morning on their chosen day, according to the original schedule. The patient must not take two 150 mg tablets within the same week. If the patient's next scheduled ibandronate day is only 1 to 7 days away, instruct the patient to wait until their next scheduled ibandronate day to take the tablet. The patient then should return to taking 1 ibandronate 150 mg tablet every month in the morning of their chosen day, according to their original schedule.
- Advise patient not to administer tablets with any liquid other than plain water.
- Instruct patient that ibandronate tablets should be swallowed whole with a full glass of plain water (180 to 240 mL) while standing or sitting in an upright position. Instruct patients to not lie down for 60 minutes after taking ibandronate.
- Advise patients to not chew or suck the tablet, or keep it in their mouths to melt or dissolve because of the potential for oropharyngeal ulceration.
- Instruct patients to take the ibandronate 150 mg tablet on the same date each month (ie, the patient's ibandronate day).
- Advise patients to take supplemental calcium or vitamin D if dietary intake is inadequate.
- Injection must be administered IV by a health care provider. Do not administer intra-arterially or paravenously; this could lead to tissue damage.
- 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.
Store at 59° to 86°F.
Drug InteractionsAntacids, calcium supplements, or other products containing calcium, or other multivalent cations (eg, aluminum, iron, magnesium)
May interfere with oral absorption of ibandronate. Ibandronate should be taken at least 60 min before any other oral medication, including multivalent cations.Aspirin, NSAIDs
Possible additive GI adverse reactions.Histamine H 2 antagonists (eg, ranitidine)
Ibandronate bioavailability may be increased; however, the amount of change is not expected to be clinically important.
Laboratory Test Interactions
May interfere with bone-imaging agents.
Headache (7%); asthenia, dizziness (4%); fatigue, insomnia, vertigo (3%); depression, nerve root lesion (2%).
Nasopharyngitis (6%); pharyngitis (3%); ocular inflammation (eg, scleritis, uveitis).
Dyspepsia (12%); abdominal pain (8%); diarrhea (7%); nausea (5%); constipation, tooth disorder (4%); gastroenteritis, vomiting (3%); gastritis (2%); dysphagia, esophageal and gastric ulcer, esophagitis.
UTI (6%); cystitis (3%).
Redness, swelling (less than 2%).
Back pain (14%); arthralgia (10%); pain in extremity (8%); myalgia (6%); joint disorder (4%); arthritis, localized osteoarthritis (3%); muscle cramp (2%); osteonecrosis of the jaw, severe or incapacitating bone, joint, or muscle pain (postmarketing).
Upper respiratory tract infection (34%); bronchitis (10%); pneumonia (6%); bronchospasm (postmarketing).
Acute-phase reaction (10%) ; influenza (8%); flu-like symptoms, hypercholesterolemia (5%); infection (4%); allergic reactions, rash (3%); anaphylaxis, angioedema, hypocalcemia (postmarketing).
Monitor patient for signs or symptoms of esophageal reaction (eg, dysphagia, new or worsening heartburn, retrosternal pain). Periodic dental exams for signs of osteonecrosis of the jaw are recommended.Injection
Measure serum creatinine in patients who receive ibandronate prior to each dosage administration.
Category C .
Safety and efficacy not established.
Age-related decreases in renal function may alter ibandronate elimination.
Not recommended for use in patients with severe renal impairment (CrCl less than 30 mL/min).
Bone and mineral metabolism disturbances, hypocalcemia, hypovitaminosis D
Treat effectively before starting therapy with ibandronate. Ibandronate injection may cause a transient decrease in serum calcium levels.
May cause upper GI disorders (eg, dysphagia, esophagitis, gastritis esophageal or gastric ulcer). Discontinue use if new or worsening symptoms develop. Use with caution in patients with active upper GI problems (eg, Barrett esophagus, duodentitis, dysphagia, gastritis, ulcer).
Osteonecrosis, primarily in the jaw, has been reported in patients receiving bisphosphonates.
Severe and occasionally incapacitating bone, joint, and/or muscle pain has been reported in patients taking bisphosphonates. Consider discontinuing use if severe symptoms develop.
May occur, manifesting as deterioration in renal function and, in rare cases, acute renal failure.
Hypocalcemia; hypomagnesemia; hypophosphatemia; upper GI adverse reactions, including dyspepsia, esophagitis, gastritis, ulcer, or upset stomach.
- 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 and effectiveness of ibandronate.
- Advise patient taking once-monthly ibandronate 150 mg tablet to take the tablet on the same date each month.
- Advise patient taking ibandronate once monthly 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 monthly 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), reduction of cigarette smoking and alcohol consumption, vitamin D supplementation, weight-bearing exercise.
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