Names and pronunciation
(eye-ban′dro-nate) Boniva
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Drug reference
(eye-ban′dro-nate) Boniva
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Func. class.: Bone-resorption inhibitor, electrolyte modifier
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Chem. class.: Bisphosphonate
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ACTION: Inhibits bone resorption, without inhibiting bone formation and min- eralization; absorbs calcium phosphate crystals in bone and may directly block dissolution of hydroxyapatite crystals of bone; more potent than other products
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USES: Postmenopausal osteoporosis and prophylaxis
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Unlabeled uses: Hypercalcemia of malignancy, osteolytic metastases, Paget’s disease
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CONTRAINDICATIONS: Achala- sia, esophageal stricture, hypocalcemia, intraarterial administration, renal failure, hypersensitivity to bisphosphonates, inabil- ity to stand or sit upright Precautions: Pregnancy, breastfeeding, children, geriatric patients, anemia, che- motherapy, coagulopathy, dental disease, diabetes mellitus, dysphagia, GI/renal dis- ease, GERD, hypertension, infection, multi- ple myeloma, phosphate hypersensitivity, vit D deficiency
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SIDE EFFECTS CNS: Fever, insomnia, dizziness, headache CV: Hypertension, atrial fibrillation EENT: Ocular pain/inflammation, uveitis, esophageal ulceration GI: Constipation, nausea, vomiting, diar- rhea, dyspepsia, esophageal/GI cancer INTEG: Rash, inj-site reaction META: Hypomagnesemia, hypophos phatemia, hypocalcemia, hypercholes- terolemia MS: Bone pain, myalgia, osteonecrosis of the jaw SYST: Stevens-Johnson syndrome, ery thema multiforme, dermatitis bullous
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INTERACTIONS Increase: GI irritation—NSAIDs, salicylates Increase: QTc prolongation—drugs that prolong QTc Decrease: ibandronate effect—PPIs Decrease: ibandronate effect—calcium/ vit D/iron/aluminum/magnesium salts; separate by 1 hr Drug/Food • Do not take with food, calcium prod- ucts; give product on empty stomach Drug/Lab Test Decrease: Alk phos, magnesium, cal- cium, phosphate
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DOSAGE AND ROUTES Postmenopausal osteoporosis/ prophylaxis • Adult: PO 150 mg/mo; IV BOL 3 mg q3mo Hypercalcemia of malignancy (unlabeled) • Adult: IV INFUSION 2 mg infused over 2 hr in moderate hypercalcemia, 4 mg in severe hypercalcemia (>3 mmol/L). The use of 6 mg should be reserved for serum calcium levels >3.5 mmol/L Renal dose • Adult: PO CCr <30 mL/min, avoid use
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Available forms: Tabs 150 mg; sol for inj 1 mg/mL (3 mg/3 mL in prefilled syringes)
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Administer: PO route • Give early AM with a glass of water; if monthly, give on same day of each month • Patient to remain upright for ≥1 hr after taking • Do not suck/chew; throat ulcers may occur • Store at room temperature Direct IV route • Use single-dose prefilled syringe; dis- card unused portion; give over 15-30 sec; give q3mo; do not use if discolored or contains particulates • Do not admix • Store at room temperature
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Assess: • Osteoporosis: before and during treat- ment; DEXA scan for bone mineral den- sity; correct electrolyte imbalances (cal- cium, magnesium, phosphate) before I starting therapy • Anaphylaxis (IV): swelling of face, lips, mouth, rash, sweating, wheezing, trouble breathing; discontinue immedi ately, provide supportive treatment • Dental health: before dental extraction, may require drug holiday for up to 2 mo; osteonecrosis of the jaw may occur • Blood studies: electrolytes, creatinine/ BUN, calcium, vit D, alkaline phosphatase; correct deficiencies before treatment • For bone pain; use analgesics; may begin within 24 hr or even years after treatment; pain usually subsides after treatment is discontinued • Esophageal irritation/ulceration: heart- burn, painful swallowing; avoid use in those with swallowing difficulties
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Evaluate: • Therapeutic response: increased bone mineral density
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CLINICAL CONSIDERATIONS
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Patient and caregiver information: • To report hypercalcemic relapse: nau- sea, vomiting, bone pain, thirst, unusual muscle twitching, muscle spasms, severe diarrhea, constipation • To continue with dietary recommenda- tions, including calcium, vit D • To obtain an analgesic from provider for bone pain, which may occur rapidly or within months • That if nausea, vomiting occur; small, frequent meals may help • To report vision symptoms: blurred vision, edema, inflammation • To exercise regularly, stop smoking, decrease alcohol intake • To notify health care professional of osteonecrosis of the jaw, after dental procedures, pain, draining, swelling, to notify dentist before dental procedures • To take PO first thing in AM at least 60 min before other medications, food, bev- erages; to take monthly dose on same day; that if IV dose is missed, to reschedule as soon as able and to reschedule subse- quent doses on new time schedule; not to receive IV dose more than once in 3 mo • To sit upright for ≥60 min after PO to prevent irritation; to swallow tab whole, not to chew or suck • To report whether pregnancy is planned or suspected or if planning to breastfeed HIGH ALERT
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PHARMACOKINETICS Half-life tabs 1.5-6 days, IV 4.5-25.5 hr; 91%- 99% protein binding; taken up mainly by bones, primarily in areas of high bone turn- over; eliminated primarily by kidneys (60%); PO: onset unknown, peak ½–2 hr, duration unknown; IV: onset rapid, peak 3 hr
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• Adult: PO 150 mg/mo; IV BOL 3 mg q3mo Hypercalcemia of malignancy (unlabeled)
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• Adult: IV INFUSION 2 mg infused over 2 hr in moderate hypercalcemia, 4 mg in severe hypercalcemia (>3 mmol/L). The use of 6 mg should be reserved for serum calcium levels >3.5 mmol/L Renal dose
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• Adult: PO CCr <30 mL/min, avoid use
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