Ibandronate intravenous
Other products: Ibandronate
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From MedlinePlus, U.S. National Library of Medicine
Dosing in kidney impairment
Dosage Modifications in Patients with Renal Impairment Do not administer to patients with severe renal impairment (creatinine clearance less than 30 mL/minute) [see Warnings and Precautions and Clinical Pharmacology] . No dose adjustment is necessary for patients with mild or moderate renal impairment (creatinine clearance greater than or equal to 30 mL/min) [see Clinical Pharmacology] .
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Preparation and administration
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Important Administration Instructions Ibandronate sodium injection must be administered intravenously only by a health care professional. Care must be taken not to administer intra-arterially or paravenously as this could lead to tissue damage [see Warnings and Precautions] . Appropriate medical support and monitoring measures should be readily available when ibandronate sodium injection is administered.
If anaphylactic or other severe hypersensitivity/allergic reactions occur, immediately discontinue the injection and initiate appropriate treatment [see Warnings and Precautions]. Visually inspect the liquid in the vial for particulate matter and discoloration before administration. Do not use vials with particulate matter or discoloration.
Discard any unused portion. Do not mix with calcium-containing solutions or other intravenously administered drugs. Vials are for single use only.
Laboratory Testing and Oral Examination Prior to Administration Prior to administration of each dose obtain a serum creatinine [see Warnings and Precautions] . Given that bisphosphonates have been associated with osteonecrosis of the jaw (ONJ), perform a routine oral examination prior to administration of ibandronate sodium injection.
Drug interactions
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- Ibandronate intravenous
Label text (4 paragraphs)
7 DRUG INTERACTIONS
7.1 Melphalan/Prednisolone Intravenous ibandronate (6 mg) did not interact with intravenous melphalan (10 mg/m 2 ) or oral prednisolone (60 mg/m 2 ). [See Clinical Pharmacology ( 12.3 )]
7.2 Tamoxifen There was no interaction between oral 30 mg tamoxifen and intravenous 2 mg ibandronate. [See Clinical Pharmacology ( 12.3 )]
7.3 Bone Imaging Agents Bisphosphonates are known to interfere with the use of bone-imaging agents. Specific studies with ibandronate sodium injection have not been performed.
Supplement interactions
Dietary supplement interactions
1 noted- Magnesium-rich supplements or medications can decrease the absorption of oral bisphosphonates, such as alendronate (Fosamax), that are used to treat osteoporosis. Taking magnesium-rich supplements or medications at least 2 hours before or after oral bisphosphonates can minimize this interaction.
Contraindications
Ibandronate sodium injection is contraindicated in patients with the following conditions: Hypocalcemia [see Warnings and Precautions ( 5.1 )] Known hypersensitivity to ibandronate sodium injection or to any of its excipients. Cases of anaphylaxis, including fatal events, have been reported. [see Warnings and Precautions ( 5.2 ), Adverse Reactions ( 6.2 )] Hypocalcemia ( 4 ) Hypersensitivity to ibandronate sodium injection ( 4 )
Safety data
Reported adverse events (FAERS)
Liver injury (LiverTox)
LiverTox has no chapter for ibandronate intravenous. Check the label's hepatic warnings.
Pregnancy and lactation
Pregnancy
8.1 Pregnancy Risk Summary Ibandronate sodium injection is not indicated for use in women of reproductive potential. There are no data with ibandronate sodium injection use in pregnant women to inform any drug-associated risks. In reproductive toxicity studies in the rat, ibandronate sodium injection caused obstruction of labor, with maternal periparturient mortality, pup loss and reduced pup weight at greater than or equal to 2 times human exposure at the recommended human intravenous dose of 3 mg. Abnormal pup odontogeny was observed at greater than or equal to 18 times human exposure.
In rats dosed during pregnancy, kidney developmental toxicity occurred in offspring at greater than or equal to 47 times human exposure. Also, fetal weight and pup growth were reduced at greater than or equal to 5 times human exposure. In reproductive studies in the rabbit, ibandronate sodium injection caused maternal mortality, reduced maternal body weight gain, decreased litter size due to increased resorption rate, and decreased fetal weight at 19 times the recommended human dose (see Data) .
Data Animal Data In pregnant rats given intravenous doses producing greater than or equal to 2 times human exposure from Day 17 post-coitum until Day 20 post-partum, ibandronate treatment resulted in dystocia, maternal mortality, and early postnatal pup loss in all dose groups. Reduced body weight at birth was observed at greater than or equal to 4 times the human exposure. Pups exhibited abnormal odontogeny that decreased food consumption and body weight gain at greater than or equal to 18 times human exposure.
Periparturient mortality has also been observed with other bisphosphonates and appears to be a class effect related to inhibition of skeletal calcium mobilization resulting in hypocalcemia and dystocia. Exposure of pregnant rats during the period of organogenesis resulted in an increased fetal incidence of RPU (renal pelvis ureter) syndrome at an intravenous dose producing greater than or equal to 47 times human exposure. In this spontaneous delivery study, dystocia was counteracted by perinatal calcium supplementation. In rat studies with intravenous dosing during gestation, fetal weight and pup growth were reduced at doses producing greater than or equal to 5 times human exposure.
In pregnant rabbits given intravenous doses during the period of organogenesis, maternal mortality, reduced maternal body weight gain, decreased litter size due to increased resorption rate, and decreased fetal weight were observed at 19 times the recommended human intravenous dose. Exposure…
Breastfeeding (LactMed)
Ibandronate is poorly absorbed orally (average in adults 6% on an empty stomach, negligible with food), so absorption of ibandronate by a breastfed infant is unlikely. However, since no information is available on the use of ibandronate during breastfeeding, an alternate drug may be preferred, especially while nursing a newborn or preterm infant.
Supply and cost
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Recalls (last 24 months)
Therapeutic equivalence (Orange Book)
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