Drug: Boniva Injection

BONIVA (ibandronate sodium) is a nitrogen-containing bisphosphonate that inhibits osteoclast-mediated bone resorption. The chemical name for ibandronate sodium is 3-(N-methyl-N-pentyl)amino-1-hydroxypropane-1,1diphosphonic acid, monosodium salt, monohydrate with the molecular formula C9H22NO7P2Na•H2O and a molecular weight of 359.24. Ibandronate sodium is a white-to off-white powder. It is freely soluble in water and practically insoluble in organic solvents. Ibandronate sodium has the following structural formula: BONIVA Injection is intended for intravenous administration only. BONIVA Injection is available as a sterile, clear, colorless, ready-to-use solution in a prefilled syringe that delivers 3.375 mg of ibandronate monosodium salt monohydrate in 3 mL of solution, equivalent to a dose of 3 mg ibandronate free acid. Inactive ingredients include sodium chloride, glacial acetic acid, sodium acetate and water.

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Adverse reactions that appear in other sections of the labeling include:
  • Hypocalcemia and Mineral Metabolism [see WARNINGS AND PRECAUTIONS]
  • Anaphylactic Reaction [see WARNINGS AND PRECAUTIONS]
  • Renal Impairment [see WARNINGS AND PRECAUTIONS]
  • Tissue Damage Related to Inappropriate Drug Administration [see WARNINGS AND PRECAUTIONS]
  • Osteonecrosis of the Jaw [see WARNINGS AND PRECAUTIONS]
  • Musculoskeletal Pain [see WARNINGS AND PRECAUTIONS]
  • Atypical Subtrochanteric and Diaphyseal Femoral Fractures [see WARNINGS AND PRECAUTIONS]
Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Quarterly Intravenous Injection In a 1-year, double-blind, multicenter study comparing BONIVA Injection administered intravenously as 3 mg every 3 months to BONIVA 2.5 mg daily oral tablet in women with postmenopausal osteoporosis, the overall safety and tolerability profiles of the two dosing regimens were similar. The incidence of serious adverse reactions was 8.0% in the BONIVA 2.5 mg daily group and 7.5% in the BONIVA Injection 3 mg once every 3 months group. The percentage of patients who withdrew from treatment due to adverse reactions was approximately 6.7% in the BONIVA 2.5 mg daily group and 8.5% in the BONIVA Injection 3 mg every 3 months group. Table 1 lists the adverse reactions reported in greater than 2% of patients. Table 1 : Adverse Reactions With an Incidence of at Least 2% in Patients Treated with BONIVA Injection (3 mg once every 3 months) or BONIVA Daily Oral Tablet (2.5 mg)
Body System/
Adverse Reaction BONIVA 2.5 mg Daily (Oral) %
(n=465) BONIVA 3 mg every 3 months (Intravenous) %
(n=469) Infections and Infestations   Influenza 8 5   Nasopharyngitis 6 3   Cystitis 3 2   Gastroenteritis 3 2   Urinary Tract Infection 3 3   Bronchitis 3 2   Upper Respiratory Tract Infection 3 1 Gastrointestinal Disorders   Abdominal Pain* 6 5   Dyspepsia 4 4   Nausea 4 2   Constipation 4 3   Diarrhea 2 3   Gastritis 2 2 Musculoskeletal and Connective Tissue Disorders   Arthralgia 9 10   Back Pain 8 7   Localized Osteoarthritis 2 2   Pain in Extremity 2 3   Myalgia 1 3 Nervous System Disorders   Dizziness 3 2   Headache 3 4 Psychiatric Disorders   Insomnia 3 1   Depression 2 1 General Disorders and Administration Site Conditions   Influenza-like Illness† 1 5   Fatigue 1 3 Skin and Subcutaneous Tissue Disorders   Rash‡ 3 2 * Combination of abdominal pain and abdominal pain upper
† Combination of influenza-like illness and acute phase reaction
‡ Combination of rash, rash pruritic, rash macular, dermatitis, dermatitis allergic, exanthema, erythema, rash papular, rash generalized, dermatitis medicamentosa, rash erythematous Acute Phase Reaction-like Events Symptoms consistent with acute phase reaction (APR) have been reported with intravenous bisphosphonate use. The overall incidence of patients with APR-like events was higher in the intravenous treatment group (4% in the BONIVA 2.5 mg daily oral tablet group vs. 10% in the BONIVA Injection 3 mg once every 3 months group). These incidence rates are based upon reporting of any of 33 potential APR-like symptoms within 3 days of an intravenous dose and lasting 7 days or less. In most cases, no specific treatment was required and the symptoms subsided within 24 to 48 hours. Injection Site Reactions Local reactions at the injection site, such as redness or swelling, were observed at a higher incidence in patients treated with BONIVA Injection 3 mg every 3 months (1.7%; 8/469) than in patients treated with placebo injections (0.2%; 1/465). In most cases, the reaction was of mild to moderate severity. Daily Oral Tablet The safety of BONIVA 2.5 mg once daily in the treatment and prevention of postmenopausal osteoporosis was assessed in 3577 patients aged 41 – 82 years. The duration of the trials was 2 to 3 years, with 1134 patients exposed to placebo and 1140 exposed to BONIVA 2.5 mg. Patients with pre-existing gastrointestinal disease and concomitant use of non-steroidal anti-inflammatory drugs, proton pump inhibitors and H2 antagonists were included in these clinical trials. All patients received 500 mg calcium plus 400 international units vitamin D supplementation daily. The incidence of all-cause mortality was 1% in the placebo group and 1.2% in the BONIVA 2.5 mg daily group. The incidence of serious adverse reactions was 20% in the placebo group and 23% in the BONIVA 2.5 mg daily oral tablet group. The percentage of patients who withdrew from treatment due to adverse reactions was approximately 17% in both the placebo group and the BONIVA 2.5 mg daily oral tablet group. Table 2 lists adverse reactions from the Treatment and Prevention Studies reported in greater than or equal to 2% of patients and in more patients treated with BONIVA 2.5 mg daily oral tablet than patients treated with placebo. Table 2 : Adverse Reactions Occurring at an Incidence greater than or equal to 2% and in More Patients Treated with BONIVA 2.5 mg Daily Oral Tablet than in Patients Treated with Placebo in the Osteoporosis Treatment and Prevention Studies
Body System Placebo %
(n=1134) BONIVA 2.5 mg daily %
(n=1140) Body as a Whole   Back Pain 12 14   Pain in Extremity 6 8   Asthenia 2 4   Allergic Reaction 2 3 Digestive System   Dyspepsia 10 12   Diarrhea 5 7   Tooth Disorder 2 4   Vomiting 2 3   Gastritis 2 2 Musculoskeletal System   Myalgia 5 6   Joint Disorder 3 4   Arthritis 3 3 Nervous System   Headache 6 7   Dizziness 3 4   Vertigo 3 3 Respiratory System   Upper Respiratory 33 34 Infection   Bronchitis 7 10   Pneumonia 4 6   Pharyngitis 2 3 Urogenital System   Urinary Tract Infection 4 6 Gastrointestinal Adverse Reactions The incidence of selected gastrointestinal adverse reactions in the placebo and BONIVA 2.5 mg daily groups were: dyspepsia (10% vs. 12%), diarrhea (5% vs. 7%), and abdominal pain (5% vs. 6%). Musculoskeletal Adverse Reactions The incidence of selected musculoskeletal adverse reactions in the placebo and BONIVA 2.5 mg daily groups were: back pain (12% vs. 14%), arthralgia (14% vs. 14%) and myalgia (5% vs. 6%). Postmarketing Experience The following adverse reactions have been identified during post-approval use of BONIVA Injection. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Hypersensitivity: Allergic reactions including anaphylaxis with fatalities, angioedema, asthma exacerbation, bronchospasm, rash, Stevens-Johnson syndrome, erythema multiforme, and dermatitis bullous [see CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS]. Hypocalcemia: Hypocalcemia [see WARNINGS AND PRECAUTIONS]. Renal Toxicity: Acute renal failure [see WARNINGS AND PRECAUTIONS]. Osteonecrosis of the Jaw: Osteonecrosis of the jaw [see WARNINGS AND PRECAUTIONS]. Musculoskeletal Pain: Bone, joint, or muscle pain (musculoskeletal pain), described as severe or incapacitating [see WARNINGS AND PRECAUTIONS]. Atypical Femoral Shaft Fracture: Atypical, low-energy, or low-trauma fractures of the femoral shaft [see WARNINGS AND PRECAUTIONS]. Eye Inflammation: Iritis and uveitis. In some cases with other bisphosphonates, these events did not resolve until the bisphosphonate was discontinued. Read the Boniva Injection (ibandronate sodium injection) Side Effects Center for a complete guide to possible side effectsLearn More »

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Important Administration Instructions BONIVA 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 BONIVA 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 prefilled syringe for particulate matter and discoloration before administration. Do not use prefilled syringes with particulate matter or discoloration.
  • Administer only with the enclosed needle.
  • Discard any unused portion.
  • Do not mix with calcium-containing solutions or other intravenously administered drugs.
  • Prefilled syringes are for single use only.
Dosage Information The recommended dose of BONIVA Injection for the treatment of postmenopausal osteoporosis is 3 mg every 3 months administered intravenously over a period of 15 to 30 seconds. Do not administer more frequently than once every 3 months. 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 BONIVA Injection. Calcium And Vitamin D Supplementation Instruct patients to take supplemental calcium and vitamin D if their dietary intake is inadequate. [see WARNINGS AND PRECAUTIONS]. Dosing After Missed Dose If the dose is missed, administer as soon as it can be re-scheduled. Thereafter, BONIVA Injection should be scheduled every 3 months from the date of the last injection. 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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Melphalan/Prednisolone Intravenous ibandronate (6 mg) did not interact with intravenous melphalan (10 mg/m²) or oral prednisolone (60 mg/m²). [See CLINICAL PHARMACOLOGY] Tamoxifen There was no interaction between oral 30 mg tamoxifen and intravenous 2 mg ibandronate. [See CLINICAL PHARMACOLOGY] Bone Imaging Agents Bisphosphonates are known to interfere with the use of bone-imaging agents. Specific studies with BONIVA have not been performed. Read the Boniva Injection Drug Interactions Center for a complete guide to possible interactions Learn More »

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Treatment Of Postmenopausal Osteoporosis BONIVA Injection is indicated for the treatment of osteoporosis in postmenopausal women. In postmenopausal women with osteoporosis, BONIVA increases bone mineral density (BMD) and reduces the incidence of vertebral fractures [see Clinical Studies]. Important Limitations Of Use The safety and effectiveness of BONIVA for the treatment of osteoporosis are based on clinical data of one year duration. The optimal duration of use has not been determined. All patients on bisphosphonate therapy should have the need for continued therapy re-evaluated on a periodic basis. Patients at low-risk for fracture should be considered for drug discontinuation after 3 to 5 years of use. Patients who discontinue therapy should have their risk for fracture re-evaluated periodically.

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Boniva is contraindicated in patients with the following conditions:
  • Hypocalcemia [see WARNINGS AND PRECAUTIONS]
  • Known hypersensitivity to BONIVA Injection or to any of its excipients. Cases of anaphylaxis, including fatal events, have been reported. [see WARNINGS AND PRECAUTIONS, ADVERSE REACTIONS]
Last reviewed on RxList: 4/7/2015
This monograph has been modified to include the generic and brand name in many instances.

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No cases of overdose were reported in premarketing studies with BONIVA Injection. Overdosage with intravenous bisphosphonates may result in hypocalcemia, hypophosphatemia, and hypomagnesemia. Clinically relevant reductions in serum levels of calcium, phosphorus, and magnesium should be corrected by intravenous administration of calcium gluconate, potassium or sodium phosphate, and magnesium sulfate, respectively. Dialysis would not be beneficial unless it is administered within 2 hours following the overdose.

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Dosage Forms And Strengths BONIVA Injection is supplied as a kit containing:
  • a 3 mg/3 mL single-use prefilled syringe.
  • a 25-gauge, 3/4 inch needle with wings, needle-stick protection device, and a 9 cm plastic tubing for attachment
BONIVA Injection (ibandronate sodium) is supplied as a kit containing a 3 mg/3 mL single-use, clear glass, 5 mL (5 cc) prefilled syringe, a 25-gauge, 3/4 inch needle with wings, needle-stick protection device, and a 9 cm plastic tubing for attachment (NDC 0004 0191 09). Storage And Handling Store at 25°C (77°F); excursions permitted between 15° and 30°C (59° and 86°F) [see USP Controlled Room Temperature]. Distributed by: Genentech USA Inc., 1 DNA Way, South San Francisco, CA 94080. Revised: Nov 2014 Last reviewed on RxList: 4/7/2015
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

Hypocalcemia and Mineral Metabolism BONIVA Injection may cause a decrease in serum calcium values. Treat hypocalcemia, hypovitaminosis D, and other disturbances of bone and mineral metabolism before starting BONIVA Injection therapy. Adequate intake of calcium and vitamin D is important in all patients. It is recommended that patients receive supplemental calcium and vitamin D if dietary intake is inadequate. Anaphylactic Reaction Cases of anaphylaxis, including fatal events, have been reported in patients treated with BONIVA Injection. Appropriate medical support and monitoring measures should be readily available when BONIVA Injection is administered. If anaphylactic or other severe hypersensitivity/allergic reactions occur, immediately discontinue the injection and initiate appropriate treatment. Renal Impairment Treatment with intravenous bisphosphonates has been associated with renal toxicity manifested as deterioration in renal function and acute renal failure. Although no cases of acute renal failure were observed in controlled clinical trials in which intravenous BONIVA was administered as a 15- to 30-second bolus, acute renal failure has been reported postmarketing. Do not administer BONIVA Injection to patients with severe renal impairment (creatinine clearance less than 30 mL/min). Obtain serum creatinine prior to each BONIVA Injection. After BONIVA Injection, assess renal function, as clinically appropriate, in patients with concomitant diseases or taking medications that have the potential for adverse effects on the kidney. BONIVA Injection should be withheld in patients with renal deterioration. Tissue Damage Related to Inappropriate Drug Administration BONIVA Injection must only be administered intravenously. Care must be taken not to administer BONIVA Injection intra-arterially or paravenously as this could lead to tissue damage. Do not administer BONIVA Injection by any other route of administration. The safety and efficacy of BONIVA Injection following non-intravenous routes of administration have not been established. Osteonecrosis of the Jaw Osteonecrosis of the jaw (ONJ) has been reported in patients treated with bisphosphonates, including BONIVA Injection. Most cases have been in cancer patients treated with intravenous bisphosphonates undergoing dental procedures. Some cases have occurred in patients with postmenopausal osteoporosis treated with either oral or intravenous bisphosphonates. A routine oral examination should be performed by the prescriber prior to initiation of bisphosphonate treatment. Consider a dental examination with appropriate preventive dentistry prior to treatment with bisphosphonates in patients with a history of concomitant risk factors (e.g., cancer, chemotherapy, radiotherapy, corticosteroids, poor oral hygiene, pre-existing dental disease or infection, anemia, coagulopathy). While on treatment, patients with concomitant risk factors should avoid invasive dental procedures if possible. For patients who develop ONJ while on bisphosphonate therapy, dental surgery may exacerbate the condition. For patients requiring dental procedures, there are no data available to suggest whether discontinuation of bisphosphonate treatment reduces the risk of ONJ. The clinical judgment of the treating physician should guide the management plan of each patient based on individual benefit/risk assessment [see ADVERSE REACTIONS]. Musculoskeletal Pain Severe and occasionally incapacitating bone, joint, and/or muscle pain has been reported in patients taking BONIVA and other bisphosphonates [see ADVERSE REACTIONS]. The time to onset of symptoms varied from one day to several months after starting the drug. Most patients had relief of symptoms after stopping the bisphosphonate. A subset of patients had recurrence of symptoms when rechallenged with the same drug or another bisphosphonate. Discontinue BONIVA if severe symptoms develop. Atypical Subtrochanteric and Diaphyseal Femoral Fractures Atypical, low-energy, or low-trauma fractures of the femoral shaft have been reported in bisphosphonate-treated patients. These fractures can occur anywhere in the femoral shaft from just below the lesser trochanter to above the supracondylar flare and are transverse or short oblique in orientation without evidence of comminution. Causality has not been established as these fractures also occur in osteoporotic patients who have not been treated with bisphosphonates. Atypical femur fractures most commonly occur with minimal or no trauma to the affected area. They may be bilateral and many patients report prodromal pain in the affected area, usually presenting as dull, aching thigh pain, weeks to months before a complete fracture occurs. A number of reports note that patients were also receiving treatment with glucocorticoids (e.g., prednisone) at the time of fracture. Any patient with a history of bisphosphonate exposure who presents with thigh or groin pain should be suspected of having an atypical fracture and should be evaluated to rule out an incomplete femur fracture. Patients presenting with an atypical fracture should also be assessed for symptoms and signs of fracture in the contralateral limb. Interruption of bisphosphonate therapy should be considered, pending a risk/benefit assessment, on an individual basis. Patient Counseling Information “See FDA-approved patient labeling (Medication Guide)” Inform patients that BONIVA Injection must be administered intravenously by a health care professional. Patients should be instructed to read the Medication Guide carefully before BONIVA is administered and to reread it each time the prescription is renewed because it contains important information the patient should know about BONIVA. Inform patients that BONIVA Injection is administered once every 3 months. If the dose is missed, the injection should be administered as soon as it can be rescheduled. Thereafter, injections should be scheduled every 3 months from the date of the last injection. Do not administer BONIVA Injection more frequently than once every 3 months. Inform patients that they should take supplemental calcium and vitamin D if their dietary intake is inadequate [see WARNINGS AND PRECAUTIONS]. Inform patients BONIVA injection should not be administered to patients with creatinine clearance less than 30 mL/min. A serum creatinine should be measured prior to each dose [see WARNINGS AND PRECAUTIONS]. Inform patients that the most common side effects of BONIVA include arthralgia, back pain, hypertension, and abdominal pain. Flu-like symptoms (acute phase reaction) may occur within 3 days following infusion, and usually subside within 24-48 hours without specific therapy. Inform patients that there have been reports of persistent pain and/or a non-healing sore of the mouth or jaw, primarily in patients treated with bisphosphonates for other illnesses. If they experience these symptoms, they should inform their physician or dentist. Inform patients that severe bone, joint, and/or muscle pain have been reported in patients taking bisphosphonates, including BONIVA. Patients should report severe symptoms if they develop. Inform patients that atypical femur fractures in patients on bisphosphonate therapy have been reported. Patients should report new thigh or groin pain and undergo evaluation to rule out a femoral fracture. Nonclinical Toxicology Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis In a 104-week carcinogenicity study, doses of 3, 7, or 15 mg/kg/day were administered by oral gavage to Wistar rats (systemic exposures in males and females up to 3 and 1 times, respectively, human exposure). There were no significant drug-related tumor findings in male or female rats. In a 78-week carcinogenicity study, doses of 5, 20, or 40 mg/kg/day were administered by oral gavage to NMRI mice (exposures in males and females up to 96 and 14 times, respectively, human exposure). There were no significant drug-related tumor findings in male or female mice. In a 90-week carcinogenicity study, doses of 5, 20, or 80 mg/kg/day were administered in the drinking water to NMRI mice. A dose-related increased incidence of adrenal subcapsular adenoma/carcinoma was observed in female mice, which was statistically significant at 80 mg/kg/day (32 to 51 times human exposure). The relevance of these findings to humans is unknown. Exposure multiples comparing human and rodent doses were calculated using human exposure at the recommended intravenous dose of 3 mg every 3 months, based on cumulative AUC comparison. Mutagenesis There was no evidence for a mutagenic or clastogenic potential of ibandronate in the following assays: in vitro bacterial mutagenesis assay in Salmonella typhimurium and Escherichia coli (Ames test), mammalian cell mutagenesis assay in Chinese hamster V79 cells, and chromosomal aberration test in human peripheral lymphocytes, each with and without metabolic activation. Ibandronate was not genotoxic in the in vivo mouse micronucleus tests for chromosomal damage. Impairment of Fertility In female rats treated from 14 days prior to mating through gestation, decreases in fertility, corpora lutea and implantation sites, and increased preimplantation loss were observed at an intravenous dose of 1.2 mg/kg/day (117 times human exposure). In male rats treated for 28 days prior to mating, a decrease in sperm production and altered sperm morphology were observed at intravenous doses greater than or equal to 0.3 mg/kg/day (greater than or equal to 40 times human exposure). Exposure multiples comparing human and rat doses were calculated using human exposure at the recommended intravenous dose of 3 mg every 3 months, based on cumulative AUC comparison. Use In Specific Populations Pregnancy Pregnancy Category C There are no adequate and well-controlled studies in pregnant women. BONIVA should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Bisphosphonates are incorporated into the bone matrix, from where they are gradually released over periods of weeks to years. The extent of bisphosphonate incorporation into adult bone, and hence, the amount available for release back into the systemic circulation, is directly related to the total dose and duration of bisphosphonate use. Although there are no data on fetal risk in humans, bisphosphonates do cause fetal harm in animals, and animal data suggest that uptake of bisphosphonates into fetal bone is greater than into maternal bone. Therefore, there is a theoretical risk of fetal harm (e.g., skeletal and other abnormalities) if a woman becomes pregnant after completing a course of bisphosphonate therapy. The impact of variables such as time between cessation of bisphosphonate therapy to conception, the particular bisphosphonate used, and the route of administration (intravenous versus oral) on this risk has not been established. In pregnant rats given intravenous doses greater than or equal to 2 times human exposure from Day 17 postcoitum 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 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 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 multiples for the rat studies were calculated using human exposure at the recommended intravenous dose of 3 mg every 3 months and were based on cumulative area under the time-concentration (AUC) comparison. Exposure multiples for the rabbit study were calculated for the recommended human intravenous dose of 3 mg every 3 months and were based on cumulative dose/[body surface area] comparison. Doses in pregnant animals were 0.05, 0.1, 0.15, 0.3, 0.5 or 1 mg/kg/day in rats, and 0.03, 0.07, or 0.2 mg/kg/day in rabbits. Nursing Mothers It is not known whether BONIVA is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when BONIVA Injection is administered to a nursing woman. In lactating rats treated with intravenous doses of 0.08 mg/kg, ibandronate was present in breast milk at concentrations of 8.1 to 0.4 ng/mL from 2 to 24 hours after dose administration. Concentrations in milk averaged 1.5 times plasma concentrations. Pediatric Use Safety and effectiveness of BONIVA in pediatric patients have not been established. Geriatric Use Of the patients receiving BONIVA Injection 3 mg every 3 months for 1 year, 51% were over 65 years of age. No overall differences in effectiveness or safety were observed between these patients and younger patients, but greater sensitivity in some older individuals cannot be ruled out. Renal Impairment BONIVA Injection should not be administered to patients with severe renal impairment (creatinine clearance less than 30 mL/min) [see WARNINGS AND PRECAUTIONS]. Last reviewed on RxList: 4/7/2015
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

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