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ibandronate sodium 150 mg tab generic boniva

Out of Stock Manufacturer ALVOGEN INC 47781010333
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Uses

Osteoporosis

Prevention in Postmenopausal Women

Ibandronate sodium is used for the prevention of osteoporosis in postmenopausal women. Risk factors include a family history of osteoporosis, early menopause, previous fracture, high bone turnover, reduced bone mineral density (at least 1 standard deviation below premenopausal mean), thin body frame, Caucasian or Asian race, excessive alcohol intake, treatment with certain drugs (e.g., corticosteroids), low dietary calcium or vitamin D intake, a sedentary lifestyle, and cigarette smoking. For additional information on osteoporosis, .

Efficacy of oral ibandronate in the prevention of osteoporosis was established in a 2-year, randomized, double-blind, placebo-controlled, dose-ranging study in postmenopausal women (41-82 years of age). In this study, ibandronate given at a dosage of 2.5 mg daily was more effective than placebo in increasing bone mineral density (BMD) of the lumbar spine and total hip.

Efficacy of oral ibandronate given once monthly for the prevention of osteoporosis has been demonstrated in a 1-year, randomized, double-blind, placebo-controlled study in 160 postmenopausal women (46-60 years of age) with low baseline bone mass. Women in the study were 5.4 years postmenopause on average, and all women received supplementation with 400 units of vitamin D and 500 mg of calcium daily. Therapy with ibandronate 150 mg once monthly was associated with a mean increase in lumbar spine BMD of 4.12% from baseline relative to placebo; BMD at other skeletal sites also increased relative to baseline values.

Treatment in Postmenopausal Women

Ibandronate sodium also is used in the treatment of osteoporosis in postmenopausal women. Efficacy of ibandronate given as a daily or once-monthly oral regimen has been established in several randomized, double-blind, multinational, dose-comparison studies in postmenopausal women with osteoporosis.

In a placebo-controlled study in postmenopausal women with osteoporosis, the rate of new vertebral fractures after 3 years of treatment (the primary end point) was substantially reduced in women receiving oral ibandronate daily (2.5 mg once daily) or intermittently (20 mg every other day for 12 doses every 3 months) compared with that in patients receiving placebo. The diagnosis of a vertebral fracture was based on qualitative diagnosis by a radiologist and on quantitative morphometric criteria (an absolute decrease in height of at least 4 mm and a relative height ratio or relative height reduction in a vertebral body of at least 20%). Over the course of the 3-year study, new vertebral fractures were found in 4.7, 4.9, or 9.6% of women receiving ibandronate 2.5 mg daily, 20 mg every other day, or placebo, respectively (relative risk reduction of 52% with daily or 50% with intermittent ibandronate, respectively, compared with placebo). The incidence of nonvertebral fractures at 3 years (a secondary end point) was similar with the active treatments; 9.1 or 8.9% with daily or intermittent ibandronate, respectively, compared with 8.2% with placebo. BMD at 3 years relative to baseline BMD (a secondary end point) increased appreciably at the lumbar spine, total hip, femoral neck, and trochanter with either daily or intermittent ibandronate therapy compared with placebo.

In a 2-year noninferiority trial comparing oral ibandronate administered monthly (100 or 150 mg once monthly) or daily (2.5 mg once daily), an ibandronate dosage of 150 mg once monthly was at least as effective as 2.5 mg once daily in increasing BMD of the lumbar spine (primary end point at 1 year) in postmenopausal women with osteoporosis. Analysis of other skeletal sites (secondary end points) indicated consistently higher BMDs of the total hip, femoral neck, and trochanter with a dosage of 150 mg once monthly compared with 2.5 mg once daily.

In a trial comparing IV ibandronate administered quarterly (3 mg once every 3 months) or bimonthly (2 mg every 2 months) with daily oral ibandronate (2.5 mg once daily), both IV regimens were more effective than the daily oral regimen in increasing BMD of the lumbar spine at 1 year compared with baseline (the primary end point) in postmenopausal women with osteoporosis.

Bone histology studies in a limited number of postmenopausal women with osteoporosis treated with oral ibandronate (2.5 mg daily for 34 months), quarterly IV ibandronate (3 mg every 3 months for 22 months), or bimonthly IV ibandronate (2 mg every 2 months for 23 months) indicated bone formation of normal quality without evidence of mineralization defects or osteomalacia during treatment with the drug.(See Musculoskeletal Pain under Warnings/Precautions: General Precautions, in Cautions.)

Dosage and Administration

Administration

Ibandronate sodium is administered orally or by IV injection.

Oral Administration

To facilitate oral absorption and reduce the potential for esophageal irritation, ibandronate should be taken with a full glass (180-240 mL) of plain water at least 60 minutes prior to the first food, beverage (other than plain water), or other orally administered drug or supplement (including vitamins, antacids, and calcium) of the day. Such supplements should be taken at a different time of the day than when ibandronate is taken. Because of the potential for oropharyngeal ulceration, patients should be instructed not to suck or chew ibandronate tablets; the tablets should be swallowed whole. Patients should be instructed to avoid lying down for at least 60 minutes following oral administration of ibandronate.

If a daily oral dose is not taken in the morning, the dose should not be taken later that same day; the next dose should be taken the next day at the regularly scheduled time.

When administered monthly, patients should take the oral dose in the morning on the same day each month. If a monthly dose is missed and the next scheduled dose is more than 7 days away, patients should take the missed dose the next morning after it is remembered and resume the regular schedule. If the next scheduled dose is 1-7 days away, patients should wait until the next regularly scheduled time to take the next dose (i.e., maintain the regular schedule); more than one 150-mg tablet should not be taken within the same week.

IV Administration

IV ibandronate must be administered by a health-care professional. Ibandronate injection should be administered IV over a period of 15-30 seconds once every 3 months. If a dose is missed, the dose should be rescheduled and administered as soon as possible. Subsequent injections should be scheduled at 3-month intervals; the drug should not be administered more often than once every 3 months.

Ibandronate injection must only be administered IV. The safety and efficacy of ibandronate injection administered by routes other than IV injection have not been established. Care should be taken not to administer ibandronate injection intra-arterially or paravenously as such administration could result in tissue damage.

Ibandronate injection must not be mixed with calcium-containing solutions or other IV drugs.

Ibandronate injection should be inspected visually for particulate matter and discoloration before administration. Prefilled syringes of the drug should be discarded if the solution is discolored or contains a precipitate.

Dosage

Dosage of ibandronate sodium, which is commercially available as the monosodium monohydrate, is expressed in terms of ibandronate.

The optimal duration of bisphosphonate treatment for osteoporosis has not been established. Some evidence suggests that bisphosphonate therapy for more than 3 years (median 7 years in one analysis of available data) in patients with osteoporosis may be associated with an increased risk of atypical fracture of the femur.(See Atypical Fracture of the Femur under Warnings/Precautions: Warnings, in Cautions.) All patients receiving a bisphosphonate should have periodic evaluations to determine the need for continued therapy with the drug.

Patients receiving oral ibandronate should receive supplemental calcium and vitamin D if dietary intake is inadequate. Patients receiving IV ibandronate must receive supplemental calcium and vitamin D regardless of the adequacy of dietary intake of calcium and vitamin D.

Osteoporosis

Prevention in Postmenopausal Women

The recommended oral dosage of ibandronate for prevention of osteoporosis is 2.5 mg once daily. Alternatively, a dosage of 150 mg once monthly may be considered.

Treatment in Postmenopausal Women

The recommended oral dosage of ibandronate for treatment of osteoporosis is 2.5 mg once daily or 150 mg once monthly.

The recommended IV dosage of ibandronate for treatment of osteoporosis is 3 mg given once every 3 months. The dose should be injected IV over a period of 15-30 seconds.

Special Populations

Renal Impairment

Dosage adjustments not necessary in patients with mild to moderate renal impairment; use of oral ibandronate is not recommended in patients with severe renal impairment (creatinine clearance less than 30 mL/minute). IV ibandronate should not be administered to patients with severe renal impairment (creatinine clearance less than 30 mL/minute, serum creatinine concentrations exceeding 2.3 mg/dL)

Dosage adjustments not necessary.

Geriatric Patients

Dosage adjustments not necessary.

Cautions

Contraindications

Hypocalcemia or known hypersensitivity to ibandronate or any ingredient in the formulation.

With oral ibandronate, abnormalities of the esophagus that delay esophageal emptying, such as stricture or achalasia.

With oral ibandronate, inability to stand or sit upright for at least 60 minutes.

Warnings/Precautions

GI Effects

Since severe adverse esophageal effects including esophagitis, esophageal ulcers, and/or erosions (occasionally with bleeding and rarely followed by esophageal stricture or perforation) have been reported in patients receiving oral bisphosphonates, clinicians should be alert to any sign or symptom associated with such adverse effects. Patients should be instructed to discontinue ibandronate and contact a clinician if dysphagia, odynophagia, retrosternal pain, or new or worsening heartburn occurs. Since the incidence of severe adverse esophageal effects is greater in patients who do not drink a full (180-240 mL) glass of water when taking the drug and in those who do not avoid lying down for at least 30 minutes following administration of ibandronate or who continue to take the drug after experiencing symptoms suggestive of esophageal irritation, patients should be instructed carefully about proper administration of the drug and should be given a copy of the patient instructions provided by the manufacturer. Ibandronate should be used with caution in patients with active upper GI disease (e.g., Barrett's esophagus, dysphagia, other esophageal diseases, gastritis, duodenitis, ulcers) or a history of such problems.

Gastric or duodenal ulcers also have been reported in patients receiving oral bisphosphonates during postmarketing experience, although no increased risk was observed in controlled clinical trials.

Although data are conflicting, there is some evidence suggesting a possible association between use of oral bisphosphonates and an increased risk of esophageal cancer. During the period of postmarketing surveillance from October 1995 (initial marketing of alendronate) through mid-May 2008, the US Food and Drug Administration (FDA) received reports of esophageal cancer in 23 patients in the US receiving alendronate (as the suspect drug in 21 cases and the concomitant drug in 2 cases); 8 deaths were reported. An additional 31 cases of esophageal cancer were reported at the time in patients in Europe and Japan who had received an oral bisphosphonate, including alendronate, risedronate, ibandronate, and etidronate. In a large case-control study in a cohort of patients from the UK General Practice Research Database, risk of esophageal cancer was increased by 30% in patients who had at least one prescription issued for an oral bisphosphonate (alendronate, etidronate, or risedronate) compared with those not receiving such prescriptions; the risk was approximately doubled among patients who had 10 or more prescriptions issued for an oral bisphosphonate or who had an estimated duration of bisphosphonate use (calculated as the time between the first and last prescription issued during the observation period) of more than 3 years. However, another retrospective cohort study that used the same database found no evidence of an increased risk of esophageal cancer in patients receiving oral bisphosphonates. Other observational studies, including a study in patients receiving long-term alendronate therapy and a cohort study of Danish patients with fractures, have shown either no risk or a reduced risk of esophageal cancer following use of oral bisphosphonates. Because of conflicting findings and limitations of currently available data, additional study is needed to determine the association, if any, between oral bisphosphonate use and esophageal cancer. FDA states that the benefits of oral bisphosphonates in reducing the risk of serious fractures continue to outweigh their potential risks in patients with osteoporosis and that it is important to consider that esophageal cancer is rare, especially in women. FDA also states that there is insufficient information at this time to recommend routine endoscopic screening in asymptomatic patients receiving oral bisphosphonates. Avoidance of oral bisphosphonates in patients with Barrett's esophagus, a known precursor to esophageal adenocarcinoma, has been recommended.

Route of Administration

Ibandronate injection must be administered IV by a health-care professional; the drug should not be administered by non-IV (e.g., intra-arterial) routes of administration.(See IV Administration under Dosage and Administration: Administration.)

Renal Effects

Use not recommended in patients with severe renal impairment (serum creatinine exceeding 2.3 mg/dL or creatinine clearance [measured or estimated] less than 30 mL/minute).

Bisphosphonates have been associated with renal toxicity, manifested as deterioration of renal function and rarely, acute renal failure. The risk of adverse renal effects during parenteral therapy with bisphosphonates depends on coexisting conditions associated with renal impairment, concomitant therapy with other nephrotoxic drugs, preexisting renal disease, dehydration, dosage, infusion volume and rate, and multiple cycles of treatment. Acute renal failure has not been observed with IV ibandronate in controlled clinical trials following administration of recommended doses administered over 15-30 seconds.

Risk factors predisposing patients to renal deterioration, such as coexisting conditions associated with renal impairment (e.g., diabetes mellitus, hypertension, heart disease) or use of other nephrotoxic agents, should be assessed appropriately. Serum creatinine concentrations should be measured prior to administration of each dose of ibandronate injection. Treatment should be withheld in patients with deterioration of renal function.

Osteonecrosis of the Jaw

Osteonecrosis and osteomyelitis of the jaw have been reported in patients, principally in those with cancer, who have received bisphosphonates. Most instances of osteonecrosis of the jaw have been observed during IV bisphosphonate therapy, but some patients have experienced this adverse effect during oral bisphosphonate therapy. While the mechanism by which these adverse effects occur has not been elucidated, it has been suggested that suppression of bone turnover and remodeling by bisphosphonates impairs the ability to repair microfractures in the maxilla and mandible that occur with daily mastication. Most cases of osteonecrosis and osteomyelitis with bisphosphonate therapy have been associated with dental procedures such as tooth extraction in cancer patients, but some have occurred in patients with postmenopausal osteoporosis or other diagnoses. Known risk factors for osteonecrosis of the jaw include invasive dental procedures (e.g., tooth extraction, dental implants, boney surgery), cancer, concomitant therapies (e.g., chemotherapy, radiation therapy, corticosteroids), poor oral hygiene, and comorbid disorders (e.g., periodontal and/or other preexisting dental disease, anemia, coagulopathy, infection, ill-fitting dentures). Discontinuance of bisphosphonate treatment may reduce the risk for osteonecrosis of the jaw in patients requiring invasive dental procedures. Clinical judgment of the treating clinician and/or oral surgeon should guide the management of each patient based on individual benefit/risk assessment. Patients who develop osteonecrosis of the jaw while receiving bisphosphonate therapy should receive care by an oral surgeon. In these patients, extensive dental surgery to treat osteonecrosis of the jaw may exacerbate the condition. Discontinuance of bisphosphonate therapy should be considered based on assessment of benefits and risks in individual patients.

Atypical Fracture of the Femur

Atypical, low-energy, or low-trauma femoral fractures have been reported in bisphosphonate-treated patients. These fractures can occur anywhere in the femoral shaft from the subtrochanteric region of the hip (i.e., below the lesser trochanter) to above the supracondylar flare and are transverse or short oblique in orientation without evidence of comminution. Such fractures generally have occurred with use of bisphosphonate therapy for more than 3 years (median 7 years in one analysis of available data). The magnitude of this risk is unclear, although such fractures appear to be rare; in addition, causality has not been established since atypical fractures also have occurred in patients not receiving bisphosphonates. Most cases of atypical femoral fractures with bisphosphonate therapy have been reported in individuals receiving treatment for osteoporosis. Such fractures most commonly occur in individuals with minimal or no trauma. Most individuals have reported prodromal symptoms presenting as dull, aching thigh pain for weeks to months prior to the occurrence of an atypical fracture. Bilateral involvement (i.e., a fracture in the contralateral limb) and evidence of delayed healing of the fracture also may be present. Concomitant use of glucocorticoid, estrogen, and proton-pump inhibitor therapy may increase the risk of an atypical fracture.

Individuals with a history of bisphosphonate exposure presenting with new thigh or groin pain should be evaluated for possible atypical femoral fracture; an assessment of the contralateral limb also should be performed to rule out possible bilateral involvement (i.e., presence of radiographic change or fracture). Interruption of bisphosphonate therapy should be considered in individuals presenting with symptoms suggestive of a possible femoral fracture following completion of a comprehensive risk-benefit assessment performed on an individualized basis. Bisphosphonate therapy should be discontinued if a femoral shaft fracture is confirmed.

Musculoskeletal Pain

Severe, occasionally incapacitating bone, joint, and/or muscle pain has been reported infrequently during postmarketing experience in patients receiving bisphosphonates. The time to onset of symptoms varied from 1 day to years (mean onset about 3 months) after treatment initiation. Musculoskeletal pain has improved following discontinuance of the drug in most patients; however, some patients have reported slow or incomplete resolution of such pain. In some patients, musculoskeletal pain recurred upon subsequent rechallenge with the same drug or another bisphosphonate. Discontinuance of ibandronate should be considered if severe symptoms develop.

Metabolic Effects

Hypocalcemia, hypovitaminosis D, and other disturbances of bone and mineral metabolism should be corrected before ibandronate therapy is initiated, and patients with osteoporosis receiving oral ibandronate should receive supplemental calcium and vitamin D if their daily dietary intake is inadequate.

IV ibandronate, like other IV bisphosphonates, may cause a transient decrease in serum calcium concentrations. Hypocalcemia has been reported during postmarketing experience with the drug. Patients receiving IV ibandronate must receive supplemental calcium and vitamin D regardless of the adequacy of their dietary intake of calcium and vitamin D.

Atrial Fibrillation

While data are conflicting, a possible increased risk of atrial fibrillation has been identified with use of bisphosphonates.

Specific Populations

Pregnancy

Category C.

Lactation

Ibandronate is distributed into milk in rats at concentrations averaging 1.5 times that in plasma; it is not known whether the drug is distributed into milk in humans. Caution is advised if the drug is administered in nursing women.

Pediatric Use

Safety and efficacy have not been established in children. Ibandronate is not indicated for use in children.

Geriatric Use

No overall differences in safety and efficacy relative to younger adults have been observed. However, the possibility that some older patients may exhibit increased sensitivity to the drug cannot be ruled out. The greater frequency of decreased renal function observed in the elderly also should be considered.

Renal Impairment

Use of oral ibandronate is not recommended in patients with severe renal impairment (creatinine clearance less than 30 mL/minute). IV ibandronate also should not be administered in patients with severe renal impairment (creatinine clearance less than 30 mL/minute, serum creatinine concentrations exceeding 2.3 mg/dL).

Common Adverse Effects

Adverse effects occurring in at least 2% of patients receiving daily oral ibandronate therapy in osteoporosis treatment or prevention studies and in more patients than with placebo include upper respiratory tract infection, back pain, dyspepsia, bronchitis, pain in the extremities, diarrhea, headache, pneumonia, myalgia, urinary tract infection, hypercholesterolemia, infection (unspecified), dizziness, joint disorder, asthenia, tooth disorder, arthritis, vertigo, vomiting, allergic reaction, pharyngitis, gastritis, and nerve root lesion.

Adverse effects occurring in at least 2% of patients receiving once-monthly oral ibandronate include upper abdominal or abdominal pain, hypertension, dyspepsia, arthralgia, nausea, diarrhea, back pain, constipation, influenza, pain in the extremities, nasopharyngitis, headache, influenza-like illness and acute phase inflammatory reaction, localized osteoarthritis, bronchitis, urinary tract infection, dizziness, rash (including pruritic, macular, papular, erythematous, or generalized rash; dermatitis or allergic dermatitis; exanthem; erythema; and dermatitis medicamentosa), myalgia, upper respiratory tract infection, and insomnia.

Adverse effects occurring in at least 2% of patients receiving quarterly IV ibandronate therapy for the treatment of osteoporosis include arthralgia, back pain, hypertension, upper abdominal or abdominal pain, influenza-like illness and acute phase inflammatory reaction, headache, dyspepsia, nasopharyngitis, constipation, fatigue, diarrhea, pain in the extremities, myalgia, urinary tract infection, rash (including pruritic, macular, papular, erythematous, or generalized rash, dermatitis or allergic dermatitis, exanthem, erythema, and dermatitis medicamentosa), bronchitis, and nausea.

Drug Interactions

Antacids or Mineral Supplements Containing Divalent Cations

Pharmacokinetic interaction (decreased absorption of ibandronate) when oral ibandronate is used concomitantly with antacids or vitamin or mineral supplements containing multivalent cations (e.g., aluminum, calcium, magnesium, iron). Oral ibandronate should be administered at least 60 minutes prior to taking any other oral drugs.

Drugs Affecting Hepatic Microsomal Enzymes

Ibandronate does not induce or inhibit cytochrome P-450 (CYP) isoenzymes and is not metabolized. Pharmacokinetic interactions unlikely.

Drugs Excreted through Renal Tubular Transport

Based on limited data in animals, ibandronate is not excreted through renal tubular transport. Pharmacokinetic interaction unlikely.

Nonsteroidal Anti-inflammatory Agents

Because aspirin, nonsteroidal anti-inflammatory agents (NSAIAs), and bisphosphonates are all associated with GI irritation, caution should be exercised in the concomitant use of NSAIAs and oral ibandronate.

Histamine H2-Receptor Antagonists, Proton Pump Inhibitors

Pharmacokinetic interaction (increased oral bioavailability of ibandronate) when IV ranitidine is administered before (15 or 90 minutes) and after (30 minutes) oral ibandronate; clinical relevance doubtful.

Among patients receiving histamine H2-receptor antagonists or proton pump inhibitors in clinical trials of ibandronate, no evidence of increased adverse upper GI effects with ibandronate compared with placebo.

Melphalan

Pharmacokinetic interaction unlikely with concomitant IV melphalan and IV ibandronate.

Prednisolone

Pharmacokinetic interaction unlikely with concomitant oral prednisolone and IV ibandronate.

Tamoxifen

Pharmacokinetic interaction unlikely with concomitant oral tamoxifen and IV ibandronate.

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