ibandronate


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Related to ibandronate: ibandronate sodium

ibandronate

(i-ban-dro-nate) ,

Boniva

(trade name)

Classification

Therapeutic: bone resorption inhibitors
Pharmacologic: biphosphonates
Pregnancy Category: C

Indications

Treatment/prevention of postmenopausal osteoporosis.

Action

Inhibits resorption of bone by inhibiting osteoclast activity.

Therapeutic effects

Reversal/prevention of progression of osteoporosis with decreased fractures.

Pharmacokinetics

Absorption: 0.6% absorbed following oral administration (significantly ↓ by food).
Distribution: Rapidly binds to bone.
Protein Binding: 90.9–99.5%.
Metabolism and Excretion: 50–60% excreted in urine; unabsorbed drug is eliminated in feces.
Half-life: PO—10–60 hr; IV—4.6–25.5 hr.

Time/action profile

ROUTEONSETPEAKDURATION
POunknown0.5–2 hrup to 1 mo
IVunknown3 hrup to 3 mo

Contraindications/Precautions

Contraindicated in: Hypersensitivity;Abnormalities of the esophagus which delay esophageal emptying (i.e. strictures, achalasia);Uncorrected hypocalcemia;Inability to stand/sit upright for at least 60 min;CCr <30 mL/min.
Use Cautiously in: History of upper GI disorders;Concurrent use of NSAIDs or aspirin;Invasive dental procedures, cancer, receiving chemotherapy or corticosteroids, poor oral hygeine, periodontal disease, dental disease, anemia, coagulopathy, infection, or poorly-fitting dentures (may ↑ risk of jaw osteonecrosis); Obstetric: Use only if potential benefit outweighs risks to mother and fetus; Lactation: Lactation; Pediatric: Children <18 yr (safety not established); Geriatric: Consider age related ↓ in body mass, renal and hepatic function, concurrent disease states and drug therapy.

Adverse Reactions/Side Effects

Gastrointestinal

  • diarrhea (most frequent)
  • dyspepsia (most frequent)
  • dysphagia
  • esophageal cancer
  • esophagitis
  • esophageal/gastric ulcer

Musculoskeletal

  • musculoskeletal pain (most frequent)
  • pain in arms/legs (most frequent)
  • femur fractures
  • osteonecrosis (primarily of jaw)

Respiratory

  • asthma exacerbation

Miscellaneous

  • anaphylaxis (life-threatening)
  • injection site reactions

Interactions

Drug-Drug interaction

Calcium-, aluminum-, magnesium-, and iron- containing products, including antacids ↓ absorption (ibandronate should be taken 60 min before).Concurrent use of NSAIDs including aspirin, may ↑ risk of gastric irritation.Milk and other foods ↓ absorption.

Route/Dosage

Oral (Adults) 150 mg once monthly.
Intravenous (Adults) 3 mg every 3 mo.

Availability (generic available)

Tablets: 150 mg
Injection: 3 mg/3 mL in prefilled single-use syringe

Nursing implications

Nursing assessment

  • Osteoporosis: Assess patients for low bone mass before and periodically during therapy.
  • Intravenous: Monitor for signs and symptoms of anaphylactic reactions (swelling of face, lips, mouth or tongue; trouble breathing; wheezing; severe itching; skin rash, redness or swelling; dizziness or fainting; fast heartbeat or pounding in chest; sweating) during therapy. Discontinue injection immediately and begin supportive treatment if symptoms occur.
  • Lab Test Considerations: Assess serum calcium before and periodically during therapy. Hypocalcemia and vitamin D deficiency should be treated before initiating ibandronate therapy.
    • May cause ↓ total alkaline phosphatase levels.
    • May cause hypercholesterolemia.

Potential Nursing Diagnoses

Risk for injury (Indications)

Implementation

  • Oral: Administer first thing in the morning with 6–8 oz plain water 30 min before other medications, beverages, or food. Tablet should be swallowed whole; do not break, crush, or chew.
    • Once-monthly tablet should be administered on the same date each month.
  • Intravenous Administration
  • Intravenous: Administer using prefilled syringe. Do not administer solution that is discolored or contains particulate matter. Administer IV only; other routes may cause tissue damage.
  • Rate: Administer as a 15–30 second bolus.
  • Y-Site Incompatibility: Do not administer with calcium-containing solutions or other IV drugs.

Patient/Family Teaching

  • Advise patient to eat a balanced diet and consult health care professional about the need for supplemental calcium and vitamin D. Wait at least 60 min after administration before taking supplemental calcium and vitamin D.
    • Encourage patient to participate in regular exercise and to modify behaviors that increase the risk of osteoporosis (stop smoking, reduce alcohol consumption).
    • Inform patient that severe musculoskeletal pain may occur within days, months, or yr after starting ibandronate. Symptoms my resolve completely after discontinuation or slow or incomplete resolution may occur. Notify health care professional if severe pain occurs.
    • Instruct patient to notify health care professional if swallowing difficulties, chest pain, new or worsening heartburn, or trouble or pain when swallowing occurs; may be signs of problems of the esophagus.
    • Advise patient to inform health care professional of ibandronate therapy prior to dental surgery.
    • Advise female patient to notify health care professional if pregnancy is planned or suspected or if breast feeding.
  • Oral: Instruct patient on the importance of taking as directed, first thing in the morning, 60 min before other medications, beverages, or food. Ibandronate should be taken with 6–8 oz plain water (mineral water, orange juice, coffee, and other beverages decrease absorption). Do not chew or suck on tablet. If a dose is missed, skip dose and resume the next morning; do not double doses or take later in the day. If a once-monthly dose is missed and the next scheduled dose is >7 days away, take in the morning following the date it is remembered. Resume original schedule the following month. If the next dose is <7 days away, omit dose and take next scheduled dose. Do not discontinue without consulting health care professional.
    • Caution patient to remain upright for 60 min following dose to facilitate passage to stomach and minimize risk of esophageal irritation. Advise patient to stop taking ibandronate and contact health care professional if symptoms of esophageal irritation (new or worsening dysphagia, pain on swallowing, retrosternal pain, or heartburn) occur.
  • Intravenous: Advise patient that IV doses should not be administered sooner that every 3 mo. If a dose is missed, have health care professional administer as soon as possible; next injection should be scheduled 3 mo from last injection.

Evaluation/Desired Outcomes

  • Prevention of or decrease in the progression of osteoporosis in postmenopausal women. Discontinuation after 3–5 years should be considered for women with low risk for fractures.

ibandronate

a bone-resorption inhibitor and electrolyte modifier.
indication This drug is used to prevent and treat osteoporosis.
contraindications Achalasia, esophageal stricture, hypocalcemia, intrarterial administration, renal failure, vitamin D deficiency, and known hypersensitivity to bisphosphonates prohibit the use of this drug.
adverse effects Adverse effects of this drug include fever, insomnia, dizziness, headache, hypertension, ocular pain or inflammation, ureitis, constipation, nausea, vomiting, diarrhea, dyspepsia, rash, injection site reaction, bone pain, and myalgia. Common side effects include hypomagnesemia, hypophosphatemia, and hypocalcemia.
References in periodicals archive ?
Changes in marker concentrations have been shown to correlate with increases in BMD after alendronate treatment in some studies (70,73) and with ibandronate (74).
In addition to their ibandronate regimens, women in all treatment groups received 500 mg of calcium and 400 IU of vitamin D daily.
Ibandronate (Boniva) was approved by the Food and Drug Administration this spring as the first once-monthly oral bisphosphonate, in part because of the persuasive 1-year results of MOBILE.
These data suggest that the renal safety profile of ibandronate in phase III trials transfers to actual clinical practice," he wrote in a poster at the meeting, which was sponsored by the Cancer and Bone Society.
Ibandronate, which is being marketed as Boniva by Roche, is the third oral bisphosphonate and the first monthly formulation marketed in the United States for osteoporosis.
The 2-year results from the Dosing IntraVenous Administration (DIVA) study show that IV ibandronate injections every 2 or 3 months were superior to oral daily ibandronate (Boniva) in terms of increased bone mineral density (BMD) at the lumbar spine.
The Monthly Oral Ibandronate in Ladies (MOBILE) study, a multinational randomized, double-blind, phase III study of women aged 55-80 years, will continue for 2 years, Michael Bolognese, M.
There are no fracture data for the intravenous dosing schedule, but the risk reduction that has been shown with oral ibandronate can probably be extrapolated to the intravenous form of the drug, Dr.
In the overall Bisphosphonate, ibandronate (Bonviva/Boniva; Roche) and zoledronate (Aclasta/Zometa; Novartis) accounted largest share in class, respectively, and showed an average sales growth rate of about of 20% in the past 2 years.
SEATTLE -- Monthly dosing of the bisphosphonate ibandronate appears to be just as effective as daily dosing, according to the findings of a controlled study presented at the annual meeting of the American Society for Bone and Mineral Research.
Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Ibandronate Sodium Tablets, 150mg.
The Food and Drug Administration has approved a daily formulation of ibandronate sodium for the treatment and prevention of postmenopausal osteoporosis, but the manufacturer has no immediate plans to launch the bisphosphonate until more convenient dosing regimens are approved.