Boniva


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Related to Boniva: Boniva Injection

ibandronate sodium

Boniva, Boniva Injection, Bonviva (UK)

ibandronic acid

Pharmacologic class: Bisphosphonate

Therapeutic class: Calcium regulator

Pregnancy risk category C

Action

Inhibits osteoclast activity and reduces bone resorption and turnover; in postmenopausal women, reduces elevated bone turnover rate, leading to (on average) net gain in bone mass

Availability

Solution for injection: 3 mg/3 ml in single-use prefilled glass syringes

Tablets (film-coated): 2.5 mg, 150 mg

Indications and dosages

Osteoporosis treatment and prevention in postmenopausal women

Adults: 2.5-mg tablet P.O. daily, or 150-mg tablet P.O. once monthly on same date each month

Osteoporosis treatment in postmenopausal women

Adults: 3 mg I.V. injection every 3 months

Contraindications

• Hypersensitivity to drug or its components

• Uncorrected hypocalcemia

• Inability to stand or sit upright for at least 60 minutes (after oral administration)

• Abnormalities of esophagus, such as stricture or achalasia, that delay esophageal emptying (tablets)

Precautions

Use cautiously in:

• severe renal impairment (not recommended)

• active upper GI disease (such as Barrett's esophagus, dysphagia, other esophageal diseases, gastritis, duodenitis, or ulcers)

• patients who develop jaw osteonecrosis during therapy

• concurrent use of aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), or other bisphosphonates

• pregnant or breastfeeding patients

• children younger than age 18 (safety and efficacy not established).

Administration

• With patient standing or sitting upright, give oral dose with 6 to 8 oz water at least 60 minutes before first food or drink (other than water) of day or before administering other oral drugs or supplements (including calcium, antacids, and vitamins).

• Give with plain water only; some mineral waters may have higher calcium concentration and shouldn't be used.

• Don't let patient chew or suck tablet because this may cause oropharyngeal ulcers.

• Keep patient upright for at least 60 minutes after oral dose to avoid serious esophageal irritation.

• Give parenteral formulation only by I.V. injection over 15 to 30 seconds.

• Don't mix parenteral formulation with calcium-containing solutions or other I.V. drugs.

• If patient misses I.V. dose, give it as soon as possible; thereafter, give dose every 3 months from date of last injection. Don't administer more often than every 3 months.

Adverse reactions

CNS: insomnia, asthenia, headache, fatigue, dizziness, vertigo, nerve root lesion

CV: hypertension

EENT: pharyngitis

GI: constipation, diarrhea, vomiting, abdominal pain, dysphagia, esophagitis, esophageal irritation (tablets), gastric ulcer, dyspepsia, gastritis, esophageal ulcer

GU: urinary tract infection

Metabolic: hypercholesterolemia, hypocalcemia

Musculoskeletal: osteonecrosis (mainly in jaw), localized osteoarthritis and muscle cramp, joint disorder, joint pain, muscle pain, back pain, extremity pain, arthritis

Respiratory: upper respiratory tract infection, bronchitis, pneumonia

Skin: rash

Other: tooth disorder, influenza, infection, injection site reaction, allergic reaction

Interactions

Drug-drug. Aspirin, NSAIDs: additive GI irritation

Drugs containing calcium and other multivalent cations (such as aluminum, iron, magnesium), including antacids, supplements, and vitamins: interference with ibandronate absorption

Drug-diagnostic tests. Alkaline phosphatase, calcium: decreased

Bone-imaging agents: interference with test results

Drug-food. Milk, mineral water, other foods and beverages: interference with ibandronate absorption, reducing drug's bioavailability and effect on bone mineral density (when patient consumes food or beverage less than 60 minutes after ibandronate dose)

Patient monitoring

• Monitor creatinine clearance in patients with mild or moderate renal impairment.

Monitor for signs and symptoms of GI irritation (including ulcers) after oral administration; discontinue drug if new or worsening symptoms occur.

• Evaluate serum calcium and phosphate levels.

• Monitor for hypocalcemia and other disturbances of bone and mineral metabolism; administer effective treatment before therapy starts.

• Monitor patient for adequate intake of supplemental calcium and vitamin D during therapy, as appropriate.

Patient teaching

• Advise patient to read patient information leaflet carefully before starting drug.

• Instruct patient to take drug first thing in morning on empty stomach with 6 to 8 oz of plain water only.

Caution patient not to chew or suck tablet because this may cause throat ulcers.

• Instruct patient not to eat, drink, or take other oral medications for 60 minutes after taking tablet.

Caution patient not to lie down for at least 60 minutes after taking drug.

• Advise patient to take once-monthly tablet (150 mg) on same date each month.

• If patient misses once-monthly dose and next scheduled dose is more than 7 days away, instruct her to take one 150-mg tablet in morning after the day she remembers it and then resume taking one 150-mg tablet every month in morning of chosen day, per original schedule. However, if next scheduled dose is only 1 to 7 days away, tell her to wait until next scheduled dose.

Instruct patient to stop drug and immediately report heartburn, serious vomiting, severe chest or abdominal pain, difficulty swallowing, severe bone, joint, or muscle pain.

• If drug is prescribed for injection, tell patient she will receive it every 3 months.

• Advise patient to take supplemental calcium and vitamin D as prescribed, if dietary intake is inadequate.

• Teach patient to take only those pain relievers recommended by prescriber. Point out that some over-the-counter pain preparations (such as aspirin and NSAIDs) may worsen adverse effects.

• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs, tests, and foods mentioned above.

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.

Boniva

(bō-nē′və)
A trademark for the drug ibandronate sodium.
References in periodicals archive ?
Boniva also is administered as an intravenous injection, as is another bisphosphonate, zoledronic acid (Reclast).
One study randomized patients to denosumab (Prolia) 60 mg subcuta- neously every 6 months or ibandronate (Boniva) 150 mg orally every month.
Most of them are looking for solutions other than bisphosphonates like Fosamax, Actonel, and Boniva. You've probably heard about the horrible side effects from these drugs and you don't want to take them.
But bisphosphonates -- such as Merck's Fosamax, Roche's Boniva, Novartis's Reclast, and Warner Chilcott's Actonel -- remain the most popular option, and can be bought for as little as $10 per month in the US.
review, published in The New England Journal of Medicine online recently, was prompted by a growing debate over how long women should continue using the drugs, known as bisphosphonates, which are sold as generic versions of brands like Fosamax and Boniva, as well as Novartis's Reclast.
Jan Towers, AANP Director of Health Policy, "Contact your local legislator, every time you take your Boniva."
The NWHN will use all the advocacy tools at its disposal to press the FDA to make changes in how drug companies are allowed to market bisphosphonates like Fosamax, Actonel, Boniva and Reclast (as well as the many generic bisphosphonates) to healthy women.
It's important to note that women taking osteoporosis drugs (e.g., Fosamax, Actonel, Boniva) should still take calcium supplements because the effectiveness of these drugs depends on ample calcium intake.
There have been concerns about the increase of dead bone forming in the mouth in people taking bisphosphonate medications (Fosamax, Actonel, Boniva) to treat osteoporosis or as part of cancer treatment.
Fosomax and Boniva are two commonly prescribed meds for the prevention of osteoporosis.
Health urgings for bone mass density testing and drug advertising for Boniva are usually aimed at menopause-age women and older, making us view osteoporosis as a problem for mature women.
Her only medications were ibandronate sodium (Boniva) taken for osteoporosis (diagnosed 2 years earlier), a multivitamin, calcium, magnesium, and vitamin E supplements.