ibandronate sodium


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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 sodium

(ī-băn′drə-nāt′)
n.
A bisphosphonate drug that inhibits bone resorption, given monthly to treat and prevent osteoporosis primarily in postmenopausal women.
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References in periodicals archive ?
According to IMS Health, Ibandronate Sodium Injection, one mg (base)/mL, packaged in three mg (base)/ three mL pre-filled glass syringes had US sales of about USD18.4m for the 12 months ending 30 June 2014.
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.
Reddya[euro](tm)s Laboratories unveils US FDA approved Ibandronate Sodium tablets 150mg(C)2012 M2 COMMUNICATIONS http://www.m2.com
In Japan, a Phase III study was conducted in approximately 400 patients with osteoporosis to assess efficacy and safety of RG484/CT-064 oral agent against ibandronate sodium hydrate injection.
Ibandronate sodium is approved by the FDA for the treatment (2.5 mg daily tablet, 150 mg monthly tablet and 3 mg every three months by intravenous injection) of postmenopausal osteoporosis.
announced today that ibandronate sodium hydrate (generic name) oral agent demonstrated non-inferiority in efficacy of increasing the bone mass of the lumbar spine compared to a comparator, ibandronate sodium hydrate injection.
announced today that they launched the ibandronate sodium hydrate, a bisphosphonate antiresorptive agent brand name: Bonviva Injection 1 mg Syringe (hereafter, Bonviva IV Injection ) , for the indication of osteoporosis on August 29, 2013.