Ibandronate

What is Ibandronate?

• Ibandronate (Boniva) is a bisphosphonate used for the treatment and prevention of post-menopausal osteoporosis.
• It is typically formulated as its sodium salt ibandronate sodium.

Ibandronate

What are the uses of this medicine?

• Ibandronate (Boniva) is prescription medicine used to treat or prevent osteoporosis in women after menopause. Ibandronate Sodium Tablets help increase bone mass and help reduce the chance of having a spinal fracture (break).

Limitations of use:

• It is not known how long Ibandronate Sodium Tablets work for the treatment and prevention of osteoporosis. You should see your doctor regularly to determine if Ibandronate Sodium Tablets are still right for you.

How does this medicine work?

• The action of ibandronate on bone tissue is based on its affinity for hydroxyapatite, which is part of the mineral matrix of bone.
• Ibandronate inhibits osteoclast activity and reduces bone resorption and turnover.
• In postmenopausal women, it reduces the elevated rate of bone turnover, leading to, on average, a net gain in bone mass.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• Have certain problems with your esophagus, the tube that connects your mouth with your stomach
• Cannot stand or sit upright for at least 60 minutes
• Have low levels of calcium in your blood
• Are allergic to Ibandronate Sodium Tablets or any of its ingredients

What drug interactions can this medicine cause?

• Tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.

Be sure to mention any of the following:

• angiogenesis inhibitors such as bevacizumab (Avastin), everolimus (Afinitor, Zortress), pazopanib (Votrient), sorafenib (Nexavar), or sunitinib (Sutent)
• aspirin and other nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen (Advil, Ibu-Tab, Motrin, others) and naproxen (Aleve, Naprelan, Naprosyn, others)
• cancer chemotherapy
• oral steroids such as dexamethasone, methylprednisolone (Medrol), and prednisone (Rayos)

• If you are taking any oral medications, including supplements, vitamins, or antacids, take them at least 60 minutes after you take ibandronate.

Is this medicine FDA approved?

• It was patented in 1986 by Boehringer Mannheim and approved for medical use in 1996.

How should this medicine be used?

Recommended dosage:

• The dose of Ibandronate Sodium Tablet is one 150 mg tablet as ibandronic acid taken once monthly on the same date each month.

Recommendations for Calcium and Vitamin D Supplementation:

• Instruct patients to take supplemental calcium and vitamin D if their dietary intake is inadequate.
• Avoid the use of calcium supplements within 60 minutes of Ibandronate Sodium Tablet administration.

Administration:

• Take 1 Ibandronate Sodium 150 mg tablet 1 time every month on the same day each month.
• Ibandronate Sodium Tablets work only if taken on an empty stomach.
• Take 1 Ibandronate Sodium Tablet, after you get up for the day and before taking your first food, drink, or other medicine.
• Take Ibandronate Sodium Tablets while you are sitting or standing.
• Do not chew or suck on a Ibandronate Sodium Tablet.
• Swallow Ibandronate Sodium Tablet with a full glass (6 to 8 oz) of plain water only.
• Do not take Ibandronate Sodium Tablets with mineral water, coffee, tea, soda, or juice.

After swallowing Ibandronate Sodium Tablet, wait at least 60 minutes:

• Before you lie down. You may sit, stand or walk, and do normal activities like reading.
• Before you take your first food or drink except for plain water.
• Before you take other medicines, including antacids, calcium, and other supplements and vitamins.
• Do not lie down for at least 60 minutes after you take Ibandronate Sodium Tablets and do not eat your first food of the day for at least 60 minutes after you take Ibandronate Sodium Tablets.

• If you miss a dose of Ibandronate Sodium Tablet, do not take it later in the day. Call your doctor for instructions.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Tablets: 150 mg as ibandronic acid
• Ibandronate sodium injection is supplied as a kit containing:
• a 3 mg/3 mL single-dose prefilled syringe
• a 25-gauge, 3/4 inch needle with wings, needle-stick protection device, and a 9 cm plastic tubing for attachment

This medicine is available in fallowing brand namesː

• Boniva

What side effects can this medication cause?

The most common side effects of this medicine include:

• Back pain
• Heartburn
• Stomach area (abdominal) pain
• Pain in your arms and legs
• Diarrhea
• Headache
• Muscle pain
• Flu-like symptoms

Ibandronate Sodium may cause serious side effects including:

• Esophagus problems
• hypocalcemia
• Bone, joint, or muscle pain
• osteonecrosis
• Unusual thigh bone fractures

What special precautions should I follow?

• Ibandronate sodium, like other bisphosphonates administered orally, may cause local irritation of the upper gastrointestinal mucosa. Instruct patients to follow dosing instructions and discontinue use if new or worsening symptoms occur.
• Hypocalcemia has been reported in patients taking ibandronate sodium. Correct hypocalcemia before use.
• Severe and occasionally incapacitating bone, joint, and/or muscle pain has been reported in patients taking ibandronate sodium and other bisphosphonates. Consider discontinuing use if symptoms develop.
• Osteonecrosis of the jaw (ONJ), which can occur spontaneously, is generally associated with tooth extraction and/or local infection with delayed healing, and has been reported in patients taking bisphosphonates, including ibandronate sodium. Patients who develop osteonecrosis of the jaw while on bisphosphonate therapy should receive care by an oral surgeon. In these patients, extensive dental surgery to treat ONJ may exacerbate the condition. Discontinuation of bisphosphonate therapy should be considered based on individual benefit/risk assessment.
• Ibandronate sodium is not recommended for use in patients with severe renal impairment (creatinine clearance of less than 30 mL/min).
• Ibandronate Sodium Tablet should be taken at least 60 minutes before the first food or drink (other than water) of the day and before taking any oral medication or supplementation including calcium, antacids or vitamins.
• To facilitate delivery to the stomach, and thus reduce the potential for esophageal irritation, Ibandronate Sodium Tablet should be swallowed whole with a full glass of plain water (6 to 8 oz) while the patient is standing or sitting in an upright position. Patients should not lie down for 60 minutes after taking Ibandronate Sodium Tablet.
• Patients should not eat, drink anything except for water, or take other medications for 60 minutes after taking Ibandronate Sodium Tablet.
• Plain water is the only drink that should be taken with Ibandronate Sodium Tablet. Note that some mineral waters may have a higher concentration of calcium and therefore should not be used.
• Patients should not chew or suck the tablet because of a potential for oropharyngeal ulceration.
• The Ibandronate Sodium Tablet 150 mg (ibandronate) should be taken on the same date each month (i.e., the patient’s Ibandronate Sodium Tablet day).
• The patient must not take two 150 mg tablets within the same week.
• If the once-monthly dose is missed, and the patient’s next scheduled Ibandronate Sodium Tablet day is more than 7 days away, the patient should be instructed to take one Ibandronate Sodium Tablet 150 mg (ibandronate) in the morning following the date that it is remembered . The patient should then return to taking one Ibandronate Sodium Tablet 150 mg (ibandronate) every month in the morning of their chosen day, according to their original schedule.
• If the once-monthly dose is missed, and the patient’s next scheduled Ibandronate Sodium Tablet day is only 1 to 7 days away, the patient must wait until the subsequent month’s scheduled Ibandronate Sodium Tablet day to take their tablet. The patient should then return to taking one Ibandronate Sodium Tablet 150 mg (ibandronate) every month in the morning of their chosen day, according to their original schedule.
• Patients should receive supplemental calcium and vitamin D if dietary intake is inadequate. Intake of supplemental calcium and vitamin D should be delayed for at least 60 minutes following oral administration of Ibandronate Sodium Tablet in order to maximize absorption of Ibandronate Sodium Tablets.
• Ibandronate sodium is not indicated for use in women of reproductive potential. There is no information on the presence of ibandronate in human milk, the effects of ibandronate.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• hypocalcemia, hypophosphatemia, and upper gastrointestinal adverse events, such as upset stomach, dyspepsia, esophagitis, gastritis, or ulcer

Management of overdosage:

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.
• No specific information is available on the treatment of overdosage of ibandronate sodium.
• Milk or antacids should be given to bind ibandronate sodium.
• Due to the risk of esophageal irritation, vomiting should not be induced, and the patient should remain fully upright.
• Dialysis would not be beneficial.

Can this medicine be used in pregnancy?

• Ibandronate sodium is not indicated for use in women of reproductive potential.
• There are no data with ibandronate sodium use in pregnant women to inform any drug-associated risks.

Can this medicine be used in children?

• Safety and effectiveness in pediatric patients have not been established.

What are the active and inactive ingredients in this medicine?

• Active ingredient: ibandronate sodium
• Inactive ingredients: lactose monohydrate, povidone, crospovidone, microcrystalline cellulose, colloidal silicon dioxide, sodium stearyl fumarate, opadry yellow and purified water.
• The components of opadry yellow are hypromellose, titanium dioxide, polyethylene glycol 6000 and iron oxide yellow.

Who manufactures and distributes this medicine?

Distributed by: Alvogen, Inc. Morristown, NJ, USA

Manufactured by:

• OrBion Pharmaceuticals Private Limited
• Irungattukottai, India

What should I know about storage and disposal of this medication?

• Store Ibandronate Sodium Tablets at room temperature, 59°F to 86°F (15°C to 30°C).
• Keep Ibandronate Sodium Tablets in a tightly closed container.

• Dailymed label info on Ibandronate
• FDA Ibandronate

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