Boniva and/or Equivalent Ibandronate Sodium Prescription Information
Boniva is indicated for the treatment and prevention of Osteoporosis in Postmenopausal Women. Boniva, containing Ibandronate Sodium as an active ingredient, is a Nitrogen-containing Bisphosphonate which inhibits the Osteoclast-mediated bone resorption process. Boniva modifies the normal bone formation and breakdown cycle in the Human body, helping to slow bone loss and increase bone mass density, which in turn results in the prevention of bone fractures.
The hormone estrogen plays a vital role in maintaining calcium levels within bones. Since women who have gone through menopause experience a decrease in their estrogen levels, their bones can become weak due to the loss in calcium. Boniva is classified as a Bisphosphonate, which helps to stop bone loss by slowing the breakdown of bones and binding to specific cells within the bone. Over time, bone mass may increase, which will reduce a woman's risk of a fracture.
Boniva is approved for the treatment and prevention of osteoporosis in postmenopausal women. Therapy duration should be evaluated periodically as the optimum duration has not yet been established. By increasing bone mass density (BMD), Boniva also helps reduce the incidence of vertebral fractures in postmenopausal women who are facing osteoporosis.
Boniva is available in 2.5 mg and 150 mg strength tablets. Recommended dosages are one 150 mg tablet orally, once monthly or one 2.5 mg tablet orally, once daily. Since food or other concomitant medication may interfere with tablet absorption, Boniva must be taken at least 60 minutes before the first food, drink or oral medication of the day. If the tablet sticks or clings in the esophageal region, it may irritate the esophagus; therefore, patients must not lie down for at least 60 minutes after taking it. Tablets should be consumed wholly and should not be chewed or allowed to melt in the mouth in order to avoid throat irritation. Boniva tablets should be stored at room temperature.
The Boniva injection is available as a sterile, clear, and colorless solution in a prefilled syringe. It delivers 3 mg Ibandronate-free acid per 3 ml of solution (3mg/3ml strength). 3 mg should be administered intravenously over 15-30 seconds, every three months.
Bisphosphonate class drugs strengthen the bone by inhibiting the bone removal process (also known as resorption) by Osteoclasts. Ibandronate sodium shows great binding affinity towards hydroxypatite (a calcium compound and part of bone mineral matrix). By binding to this site, ibandronate sodium is taken up by mature osteoclast cells during the resorption phase. Boniva acts at intracellular levels as an isoprenoid diphosphate lipid analogue which disrupts the farnesylation and geranylgeranylation of small GTPase signaling proteins and potentiates the selective osteoclast apoptosis process. This entire process results in increased bone density and decreased fractures of bones.
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Boniva Side Effects and Safety Information
Boniva is reported to cause numerous serious side-effects such as: hypocalcaemia; severe kidney issues; osteonecrosis; bone, joint or muscle pain; unusual thigh bone fractures; severe allergic reactions like hives, dyspnea, swelling of face, tongue, or throat; chest pain; difficulty in swallowing; burning sensations under the ribs; worsened heartburn; unusual pain in thigh or hip; jaw pain, etc.
Various less serious side-effects related to Boniva include:
back pain, headache, myalgia, numbness, swelling, ocular redness and swelling, diarrhea, flu related symptoms, injection site redness or swelling, nausea, upset stomach, or pain in the arms or legs.
The Boniva injection may cause a transient decrease in serum calcium levels.
Care must be taken while administering intravenous injection and it must not be administered - even accidently - as intra-arterially or para-venously.
The Boniva intravenous injection has been associated with renal toxicity which may deteriorate the renal function and, in rare circumstances, may lead to acute renal failure.
Patients must be treated for pre-existing conditions like hypocalcemia, hypovitaminosis D, etc. before starting Boniva injection therapy and must receive calcium and vitamin D supplements during Boniva injection therapy.
Atypical subtrochanteric and diaphyseal femoral fractures have been reported with bisphosphonate containing treatment drugs.
Boniva is contraindicated in patients with known hypersensitivity to ibandronate sodium.
Boniva is contraindicated in patients with uncorrected hypocalcemia.
Boniva is a pregnancy category C drug, which means that while ibandronate sodium has been shown to cause fetal harm in preclinical studies, the effects of Boniva on the fetus have not been thoroughly studied in clinical trials; therefore, it should be used in pregnant women only if the potential benefit justifies the potential risk to the fetus.
Preclinical studies have demonstrated that ibandronate sodium excretes via breast milk; however, Boniva has not been studied in humans and therefore should not be used by nursing women.
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Boniva (Ibandronate) - Also known as Bonviva
Boniva Injection (Ibandronate) - Also known as Bonviva Injection