Boniva

Boniva Manufacturers

• Physicians Total Care, Inc.
  

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  Boniva | Physicians Total Care, Inc.

  

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  2.1 Dose

  The dose of BONIVA is either one 150 mg tablet taken once monthly on the same date each month or one 2.5 mg tablet taken once daily.

  2.2 Dosing Instructions To maximize absorption and clinical benefit, BONIVA should be taken at least 60 minutes before the first food or drink (other than water) of the day or before taking any oral medication or supplementation, including calcium, antacids, or vitamins (see DRUG INTERACTIONS [7.1]). To facilitate delivery to the stomach and thus reduce the potential for esophageal irritation, BONIVA tablets 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 BONIVA (see WARNINGS AND PRECAUTIONS [5.1]). Patients should not eat, drink anything except water, or take other medications for at least 60 minutes after taking BONIVA. Plain water is the only drink that should be taken with BONIVA. 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 BONIVA 150 mg tablet should be taken on the same date each month (i.e., the patient's BONIVA 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 BONIVA day is more than 7 days away, the patient should be instructed to take one BONIVA 150 mg tablet in the morning following the date that it is remembered. The patient should then return to taking one BONIVA 150 mg tablet 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 BONIVA day is only 1 to 7 days away, the patient must wait until the subsequent month's scheduled BONIVA day to take their tablet. The patient should then return to taking one BONIVA 150 mg tablet every month in the morning of their chosen day, according to their original schedule. 2.3 Recommendations for Calcium and Vitamin D Supplementation

  Patients should receive supplemental calcium and vitamin D if dietary intake is inadequate (see DRUG INTERACTIONS [7.1]).

  2.4 use in Specific Populations

  BONIVA is not recommended for use in patients with severe renal impairment (creatinine clearance of <30 mL/min).

  No dose adjustment is necessary for patients with mild or moderate renal impairment.

  No dose adjustment is necessary for the elderly, or for patients with hepatic impairment.

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• Genentech, Inc.
  

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  Boniva | Genentech, Inc.

  

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  2.1 Dosage Information

  The dose of BONIVA is one 150 mg tablet taken once monthly on the same date each month.

  2.2 Important Administration Instructions

  Instruct Patients to do the following:

  Take BONIVA at least 60 minutes before the first food or drink (other than water) of the day or before taking any oral medication or supplementation, including calcium, antacids, or vitamins to maximize absorption and clinical benefit, (see DRUG INTERACTIONS [7.1]). Avoid the use of water with supplements including mineral water because they may have a higher concentration of calcium. Swallow BONIVA tablets whole with a full glass of plain water (6 to 8 oz) while standing or sitting in an upright position to reduce the potential for esophageal irritation. Avoid lying down for 60 minutes after taking BONIVA (see WARNINGS AND PRECAUTIONS [5.1]). Do not chew or suck the tablet because of a potential for oropharyngeal ulceration. Do not eat, drink anything except plain water, or take other medications for at least 60 minutes after taking BONIVA. 2.3 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 BONVIA administration because co-administration of BONIVA and calcium may interfere with the absorption of ibandronate sodium (see DRUG INTERACTIONS [7.1]).

  2.4 Administration Instructions for Missed Once-Monthly Doses

  If the once-monthly dose is missed, instruct patients to do the following:

  If the next scheduled BONIVA day is more than 7 days away, take one BONIVA 150 mg tablet in the morning following the date that it is remembered. If the next scheduled BONIVA day is only 1 to 7 days away, wait until the subsequent month's scheduled BONIVA day to take their tablet.

  For subsequent monthly doses for both of the above scenarios, instruct patients to return to their original schedule by taking one BONIVA 150 mg tablet every month on their previous chosen day.

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• Genentech, Inc.
  

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  Boniva | Genentech, Inc.

  

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  2.1 Important Administration Instructions

  BONIVA Injection must be administered intravenously only by a health care professional. Care must be taken not to administer intra-arterially or paravenously as this could lead to tissue damage [see Warnings and Precautions (5.4)].

  Appropriate medical support and monitoring measures should be readily available when BONIVA Injection is administered. If anaphylactic or other severe hypersensitivity/allergic reactions occur, immediately discontinue the injection and initiate appropriate treatment [see Warnings and Precautions (5.2)]. Visually inspect the liquid in the prefilled syringe for particulate matter and discoloration before administration. Do not use prefilled syringes with particulate matter or discoloration. Administer only with the enclosed needle. Discard any unused portion. Do not mix with calcium-containing solutions or other intravenously administered drugs. Prefilled syringes are for single use only. 2.2 Dosage Information

  The recommended dose of BONIVA Injection for the treatment of postmenopausal osteoporosis is 3 mg every 3 months administered intravenously over a period of 15 to 30 seconds. Do not administer more frequently than once every 3 months.

  2.3 Laboratory Testing and Oral Examination Prior to Administration

  Prior to administration of each dose obtain a serum creatinine [see Warnings and Precautions (5.3)]. Given that bisphosphonates have been associated with osteonecrosis of the jaw (ONJ), perform a routine oral examination prior to administration of BONIVA Injection.

  2.4 Calcium and Vitamin D Supplementation

  Instruct patients to take supplemental calcium and vitamin D if their dietary intake is inadequate. [see Warnings and Precautions (5.1)].

  2.5 Dosing After Missed Dose

  If the dose is missed, administer as soon as it can be re-scheduled. Thereafter, BONIVA Injection should be scheduled every 3 months from the date of the last injection.

  2.6 Dosage Modifications in Patients with Renal Impairment

  Do not administer to patients with severe renal impairment (creatinine clearance less than 30 mL/minute) [see Warnings and Precautions (5.3) and Clinical Pharmacology (12.3)]. No dose adjustment is necessary for patients with mild or moderate renal impairment (creatinine clearance greater than or equal to 30 mL/min) [see Clinical Pharmacology (12.3)].

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