Acid Ibandronic Teva

Oral

Prophylaxis of skeletal events in patients with breast cancer and bone metastases

Adult: 50 mg daily.

Renal impairment:

Oral

Postmenopausal osteoporosis; Prophylaxis of postmenopausal osteoporosis

Adult: 150 mg once mthly on the same date each mth, alternatively, 2.5 mg daily. Missed once-mthly dose: If next scheduled dose is >7 days away: Take dose the next morning and return to original schedule; if next dose is <7 days away: Wait until the next scheduled dose; 2 tabs must not be taken w/in the same wk.

Renal impairment:

Intravenous

Hypercalcaemia of malignancy

Adult: 2-4 mg as a single infusion over 2 hr. Max: 6 mg.

Renal impairment:

Reconstitution: Add contents of vial to 500 mL of NaCl 0.9% or dextrose 5%.

Incompatibility: Ca-containing soln.

Intravenous

Postmenopausal osteoporosis

Adult: 3 mg by inj over 15-30 seconds once every 3 mth. Missed dose: Give inj as soon as possible; then re-schedule next inj 3 mth from this inj; should not be given more frequently than once every 3 mth.

Renal impairment:

Incompatibility: Ca-containing soln.

Intravenous

Prophylaxis of skeletal events in patients with breast cancer and bone metastases

Adult: 6 mg by infusion over at least 15 min 3-4 wkly.

Renal impairment:

Reconstitution: Add contents of vial to 100 mL of NaCl 0.9% or dextrose 5%.

Incompatibility: Ca-containing soln.

Ibandronate injection is used to treat osteoporosis (thinning of the bone) in women after menopause.

This medicine is to be given only by or under the direct supervision of a doctor.

Recommended dose: One 150-mg FC tab once a month.

Hepatic Impairment: No dosage adjustment is necessary.

Renal Impairment: No dosage adjustment is necessary for patients with mild or moderate renal impairment where CrCl ≥30 mL/min.

Below 30 mL/min creatinine clearance, the decision to administer Acid Ibandronic Teva should be based on an individual risk-benefit assessment.

Elderly: No dosage adjustment is necessary.

Administration: The tablet should preferably be taken on the same date each month. Acid Ibandronic Teva should be taken 60 min before the first food or drink (other than water) of the day or any other oral medication or supplementation (including calcium).

Tablets should be swallowed whole with a full glass of plain water (180-240 mL) while the patient is sitting or standing in an upright position. Patients should not lie down for 60 min after taking Acid Ibandronic Teva.

Plain water is the only drink that should be taken with Acid Ibandronic Teva. Please 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.

Patients should receive supplemental calcium or vitamin D if dietary intake is inadequate.

In case a once-monthly dose is missed, patients should be instructed to take one Acid Ibandronic Teva 150 mg tablet the morning after the tablet is remembered, unless the time to the next scheduled dose is within 7 days. Patients should then return to taking their dose once a month on their originally scheduled date.

If the next scheduled dose is within 7 days, patients should wait until their next dose and then continue taking 1 tab once a month as originally scheduled. Patients should not take two 150-mg tablets within the same week.

Hypersensitivity to Acid Ibandronic Teva or to any of the excipients of Acid Ibandronic Teva.

Patients with uncorrected hypocalcemia. As with all bisphosphonates indicated in the treatment of osteoporosis, preexisting hypocalcemia needs to be corrected before initiating therapy with Acid Ibandronic Teva. As with several bisphosphonates, Acid Ibandronic Teva is contraindicated in patients with abnormalities of the esophagus which delay esophageal emptying eg, stricture or achalasia.

Patients who are unable to stand or sit upright for at least 60 min.

Use in pregnancy: Acid Ibandronic Teva should not be used during pregnancy.

There was no evidence for a direct fetal toxic or teratogenic effect of Acid Ibandronic Teva in daily orally treated rats and rabbits and there were no adverse effects on the development in F1 offspring in rats. Adverse effects of Acid Ibandronic Teva in reproductive toxicity studies in the rat were those observed with bisphosphonates as a class. They include a decreased number of implantation sites, interference with natural delivery (dystocia), and an increase in visceral variations (renal pelvis ureter syndrome). Specific studies for the monthly regimen have not been performed.

There is no clinical experience with Acid Ibandronic Teva in pregnant women.

Use in lactation: Acid Ibandronic Teva should not be used during lactation.

In lactating rats treated with 0.08 mg/kg/day IV Acid Ibandronic Teva, the highest concentration of Acid Ibandronic Teva in breast milk was 8.1 ng/mL and was seen in the first 2 hrs after IV administration. After 24 hrs, the concentration in milk and plasma was similar and corresponded to about 5% of the concentration measured after 2 hrs.

It is not known whether Acid Ibandronic Teva is excreted in human milk.

Acid Ibandronic Teva is used to treat and prevent bones from becoming weak and brittle (osteoporosis) in menopausal women. It is also used to treat high calcium levels in the blood due to secondary bone cancer and metastasis of bone due to breast cancer.

Drug-Food Interactions: Products containing calcium and other multivalent cations (eg, aluminium, magnesium, iron), including milk and food, are likely to interfere with absorption of Acid Ibandronic Teva which is consistent with findings in animal studies. Therefore, with such products, including food, intake must be delayed for 60 min following oral administration.

Drug-Drug Interactions: It is likely that calcium supplements, antacids and some oral medications containing multivalent cations (eg, aluminium, magnesium, iron) are likely to interfere with the absorption of Acid Ibandronic Teva. Therefore, patients must wait 60 min after taking Acid Ibandronic Teva before taking other oral medications.

Pharmacokinetic interaction studies in postmenopausal women have demonstrated the absence of any interaction potential with tamoxifen or hormone replacement therapy (estrogen). No interaction was observed when co-administered with melphalan/prednisolone in patients with multiple myeloma.

In healthy male volunteers and postmenopausal women, IV ranitidine caused an increase in Acid Ibandronic Teva bioavailability of about 20%, probably as a result of reduced gastric acidity. However, since this increase is within the normal range of the bioavailability of Acid Ibandronic Teva, no dosage adjustment is required when Acid Ibandronic Teva is administered with H₂-antagonists or other drugs which increase gastric pH.

In relation to disposition, no drug interactions of clinical significance are considered likely, since Acid Ibandronic Teva does not inhibit the major human hepatic P450 isoenzymes and has been shown not to induce the hepatic cytochrome P450 system in rats. Furthermore, plasma protein binding is low at therapeutic concentrations and Acid Ibandronic Teva is therefore unlikely to displace other drugs.

Acid Ibandronic Teva is eliminated by renal excretion only and does not undergo any biotransformation. The secretory pathway appears not to include known acidic or basic transport systems involved in the excretion of other drugs.

In a 1-year study in postmenopausal women with osteoporosis (BM16549), the incidence of upper gastrointestinal events in patients concomitantly taking aspirin or NSAIDs was similar in patients taking Acid Ibandronic Teva 2.5 mg daily or 150 mg once monthly.

Of over 1500 patients enrolled in study BM16549 comparing monthly with daily dosing regimens of Acid Ibandronic Teva, 14% of patients used histamine (H₂)-blockers or proton-pump inhibitors. Among these patients, the incidence of upper gastrointestinal events in the patients treated with Acid Ibandronic Teva 150 mg once monthly was similar to that in patients treated with Acid Ibandronic Teva 2.5 mg daily.

See also:
What are the possible side effects of Acid Ibandronic Teva?

Treatment of Postmenopausal Osteoporosis: Once-Monthly Dosing: In a 2-year study in postmenopausal women with osteoporosis (BM16549) the overall safety of Acid Ibandronic Teva 150 mg once monthly and Acid Ibandronic Teva 2.5 mg daily was similar. The overall proportion of patients who experienced an adverse drug reaction, ie adverse event with a possible or probable relationship to trial medication, was 22.7% and 25% for Acid Ibandronic Teva 150 mg once monthly and 21.5% and 22.5% for Acid Ibandronic Teva 2.5 mg daily after 1 and 2 years, respectively. The majority of adverse drug reactions were mild to moderate in intensity. Most cases did not lead to cessation of therapy.

Tables 2 and 3 list adverse drug reactions occurring in >1% of patients treated with Acid Ibandronic Teva 150 mg monthly or 2.5 mg daily in study BM16549 and in patients treated with Acid Ibandronic Teva 2.5 mg daily in study MF4411. The tables show the adverse drug reactions in the 2 studies that occurred with a higher incidence than in patients treated with placebo in study MF4411. Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

Data at 1 year from study BM16549 are represented in Table 2 and cumulative data for 2 years from study BM16549 are represented in Table 3.

Adverse Drug Reactions Occurring at a Frequency of ≤1%: The following list provides information on adverse drug reactions (considered possibly or probably related to treatment by the investigator) reported in study MF4411 occurring more frequently with Acid Ibandronic Teva 2.5 mg daily than with placebo and study BM16549 occurring more frequently with Acid Ibandronic Teva 150 mg once monthly than with Acid Ibandronic Teva 2.5 mg daily. Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness: Uncommon (1/100-1/1000): Gastrointestinal Disorders: Gastritis, esophagitis, including esophageal ulcerations or strictures, vomiting, dysphagia.

Nervous System Disorders: Dizziness.

Musculoskeletal and Connective Tissue Disorders: Back pain.

Rare (1/1000-1/10,000) Gastrointestinal Disorders: Duodenitis.

Immune System Disorders: Hypersensitivity reactions.

Skin and Subcutaneous Tissue Disorders: Angioedema, face edema, urticaria.

Patients with a previous history of gastrointestinal disease including patients with peptic ulcer without recent bleeding or hospitalization and patients with dyspepsia or reflux controlled by medication were included in the once-monthly treatment study. For these patients, there was no difference in the incidence of upper gastrointestinal adverse events with the 150-mg once-monthly regimen compared to the 2.5-mg daily regimen.

Laboratory Abnormalities: In the pivotal 3-year study with Acid Ibandronic Teva 2.5 mg daily (MF4411) there was no difference compared with placebo for laboratory abnormalities indicative of hepatic or renal dysfunction, impaired hematologic system, hypocalcemia or hypophosphatemia. Similarly, no differences were noted between the groups in study BM16549 after 1 and 2 years.

Post-Marketing: Musculoskeletal and Connective Tissue Disorders: Osteonecrosis of the jaw has been reported very rarely in patients treated with Acid Ibandronic Teva.

Eye Disorders: Ocular inflammation events eg, uveitis, episcleritis and scleritis have been reported with bisphosphonates, including Acid Ibandronic Teva. In some cases, these events did not resolve until the bisphosphonate was discontinued.

Immune System Disorders: Cases of anaphylactic reaction/shock, including fatal events, have been reported in patients treated with Acid Ibandronic Teva. Allergic reactions including asthma exacerbation have been reported.

Injury, Poisoning and Procedural Complications: Atypical subtrochanteric and diaphyseal femoral fractures have been reported with bisphosphonate therapy, including ibandronate, however causality has not been established.

Each FC tablet contains Ibandronic Acid monosodium salt monohydrate 168.75 mg equivalent to Acid Ibandronic Teva 150 mg.

Acid Ibandronic Teva also contains the following excipients: Tablet Core: Lactose monohydrate, povidone, microcrystalline cellulose, crospovidone, purified stearic acid and anhydrous colloidal silica. Tablet Coat: Hypromellose, titanium dioxide, talc and macrogol 6000.