Medicinal Products

IBANDRONIC ACID TEVA 150 mg

Generic drug of Bonviva
Therapeutic class: Rheumatology
active ingredients: Ibandronic acid
laboratory: Teva Pharma BV

Coated tablet
Box of 3
All forms

Indication

Treatment of postmenopausal osteoporosis in women at increased risk of fracture (see section 5.1 Pharmacodynamic properties ). A reduction in the risk of vertebral fractures has been demonstrated, the effectiveness on fractures of the femoral neck has not been established.

Dosage IBANDRONIC ACID TEVA 150 mg Film-coated tablet Box of 3

Dosage:

The recommended dosage is 1 150 mg film-coated tablet once a month. It is recommended to always take the tablet at the same time each month.

Ibandronic acid Teva should be taken in the morning on an empty stomach (after a fast of at least 6 hours) and 1 hour before the first intake of food or drink (other than water) of the day (see section Interactions with other medications and other forms of interaction ) or any other oral medication or supplement (including calcium).

If the monthly dose is missed, the patient should be instructed to take one Ibanronic Acid Teva 150 mg tablet on the morning of the day the patient is missed, unless the interval before the next dose is less than 7 days. The patient will then return to her monthly schedule of administration, on the dates initially planned. If the interval before the next dose is less than 7 days, the patient will wait for the next dose and then continue her monthly schedule on the scheduled dates. The patient should not take two tablets the same week.

Patients should be supplemented with calcium and / or vitamin D if their dietary intake is inadequate (see Warnings and Precautions and Interactions with other medicinal products and other forms of interaction ).

Special populations

Renal insufficiency

No dosage adjustment is necessary in patients with mild or moderate renal impairment, characterized by a creatinine clearance greater than or equal to 30 ml / min.

Due to limited clinical experience, the use of Ibandronic Acid Teva is not recommended in patients with creatinine clearance below 30 ml / min (see sections Warnings and Precautions and Properties) pharmacokinetics ).

Hepatic insufficiency

No dosage adjustment is necessary (see section 5.2 ).

The elderly

No dosage adjustment is necessary (see section 5.2 ).

Pediatrics

There is no specific use of Ibandronic Acid Teva in children, and ibandronic acid Teva has not been studied in pediatrics.

Administration mode :

Oral way.

The tablets should be swallowed whole with a glass of still water (180 to 240 ml), with the patient standing straight, sitting or standing. Patients should not lie down for 1 hour after taking Ibandronic Acid Teva.

Still water is the only drink that can be taken with Ibandronic Acid Teva. Indeed, some mineral waters may contain a higher concentration of calcium, therefore they should not be used.

Patients should not chew or suck the tablet because of the potential risk of oropharyngeal ulcers.

Against indications

- abnormalities of the esophagus slowing esophageal transit, such as stenosis or achalasia,

- Inability to stay upright (sitting or standing) for at least 60 minutes,

- Hypocalcemia (see section Warnings and precautions for use ),

- Hypersensitivity to ibandronic acid or to any of the excipients. See also Warnings and precautions for use .

Adverse Effects Teva Ibandronic Acid

Tolerance of oral therapy with ibandronic acid 2.5 mg once daily was evaluated in 1251 patients enrolled in 4 placebo-controlled clinical studies, the vast majority of whom came from the pivotal study evaluating the efficacy of -fracturairy over three years (MF 4411). In all these studies, the overall safety profile of ibandronic acid 2.5 mg once daily was similar to that of placebo.

In a two-year study in postmenopausal osteoporosis (BM 16549), the overall safety of ibandronic acid 150 mg once a month was similar to that of ibandronic acid 2.5 mg once day. The percentage of patients who experienced an adverse reaction was respectively one year and two years of 22.7% and 25.0% on ibandronic acid 150 mg once a month. The majority of adverse events were mild to moderate. In most cases, these effects did not result in cessation of treatment.

The most commonly reported adverse event was arthralgia.

The undesirable effects considered related to ibandronic acid by the investigators are listed below by organ system class.

Frequencies are defined as follows: frequent (≥ 1/100, <1/10), uncommon (≥ 1/1000, <1/100), and rare (≥ 1/10000, <1/1000). Within each frequency group, adverse effects are presented in order of decreasing severity.

Table 1: Adverse reactions reported in postmenopausal women treated with ibandronic acid 150 mg once a month or ibandronic acid 2.5 mg once daily in the BM 16549 and MF 4411 phase III studies.

Class organ system

Frequency

Side effects

Immune system disorders

Rare

Hypersensitivity reactions

Nervous system disorders

Frequent

headaches

Rare

Dizzying sensation

Gastrointestinal disorders

Frequent

Esophagitis, gastritis, gastroesophageal reflux, dyspepsia, diarrhea, abdominal pain, nausea

Rare

Esophagitis including ulceration or stenosis of the esophagus and dysphagia, vomiting, flatulence

Rare

duodenitis

Skin and subcutaneous tissue disorders

Frequent

Skin rash

Rare

Angioedema, edema of the face, urticaria

Musculoskeletal and systemic disorders

Frequent

Arthralgia, myalgia, musculoskeletal pain, muscle cramp, muscle stiffness

Rare

Back pain

General disorders and administration site conditions

Frequent

Flu-like syndrome *

Rare

Tired

MedDRA version 7.1

* Transient flu-like symptoms have been reported with ibandronic acid 150 mg once a month, usually at first administration. These symptoms were usually short-lasting, mild to moderate in intensity and disappeared with continued treatment without special measures. The flu-like syndrome includes such things as myalgia, arthralgia, fever, chills, fatigue, nausea, loss of appetite or bone pain.

Patients with a history of gastrointestinal ulcer disease, such as peptic ulcer disease or recent hospitalization, as well as patients with treatment-controlled dyspepsia or reflux, were included in a study conducted with ibandronic acid once a month. In these patients, there was no difference in the incidence of high GI adverse events between the two regimens, 150 mg once a month and 2.5 mg once daily.

Biological effects

In a pivotal three-year pivotal study with ibandronic acid 2.5 mg once daily (MF 4411), there was no difference compared to placebo in laboratory assessments of liver and kidney failure, haematological disorder, hypocalcemia or hypophosphoremia. Similarly, no difference was observed between the groups in the study after BM 16549 one year and two years.

Experience since marketing

Osteonecrosis of the jaw has been reported in patients treated with bisphosphonates. The majority of reported cases involved cancer patients, although some of these cases have also been reported in patients treated for osteoporosis. Osteonecrosis of the jaw is usually associated with tooth extraction and / or local infection (including osteomyelitis). Also considered as risk factors are cancer diagnosis, chemotherapy, radiotherapy, steroids and poor oral hygiene (see Warnings and Precautions section ).

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