Bonviva

ibandronic acid

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This is a summary of the European public assessment report (EPAR) for Bonviva. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Bonviva.

What is Bonviva?

Bonviva is a medicine that contains the active substance ibandronic acid. It is available as tablets (150 mg) and as a solution for injection in a prefilled syringe (3 mg).

What is Bonviva used for?

Bonviva is used to treat osteoporosis (a disease that makes bones fragile) in women who have been through the menopause and are at risk of developing bone fractures (breaks). Its effect in reducing the risk of spine fractures has been shown in studies, but its effect on the risk of fractures of the neck of the femur (the top of the thighbone) has not been established.

The medicine can only be obtained with a prescription.

How is Bonviva used?

Bonviva can be given either as a tablet or as an injection into a vein. If the tablet is used, the dose is one tablet every month, preferably on the same date each month. The tablet should be taken after an overnight fast, one hour before any food or drink except for water, and with a full glass of plain water. (In areas with hard water, where tap water contains a lot of dissolved calcium, bottled water with a low mineral content may be used.) The patient should not lie down for one hour after taking the tablet. The dose by injection is 3 mg once every three months. Patients taking Bonviva should also take vitamin D and calcium supplements if they do not get enough from their diet.

How does Bonviva work?

Osteoporosis happens when not enough new bone grows to replace the bone that is naturally broken down. Gradually, the bones become thin and fragile, and more likely to break. Osteoporosis is more common in women after the menopause, when the levels of the female hormone oestrogen fall, since oestrogen helps to keep bones healthy.

The active substance in Bonviva, ibandronic acid, is a bisphosphonate. It stops the action of the osteoclasts, the cells that are involved in breaking down the bone tissue. Blocking the action of these cells leads to less bone loss.

How has Bonviva been studied?

Bonviva has been studied in three main studies involving women with osteoporosis. The first study compared Bonviva 2.5-mg tablets taken once a day with placebo (a dummy treatment) in almost 3,000 women and looked at how many new spine fractures were seen in the patients over three years. The other two studies compared the 150-mg monthly tablets (1,609 patients) and the injections (1,395 patients) with the 2.5-mg once-daily tablets. The studies looked at the change in the density of the bones in the spine and the hip over two years.

The 2.5-mg once-daily tablets used in the studies are no longer authorised.

What benefit has Bonviva shown during the studies?

In the first study, daily treatment with Bonviva 2.5-mg tablets reduced the risk of new spine fractures by 62% in comparison with placebo. The other two studies showed that the 150-mg monthly tablets and the injections were more effective than the 2.5-mg once-daily tablets at increasing bone density in the spine and the hip. Over two years, bone density in the spine increased by 7% with the monthly tablets and by 6% with the injections, compared with 5% with the daily tablets. In the hip, bone density increased by 4% with the monthly tablets and by 3% with the injections, compared with 2% with the daily tablets.

What is the risk associated with Bonviva?

The most common side effects with Bonviva (seen in between 1 and 10 patients in 100) are arthralgia (joint pain) and influenza (flu)-like symptoms. The most serious side effects with Bonviva are anaphylactic reaction (severe allergic reaction), atypical fractures of the femur (an unusual type of fracture of the bone of the upper leg), osteonecrosis of the jaw (damage to the bones of the jaw, which could lead to pain, sores in the mouth or loosening of teeth), gastrointestinal (stomach and gut) irritation and eye inflammation. For the full list of all side effects reported with Bonviva, see the package leaflet.

Bonviva must not be used in patients who have hypocalcaemia (low blood calcium levels). The tablets must not be used in patients who have abnormalities of the oesophagus or who cannot stand or sit upright for at least an hour. For the full list of restrictions with Bonviva, see the package leaflet.

Why has Bonviva been approved?

The Committee for Medicinal Products for Human Use (CHMP) decided that Bonviva’s benefits are greater than its risks and recommended that it be given marketing authorisation.

What measures are being taken to ensure the safe and effective use of Bonviva?

A risk management plan has been developed to ensure that Bonviva is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Bonviva, including the appropriate precautions to be followed by healthcare professionals and patients.

In addition, the company that markets Bonviva will provide a card to inform patients receiving Bonviva infusion about the risk of osteonecrosis of the jaw and to instruct them to contact their doctor if they experience symptoms.

Other information about Bonviva

The European Commission granted a marketing authorisation valid throughout the European Union for Bonviva on 23 February 2004.

Name Language First published Last updated
Bonviva : EPAR - Summary for the public BG = bălgarski 2009-03-19 2016-05-18
Bonviva : EPAR - Summary for the public ES = español 2009-03-19 2016-05-18
Bonviva : EPAR - Summary for the public CS = čeština 2009-03-19 2016-05-18
Bonviva : EPAR - Summary for the public DA = dansk 2009-03-19 2016-05-18
Bonviva : EPAR - Summary for the public DE = Deutsch 2009-03-19 2016-05-18
Bonviva : EPAR - Summary for the public ET = eesti keel 2009-03-19 2016-05-18
Bonviva : EPAR - Summary for the public EL = elliniká 2009-03-19 2016-05-18
Bonviva : EPAR - Summary for the public EN = English 2009-03-19 2016-05-18
Bonviva : EPAR - Summary for the public FR = français 2009-03-19 2016-05-18
Bonviva : EPAR - Summary for the public IT = italiano 2009-03-19 2016-05-18
Bonviva : EPAR - Summary for the public LV = latviešu valoda 2009-03-19 2016-05-18
Bonviva : EPAR - Summary for the public LT = lietuvių kalba 2009-03-19 2016-05-18
Bonviva : EPAR - Summary for the public HU = magyar 2009-03-19 2016-05-18
Bonviva : EPAR - Summary for the public MT = Malti 2009-03-19 2016-05-18
Bonviva : EPAR - Summary for the public NL = Nederlands 2009-03-19 2016-05-18
Bonviva : EPAR - Summary for the public PL = polski 2009-03-19 2016-05-18
Bonviva : EPAR - Summary for the public PT = português 2009-03-19 2016-05-18
Bonviva : EPAR - Summary for the public RO = română 2009-03-19 2016-05-18
Bonviva : EPAR - Summary for the public SK = slovenčina 2009-03-19 2016-05-18
Bonviva : EPAR - Summary for the public SL = slovenščina 2009-03-19 2016-05-18
Bonviva : EPAR - Summary for the public FI = suomi 2009-03-19 2016-05-18
Bonviva : EPAR - Summary for the public SV = svenska 2009-03-19 2016-05-18
Bonviva : EPAR - Summary for the public HR = Hrvatski 2009-03-19 2016-05-18

This EPAR was last updated on 11/04/2018 .

Authorisation details

Product details

Product details for Bonviva
NameBonviva
Agency product numberEMEA/H/C/000501
Active substance

ibandronic acid

International non-proprietary name (INN) or common name

ibandronic acid

Therapeutic area Osteoporosis, Postmenopausal
Anatomical therapeutic chemical (ATC) code M05BA06

Publication details

Publication details for Bonviva
Marketing-authorisation holder

Atnahs Pharma UK Limited

Revision23
Date of issue of marketing authorisation valid throughout the European Union23/02/2004

Contact address:

Atnahs Pharma UK Limited
Sovereign House
Miles Gray Road
Basildon
SS14 3FR
United Kingdom

Product information

Product information

04/04/2018  Bonviva -EMEA/H/C/000501 -T/0064

Name Language First published Last updated
Bonviva : EPAR - Product Information HR = Hrvatski 2009-08-14 2018-04-11
Bonviva : EPAR - Product Information HR = Hrvatski 2009-08-14 2018-04-11
Bonviva : EPAR - Product Information HR = Hrvatski 2009-08-14 2018-04-11
Bonviva : EPAR - Product Information HR = Hrvatski 2009-08-14 2018-04-11
Bonviva : EPAR - Product Information HR = Hrvatski 2009-08-14 2018-04-11
Bonviva : EPAR - Product Information HR = Hrvatski 2009-08-14 2018-04-11
Bonviva : EPAR - Product Information HR = Hrvatski 2009-08-14 2018-04-11
Bonviva : EPAR - Product Information HR = Hrvatski 2009-08-14 2018-04-11
Bonviva : EPAR - Product Information HR = Hrvatski 2009-08-14 2018-04-11
Bonviva : EPAR - Product Information HR = Hrvatski 2009-08-14 2018-04-11
Bonviva : EPAR - Product Information HR = Hrvatski 2009-08-14 2018-04-11
Bonviva : EPAR - Product Information HR = Hrvatski 2009-08-14 2018-04-11
Bonviva : EPAR - Product Information HR = Hrvatski 2009-08-14 2018-04-11
Bonviva : EPAR - Product Information HR = Hrvatski 2009-08-14 2018-04-11
Bonviva : EPAR - Product Information HR = Hrvatski 2009-08-14 2018-04-11
Bonviva : EPAR - Product Information HR = Hrvatski 2009-08-14 2018-04-11
Bonviva : EPAR - Product Information HR = Hrvatski 2009-08-14 2018-04-11
Bonviva : EPAR - Product Information HR = Hrvatski 2009-08-14 2018-04-11
Bonviva : EPAR - Product Information HR = Hrvatski 2009-08-14 2018-04-11
Bonviva : EPAR - Product Information HR = Hrvatski 2009-08-14 2018-04-11
Bonviva : EPAR - Product Information HR = Hrvatski 2009-08-14 2018-04-11
Bonviva : EPAR - Product Information HR = Hrvatski 2009-08-14 2018-04-11
Bonviva : EPAR - Product Information HR = Hrvatski 2009-08-14 2018-04-11
Bonviva : EPAR - Product Information HR = Hrvatski 2009-08-14 2018-04-11
Bonviva : EPAR - Product Information HR = Hrvatski 2009-08-14 2018-04-11

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.


Name Language First published Last updated
Bonviva : EPAR - All Authorised presentations HR = Hrvatski 2009-03-19  
Bonviva : EPAR - All Authorised presentations HR = Hrvatski 2009-03-19  
Bonviva : EPAR - All Authorised presentations HR = Hrvatski 2009-03-19  
Bonviva : EPAR - All Authorised presentations HR = Hrvatski 2009-03-19  
Bonviva : EPAR - All Authorised presentations HR = Hrvatski 2009-03-19  
Bonviva : EPAR - All Authorised presentations HR = Hrvatski 2009-03-19  
Bonviva : EPAR - All Authorised presentations HR = Hrvatski 2009-03-19  
Bonviva : EPAR - All Authorised presentations HR = Hrvatski 2009-03-19  
Bonviva : EPAR - All Authorised presentations HR = Hrvatski 2009-03-19  
Bonviva : EPAR - All Authorised presentations HR = Hrvatski 2009-03-19  
Bonviva : EPAR - All Authorised presentations HR = Hrvatski 2009-03-19  
Bonviva : EPAR - All Authorised presentations HR = Hrvatski 2009-03-19  
Bonviva : EPAR - All Authorised presentations HR = Hrvatski 2009-03-19  
Bonviva : EPAR - All Authorised presentations HR = Hrvatski 2009-03-19  
Bonviva : EPAR - All Authorised presentations HR = Hrvatski 2009-03-19  
Bonviva : EPAR - All Authorised presentations HR = Hrvatski 2009-03-19  
Bonviva : EPAR - All Authorised presentations HR = Hrvatski 2009-03-19  
Bonviva : EPAR - All Authorised presentations HR = Hrvatski 2009-03-19  
Bonviva : EPAR - All Authorised presentations HR = Hrvatski 2009-03-19  
Bonviva : EPAR - All Authorised presentations HR = Hrvatski 2009-03-19  
Bonviva : EPAR - All Authorised presentations HR = Hrvatski 2009-03-19  
Bonviva : EPAR - All Authorised presentations HR = Hrvatski 2009-03-19  

Pharmacotherapeutic group

Drugs for treatment of bone diseases

Therapeutic indication

Treatment of osteoporosis in postmenopausal women at increased risk of fracture.

A reduction in the risk of vertebral fractures has been demonstrated, efficacy on femoral neck fractures has not been established.

Assessment History

Changes since initial authorisation of medicine

Initial marketing-authorisation documents

Name Language First published Last updated
Bonviva : EPAR - Procedural steps taken before authorisation HR = Hrvatski 2006-10-17  
Bonviva : EPAR - Scientific Discussion HR = Hrvatski 2006-10-17