Zometa

zoledronic acid

  • Email
  • Help

About

This is a summary of the European public assessment report (EPAR). It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach its recommendations on how to use the medicine.

If you need more information about your medical condition or your treatment, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. If you want more information on the basis of the CHMP recommendations, read the scientific discussion (also part of the EPAR).

What is Zometa?

Zometa is a medicine that contains the active substance zoledronic acid. It is available as a powder (4 mg) and solvent, and as a concentrate (4 mg / 5 ml), both of which are made up into a solution for infusion (drip into a vein), and as a pre-prepared solution for infusion (4 mg / 100 ml).

What is Zometa used for?

Zometa can be used to prevent bone complications in adults with advanced cancer that is affecting the bone. This includes fractures (breaks in the bone), spinal compression (when the spinal cord is compressed by the bone), bone disorders needing radiotherapy (treatment with radiation) or surgery, and hypercalcaemia (high levels of calcium in the blood). Zometa can also be used to treat the hypercalcaemia caused by tumours.

The medicine can only be obtained with a prescription.

How is Zometa used?

Zometa must only be used by a doctor who has experience in the use of this type of medicine given into a vein.

The usual dose of Zometa is one infusion of 4 mg over at least 15 minutes. When used to prevent bone complications, the infusion can be repeated every three to four weeks, and patients should also take supplements of calcium and vitamin D. A lower dose is recommended for patients with bone metastases (when cancer has spread to the bone) if they have mild to moderate problems with their kidneys. It is not recommended for patients with severe kidney problems.

How does Zometa work?

The active substance in Zometa, zoledronic acid, is a bisphosphonate. It stops the action of the osteoclasts, the cells in the body that are involved in breaking down the bone tissue. This leads to less bone loss. The reduction of bone loss helps to make bones less likely to break, which is useful in preventing fractures in cancer patients with bone metastases.

Patients with tumours can have high levels of calcium in their blood, released from the bones. By preventing the breakdown of bones, Zometa also helps to reduce the amount of calcium released into the blood.

How has Zometa been studied?

Zometa has been studied in over 3,000 adults with bone metastases in three main studies looking at its ability to prevent bone damage. Zometa was compared with placebo (a dummy treatment) in two of the studies, and with pamidronate (another bisphosphonate) in the third. The main measure of effectiveness was the number of patients who developed at least one new ‘skeletal event’ over 13 months. This included any bone complications needing treatment with radiotherapy or surgery, any fractures or any spinal compression.

Zometa has also been compared with pamidronate in two main studies involving a total of 287 adults with hypercalcaemia caused by tumours. The main measure of effectiveness was the number of patients whose calcium levels had returned to normal within 10 days after treatment.

What benefit has Zometa shown during the studies?

In the first two studies of patients with bone metastases, the number of patients who developed a new skeletal event was lower with Zometa (33 to 38%) than with placebo (44%). In the third study, Zometa was as effective as pamidronate: 44% of the patients receiving Zometa had at least one skeletal event, compared with 46% of those receiving pamidronate.

In patients with hypercalcaemia, Zometa was more effective than pamidronate. Looking at the results of the two studies together, 88% of the patients receiving Zometa had normal calcium levels within 10 days after treatment, compared with 70% of those receiving pamidronate.

What is the risk associated with Zometa?

The most common side effect with Zometa (seen in more than 1 patient in 10) is hypophosphataemia (low blood phosphate levels). Osteonecrosis of the jaw (damage to the bones of the jaw, which could lead to pain, sores in the mouth or loosening of teeth) has been reported uncommonly (seen in between 1 and 10 patients in 1,000). For the full list of all side effects reported with Zometa, see the package leaflet.

Zometa must not be used in people who are hypersensitive (allergic) to zoledronic acid, other bisphosphonates or any of the other ingredients. Zometa should not be used in pregnant or breast-feeding women.

Why has Zometa been approved?

The CHMP decided that Zometa’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 Zometa?

A risk management plan has been developed to ensure that Zometa 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 Zometa, including the appropriate precautions to be followed by healthcare professionals and patients.

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

Other information about Zometa

The European Commission granted a marketing authorisation valid throughout the European Union for Zometa on 20 March 2001.

For more information about treatment with Zometa, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Name Language First published Last updated
Zometa : EPAR - Summary for the public BG = bălgarski 2008-06-12 2015-11-24
Zometa : EPAR - Summary for the public ES = español 2008-06-12 2015-11-24
Zometa : EPAR - Summary for the public CS = čeština 2008-06-12 2015-11-24
Zometa : EPAR - Summary for the public DA = dansk 2008-06-12 2015-11-24
Zometa : EPAR - Summary for the public DE = Deutsch 2008-06-12 2015-11-24
Zometa : EPAR - Summary for the public ET = eesti keel 2008-06-12 2015-11-24
Zometa : EPAR - Summary for the public EL = elliniká 2008-06-12 2015-11-24
Zometa : EPAR - Summary for the public EN = English 2008-06-12 2015-11-24
Zometa : EPAR - Summary for the public FR = français 2008-06-12 2015-11-24
Zometa : EPAR - Summary for the public IT = italiano 2008-06-12 2015-11-24
Zometa : EPAR - Summary for the public LV = latviešu valoda 2008-06-12 2015-11-24
Zometa : EPAR - Summary for the public LT = lietuvių kalba 2008-06-12 2015-11-24
Zometa : EPAR - Summary for the public HU = magyar 2008-06-12 2015-11-24
Zometa : EPAR - Summary for the public MT = Malti 2008-06-12 2015-11-24
Zometa : EPAR - Summary for the public NL = Nederlands 2008-06-12 2015-11-24
Zometa : EPAR - Summary for the public PL = polski 2008-06-12 2015-11-24
Zometa : EPAR - Summary for the public PT = português 2008-06-12 2015-11-24
Zometa : EPAR - Summary for the public RO = română 2008-06-12 2015-11-24
Zometa : EPAR - Summary for the public SK = slovenčina 2008-06-12 2015-11-24
Zometa : EPAR - Summary for the public SL = slovenščina 2008-06-12 2015-11-24
Zometa : EPAR - Summary for the public FI = suomi 2008-06-12 2015-11-24
Zometa : EPAR - Summary for the public SV = svenska 2008-06-12 2015-11-24
Zometa : EPAR - Summary for the public HR = Hrvatski 2008-06-12 2015-11-24

This EPAR was last updated on 28/06/2016 .

Authorisation details

Product details

Product details for Zometa
NameZometa
Agency product numberEMEA/H/C/000336
Active substance

zoledronic acid / zoledronic acid monohydrate

International non-proprietary name (INN) or common name

zoledronic acid

Therapeutic area CancerFractures, Bone
Anatomical therapeutic chemical (ATC) code M05BA08

Publication details

Publication details for Zometa
Marketing-authorisation holder

Novartis Europharm Limited

Revision29
Date of issue of marketing authorisation valid throughout the European Union20/03/2001

Contact address:

Novartis Europharm Limited
Frimley Business Park
Camberley GU16 7SR
United Kingdom

Product information

Product information

21/06/2016  Zometa -EMEA/H/C/000336 -PSUSA/3149/201508

Name Language First published Last updated
Zometa : EPAR - Product Information HR = Hrvatski 2009-08-06 2016-06-28
Zometa : EPAR - Product Information HR = Hrvatski 2009-08-06 2016-06-28
Zometa : EPAR - Product Information HR = Hrvatski 2009-08-06 2016-06-28
Zometa : EPAR - Product Information HR = Hrvatski 2009-08-06 2016-06-28
Zometa : EPAR - Product Information HR = Hrvatski 2009-08-06 2016-06-28
Zometa : EPAR - Product Information HR = Hrvatski 2009-08-06 2016-06-28
Zometa : EPAR - Product Information HR = Hrvatski 2009-08-06 2016-06-28
Zometa : EPAR - Product Information HR = Hrvatski 2009-08-06 2016-06-28
Zometa : EPAR - Product Information HR = Hrvatski 2009-08-06 2016-06-28
Zometa : EPAR - Product Information HR = Hrvatski 2009-08-06 2016-06-28
Zometa : EPAR - Product Information HR = Hrvatski 2009-08-06 2016-06-28
Zometa : EPAR - Product Information HR = Hrvatski 2009-08-06 2016-06-28
Zometa : EPAR - Product Information HR = Hrvatski 2009-08-06 2016-06-28
Zometa : EPAR - Product Information HR = Hrvatski 2009-08-06 2016-06-28
Zometa : EPAR - Product Information HR = Hrvatski 2009-08-06 2016-06-28
Zometa : EPAR - Product Information HR = Hrvatski 2009-08-06 2016-06-28
Zometa : EPAR - Product Information HR = Hrvatski 2009-08-06 2016-06-28
Zometa : EPAR - Product Information HR = Hrvatski 2009-08-06 2016-06-28
Zometa : EPAR - Product Information HR = Hrvatski 2009-08-06 2016-06-28
Zometa : EPAR - Product Information HR = Hrvatski 2009-08-06 2016-06-28
Zometa : EPAR - Product Information HR = Hrvatski 2009-08-06 2016-06-28
Zometa : EPAR - Product Information HR = Hrvatski 2009-08-06 2016-06-28
Zometa : EPAR - Product Information HR = Hrvatski 2009-08-06 2016-06-28
Zometa : EPAR - Product Information HR = Hrvatski 2009-08-06 2016-06-28
Zometa : EPAR - Product Information HR = Hrvatski 2009-08-06 2016-06-28

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
Zometa : EPAR - All Authorised presentations HR = Hrvatski 2008-06-30 2014-02-19
Zometa : EPAR - All Authorised presentations HR = Hrvatski 2008-06-30 2014-02-19
Zometa : EPAR - All Authorised presentations HR = Hrvatski 2008-06-30 2014-02-19
Zometa : EPAR - All Authorised presentations HR = Hrvatski 2008-06-30 2014-02-19
Zometa : EPAR - All Authorised presentations HR = Hrvatski 2008-06-30 2014-02-19
Zometa : EPAR - All Authorised presentations HR = Hrvatski 2008-06-30 2014-02-19
Zometa : EPAR - All Authorised presentations HR = Hrvatski 2008-06-30 2014-02-19
Zometa : EPAR - All Authorised presentations HR = Hrvatski 2008-06-30 2014-02-19
Zometa : EPAR - All Authorised presentations HR = Hrvatski 2008-06-30 2014-02-19
Zometa : EPAR - All Authorised presentations HR = Hrvatski 2008-06-30 2014-02-19
Zometa : EPAR - All Authorised presentations HR = Hrvatski 2008-06-30 2014-02-19
Zometa : EPAR - All Authorised presentations HR = Hrvatski 2008-06-30 2014-02-19
Zometa : EPAR - All Authorised presentations HR = Hrvatski 2008-06-30 2014-02-19
Zometa : EPAR - All Authorised presentations HR = Hrvatski 2008-06-30 2014-02-19
Zometa : EPAR - All Authorised presentations HR = Hrvatski 2008-06-30 2014-02-19
Zometa : EPAR - All Authorised presentations HR = Hrvatski 2008-06-30 2014-02-19
Zometa : EPAR - All Authorised presentations HR = Hrvatski 2008-06-30 2014-02-19
Zometa : EPAR - All Authorised presentations HR = Hrvatski 2008-06-30 2014-02-19
Zometa : EPAR - All Authorised presentations HR = Hrvatski 2008-06-30 2014-02-19
Zometa : EPAR - All Authorised presentations HR = Hrvatski 2008-06-30 2014-02-19
Zometa : EPAR - All Authorised presentations HR = Hrvatski 2008-06-30 2014-02-19
Zometa : EPAR - All Authorised presentations HR = Hrvatski 2008-06-30 2014-02-19
Zometa : EPAR - All Authorised presentations HR = Hrvatski 2008-06-30 2014-02-19
Zometa : EPAR - All Authorised presentations HR = Hrvatski 2008-06-30 2014-02-19
Zometa : EPAR - All Authorised presentations HR = Hrvatski 2008-06-30 2014-02-19

Pharmacotherapeutic group

Drugs for treatment of bone diseases

Therapeutic indication

  • Prevention of skeletal related events (pathological fractures, spinal compression, radiation or surgery to bone, or tumour-induced hypercalcaemia) in patients with advanced malignancies involving bone;
  • treatment of tumour-induced hypercalcaemia (TIH);
  • prevention of skeletal related events (pathological fractures, spinal compression, radiation or surgery to bone, or tumour-induced hypercalcaemia) in patients with advanced malignancies involving bone;
  • treatment of tumour-induced hypercalcaemia (TIH);
  • prevention of skeletal related events (pathological fractures, spinal compression, radiation or surgery to bone, or tumour-induced hypercalcaemia) in adult patients with advanced malignancies involving bone;
  • treatment of adult patients with tumour-induced hypercalcaemia (TIH).

Assessment History

Authorised

This medicine is approved for use in the European Union

More information on Zometa