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Orion Pharma (UK) Limited
Oaklea Court, 22 Park Street, Newbury, Berkshire, RG14 1EA
Telephone: +44 (0)1635 520 300
Fax: +44 (0)1635 580 180
Medical Information e-mail: medicalinformation@orionpharma.com
Out of Hours Telephone: +44 (0)1635 520 300

Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?
Summary of Product Characteristics last updated on the eMC: 17/03/2011
SPC Vantas 50 mg Implant

When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC. For each version, we show the dates it was published on the eMC and the reasons for change.

Updated on 17/03/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.8 - Undesirable Effects
  • Change to section 6. 6 - Instructions for use, handling and disposal
Date of revision of text on the SPC:   01-Jan-2011
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
In section 4.4 (special warnings and precautions for use), the following has been added:

Long-term androgen deprivation either by bilateral orchiectomy or administration of GnRH analogues is associated with increased risk of bone loss and may lead to osteoporosis and increased risk of bone fracture. In addition, patients may experience metabolic changes (e.g. glucose intolerance or worsening of existing diabetes). Patients at high risk for metabolic or cardiovascular diseases should be carefully assessed before commencing treatment and adequately monitored during androgen deprivation therapy.

In section 4.8 (undesirabel effects) the following has been added:

Long-term androgen deprivation either by bilateral orchiectomy or administration of GnRH analogues is associated with increased risk of bone loss and may lead to osteoporosis and increased risk of bone fracture. In addition, patients may experience metabolic changes (e.g. glucose intolerance or worsening of existing diabetes).

In section 6.6 ( Special precautionsfor disposal and other handling) the following has been added:

Vantas implantation device is for single use only.



In section 10 ( date of revision of text) has changed to January 2011
Updated on 15/02/2011 and displayed until 17/03/2011
Reasons for adding or updating:
  • Addition of Black Triangle
Date of revision of text on the SPC:   01-Nov-2010
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
The reason for submitting this document is because there was no black triangle in the previous Vantas SPC.
Updated on 10/02/2011 and displayed until 15/02/2011
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.6 - Pregnancy and Lactation
Date of revision of text on the SPC:   01-Nov-2010
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
In section4.2 the following has been added:

Response to Vantas therapy should be monitored by clinical parameters and by measuring prostate-specific antigen (PSA) serum levels. Clinical studies have shown that serum testosterone concentrations may increase during the first week of treatment (testosterone flare-up). Testosterone concentrations then decreased and reached castrate levels (≤ 50 ng/dL) by Week 4. Once attained, castrate level was maintained as long as Vantas therapy continued. If a patient's clinical response appears to be sub-optimal, then it would be advisable to confirm that patient’s serum testosterone concentration is at castrate level.

 

The implant must be removed after 12 months of treatment. At the time the implant is removed a new implant may be inserted in order to continue the treatment. Please see insertion and removal procedures below.

 

Vantas is not indicated for use in women and children under 18 years old as the safety and efficacy of Vantas have not been established in these populations. No data are available.

 

Hepatic impairment and Renal impairment

Vantas has not been studied adequately in patients with impaired liver function.

In patients with mild to moderate renal impairment (CLcr: 15-60 ml/min), no adjustments in drug dosing are warranted. Vantas has not been studied in prostate cancer patients with severe renal impairment.

In section 4.6, the followign has been added:

Fertility, pregnancy and lactation

Preclinical studies have shown that histrelin decreases fertility in animals due to its pharmacological effect. However, fertility returns to normal after cessation of treatment (See section 5.3.).

 
Updated on 19/04/2010 and displayed until 10/02/2011
Reasons for adding or updating:
  • Change to section 10 date of revision of the text
  • Change to section 6. 3 - Shelf Life
Date of revision of text on the SPC:   01-Jan-2010
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
In section 6.3 (Shelf life) this has been changed from 2 years to 3 years
In section 10 (Date of Revision of the Text) this has been changed to January 2010
Updated on 01/07/2009 and displayed until 19/04/2010
Reasons for adding or updating:
  • New SPC for new product
Date of revision of text on the SPC:  
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
None provided

Active Ingredients/Generics

 
  histrelin acetate