VANTAS Implant 50 Milligram
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
26-05-2024
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Active ingredient:
HISTRELIN ACETATE
Available from:
Orion Corporation
Dosage:
50 Milligram
Pharmaceutical form:
Implant
Authorization date:
2008-07-11
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Vantas 50 mg implant.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each implant contains approximately 50 mg histrelin acetate corresponding to 41 mg histrelin.
For a full list of excipients, see section 6.1_._
3 PHARMACEUTICAL FORM
Implant.
The implant is in the form of a small, thin flexible tube. The histrelin acetate core is placed in a non-biodegradable 34.5
mm x 3.15 mm cylindrically shaped hydrogel reservoir.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Palliative treatment of advanced prostate cancer.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
The recommended dose of Vantas is one implant for 12 months.
An average of 50 µg histrelin acetate is delivered daily. The implant is inserted subcutaneously in the inner aspect of
the upper arm.
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
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