SUPPRELIN LA SUMMARY
SUPPRELIN LA is a sterile, non-biodegradable, diffusion-controlled, HYDRON® polymer reservoir containing histrelin acetate, a synthetic nonapeptide analog of the naturally occurring gonadotropin releasing hormone (GnRH) possessing a greater potency than the natural sequence hormone. SUPPRELIN LA is designed to deliver approximately 65 mcg histrelin per day over 12 months.
SUPPRELIN LA (histrelin acetate) subcutaneous implant is indicated for the treatment of children with central precocious puberty (CPP).
Children with CPP (neurogenic or idiopathic) have an early onset of secondary sexual characteristics (earlier than 8 years of age in females and 9 years of age in males). They also show a significantly advanced bone age that can result in diminished adult height attainment.
Prior to initiation of treatment a clinical diagnosis of CPP should be confirmed by measurement of blood concentrations of total sex steroids, luteinizing hormone (LH) and follicle stimulating hormone (FSH) following stimulation with a GnRH analog, and assessment of bone age versus chronological age. Baseline evaluations should include height and weight measurements, diagnostic imaging of the brain (to rule out intracranial tumor), pelvic/testicular/adrenal ultrasound (to rule out steroid secreting tumors), human chorionic gonadotropin levels (to rule out a chorionic gonadotropin secreting tumor), and adrenal steroids to exclude congenital adrenal hyperplasia.
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NEWS HIGHLIGHTS
Published Studies Related to Supprelin LA (Histrelin Subcutaneous)
Long-term efficacy and tolerability of once-yearly histrelin acetate subcutaneous implant in patients with advanced prostate cancer. [2011.08.18]
Study Type - Therapy (individual cohort) Level of Evidence 2b What's known on the subject? and What does the study add? Androgen deprivation therapy with a gonadotropin-releasing hormone agonist is an effective option for the palliative treatment of advanced prostate cancer. This study demonstrated the safety and efficacy of the histrelin acetate implant over successive one year treatment cycles for up to four years in an open-label extension trial. OBJECTIVE: * To evaluate the efficacy and tolerability of a once-yearly histrelin implant during an open-label extension of a pivotal study... CONCLUSIONS: * The once-yearly histrelin implant maintained testosterone suppression for repeated treatment cycles and was generally well tolerated. * The histrelin implant provides a clinically attractive option for long-term androgen deprivation therapy in patients with advanced prostate cancer seeking fewer office visits and repeated injections. (c) 2011 THE AUTHORS. BJU INTERNATIONAL (c) 2011 BJU INTERNATIONAL.
Histrelin: in advanced prostate cancer. [2010.03.26]
Histrelin is a gonadotropin-releasing hormone agonist available in a diffusion-controlled reservoir drug delivery system for subcutaneous implantation. The subcutaneous histrelin implant provided sustained suppression of serum testosterone, luteinizing hormone (LH) and prostate-specific antigen levels for up to 1 year in patients with advanced prostate cancer in two phase II or III trials...
Drug-induced liver injury caused by the histrelin (Vantus) subcutaneous implant. [2010.01]
Drug-induced liver injury (DILI) is the leading cause of acute hepatic failure in the United States... The case of a patient with liver injury following a subcutaneous histrelin (Vantus) implant as therapy for advanced prostate cancer is presented.
Clinical Trials Related to Supprelin LA (Histrelin Subcutaneous)
Prospective Multicentre Non-interventional Study of VANTAS� for the Treatment of Patients With Advanced Prostate Cancer [Recruiting]
The aim of this non-interventional (observational) study is to document, in collaboration
with established urologists in Scandinavia, experience gained from routine use of Vantas®
for the treatment of patients with advanced prostate cancer. In this observational study
particular attention will be directed to treatment duration, quality of life and patient and
physician acceptance of the medicinal product for long-term therapy. Patient-based
measurement parameters such as quality of life and degree of satisfaction will allow
registration of information that extends beyond the clinical parameters. The knowledge
gathered will enable patient acceptance of long-term therapy to be evaluated. Clinical
outcome will also be documented by measuring serum testosterone and prostate specific
antigen (PSA) levels.
Reports of Suspected Supprelin LA (Histrelin Subcutaneous) Side Effects
Headache (3),
Procedural Complication (3),
Mood Swings (3),
Drug Effect Decreased (3),
Affect Lability (3),
Abdominal Pain (2),
Personality Change (2),
Constipation (2),
Death (2),
Hot Flush (2), more >>
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Page last updated: 2011-12-09
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