VANTAS Implant (2014)

Βιβλιογραφική αναφορά

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Περιεχόμενα

1. Indications and Usage

VANTAS is indicated for the palliative treatment of advanced prostate cancer.

2. Dosage and Administration

2.1 Recommended Dose The recommended dose of VANTAS is one implant for 12 months. Each implant contains 50 mg histrelin acetate to deliver 41 mg histrelin. The implant is inserted subcutaneously in the ...

3. Dosage Forms and Strengths

VANTAS (histrelin acetate) implant is a sterile, non-biodegradable, diffusion-controlled hydrogel polymer reservoir containing histrelin acetate, a synthetic nonapeptide analog of the naturally occurring ...

4. Contraindications

4.1 Hypersensitivity VANTAS is contraindicated in patients with hypersensitivity to GnRH, GnRH agonist analogs, or any of the components in VANTAS. Anaphylactic reactions to synthetic GnRH agonist analogs ...

5. Warnings and Precautions

5.1 Transient Increase in Serum Testosterone VANTAS causes a transient increase in serum concentrations of testosterone during the first week of treatment. Patients may experience worsening of symptoms ...

6.1. Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another ...

6.2. Postmarketing Experience

The following adverse reactions have been identified during post approval use of VANTAS. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible ...

7. Drug Interactions

Overview No pharmacokinetic-based drug-drug interaction studies were conducted with VANTAS <em>[see Clinical Pharmacology (12.3)]</em>. Drug-Laboratory Test Interactions Therapy with histrelin results ...

8.1. Pregnancy

Pregnancy Category X. [see Contraindications (4.2)]. VANTAS is contraindicated in females who are or may become pregnant. VANTAS can cause fetal harm when administered to a pregnant woman. The possibility ...

8.3. Nursing Mothers

VANTAS is not indicated for use in women. It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions ...

8.4. Pediatric Use

VANTAS is not indicated for use in pediatric patients.

10. Overdosage

Histrelin acetate injection of up to 200 mcg/kg (rats, rabbits), or 2000 mcg/kg (mice) resulted in no systemic toxicity. This represents 20 to 200 times the maximal recommended human dose of 10 mcg/kg/day. ...

11. Description

12.1. Mechanism of Action

Histrelin acetate is a gonadatropin releasing hormone (GnRH) agonist that acts as a potent inhibitor of gonadotropin secretion when given continuously in therapeutic doses. Both animal and human studies ...

12.3. Pharmacokinetics

Absorption Following subcutaneous insertion of one VANTAS implant in advanced prostate cancer patients (n=17), peak serum concentrations of 1.10 ± 0.375 ng/mL (mean ± SD) occurred at a median of 12 hours. ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenicity studies were conducted in rats for 2 years at doses of 5, 25 or 150 mcg/kg/day (up to 22 times human exposures using body surface area comparisons, based on a 65 mcg/day dose in adults) ...

14. Clinical Studies

In one open-label, multicenter, Phase 3 study (Study 1), 138 patients with prostate cancer were treated with a single VANTAS implant and were evaluated for at least 60 weeks. Of these, 37 patients had ...

16.1. How Supplied

VANTAS (NDC 67979-500-01) is supplied in a carton containing 2 inner cartons, one for the VANTAS implant and one for the VANTAS Implantation Kit: The VANTAS implant contains 50 mg of histrelin acetate. ...

16.2. Storage and Handling

Store the implant refrigerated, 2-8°C (36-46°F), in the unopened glass vial with the sterile 1.8% sodium chloride solution, overwrapped in the amber plastic pouch and carton, until the expiration date ...

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