VANTAS- histrelin acetate implant

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

HISTRELIN ACETATE (UNII: QMG7HLD1ZE) (HISTRELIN - UNII:H50H3S3W74)

Dostupné s:

Endo Pharmaceuticals Inc.

INN (Mezinárodní Name):

HISTRELIN ACETATE

Složení:

HISTRELIN ACETATE 50 mg

Podání:

SUBCUTANEOUS

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

VANTAS is indicated for the palliative treatment of advanced prostate cancer. VANTAS is contraindicated in patients who are hypersensitive to gonadotropin releasing hormone (GnRH) or GnRH agonist analogs. Risk Summary The safety and efficacy of VANTAS have not been established in females. Based on findings in animal studies and its mechanism of action, VANTAS can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1)] . Expected hormonal changes that occur with VANTAS treatment increase the risk for pregnancy loss. The limited data with histrelin use in pregnant women are insufficient to determine a drug-associated risk for major birth defects or adverse developmental outcomes. In animal reproduction studies, administration of histrelin to pregnant rats and rabbits during the period of organogenesis caused an increase in fetal loss at clinically relevant exposures (see Data) . Advise pregnant patients and females of reproductive potential of the potential risk to the fetus. D

Přehled produktů:

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. The VANTAS implant carton contains a cold pack for refrigerated shipment and a small carton containing an amber plastic pouch. Inside the pouch is a glass vial with a Teflon-coated stopper and an aluminum seal, containing the implant in 2 mL of sterile 1.8% sodium chloride solution. (Note : The 3.5 mL vial is not completely filled with saline.)  Upon receipt, refrigerate the small carton containing the amber plastic pouch and glass vial (with the implant inside) until the day of insertion. The implant vial should not be opened until just before the time of insertion . Store the implant refrigerated, 2°C to 8°C (36°F to 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 provided. Excursion permitted to 25°C (77°F) for 7 days. Protect from light. Do not freeze. Store the VANTAS Implantation Kit at room temperature only. The VANTAS Implantation Kit carton contains one each of the following (individually wrapped in sterile packaging): implant insertion tool, #15 disposable scalpel, syringe with 18 gauge needle, 25 gauge 1.5” needle, SS mosquito clamp, benzoin tincture antiseptic, alcohol swabs (2 packages), fenestrated drape, non-fenestrated drape, skin antiseptic swab, gauze sponges, surgical closure strips, coated absorbable sutures, cohesive bandage, and a local anesthetic (e.g., lidocaine HCl 1% with epinephrine or lidocaine HCl 1%).

Stav Autorizace:

New Drug Application

Charakteristika produktu

VANTAS- HISTRELIN ACETATE IMPLANT
ENDO PHARMACEUTICALS INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
VANTAS® SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR VANTAS®.
VANTAS® (HISTRELIN ACETATE) SUBCUTANEOUS IMPLANT
INITIAL U.S. APPROVAL: 2004
RECENT MAJOR CHANGES
Contraindications, Pregnancy (4), Removed 12/2020
Warning and Precautions, Embryo-Fetal Toxicity (5.8) 12/2020
INDICATIONS AND USAGE
VANTAS is a gonadotropin releasing hormone (GnRH) agonist indicated
for the palliative treatment of advanced prostate
cancer. (1).
DOSAGE AND ADMINISTRATION
The recommended dose of VANTAS is one implant for 12 months. Each
implant contains 50 mg histrelin acetate to
deliver 41 mg histrelin. (2.1)
The implant provides continuous release of histrelin (50 mcg/day) for
12 months of hormonal therapy. (2.1)
The implant is inserted subcutaneously in the inner aspect of the
upper arm (2.2).
DOSAGE FORMS AND STRENGTHS
Subcutaneous implant: 50 mg histrelin acetate (3).
CONTRAINDICATIONS
Known hypersensitivity to GnRH or GnRH analogs (4).
WARNINGS AND PRECAUTIONS
Transient Increase in Serum Testosterone: Detected during the first
week of treatment and may result in worsening of
tumor symptoms. (5.1)
Spinal Cord Compression and Urinary Tract Obstruction: May cause
paralysis or renal impairment. Monitor patients at
risk closely during therapy. (5.2)
Difficulty Locating or Removing Implant: Loss of or inability to
locate or remove an inserted implant has been reported.
Caution is recommended. (5.3)
Hyperglycemia and Diabetes: Hyperglycemia and an increased risk of
developing diabetes have been reported in men
receiving GnRH analogs. Monitor blood glucose level and manage
according to current clinical practice. (5.4)
Cardiovascular Diseases: Increased risk of myocardial infarction,
sudden cardiac death and stroke has been reported in
men. Monitor for cardiovascular disease and manage according to
current clinical practice. (5.5)
Effect on QT/QTc Inte