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SUPPRELIN LA (histrelin acetate) subcutaneous

2016-07-23 13:27:02 来源: 作者: 【大中小】浏览:363次评论:0条

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use SUPPRELIN® LA safely and effectively. See full prescribing information for SUPPRELIN LA.
SUPPRELIN LA (histrelin acetate) subcutaneous implant
Initial U.S. Approval: 1991

INDICATIONS AND USAGE

SUPPRELIN LA is a gonadotropin releasing hormone (GnRH) agonist indicated for the treatment of children with central precocious puberty (CPP) (1).
DOSAGE AND ADMINISTRATION

The recommended dose of SUPPRELIN LA is one implant every 12 months. The implant is inserted subcutaneously in the inner aspect of the upper arm and provides continuous release of histrelin for 12 months of hormonal therapy (2).

DOSAGE FORMS AND STRENGTHS

SUPPRELIN LA is available as a 50 mg histrelin acetate subcutaneous implant which delivers approximately 65 mcg histrelin acetate per day over 12 months (3).
CONTRAINDICATIONS

History of hypersensitivity to gonadotropin releasing hormone (GnRH) or GnRH analogs (4).
Pregnancy: SUPPRELIN LA can cause fetal harm when used during pregnancy (4).

WARNINGS AND PRECAUTIONS

Initial Agonistic Action: Initial transient increases of estradiol and/or testosterone may cause a temporary worsening of symptoms (5.1).

ADVERSE REACTIONS

The most common adverse reaction is implant site reaction (51.1%), including complications related to the insertion or removal of the implant (6).
Adverse events related to suppression of endogenous sex steroid secretion may occur (6.1).

To report SUSPECTED ADVERSE REACTIONS, contact Endo Pharmaceuticals Solutions Inc., at 1-800-462-3636 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

USE IN SPECIFIC POPULATIONS

Use of SUPPRELIN LA in children less than 2 years of age is not recommended (8.4).

See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.

Revised: 6/2013

FULL PRESCRIBING INFORMATION: CONTENTS*

1 INDICATIONS AND USAGE

2 DOSAGE AND ADMINISTRATION

2.1 Recommended Dose

2.2 Recommended Procedure for Implant Insertion and Removal

3 DOSAGE FORMS AND STRENGTHS

4 CONTRAINDICATIONS

5 WARNINGS AND PRECAUTIONS

5.1 Initial Agonistic Action

5.2 Implant Insertion/Removal Procedure

5.3 Monitoring and Laboratory Tests

6 ADVERSE REACTIONS

6.1 Overall Adverse Reaction Profile

6.2 Adverse Reactions in Clinical Trials

6.3 Post-marketing Experience

7 DRUG INTERACTIONS

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

8.4 Pediatric Use

10 OVERDOSAGE

11 DESCRIPTION

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

12.2 Pharmacodynamics

12.3 Pharmacokinetics

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

14 CLINICAL STUDIES

16 HOW SUPPLIED/STORAGE AND HANDLING

17 PATIENT COUNSELING INFORMATION

17.1 Initial Agonistic Action

17.2 Post-insertion Care

17.3 Common Adverse Reactions

*: Sections or subsections omitted from the full prescribing information are not listed.

1 INDICATIONS AND USAGE

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 eva luations 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.

2 DOSAGE AND ADMINISTRATION

2.1 Recommended Dose

The recommended dose of SUPPRELIN LA is one implant every 12 months. Each implant contains 50 mg histrelin acetate. The implant is inserted subcutaneously in the inner aspect of the upper arm and provides continuous release of histrelin (65 mcg/day) for 12 months of hormonal therapy. SUPPRELIN LA should be removed after 12 months of therapy (the implant has been designed to allow for a few additional weeks of histrelin acetate release, in order to allow flexibility of medical appointments). At the time an implant is removed, another implant may be inserted to continue therapy. Discontinuation of SUPPRELIN LA should be considered at the discretion of the physician and at the appropriate time point for the onset of puberty (approximately 11 years for females and 12 years for males).

2.2 Recommended Procedure for Implant Insertion and Removal

This procedure section is intended to provide guidance for the insertion and removal of SUPPRELIN LA. The actual procedure used, however, is at the discretion of the qualified healthcare provider performing the procedure.

Insertion of a new implant can proceed using the following Suggested Insertion Procedure. If a previous SUPPRELIN LA implant must first be removed, please see the Suggested Removal Procedure instructions below.

Suggested Insertion Procedure
The supplies necessary to insert the implant, including the Insertion Tool and local anesthetic, are provided in a separate Implantation Kit that is shipped along with the implant.