Supprelin La

Drug overview for SUPPRELIN LA (histrelin acetate):

Generic name: HISTRELIN ACETATE (HISS-treh-lin)
Drug class: LHrH(GNrH) Agonist Analog Pituitary Suppressants
Therapeutic class: Endocrine

Histrelin acetate, a synthetic nonapeptide analog of gonadotropin-releasing hormone (GnRH, luteinizing hormone-releasing hormone (LHRH), gonadorelin), is used as an antineoplastic agent.

No enhanced Uses information available for this drug.

DRUG IMAGES

SUPPRELIN LA 50 MG KIT

The following indications for SUPPRELIN LA (histrelin acetate) have been approved by the FDA:

Indications:
Precocious puberty

Professional Synonyms:
Accelerated sexual maturity

The following dosing information is available for SUPPRELIN LA (histrelin acetate):

Dosing
Administration
Dosing Information
Generic

The usual adult dosage of histrelin acetate for the palliative treatment of advanced prostate cancer is one 50-mg implant inserted subcutaneously every 12 months. The 50-mg implant delivers 41 mg of histrelin and provides continuous release of 50 mcg of histrelin acetate (41 mcg of histrelin) daily for 12 months of hormonal therapy. The implant should be removed 12 months after insertion; the implant has been designed to allow for a few additional weeks of histrelin release to allow for flexibility in scheduling implant removal.

At the time the implant is removed, another implant may be inserted to continue therapy.

Results of a phase 2, dose-ranging study in 42 patients with advanced prostate cancer indicate that the use of 2 or 4 implants does not confer any additional benefit in suppression of testosterone beyond that produced by a single implant.

Histrelin acetate is administered as an implant that is inserted subcutaneously in the inner aspect of the upper arm. The manufacturer's labeling should be consulted for proper methods of inserting and removing histrelin acetate implants. Importance of adhering to recommended procedures to minimize the risk and complications associated with surgical insertion and removal.

(See Cautions: General Precautions.) A kit containing many of the supplies necessary to insert and/or remove the implant is provided with the implant; this kit does not require refrigeration. Histrelin acetate implants should be refrigerated at 2-8degreesC until the day of the procedure. Once removed from refrigeration, the vial containing the implant (still in its unopened pouch and carton) may remain at room temperature for up to 7 days, if necessary, before being used.

The implant vial should not be opened until just before the time of insertion. If not used in that time, the packaged implant may again be properly refrigerated until the expiration date on the carton.

No dosing information available.

No generic dosing information available.

Contraindication List
Pregnancy

Moderate List
Lower seizure threshold
Seizure disorder

The following adverse reaction information is available for SUPPRELIN LA (histrelin acetate):

Overview
Severe
Less Severe

Adverse reaction overview.

Local or insertion site reactions were reported in 13.8% of patients after insertion of a histrelin acetate implant in a single study in 138 patients. Most of these reactions were associated with initial insertion or removal and insertion of a new implant.

These reactions typically began and resolved within the first 2 weeks following implant insertion. However, in almost 3% of patients, local reactions developed after the first 2 weeks or persisted beyond 2 weeks. Local reactions reported in 2% or more of patients in this study included bruising, pain/soreness/tenderness, and erythema.

Adverse systemic effects associated with testosterone suppression occurring in 2% or more of patients receiving a histrelin acetate implant in 2 studies in a total of 171 patients included hot flushes (flashes), testicular atrophy, gynecomastia, erectile dysfunction, and decreased libido. Other adverse systemic effects occurring in 2% or more of patients included fatigue, renal impairment, constipation, headache, insomnia, and weight loss.

There are 7 severe adverse reactions.

More Frequent	Less Frequent
None.	Behavioral disorders Depression Hypersensitivity drug reaction

Rare/Very Rare
Breakage of implant Idiopathic intracranial hypertension Seizure disorder Suicidal ideation

There are 16 less severe adverse reactions.

More Frequent	Less Frequent
Headache disorder Injection site sequelae Localized edema	Epistaxis Keratoderma Mastalgia Pruritus of skin Scar of skin

Rare/Very Rare
Abnormal vaginal bleeding Aggressive behavior Dysmenorrhea Erythema Gynecomastia Irritability Mood changes Sensation of cold

The following precautions are available for SUPPRELIN LA (histrelin acetate):

Pediatric
Pregnant
Lactation
Geriatric

Not indicated for use in pediatric patients.

Contraindicated

None

Severe Precaution

None

Management or Monitoring Precaution

None

Category X. (See Cautions: Contraindications; Users Guide; and also see Fetal/Neonatal Morbidity/Mortality under Warnings/Precautions: Warnings, in Cautions.)

Not indicated for use in women. Not known whether histrelin is distributed into milk. Discontinue nursing or drug, taking into account the importance of the drug to the woman.

Clinical studies have been conducted principally in patients 65 years of age and older since prostate cancer occurs mainly in an older patient population.