SUPPRELIN LA- histrelin acetate implant

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

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

זמין מ:

ENDO USA, Inc.

INN (שם בינלאומי):

HISTRELIN ACETATE

הרכב:

HISTRELIN ACETATE 50 mg

מסלול נתינה (של תרופות):

SUBCUTANEOUS

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

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. SUPPRELIN LA is contraindicated in: - Patients who are hypersensitive to gonadotropin releasing hormone (GnRH) or GnRH agonist analogs - Pregnancy [see Use in Specific Populations (8.1) ]. Risk Summary SUPPRELIN LA is contraindicated during pregnancy [see Contraindications (4)] since expected hormonal changes that occur with SUPPRELIN LA 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. Consistent with mechanism of action for SUPPRELIN LA [see Clinical Pharmacology (12.1)], animal reproduction studies showed an increase in fetal loss at clinically relevant exposures. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the US general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Data Animal Data Histrelin acetate administered to pregnant rats during the period of organogenesis increased fetal mortality and post-implantation loss at doses of 1, 3, 5 or 15 mcg/kg/day, approximating clinical exposure based on body surface area. These dosages also reduced maternal body weight gain, stimulated ovarian follicular development, increased placental weight and caused abnormal morphology and an increase in fetal size. Histrelin acetate administered to pregnant rabbits during the period of organogenesis increased fetal mortality and abortion/early termination at the two highest doses and caused total litter loss at all doses of 20, 50 or 80 mcg/kg/day (approximately 3- to 12-times clinical exposures based on body surface area). Risk Summary There are no data on the presence of SUPPRELIN LA in human or animal milk, the effects on the breastfed infant, or the effects on milk production. Absorption and systemic activity are not expected from potential exposure to the peptide, histrelin, in the breast milk. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for SUPPRELIN LA and any potential adverse effects on the breastfed child from SUPPRELIN LA or from the underlying maternal condition. Safety and effectiveness in pediatric patients below the age of 2 years have not been established. The use of SUPPRELIN LA in children under 2 years is not recommended.

leaflet_short:

SUPPRELIN LA (NDC 67979-002-01) is supplied in a corrugated shipping carton that contains 2 inner cartons: a small one for the vial containing the SUPPRELIN LA implant, which is shipped with a cold pack inside a polystyrene cooler that must be refrigerated upon arrival, and a larger one comprising the Implantation Kit, which must not be refrigerated, for use during insertion or removal of SUPPRELIN LA. The SUPPRELIN LA implant contains 50 mg of histrelin acetate. The SUPPRELIN LA 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. SUPPRELIN LA is stable when stored refrigerated, in its sealed vial, pouch, and carton, at 2-8 °C (36-46 °F) until the expiration date provided. Excursion permitted to 25 °C (77 °F) for 7 days. Do not freeze. Protect from light.

מצב אישור:

New Drug Application

עלון מידע

ENDO USA, Inc.
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Medication Guide
SUPPRELIN® LA [Suh-Preh-Lin El-Ay]
(histrelin acetate) subcutaneous implant
What is the most important information I should know about SUPPRELIN
LA?
•
In the first week of treatment, SUPPRELIN LA can cause an increase in
some hormones. During this
time you may notice more signs of puberty in your child, including
light vaginal bleeding and breast
enlargement in girls. Within 4 weeks of treatment, you should see
signs in your child that puberty is
stopping.
•
Some people who had SUPPRELIN LA placed in their arm have had the
implant come through the
skin (extrusion). Call your child’s doctor right away if the
SUPPRELIN LA implant comes through
the skin.
•
Some people taking GnRH agonists like SUPPRELIN LA have had new or
worsening mental
(psychiatric) problems. Mental (psychiatric) problems may include
emotional symptoms such as:
•
crying
•
irritability
•
restlessness (impatience)
•
anger
•
acting aggressive
Call your child’s doctor right away if your child has any new or
worsening mental symptoms or problems
while taking SUPPRELIN LA.
•
Some people taking GnRH agonists like SUPPRELIN LA have had seizures.
The risk of seizures
may be higher in people who:
•
have a history of seizures
•
have a history of epilepsy
•
have a history of brain or brain vessel (cerebrovascular) problems or
tumors
•
are taking a medicine that has been connected to seizures such as
bupropion or selective
serotonin reuptake inhibitors (SSRIs)
Seizures have also happened in people who have not had any of these
problems.
Call your child’s doctor right away if your child has a seizure
while taking SUPPRELIN LA.
•
Increased pressure in the fluid around the brain can happen in
children taking GnRH agonist
medicines including SUPPRELIN LA.
Call your child’s doctor right away if your child has any of the
following symptoms during treatment
with SUPPRELIN LA:
•
headache
•
ringing in the ears
•
eye problems, including blurred vision, double vision, and decreased
eye

מאפייני מוצר

SUPPRELIN LA- HISTRELIN ACETATE IMPLANT
ENDO USA, INC.
----------
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 (4).
WARNINGS AND PRECAUTIONS
Initial Agnostic Action: Initial transient increases of estradiol
and/or testosterone may cause a
temporary worsening of symptoms (5.1).
Implant Breakage: Have been observed during implant removal. Monitor
luteinizing hormone, follicle
stimulating hormone or testosterone for suppression of CPP (5.2, 5.6)
Psychiatric Events: Have been reported in patients taking GnRH
agonists. Events include emotional
lability, such as crying, irritability, impatience, anger, and
aggression. Monitor for development or
worsening of psychiatric symptoms (5.3).
Convulsions: Have been observed in patients receiving GnRH agonists
with or without a history of
seizures, epilepsy, cerebrovascular disorders, central nervous system
anomalies or tumors, and in
patients on concomitant medications that have been associated with
convulsions (5.4).
Pseudotumor Cerebri (Idiopathic Intracranial Hypertension): Have been
reported in pediatric patients
receiving GnRH agonist