देश: संयुक्त राज्य
भाषा: अंग्रेज़ी
स्रोत: NLM (National Library of Medicine)
HISTRELIN ACETATE (UNII: QMG7HLD1ZE) (HISTRELIN - UNII:H50H3S3W74)
Endo Pharmaceuticals Inc.
HISTRELIN ACETATE
HISTRELIN ACETATE 50 mg
SUBCUTANEOUS
PRESCRIPTION DRUG
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 adre
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.
New Drug Application
Endo Pharmaceuticals Inc. ---------- 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 dec पूरा दस्तावेज़ पढ़ें
SUPPRELIN LA- HISTRELIN ACETATE IMPLANT ENDO PHARMACEUTICALS 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 RECENT MAJOR CHANGES Warnings and Precautions (5.5) 04/2022 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 Agonistic 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 Hypert पूरा दस्तावेज़ पढ़ें