Quốc gia: Hoa Kỳ
Ngôn ngữ: Tiếng Anh
Nguồn: NLM (National Library of Medicine)
TESTOSTERONE UNDECANOATE (UNII: H16A5VCT9C) (TESTOSTERONE - UNII:3XMK78S47O)
Endo Pharmaceuticals Inc.
TESTOSTERONE UNDECANOATE
TESTOSTERONE UNDECANOATE 250 mg in 1 mL
INTRAMUSCULAR
PRESCRIPTION DRUG
AVEED is indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone. - Primary hypogonadism (congenital or acquired): testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter's syndrome, chemotherapy, or toxic damage from alcohol or heavy metals. These men usually have low serum testosterone concentrations and gonadotropins (follicle-stimulating hormone [FSH], luteinizing hormone [LH]) above the normal range. - Hypogonadotropic hypogonadism (congenital or acquired): gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation. These men have low testosterone serum concentrations but have gonadotropins in the normal or low range. AVEED should only be used in patients who require testosterone replacement therapy and in whom the benefits of the product outweigh the serious risks of POME
AVEED, NDC 67979-511-43: 750 mg/3 mL (250 mg/mL) testosterone undecanoate sterile injectable solution is provided in an amber glass vial with silver-colored crimp seal and gray plastic cap. Each vial is individually packaged in a carton box. Store at controlled room temperature 25ºC (77ºF); excursions permitted to 15ºC - 30ºC (59ºF - 86ºF) [See USP controlled room temperature] in its original carton until the date indicated. Before use, each vial should be visually inspected. Only vials free from particles should be used. Single Use Vial. Discard unused portion.
New Drug Application
Endo Pharmaceuticals Inc. ---------- AVEED® (Uh-Veed) (testosterone undecanoate) injection Read this Medication Guide before you receive AVEED and before each injection. There may be new information. This Medication Guide does not take the place of talking with your doctor about your medical condition or your treatment. What is the most important information I should know about AVEED? AVEED may cause serious side effects, including: • A serious lung problem. AVEED can cause a serious lung problem called a pulmonary oil microembolism (POME) reaction. POME is caused by tiny droplets of oil that have traveled to the lungs. Symptoms of a POME reaction may include: o cough or urge to cough o difficulty breathing o sweating o tightening of your throat o chest pain o dizziness o fainting • Serious allergic reactions (anaphylaxis). AVEED can cause a serious allergic reaction right after receiving the injection. Some of these allergic reactions may be life threatening. These reactions can happen after you receive your first dose of AVEED or may happen after receiving more than 1 dose. You may need emergency treatment in a hospital, especially if these symptoms get worse over the 24 hours after your AVEED injection. These side effects may happen during or right after each injection. To be sure that you are not having one of these reactions: o You need to stay in the doctor’s office, clinic, or hospital for 30 minutes after having your AVEED injection so that your doctor can watch you for symptoms of POME or a serious allergic reaction. o You can only get AVEED at your doctor’s office, clinic, or hospital. AVEED is only available through a restricted program called the AVEED Risk Evaluation and Mitigation Strategy (REMS) Program. For more information about the AVEED REMS Program go to www.AveedREMS.com or call 1-855-755-0494. What is AVEED? AVEED is a prescription medicine that contains testosterone. AVEED is used to treat adult males who have low or no testosterone due to certain medical conditions. AVEED is only Đọc toàn bộ tài liệu
AVEED- TESTOSTERONE UNDECANOATE INJECTION ENDO PHARMACEUTICALS INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE AVEED SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR AVEED . AVEED (TESTOSTERONE UNDECANOATE) INJECTION, FOR INTRAMUSCULAR USE CIII INITIAL U.S. APPROVAL: 1953 WARNING: SERIOUS PULMONARY OIL MICROEMBOLISM (POME) REACTIONS AND ANAPHYLAXIS _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_ SERIOUS POME REACTIONS, INVOLVING URGE TO COUGH, DYSPNEA, THROAT TIGHTENING, CHEST PAIN, DIZZINESS, AND SYNCOPE; AND EPISODES OF ANAPHYLAXIS, INCLUDING LIFE- THREATENING REACTIONS, HAVE BEEN REPORTED TO OCCUR DURING OR IMMEDIATELY AFTER THE ADMINISTRATION OF TESTOSTERONE UNDECANOATE INJECTION. THESE REACTIONS CAN OCCUR AFTER ANY INJECTION OF TESTOSTERONE UNDECANOATE DURING THE COURSE OF THERAPY, INCLUDING AFTER THE FIRST DOSE (5.1). FOLLOWING EACH INJECTION OF AVEED, OBSERVE PATIENTS IN THE HEALTHCARE SETTING FOR 30 MINUTES IN ORDER TO PROVIDE APPROPRIATE MEDICAL TREATMENT IN THE EVENT OF SERIOUS POME REACTIONS OR ANAPHYLAXIS (5.1). AVEED IS AVAILABLE ONLY THROUGH A RESTRICTED PROGRAM CALLED THE AVEED REMS PROGRAM (5.2). RECENT MAJOR CHANGES Dosage and Administration (2.2) 08/2021 INDICATIONS AND USAGE Aveed (testosterone undecanoate) injection is an androgen indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone: Primary hypogonadism (congenital or acquired) (1) Hypogonadotropic hypogonadism (congenital or acquired) (1) Aveed should only be used in patients who require testosterone replacement therapy and in whom the benefits of the product outweigh the serious risks of pulmonary oil microembolism and anaphylaxis (1). Limitations of Use Safety and efficacy of Aveed in men with “age-related hypogonadism” have not been established (1). Safety and efficacy of Aveed in males less than 18 years old have not been established (1, 8.4). DOSA Đọc toàn bộ tài liệu