Country: Amerika Syarikat
Bahasa: Inggeris
Sumber: NLM (National Library of Medicine)
PASIREOTIDE (UNII: 98H1T17066) (PASIREOTIDE - UNII:98H1T17066)
Novartis Pharmaceuticals Corporation
PASIREOTIDE
PASIREOTIDE 0.3 mg in 1 mL
SUBCUTANEOUS
PRESCRIPTION DRUG
SIGNIFOR is indicated for the treatment of adult patients with Cushing's disease for whom pituitary surgery is not an option or has not been curative. None. Risk Summary The limited data with SIGNIFOR in pregnant women are insufficient to inform a drug-associated risk for major birth defects and miscarriage. In embryo-fetal development studies in rabbits, findings indicating developmental delay were observed with subcutaneous administration of pasireotide during organogenesis at doses less than the exposure in humans at the highest recommended dose; maternal toxicity was not observed at this dose (see Data) . The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. 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 In embryo-fetal development studies in rats given 1, 5, and 10 mg/kg/day subcutaneously throughout organog
SIGNIFOR is supplied as a single dose, colorless glass ampule packaged in a box of 60 ampules, arranged in 10 packs of 6 ampules each. The following packaging configurations are available. 0.3 mg/1 mL pasireotide (as diaspartate) Box of 60 ampules NDC# 0078-0633-20 0.6 mg/1 mL pasireotide (as diaspartate) Box of 60 ampules NDC# 0078-0634-20 0.9 mg/1 mL pasireotide (as diaspartate) Box of 60 ampules NDC# 0078-0635-20 Store at 25°C (77°F); excursions permitted to 15°C-30°C (59°F-86°F), protect from light.
New Drug Application
Novartis Pharmaceuticals Corporation ---------- This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: January 2020 Medication Guide SIGNIFOR® [sig-na-for] (pasireotide) Injection Read this Medication Guide before you start using SIGNIFOR and each time you get a refill. There may be new information. This information does not take the place of talking to your doctor about your medical condition or your treatment. What is the most important information I should know about SIGNIFOR? SIGNIFOR can cause serious side effects, including: • Low cortisol levels in your blood (hypocortisolism). Tell your doctor right away if you have any signs and symptoms of hypocortisolism. Signs and symptoms of hypocortisolism may include: • weakness • fatigue • loss of appetite • nausea • vomiting • low blood pressure • low level of sodium in your blood • low blood sugar If you get hypocortisolism while taking SIGNIFOR, your doctor may change your dose or ask you to stop taking it. • High blood sugar (hyperglycemia). Your doctor should check your blood sugar level before you start taking SIGNIFOR and while you take it. Signs and symptoms of hyperglycemia may include: • excessive thirst • high urine output • increased appetite with weight loss • tiredness If you get hyperglycemia while taking SIGNIFOR, your doctor may give you another medicine to take to lower your blood sugar. Your doctor may also change your dose of SIGNIFOR or ask you to stop taking it. What is SIGNIFOR? SIGNIFOR is a prescription medicine used to treat Cushing’s disease in adults who cannot have surgery or have failed surgery. It is not known if SIGNIFOR is safe and effective in children. What should I tell my doctor before using SIGNIFOR? Before you take SIGNIFOR, tell your doctor if you: • have or have had high blood sugar (hyperglycemia) • have diabetes • have or have had heart problems • have a history of low levels of potassium or magnesium in your blood • have or have had liver proble Baca dokumen lengkap
SIGNIFOR- PASIREOTIDE INJECTION NOVARTIS PHARMACEUTICALS CORPORATION ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE SIGNIFOR SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR SIGNIFOR. SIGNIFOR (PASIREOTIDE) INJECTION, FOR SUBCUTANEOUS USE INITIAL U.S. APPROVAL: 2012 RECENT MAJOR CHANGES Warnings and Precautions (5.2) 1/2020 Warnings and Precautions (5.5) 4/2019 INDICATIONS AND USAGE SIGNIFOR is a somatostatin analog indicated for the treatment of adult patients with Cushing’s disease for whom pituitary surgery is not an option or has not been curative (1) DOSAGE AND ADMINISTRATION Recommended initial dosage is either 0.6 mg or 0.9 mg by subcutaneous injection twice a day; recommended dosage range is 0.3 mg to 0.9 mg twice a day (2.1) Titrate dosage based on treatment response [clinically meaningful reduction in 24-hour urinary free cortisol (UFC) and/or improvements in signs and symptoms of disease] and tolerability (2.1) Testing Prior to Dosing: fasting plasma glucose (FPG), hemoglobin A1c (HbA1c), liver tests, electrocardiogram (ECG), gallbladder ultrasound, and serum potassium and magnesium levels (2.2) Patients With Hepatic Impairment: _Child-Pugh B:_ Recommended initial dosage is 0.3 mg twice a day and maximum dosage is 0.6 mg twice a day (2.3, 8.6) _Child-Pugh C:_ Avoid use in these patients (2.3, 8.6) DOSAGE FORMS AND STRENGTHS Injection: 0.3 mg/mL, 0.6 mg/mL, and 0.9 mg/mL in a single-dose ampule (3) CONTRAINDICATIONS None (4) WARNINGS AND PRECAUTIONS Hypocortisolism: Decreases in circulating levels of cortisol may occur resulting in biochemical and/or clinical hypocortisolism. SIGNIFOR dose reduction or interruption and/or adding a low-dose short-term glucocorticoid may be necessary (5.1) Hyperglycemia and Diabetes (occurs with initiation): Intensive glucose monitoring is recommended and may require initiation or adjustment of anti-diabetic treatment per standard of care (5.2) Bradycardia and QT Prolongation: Use with cauti Baca dokumen lengkap