SIGNIFOR- pasireotide injection

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

PASIREOTIDE (UNII: 98H1T17066) (PASIREOTIDE - UNII:98H1T17066)

Disponible desde:

Novartis Pharmaceuticals Corporation

Designación común internacional (DCI):

PASIREOTIDE

Composición:

PASIREOTIDE 0.3 mg in 1 mL

Vía de administración:

SUBCUTANEOUS

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

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

Resumen del producto:

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.

Estado de Autorización:

New Drug Application

Información para el usuario

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

Ficha técnica

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