Signifor

INDICATIONS

Cushing's Disease

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.

DOSAGE AND ADMINISTRATION

Recommended Dosage Range

The recommended dosage range of SIGNIFOR is 0.3 to 0.9 mg by subcutaneous injection twice a day. The recommended initial dose is either 0.6 mg or 0.9 mg twice a day. Titrate dose based on response and tolerability.

Patients should be evaluated for a treatment response [clinically meaningful reduction in 24-hour urinary free cortisol (UFC) levels and/or improvement in signs or symptoms of the disease] and should continue receiving therapy with SIGNIFOR as long as benefit is derived [see Clinical Studies]. Maximum urinary free cortisol reduction is typically seen by two months of treatment [see Clinical Studies]. For patients who are started on 0.6 mg twice a day, a dosage increase to 0.9 mg twice a day may be considered based on the response to the treatment, as long as the 0.6 mg dosage is well tolerated by the patient.

Management of suspected adverse reactions may require temporary dose reduction of SIGNIFOR. Dose reduction by 0.3 mg decrements per injection is suggested.

Recommendations Prior to Initiation of SIGNIFOR

Prior to the start of SIGNIFOR, patients should have baseline levels of the following:

Patients should also have a baseline electrocardiogram and gallbladder ultrasound [see WARNINGS AND PRECAUTIONS].

Treatment of patients with poorly controlled diabetes mellitus should be intensively optimized with anti-diabetic therapy prior to starting SIGNIFOR [see WARNINGS AND PRECAUTIONS].

Dosage in Patients with Hepatic Impairment

For patients with moderate hepatic impairment (Child Pugh B), the recommended initial dosage is 0.3 mg twice a day and the maximum dosage is 0.6 mg twice a day. Avoid the use of SIGNIFOR in patients with severe hepatic impairment (Child Pugh C) [see Use in Specific Populations].

Important Administration Instructions

Instruct patients to:

  • Refer to the FDA-approved patient labeling (Instructions for Use) for detailed administration instructions.
  • Prior to injection, visually inspect the product for particulate matter and discoloration. Do not use if particulates and/or discoloration are observed.
  • Avoid injection in sites showing signs of inflammation or irritation.
  • Prior to injection, gently pinch the skin at the injection site and hold the needle/syringe at an angle of approximately 45 degrees.
  • Administer SIGNIFOR subcutaneously by self-injection into the top of the thigh or the abdomen.
  • Avoid multiple subcutaneous injections at the same site within short periods of time. Use of the same injection site for two consecutive injections is not recommended.

HOW SUPPLIED

Dosage Forms And Strengths

Injection: 0.3 mg/mL, 0.6 mg/mL, and 0.9 mg/mL in a single-dose, 1 mL colorless glass ampule .

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-XXX-XX

0.6 mg/1 mL pasireotide (as diaspartate)

Box of 60 ampules ................................................. NDC# 0078-XXX-XX

0.9 mg/1 mL pasireotide (as diaspartate)

Box of 60 ampules ................................................. NDC# 0078-XXX-XX

Storage and Handling

Store at 25° C (77°F); excursions permitted to 15°-30°C (59°-86°F), protect from light.

Manufactured by: Distributed by: Novartis Pharma Stein AG Novartis Pharmaceuticals Corporation Stein, Switzerland East Hanover, NJ 07936. Revised: December 2012

Last reviewed on RxList: 1/3/2013
This monograph has been modified to include the generic and brand name in many instances.

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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