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Understanding Treatment

Signifor® (pasireotide) Injection

What is Signifor?

Signifor is the first Food and Drug Administration (FDA)-approved prescription medicine that lowers cortisol in patients with Cushing's disease by binding and activating the somatostatin receptors that cause inhibition of ACTH, thereby decreasing cortisol production.

Signifor is used to treat Cushing's disease in adults who cannot have surgery or have failed surgery.

Signifor should be injected twice a day subcutaneously (under the skin). Your doctor will prescribe the dose that is right for you. Your doctor will see how you respond to using Signifor, and may adjust the dose.

How does Signifor work?

Signifor is a type of somatostatin analog. It acts like somatostatin, which is normally found in the human body, and stops the production of certain hormones, including adrenocorticotropic hormone (ACTH). Signifor is able to block the production of ACTH. This helps control how much cortisol the body creates and helps decrease cortisol levels in the body.

Signifor is proven to help reduce cortisol levels. The key is that only Signifor works directly on the source of Cushing's disease by binding and activating the somatostatin receptors that cause inhibition of ACTH, thereby decreasing cortisol production. Reducing cortisol levels is the goal of Cushing's disease treatment.

Treating Cushing's disease with Signifor

Signifor is the first Food and Drug Administration (FDA)-approved prescription medicine that reduces cortisol by binding and activating the somatostatin receptors that cause inhibition of ACTH, thereby decreasing cortisol production.

Studies have shown that Signifor lowers cortisol levels as soon as 1 month after starting treatment. In fact, many patients saw their cortisol reductions continue through a year of treatment with Signifor.

In a study of Signifor, patients showed mean UFC normalization after 6 months of treatment.

  • In a clinical study of Signifor, 15% of patients taking Signifor 0.6 mg twice a day had normalized mean UFC levels after 6 months and did not receive a dose increase
  • In the same study, 26% of patients taking Signifor 0.9 mg twice a day had normalized mean UFC levels after 6 months and did not receive a dose increase

The percentages of patients with mean urinary-free cortisol ≤ULN or ≥50% reduction from baseline, a less stringent end point than the primary end point, were 34% in the 0.6 mg twice a day group and 41% in the 0.9 mg twice a day group.

In addition to lowering cortisol levels, patients taking Signifor saw an improvement in symptoms, including:

  • Body mass index
  • Waist circumference
  • Weight

Individual patients showed varying degrees of improvement in Cushing's disease manifestations, but because of the variability in response and the absence of a control group in this trial, it is uncertain whether these changes could be ascribed to the effects of Signifor.

  • Blood Pressure*

*Due to the fact that the study allowed blood pressure medication and dose increases in patients already receiving such medications, the individual contribution of Signifor or of blood pressure medication adjustments cannot be clearly established.

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