Signifor

Acromegaly, Pituitary ACTH Hypersecretion, Pituitary surgery is not an option or has not been curative

Treatment

3 FDA approvals

9 Active Studies for Signifor

What is Signifor

Pasireotide

The Generic name of this drug

Treatment Summary

Pasireotide, also known as Signifor, is a drug used to treat Cushing's disease. It is a synthetic peptide, similar to a hormone called somatostatin, that works to reduce the amount of hormones in the body that cause Cushing's disease.

Signifor

is the brand name

image of different drug pills on a surface

Signifor Overview & Background

Brand Name

Generic Name

First FDA Approval

How many FDA approvals?

Signifor

Pasireotide

2012

16

Approved as Treatment by the FDA

Pasireotide, also known as Signifor, is approved by the FDA for 3 uses which include Cushing's Disease and Pituitary ACTH Hypersecretion .

Cushing's Disease

Helps manage Cushing's Disease

Pituitary ACTH Hypersecretion

Helps manage Cushing's Disease

Pituitary surgery is not an option or has not been curative

Helps manage Pituitary surgery is not an option or has not been curative

Effectiveness

How Signifor Affects Patients

Signifor® is a medication that helps to lower the amount of cortisol (a hormone) in people with Cushing's disease.

How Signifor works in the body

Pasireotide binds to several somatostatin receptors, which in turn reduces the release of hormones like cortisol, human growth hormone, glucagon, and insulin. This makes it useful for treating conditions like Cushing's disease that involve an overproduction of hormones. Pasireotide is more powerful than somatostatin in blocking the release of these hormones.

When to interrupt dosage

The advised dosage of Signifor is contingent upon the diagnosed condition, including Cushing's Disease, Pituitary surgery is not an option or has not been curative and Acromegaly. The amount of dosage is contingent upon the technique of administration featured in the table beneath.

Condition

Dosage

Administration

Acromegaly

, 0.3 mg/mL, 0.6 mg/mL, 0.9 mg/mL, 0.3 mg, 0.6 mg, 0.9 mg, 60.0 mg, 40.0 mg, 20.0 mg, 10.0 mg, 15.0 mg/mL, 5.0 mg/mL, 30.0 mg/mL, 20.0 mg/mL, 30.0 mg, 10.0 mg/mL

, Subcutaneous, Injection, Injection - Subcutaneous, Kit, Solution, Solution - Subcutaneous, Intramuscular, Injection, solution, Injection, solution - Subcutaneous, Injection, powder, for suspension, Injection, powder, for suspension - Intramuscular, Injection, powder, for suspension, extended release; Kit, Injection, powder, for suspension, extended release; Kit - Intramuscular, Kit - Intramuscular

Pituitary ACTH Hypersecretion

, 0.3 mg/mL, 0.6 mg/mL, 0.9 mg/mL, 0.3 mg, 0.6 mg, 0.9 mg, 60.0 mg, 40.0 mg, 20.0 mg, 10.0 mg, 15.0 mg/mL, 5.0 mg/mL, 30.0 mg/mL, 20.0 mg/mL, 30.0 mg, 10.0 mg/mL

, Subcutaneous, Injection, Injection - Subcutaneous, Kit, Solution, Solution - Subcutaneous, Intramuscular, Injection, solution, Injection, solution - Subcutaneous, Injection, powder, for suspension, Injection, powder, for suspension - Intramuscular, Injection, powder, for suspension, extended release; Kit, Injection, powder, for suspension, extended release; Kit - Intramuscular, Kit - Intramuscular

Pituitary surgery is not an option or has not been curative

, 0.3 mg/mL, 0.6 mg/mL, 0.9 mg/mL, 0.3 mg, 0.6 mg, 0.9 mg, 60.0 mg, 40.0 mg, 20.0 mg, 10.0 mg, 15.0 mg/mL, 5.0 mg/mL, 30.0 mg/mL, 20.0 mg/mL, 30.0 mg, 10.0 mg/mL

, Subcutaneous, Injection, Injection - Subcutaneous, Kit, Solution, Solution - Subcutaneous, Intramuscular, Injection, solution, Injection, solution - Subcutaneous, Injection, powder, for suspension, Injection, powder, for suspension - Intramuscular, Injection, powder, for suspension, extended release; Kit, Injection, powder, for suspension, extended release; Kit - Intramuscular, Kit - Intramuscular

Warnings

There are 20 known major drug interactions with Signifor.

Common Signifor Drug Interactions

Drug Name

Risk Level

Description

Abemaciclib

Major

The metabolism of Abemaciclib can be decreased when combined with Pasireotide.

Acalabrutinib

Major

The metabolism of Acalabrutinib can be decreased when combined with Pasireotide.

Alectinib

Major

The metabolism of Alectinib can be decreased when combined with Pasireotide.

Alpelisib

Major

The metabolism of Alpelisib can be decreased when combined with Pasireotide.

Aminophylline

Major

The metabolism of Aminophylline can be decreased when combined with Pasireotide.

Signifor Toxicity & Overdose Risk

Overdosing on this drug can lead to higher than normal blood sugar levels, gallstones, diarrhea, nausea, headaches, abdominal pain, tiredness, and diabetes.

image of a doctor in a lab doing drug, clinical research

Signifor Novel Uses: Which Conditions Have a Clinical Trial Featuring Signifor?

Thirteen active clinical trials are assessing the potential of Signifor in treating Cushing's Disease, in cases where Pituitary Surgery is not an option or has not been curative, and Acromegaly.

Condition

Clinical Trials

Trial Phases

Acromegaly

6 Actively Recruiting

Phase 2, Phase 3, Phase 1

Pituitary surgery is not an option or has not been curative

0 Actively Recruiting

Pituitary ACTH Hypersecretion

3 Actively Recruiting

Phase 2, Phase 1

Signifor Reviews: What are patients saying about Signifor?

3.3

Patient Review

1/3/2014

Signifor for Cushing's Syndrome

This medication unfortunately gives my mom a lot of fatigue and loose stools, though it does help with her condition.

Patient Q&A Section about signifor

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is Signifor used for?

"SIGNIFOR is a treatment for adult patients with Cushing's disease who cannot have surgery or whose surgery did not cure them."

Answered by AI

How do you inject a Signifor?

"Signifor must be injected deep into a muscle by a trained healthcare professional. The suspension can only be prepared just before it is administered. The site for repeat injections should alternate between left and right gluteal muscles."

Answered by AI

Who makes Signifor?

"Recordati has agreed to acquire the global rights to two of Novartis' medicines, Signifor and osilodrostat. Signifor is used to treat patients suffering from Cushing's disease, while osilodrostat is used to treat patients with Cushing's syndrome and/or adrenal tumors. The acquisition will give Recordati a significant presence in the market for endocrine diseases."

Answered by AI

How is Signifor administered?

"Signifor is to be injected just below the skin by the patient. The patient should receive instructions from the physician or a healthcare professional on how to inject Signifor just below the skin. Injections should not be given in the same spot two times in a row."

Answered by AI

Clinical Trials for Signifor

Image of Ronald Reagan Medical Center in Los Angeles, United States.

Fimepinostat for Cushing's Disease

18+
All Sexes
Los Angeles, CA

Supported by the pre-clinical data (summarized in Research Strategy), the investigators propose that Fimepinostat is an ideal candidate drug in the treatment and intervention of patients with Cushing Disease. The investigators propose a pilot, short-term (4 weeks) phase II single-center study to demonstrate the safety and efficacy of Fimepinostat in the treatment of patients with de novo, persistent, and/or recurrent CD recruited at the University of California, Los Angeles. The trial will have a 2-arm design and will simultaneously examine two different doses of Fimepinostat. The study will allow the investigators to determine the efficacy and safety of these doses in the treatment of CD and guide dose selection for subsequent, larger studies. Funding Source - FDA OOPD.

Phase 2
Recruiting

Ronald Reagan Medical Center

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