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Signifor

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Overview

What is Signifor?

SIGNIFOR (pasireotide) injection is prepared as a sterile solution of pasireotide diaspartate in a tartaric acid buffer for administration by subcutaneous injection. SIGNIFOR is a somatostatin analog. Pasireotide diaspartate, chemically known as (2-Aminoethyl) carbamic acid (2R,5S,8S,11S,14R,17S,19aS)-11-(4-aminobutyl)-5-benzyl-8-(4-benzyloxybenzyl)-14-(1H-indol-3-ylmethyl)-4,7,10,13,16,19-hexaoxo-17-phenyloctadecahydro-3a,6,9,12,15,18-hexaazacyclopentacyclooctadecen-2-yl ester, di[(S)-2-aminosuccinic acid] salt, is a cyclohexapeptide with pharmacologic properties mimicking those of the natural hormone somatostatin.

The molecular formula of pasireotide diaspartate is CHNO • 2 CHNO and the molecular weight is 1313.41. The structural formula is:

SIGNIFOR is supplied as a sterile solution in a single-dose, 1 mL colorless glass ampule containing pasireotide in 0.3 mg/mL, 0.6 mg/mL, or 0.9 mg/mL strengths for subcutaneous injection.

Each glass ampule contains:



What does Signifor look like?



What are the available doses of Signifor?

Injection: 0.3 mg/mL, 0.6 mg/mL, and 0.9 mg/mL in a single-dose ampule ()

What should I talk to my health care provider before I take Signifor?

How should I use Signifor?

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 ()

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  . Maximum urinary free cortisol reduction is typically seen by two months of treatment . 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. 


What interacts with Signifor?

Sorry No Records found


What are the warnings of Signifor?

Sorry No Records found


What are the precautions of Signifor?

Sorry No Records found


What are the side effects of Signifor?

Sorry No records found


What should I look out for while using Signifor?

None.


What might happen if I take too much Signifor?

No cases of overdosage have been reported in patients with Cushing’s disease receiving SIGNIFOR subcutaneously. Doses up to 2.1 mg b.i.d. have been used in healthy volunteers with adverse reactions of diarrhea being observed at a high frequency.

In the event of overdosage, it is recommended that appropriate supportive treatment be initiated, as dictated by the patient’s clinical status, until resolution of the symptoms.

Up-to-date information about the treatment of overdose can be obtained from a certified Regional Poison Center. 


How should I store and handle Signifor?

Store at 20°C to 25°C (68°F to 77°F); excursions permitted from 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. 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# 0078-0633-200.6 mg/1 mL pasireotide (as diaspartate) Box of 60 ampules       NDC# 0078-0634-200.9 mg/1 mL pasireotide (as diaspartate) Box of 60 ampules       NDC# 0078-0635-20Store at 25° C (77°F); excursions permitted to 15°–30°C (59°–86°F), protect from light.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# 0078-0633-200.6 mg/1 mL pasireotide (as diaspartate) Box of 60 ampules       NDC# 0078-0634-200.9 mg/1 mL pasireotide (as diaspartate) Box of 60 ampules       NDC# 0078-0635-20Store at 25° C (77°F); excursions permitted to 15°–30°C (59°–86°F), protect from light.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# 0078-0633-200.6 mg/1 mL pasireotide (as diaspartate) Box of 60 ampules       NDC# 0078-0634-200.9 mg/1 mL pasireotide (as diaspartate) Box of 60 ampules       NDC# 0078-0635-20Store at 25° C (77°F); excursions permitted to 15°–30°C (59°–86°F), protect from light.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# 0078-0633-200.6 mg/1 mL pasireotide (as diaspartate) Box of 60 ampules       NDC# 0078-0634-200.9 mg/1 mL pasireotide (as diaspartate) Box of 60 ampules       NDC# 0078-0635-20Store at 25° C (77°F); excursions permitted to 15°–30°C (59°–86°F), protect from light.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# 0078-0633-200.6 mg/1 mL pasireotide (as diaspartate) Box of 60 ampules       NDC# 0078-0634-200.9 mg/1 mL pasireotide (as diaspartate) Box of 60 ampules       NDC# 0078-0635-20Store at 25° C (77°F); excursions permitted to 15°–30°C (59°–86°F), protect from light.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# 0078-0633-200.6 mg/1 mL pasireotide (as diaspartate) Box of 60 ampules       NDC# 0078-0634-200.9 mg/1 mL pasireotide (as diaspartate) Box of 60 ampules       NDC# 0078-0635-20Store at 25° C (77°F); excursions permitted to 15°–30°C (59°–86°F), protect from light.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# 0078-0633-200.6 mg/1 mL pasireotide (as diaspartate) Box of 60 ampules       NDC# 0078-0634-200.9 mg/1 mL pasireotide (as diaspartate) Box of 60 ampules       NDC# 0078-0635-20Store at 25° C (77°F); excursions permitted to 15°–30°C (59°–86°F), protect from light.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# 0078-0633-200.6 mg/1 mL pasireotide (as diaspartate) Box of 60 ampules       NDC# 0078-0634-200.9 mg/1 mL pasireotide (as diaspartate) Box of 60 ampules       NDC# 0078-0635-20Store at 25° C (77°F); excursions permitted to 15°–30°C (59°–86°F), protect from light.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# 0078-0633-200.6 mg/1 mL pasireotide (as diaspartate) Box of 60 ampules       NDC# 0078-0634-200.9 mg/1 mL pasireotide (as diaspartate) Box of 60 ampules       NDC# 0078-0635-20Store at 25° C (77°F); excursions permitted to 15°–30°C (59°–86°F), protect from light.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# 0078-0633-200.6 mg/1 mL pasireotide (as diaspartate) Box of 60 ampules       NDC# 0078-0634-200.9 mg/1 mL pasireotide (as diaspartate) Box of 60 ampules       NDC# 0078-0635-20Store at 25° C (77°F); excursions permitted to 15°–30°C (59°–86°F), protect from light.


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Clinical Information

Chemical Structure

No Image found
Clinical Pharmacology

SIGNIFOR is an injectable cyclohexapeptide somatostatin analogue. Pasireotide exerts its pharmacological activity via binding to somatostatin receptors (SSTRs). Five human somatostatin receptor subtypes are known: SSTR 1, 2, 3, 4, and 5. These receptor subtypes are expressed in different tissues under normal physiological conditions. Corticotroph tumor cells from Cushing’s disease patients frequently over-express SSTR5 whereas the other receptor subtypes are often not expressed or are expressed at lower levels. Pasireotide binds and activates the SSTRs resulting in inhibition of ACTH secretion, which leads to decreased cortisol secretion.

The binding affinities of endogenous somatostatin and pasireotide are shown in Table 2.

Non-Clinical Toxicology
None.

Use of daunorubicin in a patient who has previously received doxorubicin increases the risk of cardiotoxicity. Daunorubicin hydrochloride should not be used in patients who have previously received the recommended maximum cumulative doses of doxorubicin or daunorubicin hydrochloride. Cyclophosphamide used concurrently with daunorubicin hydrochloride may also result in increased cardiotoxicity.

Dosage reduction of daunorubicin hydrochloride may be required when used concurrently with other myelosuppressive agents.

Hepatotoxic medications, such as high-dose methotrexate, may impair liver function and increase the risk of toxicity.

Treatment with SIGNIFOR leads to suppression of adrenocorticotropic hormone (ACTH) secretion in Cushing’s disease. Suppression of ACTH may lead to a decrease in circulating levels of cortisol and potentially hypocortisolism.

Monitor and instruct patients on the signs and symptoms associated with hypocortisolism (e.g., weakness, fatigue, anorexia, nausea, vomiting, hypotension, hyponatremia or hypoglycemia). If hypocortisolism occurs, consider temporary dose reduction or interruption of treatment with SIGNIFOR, as well as temporary, exogenous glucocorticoid replacement therapy.

Clinically significant adverse reactions that appear in other sections of the labeling include:

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Interactions

Interactions

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