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Signifor LAR
Overview
What is Signifor LAR?
SIGNIFOR LAR (pasireotide) for injectable suspension is a long-acting release form of pasireotide pamoate, as powder to be suspended in the provided diluent immediately prior to intramuscular injection. SIGNIFOR LAR is a somatostatin analog. Pasireotide pamoate, 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 pamoic acid salt, is a cyclohexapeptide with pharmacologic properties mimicking those of the natural hormone somatostatin.
The molecular formula of pasireotide pamoate is CHNO • CHO and the molecular weight is 1435.58.
The structural formula is:
The drug product consists of pasireotide pamoate uniformly distributed within microspheres which are made of biodegradable copolymers of poly (D,L-lactide-co-glycolide) acids (PLGA).
SIGNIFOR LAR is available in a vial containing the sterile pasireotide pamoate, PLGA microspheres powder, 20 mg, 40 mg and 60 mg to be reconstituted with the provided 2 mL sterile diluent. The product should be prepared immediately prior to use for intramuscular injection given once every 4 weeks.
Each vial contains:
Each diluent prefilled syringe contains:
What does Signifor LAR look like?
What are the available doses of Signifor LAR?
SIGNIFOR LAR for injectable suspension: 20 mg, 40 mg, and 60 mg, powder in a vial to be reconstituted with the provided 2 mL diluent. ()
What should I talk to my health care provider before I take Signifor LAR?
How should I use Signifor LAR?
SIGNIFOR LAR is a somatostatin analog indicated for the treatment of patients with acromegaly who have had an inadequate response to surgery and/or for whom surgery is not an option. ()
SIGNIFOR LAR must be reconstituted by a trained healthcare professional immediately before use. Illustrations on reconstitution are found in Instructions for Use .
SIGNIFOR LAR must be inspected visually before use. The suspension should appear free of foreign particulates and should be homogeneous after mixing.
SIGNIFOR LAR must be administered by a trained healthcare professional only by intramuscular injection in the right or left gluteus immediately after reconstitution. SIGNIFOR LAR must never be administered intravenously.
What interacts with Signifor LAR?
Sorry No Records found
What are the warnings of Signifor LAR?
Sorry No Records found
What are the precautions of Signifor LAR?
Sorry No Records found
What are the side effects of Signifor LAR?
Sorry No records found
What should I look out for while using Signifor LAR?
None.
What might happen if I take too much Signifor LAR?
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. In the event of an overdose, contact the National Capital Poison Center at 1-800-222-1222 or www.poison.org.
How should I store and handle Signifor LAR?
SIGNIFOR LAR (pasireotide) for injectable suspension is supplied in a single-use kit containing the following:After reconstitution of the 20 mg, 40 mg, or 60 mg SIGNIFOR LAR vials with the provided 2 mL diluent, the injectable suspension will have a final concentration of 10 mg/mL, 20 mg/mL and 30 mg/mL and should be delivered in its entirety.Drug Product Kits:20 mg kit NDC 0078-0641-81 40 mg kit NDC 0078-0642-81 60 mg kit NDC 0078-0643-81 Store at 2°C–8°C (36°F–46°F). Do not freeze. SIGNIFOR LAR should be stored at refrigerated temperatures between 2°C–8°C (36°F–46°F) until the time of use. SIGNIFOR LAR drug product kit should remain at room temperature for a minimum of 30 minutes before reconstitution, but should not exceed 24 hours at room temperature. However, after preparation of the drug suspension, it must be administered immediately. SIGNIFOR LAR (pasireotide) for injectable suspension is supplied in a single-use kit containing the following:After reconstitution of the 20 mg, 40 mg, or 60 mg SIGNIFOR LAR vials with the provided 2 mL diluent, the injectable suspension will have a final concentration of 10 mg/mL, 20 mg/mL and 30 mg/mL and should be delivered in its entirety.Drug Product Kits:20 mg kit NDC 0078-0641-81 40 mg kit NDC 0078-0642-81 60 mg kit NDC 0078-0643-81 Store at 2°C–8°C (36°F–46°F). Do not freeze. SIGNIFOR LAR should be stored at refrigerated temperatures between 2°C–8°C (36°F–46°F) until the time of use. SIGNIFOR LAR drug product kit should remain at room temperature for a minimum of 30 minutes before reconstitution, but should not exceed 24 hours at room temperature. However, after preparation of the drug suspension, it must be administered immediately. SIGNIFOR LAR (pasireotide) for injectable suspension is supplied in a single-use kit containing the following:After reconstitution of the 20 mg, 40 mg, or 60 mg SIGNIFOR LAR vials with the provided 2 mL diluent, the injectable suspension will have a final concentration of 10 mg/mL, 20 mg/mL and 30 mg/mL and should be delivered in its entirety.Drug Product Kits:20 mg kit NDC 0078-0641-81 40 mg kit NDC 0078-0642-81 60 mg kit NDC 0078-0643-81 Store at 2°C–8°C (36°F–46°F). Do not freeze. SIGNIFOR LAR should be stored at refrigerated temperatures between 2°C–8°C (36°F–46°F) until the time of use. SIGNIFOR LAR drug product kit should remain at room temperature for a minimum of 30 minutes before reconstitution, but should not exceed 24 hours at room temperature. However, after preparation of the drug suspension, it must be administered immediately. SIGNIFOR LAR (pasireotide) for injectable suspension is supplied in a single-use kit containing the following:After reconstitution of the 20 mg, 40 mg, or 60 mg SIGNIFOR LAR vials with the provided 2 mL diluent, the injectable suspension will have a final concentration of 10 mg/mL, 20 mg/mL and 30 mg/mL and should be delivered in its entirety.Drug Product Kits:20 mg kit NDC 0078-0641-81 40 mg kit NDC 0078-0642-81 60 mg kit NDC 0078-0643-81 Store at 2°C–8°C (36°F–46°F). Do not freeze. SIGNIFOR LAR should be stored at refrigerated temperatures between 2°C–8°C (36°F–46°F) until the time of use. SIGNIFOR LAR drug product kit should remain at room temperature for a minimum of 30 minutes before reconstitution, but should not exceed 24 hours at room temperature. However, after preparation of the drug suspension, it must be administered immediately. SIGNIFOR LAR (pasireotide) for injectable suspension is supplied in a single-use kit containing the following:After reconstitution of the 20 mg, 40 mg, or 60 mg SIGNIFOR LAR vials with the provided 2 mL diluent, the injectable suspension will have a final concentration of 10 mg/mL, 20 mg/mL and 30 mg/mL and should be delivered in its entirety.Drug Product Kits:20 mg kit NDC 0078-0641-81 40 mg kit NDC 0078-0642-81 60 mg kit NDC 0078-0643-81 Store at 2°C–8°C (36°F–46°F). Do not freeze. SIGNIFOR LAR should be stored at refrigerated temperatures between 2°C–8°C (36°F–46°F) until the time of use. SIGNIFOR LAR drug product kit should remain at room temperature for a minimum of 30 minutes before reconstitution, but should not exceed 24 hours at room temperature. However, after preparation of the drug suspension, it must be administered immediately. SIGNIFOR LAR (pasireotide) for injectable suspension is supplied in a single-use kit containing the following:After reconstitution of the 20 mg, 40 mg, or 60 mg SIGNIFOR LAR vials with the provided 2 mL diluent, the injectable suspension will have a final concentration of 10 mg/mL, 20 mg/mL and 30 mg/mL and should be delivered in its entirety.Drug Product Kits:20 mg kit NDC 0078-0641-81 40 mg kit NDC 0078-0642-81 60 mg kit NDC 0078-0643-81 Store at 2°C–8°C (36°F–46°F). Do not freeze. SIGNIFOR LAR should be stored at refrigerated temperatures between 2°C–8°C (36°F–46°F) until the time of use. SIGNIFOR LAR drug product kit should remain at room temperature for a minimum of 30 minutes before reconstitution, but should not exceed 24 hours at room temperature. However, after preparation of the drug suspension, it must be administered immediately. SIGNIFOR LAR (pasireotide) for injectable suspension is supplied in a single-use kit containing the following:After reconstitution of the 20 mg, 40 mg, or 60 mg SIGNIFOR LAR vials with the provided 2 mL diluent, the injectable suspension will have a final concentration of 10 mg/mL, 20 mg/mL and 30 mg/mL and should be delivered in its entirety.Drug Product Kits:20 mg kit NDC 0078-0641-81 40 mg kit NDC 0078-0642-81 60 mg kit NDC 0078-0643-81 Store at 2°C–8°C (36°F–46°F). Do not freeze. SIGNIFOR LAR should be stored at refrigerated temperatures between 2°C–8°C (36°F–46°F) until the time of use. SIGNIFOR LAR drug product kit should remain at room temperature for a minimum of 30 minutes before reconstitution, but should not exceed 24 hours at room temperature. However, after preparation of the drug suspension, it must be administered immediately. SIGNIFOR LAR (pasireotide) for injectable suspension is supplied in a single-use kit containing the following:After reconstitution of the 20 mg, 40 mg, or 60 mg SIGNIFOR LAR vials with the provided 2 mL diluent, the injectable suspension will have a final concentration of 10 mg/mL, 20 mg/mL and 30 mg/mL and should be delivered in its entirety.Drug Product Kits:20 mg kit NDC 0078-0641-81 40 mg kit NDC 0078-0642-81 60 mg kit NDC 0078-0643-81 Store at 2°C–8°C (36°F–46°F). Do not freeze. SIGNIFOR LAR should be stored at refrigerated temperatures between 2°C–8°C (36°F–46°F) until the time of use. SIGNIFOR LAR drug product kit should remain at room temperature for a minimum of 30 minutes before reconstitution, but should not exceed 24 hours at room temperature. However, after preparation of the drug suspension, it must be administered immediately.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
SIGNIFOR LAR is an injectable cyclohexapeptide, somatostatin analog. Pasireotide exerts its pharmacological activity via binding to somatostatin receptors (SSTR). There are 5 known human somatostatin receptor subtypes: SSTR 1, 2, 3, 4, and 5. These receptor subtypes are expressed in different tissues under normal physiological conditions. Somatostatin analogs bind to SSTRs with different potencies. Pasireotide binds with high affinity to 4 of the 5 SSTRs (see Table 3).
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.
SIGNIFOR LAR can cause increases in blood glucose levels which are sometimes severe. In the study of patients with acromegaly, 5 patients naïve to drug therapy exposed to SIGNIFOR LAR (2 of whom were normoglycemic at baseline) were hospitalized for blood glucose in the range of 359–506 mg/dL and none in the active comparator group. Two additional patients who had received active comparator in the main trial were switched to SIGNIFOR LAR in the extension trial were hospitalized for elevated glucose levels while on SIGNIFOR LAR treatment during the extension; 1 of those patients developed diabetic ketoacidosis. Patients with poor baseline glycemic control are at higher risk of developing severe hyperglycemia .
In the clinical development program, treatment with SIGNIFOR LAR caused an increase in the incidence of diabetes and prediabetes. A majority of patients, including those with normal glucose tolerance, prediabetes and diabetes, experienced increased glucose levels within the first 2 to 3 months of treatment with SIGNIFOR LAR . In the drug-naïve patient trial, the prevalence of diabetes increased from 30% at baseline to 60% at month 12. In the trial evaluating patients previously treated with somatostatin analogs, the prevalence of diabetes increased from 71% at baseline to 87% at month 6 in patients treated with SIGNIFOR LAR 40 mg and from 60% to 84% in patients treated with SIGNIFOR LAR 60 mg.
Fasting plasma glucose and hemoglobin A1c should be assessed prior to starting treatment with SIGNIFOR LAR. In patients with poorly controlled diabetes mellitus, antidiabetic treatment should be optimized before SIGNIFOR LAR treatment is started. Blood glucose monitoring should be done weekly for the first 3 months after initiating SIGNIFOR LAR and the first 4 to 6 weeks after dose increases. Periodic monitoring should continue thereafter, as clinically appropriate.
Patients who develop significant hyperglycemia on SIGNIFOR LAR may require initiation of antidiabetic therapy(ies) or adjustment in the dose or type of antidiabetic therapy(ies) per standard of care. The optimal treatment for the management of SIGNIFOR LAR-induced hyperglycemia is not known. If hyperglycemia cannot be controlled despite medical management, the dose of SIGNIFOR LAR should be reduced or SIGNIFOR LAR should be discontinued.
After treatment discontinuation, fasting plasma glucose and hemoglobin A1c should be assessed if indicated. Patients on antidiabetic therapy discontinuing SIGNIFOR LAR may require more frequent blood glucose monitoring and antidiabetic drug therapy dose adjustment to mitigate the risk of hypoglycemia.
Clinically significant adverse reactions that appear in other sections of the labeling include:
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
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