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SIGNIFOR LAR is a brand name for Pasireotide, supplied as a powder for suspension, sustained-release. The medicine, its uses, side effects and dosage are the same regardless of brand.
Verbatim from this product's HC label. Tap a section to expand.
– Monitoring and Laboratory Tests). Pancreatic enzymes Acromegaly In the drug-naïve Study C2305, asymptomatic elevations in lipase and alpha amylase were observed in 31% and 24% of patients. In Study C2402 evaluating patients previously treated with somatostatin analogs, asymptomatic elevations in alpha amylase were reported in 10% in the 40 mg arm and in 5% in the 60 mg arm.
Asymptomatic elevations in lipase were reported only in the 40 mg arm in 2% of patients. 9 per 100 PYE in both phase 3 studies and across all doses. 7%) patients, respectively. 7%) patient in the 30 mg group. There were no grade 4 events reported.
3%) in the 10 mg and 30 mg dose groups, respectively) (see 7 WARNINGS AND PRECAUTIONS – Monitoring and Laboratory Tests). Pancreatitis is a potential adverse reaction associated with the use of somatostatin analogs due to the association between cholelithiasis and acute pancreatitis.
1 Clinical Trials by Indication, Acromegaly). 2. 1 Clinical Trials by Indication, Cushing's disease). No patient administered SIGNIFOR LAR had a QTcF value of >500 ms in any of the pivotal clinical studies. 5. Post-Market Adverse Reactions The following adverse drug reactions have been derived from post-marketing experience with SIGNIFOR LAR.
Because these reactions were reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency Metabolism and nutrition disorders: Diabetic ketoacidosis.
Hepatobiliary Disorders:
Cholangitis Gastrointestinal Disorders: Malabsorption of dietary fat, Steatorrhea, Feces discolored including Feces pale 9. 2. Drug Interactions Overview Caution is required when co-administering SIGNIFOR LAR with drugs that are known to have hepatotoxic potential, or with anti-arrhythmic medicines and other drugs that may prolong the QT interval (see 7.
Warnings and Precautions). Medications that may disrupt electrolyte levels should be avoided when using SIGNIFOR LAR. SIGNIFOR LAR (Pasireotide for injectable suspension) Page 40 of 70 In vitro assessment of drug interactions: Pasireotide appears to be a substrate of efflux transporter P-gp (P-glycoprotein), but is not an inducer of P-gp.
In addition, at therapeutic dose levels, pasireotide is not expected to be: • A substrate of the efflux transporter BCRP (breast cancer resistance protein) nor of the influx transporters OCT1 (organic cation transporter 1) and OATP (organic anion- transporting polypeptide) 1B1, 1B3 or 2B1; • An inhibitor of UGT1A1 (uridine diphosphate glucuronosyltransferase 1A1), influx transporter OAT1 or OAT3, OATP 1B1 or 1B3, and OCT1 or OCT2, efflux transporter P- gp, BCRP, MRP2 (multi-drug resistance protein 2) or BSEP (bile salt export pump).
3. Drug-Behavioural Interactions Patients should be warned to exercise caution when driving or using machinery if they experience fatigue, headache, or dizziness during treatment with SIGNIFOR LAR. g. cigarette smoking, cannabis use, and/or alcohol consumption) has not been studied.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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4. Drug-Drug Interactions No clinical drug-drug interaction studies have been performed with SIGNIFOR LAR.
General:
The lists below of potentially interacting drugs are not comprehensive. Current information sources should be consulted for newly approved drugs that prolong the QTc interval, decrease heart rate, prolong the PR interval, or cause electrolyte disturbances, as well as for older drugs for which these effects have recently been established.
Effect of Other Drugs on SIGNIFOR LAR QTc-Prolonging Drugs:
The concomitant use of SIGNIFOR LAR with another QTc-prolonging drug should be avoided (see 7. Warnings and Precautions – Cardiovascular and Monitoring and Laboratory Tests; 8. 2 Pharmacodynamics – Cardiac Electrophysiology). Drugs that have been associated with QTc interval prolongation and/or torsades de pointes include, but are not limited to, the examples in the following list.
Chemical/ pharmacological classes are listed if some, although not necessarily all, class members have been implicated in QTc prolongation and/or torsades de pointes: • Class IA, III, and 1C antiarrhythmics • antipsychotics • antidepressants • opioids • macrolide antibiotics and analogues • quinolone antibiotics • antimalarials • azole antifungals • dopamine receptor antagonists SIGNIFOR LAR (Pasireotide for injectable suspension) Page 41 of 70 • serotonin 5-hydroxytryptamine (5-HT3) receptor antagonists • tyrosine kinase inhibitors • histone deacetylase inhibitors • beta-2 adrenoceptor agonists Drugs that Decrease Heart Rate […]