rope interferon Alpha 2B njf in polycythemia vera polycythemia vera or PV is a Milo proliferative neoplasm characterized by an increased number of red blood cells white blood cells and platelets leading to an increased risk of thrombosis in approximately 95% of patients PV begins with an acquired mutation in the Janis kyes 2 or Jack 2 Gene which drives the clonal expansion of mutant hematopoetic stem cells or hsc's this Jack 2 mutation leads to constitutive activation of the Jack stat pathway and affects several cellular processes including the overproduction of blood cells interferon Alpha is a cytokine with a broad range of biological activities including depleting the mutant HSC population interferon Alpha binds to cell surface receptors initiating a signaling Cascade this leads to a downstream gene expression and modulation of cellular outcomes including cell differentiation and apoptosis the actions involved in the therapeutic effects of interferon Alpha inpv are not fully understood roeg interferon Alpha 2B N jft is a novel monopulsante [Music] was specifically designed with stable sight specific monop pegulan resulting in a 7-Day halflife this allows for an extended dosing interval of one subcutaneous dose every 2 [Music] weeks introducing bz Remy bz Remy is indicated for the treatment of adults with polycythemia vera first I would like to highlight some of this safety information in including a boxed warning with regard to interferon Alpha risk of serious disorders interferon Alpha products may cause or aggravate fatal or life-threatening neuros pych cric autoimmune ischemic and infectious disorders patients should be monitored closely with periodic clinical and laboratory evaluations therapy should be withdrawn in patients with persistently severe or worsening signs of symptoms of these conditions in many but not all cases the these disorders resolve after stopping therapy contraindications existence of or history of severe psychiatric disorders particularly severe depression suicidal ideation or suicide attempt hyp sensitivity to interferons including interferon Alpha 2B or any of the inactive ingredients of BZ Remy moderate or severe hepatic impairment history or presence of active serious or untreated autoimmune disease history of transplantation and receiving immunosuppressant agents warnings and precautions depression and suicide life-threatening or fatal neuros pych atric reactions have occurred in patients receiving interferon Alpha 2B products including bz Remy these reactions may occur in patients with and without previous psychiatric illness closely monitor for any symptoms of psychiatric disorders if psychiatric symptoms worsen it is recommended to discontinue bz Remy therapy endocrine toxicity these toxicities may include worsening hypothyroidism and hyperthyroidism do not use Basi in patients with active serious or untreated endocrine disorders associated with autoimmune disease discontinue bz Remy in patients who develop endocrine disorders that cannot be adequately managed during treatment with bz Remy cardiovascular toxicity patients with a history of cardiovascular disorders should be closely monitored for cardiovas ular toxicity during bz therapy avoid use of basy in patients with severe or unstable cardiovascular disease or recent stroke or myocardial infarction decreased peripheral blood counts monitor complete blood counts at Baseline during titration and every 3 to 6 months during the maintenance phase monitor patients for signs and symptoms of infection or bleeding hyp sensitivity reactions toxicities may include serious acute hypens sensitivity reactions if such reactions occur discontinue bz Remy and Institute appropriate medical therapy immediately pancreatitis pancreatitis has occurred in 2.2% of patients receiving bz Remy interrupt Basi treatment in patients with possible pancreatitis and evaluate promptly consider discontinuation of basy in patients with confirmed pancreatitis colitis fatal and serious ulcerative or hemorrhagic iema colitis have occurred in patients receiving interferon Alpha products discontinu bz Remi in patients who develop these signs or symptoms pulmonary toxicity discontinu bz Remy in patients who develop pulmonary infiltrates or pulmonary function impairment opthalmologic toxicity these toxicities may include severe eye disorders which may result in blindness advise patients to have eye examinations before and during bz Remi therapy specifically in those patients with retinopathy Associated disease discontinue bz in patients who develop new or worsening eye disorders hyper lipidemia elevated triglycerides may result in pancreatitis monitor serum triglycerides before bz Remi treatment and intermittently during therapy and manage when elevated consider discontinuation of BZ Remi in patients with persistently markedly elevated triglycerides heppa toxicity these toxicities may include increases in serum melanine aminot transferase aspartate aminot transferase gamma glutamil transferase and Billy Rubin monitor liver enzymes and hepatic function at Baseline and during Basi treatment discontinue Basi in patients who develop evidence of hypac decompensation during treatment renal toxicity monitor serum creatinine at Baseline and during therapy avoid use of BZ Remi in patients with egfr less than 30 m L per minute discontinue bz Remy if severe renal impairment develops during treatment dental and periodontal toxicity these toxicities may include dental and periodontal disorders which may lead to loss of teeth patients should have good oral hygiene and regular Dental examinations dermatologic toxicity consider discontinuation of BZ Remy if clinically significant dermatologic toxicity occurs driving and operating Machinery bz Remy may impact the ability to drive and use Machinery patients should not drive or use heavy machinery until they know how bz Remy affects their abilities embryo fetal toxicity based on the mechanism of action bz Remy can cause fetal harm when administered to pregnant women obtain a pregnancy test in females of reproductive potential prior to initiating treatment with bz Remy advise females of reproductive potential to use an effective method of contraception during treatment with bz Remy and for at least 8 weeks after the final dose adverse reactions the most common adverse reactions reported in greater than 40% of patients in the pegan Vera study were influenza like illness arthralgia fatigue puitis nasitis and musculoskeletal pain in the pooled safety population the most common adverse reactions greater than 10% were liver enzyme elevations gluc Opia thrombocytopenia arthralgia fatigue myalgia and influenza like illness drug interactions patients on bz Remy who are receiving concomittant drugs which are cyp450 substrates with Naro therapeutic index should be monitored to inform the need for dosage modification avoid use with MOS supressive agents narcotics hypnotics or sedatives and monitor patients receiving the combination for effects of excess Ive CNS toxicity use in specific populations pregnancy based on mechanism of action and the role of interferon Alpha in pregnancy and Fetal development bz Remy may cause fetal harm and should be assumed to have abortive facient potential advise pregnant women of the potential risk to a fetus lactation advise women not to breastfeed during treatment and for 8 weeks after the final dose renal impairment avoid use of Remy and patients with egfr less than 30 ml per minute pediatric use safety and Effectiveness in pediatric patients have not been established