CLINICAL NEWS to leave their comfort zones . The hope is that , when they go back to the clinical setting , they will be better observers of patients .
The program was so successful at The Frick that we expanded it to seven medical schools . In 2004 , I expanded it to include the law-enforcement and intelligence communities . I still do grand rounds around the country , working with hospitals and first responders .
OVERDOSAGE There is no specific antidote for VENCLEXTA . For patients who experience overdose , closely monitor and provide appropriate supportive treatment ; during ramp-up phase interrupt VENCLEXTA and monitor carefully for signs and symptoms of TLS along with other toxicities . Based on venetoclax large volume of distribution and extensive protein binding , dialysis is unlikely to result in significant removal of venetoclax . NONCLINICAL TOXICOLOGY Carcinogenesis , Mutagenesis , Impairment of Fertility Carcinogenicity studies have not been conducted with venetoclax . Venetoclax was not mutagenic in an in vitro bacterial mutagenicity ( Ames ) assay , did not induce numerical or structural aberrations in an in vitro chromosome aberration assay using human peripheral blood lymphocytes , and was not clastogenic in an in vivo mouse bone marrow micronucleus assay at doses up to 835 mg / kg . The M27 metabolite was negative for genotoxic activity in in vitro Ames and chromosome aberration assays . Fertility and early embryonic development studies were conducted in male and female mice . These studies evaluate mating , fertilization , and embryonic development through implantation . There were no effects of venetoclax on estrus cycles , mating , fertility , corpora lutea , uterine implants or live embryos per litter at dosages up to 600 mg / kg / day . However , a risk to human male fertility exists based on testicular toxicity ( germ cell loss ) observed in dogs at exposures as low as 0.5 times the human AUC exposure at the recommend dose . Animal Toxicology and / or Pharmacology In dogs , venetoclax caused single-cell necrosis in various tissues , including the gallbladder , exocrine pancreas , and stomach with no evidence of disruption of tissue integrity or organ dysfunction ; these findings were minimal to mild in magnitude . Following a 4-week dosing period and subsequent 4-week recovery period , minimal single-cell necrosis was still present in some tissues and reversibility has not been assessed following longer periods of dosing or recovery . In addition , after approximately 3 months of daily dosing in dogs , venetoclax caused progressive white discoloration of the hair coat , due to loss of melanin pigment . PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling ( Medication Guide ).
• Tumor Lysis Syndrome Advise patients of the potential risk of TLS , particularly at treatment initiation and during ramp-up phase , and to immediately report any signs and symptoms associated with this event ( fever , chills , nausea , vomiting , confusion , shortness of breath , seizure , irregular heartbeat , dark or cloudy urine , unusual tiredness , muscle pain , and / or joint discomfort ) to their doctor for evaluation [ see Warnings and Precautions ].
When did you recognize the connection between medicine and art ? I ’ m a firm believer in both the science and art of medicine – each is equally important . The science involves the acquisition of knowledge , pattern recognition , and understanding disease and diagnosis . The art of medicine is the safe , compassionate care of the patient , and treating the whole person rather than just a set of symptoms .
Advise patients to be adequately hydrated every day when taking VENCLEXTA to reduce the risk of TLS . The recommended volume is 6 to 8 glasses ( approximately 56 ounces total ) of water each day . Patients should drink water starting 2 days before and on the day of the first dose , and every time the dose is increased . Advise patients of the importance of keeping scheduled appointments for blood work or other laboratory tests . Advise patients that it may be necessary to take VENCLEXTA in the presence of a doctor to allow monitoring for TLS .
• Neutropenia Advise patients to contact their doctor immediately if they develop a fever or any signs of infection . Advise patients of the need for periodic monitoring of blood counts [ see Warnings and Precautions ].
• Drug Interactions Advise patients to avoid consuming grapefruit products , Seville oranges , or starfruit during treatment with VENCLEXTA . Advise patients that VENCLEXTA may interact with some drugs ; therefore , advise patients to inform their doctor of the use of any prescription medication , over-thecounter drugs , vitamins and herbal products [ see Contraindications and Drug Interactions ].
• Immunizations Advise patients to avoid vaccination with live vaccines because they may not be safe or effective during treatment with VENCLEXTA [ see Warnings and Precautions ].
• Pregnancy and Lactation Advise women of the potential risk to the fetus and to avoid pregnancy during treatment with VENCLEXTA . Advise female patients of reproductive potential to use effective contraception during therapy and for at least 30 days after completing of therapy . Advise females to contact their doctor if they become pregnant , or if pregnancy is suspected , during treatment with VENCLEXTA . Also advise patients not to breastfeed while taking VENCLEXTA [ see Warnings and Precautions and Use in Specific Populations ].
• Male Infertility Advise patients of the possibility of infertility and possible use of sperm banking for males of reproductive potential [ see Use in Specific Populations ].
Instructions for Taking VENCLEXTA Advise patients to take VENCLEXTA exactly as prescribed and not to change their dose or to stop taking VENCLEXTA unless they are told to do so by their doctor . Advise patients to take VENCLEXTA orally once daily , at approximately the same time each day , according to their doctor ’ s instructions and that the tablets should be swallowed whole with a meal and water without being chewed , crushed , or broken . Advise patients to keep VENCLEXTA in the original packaging during the first 4 weeks of treatment , and not to transfer the tablets to a different container .
This became even clearer to me during my own battle with cancer . I spent hours , days , months , years in treatment at Memorial Sloan Kettering Cancer Center . I was successfully treated , which I believe depended as much on the art of medicine as it did on the science of medicine .
We can ’ t let the humanity leave the practice . Without the humanity , you ’ re left with only the terrible stuff : the administrative tasks , the bills , the invoicing ,
Advise patients that if a dose of VENCLEXTA is missed by less than 8 hours , to take the missed dose right away and take the next dose as usual . If a dose of VENCLEXTA is missed by more than 8 hours , advise patients to wait and take the next dose at the usual time . Advise patients not to take any additional dose that day if they vomit after taking VENCLEXTA , and to take the next dose at the usual time the following day .
Manufactured and Marketed by : AbbVie Inc . North Chicago , IL 60064 and Marketed by : Genentech USA , Inc . A Member of the Roche Group South San Francisco , CA 94080-4990 the insurance . … It ’ s the humanity that breathes life into medicine .
Could you walk us through a typical seminar ? What are the medical students doing as they look at the art ? This is not a subjective program about liking the art or learning the differences between van Gogh and Monet . It ’ s about looking closely at a new set of visual data ( artwork rather than a patient encounter or an electronic medical record ); analyzing it ; and communicating with clarity , precision , and objectivity exactly what it is you see – or don ’ t see . © 2016 AbbVie Inc . © 2016 Genentech , Inc . Ref : 03-B232 Revised April 2016
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Outside of the 2016 ASH Annual Meeting in San Diego .
Each session is divided into three sections . In the first , I show students a slideshow of artwork and we discuss how we are going to talk about art . In the next section , we go into the galleries , and pairs of medical students spend five minutes with each of 10 works of art , putting those skills we just introduced into practice and deciding how they would describe what they see to their colleagues . They are not allowed to read the labels that accompany each piece ; everything must be based on their inherent observation , not knowledge they are presented with .
Finally , we head back to the classroom for a series of interactive exercises that bring everything together . The students describe works of art to each other – talking , drawing , writing . … This is when we bring it back to the practice of medicine , to make sure that when they leave the session , they have the tools to make them more effective clinicians .
ASH Clinical News 87