Calendar
Lisbon , Portugal
11th International Congress on Autoimmunity
May 16 – 20 , 2018 Lisbon , Portugal Attendees will learn about more than 80 autoimmune diseases from both research-based and clinical perspectives , including the newest therapeutic techniques and diagnostic tools .
Oncology Nursing Society Annual Congress
May 17 – 20 , 2018 Washington , DC The 43rd Annual Congress features the latest in research , clinical practice , advanced practice , and leadership , presented by oncology nursing professionals .
2018 American Society of Clinical Oncology Annual Meeting
June 1 – 5 , 2018 Chicago , IL The American Society of Clinical Oncology brings together 32,000 oncology professionals from around the world to discuss state-of-the-art treatment modalities , new therapies , and ongoing controversies in the field .
European Hematology Association Annual Congress
June 14 – 17 , 2018 Stockholm , Sweden The 23nd Annual Congress covers every subspecialty in hematology with experts from around the world . The educational and scientific program will highlight state-of-the-art clinical practice and the latest findings in hematology research .
8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Risk Summary
ADCETRIS can cause fetal harm based on the findings from animal studies and the drug ’ s mechanism of action . In animal reproduction studies , administration of brentuximab vedotin to pregnant rats during organogenesis at doses similar to the clinical dose of 1.8 mg / kg every three weeks caused embryo-fetal toxicities , including congenital malformations [ see Data ]. Consider the benefits and risks of ADCETRIS and possible risks to the fetus when prescribing ADCETRIS to a pregnant woman .
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown . All pregnancies have a background risk of birth defect , loss , or other adverse outcomes . In the U . S . general population , the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 – 4 % and 15 – 20 %, respectively .
Data Animal Data
In an embryo-fetal developmental study , pregnant rats received 2 intravenous doses of 0.3 , 1 , 3 , or 10 mg / kg brentuximab vedotin during the period of organogenesis ( once each on Pregnancy Days 6 and 13 ). Drug-induced embryo-fetal toxicities were seen mainly in animals treated with 3 and 10 mg / kg of the drug and included increased early resorption ( ≥99 %), post-implantation loss ( ≥99 %), decreased numbers of live fetuses , and external malformations ( i . e ., umbilical hernias and malrotated hindlimbs ). Systemic exposure in animals at the brentuximab vedotin dose of 3 mg / kg is approximately the same exposure in patients with cHL or sALCL who received the recommended dose of 1.8 mg / kg every three weeks .
8.2 Lactation Risk Summary
There is no information regarding the presence of brentuximab vedotin in human milk , the effects on the breastfed child , or the effects on milk production . Because of the potential for serious adverse reactions in a breastfed child from ADCETRIS , including cytopenias and neurologic or gastrointestinal toxicities , advise patients that breastfeeding is not recommended during ADCETRIS treatment .
8.3 Females and Males of Reproductive Potential
ADCETRIS can cause fetal harm based on the findings from animal studies and the drug ’ s mechanism of action .
Pregnancy Testing
Verify the pregnancy status of females of reproductive potential prior to initiating ADCETRIS therapy .
Contraception Females
Advise females of reproductive potential to avoid pregnancy during ADCETRIS treatment and for at least 6 months after the final dose of ADCETRIS . Advise females to immediately report pregnancy .
Males
ADCETRIS may damage spermatozoa and testicular tissue , resulting in possible genetic abnormalities . Males with female sexual partners of reproductive potential should use effective contraception during ADCETRIS treatment and for at least 6 months after the final dose of ADCETRIS .
Infertility Males
Based on findings in rats , male fertility may be compromised by treatment with ADCETRIS .
8.4 Pediatric Use Safety and effectiveness of ADCETRIS have not been established in pediatric patients . 8.5 Geriatric Use
Clinical trials of ADCETRIS in cHL ( Studies 1 and 3 : AETHERA ) and sALCL ( Study 2 ) did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients .
In the clinical trial of ADCETRIS in pcALCL or CD30-expressing MF ( Study 4 : ALCANZA ), 42 % of ADCETRIS-treated patients were aged 65 or older . No meaningful differences in safety or efficacy were observed between these patients and younger patients .
8.6 Renal Impairment
Avoid the use of ADCETRIS in patients with severe renal impairment ( CrCL < 30 mL / min ). No dosage adjustment is required for mild ( CrCL > 50 – 80 mL / min ) or moderate ( CrCL 30 – 50 mL / min ) renal impairment .
8.7 Hepatic Impairment
Avoid the use of ADCETRIS in patients with moderate ( Child-Pugh B ) or severe ( Child- Pugh C ) hepatic impairment . Dosage reduction is required in patients with mild ( Child-Pugh A ) hepatic impairment .
10 OVERDOSAGE
There is no known antidote for overdosage of ADCETRIS . In case of overdosage , the patient should be closely monitored for adverse reactions , particularly neutropenia , and supportive treatment should be administered .
17 PATIENT COUNSELING INFORMATION Peripheral Neuropathy
Advise patients that ADCETRIS can cause a peripheral neuropathy . They should be advised to report to their health care provider any numbness or tingling of the hands or feet or any muscle weakness .
Fever / Neutropenia
Advise patients to contact their health care provider if a fever of 100.5 ° F or greater or other evidence of potential infection such as chills , cough , or pain on urination develops .
Infusion Reactions
Advise patients to contact their health care provider if they experience signs and symptoms of infusion reactions including fever , chills , rash , or breathing problems within 24 hours of infusion .
Hepatotoxicity
Advise patients to report symptoms that may indicate liver injury , including fatigue , anorexia , right upper abdominal discomfort , dark urine , or jaundice .
Progressive Multifocal Leukoencephalopathy
Instruct patients receiving ADCETRIS to immediately report if they have any of the following neurological , cognitive , or behavioral signs and symptoms or if anyone close to them notices these signs and symptoms :
• changes in mood or usual behavior
• confusion , thinking problems , loss of memory
• changes in vision , speech , or walking
• decreased strength or weakness on one side of the body Pulmonary Toxicity
Instruct patients to report symptoms that may indicate pulmonary toxicity , including cough or shortness of breath .
Acute Pancreatitis
Advise patients to contact their health care provider if they develop severe abdominal pain .
Gastrointestinal Complications
Advise patients to contact their health care provider if they develop severe abdominal pain , chills , fever , nausea , vomiting , or diarrhea .
Females and Males of Reproductive Potential
ADCETRIS can cause fetal harm . Advise women receiving ADCETRIS to avoid pregnancy during ADCETRIS treatment and for at least 6 months after the final dose of ADCETRIS .
Advise males with female sexual partners of reproductive potential to use effective contraception during ADCETRIS treatment and for at least 6 months after the final dose of ADCETRIS .
Advise patients to report pregnancy immediately . Lactation Advise patients to avoid breastfeeding while receiving ADCETRIS .
ADCETRIS and its logo , Seattle Genetics and are US registered trademarks of Seattle Genetics , Inc . © 2017 Seattle Genetics , Inc ., Bothell , WA 98021 . All rights reserved
USP-BVP-2017-0126 ( 1 )
ASH Summit on Emerging Immunotherapies for Hematologic Diseases
July 12 – 13 , 2018 Washington , DC ASH ’ s newest meeting examines preclinical and clinical factors influencing the effective development , regulation , and implementation of immunotherapies for hematologic diseases .
Mark your calendar for the 2018 ASH Annual Meeting taking place December 1-4 , 2018 , in San Diego , CA .
Washington , DC
San Diego , CA
January 2018 Annual Meeting Edition