ASH Clinical News ACN_4.5_FULL_ISSUE_DIGITAL - Page 30

Literature Scan

Myeloma Outcomes Differ Based on Socioeconomic Factors

Despite the gains made in improving treatment for and care of patients with multiple myeloma ( MM ), disparities persist based on race and socioeconomic status . In a population-based analysis , Sikander Ailawadhi , MD , of the
Division of Hematology / Oncology at the Mayo Clinic in Jacksonville , Florida , and co-authors assessed these discrepancies and observed inferior survival for women , increased costs of care for minorities , and a decrease in mortality for those with higher incomes . The findings were published in Cancer .
Using the National Cancer Institute ’ s Surveillance , Epidemiology , and End Results Program database , the researchers assessed linked Medicare claims to identify 35,842 cases of primary MM reported between 1991 and 2010 . Patients with full Medicare coverage ( defined as 12 months of coverage each year ) beginning one year prior to diagnosis through the end of 2012 were included . Patients who
IMPORTANT SAFETY INFORMATION FOR KYMRIAH™ ( tisagenlecleucel ) ( continued )
Hypersensitivity Reactions : Allergic reactions may occur with KYMRIAH . Serious hypersensitivity reactions , including anaphylaxis , may be due to dimethyl sulfoxide or dextran 40 in KYMRIAH .
Serious Infections : Serious infections , including lifethreatening or fatal infections , occurred in patients after KYMRIAH infusion . In Study 1 , infections ( all grades ) after KYMRIAH infusion occurred in 40 patients ( 59 %), including 24 patients ( 35 %) with grade 3 and 4 infections and 2 patients ( 3 %) with fatal infections . Infections with an unknown pathogen occurred in 41 % of patients , viral infections in 26 %, bacterial infections in 19 %, and fungal infections in 13 %. Prior to KYMRIAH infusion , infection prophylaxis should follow local guidelines . Monitor patients for signs and symptoms of infection after treatment with KYMRIAH and treat appropriately . Febrile neutropenia ( grade 3 or 4 ) was also observed in 37 % of patients after KYMRIAH infusion and may be concurrent with CRS . In the event of febrile neutropenia , evaluate for infection and manage with broad spectrum antibiotics , fluids , and other supportive care as medically indicated .
Hepatitis B virus ( HBV ) reactivation , in some cases resulting in fulminant hepatitis , hepatic failure and death , can occur in patients treated with drugs directed against B cells . HBV reactivation is defined as an abrupt increase in HBV replication manifesting as a rapid increase in serum HBV DNA level or detection of HBsAg in a person who was previously HBsAg negative and anti-HBc positive . Reactivation of HBV replication is often followed by hepatitis . Perform screening for HBV , HCV and HIV in accordance with clinical guidelines before cell collection for manufacturing .
Prolonged Cytopenias : Patients may exhibit cytopenias for several weeks following lymphodepleting chemotherapy and KYMRIAH infusion . Grades 3 and 4 cytopenias not resolved by Day 28 following KYMRIAH treatment included neutropenia ( 40 %) and thrombocytopenia ( 27 %) among 52 responding patients . At 56 days following KYMRIAH , 17 % and 12 % of responding patients had grades 3 and 4 neutropenia or thrombocytopenia respectively . Prolonged neutropenia has been associated with increased risk of infection . Myeloid growth factors , particularly GM-CSF , are not recommended during the first 3 weeks after KYMRIAH infusion or until CRS has resolved .
Hypogammaglobulinemia : Hypogammaglobulinemia and agammaglobulinemia ( IgG ) can occur in patients with a complete remission after KYMRIAH infusion . In Study 1 , 43 % of patients had hypogammaglobulinemia . B-cell aplasia is an on-target effect of KYMRIAH and therefore a patient may experience hypogammaglobulinemia for as long as KYMRIAH persists . Monitor immunoglobulin levels after treatment with KYMRIAH and manage using infection precautions , antibiotic prophylaxis , and immunoglobulin replacement standard guidelines .
The safety of immunization with live viral vaccines during or following KYMRIAH treatment has not been studied . Vaccination with live virus vaccines is not recommended for at least 2 weeks prior to the start of lymphodepleting chemotherapy , during KYMRIAH treatment , and until immune recovery following treatment with KYMRIAH .
Pregnant women who have received KYMRIAH may have hypogammaglobulinemia . Assess immunoglobulin levels in newborns of mothers treated with KYMRIAH .
Secondary Malignancies : Patients treated with KYMRIAH may develop secondary malignancies or recurrence of their leukemia . Monitor life-long for secondary malignancies . If a second malignancy occurs , call 1-844-4KYMRIAH ( 1-844-459-6742 ) to obtain instructions on patient samples to collect for testing .
Effects on Ability to Drive and Use Machines : Due to the potential for neurological events , patients receiving KYMRIAH are at risk for altered or decreased consciousness or coordination in the 8 weeks following infusion . Advise patients to refrain from driving and engaging in hazardous occupations or activities during this initial period .
DRUG INTERACTIONS HIV and the lentivirus used to make KYMRIAH have limited short spans of identical genetic material ( RNA ). Therefore , some commercial HIV nucleic acid tests ( NATs ) may yield false positive results in patients who have received KYMRIAH .
PREGNANCY , LACTATION , FEMALES AND MALES OF REPRODUCTIVE POTENTIAL There are no available data of KYMRIAH use in pregnant or lactating women . Therefore , KYMRIAH is not recommended for women who are pregnant or breastfeeding . Pregnancy after KYMRIAH administration should be discussed with the treating physician . Pregnancy status of females of reproductive potential should be verified with a pregnancy test prior to starting treatment with KYMRIAH . Report pregnancies to Novartis Pharmaceuticals Corporation at 1-888-669-6682 .
ADVERSE REACTIONS The most common adverse reactions ( incidence greater than 20 %) are cytokine release syndrome , hypogammaglobulinemia , infections-pathogen unspecified , pyrexia , decreased appetite , headache , encephalopathy , bleeding , hypotension , tachycardia , nausea , diarrhea , vomiting , viral infection disorders , hypoxia , fatigue , acute kidney injury , and delirium .
Please see Brief Summary of Prescribing Information , including Boxed WARNING , on following pages .
Visit KYMRIAH-hcp . com to learn more about KYMRIAH and find treatment center locations .
Novartis Pharmaceuticals Corporation
East Hanover , New Jersey 07936-1080
© 2018 Novartis
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Literature Scan Myeloma Outcomes Differ Based on Socioeconomic Factors Despite the gains made in improving treatment for and care of patients with multiple myeloma (MM), disparities persist based on race and socioeconomic status. In a population-based analysis, Sikander Ailawadhi, MD, of the Division of Hematology/Oncology at the Mayo Clinic in Jacksonville, Florida, and co-authors assessed these discrepancies and B:7.75” observed infe- rior survival for women, increased costs of care T:7.5” for minorities, and a decrease in mortality for S:7” those with higher incomes. The findings were published in Cancer. Using the National Cancer Institute’s Surveillance, Epidemiology, and End Results Program database, the researchers assessed linked Medicare claims to identify 35,842 cases of primary MM reported between 1991 and 2010. Patients with full Medicare coverage (defined as 12 months of coverage each year) beginning one year prior to diagnosis through the end of 2012 were included. Patients who IMPORTANT SAFETY INFORMATION FOR KYMRIAH™ (tisagenlecleucel) (continued) Hypersensitivity Reactions: Allergic reactions may occur with KYMRIAH. Serious hypersensitivity reactions, including anaphylaxis, may be due to dimethyl sulfoxide or dextran 40 in KYMRIAH. Serious Infections: Serious infections, including life- threatening or fatal infections, occurred in patients after KYMRIAH infusion. In Study 1, infections (all grades) after KYMRIAH infusion occurred in 40 patients (59%), including 24 patients (35%) with grade 3 and 4 infections and 2 patients (3%) with fatal infections. Infections with an unknown pathogen occurred in 41% of patients, viral infections in 26%, bacterial infections in 19%, and fungal infections in 13%. Prior to KYMRIAH infusion, infection prophylaxis should follow local guidelines. Monitor patients for signs and symptoms of infection after treatment with KYMRIAH and treat appropriately. Febrile neutropenia (grade 3 or 4) was also observed in 37% of patients after KYMRIAH infusion and may be concurrent with CRS. In the event of febrile neutropenia, evaluate for infection and manage with broad spectrum antibiotics, fluids, and other supportive care as medically indicated. Hepatitis B virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure and death, can occur in patients treated with drugs directed against B cells. HBV reactivation is defined as an abrupt increase in HBV replication manifesting as a rapid increase in serum HBV DNA level or detection of HBsAg in a person who was previously HBsAg negative and anti-HBc positive. Reactivation of HBV replication is often followed by hepatitis. Perform screening for HBV, HCV and HIV in accordance with clinical guidelines before cell collection for manufacturing. Prolonged Cytopenias: Patients may exhibit cytopenias for several weeks following lymphodepleting chemotherapy and KYMRIAH infusion. Grades 3 and 4 cytopenias not resolved by Day 28 following KYMRIAH treatment included neutropenia (40%) and thrombocytopenia (27%) among 52 responding patients. At 56 days following KYMRIAH, 17% and 12% of responding patients had grades 3 and 4 neutropenia or thrombocytopenia respectively. Prolonged neutropenia has been associated with increased risk of infection. Myeloid growth factors, particularly GM-CSF, are not recommended during the first 3 weeks after KYMRIAH infusion or until CRS has resolved. Hypogammaglobulinemia: Hypogammaglobulinemia and agammaglobulinemia (IgG) can occur in patients with a complete remission after KYMRIA gW6ख7GVGC2RbFVG2Bvv'VƖV֖"6V62F&vWBVffV7Bb$BFW&Vf&RFVBWW&V6Pvv'VƖV֖f"2r2$W'67G2F"Vv'VƖWfV2gFW G&VFVBvF$BvRW6pfV7F&V6WF2F&F2&2@Vv'VƖ&W6VVB7FF&BwVFVƖW2f'F2&6WWF626'&FV7BfW"WrW'6Ws3bFR6fWGbV旦FvFƗfRf&f66W2GW&p"fvr$G&VFVB2B&VV7GVFVBf66FvFƗfRf'W2f66W22B&V6VFV@f"BV7B"vVV2&"FFR7F'BbǖFWWFp6VFW&GW&r$G&VFVBBVFVR&V6fW'fvrG&VFVBvF$&VvBvVvfR&V6VfVB$fRvv'VƖV֖76W72Vv'VƖWfV2Wv&&2bFW'2G&VFVBvF$6V6F'Ɩv6W3FVG2G&VFVBvF$FWfV6V6F'Ɩv6W2 &V7W'&V6RbFV"WVV֖F"ƖfRrf 6V6F'Ɩv6W2b6V6BƖv767W'26ӃCBD$ӃCBCScsC"F'Fখ7G'V7F2FVB6W2F6V7Bf"FW7FrVffV7G2&ƗGFG&fRBW6R6W3GVPFFRFVFf"WW&v6WfVG2FVG0&V6Vfr$&RB&6f"FW&VB"FV7&V6V@666W6W72"6&FFFRvVV2fvpgW6Gf6RFVG2F&Vg&g&G&fr@Vvvr&FW267WF2"7FfFW2GW&pF2FW&BE%TrDU$5D0bBFRVFf'W2W6VBFR$fPƖ֗FVB6'B72bFVF6vVWF2FW&$FW&Vf&R6R6W&6bV6V26BFW7G2G2VBf6R6FfR&W7VG2FVG2vfP&V6VfVB$$Tt55DDdTU2BU0b$U$ET5DdRDTDFW&R&Rf&RFFb$W6R&VvB"7FFrvVFW&Vf&R$2B&V6VFVBf"vVv&R&VvB '&V7FfVVFr&Vv7gFW"$F֖7G&F6VB&RF67W76VBvFFRG&VFr66&Vv77FGW2bfVW2b&W&GV7FfRFVF6VB&RfW&fVBvF&Vv7FW7B&"F7F'FrG&VFVBvF$&W'B&Vv6W2Ff'F2&6WWF626'&FBӃcccc"EdU%4R$T5D0FR7B6GfW'6R&V7F26FV6Pw&VFW"F#R&R7FR&VV6R7G&Rvv'VƖV֖fV7F2FvVV7V6fVB&WFV7&V6VBWFFRVF6RV6WF&VVFrFV6F66&FW6VF'&Vf֗Frf&fV7FF6&FW'2fFwVR7WFRFWW'BFVƗ&VV6R6VR'&Vb7V'b&W67&&pf&F6VFr&VBt$rfvrvW2f6B$ֆ76FV&&R&W@$BfBG&VFVB6VFW"6F2*#f'F0BԵsCS