ACN_7.4_Full Issue_Digital | Page 29

THE FIRST AND ONLY TARGETED KINASE INHIBITOR OF PI3K-DELTA AND CK1-EPSILON

THE FIRST AND ONLY TARGETED KINASE INHIBITOR OF PI3K-DELTA AND CK1-EPSILON

INDICATIONS
UKONIQ is indicated for the treatment of adult patients with :
MZL
Relapsed or refractory marginal zone lymphoma ( MZL ) who have received at least 1 prior anti-CD20-based regimen
FL
Relapsed or refractory follicular lymphoma ( FL ) who have received at least 3 prior lines of systemic therapy
These indications are approved under accelerated approval based on overall response rate . Continued approval for these indications may be contingent upon veri�cation and description of clinical bene�t in a con�rmatory trial .
IMPORTANT SAFETY INFORMATION
Infections : Serious , including fatal , infections occurred in patients treated with UKONIQ . Grade 3 or higher infections occurred in 10 % of 335 patients , with fatal infections occurring in < 1 %. The most frequent Grade ≥3 infections included pneumonia , sepsis , and urinary tract infection . Provide prophylaxis for Pneumocystis jirovecii pneumonia ( PJP ) and consider prophylactic antivirals during treatment with UKONIQ to prevent CMV infection , including CMV reactivation . Monitor for any new or worsening signs and symptoms of infection , including suspected PJP or CMV , during treatment with UKONIQ . For Grade 3 or 4 infection , withhold UKONIQ until infection has resolved . Resume UKONIQ at the same or a reduced dose . Withhold UKONIQ in patients with suspected PJP of any grade and permanently discontinue in patients with con�rmed PJP . For clinical CMV infection or viremia , withhold UKONIQ until infection or viremia resolves . If UKONIQ is resumed , administer the same or reduced dose and monitor patients for CMV reactivation by PCR or antigen test at least monthly .
Neutropenia : Serious neutropenia occurred in patients treated with UKONIQ . Grade 3 neutropenia developed in 9 % of 335 patients and Grade 4 neutropenia developed in 9 %. Monitor neutrophil counts at least every 2 weeks for the �rst 2 months of UKONIQ and at least weekly in patients with neutrophil count < 1 x 10 9 / L ( Grade 3-4 ) neutropenia during treatment with UKONIQ . Consider supportive care as appropriate . Withhold , reduce dose , or discontinue UKONIQ depending on the severity and persistence of neutropenia .
Diarrhea or Non-Infectious Colitis : Serious diarrhea or non-infectious colitis occurred in patients treated with UKONIQ . Any grade diarrhea or colitis occurred in 53 % of 335 patients and Grade 3 occurred in 9 %. For patients with severe diarrhea ( Grade 3 , i . e ., > 6 stools per day over baseline ) or abdominal pain , stool with mucus or blood , change in bowel habits , or peritoneal signs , withhold UKONIQ until resolved and provide supportive care with antidiarrheals or enteric acting steroids as appropriate . Upon resolution , resume UKONIQ at a reduced dose . For recurrent Grade 3 diarrhea or recurrent colitis of any grade , discontinue UKONIQ . Discontinue UKONIQ for life-threatening diarrhea or colitis .
Hepatotoxicity : Serious hepatotoxicity occurred in patients treated with UKONIQ . Grade 3 and 4 transaminase elevations ( ALT and / or AST ) occurred in 8 % and < 1 %, respectively , in 335 patients . Monitor hepatic function at baseline and during treatment with UKONIQ . For ALT / AST greater than 5 to less than 20 times ULN , withhold UKONIQ until return to less than 3 times ULN , then resume at a reduced dose . For ALT / AST elevation greater than 20 times ULN , discontinue UKONIQ .
VISIT UKONIQ . COM TO LEARN MORE .
Severe Cutaneous Reactions : Severe cutaneous reactions , including a fatal case of exfoliative dermatitis , occurred in patients treated with UKONIQ . Grade 3 cutaneous reactions occurred in 2 % of 335 patients and included exfoliative dermatitis , erythema , and rash ( primarily maculo-papular ). Monitor patients for new or worsening cutaneous reactions . Review all concomitant medications and discontinue any potentially contributing medications . Withhold UKONIQ for severe ( Grade 3 ) cutaneous reactions until resolution . Monitor at least weekly until resolved . Upon resolution , resume UKONIQ at a reduced dose . Discontinue UKONIQ if severe cutaneous reaction does not improve , worsens , or recurs . Discontinue UKONIQ for life-threatening cutaneous reactions or SJS , TEN , or DRESS of any grade . Provide supportive care as appropriate .
Allergic Reactions Due to Inactive Ingredient FD & C Yellow No . 5 : UKONIQ contains FD & C Yellow No . 5 ( tartrazine ), which may cause allergic-type reactions ( including bronchial asthma ) in certain susceptible persons , frequently in patients who also have aspirin hypersensitivity .
Embryo-fetal Toxicity : Based on �ndings in animals and its mechanism of action , UKONIQ can cause fetal harm when administered to a pregnant woman . Advise pregnant women of the potential risk to a fetus . Advise females and males with female partners of reproductive potential to use effective contraception during treatment and for at least one month after the last dose .
Serious adverse reactions occurred in 18 % of 221 patients who received UKONIQ . Serious adverse reactions that occurred in ≥2 % of patients were diarrhea-colitis ( 4 %), pneumonia ( 3 %), sepsis ( 2 %), and urinary tract infection ( 2 %). Permanent discontinuation of UKONIQ due to an adverse reaction occurred in 14 % of patients . Dose reductions of UKONIQ due to an adverse reaction occurred in 11 % of patients . Dosage interruptions of UKONIQ due to an adverse reaction occurred in 43 % of patients .
The most common adverse reactions (> 15 %), including laboratory abnormalities , in 221 patients who received UKONIQ were increased creatinine ( 79 %), diarrhea-colitis ( 58 %, 2 %), fatigue ( 41 %), nausea ( 38 %), neutropenia ( 33 %), ALT increase ( 33 %), AST increase ( 32 %), musculoskeletal pain ( 27 %), anemia ( 27 %), thrombocytopenia ( 26 %), upper respiratory tract infection ( 21 %), vomiting ( 21 %), abdominal pain ( 19 %), decreased appetite ( 19 %), and rash ( 18 %).
Lactation : Because of the potential for serious adverse reactions from umbralisib in the breastfed child , advise women not to breastfeed during treatment with UKONIQ and for at least one month after the last dose .
Please see Brief Summary of the full Prescribing Information on the following pages .
© 2021 TG Therapeutics , Inc . All rights reserved . UKONIQ is a registered trademark of TG Therapeutics , Inc . 02 / 2021 US-UMB-2000041