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UKONIQ is indicated for the treatment of adult patients with relapsed or refractory marginal zone lymphoma (MZL) who have received at least one prior anti-CD20-based regimen and adult patients with relapsed or refractory follicular lymphoma (FL) who have received at least three 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 verification and description of clinical benefit in a confirmatory 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 confirmed 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 first 2 months of UKONIQ and at least weekly in patients with neutrophil count <1 x 109/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.
  • 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 findings 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.

Reference: 1. UKONIQ [prescribing information]. New York, NY: TG Therapeutics; 2021.

INDICATIONS

UKONIQ is indicated for the treatment of adult patients with:

  • Relapsed or refractory marginal zone lymphoma (MZL) who have received at least 1 prior anti-CD20-based regimen
  • 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 verification and description of clinical benefit in a confirmatory trial.

Please see full Prescribing Information.
Recommended dose reductions
Recommended dose reductions

RECOMMENDED DOSE REDUCTIONS1

  • FULL DOSE

    800 mg

    1. UKONIQ
    2. UKONIQ
    3. UKONIQ
    4. UKONIQ
  • FIRST DOSE
    REDUCTION

    600 mg

    1. UKONIQ
    2. UKONIQ
    3. UKONIQ
  • SECOND DOSE
    REDUCTION

    400 mg

    1. UKONIQ
    2. UKONIQ
  • SUBSEQUENT
    DOSE REDUCTION

    Permanently discontinue if patient is unable to tolerate 400 mg daily

RECOMMENDED DOSE MODIFICATIONS FOR ADVERSE REACTIONS1

Adverse reaction Severitya Dosage modification

Neutropenia

ANC 0.5 to 1 × 109/L

  • Maintain UKONIQ
  • If ANC 0.5 to 1 × 109/L recurs or is persistent, then withhold UKONIQ until ANC 1 × 109/L or greater, then resume at same dose

ANC less than 0.5 × 109/L

  • Withhold UKONIQ until ANC 0.5 × 109/L or greater, then resume at same dose
  • If recurrence, then resume at reduced dose

Thrombocytopenia

Platelet count 25 to less than
50 × 109/L with bleeding
OR
Platelet count less than 25 × 109/L

  • Withhold UKONIQ until platelet count 25 × 109/L or greater and resolution of bleeding (if applicable), then resume at same dose
  • If recurrence, withhold until resolution and then resume at reduced dose

Infection, including opportunistic infection

Grade 3 or 4

Withhold UKONIQ until resolved, then resume at same or reduced dose.

PJP

  • For suspected PJP, withhold UKONIQ until evaluated
  • For confirmed PJP, discontinue UKONIQ

CMV infection or viremia

Withhold UKONIQ until infection or viremia resolves, then resume at same or reduced dose.

ALT or AST elevation

AST or ALT 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.

AST or ALT greater than 20 times ULN

Discontinue UKONIQ.

Diarrhea or noninfectious colitis

Mild or moderate diarrhea (up to 6
stools per day over baseline)
OR
Asymptomatic (Grade 1) colitis

  • If persistent, withhold UKONIQ until resolved, then resume at same or reduced dose
  • If recurrence, withhold until resolution and then resume at reduced dose

Severe diarrhea (greater than
6 stools per day over baseline)
OR
Abdominal pain, stool with mucus
or blood, change in bowel habits,
peritoneal signs

  • Withhold UKONIQ until resolved, then resume at a reduced dose
  • For recurrent severe diarrhea or recurrent colitis of any grade, discontinue UKONIQ

Life-threatening

Discontinue UKONIQ.

Severe cutaneous reactions

Severe

  • Withhold UKONIQ until resolved, then resume at a reduced dose or discontinue
  • If recurrence after re-challenge, discontinue UKONIQ

Life-threatening

Discontinue UKONIQ.

SJS, TEN, DRESS (any grade)

Discontinue UKONIQ.

Other adverse reactions

Severe

Withhold UKONIQ until resolved, then resume at the same or reduced dose.

Life-threatening

Discontinue UKONIQ.

aNational Cancer Institute Common Terminology Criteria for Adverse Events version 4.03.
ANC=absolute neutrophil count; DRESS=drug reaction with eosinophilia and systemic symptoms; SJS=Stevens-Johnson syndrome; TEN=toxic epidermal necrolysis; ULN=upper limit of normal.

Adverse reaction

  • Neutropenia

    Severitya Dosage modification

    ANC 0.5 to 1 ×109/L

    • Maintain UKONIQ
    • If ANC 0.5 to 1 × 109/L recurs or is persistent, then withhold UKONIQ until ANC 1 × 109/L or greater, then resume at same dose

    ANC less than 0.5 × 109/L

    • Withhold UKONIQ until ANC 0.5 × 109/L or greater, then resume at same dose
    • If recurrence, then resume at reduced dose
  • Thrombocytopenia

    Severitya Dosage modification

    Platelet count 25 to less than 50 × 109/L with bleeding
    OR
    Platelet count less than 25 × 109/L

    • Withhold UKONIQ until platelet count 25 × 109/L or greater and resolution of bleeding (if applicable), then resume at same dose
    • If recurrence, withhold until resolution and then resume at reduced dose
  • Infection, including opportunistic infection

    Severitya Dosage modification

    Grade 3 or 4

    Withhold UKONIQ until resolved, then resume at same or reduced dose.

    PJP

    • For suspected PJP, withhold UKONIQ until evaluated
    • For confirmed PJP, discontinue UKONIQ

    CMV infection
    or viremia

    Withhold UKONIQ until infection or viremia resolves, then resume at same or reduced dose.

  • ALT or AST elevation

    Severitya Dosage modification

    AST or ALT 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.

    AST or ALT greater than 20 times ULN

    Discontinue UKONIQ.

  • Diarrhea or noninfectious colitis

    Severitya Dosage modification

    Mild or moderate diarrhea (up to 6 stools per day over baseline)
    OR
    Asymptomatic (Grade 1) colitis

    • If persistent, withhold UKONIQ until resolved, then resume at same or reduced dose
    • If recurrence, withhold until resolution and then resume at reduced dose

    Severe diarrhea (greater than 6 stools per day over baseline)
    OR
    Abdominal pain, stool with mucus or blood, change in bowel habits, peritoneal signs

    • Withhold UKONIQ until resolved, then resume at a reduced dose
    • For recurrent severe diarrhea or recurrent colitis of any grade, discontinue UKONIQ

    Life-threatening

    Discontinue UKONIQ.

  • Severe cutaneous reactions

    Severitya Dosage modification

    Severe

    • Withhold UKONIQ until resolved, then resume at a reduced dose or discontinue
    • If recurrence after re-challenge, discontinue UKONIQ

    Life-threatening

    Discontinue UKONIQ.

    SJS, TEN, DRESS (any grade)

    Discontinue UKONIQ.

  • Other adverse reactions

    Severitya Dosage modification

    Severe

    Withhold UKONIQ until resolved, then resume at the same or reduced dose.

    Life-threatening

    Discontinue UKONIQ.

*See UKONIQ dose reduction levels.

aNational Cancer Institute Common Terminology Criteria for Adverse Events version 4.03. ANC=absolute neutrophil count; DRESS=drug reaction with eosinophilia and systemic symptoms; SJS=Stevens-Johnson syndrome; TEN=toxic epidermal necrolysis; ULN=upper limit of normal.

indications

UKONIQ is indicated for the treatment of adult patients with:

  • Relapsed or refractory marginal zone lymphoma (MZL) who have received at least 1 prior anti-CD20-based regimen
  • 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 verification and description of clinical benefit in a confirmatory 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 confirmed 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 first 2 months of UKONIQ and at least weekly in patients with neutrophil count <1 x 109/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.
  • 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 findings 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 full Prescribing Information.

Reference: 1. UKONIQ [prescribing information]. New York, NY: TG Therapeutics; 2021.

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