UKONIQ

UKONIQ- umbralisib tosylate tablet, film coated
TG Therapeutics, Inc.

1 INDICATIONS AND USAGE

1.1 Marginal Zone Lymphoma

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.

This indication is approved under accelerated approval based on overall response rate [see Clinical Studies (14.1)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

1.2 Follicular Lymphoma

UKONIQ is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) who have received at least three prior lines of systemic therapy.

This indication is approved under accelerated approval based on overall response rate [see Clinical Studies (14.2)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

2 DOSAGE AND ADMINISTRATION

2.1 Recommended Dosage

The recommended dosage of UKONIQ is 800 mg taken orally once daily with food [see Clinical Pharmacology (12.3)] until disease progression or unacceptable toxicity.

Advise patients of the following:

  • Swallow tablets whole. Do not crush, break, cut, or chew tablets.
  • Take UKONIQ at the same time each day.
  • If vomiting occurs, do not take an additional dose; continue with the next scheduled dose.
  • If a dose is missed, take a missed dose unless it is less than 12 hours until the next scheduled dose.

2.2 Recommended Prophylaxis

Provide prophylaxis for Pneumocystis jirovecii pneumonia (PJP) during treatment with UKONIQ [see Warnings and Precautions (5.1)].

Consider prophylactic antivirals during treatment with UKONIQ to prevent cytomegalovirus (CMV) infection, including CMV reactivation [see Warnings and Precautions (5.1)].

2.3 Dosage Modifications for Adverse Reactions

Recommended dosage modifications of UKONIQ for adverse reactions are presented in Table 1 and the recommended dose reductions of UKONIQ for adverse reactions are presented in Table 2.

Table 1: Recommended Dosage Modifications of UKONIQ for Adverse Reactions

ALT, alanine aminotransferase; ANC, absolute neutrophil count; AST, aspartate aminotransferase; CMV, cytomegalovirus; PJP, Pneumocystis jirovecii pneumonia; ULN, upper limit of normal; SJS, Stevens-Johnson syndrome; TEN, toxic epidermal necrolysis; DRESS, drug reaction with eosinophilia and systemic symptoms. a National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03.

Adverse Reactions Severity a Dosage Modification
Hematologic Adverse Reactions
Neutropenia[see Warnings and Precautions (5.2)] 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[see Adverse Reactions (6.1)] Platelet count 25 to less than 50 × 109 /L with bleedingORPlatelet 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.
Nonhematologic Adverse Reactions
Infection, including opportunistic infection[see Warnings and Precautions (5.1)] 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[see Warnings and Precautions (5.4)] 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 reduced dose.
AST or ALT greater than 20 timesULN Discontinue UKONIQ.
Diarrhea or Noninfectious Colitis[see Warnings and Precautions (5.3)] Mild or moderate diarrhea (up to 6 stools per day over baseline)ORAsymptomatic (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.
Adverse Reactions Severity a Dosage Modification
Severe diarrhea (greater than 6 stools per day over baseline)ORAbdominal pain, stool with mucus or blood, change in bowel habits, peritoneal signs
  • Withhold UKONIQ until resolved, then resume at reduced dose.
  • For recurrent severe diarrhea or recurrent colitis of any grade, discontinue UKONIQ.
Life-threatening Discontinue UKONIQ.
Severe CutaneousReactions [see Warnings and Precautions (5.5)] Severe
  • Withhold UKONIQ until resolved, then resume at reduced dose or discontinue.
  • If recurrence after re-challenge, discontinue UKONIQ.
Life-threatening Discontinue UKONIQ.
SJS, TEN, DRESS (any grade) Discontinue UKONIQ.
Other AdverseReactions [see Adverse Reactions (6.1)] Severe Withhold UKONIQ until resolved, then resume at the same or reduced dose.
Life-threatening Discontinue UKONIQ.
Table 2: Recommended Dose Reductions of UKONIQ for Adverse Reactions
Dose Reduction Dosage
First 600 mg orally daily
Second 400 mg orally daily
Subsequent Permanently discontinue UKONIQ in patients unable to tolerate 400 mg orally daily

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