Ukoniq Dosage

Generic name: UMBRALISIB TOSYLATE 260.2mg
Dosage form: tablet, film coated
Drug class: Multikinase inhibitors

Medically reviewed by Drugs.com. Last updated on Dec 15, 2022.

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.

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)].

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. aNational Cancer Institute Common Terminology Criteria for Adverse Events version 4.03.
Adverse Reactions	Severitya	Dosage Modification
Hematologic Adverse Reactions
Neutropenia [see Warnings and Precautions ( 5.2)]	ANC 0.5 to 1 ×10 9/L	Maintain UKONIQ. If ANC 0.5 to 1 × 10 9/L recurs or is persistent, then withhold UKONIQ until ANC 1 × 10 9/L or greater, then resume at same dose.
Neutropenia [see Warnings and Precautions ( 5.2)]	ANC less than 0.5 × 10 9/L	Withhold UKONIQ until ANC 0.5 × 10 9/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 × 10 9/L with bleeding OR Platelet count less than 25 × 10 9/L	Withhold UKONIQ until platelet count 25 × 10 9/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.
ALT or AST Elevation [see Warnings and Precautions ( 5.4)]	AST or ALT greater than 20 times ULN	Discontinue UKONIQ.
Diarrhea or Noninfectious Colitis [see Warnings and Precautions ( 5.3)]	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.
Adverse Reactions	Severitya	Dosage Modification
	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 reduced dose. For recurrent severe diarrhea or recurrent colitis of any grade, discontinue UKONIQ.
	Life-threatening	Discontinue UKONIQ.
Severe Cutaneous Reactions [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 Adverse Reactions [see Adverse Reactions ( 6.1)]	Severe	Withhold UKONIQ until resolved, then resume at the same or reduced dose.
Other Adverse Reactions [see Adverse Reactions ( 6.1)]	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