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 5, 2024.
Recommended Dosage
The recommended dosage of UKONIQ is 800 mg taken orally once daily with food 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.
Consider prophylactic antivirals during treatment with UKONIQ to prevent cytomegalovirus (CMV) infection, including CMV reactivation.
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.
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 |
ANC 0.5 to 1 ×10 9/L |
|
ANC less than 0.5 × 10 9/L |
|
|
Thrombocytopenia |
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 |
Grade 3 or 4 | Withhold UKONIQ until resolved, then resume at same or reduced dose. |
PJP |
|
|
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 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 |
|
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 |
|
|
Life-threatening | Discontinue UKONIQ. | |
Severe Cutaneous Reactions |
Severe |
|
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. |
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 |
More about Ukoniq (umbralisib)
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- Drug class: multikinase inhibitors
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