COPIKTRA — duvelisib capsule
Secura Bio, Inc.
WARNING: FATAL AND SERIOUS TOXICITIES: INFECTIONS, DIARRHEA OR COLITIS, CUTANEOUS REACTIONS, and PNEUMONITIS
- Fatal and/or serious infections occurred in 31% of COPIKTRA-treated patients. Monitor for signs and symptoms of infection. Withhold COPIKTRA if infection is suspected [see Warnings and Precautions (5.1)].
- Fatal and/or serious diarrhea or colitis occurred in 18% of COPIKTRA-treated patients. Monitor for the development of severe diarrhea or colitis. Withhold COPIKTRA [see Warnings and Precautions (5.2)].
- Fatal and/or serious cutaneous reactions occurred in 5% of COPIKTRA-treated patients. Withhold COPIKTRA [see Warnings and Precautions (5.3)] .
- Fatal and/or serious pneumonitis occurred in 5% of COPIKTRA-treated patients. Monitor for pulmonary symptoms and interstitial infiltrates. Withhold COPIKTRA [see Warnings and Precautions (5.4)].
The recommended dose of COPIKTRA is 25 mg administered as oral capsules twice daily (BID) with or without food. A cycle consists of 28 days. The capsules should be swallowed whole. Advise patients not to open, break, or chew the capsules.
Advise patients that if a dose is missed by fewer than 6 hours, to take the missed dose right away and take the next dose as usual. If a dose is missed by more than 6 hours, advise patients to wait and take the next dose at the usual time.
Provide prophylaxis for Pneumocystis jirovecii (PJP) during treatment with COPIKTRA. Following completion of COPIKTRA treatment, continue PJP prophylaxis until the absolute CD4+ T cell count is greater than 200 cells/µL.
Withhold COPIKTRA in patients with suspected PJP of any grade, and discontinue if PJP is confirmed.
Consider prophylactic antivirals during COPIKTRA treatment to prevent cytomegalovirus (CMV) infection including CMV reactivation.
Manage toxicities per Table 1 with dose reduction, treatment hold, or discontinuation of COPIKTRA.
Abbreviations: ALT = alanine aminotransferase; ANC = absolute neutrophil count; AST = aspartate aminotransferase;
CMV = cytomegalovirus; DRESS = drug reaction with eosinophilia and systemic systems; PCR = polymerase chain reaction; PJP = Pneumocystis jirovecii; pneumonia; SJS = Stevens-Johnson syndrome; TEN = toxic epidermal necrolysis; ULN = upper limit of normal
|Toxicity||Adverse Reaction Grade||Recommended Management|
|Nonhematologic Adverse Reactions|
|Infections||Grade 3 or higher infection|| |
|Clinical CMV infection or viremia (positive PCR or antigen test)|| |
|Non-infectious Diarrhea or colitis||Mild/moderate diarrhea (Grade 1-2, up to 6 stools per day over baseline) and responsive to antidiarrheal agents, OR Asymptomatic (Grade 1) colitis|| |
|Mild/moderate diarrhea (Grade 1-2, up to 6 stools per day over baseline) and unresponsive to antidiarrheal agents|| |
|Abdominal pain, stool with mucus or blood, change in bowel habits, peritoneal signs, OR Severe diarrhea (Grade 3, >6 stools per day over baseline)|| |
|Cutaneous reactions||Grade 1-2|| |
|Grade 3|| |
|SJS, TEN, DRESS (any grade)|| |
|Pneumonitis without suspected infectious cause||Moderate (Grade 2) symptomatic pneumonitis|| |
|Severe (Grade 3) or life-threatening pneumonitis|| |
|ALT/AST elevation||3 to 5 × upper limit of normal (ULN) (Grade 2)|| |
|> 5 to 20 × ULN (Grade 3)|| |
|> 20 × ULN (Grade 4)|| |
|Hematologic Adverse Reactions|
|Neutropenia||Absolute neutrophil count (ANC) 0.5 to 1.0 Gi/L|| |
|ANC less than 0.5 Gi/L|| |
|Thrombocytopenia||Platelet count 25 to < 50 Gi/L (Grade 3) with Grade 1 bleeding|| |
|Platelet count 25 to < 50 Gi/L (Grade 3) with Grade 2 bleeding or Platelet count < 25 Gi/L (Grade 4)|| |
Recommended dose modification levels for COPIKTRA are presented in Table 2.
|Initial Dose||25 mg twice daily|
|Dose Reduction||15 mg twice daily|
|Subsequent Dose Modification||Discontinue COPIKTRA if patient is unable to tolerate 15 mg twice daily.|
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