What is Copiktra (duvelisib), and how does it work?
Generic drug: duvelisib
Brand name: Copiktra
Copiktra (duvelisib) is a prescription medicine used to treat adults with:
- Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) who have received at least 2 prior therapies and they did not work or are no longer working.
- Follicular Lymphoma (FL) who have received at least 2 prior therapies and they did not work or are no longer working.
It is not known if Copiktra is safe and effective in children less than 18 years of age.
What are the side effects of Copiktra?
Copiktra may cause serious side effects, including:
- Elevated liver enzymes. Copiktra may cause abnormalities in liver blood tests. Your healthcare provider should do blood tests during your treatment with Copiktra to check for liver problems. Tell your healthcare provider right away if you get any symptoms of liver problems, including yellowing of your skin or the white part of your eyes (jaundice), pain in the abdominal region, bruising or bleeding more easily than normal.
- Low white blood cell count (neutropenia). Neutropenia is common with Copiktra treatment and can sometimes be serious. Your healthcare provider should check your blood counts regularly during treatment with Copiktra. Tell your healthcare provider right away if you have a fever or any signs of infection during treatment with Copiktra.
Common side effects of Copiktra include:
These are not all the possible side effects of Copiktra.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
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.
- 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.
- Fatal and/or serious cutaneous reactions occurred in 5% of Copiktra-treated patients. Withhold Copiktra.
- Fatal and/or serious pneumonitis occurred in 5% of Copiktra-treated patients. Monitor for pulmonary symptoms and interstitial infiltrates. Withhold Copiktra.
What is the dosage for Copiktra?
- 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.
Dose Modifications For Adverse Reactions
Manage toxicities per Table 1 with dose reduction, treatment hold, or discontinuation of Copiktra.
Table 1: Copiktra Dose Modifications and Toxicity Management
|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|
|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 x upper limit of normal (ULN) (Grade 2)|
|> 5 to 20 x ULN (Grade 3)|
|> 20 x 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)|
|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 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|
Recommended dose modification levels for Copiktra are presented in Table 2.
Table 2: Dose Modification Levels
|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.|
Dose Modification For Concomitant Use With CYP3A4 Inhibitors
- Reduce Copiktra dose to 15 mg twice daily when co-administered with strong CYP3A4 inhibitors (e.g. ketoconazole).
What drugs interact with Copiktra?
Effects Of Other Drugs On Copiktra
- Co-administration with a strong CYP3A inducer decreases duvelisib area under the curve (AUC), which may reduce Copiktra efficacy.
- Avoid co-administration of Copiktra with strong CYP3A4 inducers.
- Co-administration with a strong CYP3A inhibitor increases duvelisib AUC, which may increase the risk of Copiktra toxicities.
- Reduce Copiktra dose to 15 mg BID when co-administered with a strong CYP3A4 inhibitor.
Effects Of Copiktra On Other Drugs
- Co-administration with Copiktra increases AUC of a sensitive CYP3A4 substrate which may increase the risk of toxicities of these drugs.
- Consider reducing the dose of the sensitive CYP3A4 substrate and monitor for signs of toxicities of the co-administered sensitive CYP3A substrate.
Is Copiktra safe to use while pregnant or breastfeeding?
- Based on findings from animal studies and the mechanism of action, Copiktra can cause fetal harm when administered to a pregnant woman.
- There are no data on the presence of duvelisib and/or its metabolites in human milk, the effects on the breastfed child, or on milk production.
- Because of the potential for serious adverse reactions from duvelisib in a breastfed child, lactating women should not breastfeed while taking Copiktra and for at least 1 month after the last dose.
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Copiktra is a prescription medicine used to treat adults with Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) who have received at least 2 prior therapies and they did not work or are no longer working. It is also used to treat Follicular Lymphoma (FL) who have received at least 2 prior therapies and they did not work or are no longer working. Serious side effects of Copiktra include elevated liver enzymes and low white blood cell count (neutropenia).
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