Copiktra Capsules (Hard Gelatin)
Duvelisib
15mg
GENZYME EUROPE B.V
| Pack size | 56's [28's (14's Blister x2) x 2] |
|---|---|
| Dispensing mode | POM |
| Source | NETHERLANDS |
| Agent | CITY MEDICAL STORE |
| Retail Price | 58463.00 AED |
Available as:
Indications
Copiktra Capsules (Hard Gelatin) is used for:
Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, Follicular Lymphoma
Adult Dose
Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
Indicated for adults with relapsed/refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) after at least 2 prior therapies
25 mg PO BID with or without food
Cycle consists of 28 days
Follicular Lymphoma
Indicated for adults with relapsed/refractory follicular lymphoma (FL) after at least 2 prior therapies
25 mg PO BID with or without food
Cycle consists of 28 days
ALT/AST elevation
Grade 2 (3-5x upper limit of normal [ULN]): Maintain dose; monitor at least weekly until return to <3x ULN
Grade 3 (>5-20x ULN): Withhold treatment and monitor at least weekly until return to <3x ULN; resume at same dose (first occurrence) or at a reduced dose for subsequent occurrence
Grade 4 (>20x ULN): Discontinue treatment
Child Dose
Renal Dose
Renal impairment (CrCl 23-80 mL/min) and hepatic impairment (Child-Pugh Class A, B, and C) had no clinically significant effect on duvelisib
Administration
Administer with or without food
Contra Indications
Precautions
Serious, including fatal (4%), infections occurred in 31%; most common serious infections were pneumonia, sepsis, and lower respiratory tract infections; median time to onset of any grade infection was 3 months, with 75% of cases occurring within 6 months
CMV reactivation/infection and serious/fatal PJP occurred in 1% of treated patients; consider prophylactic antivirals during treatment
Treat infections prior to initiation of therapy; advise patients to report any new or worsening signs and symptoms of infection
Serious, including fatal (≤1%), cutaneous reactions occurred in 5%; fatal cases included DRESS and TEN; median time to onset of any grade cutaneous reaction was 3 months, with a median event duration of 1 month; presenting features for serious events include pruritic, erythematous, or maculopapular rash; less common features include exanthem, desquamation, erythroderma, skin exfoliation, keratinocyte necrosis, and papular rash
Serious, including fatal (<1%), pneumonitis without an apparent infectious cause occurred in 5%; median time to onset of any grade pneumonitis was 4 months, with 75% of cases occurring within 9 months; median event duration was 1 month, with 75% of cases resolving by 2 months
Pregnancy-Lactation
Pregnancy
There are no available data in pregnant women to inform the drug-associated risk
Based on findings from animal studies and its mechanism of action, duvelisib can cause fetal harm when administered to a pregnant woman
Conduct pregnancy testing before initiation of treatment
Animal data
In animal reproduction studies, administration of duvelisib to pregnant rats and rabbits during organogenesis caused adverse developmental outcomes, including embryofetal mortality (eg, resorptions, postimplantation loss, decreased viable fetuses), alterations to growth, and structural abnormalities (malformations) at maternal doses 10 times and 39 times the maximum recommended human dose (MRHD) of 25 mg BID in rats and rabbits, respectively
Contraception
Females of reproductive potential: Use effective contraception during treatment and for at least 1 month after last dose
Males: Male patients with female partners of reproductive potential should use effective contraception during treatment and for at least 1 month after last dose
Infertility
Based on testicular findings in animals, male fertility may be impaired by treatment; no data available on drug effects of on human fertility
Interactions
Effects of other drugs on duvelisib
Strong CYP3A4 inducers: Coadministration with a strong CYP3A inducer decreases duvelisib area under the curve (AUC), which may reduce the efficacy of duvelisib
Moderate CYP3A4 inducers: Not studied
Strong CYP3A inhibitors: Coadministration with a strong CYP3A inhibitor increases duvelisib AUC, which may increase the risk of duvelisib toxicities
Mild or moderate CYP3A4 inhibitors: No effect based on physiologically based pharmacokinetic modeling and simulation
Effects of duvelisib on other drugs
Sensitive CYP3A substrates: Coadministration with duvelisib 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 coadministered sensitive CYP3A substrate
Adverse Effects
Side effects of Duvelisib :
>10%
Neutropenia (67%)
Diarrhea or colitis (57%)
Anemia (55%)
Neutropenia, Grade ≥3 (49%)
Thrombocytopenia (43%)
ALT increased (42%)
Lipase increased (37%)
AST increased (36%)
Phosphate decreased (34%)
Hyperkalemia (31%)
Hyponatremia (31%)
Amylase increased (31%)
Hypoalbuminemia (31%)
Lymphocytosis (30%)
Pyrexia (29%)
Creatinine increased (29%)
Upper respiratory tract infection (28%)
Pneumonia (27%)
Rash (27%)
Alkaline phosphatase increased (27%)
Hypocalcemia (25%)
Fatigue (25%)
Diarrhea or colitis, Grade ≥3 (25%)
Nausea (23%)
Cough (23%)
Lymphocytosis, Grade ≥3 (22%)
Pneumonia, Grade ≥3 (22%)
Anemia, Grade ≥3 (20%)
Hypokalemia (20%)
Lower respiratory tract infection (18%)
Constipation (17%)
Musculoskeletal pain (17%)
Abdominal pain (16%)
Vomiting (15%)
Decreased appetite (13%)
Dyspnea (12%)
Lipase increased, Grade ≥3 (12%)
Edema (11%)
Transaminase elevation (11%)
Decreased weight (11%)
Rash, Grade >3 (11%)
Mechanism of Action
Selective oral small molecule inhibitor of PI3K-delta and PI3K-gamma
This PI3K inhibitor induces growth inhibition and reduces viability in cell lines derived from malignant B cells and in primary CLL tumor cells; inhibits several key cell-signaling pathways (eg, B cell receptor signaling, CXCR12-mediated chemotaxis of malignant B cells)
Additionally, duvelisib inhibits CXCL12-induced T-cell migration and M-CSF- and IL-4-driven M2 polarization of macrophage
Note
Copiktra 15mg Capsules (Hard Gelatin) manufactured by GENZYME EUROPE B.V . Its generic name is Duvelisib. Copiktra is availble in United Arab Emirates.
Farmaco UAE drug index information on Copiktra Capsules (Hard Gelatin) is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.