Copiktra

Treatment with Copiktra should be conducted by a physician experienced in the use of anti-cancer therapies. PosologyMedicinal product no longer authorised The recommended dose is 25 mg duvelisib twice daily. A cycle consists of 28 days.

Treatment should be continued until disease progression or unacceptable toxicity. Delayed or missed doses Patients should be advised that if a dose is missed by less than 6 hours, the missed dose should be taken right away and the next dose should be taken as usual.

If a dose is missed by more than 6 hours, patients should be advised to wait and to take the next dose at the usual time. g. 5]. g. fluconazole) but potential adverse reactions of duvelisib should be closely monitored. Dose modifications for adverse reactions Toxicities should be managed as 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 • Withhold Copiktra until resolved • Resume at the same or reduced dose (25 mg or 15 mg twice daily) Clinical CMV infection or viremia (positive PCR or antigen test) • Withhold Copiktra until resolved • Resume at the same or reduced dose (25 mg or 15 mg twice daily) • If Copiktra is resumed, monitor patients for CMV reactivation (by PCR or antigen test) at least monthly.

5 × 109 /L • Withhold Copiktra. 5 × 109 /L • Resume Copiktra at same dose (25 mg twice daily) for first occurrence or at a reduced dose (15 mg twice daily) for subsequent occurrence Thrombocytopenia Platelet count 25 to < 50 × 109 /L (Grade 3) with Grade 1 bleeding • No change in dose • Monitor platelet counts at least weekly Platelet count 25 to < 50 × 109 /L (Grade 3) with Grade 2 bleeding or Platelet count < 25 × 109 /L (Grade 4) • Withhold Copiktra • Monitor platelet counts until ≥ 25 × 109 /L and resolution of bleeding (if applicable) • Resume Copiktra at the same dose (25 mg twice daily) for first occurrence or resume at a reduced dose (15 mg twice daily) for subsequent occurrence Abbreviations: ALT = alanine aminotransferase; ANC = absolute neutrophil count; AST = aspartate aminotransferase; CMV […]

Summary of the safety profile The most commonly reported adverse reactions (incidence ≥ 20%) are diarrhoea or colitis, neutropenia, rash, fatigue, pyrexia, cough, nausea, upper respiratory infection, pneumonia, musculoskeletal pain, and anaemia.

The most frequently reported serious adverse reactions were pneumonia, colitis and diarrhoea. Tabulated list of adverse reactions The adverse reactions reported with duvelisib treatment are listed by system organ class and frequency in Table 2.

Frequencies are defined as very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000) and very rare (< 1/10,000) and not known (cannot be estimated from the available data). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.

Table 2:

Adverse drug reactions reported in patients with haematologic malignancies receiving duvelisib (N=442) System organ class / preferred term or adverse reaction All grades Grade 3 or more Infections and infestations Lower respiratory tract infection1 Very common Common Sepsis Common Common Upper respiratory tract infection1 Very common Uncommon Blood and lymphatic system disorders Neutropenia1 Very common Very common Anaemia1 Very common Very common Thrombocytopenia1 Very common Very common Metabolism and nutrition disorders Decreased appetite Very common Uncommon Nervous system disorders Headache1 Very common Uncommon Respiratory, thoracic and mediastinal disordersMedicinal product no longer authorised System organ class / preferred term or adverse reaction All grades Grade 3 or more Dyspnoea1 Very common Common Pneumonitis2 Common Common Cough1 Very common Uncommon Gastrointestinal disorders Diarrhoea/Colitis3 Very common Very common Nausea1 Very common Uncommon Vomiting Very common Common Abdominal pain1 Very common Common Constipation Very common Uncommon Skin and subcutaneous tissue disorders Rash4 Very common Common Pruritus1 Common Uncommon Musculoskeletal and connective tissue disorders Musculoskeletal pain1 Very common Common Arthralgia Very common Uncommon General disorders and administration site conditions Pyrexia Very common Common Fatigue1 Very common Common Investigations Lipase increased Common Common Transaminases increased5 Very common Common 1 Grouped term for reactions with multiple preferred terms 2 Pneumonitis includes the preferred terms: pneumonitis, interstitial lung disease, lung infiltration 3 Diarrhoea or colitis includes the preferred terms: colitis, enterocolitis, colitis microscopic, colitis ulcerative, diarrhoea, diarrhoea haemorrhagic 4 Rash includes the preferred terms: dermatitis (including allergic, exfoliative, perivascular), erythema (including multiforme), rash (including exfoliative, erythematous, follicular, generalized, macular & papular, pruritic, pustular), toxic epidermal necrolysis and toxic skin eruption, drug reaction with eosinophilia and systemic symptoms, drug eruption, Stevens- Johnson syndrome.

General The safety and efficacy of duvelisib after prior idelalisib use has not been established. Infections Serious, including fatal infections have occurred in patients receiving duvelisib. The most common serious infections were pneumonia, sepsis, and lower respiratory infections.

8). Any infections should be treated prior to initiation of duvelisib. Patients should be monitored for infection, including respiratory signs and symptoms, throughout treatment. Patients should be advised to report any new or worsening infections promptly (see Table 1 for management).

Serious, including fatal, PJP pneumonia occurred in patients taking duvelisib. Prophylaxis for PJP should, therefore, be administered to all patients (see Table 1). CMV reactivation/infection occurred in patients taking duvelisib. Prophylactic antivirals should be considered during treatment to prevent CMV infection including CMV reactivation (see Table 1).

Recommended prophylaxis Any infections should be treated prior to initiation of duvelisib . Patients should be monitored for infection, including respiratory signs and symptoms, throughout treatment. Patients should be advised to report any new or worsening infections promptly (see Table 1 for management).

Prophylaxis for PJP should be provided during treatment with duvelisib. Following completion of duvelisib treatment, PJP prophylaxis should be continued until the absolute CD4+ T cell count is greater than 200 cells/μL. Duvelisib should be withheld in patients with suspected PJP of any grade and discontinued if PJP is confirmed.

Prophylactic antivirals should be considered during duvelisib treatment to prevent CMV infection including CMV reactivation. Diarrhoea or colitis Serious, including fatal diarrhoea or colitis occurred in patients receiving duvelisib.

The median time to onset of any grade diarrhoea or colitis was 4 months, with 75% of cases occurring by 8 months. 5 months. 8). Cutaneous reactions Serious, including fatal cutaneous reactions occurred in patients receiving duvelisib.

Medicinal product no longer authorised