Calquence Special Precautions

Haemorrhage: Serious haemorrhagic events, including fatal events, have occurred in patients with haematologic malignancies (n=1,478) treated with CALQUENCE monotherapy. Major haemorrhage (Grade 3 or higher bleeding events, serious, or any central nervous system events) occurred in 5.5% of patients, with fatalities occurring in 0.1% of patients. Overall, bleeding events including bruising and petechiae of any grade occurred in 46.1% of patients with haematological malignancies.
The mechanism for the bleeding events is not well understood.
Patients receiving antithrombotic agents may be at increased risk of haemorrhage. Use caution with antithrombotic agents and consider additional monitoring for signs of bleeding when concomitant use is medically necessary.
Consider the benefit-risk of withholding CALQUENCE for at least 3 days pre- and post-surgery.
Infections: Serious infections (bacterial, viral or fungal), including fatal events have occurred in patients with haematologic malignancies (n=1,478) treated with CALQUENCE monotherapy. Grade 3 or higher infections occurred in 26.4% of these patients. The most frequently reported Grade 3 or higher infection was pneumonia. Infections due to hepatitis B virus (HBV) reactivation, aspergillosis, and progressive multifocal leukoencephalopathy (PML) have occurred.
Consider prophylaxis in patients who are at increased risk for opportunistic infections. Monitor patients for signs and symptoms of infection and treat as medically appropriate.
Cytopenias: Treatment-emergent Grade 3 or 4 cytopenias, including neutropenia (17.5%), anaemia (9.5%) and thrombocytopenia (6.2%), occurred in patients with haematologic malignancies (n=1,478) treated with CALQUENCE monotherapy.
Monitor complete blood counts as medically appropriate.
Second Primary Malignancies: Second primary malignancies, including non-skin cancers, occurred in 17.6% of patients with haematologic malignancies (n=1,478) treated with CALQUENCE monotherapy. The most frequent second primary malignancy was skin cancer, which occurred in 9.9% of patients. Monitor patients for the appearance of skin cancers.
Atrial Fibrillation: In patients with haematologic malignancies (n=1,478) treated with CALQUENCE monotherapy, atrial fibrillation/flutter of any grade occurred in 7.4% of patients and Grade 3 or higher occurred in 2.3% of patients. Monitor for symptoms (e.g., palpitations, dizziness, syncope, chest pain, dyspnoea) of atrial fibrillation and atrial flutter and obtain an ECG as appropriate.
Tumour lysis syndrome: Tumour lysis syndrome (TLS) has been reported with CALQUENCE therapy. Patients considered at risk for TLS (e.g., presence of bulky disease at baseline) should be assessed for possible risk of TLS and closely monitored as clinically indicated.
Interstitial lung disease/pneumonitis: Interstitial lung disease (ILD)/pneumonitis has been reported in patients treated with CALQUENCE in combination with bendamustine and rituximab in MCL. Monitor patients for pulmonary symptoms indicative of ILD/pneumonitis (e.g., cough, dyspnoea or hypoxia) and manage ILD/pneumonitis as clinically indicated.
Effects on ability to drive and use machines: CALQUENCE has no or negligible influence on the ability to drive and use machines. However, during treatment with acalabrutinib fatigue and dizziness have been reported and patients who experience these symptoms should observe caution when driving or using machines.