CALQUENCE 100 MG — DIN 02535696

What is CALQUENCE?

CALQUENCE 100 MG contains ACALABRUTINIB (ACALABRUTINIB MALEATE) : 100 MG. It is listed in the Health Canada Drug Product Database under DIN 02535696, held by ASTRAZENECA CANADA INC, supplied as TABLET for ORAL administration. Health Canada currently lists it as marketed, status dated 01-May-2023. Nexara Health is a licensed Canadian wholesale distributor (DEL 3-002896-A) and can source this product for hospitals, pharmacies and clinics. Availability and lead time are confirmed per order.

What is CALQUENCE used for?

CALQUENCE® (acalabrutinib tablets) is indicated for: Chronic Lymphocytic Leukemia (CLL): - In combination with venetoclax for the treatment of patients with previously untreated CLL. - In combination with obinutuzumab or as monotherapy for the treatment of patients with previously untreated CLL. - As monotherapy for the treatment of patients with CLL who have received at least one prior therapy. Mantle Cell Lymphoma (MCL): - In combination with bendamustine and rituximab for the treatment of adult patients with previously untreated MCL who are ineligible for autologous stem cell transplant. - As monotherapy for the treatment of patients with MCL who have received at least one prior therapy.

Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.

How is it administered?

The recommended dose of CALQUENCE for patients with CLL or MCL is 100 mg (1 tablet) twice daily, separated by approximately 12 hours. CALQUENCE should be swallowed whole with water at approximately the same time each day, with or without food. The tablet should not be chewed, crushed, dissolved, or divided. For CLL: - In combination with venetoclax: Start CALQUENCE at cycle 1 (each cycle is 28 days) for 14 cycles. Start venetoclax at cycle 3 as per the dose titration schedule (20 mg Week 1, 50 mg Week 2, 100 mg Week 3, 200 mg Week 4, 400 mg Cycle 4 Week 1 and subsequent dosing up to and including Cycle 14). Administer venetoclax for a total of 12 cycles. - In combination with obinutuzumab or as monotherapy: Treatment with CALQUENCE should continue until disease progression or unacceptable toxicity. Start CALQUENCE at cycle 1 (each cycle is 28 days). Start obinutuzumab at cycle 2 for a total of 6 cycles. - For patients with CLL who have received at least one prior therapy: CALQUENCE is used as monotherapy until disease progression or unacceptable toxicity. For MCL: - In combination with bendamustine and rituximab: Start CALQUENCE at cycle 1 (each cycle is 28 days). Start bendamustine and rituximab at cycle 1 for 6 cycles. Bendamustine (90mg/m²) on Days 1 and 2. Rituximab (375 mg/m²) on Day 1. For patients achieving a response, rituximab continues for a maximum of additional 12 doses every other cycle. Treatment with CALQUENCE should continue until disease progression or unacceptable toxicity. - For patients with MCL who have received at least one prior therapy: CALQUENCE is used as monotherapy until disease progression or unacceptable toxicity. Missed Dose: If a patient misses a dose by more than 3 hours, instruct the patient to take the next dose at its regularly scheduled time. Extra tablets should not be taken to make up for a missed dose. Dose Adjustments for Adverse Reactions: Refer to Tables 2, 3, and 4 in the monograph for specific dose modifications based on adverse reaction grade and occurrence. For strong CYP3A inhibitors, avoid concomitant use or interrupt CALQUENCE for short-term use. For moderate CYP3A inhibitors, reduce CALQUENCE to 100 mg once daily. No dose adjustment for mild CYP3A inhibitors. No dose adjustment for mild to moderate renal impairment or mild to moderate hepatic impairment. Avoid in severe hepatic impairment (Child-Pugh C or total bilirubin >3 times ULN).

Included because it drives pack selection and wastage. Consult the monograph.

Contraindications

CALQUENCE (acalabrutinib) is contraindicated in patients who are hypersensitive to acalabrutinib or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.

Warnings and precautions

Serious Warnings and Precautions Box: - Treatment with CALQUENCE should be initiated and supervised by a qualified physician experienced in the use of anticancer therapies. - Concomitant use of CALQUENCE with a strong CYP3A inhibitor should be avoided. - Serious Hemorrhage: Monitor for bleeding and manage appropriately. Carcinogenesis and Genotoxicity: Second primary malignancies, including skin and other solid tumours, have been reported more frequently. Monitor patients for the development of second cancers and advise protection from the sun. Cardiovascular: Atrial Fibrillation or atrial flutter reported in 6% of patients (Grade 3 or 4 in 2.1%). Risk may be increased in patients with pre-existing cardiovascular disease, hypertension, previous history of atrial fibrillation, and infection/pneumonia. Monitor for symptoms of cardiac arrhythmia. Driving and Operating Machinery: Fatigue and dizziness have been reported. Patients experiencing these symptoms should observe caution when driving or operating a vehicle or potentially dangerous machinery. Hematologic: Cytopenias (Grade 3 or higher absolute neutrophil count decreased (35%), absolute lymphocyte count decreased (22%), platelets decreased (11%) and hemoglobin decreased (9%)) occurred. Monitor complete blood counts regularly. Interrupt treatment, reduce the dose, or discontinue treatment as necessary. Hemorrhage: Serious hemorrhagic events, including fatal events, reported in 4.5% of patients. Overall bleeding events (including bruising and petechiae) occurred in 40%. Patients receiving antithrombotic agents concomitantly may be at increased risk. Consider risks and benefits of antithrombotic agents. Consider withholding CALQUENCE for at least 3 days pre- and post-surgery. Hepatic: Hepatotoxicity, including severe, life-threatening, and potentially fatal cases of drug-induced liver injury (DILI), has occurred. Evaluate bilirubin and transaminases at baseline and throughout treatment. Monitor for liver test abnormalities and clinical signs/symptoms of hepatic toxicity. Withhold CALQUENCE if DILI suspected; discontinue upon confirmation. Immune (Infections): Serious and fatal infections (bacterial, viral or fungal) have occurred. Most frequently reported Grade 3 or higher infection was pneumonia. Monitor patients for signs and symptoms of infection and treat promptly. Opportunistic infections (PML, hepatitis B virus reactivation, herpes zoster, aspergillosis, fungal pneumonia, Pneumocystis Jiroveci Pneumonia) have been reported. Consider prophylaxis in patients at increased risk for opportunistic infections.