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Calquence is a brand name for Acalabrutinib. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Calquence as monotherapy or in combination with obinutuzumab is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL). Calquence in combination with venetoclax with or without obinutuzumab is indicated for the treatment of adult patients with previously untreated…
Verbatim from this product's EMA label. Tap a section to expand.
Treatment with this medicinal product should be initiated and supervised by a physician experienced in the use of anticancer medicinal products. Posology The recommended dose of Calquence in monotherapy or in combination with other medicinal products is 100 mg acalabrutinib twice daily (equivalent to a total daily dose of 200 mg).
Calquence dose interval is approximately 12 hours. 1). Calquence in monotherapy or in combination with obinutuzumab Treatment with Calquence in monotherapy or in combination with obinutuzumab should be continued until disease progression or unacceptable toxicity.
Calquence in combination with venetoclax with or without obinutuzumab Treatment with Calquence in combination with venetoclax with or without obinutuzumab, should continue until disease progression, unacceptable toxicity or completion of 14 cycles of treatment (each cycle is 28 days).
Calquence should be administered on Day 1 of Cycle 1 for a total of 14 cycles. Venetoclax should be administered on Day 1 of Cycle 3 for a total of 12 cycles, starting at 20 mg and increasing weekly to 50 mg, 100 mg, 200 mg and finally 400 mg.
If Calquence is given in combination with venetoclax and obinutuzumab, obinutuzumab should be administered at 100 mg on Day 1 of Cycle 2, followed by 900 mg which may be administered on Day 1 or 2. Administer obinutuzumab at 1 000 mg on Day 8 and 15 of Cycle 2, followed by 1 000 mg on Day 1 of Cycles 3 to 7.
Obinutuzumab is administered for a total of 6 cycles. Calquence in combination with bendamustine and rituximab Calquence should be administered on Day 1 on Cycle 1 (each cycle is 28 days) until disease progression or unacceptable toxicity.
Bendamustine should be administered at 90 mg/m2 on Days 1 and 2 of each cycle for a total of 6 cycles. Rituximab should be administered at 375 mg/m2 on Day 1 each cycle for a total of 6 cycles. Patients achieving a response (partial response [PR] or complete response [CR]) after the first 6 cycles, may receive maintenance rituximab at 375 mg/m2 on Day 1 of every other cycle for a maximum of 12 additional doses, starting on Cycle 8 up to Cycle 30.
Dose adjustments Adverse reactions Recommended dose modifications of Calquence for Grade ≥ 3 adverse reactions in patients receiving Calquence monotherapy, Calquence in combination with obinutuzumab and Calquence in combination with venetoclax with or without obinutuzumab are provided in Table 1.
Summary of the safety profile Calquence monotherapy Of the 1 478 patients treated with Calquence monotherapy, the most common (≥ 20%) adverse drug reactions (ADRs) of any grade were infection, diarrhoea, headache, musculoskeletal pain, bruising, cough, arthralgia, fatigue, nausea and rash.
The most commonly reported (≥ 5%) Grade ≥ 3 adverse drug reactions were infection, leukopenia, neutropenia, anaemia, second primary malignancy, and thrombocytopenia. Calquence in combination with obinutuzumab Of the 223 patients treated with Calquence in combination with obinutuzumab, the most common (≥ 20%) ADRs of any grade were infection, musculoskeletal pain, diarrhoea, headache, leukopenia, neutropenia, cough, fatigue, arthralgia, nausea, dizziness, and constipation.
The most commonly reported (≥ 5%) Grade ≥ 3 adverse drug reactions were leukopenia, neutropenia, infection, thrombocytopenia and anaemia. Calquence in combination with venetoclax Of the 291 patients treated with Calquence in combination with venetoclax, the most common (≥ 20%) ADRs of any grade were infections, neutropenia, headache, bruising, diarrhoea and musculoskeletal pain.
The most commonly reported (≥ 5%) Grade ≥ 3 adverse drug reaction was neutropenia. Calquence in combination with venetoclax and obinutuzumab Of the 284 patients treated with Calquence in combination with venetoclax and obinutuzumab, the most common (≥ 20%) ADRs of any grade were infections, neutropenia, headache, bruising, diarrhoea, nausea 12 and musculoskeletal pain.
The most commonly reported (≥ 5%) Grade ≥ 3 adverse drug reactions were neutropenia and thrombocytopenia. Calquence in combination with bendamustine and rituximab Of the 297 patients treated with Calquence in combination with bendamustine and rituximab, the most common (≥ 20%) ADRs of any grade were neutropenia, nausea, rash, diarrhoea, musculoskeletal pain, headache, fatigue, vomiting, constipation, anaemia and thrombocytopenia.
Haemorrhage Major haemorrhagic events including central nervous system and gastrointestinal haemorrhage, some with fatal outcome, have occurred in patients with haematologic malignancies treated with Calquence monotherapy and in combination with other medicinal products.
These events have occurred in patients both with and without thrombocytopenia. 8). The mechanism for the bleeding events is not well understood. Patients receiving antithrombotic agents may be at increased risk of haemorrhage. Caution should be used with antithrombotic agents and additional monitoring considered for signs of bleeding when concomitant use is medically necessary.
Warfarin or other vitamin K antagonists should not be administered concomitantly with Calquence. 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 treated with Calquence monotherapy and in combination with other medicinal products.
8% in patients receiving combination therapy. 8). Viral reactivation Cases of hepatitis B reactivation have been reported in patients receiving Calquence. Hepatitis B virus (HBV) status should be established before initiating treatment with Calquence.
If patients have positive hepatitis B serology, a liver disease expert should be consulted before the start of treatment and the patient should be monitored and managed following local medical standards to prevent hepatitis B reactivation.
Cases of progressive multifocal leukoencephalopathy (PML) including fatal ones have been reported following the use of Calquence within the context of a prior or concomitant immunosuppressive therapy. Physicians should consider PML in the differential diagnosis in patients with new or worsening neurological, cognitive or behavioural signs or symptoms.
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Recommended dose modifications for Grade ≥ 3 adverse reactions in patients receiving Calquence in combination with bendamustine and rituximab are provided in Table 2. 4 Table 1. Grade 3 or greater non-haematological toxicities First and second Interrupt Calquence.
Once toxicity has resolved to Grade 1 or baseline, Calquence may be resumed at 100 mg approximately every 12 hours. Third Interrupt Calquence. Once toxicity has resolved to Grade 1 or baseline, Calquence may be resumed at a reduced frequency of 100 mg once daily.
Fourth Discontinue Calquence. 0. Table 2. Recommended dose adjustments for Grade ≥ 3 adverse reactions* in patients receiving Calquence in combination with bendamustine and rituximab Adverse reaction Bendamustine dose modification† Calquence dose modification Neutropenia If Grade 3 or Grade 4 neutropenia‡: Interrupt bendamustine.
Once toxicity has resolved to Grade ≤ 2 or baseline level, bendamustine may be resumed at 70 mg/m2. Discontinue bendamustine if additional dose reduction is required. If Grade 4 neutropenia lasting longer than 7 days then interrupt Calquence.
¶ Discontinue Calquence at 4th adverse reaction occurrence.
Thrombocytopenia If Grade 3 or Grade 4 thrombocytopenia:
Interrupt bendamustine. Once toxicity has resolved to Grade ≤ 2 or baseline level, bendamustine may be resumed at 70 mg/m2. Discontinue bendamustine if additional dose reduction is required. If Grade 3 thrombocytopenia with significant bleeding or Grade 4 then interrupt Calquence.
¶ Discontinue Calquence at 3rd adverse reaction occurrence for thrombocytopenia with significant bleeding. Discontinue Calquence at 4th adverse reaction occurrence. 5 Adverse reaction Bendamustine dose modification† Calquence dose modification Other hematologic Grade 4§ or unmanageable Grade 3 toxicity Interrupt bendamustine.
Once toxicity has resolved to Grade ≤ 2 or baseline level, bendamustine may be resumed at 70 mg/m2. Discontinue bendamustine if additional dose reduction is required. Interrupt Calquence. ¶ Discontinue Calquence at 4th adverse reaction occurrence.
Grade 3 or greater non-hematologic toxicities Interrupt bendamustine. Once toxicity has resolved to Grade 1 or baseline level, bendamustine may be resumed at 70 mg/m2. Discontinue bendamustine if additional dose reduction is required.
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The most commonly reported (≥ 5%) Grade ≥ 3 adverse drug reactions were neutropenia, rash, thrombocytopenia, anaemia, pneumonia, second primary malignancies, hypertension and second primary malignancies excluding non-melanoma skin.
Tabulated list of adverse reactions The below tables present adverse drug reactions (ADRs) identified in clinical studies with patients receiving Calquence monotherapy or combination therapy for haematological malignancies. 2 months.
6 months. 9 months. Adverse drug reactions are listed according to system organ class (SOC) in MedDRA. Within each system organ class, the adverse drug reactions are sorted by frequency, with the most frequent reactions first. In addition, the corresponding frequency category for each ADR is 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); very rare (< 1/10 000); not known (cannot be estimated from available data).
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. Table 4. 9)
If PML is suspected, then appropriate 8 diagnostic evaluations should be undertaken and treatment with Calquence should be suspended until PML is excluded. If any doubt exists, referral to a neurologist and appropriate diagnostic measures for PML including MRI scan preferably with contrast, cerebrospinal fluid (CSF) testing for JC Viral DNA and repeat neurological assessments should be considered.
Consider prophylaxis according to standard of care 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, anaemia and thrombocytopenia, occurred in patients with haematologic malignancies treated with Calquence monotherapy and in combination with other medicinal products.
8). Second primary malignancies Second primary malignancies, including skin and non-skin cancers, occurred in patients with haematologic malignancies treated with Calquence monotherapy and in combination with other medicinal products.
Skin cancers were commonly reported. 8). Atrial fibrillation Atrial fibrillation/flutter occurred in patients with haematologic malignancies treated with Calquence monotherapy and in combination with other medicinal products. 2). In patients who develop atrial fibrillation on therapy with Calquence, a thorough assessment of the risk for thromboembolic disease should be undertaken.
In patients at high risk for thromboembolic disease, tightly controlled treatment with anticoagulants and alternative treatment options to Calquence should be considered. Tumour lysis syndrome Tumour lysis syndrome (TLS) has been reported with Calquence therapy.
, 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.
g. cough, dyspnea or hypoxia) and manage ILD/pneumonitis as clinically indicated. Other medicinal products Co-administration of strong CYP3A inhibitors with Calquence may lead to increased acalabrutinib exposure and consequently a higher risk for toxicity.
On the contrary, co-administration of CYP3A inducers may lead to decreased acalabrutinib exposure and consequently a risk for lack of efficacy. 9 Concomitant use with strong CYP3A inhibitors should be avoided. If these inhibitors will be used short-term (such as anti-infectives for up to seven days), treatment with Calquence should be interrupted.
5). Concomitant use with strong CYP3A4 inducers should be avoided due to risk for lack of efficacy. Calquence contains sodium This medicinal product contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free’.