General Information
Manufacturer: AstraZeneca
Medical Name: acalabrutinib
Purpose: Calquence is used to treat adults with:
- Mantle cell lymphoma (MCL) in combination with bendamustine and rituximab in people who have not had prior treatment for MCL and who cannot receive a type of stem cell transplant that uses their own blood stem cells (autologous hematopoietic stem cell transplantation [HSCT]).
- Mantle cell lymphoma (MCL) who have received at least one prior therapy.
- Chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL)
Common Side Effects
| Side Effect | Percentage Affected |
|---|---|
| Infections | 56-68% (any grade), including upper respiratory tract infections and pneumonia. |
| Headache | 22-43% |
| Muscle pain (myalgia) | 21-22% |
| Cough | 19-23% |
| Diarrhea | 18-39% |
| Bruising | 18-37% |
| Fatigue/Tiredness | 9-30% |
| Nausea | 7-22% |
Serious Side Effects
| Side Effect | Description |
|---|---|
| Serious Infections | Occurred in approximately 32% of patients in one pooled analysis, with fatal infections reported in 2% of previously untreated CLL patients. |
| Bleeding Problems | Bleeding events of any grade (excluding bruising) occurred in 22-40% of patients, while major hemorrhage occurred in 3.0-4.4% of patients. |
| Heart Rhythm Problems | Atrial fibrillation or flutter of any grade occurred in 4.1-5% of patients, with serious (Grade >= 3 events in about 1.1-1.3%. |
| Second Primary Cancers | Occurred in 12% of patients in clinical trials, with skin cancer being the most frequent. |
Medical Preconditions
| Precondition | Description |
|---|---|
| Bleeding Problems | Calquence can increase the risk of serious bleeding events. It should be used with caution in patients with pre-existing bleeding disorders (e.g., hemophilia). The risk may be further increased with the concurrent use of anticoagulant or antiplatelet therapies. |
| Severe Hepatic Impairment | Avoid the use of Calquence in patients with severe liver problems (Child-Pugh class C). Liver function should be evaluated at baseline and monitored throughout treatment. |
| Active Infections | Fatal and serious infections, including opportunistic infections, have occurred with Calquence treatment. Patients with an active infection, including a history of hepatitis B virus (HBV) infection, may have their treatment delayed or require prophylaxis and close monitoring. |
| Heart Rhythm Problems | Caution is advised in patients with a history of heart issues, as Calquence has been associated with atrial fibrillation and flutter. Patients with cardiac risk factors, hypertension, or previous arrhythmias should be monitored for symptoms. |
| Pregnancy and Breastfeeding | Calquence may cause fetal harm and complications during childbirth. It is not recommended during pregnancy, and women of reproductive potential should use effective contraception. It is not known if the drug passes into breast milk, so breastfeeding should be avoided during treatment and for two weeks after the last dose. |
| Planned Surgery | Due to the increased risk of bleeding, healthcare providers may recommend temporarily stopping Calquence for a period (e.g., 3-7 days) before and after any planned medical, surgical, or dental procedures. |
Drug-Drug Interaction Preconditions
| Precondition | Description |
|---|---|
| Strong CYP3A Inhibitors | The co-administration of strong CYP3A inhibitors should generally be avoided. If short-term use (up to seven days) is necessary, Calquence treatment should be interrupted. |
| Strong CYP3A Inducers | Co-administration with strong CYP3A inducers should also be avoided, as they can reduce the effectiveness of Calquence. |