Side Effects of acalabrutinib: A Synthesis of Findings from 17 Studies

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Original Abstract of the Article

Major Research Findings

Acalabrutinib, a second-generation BTK inhibitor, has been approved by the FDA for the treatment of adults with MCL who have received at least one prior therapy. 16 , 14 . Acalabrutinib is more selective for BTK than ibrutinib, the first-generation BTK inhibitor, and therefore may cause fewer side effects. 16 , 14 . However, more research is needed to directly compare acalabrutinib to ibrutinib, as well as to evaluate combination treatment options. 14 .

Reasons for Side Effects

Acalabrutinib, like other BTK inhibitors, works by blocking the B-cell receptor (BCR) signaling pathway, which is essential for B-cell function and survival. 14 . This inhibition can disrupt the normal development and function of B-cells, potentially leading to side effects. Additionally, while acalabrutinib is designed to be more selective for BTK than ibrutinib, it may still inhibit other kinases, which could contribute to side effects. 17 .

Common Side Effects

Headache

Headache is a common side effect of acalabrutinib, reported in 38% of patients in a pooled analysis of clinical trials. 10 .

Diarrhea

Diarrhea is another frequently reported side effect, occurring in 37% of patients. 10 .

Upper Respiratory Tract Infection

Upper respiratory tract infections were reported in 22% of patients receiving acalabrutinib. 10 .

Contusion

Contusions were reported in 22% of patients receiving acalabrutinib. 10 .

Nausea

Nausea was reported in 22% of patients receiving acalabrutinib. 10 .

Fatigue

Fatigue was reported in 21% of patients receiving acalabrutinib. 10 .

Cough

Cough was reported in 21% of patients receiving acalabrutinib. 10 .

Serious Adverse Events

Serious adverse events occurred in 39% of patients receiving acalabrutinib. 10 . The most common serious adverse event was pneumonia, occurring in 6% of patients. 10 . Deaths due to adverse events occurred in 52 patients (5%), with pneumonia being the most common cause of death. 10 .

Other Side Effects

Other potential side effects include infections (67%), hemorrhages (46%), neutropenia (16%), anemia (14%), second primary malignancies (12%), thrombocytopenia (9%), hypertension (8%), and atrial fibrillation (4%). 10 . While acalabrutinib seems to cause less platelet dysfunction than ibrutinib, mild bleeding is still a common side effect. 15 . A meta-analysis of clinical trials found a higher risk of any-grade cardiac events (risk ratio, 1.75; p = 0.01) and a trend towards statistical significance for any-grade atrial fibrillation (risk ratio, 2.56; p = 0.05) in patients on acalabrutinib. 4 .

Countermeasures for Side Effects

Headache

Consult your doctor if you experience severe headaches. Treatment may include analgesics or other medications.

Diarrhea

If you experience severe diarrhea, consult your doctor and consider antidiarrheal medications. Stay hydrated.

Upper Respiratory Tract Infection

Seek medical attention for upper respiratory tract infections. Practice preventive measures such as handwashing and gargling.

Contusion

Apply first aid such as cooling for contusions, and consult your doctor.

Nausea

Consult your doctor for nausea and consider antiemetics. Eat easily digestible foods.

Fatigue

Consult your doctor to investigate the cause of severe fatigue.

Cough

If you have a severe cough, consult your doctor and consider cough suppressants.

Bleeding

To reduce the risk of bleeding, follow your doctor's instructions and have regular blood tests. Receive treatment as needed. 11 .

Atrial Fibrillation

Consult your doctor for symptoms of atrial fibrillation. Receive appropriate treatment. 4 .

Infections

Reduce the risk of infections with handwashing and gargling. Have regular tests according to your doctor's instructions. 9 .

Comparison Between Studies

Commonalities of Studies

Multiple studies suggest that acalabrutinib may cause fewer side effects than ibrutinib due to its higher selectivity for BTK. 16 , 14 , 15 .

Differences of Studies

A meta-analysis found a higher risk of any-grade cardiac events and a trend towards statistical significance for any-grade atrial fibrillation in patients on acalabrutinib. 4 . Additionally, there is a lack of clinical trials directly comparing acalabrutinib to ibrutinib, and further research on combination treatment options is needed. 14 .

Cautions for Real-Life Applications

While acalabrutinib is an effective treatment for certain B-cell malignancies, it is important to be aware of its potential side effects. Common side effects include headache, diarrhea, upper respiratory tract infections, contusions, nausea, fatigue, and cough. 10 . While these are not experienced by all patients, it is important to consult your doctor if you experience them. Additionally, be aware of the risk of serious adverse events such as bleeding, neutropenia, anemia, second primary malignancies, thrombocytopenia, hypertension, and atrial fibrillation. 10 . These side effects may not occur in all patients, but it is crucial to consult a doctor immediately if they occur.

Limitations of Current Research

Research on the side effects of acalabrutinib is still ongoing. Long-term side effects and interactions with other medications are not yet fully understood. 10 . Furthermore, clinical trials directly comparing acalabrutinib to ibrutinib are limited, and further research on combination treatment options is needed. 14 .

Future Research Directions

Further research is essential to understand the full range of side effects of acalabrutinib. Long-term side effects and interactions with other medications require more investigation. 10 . Directly comparing acalabrutinib to ibrutinib in clinical trials is needed to further evaluate its efficacy and safety. 14 . Finally, research on the effectiveness and safety of acalabrutinib in combination with other medications is essential. 14 .

Conclusion

Acalabrutinib is a promising treatment option for B-cell malignancies like CLL and MCL. 14 . It may offer a lower risk of certain side effects compared to ibrutinib. 16 . However, it is important to be aware of its potential side effects and to discuss any concerns with your doctor. More research is needed to fully understand the long-term effects of acalabrutinib and to optimize its use in clinical practice. 10 .

Literature analysis of 17 papers
Positive Content
16
Neutral Content
0
Negative Content
1
Article Type
2
0
0
9
17
1.

Double-blind controlled study of central nervous system side effects of amantadine, rimantadine, and chlorpheniramine.

Author: MilletV M, DreisbachM, BrysonY J

No effect on cognitive performance
Enhanced side effects with combination therapy
Side effects

Amantadine, rimantadine, and chlorpheniramine did not affect cognitive performance in 52 healthy volunteers. Subjective side effects were minimal and comparable across groups. Combining amantadine and chlorpheniramine appeared to enhance side effects.

Clinical TrialA clinical trial is a planned study conducted on humans to evaluate the efficacy and safety of pharmaceuticals, medical devices, and treatment methods. It aims to explore the possibilities of new treatments and improve the health of patients.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, U.S. Gov't, P.H.S.Research funding provided by the Public Health Service (PHS).

Language : English

2.

A prospective double-blind study of side effects associated with the administration of amantadine for influenza A virus prophylaxis.

Author: BrysonY J, MonahanC, PollackM, ShieldsW D

Amantadine efficacy
Amantadine side effects

Amantadine had notable side effects such as dizziness, nervousness, insomnia, and decreased attention span.

Clinical TrialA clinical trial is a planned study conducted on humans to evaluate the efficacy and safety of pharmaceuticals, medical devices, and treatment methods. It aims to explore the possibilities of new treatments and improve the health of patients.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, U.S. Gov't, P.H.S.Research funding provided by the Public Health Service (PHS).

Language : English

3.

Ibrutinib impairs IGF-1-dependent activation of intracellular Ca handling in isolated mouse ventricular myocytes.

Author: TarnowskiDaniel, FederAnna-Lena, TrumMaximilian, KreitmeierKlaus-Georg, StengelLaura, MaierLars S, SagCan Martin

Cardiotoxicity
Heart failure

Inhibition of Bruton tyrosine kinase (BTK) by Ibrutinib impairs insulin-like growth factor 1 (IGF-1)-dependent activation of intracellular Ca handling in adult ventricular mouse myocytes in the face of disrupted Akt signaling and absent SERCA2a upregulation.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

4.

Acalabrutinib-Related Cardiac Toxicities in Patients with Chronic Lymphocytic Leukemia: A Meta-Analysis of Randomized Controlled Trials.

Author: HtutThura Win, HanMyat Min, TheinKyaw Zin

Minimized Side Effects
Atrial Fibrillation
Cardiac Events

Acalabrutinib, a new Bruton's tyrosine kinase inhibitor, has been shown to be effective in treating chronic lymphocytic leukemia. This meta-analysis found that acalabrutinib is associated with an increased risk of cardiac events compared to ibrutinib.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

6.

Targeted Treatment of Chronic Lymphocytic Leukemia: Clinical Utility of Acalabrutinib.

Author: VitaleCandida, GibbonsJamie Lynn, FerrajoliAlessandra

CLL treatment
Reduced side effects

This review discusses the clinical efficacy and safety profile of acalabrutinib, a selective Bruton tyrosine kinase inhibitor, in the treatment of chronic lymphocytic leukemia.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

7.

The TKI Era in Chronic Leukemias.

Author: De NovellisDanilo, CacaceFabiana, CaprioliValeria, WierdaWilliam G, MahadeoKris M, TambaroFrancesco Paolo

CLL remission
CML remission
Improved outcomes
Side effects

Tyrosine kinase inhibitors (TKIs) have revolutionized the treatment of chronic myeloid leukemia (CML) and chronic lymphocytic leukemia (CLL). TKIs like imatinib, dasatinib, and nilotinib target BCR-ABL1 in CML, while BTK inhibitors like ibrutinib and acalabrutinib target the B-cell receptor signaling pathway in CLL. These agents have improved outcomes for patients with these hematologic malignancies but may have associated side effects.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

8.

Acalabrutinib: Nursing Considerations for Use in Patients With Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma.

Author: NiermanPia

CLL treatment
SLL treatment
Adverse events
Toxicities

Acalabrutinib is a newer Bruton tyrosine kinase inhibitor (BTKi) used to treat chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). While effective, BTKi therapy can cause unique adverse events and toxicities in patients with CLL/SLL, requiring careful monitoring and management.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, N.I.H., IntramuralFunding provided by the NIH for research projects within the NIH.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

9.

BTK Inhibitors in Chronic Lymphocytic Leukemia: Biological Activity and Immune Effects.

Author: PalmaMarzia, MulderTom A, ÖsterborgAnders

Anti-tumor effects
BTKi for CLL
Infection susceptibility
Off-target effects

This review discusses the impact of Bruton's tyrosine kinase inhibitors (BTKIs) on the immune system in patients with chronic lymphocytic leukemia (CLL). BTKIs are effective in treating CLL by blocking B-cell receptor signaling, but their impact on both innate and adaptive immunity needs further investigation. Understanding this impact is crucial for managing infections and ensuring optimal treatment outcomes in CLL patients.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

10.

Pooled analysis of safety data from clinical trials evaluating acalabrutinib monotherapy in mature B-cell malignancies.

Author: FurmanRichard R, ByrdJohn C, OwenRoger G, O'BrienSusan M, BrownJennifer R, HillmenPeter, StephensDeborah M, ChernyukhinNataliya, LezhavaTamara, HamdyAhmed M, IzumiRaquel, PatelPriti, BaekMarshall, ChristianBeth, DyerMartin J S, StreetlyMatthew J, SunClare, RuleSimon, WangMichael, GhiaPaolo, JurczakWojciech, PagelJohn M, SharmanJeff P

Treats B-cell malignancies
Anemia
Hemorrhage
Infection
Neutropenia

Acalabrutinib, a highly selective BTK inhibitor, is effective for many B-cell malignancies. This pooled analysis of 1040 patients evaluated the tolerability of acalabrutinib monotherapy across nine clinical studies. The most common adverse events were headache, diarrhea, upper respiratory tract infection, contusion, nausea, fatigue, and cough. Serious adverse events occurred in 39%, with pneumonia being the most frequent. Overall, acalabrutinib demonstrated good tolerability with no new late toxicities identified, supporting its use for long-term treatment of mature B-cell malignancies.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, N.I.H., ExtramuralResearch funding provided by the NIH to external research institutions and researchers.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

12.

Current Treatment of Refractory/Relapsed Chronic Lymphocytic Leukemia: A Focus on Novel Drugs.

Author: SmolewskiPiotr, RobakTadeusz

CLL treatment
Drug toxicity

Treatment strategies for relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL) include Bruton tyrosine kinase inhibitors, PI3K inhibitors, B-cell lymphoma 2 inhibitors, and novel CD20 monoclonal antibodies. Treatment selection depends on various factors, including prior therapy response, side effects, and comorbidities.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

13.

Novel Bruton tyrosine kinase inhibitor acalabrutinib quantification by validated LC-MS/MS method: An application to pharmacokinetic study in Sprague Dawley rats.

Author: SurendranShruti, PaulDavid, PokharkarSunil, ChoulwarSagar, DeshpandeAbhijeet, GiriSanjeev, SatheeshkumarN

Treatment of mantle cell lymphoma

A sensitive and specific LC-MS/MS method was developed for the estimation of acalabrutinib (ACA) in rat plasma. The method was validated according to USFDA bioanalytical guidelines and successfully applied for in vivo pharmacokinetic studies.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Validation StudyResearch to assess the validity and reliability of new measurement methods or diagnostic tests.

Language : English

15.

Severe platelet dysfunction in NHL patients receiving ibrutinib is absent in patients receiving acalabrutinib.

Author: ByeAlexander P, UnsworthAmanda J, DesboroughMichael J, HildyardCatherine A T, ApplebyNiamh, BruceDavid, KriekNeline, NockSophie H, SageTanya, HughesCraig E, GibbinsJonathan M

NHL treatment
platelet function enhancement
bleeding risk
platelet dysfunction

Ibrutinib is a Bruton tyrosine kinase (Btk) inhibitor that can cause platelet dysfunction and bleeding. Acalabrutinib is a second-generation Btk inhibitor with improved specificity for Btk over Tec. This study found that acalabrutinib avoids the major platelet dysfunction associated with ibrutinib therapy. The study also suggests that increasing plasma von Willebrand factor (VWF) and factor VIII (FVIII) levels may enhance platelet function in patients receiving Btk inhibitors.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

16.

Acalabrutinib Approved for MCL.

Author:

Fewer side effects

The FDA approved acalabrutinib, a second-generation BTK inhibitor, which, due to its increased selectivity, appears to cause fewer side effects than ibrutinib.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

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