Side Effects of venetoclax: A Synthesis of Findings from 23 Studies

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Original Abstract of the Article

Major Research Findings

Venetoclax is a drug that has shown promise in treating various types of blood cancers, particularly chronic lymphocytic leukemia (CLL) and acute myeloid leukemia (AML). 5 20 1 22 17 15 2 10 4 11 19 8 12 23 16 9 11 13 14 6 3 These studies highlight both the benefits and potential risks associated with venetoclax. While it offers a promising therapeutic option for blood cancers, it’s important to be aware of the possible side effects.

Reasons for Side Effects

Venetoclax works by inhibiting a protein called BCL-2, which plays a crucial role in preventing cell death. 13 By blocking BCL-2, venetoclax triggers the death of cancer cells. However, since it targets BCL-2 in both cancerous and healthy cells, it can lead to side effects.

Common Side Effects

Low White Blood Cell Count (Neutropenia)

Venetoclax can lower the white blood cell count. 22 17 6 White blood cells are essential for fighting infections. A low white blood cell count increases the risk of infections, so careful monitoring is necessary.

Anemia

Venetoclax can cause anemia. 22 17 Anemia is a condition where the red blood cell count is low, leading to symptoms like fatigue, shortness of breath, and dizziness.

Low Platelet Count (Thrombocytopenia)

Venetoclax can lower platelet levels. 22 Platelets are crucial for blood clotting and preventing excessive bleeding. A low platelet count increases the risk of bruising and bleeding.

Gastrointestinal Symptoms

Venetoclax can cause gastrointestinal side effects. 20 22 17 6 These can include diarrhea, nausea, and vomiting.

Tumor Lysis Syndrome (TLS)

Venetoclax can cause TLS. 22 TLS occurs when cancer cells are rapidly destroyed, releasing their contents into the bloodstream. This can lead to complications like high potassium levels, high uric acid levels, high phosphate levels, and low calcium levels. 19

Skin Reactions

Skin reactions, such as rash and vitiligo (loss of skin pigmentation), have been reported as side effects of venetoclax. 23 While most skin rashes are mild and don’t require treatment, severe reactions are possible.

Respiratory Problems

Venetoclax can cause inflammation of the lungs, leading to symptoms like shortness of breath and cough. 3

Side Effect Management

Low White Blood Cell Count

To manage low white blood cell count, growth factors like granulocyte colony-stimulating factor (G-CSF) may be administered. 22

Anemia

Anemia can be managed with iron supplements or hematopoietic growth factors.

Low Platelet Count

Low platelet count can be addressed through platelet transfusions.

Gastrointestinal Symptoms

Gastrointestinal symptoms can be treated with antiemetics (to reduce nausea and vomiting) and antidiarrheals (to manage diarrhea).

Tumor Lysis Syndrome

TLS management typically involves hydration (intravenous fluids) and potentially dialysis. 19

Skin Reactions

Skin reactions can be treated with topical corticosteroids or other appropriate medications. 23

Respiratory Problems

Respiratory problems can be addressed with corticosteroids, antibiotics, or other therapies as needed. 3

Comparison between Studies

Similarities in Studies

These studies consistently demonstrate the effectiveness of venetoclax in treating certain types of blood cancers. They also consistently highlight the potential for side effects.

Differences in Studies

The studies vary in terms of the specific treatment regimens, dosages, and the observed frequencies of different side effects. 16

Precautions for Applying to Real Life

Venetoclax is a valuable tool for cancer treatment, but remember that side effects can occur. 22 17 6 It’s crucial to adhere to your doctor’s instructions and report any side effects promptly. Additionally, venetoclax is generally not recommended for pregnant or breastfeeding women. 17

Limitations of Current Research

While extensive research has been conducted on venetoclax, there is still much to be learned about its precise mechanisms of action and how it causes specific side effects.

Future Research Directions

Continued research aimed at understanding the detailed mechanisms of venetoclax’s effects, both beneficial and adverse, could lead to improved treatment strategies with potentially fewer side effects.

Conclusion

Venetoclax holds promise as a treatment for certain blood cancers, but it’s essential to be aware of potential side effects. Close collaboration with your doctor, careful monitoring, and prompt reporting of any issues are crucial for managing this medication effectively.

Literature analysis of 23 papers
Positive Content
21
Neutral Content
1
Negative Content
1
Article Type
1
0
0
9
21
1.

AML under the Scope: Current Strategies and Treatment Involving FLT3 Inhibitors and Venetoclax-Based Regimens.

Author: MilnerowiczSzymon, MaszewskaJulia, SkoweraPaulina, StelmachMagdalena, LejmanMonika

AML treatment
Synergistic effect

This review investigates the potential of combining venetoclax, a BCL-2 inhibitor, with FLT3 inhibitors for the treatment of acute myeloid leukemia (AML).

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

2.

Venetoclax or Ruxolitinib in Pre-Transplant Conditioning Lowers the Engraftment Barrier by Different Mechanisms in Allogeneic Stem Cell Transplant Recipients.

Author: DavisJoanne E, DuKelei, Ludford-MentingMandy J, PrabahranAshvind, WongEric, HuntingtonNicholas D, KoldejRachel M, RitchieDavid S

Improved alloSCT outcomes
Reduced GVHD
Conditioning-related toxicity

This study explored the modulation of JAK1/2 as a strategy to lower the barrier to donor engraftment in allogeneic stem cell transplantation (alloSCT). The study found that short-term treatment with ruxolitinib or venetoclax could be used as pre-transplant immune-modulators to promote the efficacy of alloSCT while reducing its toxicity.

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

3.

Azacitidine-induced pneumonitis and literature review.

Author: NguyenPaul, SafdarJawarya, MohamedAbdelaziz, SoubaniAyman

AML treatment
Azacitidine-induced pneumonitis

This case report describes a rare case of azacitidine-induced pneumonitis in a patient with acute myeloid leukaemia.

Case ReportsIn the medical field, a report that describes in detail a unique case, an unusual medical condition, or the effect of a treatment. Provides new insights and possibilities for treatment through individual patient cases.
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

4.

Balancing efficacy and toxicity of targeted agents currently used for the treatment of patients with chronic lymphocytic leukemia.

Author: MauroFrancesca R, CaputoMaria D, RosatiSerena, PepeSara, De BenedittisDaniela, De LucaMaria L, FoàRobin

CLL treatment
Chemo-free options
Targeted agents
Unique side effects

This review discusses the use of small molecules to treat chronic lymphocytic leukemia (CLL). While these drugs offer new chemo-free options, they can also cause unique side effects. The review highlights the importance of awareness and management of these toxicities for successful treatment.

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

5.

Venetoclax consolidation after fixed-duration venetoclax plus obinutuzumab for previously untreated chronic lymphocytic leukaemia (HOVON 139/GiVe): primary endpoint analysis of a multicentre, open-label, randomised, parallel-group, phase 2 trial.

Author: KerstingSabina, DuboisJulie, NasserinejadKazem, DobberJohan A, MellinkClemens, van der Kevie-KersemaekersAnne-Marie F, EversLudo M, de BoerFransien, KoeneHarry R, SchreursJohn, van der KliftMarjolein, VeldersGerjo A, van der SpekEllen, van der StraatenHanneke M, HoogendoornMels, van GelderMichel, PosthumaEduardus F M, VisserHein P J, HoutenbosIlse, IdinkCecile A M, IssaDjamila E, DompelingEllen C, van ZaanenHenk C T, VeelkenHendrik, LevengaHenriette, TickLidwine W, TerpstraWim E, ToninoSanne H, BoyerMichelle, MobasherMehrdad, LevinMark-David, KaterArnon P,

CLL treatment

This study aims to determine the activity and safety of 12 cycles of venetoclax consolidation after fixed-duration venetoclax plus obinutuzumab for previously untreated patients with chronic lymphocytic leukaemia who were unfit for fludarabine-based treatment, and whether this could be guided by minimal residual disease status.

Clinical Trial, Phase IIA Phase II trial is a trial that further evaluates the efficacy and safety of a new drug or treatment, whose safety has been confirmed to some extent in a Phase I trial, in a small number of patients.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.

Language : English

6.

Practical Management of the Venetoclax-Treated Patient in Chronic Lymphocytic Leukemia and Acute Myeloid Leukemia.

Author: WaggonerMatthew, KatsetosJohn, ThomasEmilee, GalinskyIlene, FoxHeather

AML treatment
CLL treatment
Gastrointestinal disorders
Neutropenia

This article reviews the efficacy and safety of venetoclax, a B-cell lymphoma 2 inhibitor used to treat chronic lymphocytic leukemia (CLL) and acute myeloid leukemia (AML). It focuses on strategies for managing common side effects, including neutropenia and gastrointestinal disorders.

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.

Ibrutinib-induced acute kidney injury via interstitial nephritis.

Author: MarkóthCsilla, FileIbolya, SzászRóbert, BidigaLászló, BallaJózsef, MátyusJános

leukemia treatment
acute kidney injury
hypersensitivity reaction

Ibrutinib, a Bruton's tyrosine kinase inhibitor, can cause acute interstitial nephritis, a severe hypersensitivity reaction. This case report highlights the importance of early detection and management of this side effect.

Case ReportsIn the medical field, a report that describes in detail a unique case, an unusual medical condition, or the effect of a treatment. Provides new insights and possibilities for treatment through individual patient cases.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

8.

New treatment opportunities for older patients with acute myeloid leukemia and the increasing importance of frailty assessment - An oncogeriatric perspective.

Author: DiekmannBenno, TimmermanMarjolijn, HempeniusLiesbeth, van RoonEric, FrankenBas, HoogendoornMels

AML treatment
Improved overall survival
Increased remission rates
Increased response rates
Increased adverse events
Increased healthcare costs
Increased time toxicity

This review discusses the use of targeted chemotherapy drugs for treating acute myeloid leukemia (AML). These drugs have improved survival rates but can also have 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

9.

Lipase-triggered drug release from BCL2 inhibitor ABT-199-loaded nanoparticles to elevate anti-leukemic activity through enhanced drug targeting on the mitochondrial membrane.

Author: LiangBin, JiangDawei, PanLuqi, XiongFang, FengShuya, WuShenghao, YeHaige, YuZhijie, ShiChangcan, GaoShenmeng

Anti-leukemic ability
Increased OS
Acquired drug resistance
Severe side effects

PEG-ABT-199, a nanoparticle formulation of the BCL2 inhibitor ABT-199, has enhanced anti-leukemic ability compared to free ABT-199 in both in vitro and in vivo models. PEG-ABT-199 significantly induced apoptosis, reduced leukemic burden, and extended overall survival in mice with AML.

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

10.

Magic pills: new oral drugs to treat chronic lymphocytic leukemia.

Author: VitaleCandida, GriggioValentina, TodaroMaria, SalvettiChiara, BoccadoroMario, CosciaMarta

CLL treatment

New oral drugs are emerging as valuable alternatives to chemotherapy for chronic lymphocytic leukemia (CLL) patients, particularly those with high-risk disease or those ineligible for standard treatments. This review provides an overview of the mechanisms of action, clinical data, and side effects of these new therapies.

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

13.

Targeting the Pro-survival Protein BCL-2 to Prevent Breast Cancer.

Author: YoungAdelaide, BuWen, JiangWeiyu, KuAmy, KapaliJyoti, DhamneSagar, QinLan, HilsenbeckSusan G, DuYi-Chieh Nancy, LiYi

Breast cancer prevention
PIK3CA mutant
Venetoclax efficacy

This study developed a new murine model of breast cancer and investigated the chemopreventive efficacy of venetoclax. Venetoclax treatment delayed tumor progression, improved survival, and reduced metastasis, suggesting its potential as a chemopreventive agent for breast cancer.

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

14.

Oral adherence in adults with acute myeloid leukemia (AML): results of a mixed methods study.

Author: BryantAshley Leak, LeBlancThomas W, AlbrechtTara, ChanYa-Ning, RichardsonJaime, FosterMatthew, DangMalisa, DudleyWilliam, OwenbySusie, WujcikDebra

Decreased adherence
Oral medication side effects

This study aims to identify and summarize adherence to oral medications (OMs) in patients with acute myeloid leukemia (AML).

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

Language : English

16.

Real-world effectiveness of CPX-351 vs venetoclax and azacitidine in acute myeloid leukemia.

Author: MatthewsAndrew H, PerlAlexander E, LugerSelina M, LorenAlison W, GillSaar I, PorterDavid L, BabushokDaria V, MaillardIvan P, CarrollMartin P, FreyNoelle V, HexnerElizabeth O, MartinMary Ellen, McCurdyShannon R, StadtmauerEdward A, ParalkarVikram R, BrunoXimena Jordan, HwangWei-Ting, MargolisDavid, PratzKeith W

Treat AML
Early mortality
Febrile neutropenia
Infections
Long hospital stay

This retrospective study compared CPX-351 and venetoclax and azacitidine (ven/aza) in older adults with newly diagnosed AML. While ven/aza patients were older and more likely treated in the community, there was no significant difference in overall survival between the two groups (13 months for CPX-351 vs 11 months for ven/aza). CPX-351 was associated with higher infection rates and longer hospital stays. Prospective randomized studies are needed to further evaluate these regimens.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

18.

Guidelines for non-transplant chemotherapy for treatment of systemic AL amyloidosis: EHA-ISA working group.

Author: WechalekarAshutosh D, CibeiraM Teresa, GibbsSimon D, JaccardArnaud, KumarShaji, MerliniGiampaolo, PalladiniGiovanni, SanchorawalaVaishali, SchönlandStefan, VennerChristopher, BoccadoroMario, KastritisEfstathios

Improved treatment outcomes
Side effects

These guidelines from the European Society of Haematology and International Society of Amyloidosis recommend non-transplant chemotherapy treatment for patients with AL amyloidosis. Treatment selection should consider clinical presentation, treatment tolerance, potential side effects, and patient fitness. Daratumumab-VCD is recommended for most untreated patients.

GuidelineRecommendations and best practices developed by experts for healthcare professionals to refer to when making clinical judgments and providing care.
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

19.

Tumor Lysis, Adverse Events, and Dose Adjustments in 297 Venetoclax-Treated CLL Patients in Routine Clinical Practice.

Author: RoekerLindsey E, FoxChristopher P, EyreToby A, BranderDanielle M, AllanJohn N, SchusterStephen J, NabhanChadi, HillBrian T, ShahNirav N, LansiganFrederick, YazdyMaryam, ChesonBruce D, LamannaNicole, SingaviArun K, CoombsCatherine C, BarrPaul M, SkarbnikAlan P, ShadmanMazyar, UjjaniChaitra S, TuncerHande H, WinterAllison M, RhodesJoanna, DorseyColleen, MorseHannah, KabelCharlene, PagelJohn M, WilliamsAnnalynn M, JacobsRyan, GoyAndre, MuralikrishnanSivraj, PearsonLaurie, SitlingerAndrea, BaileyNeil, SchuhAnna, KirkwoodAmy A, MatoAnthony R

TLS prevention
Adverse events

This study investigated the incidence of tumor lysis syndrome (TLS) and adverse events (AEs) associated with venetoclax, a drug used to treat chronic lymphocytic leukemia (CLL), in routine clinical practice. The study found that TLS rates were negligible with an extended dose escalation schedule, but further research is needed to understand the impact of dosing modifications and TLS prophylaxis.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.

Language : English

20.

Role of Venetoclax in the Treatment of Relapsed and Refractory Multiple Myeloma.

Author: EhsanHamid, WahabAhsan, ShahZunairah, SanaMuhammad Khawar, MasoodAdeel, RafaeAbdul, HashmiHamza

ORR
VEN for MM
Cytopenias
Gastrointestinal side effects

This review explores the use of venetoclax (VEN), a BCL-2 inhibitor, in treating relapsed or refractory multiple myeloma (MM). VEN is effective in MM subsets with BCL-2 overexpression, leading to response rates ranging from 40% to 100%. While VEN monotherapy and combination regimens have shown promising results, the most common side effects include cytopenias and gastrointestinal issues.

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

22.

Comprehensive Safety Analysis of Venetoclax Monotherapy for Patients with Relapsed/Refractory Chronic Lymphocytic Leukemia.

Author: DavidsMatthew S, HallekMichael, WierdaWilliam, RobertsAndrew W, StilgenbauerStephan, JonesJeffrey A, GerecitanoJohn F, KimSu Young, PotluriJalaja, BusmanTodd, BestAndrea, VerdugoMaria E, CerriElisa, DesaiMonali, HillmenPeter, SeymourJohn F

Venetoclax efficacy
Venetoclax safety

Venetoclax, an oral BCL-2 inhibitor, is generally well tolerated in patients with relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL) when initiated with the current treatment algorithm.

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

23.

Venetoclax-induced vitiligo in a patient with chronic lymphocytic leukemia.

Author: AbdeenMuath, VusqaUrwat Til, AsawaPalash, FeltonKiley, RinchuseDerek, KhanCyrus, SamhouriYazan, ListerJohn

CLL treatment
Improved prognosis
Cytopenias
Tumor lysis syndrome
Vitiligo

Vitiligo, a skin condition, was reported in a patient receiving venetoclax for chronic lymphocytic leukemia (CLL). This is potentially the second documented case of venetoclax-induced vitiligo.

Case ReportsIn the medical field, a report that describes in detail a unique case, an unusual medical condition, or the effect of a treatment. Provides new insights and possibilities for treatment through individual patient cases.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

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