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Venetoclax: Drug information

Venetoclax: Drug information
(For additional information see "Venetoclax: Patient drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • Venclexta;
  • Venclexta Starting Pack
Brand Names: Canada
  • Venclexta;
  • Venclexta Starting Pack
Pharmacologic Category
  • Antineoplastic Agent;
  • Antineoplastic Agent, BCL-2 Inhibitor
Dosing: Adult

Note: Assess risk for tumor lysis syndrome (TLS) in all patients; administer prophylactic hydration and antihyperuricemics prior to the first venetoclax dose. TLS may also occur upon venetoclax reinitiation following therapy interruption. The ramp-up schedule/dose varies by indication. Also refer to the Azacitidine, Decitabine, Cytarabine, Obinutuzumab, or Rituximab monographs.

Acute myeloid leukemia, newly diagnosed

Acute myeloid leukemia, newly diagnosed: Adults ≥75 years of age or with comorbidities: Note: Initiate azacitidine, decitabine, or low-dose cytarabine on cycle 1, day 1. The venetoclax dose depends upon the concomitant chemotherapy agent. WBC should be <25,000/mm3 prior to initiation of venetoclax; cytoreduction prior to treatment may be required.

Day 1: Oral: 100 mg once daily.

Day 2: Oral: 200 mg once daily.

Day 3: Oral: 400 mg once daily.

Venetoclax in combination with azacitidine or decitabine: Day 4 and beyond: Oral: 400 mg once daily until disease progression or unacceptable toxicity (DiNardo 2019; DiNardo 2020).

Venetoclax in combination with low-dose cytarabine: Day 4 and beyond: Oral: 600 mg once daily until disease progression or unacceptable toxicity (Wei 2019; Wei 2020).

Tumor lysis syndrome risk assessment and p remedication : Assess patient-specific factors for TLS and provide prophylactic hydration and antihyperuricemic therapy prior to the first venetoclax dose.

WBC should be <25,000/mm3 prior to venetoclax initiation; pretreatment cytoreduction may be required.

Administer adequate hydration and antihyperuricemic agents prior to the first venetoclax dose; continue during the ramp-up phase.

Assess blood chemistries (potassium, uric acid, phosphorus, calcium, and creatinine) and correct preexisting electrolyte abnormalities prior to venetoclax initiation.

Monitor blood chemistries for TLS at pre-dose, 6 to 8 hours after each new dose during ramp-up, and 24 hours after reaching final dose.

For patients at high risk of TLS (eg, circulating blasts, high leukemia burden in the bone marrow, elevated pretreatment lactate dehydrogenase levels, reduced kidney function), consider additional TLS preventative measures, including increased laboratory monitoring and reduced initial venetoclax doses.

Chronic lymphocytic leukemia/small lymphocytic lymphoma

Chronic lymphocytic leukemia/small lymphocytic lymphoma: Note: The 5-week ramp up schedule is designed to gradually reduce tumor burden and the risk of TLS.

Week 1: Oral: 20 mg once daily.

Week 2: Oral: 50 mg once daily.

Week 3: Oral: 100 mg once daily.

Week 4: Oral: 200 mg once daily.

Week 5: Oral: 400 mg once daily.

Venetoclax monotherapy: Week 5 and thereafter: Oral: 400 mg once daily; continue until disease progression or unacceptable toxicity.

Venetoclax in combination with obinutuzumab: Note: Obinutuzumab begins on day 1 of cycle 1; initiate venetoclax on day 22 of cycle 1 according to the 5-week ramp-up schedule for chronic lymphocytic leukemia/small lymphocytic lymphoma above; ramp-up will be completed at the end of cycle 2. Cycle 3 (day 1 and beyond): Oral: 400 mg once daily until the end of cycle 12. Each cycle is 28 days (Fischer 2019).

Venetoclax in combination with rituximab: Week 5 and thereafter: Oral: 400 mg once daily; continue venetoclax until disease progression or unacceptable toxicity, for up to 24 months from day 1 (cycle 1) of rituximab; begin rituximab after receiving venetoclax at the 400 mg once daily dose for 7 days (Kater 2020; Seymour 2018).

Tumor lysis syndrome risk assessment and premedication: Assess patient-specific factors for TLS and provide prophylactic hydration and antihyperuricemic therapy prior to the first venetoclax dose (venetoclax causes a rapid reduction in tumor and poses a risk for TLS in the initial 5-week ramp-up phase). The risk of TLS is based on multiple factors, particularly reduced kidney function (CrCl <80 mL/minute) and tumor burden; splenomegaly may also increase the risk of TLS. Perform tumor burden assessments, including radiographic evaluation (eg, CT scan); assess blood chemistries in all patients (potassium, uric acid, phosphorus, calcium, and creatinine; changes in blood chemistries consistent with TLS requiring prompt management can occur as early as 6 to 8 hours following the first venetoclax dose and with each dose increase); correct preexisting abnormalities prior to initiation of venetoclax. Consider all patient comorbidities prior to determining prophylaxis and monitoring schedule. TLS risk may decrease as tumor burden decreases. TLS can also occur upon resumption of venetoclax following a dosage interruption; reassess TLS risk when reinitiating venetoclax following therapy interruption lasting >1 week during the ramp-up phase, or >2 weeks after ramp-up completion. Institute prophylaxis and monitoring as needed.

Low tumor burden (all lymph nodes <5 cm and absolute lymphocyte count [ALC] <25,000/mm3): Outpatient: Hydrate with 1.5 to 2 L of oral hydration and administer allopurinol or xanthine oxidase inhibitor (beginning 2 to 3 days prior to venetoclax initiation). Administer IV hydration for patients unable to tolerate oral hydration.

Medium tumor burden (any lymph node 5 to <10 cm or ALC ≥25,000/mm3): Outpatient: Hydrate with 1.5 to 2 L of oral hydration (administer IV hydration for patients unable to tolerate oral hydration; consider additional IV hydration) and administer allopurinol or xanthine oxidase inhibitor (beginning 2 to 3 days prior to venetoclax initiation).

High tumor burden (any lymph node ≥10 cm OR ALC ≥25,000/mm3 and any lymph node ≥5 cm): Inpatient: Hydrate with 1.5 to 2 L of oral hydration (administer IV hydration for patients unable to tolerate oral hydration) and 150 to 200 mL/hour IV hydration as tolerated; administer allopurinol or xanthine oxidase inhibitor (beginning 2 to 3 days prior to venetoclax initiation); consider rasburicase if baseline uric acid is elevated. Ramp-up may be completed outpatient if clinically indicated.

Mantle cell lymphoma, relapsed/refractory

Mantle cell lymphoma, relapsed/refractory (off-label use):

Venetoclax monotherapy: Oral: Initial: 20 mg once daily for week 1, followed by 50 mg once daily for week 2, followed by 100 mg once daily for week 3, followed by 200 mg once daily for week 4, followed by 400 mg once daily for week 5. Week 6 and thereafter: 800 mg once daily until disease progression or unacceptable toxicity occurs or until proceeding to allogeneic stem cell transplant (Davids 2017; Davids 2018). Refer to protocols for further details.

Venetoclax in combination with ibrutinib: Note: Venetoclax is initiated after 4 weeks of ibrutinib monotherapy to reduce the risk of tumor lysis syndrome. Initial: Oral: 20 mg once daily for week 5, followed by 50 mg once daily for week 6, followed by 100 mg once daily for week 7, followed by 200 mg once daily for week 8. Week 9 and thereafter: Oral: 400 mg once daily; continue until disease progression or unacceptable toxicity occurs. Venetoclax dose may be increased to 800 mg once daily after week 16 if complete response has not occurred (Tam 2018). Refer to protocols for further details.

Multiple myeloma, relapsed/refractory

Multiple myeloma, relapsed/refractory (off-label use):

With translocation t(11;14):

Venetoclax in combination with dexamethasone: Oral: 800 mg once daily; continue until disease progression or unacceptable toxicity (Kaufman 2021). Refer to protocol for further information. Note: A venetoclax dose ramp-up phase has been described in some studies; refer to articles for details (Basali 2020; Kumar 2017).

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult Drug Interactions database for more information.

Dosing: Kidney Impairment: Adult

CrCl may be estimated using the Cockcroft-Gault formula. Patients with decreased kidney function (CrCl <80 mL/minute) may require more intensive prophylaxis and monitoring to reduce the risk of tumor lysis syndrome during treatment initiation.

CrCl ≥15 mL/minute: No dosage adjustment necessary; use with caution due to increased risk for tumor lysis syndrome.

CrCl <15 mL/minute: There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).

End-stage kidney disease requiring dialysis: There are no dosage adjustments provided in the manufacturer's labeling (has not been studied). Dialysis is unlikely to significantly remove venetoclax (due to large volume of distribution and extensive protein binding).

Dosing: Hepatic Impairment: Adult

Mild or moderate impairment (Child-Pugh classes A or B): No dosage adjustment necessary.

Severe impairment (Child-Pugh class C): Reduce the daily venetoclax dose by 50%; monitor closely for adverse reactions.

Dosing: Older Adult

Refer to adult dosing.

Dosing: Adjustment for Toxicity: Adult

Acute myeloid leukemia: Note: Monitor blood counts frequently until cytopenias resolve. Toxicity may require venetoclax dose interruptions or permanent discontinuation.

Grade 4 neutropenia (with or without fever or infection) or grade 4 thrombocytopenia:

Occurring prior to achieving remission: Consider supportive measures, including anti-infectives and WBC growth factors, as clinically necessary. In most instances, do not interrupt treatment cycles (of venetoclax and azacitidine, decitabine, or low-dose cytarabine) due to cytopenias (prior to achieving remission). Bone marrow evaluation is recommended.

First occurrence after achieving remission and lasting at least 7 days: Delay subsequent treatment cycle (of venetoclax and azacitidine, decitabine, or low-dose cytarabine) and monitor blood counts. Once neutropenia has resolved to ≤ grade 2, resume venetoclax at the same dose in combination with azacitidine, decitabine, or low-dose cytarabine. Consider supportive measures, including anti-infectives and WBC growth factors, as clinically necessary.

Subsequent occurrences in cycles after achieving remission and lasting 7 days or longer: Delay subsequent treatment cycle (of venetoclax and azacitidine, decitabine, or low-dose cytarabine) and monitor blood counts. Once neutropenia has resolved to ≤ grade 2, resume venetoclax at the same dose and reduce the venetoclax duration by 7 days during each subsequent cycle (eg, reduce cycle from 28 days to 21 days). Consider supportive measures, including anti-infectives and WBC growth factors, as clinically necessary.

Nonhematologic toxicities, grade 3 or 4 toxicity (any occurrence): Interrupt venetoclax if not resolved with supportive measures. Resume at the same dose once toxicity is resolved to grade 1 or baseline.

Chronic lymphocytic leukemia/small lymphocytic lymphoma:

Interrupt or reduce dose for toxicities. Reassess risk for tumor lysis syndrome in patients who have had an interruption in dosing of >1 week during ramp-up or >2 weeks after completion of ramp-up (to determine if re-initiation with a reduced dose is necessary).

Dose Reduction Levels for Venetoclax Toxicity in Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Dose at interruption

Restart dosea

Consider discontinuation for patients who require dose reductions to less than 100 mg for more than 2 weeks.

aDuring dose escalation phase, continue the reduced dose for 1 week prior to increasing the dose.

400 mg

300 mg

300 mg

200 mg

200 mg

100 mg

100 mg

50 mg

50 mg

20 mg

20 mg

10 mg

Tumor lysis syndrome:

Blood chemistry changes or symptoms suggestive of tumor lysis syndrome (TLS): Withhold the next day's dose.

If resolved within 24 to 48 hours of the last dose: Resume at the same dose.

If blood chemistry changes require more than 48 hours to resolve: Resume at a reduced dose.

Clinical TLS (laboratory TLS with clinical consequences such as acute renal failure, cardiac arrhythmias, and/or seizure): Withhold dose; following resolution, resume at a reduced dose.

Hematologic toxicity: Grade 3 neutropenia with infection or fever or grade 4 hematologic toxicities (except lymphopenia):

First occurrence: Interrupt treatment. Resume at the same dose once toxicity is resolved to grade 1 or baseline. Consider supportive measures, including anti-infectives and WBC growth factors, as clinically necessary.

Second and subsequent occurrences: Interrupt treatment. Resume at a lower dose level once toxicity is resolved (see dosage reduction levels in above table; a larger dose reduction may be necessary based on clinical discretion). Consider supportive measures, including anti-infectives and WBC growth factors, as clinically necessary.

Nonhematologic toxicities, Grade 3 or 4 toxicity:

First occurrence: Interrupt treatment. Resume at the same dose once toxicity is resolved to grade 1 or baseline (no dosage adjustment is necessary).

Second and subsequent occurrences: Interrupt treatment. Resume at a lower dose level once toxicity is resolved (see dosage reduction levels in above table; a larger dose reduction may be necessary based on clinical discretion).

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Tablet, Oral:

Venclexta: 10 mg, 50 mg, 100 mg

Tablet Therapy Pack, Oral:

Venclexta Starting Pack: Week 1: 10 mg (14); Week 2: 50 mg (7); Week 3: 100 mg (7); Week 4: 100 mg (14) (42 ea)

Generic Equivalent Available: US

No

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Tablet, Oral:

Venclexta: 10 mg, 50 mg, 100 mg

Tablet Therapy Pack, Oral:

Venclexta Starting Pack: Week 1: 10 mg (14); Week 2: 50 mg (7); Week 3: 100 mg (7); Week 4: 100 mg (14) (42 ea)

Prescribing and Access Restrictions

Available through specialty pharmacies and distributors. Further information may be obtained from the manufacturer.

Medication Guide and/or Vaccine Information Statement (VIS)

An FDA-approved patient medication guide, which is available with the product information and as follows, must be dispensed with this medication:

Venclexta: https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208573s026lbl.pdf#page=54

Administration: Adult

Oral: Administer with a meal and water at approximately the same time each day. Swallow whole; do not crush, chew, or break prior to administration.

Missed or vomited doses: If a dose is missed and it is within 8 hours of the missed usual dosing time, administer the missed dose as soon as possible and resume the normal daily dosing schedule. If it is more than 8 hours, do not administer the missed dose and resume the usual dosing schedule the next day. If the patient vomits following administration of a dose, no additional doses should be administered that day; administer the next prescribed dose at the usual time.

Hazardous Drugs Handling Considerations

This medication is not on the NIOSH (2016) list; however, it may meet the criteria for a hazardous drug. Venetoclax may cause teratogenicity and reproductive toxicity.

Use appropriate precautions for receiving, handling, storage, preparation, dispensing, transporting, administration, and disposal. Follow NIOSH and USP 800 recommendations and institution-specific policies/procedures for appropriate containment strategy (NIOSH 2016; USP-NF 2020).

Note: Facilities may perform risk assessment of some hazardous drugs to determine if appropriate for alternative handling and containment strategies (USP-NF 2020). Refer to institution-specific handling policies/procedures.

Use: Labeled Indications

Acute myeloid leukemia: Treatment of newly-diagnosed acute myeloid leukemia (in combination with azacitidine, decitabine, or low-dose cytarabine) in patients ≥75 years of age, or in patients with comorbidities that preclude use of intensive induction chemotherapy.

Chronic lymphocytic leukemia/small lymphocytic lymphoma: Treatment of chronic lymphocytic leukemia or small lymphocytic lymphoma in adults.

Use: Off-Label: Adult

Mantle cell lymphoma, relapsed/refractory; Multiple myeloma, relapsed/refractory, t(11;14)

Medication Safety Issues
Sound-alike/look-alike issues

Venetoclax may be confused with vandetanib, vemurafenib, venlafaxine, vismodegib, vorinostat

Venclexta may be confused with venlafaxine

High alert medication

This medication is in a class the Institute for Safe Medication Practices (ISMP) includes among its list of drug classes which have a heightened risk of causing significant patient harm when used in error.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

>10%:

Cardiovascular: Edema (22%)

Dermatologic: Skin rash (18%)

Endocrine & metabolic: Hyperglycemia (67%), hyperkalemia (59%), hypoalbuminemia (49%), hypocalcemia (87%), hyponatremia (40%), hypophosphatemia (45%)

Gastrointestinal: Abdominal pain (18%), constipation (16%), diarrhea (43%), nausea (42%), stomatitis (13%; grades ≥3: <1%), vomiting (16%)

Hematologic & oncologic: Anemia (33% to 71%; grades ≥3: 18% to 26%), leukopenia (89%; grades 3/4: 42%; grade 4: 11%), lymphocytopenia (11% to 74%; grades ≥3: 7% to 40%; grade 4: 9%), neutropenia (50% to 87%; grades ≥3: 45% to 63%; grade 4: 33%), thrombocytopenia (29% to 64%; grades ≥3: 20% to 31%; grade 4: 15%)

Hepatic: Increased serum aspartate aminotransferase (53%)

Nervous system: Dizziness (14%), fatigue (32%), headache (18%)

Neuromuscular & skeletal: Arthralgia (12%), musculoskeletal pain (29%)

Respiratory: Cough (22%), dyspnea (13%), lower respiratory tract infection (11%), pneumonia (14%), upper respiratory tract infection (36%)

Miscellaneous: Fever (18%)

1% to 10%:

Hematologic & oncologic: Febrile neutropenia (6%; grades ≥3: 6%), tumor lysis syndrome (5-week ramp-up phase: 2%)

Infection: Sepsis (5%)

Frequency not defined: Hematologic & oncologic: Hemolytic anemia

Contraindications

Concomitant use with strong CYP3A inhibitors at initiation and during ramp-up phase in patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) due to the potential for increased risk of tumor lysis syndrome.

Canadian labeling: Additional contraindications (not in the US labeling): Hypersensitivity to venetoclax or any component of the formulation

Warnings/Precautions

Concerns related to adverse effects:

• Bone marrow suppression: Neutropenia, thrombocytopenia, and anemia may occur. Grade 3 and 4 neutropenia commonly occurred in chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) patients receiving venetoclax, either as monotherapy or in combination with rituximab or obinutuzumab. Neutropenic fever has been reported both with monotherapy and combination therapy. When used in combination with azacitidine, decitabine, or low-dose cytarabine for acute myeloid leukemia (AML), baseline neutrophil counts worsened in almost all patients; neutropenia may occur with subsequent cycles.

• Infection: Serious and fatal infections, including pneumonia and sepsis, have occurred.

• Tumor lysis syndrome: Tumor lysis syndrome (TLS) (including fatalities and kidney failure requiring dialysis) has occurred in patients with high tumor burden when treated with venetoclax. Venetoclax may cause a rapid reduction in tumor volume and therefore a risk for TLS is present during initiation and during the ramp-up phase of treatment (as well as during reinitiation after therapy interruption in CLL/SLL). The use of the ramp-up dose, TLS prophylaxis, and monitoring reduced the rate of TLS in venetoclax monotherapy studies; a shorter ramp up (eg, 2 to 3 weeks) and higher initial doses have resulted in higher rates of TLS and related complications in patients with CLL/SLL. Changes in blood chemistries consistent with TLS may occur as early as 6 to 8 hours after the first venetoclax dose and with each dose increase and require prompt management. The risk for TLS is increased with high tumor burden, comorbidities, and type of malignancy; splenomegaly may also increase TLS risk in CLL/SLL. Reduced kidney function further increases TLS risk. The risk for TLS may decrease as tumor burden decreases. Concomitant use of strong or moderate CYP3A inhibitors or P-gp inhibitors at initiation or during ramp-up may increase the risk for TLS and requires venetoclax dosage modification.

Disease related concerns:

• Multiple myeloma: In patients with relapsed or refractory multiple myeloma, an increase in mortality was noted when venetoclax was added to bortezomib and dexamethasone (in patients without the t(11;14) translocation [Kumar 2020]). Relapsed/refractory t(11;14) multiple myeloma is an off-label use for venetoclax.

Other warnings/precautions:

• Immunizations: Live vaccinations should not be administered prior to, during, or after venetoclax treatment until B-cell recovery occurs. Vaccines may be less effective.

Metabolism/Transport Effects

Substrate of BCRP/ABCG2, CYP3A4 (major), P-glycoprotein/ABCB1 (minor); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.

5-Aminosalicylic Acid Derivatives: May enhance the myelosuppressive effect of Myelosuppressive Agents. Risk C: Monitor therapy

Abrocitinib: May enhance the immunosuppressive effect of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid combination

Antidiabetic Agents: Hyperglycemia-Associated Agents may diminish the therapeutic effect of Antidiabetic Agents. Risk C: Monitor therapy

Asciminib: May increase the serum concentration of P-glycoprotein/ABCB1 Substrates (Narrow Therapeutic Index/Sensitive with Inhibitors). Risk C: Monitor therapy

Baricitinib: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Baricitinib. Risk X: Avoid combination

BCG (Intravesical): Myelosuppressive Agents may diminish the therapeutic effect of BCG (Intravesical). Risk X: Avoid combination

BCG Products: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the adverse/toxic effect of BCG Products. Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of BCG Products. Risk X: Avoid combination

Bitter Orange: May increase the serum concentration of Venetoclax. Risk X: Avoid combination

Brincidofovir: Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Brincidofovir. Risk C: Monitor therapy

Chloramphenicol (Ophthalmic): May enhance the adverse/toxic effect of Myelosuppressive Agents. Risk C: Monitor therapy

Cladribine: May enhance the myelosuppressive effect of Myelosuppressive Agents. Risk X: Avoid combination

Cladribine: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Cladribine. Risk X: Avoid combination

Clofazimine: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk C: Monitor therapy

CloZAPine: Myelosuppressive Agents may enhance the adverse/toxic effect of CloZAPine. Specifically, the risk for neutropenia may be increased. Risk C: Monitor therapy

Coccidioides immitis Skin Test: Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the diagnostic effect of Coccidioides immitis Skin Test. Management: Consider discontinuing these oncologic agents several weeks prior to coccidioides immitis skin antigen testing to increase the likelihood of accurate diagnostic results. Risk D: Consider therapy modification

COVID-19 Vaccine (Adenovirus Vector): Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of COVID-19 Vaccine (Adenovirus Vector). Management: Administer a 2nd dose using an mRNA COVID-19 vaccine (at least 4 weeks after the primary vaccine dose) and a bivalent booster dose (at least 2 months after the additional mRNA dose or any other boosters). Risk D: Consider therapy modification

COVID-19 Vaccine (Inactivated Virus): Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of COVID-19 Vaccine (Inactivated Virus). Risk C: Monitor therapy

COVID-19 Vaccine (mRNA): Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of COVID-19 Vaccine (mRNA). Management: Give a 3-dose primary series for all patients aged 6 months and older taking immunosuppressive medications or therapies. Booster doses are recommended for certain age groups. See CDC guidance for details. Risk D: Consider therapy modification

COVID-19 Vaccine (Subunit): Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of COVID-19 Vaccine (Subunit). Risk C: Monitor therapy

COVID-19 Vaccine (Virus-like Particles): Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of COVID-19 Vaccine (Virus-like Particles). Risk C: Monitor therapy

CYP3A4 Inducers (Moderate): May decrease the serum concentration of Venetoclax. Risk X: Avoid combination

CYP3A4 Inducers (Strong): May decrease the serum concentration of Venetoclax. Risk X: Avoid combination

CYP3A4 Inhibitors (Moderate): May increase the serum concentration of Venetoclax. Management: Reduce the venetoclax dose by at least 50% in patients requiring concomitant treatment with moderate CYP3A4 inhibitors. Resume the previous venetoclax dose 2 to 3 days after discontinuation of moderate CYP3A4 inhibitors. Risk D: Consider therapy modification

CYP3A4 Inhibitors (Strong): May increase the serum concentration of Venetoclax. Management: Coadministration is contraindicated during venetoclax initiation and ramp-up in CLL/SLL patients. Reduced venetoclax doses are required during ramp-up for patients with AML, and all maintenance therapy. See full Lexi Interact monograph for details. Risk D: Consider therapy modification

Deferiprone: Myelosuppressive Agents may enhance the neutropenic effect of Deferiprone. Management: Avoid the concomitant use of deferiprone and myelosuppressive agents whenever possible. If this combination cannot be avoided, monitor the absolute neutrophil count more closely. Risk D: Consider therapy modification

Dengue Tetravalent Vaccine (Live): Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the adverse/toxic effect of Dengue Tetravalent Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Dengue Tetravalent Vaccine (Live). Risk X: Avoid combination

Denosumab: May enhance the immunosuppressive effect of Immunosuppressants (Miscellaneous Oncologic Agents). Management: Consider the risk of serious infections versus the potential benefits of coadministration of denosumab and immunosuppressants. If combined, monitor patients for signs/symptoms of serious infections. Risk D: Consider therapy modification

Desmopressin: Hyponatremia-Associated Agents may enhance the hyponatremic effect of Desmopressin. Risk C: Monitor therapy

Deucravacitinib: May enhance the immunosuppressive effect of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid combination

Digoxin: Venetoclax may increase the serum concentration of Digoxin. Management: Avoid concomitant use of venetoclax and digoxin if possible. If combined, administer digoxin at least 6 hours before venetoclax to minimize the potential for an interaction. Risk D: Consider therapy modification

Dipyrone: May enhance the adverse/toxic effect of Myelosuppressive Agents. Specifically, the risk for agranulocytosis and pancytopenia may be increased Risk X: Avoid combination

Erdafitinib: May increase the serum concentration of P-glycoprotein/ABCB1 Substrates (Narrow Therapeutic Index/Sensitive with Inhibitors). Management: If coadministration with these narrow therapeutic index/sensitive P-gp substrates is unavoidable, separate erdafitinib administration by at least 6 hours before or after administration of these P-gp substrates. Risk D: Consider therapy modification

Fexinidazole: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk X: Avoid combination

Fexinidazole: Myelosuppressive Agents may enhance the myelosuppressive effect of Fexinidazole. Risk X: Avoid combination

Filgotinib: May enhance the immunosuppressive effect of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid combination

Fusidic Acid (Systemic): May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk X: Avoid combination

Futibatinib: May increase the serum concentration of P-glycoprotein/ABCB1 Substrates (Narrow Therapeutic Index/Sensitive with Inhibitors). Risk C: Monitor therapy

Gilteritinib: May increase the serum concentration of P-glycoprotein/ABCB1 Substrates (Narrow Therapeutic Index/Sensitive with Inhibitors). Risk C: Monitor therapy

Grapefruit Juice: May increase the serum concentration of Venetoclax. Risk X: Avoid combination

Inebilizumab: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Inebilizumab. Risk C: Monitor therapy

Influenza Virus Vaccines: Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Influenza Virus Vaccines. Management: Administer influenza vaccines at least 2 weeks prior to initiating immunosuppressants if possible. If vaccination occurs less than 2 weeks prior to or during therapy, revaccinate at least 3 months after therapy discontinued if immune competence restored. Risk D: Consider therapy modification

Lasmiditan: May increase the serum concentration of P-glycoprotein/ABCB1 Substrates (Narrow Therapeutic Index/Sensitive with Inhibitors). Risk X: Avoid combination

Leflunomide: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Leflunomide. Management: Increase the frequency of chronic monitoring of platelet, white blood cell count, and hemoglobin or hematocrit to monthly, instead of every 6 to 8 weeks, if leflunomide is coadministered with immunosuppressive agents. Risk D: Consider therapy modification

Natalizumab: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Natalizumab. Risk X: Avoid combination

Ocrelizumab: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Ocrelizumab. Risk C: Monitor therapy

Ofatumumab: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Ofatumumab. Risk C: Monitor therapy

Olaparib: Myelosuppressive Agents may enhance the myelosuppressive effect of Olaparib. Risk C: Monitor therapy

Pacritinib: May increase the serum concentration of P-glycoprotein/ABCB1 Substrates (Narrow Therapeutic Index/Sensitive with Inhibitors). Risk X: Avoid combination

P-glycoprotein/ABCB1 Inhibitors: May increase the serum concentration of Venetoclax. Management: Reduce the venetoclax dose by at least 50% in patients requiring concomitant treatment with P-glycoprotein (P-gp) inhibitors. Resume the previous venetoclax dose 2 to 3 days after discontinuation of a P-gp inhibitor. Risk D: Consider therapy modification

Pidotimod: Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Pidotimod. Risk C: Monitor therapy

Pimecrolimus: May enhance the immunosuppressive effect of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid combination

Pneumococcal Vaccines: Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Pneumococcal Vaccines. Risk C: Monitor therapy

Poliovirus Vaccine (Live/Trivalent/Oral): Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the adverse/toxic effect of Poliovirus Vaccine (Live/Trivalent/Oral). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Poliovirus Vaccine (Live/Trivalent/Oral). Risk X: Avoid combination

Polymethylmethacrylate: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the potential for allergic or hypersensitivity reactions to Polymethylmethacrylate. Management: Use caution when considering use of bovine collagen-containing implants such as the polymethylmethacrylate-based Bellafill brand implant in patients who are receiving immunosuppressants. Consider use of additional skin tests prior to administration. Risk D: Consider therapy modification

Posaconazole: May increase the serum concentration of Venetoclax. Management: Coadministration is contraindicated during venetoclax initiation and ramp-up in CLL/SLL patients. Reduced venetoclax doses are required during ramp-up for patients with AML, and all maintenance therapy. See full Lexi Interact monograph for details. Risk D: Consider therapy modification

Promazine: May enhance the myelosuppressive effect of Myelosuppressive Agents. Risk C: Monitor therapy

Rabies Vaccine: Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Rabies Vaccine. Management: Complete rabies vaccination at least 2 weeks before initiation of immunosuppressant therapy if possible. If combined, check for rabies antibody titers, and if vaccination is for post exposure prophylaxis, administer a 5th dose of the vaccine. Risk D: Consider therapy modification

Ropeginterferon Alfa-2b: Myelosuppressive Agents may enhance the myelosuppressive effect of Ropeginterferon Alfa-2b. Management: Avoid coadministration of ropeginterferon alfa-2b and other myelosuppressive agents. If this combination cannot be avoided, monitor patients for excessive myelosuppressive effects. Risk D: Consider therapy modification

Rubella- or Varicella-Containing Live Vaccines: May enhance the adverse/toxic effect of Immunosuppressants (Miscellaneous Oncologic Agents). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Rubella- or Varicella-Containing Live Vaccines. Risk X: Avoid combination

Ruxolitinib (Topical): Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Ruxolitinib (Topical). Risk X: Avoid combination

Sipuleucel-T: Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Sipuleucel-T. Management: Consider reducing the dose or discontinuing the use of immunosuppressants prior to initiating sipuleucel-T therapy. Risk D: Consider therapy modification

Sphingosine 1-Phosphate (S1P) Receptor Modulator: May enhance the immunosuppressive effect of Immunosuppressants (Miscellaneous Oncologic Agents). Risk C: Monitor therapy

Star Fruit: May increase the serum concentration of Venetoclax. Risk X: Avoid combination

Tacrolimus (Topical): Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Tacrolimus (Topical). Risk X: Avoid combination

Talimogene Laherparepvec: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the adverse/toxic effect of Talimogene Laherparepvec. Specifically, the risk of infection from the live, attenuated herpes simplex virus contained in talimogene laherparepvec may be increased. Risk X: Avoid combination

Taurursodiol: May increase the serum concentration of P-glycoprotein/ABCB1 Substrates (Narrow Therapeutic Index/Sensitive with Inhibitors). Risk X: Avoid combination

Tertomotide: Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Tertomotide. Risk X: Avoid combination

Tofacitinib: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Tofacitinib. Risk X: Avoid combination

Typhoid Vaccine: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the adverse/toxic effect of Typhoid Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Typhoid Vaccine. Risk X: Avoid combination

Upadacitinib: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Upadacitinib. Risk X: Avoid combination

Vaccines (Inactivated/Non-Replicating): Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Give inactivated vaccines at least 2 weeks prior to initiation of immunosuppressants when possible. Patients vaccinated less than 14 days before initiating or during therapy should be revaccinated at least 3 after therapy is complete. Risk D: Consider therapy modification

Vaccines (Live): Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the adverse/toxic effect of Vaccines (Live). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Vaccines (Live). Risk X: Avoid combination

Warfarin: Venetoclax may increase the serum concentration of Warfarin. Risk C: Monitor therapy

Yellow Fever Vaccine: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the adverse/toxic effect of Yellow Fever Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Yellow Fever Vaccine. Risk X: Avoid combination

Food Interactions

Administration with a low-fat meal (~512 kilocalories; 25% fat calories, 60% carbohydrate calories, and 15% protein calories) increased exposure by ~3.4-fold and administration with a high-fat meal (~753 kilocalories; 55% fat calories, 28% carbohydrate calories, and 17% protein calories) increased exposure by ~5.1- to 5.3-fold, compared to fasting. Management: Administer with a meal.

Coadministration with grapefruit products, Seville oranges, and/or Star Fruit may increase venetoclax plasma concentrations. Management: Avoid concomitant administration with grapefruit products, Seville oranges, and Star Fruit.

Reproductive Considerations

Verify pregnancy status prior to initiating venetoclax treatment in patients who could become pregnant. Patients who could become pregnant should use effective contraception during treatment and for 30 days after the final venetoclax dose.

Pregnancy Considerations

Based on the mechanism of action and data from animal reproduction studies, venetoclax is expected to cause fetal harm if administered during pregnancy.

Guidance is available for the management of acute myeloid leukemia during pregnancy (Ali 2015). A case report describes use of venetoclax in a pregnant patient refractory to recommended treatment (Karagiannis 2021).

The European Society for Medical Oncology has published guidelines for diagnosis, treatment, and follow-up of cancer during pregnancy; the guidelines recommend referral to a facility with expertise in cancer during pregnancy and encourage a multidisciplinary team (obstetrician, neonatologist, oncology team). In general, if chemotherapy is indicated, it should be avoided in the first trimester and there should be a 3-week time period between the last chemotherapy dose and anticipated delivery, and chemotherapy should not be administered beyond week 33 of gestation (ESMO [Peccatori 2013]).

A long-term observational research study is collecting information about the diagnosis and treatment of cancer during pregnancy. For additional information about the pregnancy and cancer registry or to become a participant, contact Cooper Health (877-635-4499).

Breastfeeding Considerations

It is not known if venetoclax is present in breast milk.

Due to the potential for serious adverse reactions in the breastfed infant, breastfeeding is not recommended by the manufacturer during treatment and for 1 week after the last venetoclax dose.

Dietary Considerations

Avoid grapefruit products, Seville oranges, and Star Fruit.

Monitoring Parameters

CBC with differential (throughout treatment); blood chemistries (potassium, uric acid, phosphorus, calcium, and creatinine). Evaluate pregnancy status prior to treatment in patients who could become pregnant. Assess tumor burden, including radiographic evaluation (eg, CT scan), for tumor lysis syndrome (TLS) risk evaluation. Monitor for signs/symptoms of infection. Monitor for adverse reactions in patients with hepatic impairment. Monitor adherence.

Blood chemistry monitoring in acute myeloid leukemia: Assess and correct preexisting abnormalities prior to therapy initiation; monitor blood chemistries for TLS prior to first dose, 6 to 8 hours after each new dose during ramp-up, and 24 hours after reaching the final dose. Increased monitoring may be necessary in patients at high risk for TLS.

Blood chemistry monitoring based on tumor burden/TLS risk in chronic lymphocytic leukemia/small lymphocytic lymphoma:

Low risk (all lymph node <5 cm and absolute lymphocyte count [ALC] <25,000/mm3) or medium risk (any lymph node 5 to <10 cm or ALC ≥25,000/mm3): Prior to first dose, 6 to 8 hours, and 24 hours after first 20 mg and 50 mg dose, and prior to each subsequent initial ramp up dose.

High risk (any lymph node ≥10 cm OR ALC ≥25,000/mm3 and any lymph node ≥5 cm): Prior to first dose, 4, 8, 12, and 24 hours after first 20 mg and 50 mg dose, and prior to plus 6 to 8 hours and 24 hours after each subsequent initial ramp up dose.

The American Society of Clinical Oncology hepatitis B virus (HBV) screening and management provisional clinical opinion (ASCO [Hwang 2020]) recommends HBV screening with hepatitis B surface antigen, hepatitis B core antibody, total Ig or IgG, and antibody to hepatitis B surface antigen prior to beginning (or at the beginning of) systemic anticancer therapy; do not delay treatment for screening/results. Detection of chronic or past HBV infection requires a risk assessment to determine antiviral prophylaxis requirements, monitoring, and follow-up.

Mechanism of Action

Venetoclax has cytotoxic activity in tumor cells which overexpress BCL-2. Venetoclax selectively inhibits the anti-apoptotic protein BCL-2, which is overexpressed in chronic lymphocytic leukemia (CLL) cells and acute myeloid leukemia (AML) cells. BCL-2 mediates tumor cell survival and has been associated with chemotherapy resistance. Venetoclax binds directly to the BCL-2 protein, displacing pro-apoptotic proteins and restoring the apoptotic process.

Pharmacokinetics

Distribution: Vdss: 256 to 321 L

Protein binding: Highly bound to plasma proteins

Metabolism: Hepatic, predominantly via CYP3A; the major metabolite is M27 (has BCL-2 inhibitory activity)

Half-life, elimination: ~26 hours

Time to peak: 5 to 8 hours

Excretion: Feces (>99.9%; ~21% as unchanged drug); Urine (<0.1%)

Pharmacokinetics: Additional Considerations

Hepatic function impairment: Following a single 50 mg venetoclax dose, systemic exposure (AUC0 to inf) was 2.7-fold higher in subjects with severe impairment (Child-Pugh class C), compared to subjects with normal hepatic function.

Race/ethnicity: Based on a study in patients with acute myeloid leukemia enrolled from Asian countries, venetoclax exposure was 63% higher in patients of East-Asian ethnicity (Chinese, Japanese, South Korean, and Taiwanese).

Pricing: US

Tablet Therapy Pack (Venclexta Starting Pack Oral)

10 & 50 & 100 mg (per each): $85.26

Tablets (Venclexta Oral)

10 mg (per each): $13.83

50 mg (per each): $69.13

100 mg (per each): $138.25

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Brand Names: International
  • Venclexta (AU, CR, DO, GT, HN, IL, LB, NI, PA, SA, SV, TW);
  • Venclyxto (AT, BE, CH, CZ, DE, DK, EE, ES, FI, FR, GB, HR, HU, LT, LU, LV, NL, NO, PL, PT, RO, SE, SK)


For country code abbreviations (show table)
  1. <800> Hazardous Drugs—Handling in Healthcare Settings. United States Pharmacopeia and National Formulary (USP 43-NF 38). Rockville, MD: United States Pharmacopeia Convention; 2020:74-92.
  2. Ali S, Jones GL, Culligan DJ, et al; British Committee for Standards in Haematology. Guidelines for the diagnosis and management of acute myeloid leukaemia in pregnancy. Br J Haematol. 2015;170(4):487-495. doi:10.1111/bjh.13554 [PubMed 26081614]
  3. Basali D, Chakraborty R, Rybicki L, et al. Real-world data on safety and efficacy of venetoclax-based regimens in relapsed/refractory t(11;14) multiple myeloma. Br J Haematol. 2020;189(6):1136-1140. doi:10.1111/bjh.16454 [PubMed 32012228]
  4. Coutre S, Choi M, Furman RR, et al. Venetoclax for patients with chronic lymphocytic leukemia who progressed during or after idelalisib therapy. Blood. 2018;131(15):1704-1711. [PubMed 29305552]
  5. Davids MS, Roberts AW, Seymour JF, et al. Phase I first-in-human study of venetoclax in patients with relapsed or refractory non-Hodgkin lymphoma. J Clin Oncol. 2017;35(8):826-833. doi: 10.1200/JCO.2016.70.4320. [PubMed 28095146]
  6. Davids MS, von Keudell G, Portell CA, et al. Revised dose ramp-up to mitigate the risk of tumor lysis syndrome when initiating venetoclax in patients with mantle cell lymphoma. J Clin Oncol. 2018;36(35):3525-3527. doi: 10.1200/JCO.18.00359. [PubMed 30359156]
  7. DiNardo CD, Jonas BA, Pullarkat V, et al. Azacitidine and venetoclax in previously untreated acute myeloid leukemia. N Engl J Med. 2020;383(7):617-629. doi:10.1056/NEJMoa2012971 [PubMed 32786187]
  8. DiNardo CD, Pratz K, Pullarkat V, et al. Venetoclax combined with decitabine or azacitidine in treatment-naive, elderly patients with acute myeloid leukemia. Blood. 2019;133(1):7-17. doi: 10.1182/blood-2018-08-868752. [PubMed 30361262]
  9. Eyre TA, Walter HS, Iyengar S, et al. Efficacy of venetoclax monotherapy in patients with relapsed, refractory mantle cell lymphoma after Bruton tyrosine kinase inhibitor therapy. Haematologica. 2019;104(2):e68-e71. doi: 10.3324/haematol.2018.198812. [PubMed 30190341]
  10. Fischer K, Al-Sawaf O, Bahlo J, et al. Venetoclax and obinutuzumab in patients with CLL and coexisting conditions. N Engl J Med. 2019;380(23):2225-2236. doi: 10.1056/NEJMoa1815281. [PubMed 31166681]
  11. Hwang JP, Feld JJ, Hammond SP, et al. Hepatitis B virus screening and management for patients with cancer prior to therapy: ASCO provisional clinical opinion update. J Clin Oncol. 2020;38(31):3698-3715. doi:10.1200/JCO.20.01757 [PubMed 32716741]
  12. Karagiannis P, Alsdorf W, Tallarek AC, et al. Treatment of refractory acute myeloid leukaemia during pregnancy with venetoclax, high-dose cytarabine and mitoxantrone. Br J Haematol. 2021;192(2):e60-e63. doi:10.1111/bjh.17220 [PubMed 33222152]
  13. Kater AP, Wu JQ, Kipps T, et al. Venetoclax plus rituximab in relapsed chronic lymphocytic leukemia: 4-year results and evaluation of impact of genomic complexity and gene mutations from the MURANO phase III study. J Clin Oncol. 2020;38(34):4042-4054. doi:10.1200/JCO.20.00948 [PubMed 32986498]
  14. Kaufman JL, Gasparetto C, Schjesvold FH, et al. Targeting BCL-2 with venetoclax and dexamethasone in patients with relapsed/refractory t(11;14) multiple myeloma. Am J Hematol. 2021;96(4):418-427. doi:10.1002/ajh.26083 [PubMed 33368455]
  15. Kumar SK, Harrison SJ, Cavo M, et al. Venetoclax or placebo in combination with bortezomib and dexamethasone in patients with relapsed or refractory multiple myeloma (BELLINI): a randomised, double-blind, multicentre, phase 3 trial. Lancet Oncol. 2020;21(12):1630-1642. doi:10.1016/S1470-2045(20)30525-8 [PubMed 33129376]
  16. Kumar S, Kaufman JL, Gasparetto C, et al. Efficacy of venetoclax as targeted therapy for relapsed/refractory t(11;14) multiple myeloma. Blood. 2017;130(22):2401-2409. doi:10.1182/blood-2017-06-788786 [PubMed 29018077]
  17. Peccatori FA, Azim HA Jr, Orecchia R, et al; ESMO Guidelines Working Group. Cancer, pregnancy and fertility: ESMO clinical practice guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2013;24(suppl 6):vi160-70. doi:10.1093/annonc/mdt199 [PubMed 23813932]
  18. Roberts AW, Davids MS, Pagel JM, et al. Targeting BCL2 with Venetoclax in Relapsed Chronic Lymphocytic Leukemia. N Engl J Med. 2016;374(4):311-22. [PubMed 26639348]
  19. Seymour JF, Kipps TJ, Eichhorst B, et al. Venetoclax-rituximab in relapsed or refractory chronic lymphocytic leukemia. N Engl J Med. 2018;378(12):1107-1120. doi: 10.1056/NEJMoa1713976. [PubMed 29562156]
  20. Stilgenbauer S, Eichhorst B, Schetelig J, et al. Venetoclax in relapsed or refractory chronic lymphocytic leukaemia with 17p deletion: a multicentre, open-label, phase 2 study. Lancet Oncol. 2016;17(6):768-778. [PubMed 27178240]
  21. Tam CS, Anderson MA, Pott C, et al. Ibrutinib plus venetoclax for the treatment of mantle-cell lymphoma. N Engl J Med. 2018;378(13):1211-1223. doi: 10.1056/NEJMoa1715519. [PubMed 29590547]
  22. US Department of Health and Human Services; Centers for Disease Control and Prevention; National Institute for Occupational Safety and Health. NIOSH list of antineoplastic and other hazardous drugs in healthcare settings 2016. http://www.cdc.gov/niosh/topics/antineoplastic/pdf/hazardous-drugs-list_2016-161.pdf. Updated September 2016. Accessed October 3, 2016.
  23. Venclexta (venetoclax) [prescribing information]. North Chicago, IL: AbbVie Inc; June 2022.
  24. Venclexta (venetoclax) [product monograph]. St-Laurent, Quebec, Canada: AbbVie Corporation; April 2022.
  25. Wei AH, Montesinos P, Ivanov V, et al. Venetoclax plus LDAC for newly diagnosed AML ineligible for intensive chemotherapy: a phase 3 randomized placebo-controlled trial. Blood. 2020;135(24):2137-2145. doi:10.1182/blood.2020004856 [PubMed 32219442]
  26. Wei AH, Strickland SA Jr, Hou JZ, et al. Venetoclax combined with low-dose cytarabine for previously untreated patients with acute myeloid leukemia: results from a phase Ib/II study. J Clin Oncol. 2019;37(15):1277-1284. doi: 10.1200/JCO.18.01600. [PubMed 30892988]
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