VENCLEXTA® (venetoclax tablets) | Ordering Information for AML

To order any of the following, please contact one of the specialty pharmacies (SPs) or distributors listed below.

VENCLEXTA for AML — standard supply header

Image of VENCLEXTA pill bottle 400 milligram

The recommended daily dose of 400 mg, in combination with azacitidine or decitabine, is supplied as 100-mg tablets.
100-mg bottle (qty 120): NDC # 0074-0576-22

Image of VENCLEXTA pill bottle 600 milligram

The recommended daily dose of 600 mg, in combination with low-dose cytarabine, is supplied as 100-mg tablets.
100-mg bottle (qty 180): NDC # 0074-0576-34

Image of VENCLEXTA unit dose packets 10 milligram and 50 milligram

10-mg and 50-mg unit doses are available if dose holds should occur.
10-mg wallet (qty 14): NDC # 0074-0561-14
50-mg wallet (qty 7): NDC # 0074-0566-07

Image of VENCLEXTA unit dose packets 10 milligram, 50 milligram, and 100 milligram

Unit doses. 
10-mg unit dose (qty 2): NDC # 0074-0561-11
50-mg unit dose (qty 1): NDC # 0074-0566-11
100-mg unit dose (qty 1): NDC # 0074-0576-11

Specialty pharmacies (SPs) and distributors

The following network of SPs and distributors is authorized to dispense VENCLEXTA (venetoclax tablets). This network will assist providers and patients in obtaining VENCLEXTA. SPs may be able to provide services such as prior authorization assistance and identifying co-pay support options for eligible patients.

Specialty pharmacies

Avella: DBA Optum Specialty
Phone: (877) 546-5779
Fax: (877) 546-5780
avella.com

Biologics by McKesson
Phone: (800) 850-4306
Fax: (800) 823-4506
biologics.mckesson.com

Diplomat: DBA Optum Specialty
Phone: (877) 977-9118
Fax: (800) 550-6272
diplomatpharmacy.com

Onco360 Oncology Pharmacy
Phone: (877) 662-6633
Fax: (877) 662-6355
onco360.com  

Specialty distributors

ASD Healthcare
Phone: (800) 746-6273
Fax: (800) 547-9413
asdhealthcare.com

Cardinal Health Specialty Distribution
Phone: (855) 855-0708
Fax: (888) 345-4916
specialtyonline.cardinalhealth.com

McKesson Plasma and Biologics (MPB)
Phone: (877) 625-2566
Fax: (888) 752-7626
connect.mckesson.com

McKesson Specialty Health
Phone: (800) 482-6700
Fax: (800) 289-9285
mscs.mckesson.com

Oncology Supply
Phone: (800) 633-7555
Fax: (800) 248-8205
oncologysupply.com

Genentech and AbbVie do not influence or advocate the use of any one specialty distributor or specialty pharmacy. There is no representation or guarantee of service or coverage of any item.

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Efficacy

Review study design, overall survival data, remission rates, and more

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Safety Data

Review adverse reactions, duration of exposure, and discontinuation rates

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Dosing/Management

Review appropriate dosing and management of select adverse reactions

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Indication

VENCLEXTA is indicated in combination with azacitidine, or decitabine, or low-dose cytarabine for the treatment of newly diagnosed acute myeloid leukemia (AML) in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy.

Important Safety Information

Tumor Lysis Syndrome

Tumor lysis syndrome (TLS), including fatal events and renal failure requiring dialysis, has occurred in patients treated with VENCLEXTA.
VENCLEXTA can cause rapid reduction in tumor and thus poses a risk for TLS at initiation and during the ramp-up phase in all patients. Changes in blood chemistries consistent with TLS that require prompt management can occur as early as 6 to 8 hours following the first dose of VENCLEXTA and at each dose increase.
In patients with AML who followed the current 3-day ramp-up dosing schedule and the TLS prophylaxis and monitoring measures, the rate of TLS was 1.1% in patients who received VENCLEXTA in combination with azacitidine. In patients with AML who followed a 4-day ramp-up dosing schedule and the TLS prophylaxis and monitoring measures, the rate of TLS was 5.6% and included deaths and renal failure in patients who received VENCLEXTA in combination with low-dose cytarabine.
The risk of TLS is a continuum based on multiple factors, particularly reduced renal function, tumor burden, and type of malignancy.
Assess all patients for risk and provide appropriate prophylaxis for TLS, including hydration and anti-hyperuricemics. Monitor blood chemistries and manage abnormalities promptly. Employ more intensive measures (IV hydration, frequent monitoring, hospitalization) as overall risk increases. Interrupt dosing if needed; when restarting VENCLEXTA follow dose modification guidance in the Prescribing Information.
Concomitant use of VENCLEXTA with P-gp inhibitors or strong or moderate CYP3A inhibitors increases venetoclax exposure, which may increase the risk of TLS at initiation and during the ramp-up phase, and requires VENCLEXTA dose reduction.

Neutropenia

In patients with AML, baseline neutrophil counts worsened in 95% to 100% of patients treated with VENCLEXTA in combination with azacitidine or decitabine or low-dose cytarabine. Neutropenia can recur with subsequent cycles.
Monitor complete blood counts. Interrupt dosing for severe neutropenia. Resume at same dose then reduce duration based on remission status and first or subsequent occurrence of neutropenia. Consider supportive measures including antimicrobials and growth factors (e.g., G-CSF).

Infections

Fatal and serious infections such as pneumonia and sepsis have occurred in patients treated with VENCLEXTA. Monitor patients for signs and symptoms of infection and treat promptly. Withhold VENCLEXTA for Grade 3 and 4 infection until resolution and resume at same dose.

Immunization

Do not administer live attenuated vaccines prior to, during, or after treatment with VENCLEXTA until B-cell recovery occurs. Advise patients that vaccinations may be less effective.

Embryo-Fetal Toxicity

VENCLEXTA may cause embryo-fetal harm when administered to a pregnant woman. Advise females of reproductive potential to use effective contraception during treatment with VENCLEXTA and for 30 days after the last dose.

Increased Mortality in Patients with Multiple Myeloma when VENCLEXTA is Added to Bortezomib and Dexamethasone

In a randomized trial (BELLINI; NCT02755597) in patients with relapsed or refractory multiple myeloma, the addition of VENCLEXTA to bortezomib plus dexamethasone, a use for which VENCLEXTA is not indicated, resulted in increased mortality. Treatment of patients with multiple myeloma with VENCLEXTA in combination with bortezomib plus dexamethasone is not recommended outside of controlled clinical trials.

Adverse Reactions

In patients with AML receiving combination therapy with azacitidine, the most frequent serious adverse reactions (≥5%) were febrile neutropenia (30%), pneumonia (22%), sepsis (excluding fungal; 19%), and hemorrhage (6%). The most common adverse reactions including hematological abnormalities (≥30%) of any grade were neutrophils decreased (98%), platelets decreased (94%), lymphocytes decreased (91%), hemoglobin decreased (61%), nausea (44%), diarrhea (43%), febrile neutropenia (42%), musculoskeletal pain (36%), pneumonia (33%), fatigue (31%), and vomiting (30%). Fatal adverse reactions occurred in 23% of patients who received VENCLEXTA in combination with azacitidine, with the most frequent (≥2%) being pneumonia (4%), sepsis (excluding fungal; 3%), and hemorrhage (2%).
In patients with AML receiving combination therapy with decitabine, the most frequent serious adverse reactions (≥10%) were sepsis (excluding fungal; 46%), febrile neutropenia (38%), and pneumonia (31%). The most common adverse reactions including hematological abnormalities (≥30%) of any grade were neutrophils decreased (100%), lymphocytes decreased (100%), white blood cells decreased (100%), platelets decreased (92%), hemoglobin decreased (69%), febrile neutropenia (69%), fatigue (62%), constipation (62%), musculoskeletal pain (54%), dizziness (54%), nausea (54%), abdominal pain (46%), diarrhea (46%), pneumonia (46%), sepsis (excluding fungal; 46%), cough (38%), pyrexia (31%), hypotension (31%), oropharyngeal pain (31%), edema (31%), and vomiting (31%). One (8%) fatal adverse reaction of bacteremia occurred within 30 days of starting treatment.
In patients with AML receiving combination therapy with low-dose cytarabine, the most frequent serious adverse reactions (≥10%) were pneumonia (17%), febrile neutropenia (16%), and sepsis (excluding fungal; 12%). The most common adverse reactions including hematological abnormalities (≥30%) of any grade were platelets decreased (97%), neutrophils decreased (95%), lymphocytes decreased (92%), hemoglobin decreased (63%), nausea (42%), and febrile neutropenia (32%). Fatal adverse reactions occurred in 23% of patients who received VENCLEXTA in combination with LDAC, with the most frequent (≥5%) being pneumonia (6%) and sepsis (excluding fungal; 7%).

Drug Interactions

Concomitant use with a P-gp inhibitor or a strong or moderate CYP3A inhibitor increases VENCLEXTA exposure, which may increase VENCLEXTA toxicities, including the risk of TLS. Consider alternative medications or adjust VENCLEXTA dosage and monitor more frequently for adverse reactions. Resume the VENCLEXTA dosage that was used prior to concomitant use of a P-gp inhibitor or a strong or moderate CYP3A inhibitor 2 to 3 days after discontinuation of the inhibitor.
Patients should avoid grapefruit products, Seville oranges, and starfruit during treatment as they contain inhibitors of CYP3A.
Avoid concomitant use of strong or moderate CYP3A inducers.
Monitor international normalized ratio (INR) more frequently in patients receiving warfarin.
Avoid concomitant use of VENCLEXTA with a P-gp substrate. If concomitant use is unavoidable, separate dosing of the P-gp substrate at least 6 hours before VENCLEXTA.

Lactation

Advise nursing women not to breastfeed during treatment with VENCLEXTA and for 1 week after the last dose.

Females and Males of Reproductive Potential

Advise females of reproductive potential to use effective contraception during treatment with VENCLEXTA and for 30 days after the last dose.
Based on findings in animals, VENCLEXTA may impair male fertility.

Hepatic Impairment

Reduce the dose of VENCLEXTA for patients with severe hepatic impairment (Child-Pugh C); monitor these patients more frequently for signs of adverse reactions. No dose adjustment is recommended for patients with mild (Child-Pugh A) or moderate (Child-Pugh B) hepatic impairment.

Please see full Prescribing Information.

VENCLEXTA^®, VENCOMPASS^® and their designs are registered trademarks of AbbVie Inc.

- VENCLEXTA Prescribing Information.
  
  VENCLEXTA Prescribing Information.
- Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines^®) for Acute Myeloid Leukemia V.3.2021. © National Comprehensive Cancer Network, Inc. 2021. All rights reserved. Accessed March 2, 2021. To view the most recent and complete version of the guideline, go online to NCCN.org. NATIONAL COMPREHENSIVE CANCER NETWORK^®, NCCN^®, NCCN GUIDELINES^®, and all other NCCN Content are trademarks owned by the National Comprehensive Cancer Network, Inc.
  
  Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines^®) for Acute Myeloid Leukemia V.3.2021. © National Comprehensive Cancer Network, Inc. 2021. All rights reserved. Accessed March 2, 2021. To view the most recent and complete version of the guideline, go online to NCCN.org. NATIONAL COMPREHENSIVE CANCER NETWORK^®, NCCN^®, NCCN GUIDELINES^®, and all other NCCN Content are trademarks owned by the National Comprehensive Cancer Network, Inc.
- 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.
  
  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.
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- CRESEMBA Prescribing Information.
  
  CRESEMBA Prescribing Information.
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  Drug development and drug interactions: table of substrates, inhibitors and inducers. US Food and Drug Administration website. https://www.fda.gov/drugs/developmentapprovalprocess/developmentresources/druginteractionslabeling/ucm093664.htm. Updated March 6, 2020. Accessed October 15, 2020.
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How VENCLEXTA is supplied