How VENCLEXTA is supplied

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

View the AML Standard Supply of VENCLEXTA. Graphic of a 100-mg pill bottle. The recommended daily dose of 400 mg, in combination with azacitidine or decitabine, is supplied as 100-mg tablets (quantity 120). Graphic of a 100-mg pill bottle. The recommended daily dose of 600 mg, in combination with low-dose cytarabine, is supplied as 100-mg tablets (quantity 180). Graphic of two pill-wallets. 10-mg and 50-mg unit doses are available if dose holds should occur. Graphic of three pill-wallets. Unit doses.

Specialty pharmacies and distributors

The following network of SPs and distributors is authorized to dispense VENCLEXTA. 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 Specialty Pharmacy
www.avella.com
Phone: (877) 546-5779
Fax: (877) 546-5780

Biologics
www.biologicsinc.com
Phone: (800) 850-4306
Fax: (800) 823-4506

Diplomat Specialty Pharmacy
www.diplomat.is
Phone: (877) 977-9118
Fax: (800) 550-6272

Onco360
www.onco360.com
Phone: (877) 662-6633
Fax: (800) 662-6355

Specialty distributors

McKesson Specialty Health
https://mscs.mckesson.com
Phone, Oncology: (800) 482-6700
Phone, Multispecialty: (855) 477-9800
Fax: (800) 800-5673

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

ASD Healthcare
www.asdhealthcare.com
Phone: (877) 746-6273
Fax: (800) 547-9413

McKesson Plasma & Biologics
https://connect.mckesson.com
Phone: (877) 625-2566
Fax: (800) 752-7626

Cardinal Health
www.cardinalhealth.com/spd
Phone, Hospitals: (866) 677-4844
Phone, Oncology: (877) 453-3972
Fax: (877) 274-9897

See dosing information

Download the Patient Support Brochure

Important Safety Information

Tumor Lysis Syndrome

Tumor lysis syndrome (TLS), including fatal events and renal failure requiring dialysis, has occurred in patients with high tumor burden when treated with VENCLEXTA.
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.
VENCLEXTA can cause rapid reduction in tumor and thus poses a risk for TLS at initiation and during the ramp-up phase. 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.
The risk of TLS is a continuum based on multiple factors, including tumor burden and comorbidities. Reduced renal function further increases the risk.
Assess patients for TLS risk and provide appropriate prophylaxis for TLS, including hydration and anti-hyperuricemics. Monitor blood chemistries and manage abnormalities promptly. Interrupt dosing if needed. Employ more intensive measures (IV hydration, frequent monitoring, hospitalization) as overall risk increases.
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 adjustment.

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 throughout the treatment period. For severe neutropenia, interrupt dosing or reduce duration based on remission status and occurrence. 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 or reduced dose based on occurrence.

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 at least 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 (≥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 (≥30%) of any grade were 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 (≥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.
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.
Monitor international normalized ratio (INR) more frequently in patients receiving warfarin.

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 at least 30 days after the last dose.
Based on findings in animals, VENCLEXTA may impair male fertility.

Renal Impairment

Patients with reduced renal function (CLcr <80 mL/min, calculated by Cockcroft-Gault formula) require more intensive prophylaxis and monitoring to reduce the risk of TLS when initiating treatment with VENCLEXTA.

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.

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 the use of intensive induction chemotherapy.

VENCLEXTA^® and its design are registered trademarks of AbbVie Inc.