Venetoclax
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Martin Nino, M.D. [2]
Disclaimer
WikiDoc MAKES NO GUARANTEE OF VALIDITY. WikiDoc is not a professional health care provider, nor is it a suitable replacement for a licensed healthcare provider. WikiDoc is intended to be an educational tool, not a tool for any form of healthcare delivery. The educational content on WikiDoc drug pages is based upon the FDA package insert, National Library of Medicine content and practice guidelines / consensus statements. WikiDoc does not promote the administration of any medication or device that is not consistent with its labeling. Please read our full disclaimer here.
Overview
Venetoclax is a BCL-2 inhibitor that is FDA approved for the treatment of patients with chronic lymphocytic leukemia (CLL) with 17p deletion, as detected by an FDA approved test, who have received at least one prior therapy. This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. Common adverse reactions include neutropenia, diarrhea, nausea, anemia, upper respiratory tract infection, thrombocytopenia, and fatigue (≥20%).
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
Patient Selection
Select patients for the treatment of relapsed or refractory CLL with Venetoclax based on the presence of 17p deletions in blood specimens. Patients without 17p deletion at diagnosis should be retested at relapse because acquisition of 17p deletion can occur.
Dosage
Venetoclax should be taken orally once daily until disease progression or unacceptable toxicity is observed. Assess patient-specific factors for level of risk of tumor lysis syndrome (TLS) and provide prophylactic hydration and anti-hyperuricemics to patients prior to first dose of Venetoclax to reduce risk of TLS. Administer the Venetoclax dose according to a weekly ramp-up schedule over 5 weeks to the recommended daily dose of 400 mg as shown in Table 1. The 5-week ramp-up dosing schedule is designed to gradually reduce tumor burden (debulk) and decrease the risk of TLS. Once the ramp-up phase is completed, the 400 mg dose is achieved using 100 mg tablets.
Instruct patients to take Venetoclax tablets with a meal and water at approximately the same time each day. Venetoclax tablets should be swallowed whole and not chewed, crushed, or broken prior to swallowing.
Risk Assessment and Prophylaxis for Tumor Lysis Syndrome
Venetoclax can cause rapid reduction in tumor and thus poses a risk for TLS in the initial 5-week 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. Perform tumor burden assessments, including radiographic evaluation (e.g., CT scan), assess blood chemistry (potassium, uric acid, phosphorus, calcium, and creatinine) in all patients and correct pre-existing abnormalities prior to initiation of treatment with Venetoclax. Reduced renal function (creatinine clearance [CrCl] <80 mL/min) further increases the risk. The risk may decrease as tumor burden decreases.
Table 2 below describes the recommended TLS prophylaxis and monitoring during Venetoclax treatment based on tumor burden determination from clinical trial data.
Important Administration Instructions
There are two presentations for Ixekizumab (i.e., autoinjector and prefilled syringe).
Ixekizumab is intended for use under the guidance and supervision of a physician. Patients may self-inject after training in subcutaneous injection technique using the autoinjector or prefilled syringe. Administer each injection at a different anatomic location (such as upper arms, thighs or any quadrant of abdomen) than the previous injection, and not into areas where the skin is tender, bruised, erythematous, indurated or affected by psoriasis. Administration of Ixekizumab in the upper, outer arm may be performed by a caregiver or healthcare provider.
If a dose is missed, administer the dose as soon as possible. Thereafter, resume dosing at the regular scheduled time.
Preparation for Use of Ixekizumab Autoinjector and Prefilled Syringe
Before injection, remove Ixekizumab autoinjector or Ixekizumab prefilled syringe from the refrigerator and allow Ixekizumab to reach room temperature (30 minutes) without removing the needle cap.
Inspect Ixekizumab formulation visually for particulate matter and discoloration prior to administration. Ixekizumab formulation is a clear and colorless to slightly yellow solution. Do not use if the liquid contains visible particles, is discolored or cloudy (other than clear and colorless to slightly yellow). Ixekizumab formulation does not contain preservatives, therefore discard any unused product remaining in the autoinjector or prefilled syringe.
Instruct patients using the autoinjector or prefilled syringe to inject the full amount (1 mL), which provides 80 mg of Ixekizumab, according to the directions.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Ixekizumab in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Ixekizumab in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
FDA Package Insert for Ixekizumab contains no information regarding Pediatric Indications and Dosage.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Ixekizumab in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Ixekizumab in pediatric patients.
Contraindications
There is limited information regarding Venetoclax Contraindications in the drug label.
Warnings
There is limited information regarding Venetoclax Warnings' in the drug label.
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Venetoclax Clinical Trials Experience in the drug label.
Postmarketing Experience
There is limited information regarding Venetoclax Postmarketing Experience in the drug label.
Drug Interactions
There is limited information regarding Venetoclax Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Venetoclax in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Venetoclax in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Venetoclax during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Venetoclax in women who are nursing.
Pediatric Use
There is no FDA guidance on the use of Venetoclax in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Venetoclax in geriatric settings.
Gender
There is no FDA guidance on the use of Venetoclax with respect to specific gender populations.
Race
There is no FDA guidance on the use of Venetoclax with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Venetoclax in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Venetoclax in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Venetoclax in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Venetoclax in patients who are immunocompromised.
Administration and Monitoring
Administration
There is limited information regarding Venetoclax Administration in the drug label.
Monitoring
There is limited information regarding Venetoclax Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of Venetoclax and IV administrations.
Overdosage
There is limited information regarding Venetoclax overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.
Pharmacology
There is limited information regarding Venetoclax Pharmacology in the drug label.
Mechanism of Action
There is limited information regarding Venetoclax Mechanism of Action in the drug label.
Structure
There is limited information regarding Venetoclax Structure in the drug label.
Pharmacodynamics
There is limited information regarding Venetoclax Pharmacodynamics in the drug label.
Pharmacokinetics
There is limited information regarding Venetoclax Pharmacokinetics in the drug label.
Nonclinical Toxicology
There is limited information regarding Venetoclax Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Venetoclax Clinical Studies in the drug label.
How Supplied
There is limited information regarding Venetoclax How Supplied in the drug label.
Storage
There is limited information regarding Venetoclax Storage in the drug label.
Images
Drug Images
{{#ask: Page Name::Venetoclax |?Pill Name |?Drug Name |?Pill Ingred |?Pill Imprint |?Pill Dosage |?Pill Color |?Pill Shape |?Pill Size (mm) |?Pill Scoring |?NDC |?Drug Author |format=template |template=DrugPageImages |mainlabel=- |sort=Pill Name }}
Package and Label Display Panel
{{#ask: Label Page::Venetoclax |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}
Patient Counseling Information
There is limited information regarding Venetoclax Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol-Venetoclax interaction has not been established. Talk to your doctor regarding the effects of taking alcohol with this medication.
Brand Names
There is limited information regarding Venetoclax Brand Names in the drug label.
Look-Alike Drug Names
There is limited information regarding Venetoclax Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.