Introduction for Venex 100 mg (Venetoclax):

Venex 100 mg  is an anticancer drug used to treat white blood cell cancers. Venex Tablet is indicated to treat chronic lymphocytic leukemia and small lymphocytic lymphoma. Venetoclax, commonly known as Venclexta, is an FDA-approved drug that treats adults with chronic lymphocytic leukemia.Venex and Rituximab are used to treat adult patients with chronic lymphocytic leukemia (CLL) who have received at least one prior treatment. Venex is available as an oral tablet.

Indications:

Venex 100 (Venetoclax) is used to treat adult patients who have chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
Acute Myeloid Leukemia: Venetoclax 100 is indicated when used with Azacitidine, Decitabine, or low-dose Cytarabine for the treatment of newly diagnosed acute myeloid leukemia (AML) in persons 75 years or older, or who have illness that prevent use of active induction chemotherapy.

Drug/Therapeutic Class:

Cytotoxic chemotherapy.

Pharmacology:

Venex 100 mg is an orally available small-molecule inhibitor of the antiapoptotic protein BCL-2.Overexpression of BCL-2 has been seen in CLL cells, where it promotes malignant cell survival and has been linked to chemotherapy resistance. Venex 100 aids in the restoration of apoptosis by binding directly to the BCL-2 protein, displacing pro-apoptotic proteins such as BIM, inducing mitochondrial outer membrane permeabilization, and activating caspases. In nonclinical trials, venex 100  was found to be cytotoxic in tumor cells that overexpress BCL-2.

Dosage and administration:

In combination with Obinutuzumab: Initiate giving Obinutuzumab at 100 mg on Cycle 1 Day 1, followed by 900 mg on Cycle 1 Day 2. For a total of six cycles, administer 1000 mg on Days 8 and 15 of Cycle 1, as well as on Day 1 of each consecutive 28-day cycle. For more information about dosing with Obinutuzumab, see the prescription information. On Cycle 1, Day 22, begin Venex dose according to the 5-week ramp-up strategy . After completing the ramp-up phase on Cycle 2 Day 28, continue taking Venex orally once day from Cycle 3 Day 1 until the end of Cycle 12.

In combination with Rituximab: Initiate Rituximab administration once the patient has completed the Venex 5-week ramp-up dosing regimen and has received the prescribed dose of 400 mg orally once daily for 7 days.
For monotherapy, the recommended dose of Venex is 400 mg once daily after completing the 5-week ramp-up dosing program . Continue using Venex until disease progression or intolerable toxicity.

OVERDOSE:

There is no specific antidote to Venex 100 mg (Venetoclax) . Patients who overdose venex should be closely watched and receive appropriate supportive treatment. During the dose-titration phase, patients should be closely monitored for TLS symptoms (fever, chills, nausea, vomiting, confusion, shortness of breath, seizures, irregular heartbeat, dark or cloudy urine, unusual tiredness, muscle or joint pain, abdominal pain, and distension), as well as other toxicities.

Side Effects:
The most common side events (>20%) among patients receiving Venex in the the combination with Rituximab were neutropenia, diarrhea, and upper respiratory tract infection. The most frequent adverse reactions in monotherapy studies were neutropenia (decreased neutrophil count), diarrhoea, nausea, anemia, tiredness, and upper respiratory tract infection, pneumonia, febrile neutropenia, and TLS. In monotherapy studies, pneumonia and febrile neutropenia were the most commonly reported  side events (>2%).

Pregnancy & Lactation:
There is no human data on its use in pregnant women. Based on its mechanism of action and observations in animals, it may cause embryofetal damage when taken to a pregnant woman. Females with reproductive potential should receive pregnancy testing before beginning. Advise females with reproductive potential to take effective contraception during therapy and for at least 30 days following the final dosage.
Treatment may affect male fertility.
Breastfeeding mothers should quit breastfeeding while taking venex treatment and for at least one week after the final dosage due to unknown distribution of venex 100 in human breast milk.

Storage Conditions:

Venex 100 mg should be kept between 25°C and 30°C at room temperature. When a medication is no longer needed or has expired, dispose of it safely. Protect Venex from sunlight and humidity. Keep Venex 100 mg and all medicines out of the reach of children.

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