Venex – Uses, Side Effects, and More

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Venex (Venetoclax) is a targeted cancer treatment that has been remarkably effective for certain hematologic malignancies. It acts as a potent, selective BCL-2 protein inhibitor, which is a key mediator of apoptosis. BCL2 is overexpressed in many cancers and as cancer cells develop the capacity to evade apoptosis, they may survive the usual cell turnover, making Venex effective against these cancers. In this article, we will list some important details about Venex for the patients, including its uses, how it works, side effects but most importantly what patients should keep in mind before taking Venex.

Therapeutic Indications and Uses of Venex

Venex is primarily indicated for the treatment of: 

1. Chronic Lymphocytic Leukemia (CLL)

Venex is recommended for adult patients with Chronic Lymphocytic Leukemia (CLL), either as a sole therapy or in combination with other treatments like rituximab or obinutuzumab. It works especially well for patients who have had a relapse or become resistant to previous therapies.

2. Small Lymphocytic Lymphoma (SLL)

Venex is also called to treat Small Lymphocytic Lymphoma (SLL), a closely-related type of non-Hodgkin lymphoma. Venex works by inducing the process of apoptosis in cancer cells, which subsequently decreases both tumor burden and disease advancement.

3. Acute Myeloid Leukemia (AML)

Venetoclax + azacitidine, decitabine, or low-dose cytarabine is indicated for the treatment of newly diagnosed AML in adults not eligible for intensive chemotherapy. This usually goes for older adults or those with specific health conditions that make them unfit for aggressive treatment.

Clinical Pharmacology of Venex

Drug Classes

• B-cell lymphoma-2 (BCL-2) inhibitors
• Antineoplastic agents
• Miscellaneous antineoplastics

How it works

Venex targets cancer by inhibiting the B-cell lymphoma-2 (BCL-2) protein. BCL-2 is a protein that usually prevents apoptosis or programmed cell death, a natural process that removes unwanted cells. BCL-2 is overexpressed in some cancers, helping cancer cells to survive and grow. It is a selective BCL-2 inhibitor that binds with high affinity to BCL-2 to inhibit its function, thereby inducing apoptosis in cancer cells. This triggers a cascade of caspase activation leading to the subsequent destruction of the cell from the inside out and ultimately to cancer cell death. Venetoclax is predominantly in applications in hematologic cancers in which there is significant BCL-2 overexpression, including chronic lymphocytic leukemia (CLL) and acute myeloid leukemia (AML).

Dosage & Administration

Venex is not a standard medication, so its dosage and administration are not similar to any other conventional pharmaceutical drug. This is a general guide for Venetoclax administration, please always follow the specific guidance given by the healthcare provider.

Dosage

Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL):

Starting Dose: Venetoclax is typically initiated at a low dose to mitigate the risk of Tumor Lysis Syndrome (TLS), which can be a serious, but rare, adverse event. The dose is increased steadily over a period of 5 weeks.

Week 1: 20 mg daily.

Week 2: 50 mg daily.

Week 3: 100 mg daily.

Week 4: 200 mg daily.

Week 5 onward: 400 mg daily (regular maintenance dose)

Acute Myeloid Leukemia (AML):

• Venetoclax is typically combined with other agents such as azacitidine, decitabine, or low-dose cytarabine.
• 100 mg po qd, typically initiated after a 5-day ramp-up phase (like the CLL schedule) to reduce the chance of TLS.

Administration

• Administer Venetoclax with a meal and water.
• Take Venetoclax around the same time each day.
• Do not chew, dissolve or break Venetoclax tablets. Do not chew, crush, or break the tablets before swallowing.

Contraindications

Co-administration of venetoclax with a strong CYP3A inhibitor at initiation and during the ramp-up (dose-escalation) period is contraindicated in patients with CLL/SLL at high risk for tumor lysis syndrome.

TLS Prophylaxis: Patients should be well hydrated and TLS must be assessed with laboratory tests before commencing Venetoclax. A prophylactic regimen, which may include medications (for example, allopurinol) may be indicated if necessary.

Dose Modifications: Dose may be modified or interrupted based on tolerability or side effects (especially TLS or infections or low blood cells).

Child Dose:

Venex (Venetoclax) is not well defined in terms of pediatric child dose, as the drug Venetoclax is mainly examined and approved for use in adults. However, in some clinical contexts, Venetoclax has been used off-label in pediatric patients with hematologic cancers, especially acute leukemia or non-Hodgkin lymphoma.

Miss a dose:

If the patient misses a dose of Venetoclax and it is less than 8 hours from when it is usually taken, the patient should take the missed dose as soon as possible and return to the normal daily dosing schedule. If a patient misses a dose within 8 hours of the latest scheduled dose, instruct the patient to take the missed dose and continue the usual dosing schedule the following day. If the patient vomits this product after dosing, advise the patient not to take an extra dose that day, and to take the next prescribed dose at the regularly scheduled time. Or, as instructed by the registered physicians.

Overdosage:

Venex is not known to have a specific antidote. For patients with overdose sending supportive treatment as needed monitor closely; Interruption of Venex during ramp-up phase as well as close monitoring for signs and symptoms of TLS and other toxicities. In view of Venex’s wide volume of distribution and high protein binding, dialysis would not be expected to remove substantial amounts of Venex.

Side Effects of Venex

As with all medicines, Venex can cause side effects. Most side effects are mild and temporary, but some may be serious and need medical treatment.

Common Side Effects:

• Low white blood cell count (neutropenia)  
• Low red blood cell count (anemia)
• Low platelet count (thrombocytopenia)  
• Nausea  
• Diarrhea
• Cough

Rare Side Effects:

• Tumor lysis syndrome (TLS)  
• Serious infections  
• Constipation 
• Muscle or joint pain
• Swelling in the hands or feet 

If you experience any severe or persistent side effects, consult your doctor immediately.

Precautions & Warnings

The use of Venex (Venetoclax) requires careful precautions and warnings to ensure patient safety and minimize potential risks. Below are the key precautions and warnings associated with Venetoclax:

1. Tumor Lysis Syndrome (TLS):

One such risk is Tumor Lysis Syndrome, which is a potentially life threatening condition that occurs when large numbers of cancer cells are killed off simultaneously by the venetoclax, leading to release of toxic contents into the bloodstream, which may overwhelm the kidneys and cause electrolyte changes.

Tumor lysis syndrome (TLS), including fatal events and renal failure that required dialysis, has occurred in patients with high tumor burden that were treated with Venetoclax. In the Venetoclax CLL monotherapy trials, patients with CLL who followed the current 5-week ramp-up dosing schedule and the TLS prophylaxis and monitoring measures had a TLS rate of 2%. The incidence of TL remained consistent with Venetoclax plus Obinutuzumab or Rituximab.

2. Neutropenia (Low Neutrophil Count):

Expansion of the description of neutropenia to include severe neutropenia, which may increase the risk of serious infections. In patients with CLL, Grade 3 or 4 neutropenia occurred in 63% to 64% of patients and Grade 4 neutropenia occurred in 31% to 33% of patients in Venetoclax combination and monotherapy studies. Febrile neutropenia occurred in 4% to 6% of patients.

3. Infections:

Fatal and serious infections, including pneumonia and sepsis, have been observed in patients treated with Venetoclax. Observe patients for signs and symptoms of infection and treat in a timely manner. Hold Venetoclax for Grade 3 and 4 infection until resolved. Dose resumption information and adjustments are shown in Table 4 for CLL and Table 6 for AML.

4. Immunization:

Live attenuated vaccines should not be given before, during, or after Venetoclax therapy until recovery of B-cells. Immunization with live attenuated vaccines is not studied in regard to safety and efficacy during and after Venetoclax therapy. Tell patients that vaccines also may have reduced effectiveness.

Use In Specific Populations

Pregnancy

Administration of venetoclax to a pregnant woman may cause embryo-fetal harm. Data on use of Venetoclax in pregnant women are insufficient to inform a drug-associated risk. Including the pregnancy warning for pregnant women about the potential for risk to a fetus. The population background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss and other adverse outcomes.

Risk Summary: Venetoclax was fetotoxic to pregnant mice when given during the period of organogenesis at exposures approximately 1.2 times the human exposure at the recommended dose of 400 mg once daily based on AUC.

Lactation

No information is available on the presence of venetoclax in human milk, the effects of venetoclax on a breastfed infant, or the effects of venetoclax on milk production. Avoid breast-feeding during treatment with Venetoclax and for 1 week after the last dose because of the potential for serious adverse reactions in a breastfed.

Contraception

Females of Reproductive Potential: Advise females of reproductive potential to use effective contraception during treatment with Venetoclax and for at least 30 days after the last dose.

Pediatric Use

The safety and effectiveness of Venetoclax have not been established in pediatric patients.

Adverse Reactions

In CLL/SLL patients dosed with Venetoclax in a steady state (after ramp-up phase), consider alternative agents or modify the dose of Venetoclax and increase the frequency of monitoring for adverse actions.

In AML patients, dose-adjust and monitor for AEs more often.

Interaction of Venex

Drug Interactions

Venex can interact with numerous other medications, which can either reduce its potency or raise the potential for side effects. Before taking Venex with other medications, it is important to consult a healthcare professional. Here are some of the most common types of drug interactions:

1. Anticoagulants
2. CYP450 Enzyme Modulators
3. Nonsteroidal Anti-inflammatory Drugs (NSAIDs)
4. Antihypertensives

Food Interactions

Food may affect the absorption and effectiveness of Venex. Here’s what you need to know:

High-fat Meals: The absorption of Venex may be delayed by a high-fat meal, resulting in a decrease in its peak plasma concentration, although the overall bioavailability of the drug is not expected to be affected. When on this medicine, you need to follow a regular dietary regime.

Alcohol: Avoid drinking alcohol while taking Venex as it may increase the risk of liver injury and gastrointestinal side effects like nausea and upset stomach. Patients should limit or stop alcohol during treatment.

Grapefruit and grapefruit juice: Therefore, grapefruit products may block the metabolism of Venex, causing supra­therapeutic plasma levels and the risk of side effects. Grapefruit should be avoided while on this medication.

Note:

• Always tell your health care provider about all the medicines, herbs, and supplements you take.
• To maximize the benefits and minimize the risks of Venex, follow the dietary preferences recommended by your doctor or pharmacist.
• Report any unusual symptoms or side effects to your healthcare professional promptly.

Presentation

Storage Conditions

Store in a cool & dry place below 30° C & protect from sunlight. Keep out of reach of children.

Manufactured by:

Venex is specifically manufactured and marketed by Drug International Limited (established in 1974), one of the leading pharmaceuticals companies of Bangladesh.

Venex is drug(Generic Name: Venetoclax) which was licensed to Drug International Limited.

FAQs

1. How is Venex taken?

Venex is usually taken once a day with a meal and a full glass of water. Dosage and schedule vary based on condition being treated and patient factors. Always obey your health professional on how much to take and how to take it.

2. How long do I have to take Venex?

The length will depend on each individual case, the type of cancer, response to therapy, etc. The length of treatment will be determined by your healthcare provider based on your individual needs.

3. Is it safe to use Venex with other medications?

Venex may interfere with some medicines, which can alter its effectiveness or increase the possibility of adverse effects. It’s important that you tell your health care provider about all the medicines, supplements and herbal products you take to evaluate for possible interactions.

4. What should I avoid while taking Venex?

You should avoid eating grapefruit and drinking grapefruit juice while taking Venex; it can interfere with the drug’s metabolism. And speak with your care provider if there are other foods or activities you should steer clear of during treatment.

5. Does Venex cure cancer?

Venex is not a cure for cancer, but is intended to treat iron overload in myeloid malignancies. Its effectiveness is variable among individuals, with the goal of inducing remission and prolonging survival.

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Disclaimer: This information is provided solely for educational reasons and should not be considered medical advice. Always consult with your doctor or healthcare professional before taking any drug.