Descriptions
Venclexta (venetoclax) is a BCL-2 inhibitor indicated 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.
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Venex-100 (Venetoclax)
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Venex Tablet: Each Tablet contains Venetoclax INN 1000 mg.
Venetoclax is a prescription medicine used:
- to treat adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
- in combination with azacitidine, or decitabine, or low-dose cytarabine to treat adults with newly-diagnosed acute myeloid leukemia (AML) who:
- are 75 years of age or older, or
- have other medical conditions that prevent the use of standard chemotherapy.
Venetoclax was approved based on response rates. Continued approval for this use may depend on the results of an ongoing study to find out how Venetoclax works over a longer period of time.
It is not known if Venetoclax is safe and effective in children.
Venetoclax is a small molecule type of targeted therapy. Venetoclax is a pill that promotes apoptosis, a common way by which cells die. It does this by binding to BCL-2, an anti-apoptotic protein. Overexpression of BCL-2 has been demonstrated in CLL cells where it mediates tumor cell survival and has been associated with resistance to chemotherapies. Venetoclax helps restore the process of apoptosis by binding directly to the BCL-2 protein, displacing pro-apoptotic proteins. Venetoclax blocks an important pathway that promotes cell survival in tumor cells that overexpress BCL-2, so venetoclax causes cells to die (pro-apoptotic).
- Venetoclax is a tablet, taken by mouth.
- Venetoclax should be taken orally once daily with a meal and water.
- Dosage may be adjusted based on side effects.
- Take venetoclax exactly as prescribed.
- Swallow venetoclax tablets whole. Do not crush, chew, break or dissolve tablets.
- Do not change your dose or stop venetoclax.
- Take your dose of venetoclax at approximately the same time each day. If you miss a dose of venetoclax by less than 8 hours, take the missed dose right away. Then take your next dose as usual. If you miss a dose of venetoclax and it has been more than 8 hours, wait and take the next dose of venetoclax at your usual time.
- Do not take more than 1 dose of venetoclax at one time. Call your health care provider right away if you take too much.
- You should not drink grapefruit juice, eat grapefruit, Seville oranges (often used in marmalades), or starfruit while you are taking venetoclax. These foods may increase the amount of venetoclax in your blood.
The amount of venetoclax that you will receive depends on many factors, your general health or other health problems, and the type of cancer or condition being treated.
Important things to remember about the side effects of venetoclax:
Most people do not experience all of the side effects listed.
Side effects are often predictable in terms of their onset and duration.
Side effects are usually reversible and often improve or go away after treatment is stopped.
There are many options to help minimize or prevent side effects.
There is no relationship between the presence or severity of side effects and the effectiveness of the medication.
The following side effects are common (occurring in greater than 30%) for patients taking venetoclax:
Low white blood cell counts (increases risk of infection)
Diarrhea
Nausea
These side effects are less common side effects (occurring in about 10-29%) of patients receiving venetoclax:
Anemia
Low platelets (increases risk of bleeding)
Upper respiratory tract infection (cold symptoms)
Fatigue
High potassium in the blood
Fever
Vomiting
Headache
High phosphate in the blood
Constipation
Cough
Low potassium in the blood
Swelling
Back pain
A serious, but very rare side effect of venetoclax may be:
Tumor Lysis Syndrome- may occur as a result of leukemia treatment. Tumor lysis syndrome occurs when large amounts of cancerous cells are rapidly killed by the therapy. These cells release uric acid, potassium, and phosphorous into the blood stream. Tumor lysis syndrome can lead to kidney failure. Tumor lysis syndrome usually occurs within 24-48 hours of therapy. Care must be taken to prevent the development of tumor lysis syndrome. Your health care provider will prescribe plenty of fluids to keep you hydrated. Drink at least two to three quarts of fluid every 24 hours, unless you are instructed otherwise. This is especially important starting 2 days before your first dose of venetoclax, on the day of your first dose, and any time your dose is increased. In some cases, your health care provider may prescribe other measures to lower your white blood count before therapy. Let your health care provider know immediately if you are unable to urinate. Your health care provider will monitor your progress.
Not all side effects are listed above. Some that are rare (occurring in less than 10% of patients) are not listed here. However, you should always inform your health care provider if you experience any unusual symptoms.
Before starting venetoclax treatment, make sure you tell your doctor about any other medications you are taking (including prescription, over-the-counter, vitamins, herbal remedies, etc.)
You should not drink grapefruit juice, eat grapefruit, Seville oranges (often used in marmalades), or starfruit while you are taking venetoclax. These foods may increase the amount of venetoclax in your blood.
Do not receive any kind of immunization or vaccination without your doctor’s approval while taking venetoclax.
Inform your health care professional if you are pregnant or may be pregnant prior to starting this treatment. Venetoclax may be hazardous to the fetus. Women who are pregnant or become pregnant must be advised of the potential hazard to the fetus.
For both men and women: Do not conceive a child (get pregnant) while taking venetoclaz. Barrier methods of contraception, such as condoms, are recommended during treatment and for at least 1 month after completing therapy. Discuss with your doctor when you may safely become pregnant or conceive a child after therapy.
Venetoclax may cause fertility problems in males. This may affect your ability to father a child. Talk to your health care provider if you have concerns about fertility.
Do not breast feed while taking this medication.
What should I avoid while taking VENCLEXTA?
You should not drink grapefruit juice or eat grapefruit, Seville oranges (often used in marmalades), or starfruit while you are taking Venetoclax. These products may increase the amount of Venetoclax in your blood.
There are no available human data on use in pregnant women; based on its mechanism of action and findings in animals, may cause embryofetal harm when administered to a pregnant woman
Females of reproductive potential should undergo pregnancy testing before initiation
Animal studies
- In mice, venetoclax was fetotoxic at exposures 1.2 times the human clinical exposure based on AUC at the recommended human dose of 400 mg daily
Fertility and contraception
- Advise females of reproductive potential to use effective contraception during treatment and for at least 30 days after the last dose
- Male fertility may be compromised by treatment
Lactation
Unknown if distributed in human breast milk; advise nursing women to discontinue breastfeeding during treatment
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
When to contact your doctor or health care provider:
Contact your health care provider immediately, day or night, if you should experience any of the following symptoms:
- Fever of 100.4° F (38° C) or higher, chills
- Sudden onset of shortness of breath, cough, difficulty breathing or wheezing
- New or worsening stomach pain, chills, fever, nausea, or vomiting
- Seizures, confusion, irregular heartbeat, dark or cloudy urine, extreme tiredness, muscle or joint pain
The following symptoms require medical attention, but are not an emergency. Contact your health care provider within 24 hours of noticing any of the following:
- Diarrhea (4-6 episodes in a 24-hour period)
- Nausea (interferes with ability to eat and unrelieved with prescribed medication).
- Unable to eat or drink for 24 hours or have signs of dehydration: tiredness, thirst, dry mouth, dark and decrease amount of urine, or dizziness
- Skin of the whites of your eyes turn yellow
- Decreased appetite
- Signs of an infection (cough with or without mucus, nasal drainage, burning with urination, redness or swelling, pus formation at the site of an injury or incision)
- Fatigue that interferes with activities of daily living (showering, bathing, making meals, etc.)
- Swelling
- Any signs of unusual bleeding (blood in the urine or stool, increased bruising, heavy menstrual bleeding)
Always inform your health care provider if you experience any unusual symptoms.
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