How does this medication work? What will it do for me?
Venetoclax belongs to the group of cancer-fighting medications called antineoplastics. It is used by people with chronic lymphocytic leukemia (CLL) who have tried at least one other treatment without success.
CLL is a blood cancer that causes too many white blood cells to be produced and causes them to live too long. Venetoclax works by blocking the action of a protein in the body that helps cancer cells survive. This helps to kill and lower the number of cancer cells.
Venetoclax has been granted a notice of compliance with conditions (NOC/c) by Health Canada. This means that Health Canada has approved this medication to be marketed based on promising evidence of effectiveness, but additional results of studies are needed to verify its effectiveness. An NOC/c is used to allow access to products that are used to treat or prevent serious, life-threatening, or severely debilitating illness.
What form(s) does this medication come in?
Each pale yellow, round, biconvex, film-coated tablet debossed with "V" on one side and "10" on the other contains 10 mg of venetoclax. Nonmedicinal ingredients: calcium phosphate dibasic, colloidal silicon dioxide, copovidone, iron oxide yellow, polyethylene glycol, polysorbate 80, polyvinyl alcohol, sodium stearyl fumarate, talc, and titanium dioxide.
Each beige, oblong, biconvex, film-coated tablet debossed with "V" on one side and "50" on the other contains 50 mg of venetoclax. Nonmedicinal ingredients: calcium phosphate dibasic, colloidal silicon dioxide, copovidone, iron oxide black, iron oxide red, iron oxide yellow, polyethylene glycol, polysorbate 80, polyvinyl alcohol, sodium stearyl fumarate, talc and titanium dioxide.
Each pale yellow, oblong, biconvex, film-coated tablet debossed with "V" on one side and "100" on the other contains 100 mg of venetoclax. Nonmedicinal ingredients: calcium phosphate dibasic, colloidal silicon dioxide, copovidone, iron oxide yellow, polyethylene glycol, polysorbate 80, polyvinyl alcohol, sodium stearyl fumarate, talc and titanium dioxide.
How should I use this medication?
The starting dose of venetoclax is 20 mg (2 × 10 mg tablets), taken by mouth, once daily for 7 days. The dose is gradually increased each week, until the treatment dose of 400 mg (4 × 100 mg tablets) daily is reached. Your doctor will do blood tests before increasing the dose each week.
The gradual increase in dose helps to reduce the chance of experiencing severe side effects. To further reduce the chance of experiencing these side effects, drink at least 1.75 litres of water (7 glasses) each day.
Venetoclax tablets should be swallowed whole with water and taken with a meal. Do not chew, crush or split the tablets. Do not drink grapefruit juice or eat Seville oranges or starfruit while taking this medication, as they may increase the amount of venetoclax in your blood.
Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.
It is important to take this medication exactly as prescribed by your doctor. If you vomit after taking this medication, do not take another dose. Take the next dose at your regular dosing time.
If you miss a dose, and it is within 8 hours of the missed dose, take it as soon as possible and continue with your regular schedule. If it is more than 8 hours since the missed dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.
Who should NOT take this medication?
Do not take this medication if you:
- are allergic to venetoclax or any ingredients of the medication
- are taking any of the following medications:
- "azole" antifungals (e.g., ketoconazole, itraconazole, voriconazole, posaconazole)
- clarithromycin or erythromycin
- protease inhibitors (e.g., indinavir, lopinavir, ritonavir)
What side effects are possible with this medication?
Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.
The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.
Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.
Check with your doctor as soon as possible if any of the following side effects occur:
- signs of anemia (low red blood cells; e.g., dizziness, pale skin, unusual tiredness or weakness, shortness of breath)
- signs of clotting problems (e.g., unusual nosebleeds, bruising, blood in urine, coughing blood, bleeding gums, cuts that don't stop bleeding)
- signs of infection (symptoms may include fever or chills, severe diarrhea, shortness of breath, prolonged dizziness, headache, stiff neck, weight loss, or listlessness)
- symptoms of pneumonia (e.g., chills, cough with or without mucus, fever, shortness of breath)
- upper respiratory tract infection (e.g., nasal congestion, cough, runny nose, sinusitis)
Stop taking the medication and seek immediate medical attention if any of the following occur:
- signs of a serious allergic reaction (e.g., abdominal cramps, difficulty breathing, nausea and vomiting, or swelling of the face and throat)
- symptoms of tumour lysis syndrome (e.g., producing less urine, cloudy urine, kidney problems, muscle spasms, nausea, shortness of breath)
Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.
Are there any other precautions or warnings for this medication?
Fertility: This medication may cause low or no sperm production when taken by males. This may affect the ability to father a child after taking venetoclax. Talk to your doctor about this before starting this medication.
Infection: Venetoclax reduces the number of cells that fight infection in the body (white blood cells). If possible, avoid contact with people with contagious infections. Tell your doctor immediately if you notice signs of an infection, such as fever or chills, severe diarrhea, shortness of breath, prolonged dizziness, headache, stiff neck, weight loss, or listlessness. Your doctor will do blood tests regularly to monitor the number of specific types of blood cells in your blood.
Kidney function: The effect of kidney function on how this medication works has not been determined. It is possible that decreased kidney function may increase the likelihood of experiencing side effects of venetoclax. If you have kidney disease or decreased kidney function, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Liver function: The effect of liver function on how this medication works for you has not been determined. It is possible that decreased liver function may increase the likelihood of experiencing side effects. If you have liver disease or decreased liver function, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Other cancers: Taking venetoclax, may increase your risk of developing skin cancer. Report any unusual growths on your skin or changes to growths on your skin to your doctor as soon as possible. Discuss any concerns you may have with your doctor.
Tumour lysis syndrome: Venetoclax, like many other cancer medications, causes many cancer cells to be suddenly killed when treatment is first started. This can overwhelm the body with waste products from the cells. As a result, the body may not be able to keep up with getting rid of all the waste. When this happens, you may have nausea, shortness of breath, cloudy urine, or joint pain. This is called tumour lysis syndrome. Your doctor may prescribe some medications to help your body get rid of the waste products. Make sure you understand how to use these medications and report any of these signs or symptoms to your doctor immediately.
The gradual increase in your dose of venetoclax is intended to decrease the risk of developing severe tumour lysis syndrome. Drinking plenty of fluids while taking this medication will help reduce your risk of developing tumour lysis syndrome.
Vaccines: Vaccines (e.g., yellow fever, BCG, cholera, typhoid, varicella, meningococcal, diphtheria) should not be given while you are taking venetoclax. Vaccinations should be completed before starting venetoclax or should be postponed until treatment with venetoclax is complete.
Pregnancy: This medication should not be used during pregnancy unless the benefits outweigh the risks. If you may become pregnant and are taking venetoclax, use an effective method of birth control such as condoms during treatment and for at least 30 days after stopping the medication. If you become pregnant while taking this medication, contact your doctor immediately.
Breast-feeding: It is not known if venetoclax passes into breast milk. If you are a breast-feeding mother and are taking this medication, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.
Children: The safety and effectiveness of using this medication have not been established for children.
What other drugs could interact with this medication?
There may be an interaction between venetoclax and any of the following:
- antiarrhythmics (e.g., amiodarone, dronedarone, propafenone, quinidine)
- "azole" antifungals (e.g., itraconazole, ketoconazole, voriconazole)
- bacillus Calmette-Guérin (BCG)
- calcium channel blockers (e.g., amlodipine, diltiazem, nifedipine, verapamil)
- grapefruit juice
- HIV non-nucleoside reverse transcriptase inhibitors (NNRTIs; e.g., delavirdine, efavirenz, etravirine, nevirapine)
- HIV protease inhibitors (e.g., atazanavir, indinavir, ritonavir, saquinavir)
- macrolide antibiotics (e.g., clarithromycin, erythromycin)
- protein kinase inhibitors (e.g., crizotinib, dasatinib, imatinib, nilotinib)
- St. John's wort
- seizure medications (e.g., carbamazepine, phenobarbital, phenytoin, primidone)
- stop taking one of the medications,
- change one of the medications to another,
- change how you are taking one or both of the medications, or
- leave everything as is.
Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.
All material copyright MediResource Inc. 1996 – 2019. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Source: www.medbroadcast.com/drug/getdrug/Venclexta