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Venclexta

(venetoclax)

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 alone or with other medications for people with chronic lymphocytic leukemia (CLL). CLL is a blood cancer that causes too many white blood cells to be produced and causes them to live too long.

Venetoclax is also used with other medications to treat acute myeloid leukemia (AML) in adults who are 75 years or older or who will not be able to tolerate other chemotherapy. AML is a blood cancer that causes too many of several types of blood cells to be produced in the body.

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.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

How should I use this medication?

For the treatment of CLL, 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.

When used to treat AML, the starting dose of venetoclax is 100 mg taken by mouth on the first day, then increased to 200 mg on day 2, and 400 mg on day 3. Depending on which other medication is being used, the daily dose may continue as 400 mg daily or be increased to 600 mg on day 4.

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.

Store this medication at room temperature, protect it from light and moisture, and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

What form(s) does this medication come in?

10 mg
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.

50 mg
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.

100 mg 
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.

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.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

  • constipation
  • cough
  • decreased appetite
  • diarrhea
  • dizziness
  • fever
  • headache
  • itching
  • mouth sores
  • muscle and joint pain
  • nausea
  • rash
  • shortness of breath
  • stomach pain
  • tiredness
  • vomiting
  • weakness
  • weight loss

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:

  • low blood pressure (e.g., dizziness or fainting when rising from a laying or sitting position, blurred vision, fatigue)
  • 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)
  • signs of sepsis (blood infection; e.g., fever; dizziness; chills; very high or very low body temperature; low blood pressure; pounding or rapid heartbeat; rapid, shallow breathing)
  • swelling of the ankles or feet
  • symptoms of liver problems (e.g., swelling, pain, or tenderness or lump in upper abdominal area; yellowing of eyes or skin; skin itching)
  • symptoms of pneumonia (e.g., chills, cough with or without mucus, fever, shortness of breath)
  • symptoms of too much potassium in the body (e.g., muscle fatigue, weakness, difficulty moving, abnormal heart rhythms, nausea)
  • symptoms of a urinary tract infection (e.g., pain when urinating, urinating more often than usual, low back or flank pain)
  • 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:

  • chest pain
  • irregular heartbeat
  • signs of a serious allergic reaction (e.g., abdominal cramps, difficulty breathing, nausea and vomiting, or swelling of the face and throat)
  • signs of a serious blood infection (sepsis) (e.g., fever, chills, dizziness, high or low body temperature, weakness, rapid breathing, rapid heartbeat)
  • 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?

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Bleeding: When it is used with other medications to treat AML, venetoclax has been reported to cause severe episodes of bleeding, which can become life-threatening. If you notice any signs of bleeding, such as frequent nosebleeds, unexplained bruising, or black and tarry stools, notify your doctor as soon as possible.

Fertility: This medication may cause low or no sperm production when taken by men. 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: 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:  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.

Seniors: People over the age of 65 may experience more side effects from this medication.

What other drugs could interact with this medication?

There may be an interaction between venetoclax and any of the following:

  • 5-ASA medications (e.g.,  mesalamine, olsalazine, sulfasalazine)
  • antiarrhythmics (e.g., amiodarone, dipyridamole, dronedarone, propafenone, quinidine)
  • apalutamide
  • aprepitant
  • "azole" antifungals (e.g., itraconazole, ketoconazole, voriconazole)
  • bacillus Calmette-Guérin (BCG)
  • baricitinib
  • birth control pills
  • bosentan
  • calcium channel blockers (e.g., amlodipine, diltiazem, nifedipine, verapamil)
  • carvedilol
  • ciprofloxacin
  • cladribine
  • clozapine
  • conivaptan
  • cyclosporine
  • denosumab
  • deferasirox
  • diabetes medications (e.g. acarbose, canagliflozin, glyburide, insulin, linagliptin. lixisenatide, metformin, repaglinide)
  • digoxin
  • echinacea
  • elagolix
  • eliglustat
  • enzalutamide
  • fingolimod
  • flibanserin
  • glecavir and pibrentasvir
  • grapefruit juice
  • HIV non-nucleoside reverse transcriptase inhibitors (NNRTIs; e.g., efavirenz, etravirine, nevirapine)
  • HIV protease inhibitors (e.g., atazanavir, indinavir, ritonavir, saquinavir)
  • ledipasvir
  • leflunomide
  • lumacaftor and ivacaftor
  • macrolide antibiotics (e.g., clarithromycin, erythromycin)
  • mifepristone
  • mitotane
  • modafinil
  • natalizumab
  • ocrelizumab
  • ozanimod
  • pimecrolimus
  • protein kinase inhibitors (e.g., ceritinib, crizotinib, dasatinib, imatinib, nilotinib)
  • quinine
  • rifabutin
  • rifampin
  • roflumilast
  • St. John's wort
  • sarilumab
  • seizure medications (e.g., carbamazepine, phenobarbital, phenytoin, primidone)
  • star fruit
  • siponimod
  • stiripentol
  • tacrolimus
  • tocilizumab
  • vaccines
  • velpatasvir
  • warfarin

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

  • 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.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

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 – 2024. 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

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