VENCLEXTA (VENETOCLAX)
A GUIDE FOR PATIENTS

 

This information is intended for New Zealand patients prescribed VENCLEXTA in combination with rituximab by a healthcare professional.

Please read the VENCLEXTA Consumer Medical Information before you start treatment.

Contents

VENCLEXTA (VENETOCLAX)
A GUIDE FOR PATIENTS

This information is intended for New Zealand patients prescribed VENCLEXTA in combination with rituximab by a healthcare professional.

Please read the VENCLEXTA Consumer Medical Information before you start treatment.

Contents

YOUR TREATMENT JOURNEY WITH VENCLEXTA

This information is intended for New Zealand patients prescribed VENCLEXTA in combination with rituximab by a healthcare professional.

VENCLEXTA + rituximab is fully funded by PHARMAC for the treatment of relapsed or refractory chronic lymphocytic leukaemia (CLL). The information provided on this site is not intended to take the place of discussions with your doctor or other healthcare professionals (HCP’s) who are treating your CLL.

Please read the VENCLEXTA Consumer Medical Information before you start treatment.

Download Consumer Medicine Information

Download CMI

WHAT IS CLL?

CLL is a type of cancer that affects white blood cells called “B lymphocytes” and may also involve the lymph nodes, which are glands throughout the body that contain white blood cells.

In CLL, the B lymphocytes multiply too quickly and live for too long, so that there are too many of them in the blood.

WHAT IS VENCLEXTA AND HOW DOES IT WORK?

VENCLEXTA is an oral medication (in tablet form) that you take once a day with food at roughly the same time each day. Tablets should be swallowed whole without chewing, crushing or breaking.

  • VENCLEXTA works by blocking a specific protein in your body called BCL-2 (B Cell Lymphoma-2).
  • This BCL-2 protein helps cancer cells survive.
  • Blocking the BCL-2 protein helps to kill and reduce the number of cancer cells and may slow the spread of CLL.

HOW IS VENCLEXTA GIVEN?

There are 3 main phases of treatment that last about 2 years (24 months) in total: VENCLEXTA alone, VENCLEXTA in combination with rituximab and finally a maintenance period of VENCLEXTA alone.

Phase 1: VENCLEXTA alone (gradual dose-increase phase). Phase 2: VENCLEXTA with rituximab. Phase 3: VENCLEXTA alone (maintenance phase).

Phase 1: VENCLEXTA alone (gradual dose-increase phase)

Your doctor will start you on a low dose of VENCLEXTA and gradually increase the amount you take until you are at the full dose.

This phase usually lasts about 5 weeks, but your doctor may extend this dose increase period based on your response to the therapy.

Phase 2: VENCLEXTA with rituximab

Once you’ve completed the gradual dose-increase phase, the rituximab treatment should then begin. You will continue taking the full dose of your VENCLEXTA treatment (4 x 100 mg tablets per day) throughout this phase, unless your doctor tells you to stop or reduces the dose temporarily.

While VENCLEXTA comes as an oral tablet that you can take at home, rituximab will be given to you each time by a healthcare professional as an “infusion”. An infusion is where a medicine is fed gradually into your veins from an intravenous (IV) bag (similar to a “drip”).

You will be given rituximab 6 times in total, once every 28 days (4 weeks). This is sometimes referred to as “6 cycles” of rituximab.

Your healthcare team will discuss with you about scheduling these infusion appointments and how long they will take.

Phase 3: VENCLEXTA alone (maintenance phase)

After your last rituximab infusion, you will continue taking the full dose of your VENCLEXTA treatment (4 x 100 mg tablets per day), for another 18 months unless your doctor tells you to stop or reduces the dose temporarily.

You do not need to keep taking VENCLEXTA forever. Once you reach a full 24 months since your first rituximab infusion, you have finished treatment and your doctor will tell you to stop taking your VENCLEXTA tablets.

WHAT SIDE EFFECTS CAN VENCLEXTA CAUSE?

Like all medicines, VENCLEXTA can cause side effects.

Not everyone will get them, but it’s important to be aware of what they are so you can get help from your healthcare team right away if necessary.

Low white blood cell count (neutropenia):

Low white blood cell counts are common with VENCLEXTA but can in some cases be severe. Your doctor will do blood tests to check your blood counts during treatment with VENCLEXTA. Tell your doctor right away if you have a fever or any signs of an infection. Your doctor may prescribe additional medicines to help with this.

Tumour Lysis Syndrome (TLS):

Some people having treatment for cancer can develop Tumour Lysis Syndrome, which is caused by the fast breakdown of cancer cells. As the cancer cells are destroyed, they break open and what is inside the cells (uric acid, potassium phosphorous) gets into the blood. This can lead to changes in kidney function, sudden kidney failure or even death. VENCLEXTA can cause Tumour Lysis Syndrome.

TLS is most likely to occur in the first 5 weeks of your treatment which is why you follow the 5-week gradual dose- increase phase when starting VENCLEXTA.

A VENCLEXTA STARTER PACK will be prescribed to help with this gradual increase in dose.

TLS can occur within 6–8 hours after the first dose and at each dose increase during the gradual dose increase phase.

Having your blood tested is important in order to treat and prevent TLS.

Before you start your treatment, your doctor will do blood tests and a scan (for example, a CT scan) to see if you are at risk of developing TLS.

It is important for you to keep your scheduled appointments for blood tests.

The changes in your blood that could led to TLS may have no symptoms.

The following symptoms are associated with TLS. If you notice any of these symptoms, contact your doctor immediately:

Symptoms associated with TLS:
  • Fever or chills
  • Nausea or vomiting
  • Confusion
  • Shortness of breath
  • Irregular heart beat
  • Fits or seizures
  • Dark or cloudy urine
  • Unusual tiredness
  • Muscle pain or joint discomfort

To help reduce your risk of TLS:

Drink plenty of water when taking VENCLEXTA. It is important to remain hydrated throughout your treatment to reduce the risk of TLS.
Drink 6-8 glasses of water each day, especially starting 2 days before your first dose, on the day of your first dose, and each time your dose is increased.
You may receive other medicines before starting and during treatment with VENCLEXTA to help reduce your risk of TLS. You may also need to receive intravenous (IV) fluids. Your doctor will advise if this is necessary.
Your doctor will do blood tests in your first 5 weeks of treatment to check for TLS during treatment with VENCLEXTA. It is important to follow your doctor or nurse’s instructions very carefully regarding when to have your blood tests.
Your doctor may delay, decrease your dose, or stop treatment with VENCLEXTA if you have signs of TLS developing.
Tell your doctor right away if you have any symptoms of TLS during treatment with VENCLEXTA, including fever, chills, nausea, vomiting, confusion, shortness of breath, seizures (fits), irregular heartbeat, dark or cloudy urine, unusual tiredness, or muscle pain and joint discomfort

Some people may experience other side effects

Most common side effects include:
  • Feeling very tired
  • Feeling sick
  • Unusual weakness or lack of energy
  • Anaemia (symptoms include tiredness, headaches, being short of breath when exercising, dizziness & looking pale)
  • Diarrhoea and vomiting
  • Decreased appetite
  • Dizziness
  • Headache
  • Cough
  • Shortness of breath
  • Difficulty breathing or chest tightness

Tell your doctor if you notice any of the above more common side effects and they worry you.

These more common side effects are usually mild and short-lived. Do not be alarmed by the list of possible side effects. You may not experience any of them.

If you have any questions or concerns about side effects, speak to your doctor. If you are being treated with VENCLEXTA you can get further information about potential side effects by reading the VENCLEXTA Consumer Medicine Information available at medsafe.govt.nz.

HOW TO LIVE WELL WITH CLL?

Looking after yourself, good nutrition, staying hydrated, staying active and dealing with stress and anxiety are important.

Looking after yourself

Having cancer can be very strenuous, both physically and emotionally.

Therefore, it’s important to try to look after yourself and your wellbeing as much as possible.

Nutrition - Good nutrition can help your body cope with your treatment and any side effects that occur. If you need some help in determining your dietary needs, your healthcare team may be able to help, or may refer you to a dietitian.
Stay hydrated - As mentioned earlier, staying hydrated is very important while taking VENCLEXTA, as this can help flush any cancer cell breakdown products from your blood through your urine and reduce the risk of side effects.
Staying active - Physical activity may help you feel better, less tired and has many other health benefits. However, everyone has different capabilities when it comes to exercising. Your doctor will be able to advise you on the amount and type of exercises that might suit you.
Dealing with stress and anxiety - Being diagnosed with cancer and the subsequent treatment of it can be a very stressful and overwhelming time in your life. If you are feeling depressed or anxious, it’s important that you discuss this with your doctor in order to receive professional help.

However, there are many things you can also do yourself to try to minimise the stress in your life. These include:

  • Looking beyond your cancer and making sure you connect with people and activities that are separate from it.
  • Set yourself small, simple, manageable goals.
  • Not isolating yourself: try to maintain your regular social interactions as much as possible.
Find support - Talking about your feelings can sometimes be difficult, but people often cope better with cancer when they’re open with their partners, family members and friends about their condition and their fears and concerns. You may also find it easier to talk to people going through a similar experience via a dedicated support group. To find and join such a group ask your doctor.

QUESTIONS TO ASK YOUR DOCTOR ABOUT VENCLEXTA

You may have many questions for your doctor about VENCLEXTA and sometimes it can be hard to remember everything. Writing down the questions in advance can help.

Here are some questions to get you started.

  • What is the medicine?
  • Can I take it from home or in a clinic?
  • Are there any special dietary requirements when taking the medicine?
  • How long will I need to take it for?
  • How will it make me feel?
  • What can you tell me about any side effects with this medicine?
  • How will we know if it is working?
  • What plan do we have to avoid Tumour Lysis Syndrome?
  • When should I start taking the medicine?
  • What other options are available to me?
  • Who will I contact if I have any questions?

PATIENT RESOURCES

Starting VENCLEXTA Guide

Starting VENCLEXTA Guide
This short guide is intended to provide information for patients on:
  • How to start VENCLEXTA during the gradual dose-increase phase
  • Information on tumour lysis syndrome
  • Information of potential side effects of VENCLEXTA
Download

Patient guide to CLL and treatment with VENCLEXTA + rituximab

Patient guide to CLL and treatment with VENCLEXTA + rituximab
This guide is intended only for patients prescribed VENCLEXTA + rituximab by a healthcare professional to treat relapsed or refractory CLL. The guide contains information on:
  • What to do before starting VENCLEXTA
  • After treatment
  • Useful resources
  • Treatment cards to complete during the first few weeks of treatment.
These are intended to be an easy way to remember the dose of VENCLEXTA to be taken each week and any other special instructions given by the healthcare team. Download

FOR MORE INFORMATION

If you have any concerns about VENCLEXTA or CLL, please, talk to your doctor, nurse or pharmacist.

Medsafe Consumer Information

Download VENCLEXTA Consumer Medicine Information (PDF)

Leukaemia & Blood Cancer New Zealand

Website: www.leukaemia.org.nz

Phone: 0800 15 10 15

Email: info@leukaemia.org.nz

References:
VENCLEXTA Approved Data Sheet
VENCLEXTA approved Consumer Medicine Information
Stilgenbauer S et al. The Lancet 2016; 17: 768-778

For more information about AbbVie, the maker of VENCLEXTA, visit www.AbbVie.co.nz
For Medical Information Enquiries regarding VENCLEXTA please contact medinfoanz@abbvie.com

  • Abbvie
  • VENCLEXTA


Consumer Medicine Information:
The content on this site is intended solely for New Zealand residents. It is intended for informational purposes only and should not be used to replace a discussion with a healthcare professional. All decisions made regarding patient care must be handled by a healthcare professional and be made based on the unique needs of each patient.
This website has been developed and is funded by AbbVie Limited, Wellington.

IMPORTANT INFORMATION ABOUT VENCLEXTA®
Venclexta is a prescription medicine containing venetoclax, which blocks a protein that helps cancer cells survive. Venclexta is available as film-coated tablets of various strength (10 mg, 50 mg, 100 mg venetoclax). It is used, in combination with obinutuzumab to treat patients with chronic lymphocytic leukaemia (CLL) or Small Lymphocytic Lymphoma (SLL) that has not been treated before. Venclexta is taken in combination with rituximab or alone, to treat patients with CLL or SLL when the condition comes back after it has already been treated. Your doctor will determine which treatment is suitable for your condition. Typically, you will begin treatment with Venclexta at a low dose for 1 week. Your doctor will gradually increase your dose over the following four weeks to the full standard dose. Use strictly as directed by your doctor.

VENCLEXTA has risks and benefits. You must not take it if you are allergic to venetoclax or to any of the inactive ingredients. Do not take it if you are taking certain medicines broken down in the liver, including: ketoconazole, posaconazole, voriconazole, itraconazole, clarithromycin or ritonavir. Do not drink grapefruit juice, or eat grapefruit, starfruit or Seville oranges or marmalades. Do not give Venclexta to children and adolescents under 18 years of age. Do not take Venclexta if you are pregnant or plan to become pregnant, or if you are breastfeeding or plan to breastfeed. Tell your doctor if you have recently received or are scheduled for any vaccinations.
VENCLEXTA can cause tumour lysis syndrome (TLS), which is caused by the fast breakdown of cancer cells. TLS is a very serious side effect that can be fatal. TLS is most likely to occur when you are first starting treatment. Tell your doctor, nurse or pharmacist if you have or have had heart, kidney or liver problems. Let your healthcare provider know immediately if you experience: fever or chills, nausea or vomiting, confusion, shortness of breath, irregular heartbeat, dark or cloudy urine, fits or seizures, feeling unusually tired, or muscle pain or discomfort while on treatment with Venclexta. Ensure you follow all your doctor’s instructions carefully. Tell your doctor immediately if you have signs of an infection before or while taking Venclexta, including fever, chills, feeling weak or confused, cough, or pain or burning feeling when passing urine. Some of the more common side effects of Venclexta include feeling very tired, feeling sick, unusual weakness or lack of energy, tiredness, headaches, shortness of breath when exercising, dizziness and looking pale, diarrhoea, vomiting, decreased appetite, cough, difficulty breathing or chest tightness. Tell your doctor or pharmacist if you notice anything else that is making you feel unwell. Some medicines and Venclexta may interfere with each other, so tell your doctor if you are taking medicines containing any of the following: fluconazole, ciprofloxacin, erythromycin, azithromycin, nafcillin, rifampicin, carbamazepine, phenytoin, efavirenz, etravirine, captopril, carvedilol, felodipine, quinidine, ranolazine, bosentan, verapamil, diltiazem, modafinil, herbal medicines; St John’s wort (Hypericum perforatum) and quercetin, warfarin, amiodarone, ticagrelor, digoxin, dronedarone, everolimus, sirolimus and ciclosporin. Tell any other doctors, pharmacists, dentists or surgeons treating you that you are taking Venclexta and remind them before you start any new medicines.

If you have any questions about using Venclexta, including its risks and benefits, how much to use, how and when to use it, or storage conditions, ask your healthcare professional and refer to the Consumer Medicine Information (CMI) available from www.medsafe.govt.nz or free phone 0800 900 030. Ask your doctor if Venclexta is right for you. Use strictly as directed. If symptoms continue, or you have side effects, see your doctor, pharmacist or healthcare professional.

VENCLEXTA® in combination with rituximab is fully funded for relapsed refractory chronic lymphocytic leukaemia (CLL). Special authority criteria apply. Normal prescription charges and doctor's fees apply. Venclexta® is supplied in New Zealand by: AbbVie Limited, 6th floor, 156-158 Victoria Street, Wellington, 6011, New Zealand Tel: 0800 900 030. Version 5a based on CMI version 7 dated November 2019.

TAPS PP 4816. NZ-VENC-190038. Prepared November 2019.

You are now leaving VENCLEXTA.co.nz. Links to external websites are offered for your convenience. References to any products, services or other information by trademark or otherwise is not intended to imply endorsement by AbbVie Ltd.

Any healthcare information provided within these sources should be discussed with your healthcare professional and does not replace their advice.

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