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ROZLYTREK®

(entrectinib)

Pronounced Roz-leee-treck

ROZLYTREK is a prescription medicine used to treat adults with ROS1+ non-small cell lung cancer (NSCLC), or with NTRK+ cancer. ROZLYTREK contains the active ingredient entrectinib. It belongs to a group of medicines called anti-neoplastic (or anti-cancer) agents which are used to treat cancer. It is a type of targeted therapy called a ‘TKI’ (tyrosine kinase inhibitor) – it is not a chemotherapy or an immunotherapy. It comes in the form of 200mg capsules and the recommended dosage for adults is three capsules once a day.

Have you been tested for ROS1+ NSCLC, or NTRK+ cancer?

To establish if an alteration in your ROS1 or NTRK genes are causing your lung cancer, your doctor needs to request a special type of test designed to look at the DNA in your tumour. If a ROS1 or NTRK gene fusion is detected, ROZLYTREK is likely to be a suitable treatment for your cancer.
Not all patients in New Zealand are tested for ROS1 or NTRK gene fusions.
If you’re not sure if you’ve had one of these tests, talk to your doctor who will be able to advise you.

Clinical trial data

In an analysis of people with advanced or metastatic ROS1+ NSCLC who received ROZLYTREK across three different clinical trials, it was found that 77% of people responded to the drug (ie, it caused their cancer to stabilise or shrink). They responded to this treatment for a median of 24.6 months. ROZLYTREK was able to control tumours that had spread to the brain in 55% of people.

In an analysis of people with advanced or metastatic NTRK+ solid tumours who received ROZLYTREK across three different clinical trials, it was found that 57% of people responded to the drug (ie, it caused their cancer to stabilise or shrink). They responded to this treatment for a median of 10 months. ROZLYTREK was able to control tumours that had spread to the brain in a number of people.

Keep in mind that everyone is different, and the response and benefit you may experience cannot be predicted. Ask your doctor about the clinical evidence for ROZLYTREK and if it is right for you.

Possible side effects of ROZLYTREK

All medicines can have side effects. You’ll find a list of possible side effects in the Consumer Medicines Information here.

Always talk to your doctor if you have any questions or concerns.

How to access ROZLYTREK

ROZLYTREK is not a PHARMAC funded medicine. This means you will have to pay for this medicine. Paying for treatment requires careful thought, but there are financial options and programmes that may help you fund private treatment. If you have health insurance, carefully check what’s covered — every health insurance provider has different rules and benefits that cover cancer treatment, surgery, tests and doctor appointments.

Roche also offers support through a Cost Share Programme, which is designed to help you pay for certain medicines (including ROZLYTREK) which are not funded by PHARMAC. Your doctor can provide you with further information regarding the criteria for enrolling into the ROZLYTREK Cost Share Programmes.

Ready to take the next step?

Because every situation is different, it’s important to speak to your doctor to find out if ROZLYTREK is right for you.

If you’re now considering treatment with ROZLYTREK

We’ve put together a discussion guide to help you begin a conversation with your doctor. Print it off, take it along to your next appointment, and take notes in the spaces provided.

Talking to your doctor about ROZLYTREK

Download Discussion guide

Handy resources

ROZLYTREK ROS1+ NSCLC Patient Booklet
DOWNLOAD
ROZLYTREK Consumer Medicine Information
DOWNLOAD

ROZLYTREK® (entrectinib) 100mg/200mg capsules, is a Prescription Medicine used for:

•  the treatment of adult patients with ROS1-positive, locally advanced or metastatic (spreading) NSCLC.
•  the treatment of adult and paediatric patients 12 years of age and older, with neurotrophic tyrosine receptor kinase (NTRK) fusion-positive locally advanced or metastatic solid tumours, where other treatments have not worked or are not suitable for you.

Ask your doctor if ROZLYTREK is right for you.

ROZLYTREK is an unfunded medicine. Ask your health professional about the cost of the medicine and other fees that may apply.

 Use only as directed. If symptoms continue or you have side effects, see your healthcare professional. For more information about ROZLYTREK:

• talk to your health professional; or
• visit medsafe.govt.nz for ROZLYTREK Consumer Medicine Information; or
• visit roche.co.nz or call Roche on 0800 276 243.

ROZLYTREK has risks and benefits.

Possible common side effects include:  feeling tired, pain including headache or head pain or joint or muscle pain or pain or discomfort in limbs or bones, fever, constipation, diarrhoea, feeling sick (nausea) or being sick (vomiting) or stomach pain, difficulty in swallowing, changes in taste, an abnormal or unpleasant sense of touch, numbness or weakness of the arms and legs, loss of muscle coordination or being unsteady when walking, symptoms of anaemia such as tiredness/headaches/being short of breath when exercising/dizziness/looking pale, weight gain, loss of appetite, dehydration, muscle weakness, bone fractures, lung infection, urinary tract infection,  blurred vision, rash, swelling or puffiness of the skin, disturbances in your sleep pattern.

Do not use ROZLYTREK if: you are allergic to entrectinib or any of the other ingredients in this medicine, or if you or your partner are pregnant or you are breastfeeding. Do not take this medicine after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering.

Tell your doctor if:  you have allergies to any other medicines/foods/preservatives/dyes, you have heart problems such as a condition called ‘prolonged QT interval’ or a condition called ‘congestive heart failure’ or ‘heart failure’, you have an inherited problem called ‘galactose intolerance’, ‘congenital lactase deficiency’ or ‘glucose-galactose malabsorption’, liver or kidney problems, or if you are planning a pregnancy or plan to breastfeed. Tell your doctor if you are taking any other medicines.

Tell your doctor immediately or go to your nearest Accident and Emergency Centre if you notice any of the following: signs of heart problems (heart failure) such as persistent coughing or wheezing, shortness of breath, and swelling in your legs or arms (fluid retention); feeling dizzy or light-headed as this may be a sign of an abnormal heart rhythm or low blood pressure; feeling confused, changes in mood, having memory problems or seeing things that are not there (hallucinations); loss of consciousness or fainting; symptoms of a condition called tumour lysis syndrome, including nausea or vomiting, muscle cramps or twitches, decreased urination, irritability, sudden uncontrolled fits (seizures).

Panel dated 20 July 2020.

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