[Withdrawn] Asciminib Treatment protocol Information for patients

Updated 13 December 2022

Withdrawn due to granting of marketing authorisation

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This publication is available at https://www.gov.uk/government/publications/asciminib-in-the-treatment-of-chronic-myeloid-leukaemia/asciminib-treatment-protocol-information-for-patients

The aim of the Early Access to Medicines Scheme (EAMS) is to provide earlier availability of promising new unlicensed medicines (medicines that do not have a marketing authorisation or are used outside their licence) to UK patients that have a high unmet clinical need. The medicines included in the scheme after they have received a positive scientific opinion are those that are intended to treat, diagnose or prevent seriously debilitating or life-threatening conditions where there are no adequate treatment options. More information about the scheme can be found here: http://www.mhra.gov.uk/Howweregulate/Innovation/EarlyaccesstomedicinesschemeEAMS/index.htm

The information below is intended for you, the patient, and is provided by the pharmaceutical company (called scientific opinion holder) that manufactures the EAMS medicine. This medicine, which does not yet have a drug licence or is used outside its licence, may also be used in combination with other medicines. More information about medicines licensing can be found here:http://www.nhs.uk/conditions/medicines-information

This medicine can be prescribed for individual patients to meet specific needs provided they are given sufficient information about the medicine to make an informed decision. Your physician will be responsible for giving you all the information you need to make this decision and for obtaining informed consent from you prior to treatment. You will be asked to sign a form to confirm that you are providing informed consent to receiving the EAMS treatment. Information on consent can be found here: https://www.nhs.uk/conditions/Consent-to-treatment

The information below is provided to help you decide with your physician on whether to use the EAMS medicine and helps explain how to use it in accordance with the pharmaceutical company's instructions for safe and proper use. A positive scientific opinion is not a recommendation for use of the medicine and should not be interpreted as such. Under EAMS, the risk and legal responsibility for prescribing the medicine remains with the physician, and the opinion and EAMS documentation published by the MHRA are intended only to inform physicians’ decision making and not to recommend use. An EAMS scientific opinion does not affect the civil liability of the manufacturer or any physician in relation to the product.

The information below may change during the time you are using the medicine if more data become available. Your physician will highlight to you any changes that you need to be aware of.

Whilst you are using this medicine, data will be collected on the use and safety profile of the medicine, to ensure that the benefits of taking the medicine continue to outweigh any potential risks. Your physician will answer all your questions during and after the treatment and will provide you with contact details that you should use in case of any events or problems.

Each patient enrolled in the scheme will continue to receive the EAMS product until the end of the treatment in line with prescribing and NHS guidance and as long as benefit is seen. In rare cases where the EAMS treatment may not be available anymore, your physician will discuss other options with you. ##Information for the patient

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

Asciminib contains the active substance asciminib, which belongs to a group of medicines called protein kinase inhibitors.

Asciminib is used to treat adults with Philadelphia chromosome positive chronic myeloid leukaemia (Ph+ CML) in chronic phase that do not have a gene defect called T315I mutation and who are no longer benefiting from at least two previous medicines of a similar type called tyrosine kinase inhibitors

Ph+ CML is a type of blood cancer (leukaemia) in which the body produces too many abnormal white blood cells. Chronic phase is the first phase of this blood cancer.

Asciminib blocks the action of a protein (BCR ABL1) produced by the abnormal white blood cells and stops their division and growth.

If you have any questions about how asciminib works or why this medicine has been prescribed for you, ask your doctor or nurse.

You must not take asciminib

Talk to your doctor or nurse before taking asciminib if any of the following applies to you:* if you have or have ever had pancreas problems (inflamed pancreas, pancreatitis).* if you have ever had or might now have a hepatitis B infection. This is because asciminib could cause hepatitis B to become active again. You will be carefully checked by your doctor for signs of this infection before treatment is started.

Tell your doctor or nurse immediately if you get any of the following during treatment with asciminib:

Your doctor will regularly monitor your condition to check that the treatment is having the desired effect. You will have regular tests including blood tests during treatment. These tests will monitor:

This medicine is not recommended for patients aged under 18 years. No data are available in this age group.

Other medicines and asciminib

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. In particular, tell your doctor or pharmacist if you are using:

The medicines listed here may not be the only ones that could interact with asciminib.

You should also tell your doctor if you are already taking asciminib and you are prescribed any new medicine that you have not taken previously during asciminib treatment.

Ask your doctor or nurse if you are not sure whether your medicine is one of the medicines listed above.

Do not take Asciminib with food. Take it at least 2 hours after and 1 hour before any food. For more information, see "When to take Asciminib" in section 3.

If you are pregnant or breast feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Asciminib may harm your unborn baby. If you are a woman who could become pregnant, your doctor will discuss with you the potential risks of taking Asciminib during pregnancy or breast feeding.

If you are a woman who could become pregnant, your doctor will perform a pregnancy test if necessary before starting treatment with Asciminib.

If you do become pregnant, or think you may be pregnant, after starting treatment with Asciminib, tell your doctor straight away.

It is not known if Asciminib passes into breast milk. It is recommended that you do not breast feed while you are taking Asciminib and for at least 3 days after you stop taking it.

If you are a woman who could become pregnant, you should use an effective method of contraception during treatment with Asciminib and for at least 3 days after you stop taking it to avoid becoming pregnant. Ask your doctor about effective methods of contraception.

If you experience side effects (such as dizziness or visual disorders) with a potential impact on the ability to safely drive, cycle or use any tools or machines after taking this medicine, you should refrain from these activities until the effect has disappeared.

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

This medicine contains less than 1 mmol sodium (23 mg) per film-coated tablet, that is to say essentially ‘sodium-free’.

Always take this medicine exactly as your doctor has told you. Check with your doctor or nurse if you are not sure.

Do not exceed the recommended dose prescribed by your doctor.

Asciminib will only be prescribed to you by a doctor with experience in medicines to treat leukaemia.

Your doctor will tell you exactly how many asciminib tablets you should take per day, and how to take them.

The usual total daily dose of asciminib is 80 mg (2 tablets of Asciminib 40 mg per day). You may take your daily dose:

You should not change the asciminib dose or schedule without first talking to your doctor.

Depending on how you respond to treatment, your doctor may ask you to change to a lower dose or to temporarily or permanently stop the treatment.

Do not take asciminib with food.

Take asciminib:

Taking asciminib at the same time each day will help you to remember when to take your medicine.

Swallow asciminib tablets whole. Do not break, crush or chew the tablets.

Continue taking Asciminib for as long as your doctor tells you. This is a long term treatment, possibly lasting for months or years. Your doctor will regularly monitor your condition to check that the treatment is having the desired effect.

If you have questions about how long to take asciminib, talk to your doctor or nurse.

If you have taken more Asciminib than you should have, or if someone else accidentally takes your medicine, contact a doctor for advice straight away. Show them the pack of asciminib. Medical treatment may be necessary.

If you miss asciminib by more than 12 hours, skip the missed dose and take the next one as usual.

If you miss asciminib by more than 6 hours, skip the missed dose and take the next one as usual.

Do not stop taking asciminib unless your doctor tells you to.

If you have any further questions on the use of this medicine, ask your doctor or nurse.

Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects have been reported with this medicine:

If you experience any serious side effects, stop taking this medicine and tell your doctor immediately.

Other side effects include the following listed below. If these side effects become severe, tell your doctor or nurse.

During asciminib treatment, the results of blood tests may be abnormal, which can give your doctor information on the function of your organs. For example:

A decrese in phospate levels may also be obsvered.

If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to MHRA via the Yellow Card scheme via www.mhra.gov.uk/yellowcard. By reporting side effects, you can help provide more information on the safety of this medicine.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.

Do not store above 25°C.After first opening of the bottle, the tablets can be stored for 3 months.Do not use this medicine if you notice any damage to the packaging or if there are any signs of tampering.Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

Asciminib 20mg film-coated tablets are pale yellow, round curved with bevelled edges 6mm film-coated tablets debossed with NVR on one side ad "20" on the other.

Asciminib 40mg film-coated tablets are violet white, round curved with bevelled edges 8mm film-coated tablets debossed with NVR on one side ad "40" on the other.

Asciminib film coated tablets are supplied in HDPE bottles fitted with child-resistant closure containing 30 film coated tablets.

Novartis Pharmaceuticals UK Ltd2nd Floor, The WestWorks BuildingWhite City195 Wood Lane LondonW12 7FQUK

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This protocol was revised in November 2021

You will have the Early Access to Medicines Scheme explained to you using the informed consent form. You will be asked to sign this form and a copy of the signed consent form will be given to you to keep.

You will also be given a Patient Alert Card before you start treatment with asciminib. You must keep this Patient Alert Card with you at all times during the treatment and for at least 30 days after completing your treatment with asciminib. The card alerts any other healthcare professional who may treat you that you are currently receiving asciminib through an early access scheme, provides information regarding the important known side effects for which you should seek assistance should they occur, contact details for the doctor managing your treatment and the company's contact details.

Information collected during the scheme will mostly be used for safety surveillance and cannot replace a proper clinical trial to support a marketing authorisation. These data are required by the MHRA to help verify that your condition complies with the EAMS indication and help interpret the side effects and other events occurring during and after the EAMS treatment. These data include your initials, year of birth, gender, information about cancer, comorbidities, response data and any medications you may be taking.

Novartis Pharmaceuticals UK Limited, medical information, Tel 01276698370 or email [email protected]