Patient leaflet - Exkivity 40 mg hard capsules
1. What EXKIVITY is and what it is used for
This medicine is a cancer medicine that contains the active substance mobocertinib. This medicine is used to treat adults with a type of lung cancer called ‘non-small cell lung cancer’ (NSCLC) that is caused by a specific change in the EGFR (epidermal growth factor receptor) gene.
It is used when:
a test has shown that your cancer cells contain an ‘exon 20 insertion mutation’ in the EGFR gene and
has spread within the lung or to other organs in your body and cannot be removed by surgery. • your cancer has been previously treated with a type of chemotherapy that contains platinum
(e.g., cisplatin or carboplatin).
How EXKIVITY works
EXKIVITY works by blocking the activity of EGFR when your cancer contains a modification called ‘exon 20 insertion mutation.’ This modified EGFR is known to be involved in the growth and spread of cancer cells. EXKIVITY may slow or stop cancer cells from growing.
2. What you need to know before you take EXKIVITY
Do not take EXKIVITY
if you are allergic to mobocertinib or any of the other ingredients of this medicine
(listed in section 6).
if you take certain medications known as strong CYP3A inhibitors, grapefruit or grapefruit juice, or
St. John’s Wort.
If you are not sure, talk to your doctor, pharmacist or nurse before taking EXKIVITY.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking EXKIVITY or during treatment if:
- you have a change in the electrical activity of your heart called ‘prolonged QTc interval’ • you have heart problems, including heart failure
- you have lung or breathing problems other than lung cancer
- you have problems with your electrolytes, such as sodium, potassium, calcium or magnesium • you have diarrhoea
- you take other medicines (see Other medicines and EXKIVITY)
Your doctor may need to adjust your treatment or stop EXKIVITY temporarily or permanently. See also section 4.
Children and adolescents
EXKIVITY has not been studied in children or adolescents. Treatment with EXKIVITY is not recommended in persons under 18 years of age.
Other medicines and EXKIVITY
Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines.
The following medicines can affect or be affected by EXKIVITY:
indinavir, nelfinavir, ritonavir, saquinavir: medicines to treat HIV infection • clarithromycin, telithromycin, troleandomycin, erythromycin: medicines to treat bacterial
infections
- ketoconazole, voriconazole, fluconazole: medicines to treat fungal infections • nefazodone: a medicine to treat depression
rifampicin, rifabutin: medicines to treat tuberculosis or certain other infections • carbamazepine: a medicine to treat epilepsy, euphoric/depressive episodes and certain pain
conditions
- phenytoin, phenobarbital: medicines to treat epilepsy
- St. John’s wort: a herbal product used to treat depression
- efavirenz, etravirine: medicines to treat HIV infection
- bosentan: a medicine to treat pulmonary hypertension
- nafcillin: a medicine to treat bacterial infections
- hormonal contraceptives: medicines to prevent pregnancy
medicines that prolong the QTc interval: for example, amiodarone, azithromycin, dronedarone,
moxifloxacin, ondansetron
EXKIVITY with food and drink
Avoid any grapefruit products during treatment as they may change the amount of mobocertinib in your body.
Pregnancy, breast-feeding and fertility
Women and contraception
Women of childbearing age being treated with EXKIVITY should avoid becoming pregnant. Highly effective non-hormonal contraception should be used during treatment and for 1 month after stopping EXKIVITY. Ask your doctor about the birth control methods that may be right for you.
Men and contraception
Men with female partners of childbearing age should use effective contraception during treatment and for 1 week after stopping EXKIVITY. Ask your doctor about the birth control methods that may be right for you.
Pregnancy
This medicine is not recommended during pregnancy as it may harm your unborn baby. If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Breast-feeding
Do not breastfeed while taking this medicine and for 1 week after stopping this medicine. This is because it is not known if this medicine can pass over into breast milk and could therefore harm the baby.
Driving and using machines
This medicine may cause you to feel tired. Do not drive or use machines during treatment if you are tired.
3. How to take EXKIVITY
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor, pharmacist or nurse if you are not sure.
How much EXKIVITY to take
The recommended dose is 4 capsules of 40 mg once a day (total amount 160 mg).
Do not change the dose without talking to your doctor. If you feel unwell, sometimes your doctor may lower your dose, stop treatment for a short time or stop treatment completely.
How to take EXKIVITY
- Take this medicine once daily at the same time each day.
- Take this medicine by mouth – with or without food.
- Swallow each capsule whole. Do not open, chew or dissolve the contents of the capsules.
If you vomit after taking EXKIVITY
If you vomit after taking this medicine, do not take any more capsules until your next scheduled dose.
If you take more EXKIVITY than you should
Tell your doctor, pharmacist or nurse right away if you have taken more capsules than recommended.
If you forget to take EXKIVITY
If you miss a dose of this medicine, and it has been more than 6 hours, do not take a dose to make up for a forgotten dose. Take your next dose at your regular time.
If you stop taking EXKIVITY
Do not stop taking this medicine without talking to your doctor first. It is important to take this medicine every day for as long as your doctor prescribes it for you.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects
Tell your doctor or nurse immediately if you have any of the following serious side effects:
Very common (may affect more than 1 in 10 people):
diarrhoea
Diarrhoea is generally mild to moderate, but may sometimes be severe. You should have medicine to help control diarrhoea (such as loperamide) readily available to begin treatment. Your doctor or nurse may also recommend changes to your diet and tell you to start drinking more fluids. Diarrhoea can cause loss of too much body fluid (dehydration) and kidney problems and your doctor or nurse may need to give you fluids and electrolytes to replace body salts. Tell your doctor or nurse right away if you have any loose stools or have stools more often than is normal for you. In general, the sooner and better diarrhoea is managed, the more likely it will be controlled and tolerable.
Common (may affect up to 1 in 10 people):
heart problems, including heart failure and abnormal electrical activity of the heart (a heart conduction problem called ‘prolonged QTc interval)’
EXKIVITY may cause heart problems, which have the potential to be fatal. Your doctor or nurse should check your heart function before you start taking EXKIVITY and during treatment as needed. Tell your doctor or nurse right away if you have any signs and symptoms of a heart problem, including feeling like your heart is pounding or racing, irregular heartbeat, shortness of breath, chest pain, swelling of your ankles and feet, or feeling faint, dizzy or lightheaded. • lung problems
EXKIVITY may cause inflammation of the lungs, which has the potential to be fatal. Symptoms may be similar to those symptoms from lung cancer. Tell your doctor or nurse right away if you develop any new or worsening symptoms, including trouble breathing or shortness of breath, cough, or fever.
Other side effects are:
Tell your doctor or nurse if you notice any of the following side effects
Very common (may affect more than 1 in 10 people):
- loss of appetite
- nausea
- inflammation of the mouth and lips (stomatitis)
- vomiting
- rash
- dry skin
- changes in your nails, including redness, tenderness, pain, inflammation, brittleness, separation from nailbed, and shedding of nails (paronychia)
- weight loss
- dehydration
- vision problems
- high blood pressure
- difficulty breathing
- cough
- runny nose
- itchy skin
- hair loss
- fatigue (feeling tired)
Very common side effects seen in laboratory tests:
- reduced number of red blood cells (anaemia)
- increased blood levels of digestive enzymes (amylase or lipase) in tests
- increased blood levels of liver enzymes (aspartate aminotransferase, alanine aminotransferase) in tests
- increased blood levels of creatinine
- low platelet counts in blood tests, which may increase the risk of bleeding and bruising • reduced number of white blood cells
- reduced blood levels of potassium
- reduced blood levels of magnesium
Common (may affect more than 1 in 100 people):
- kidney failure
- insomnia (difficulty sleeping)
- hand-foot syndrome (redness, swelling and blistering on the palms of the hands and soles of the feet). • hives (urticaria)
Reporting of side effects
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 via the Yellow Card Scheme. Website www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store EXKIVITY
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 blister and carton after EXP. The expiry date refers to the last day of that month.
Do not store above 30 °C. Do not freeze.
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.
6. Contents of the pack and other information
What EXKIVITY contains
The active substance is mobocertinib.
Each capsule contains 40 mg mobocertinib (as 48.06 mg mobocertinib succinate).
The other ingredients are:
- Capsule shell: gelatin and titanium dioxide
- Printing ink: shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, potassium hydroxide and purified water
What EXKIVITY looks like and contents of the pack
EXKIVITY 40 mg hard capsule: White, size 2, imprinted with “MB788” on the cap and “40mg” on the body in black ink.
The capsules are provided in blisters and are available in cartons containing 112 capsules.
Instructions for opening the blisters
- Fold along perforated line and separate one individual blister.
- Peel back the paper at the corner arrow to expose the capsule.
- Carefully remove capsule from blister.
Marketing Authorisation Holder
Takeda UK Limited
1 Kingdom Street, London
W2 6BD
United Kingdom
Tel: +44 (0)3333 000181
e-mail: medinfoemea@takeda.com
Manufacturer
Takeda Ireland Limited
Bray Business Park, Kilruddery
Co. Wicklow, A98 CD36
Ireland
This leaflet was last revised in February 2022.
EXKIVITY mobocertinib
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