What is a Patient Information Leaflet and why is it useful?

The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.

Black triangle. This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information.

Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.

The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: EU/1/16/1128/001.


Kisplyx 4mg and 10mg hard capsules

Package leaflet: Information for the user

Kisplyx 4 mg hard capsules

Kisplyx 10 mg hard capsules

lenvatinib

▼This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.

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

  • Keep this leaflet. You may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
  • If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1. What Kisplyx is and what it is used for
2. What you need to know before you take Kisplyx
3. How to take Kisplyx
4. Possible side effects
5. How to store Kisplyx
6. Contents of the pack and other information

1. What Kisplyx is and what it is used for

What Kisplyx is

Kisplyx is a medicine that contains the active substance lenvatinib. It is used in combination with everolimus to treat patients with advanced kidney cancer (advanced renal cell carcinoma) where other treatments (so-called “VEGF-targeted therapy”) have not helped stop the disease.

How Kisplyx works

Kisplyx blocks the action of proteins called receptor tyrosine kinases (RTKs), which are involved in the development of new blood vessels that supply oxygen and nutrients to cells and help them to grow. These proteins can be present in high amounts in cancer cells, and by blocking their action Kisplyx may slow the rate at which the cancer cells multiply and the tumour grows and help to cut off the blood supply that the cancer needs.

2. What you need to know before you take Kisplyx

Do not take Kisplyx if:

  • you are allergic to lenvatinib or any of the other ingredients of this medicine (listed in section 6).
  • you are breast-feeding (see the section below on Contraception, pregnancy and breast-feeding).

Warnings and precautions

Talk to your doctor before taking Kisplyx if you:

  • have high blood pressure
  • are a woman able to become pregnant (see the section “Contraception, pregnancy and breast-feeding” below)
  • have a history of heart problems or stroke
  • have liver or kidney problems
  • have had recent surgery or radiotherapy
  • need to have a surgical procedure. Your doctor may consider stopping Kisplyx if you will be undergoing a major surgical procedure as Kisplyx may affect wound healing. Kisplyx may be restarted once adequate wound healing is established.
  • are over 75 years old
  • belong to an ethnic group other than White or Asian
  • weigh less than 60 kg
  • have a history of abnormal passageways (known as a fistula) between different organs in the body or from an organ to the skin

Before taking Kisplyx, your doctor may carry out some blood tests, for example to check your blood pressure and your liver or kidney function and to see if you have low levels of salt and high levels of thyroid stimulating hormone in your blood. Your doctor will discuss the results of these tests with you and decide whether you can be given Kisplyx. You may need to have additional treatment with other medicines, to take a lower dose of Kisplyx, or to take extra care due to an increased risk of side effects.

If you are not sure talk to your doctor before taking Kisplyx.

Children and adolescents

Kisplyx is not recommended for use in children and adolescents. The effects of Kisplyx in people younger than 18 years old are not known.

Other medicines and Kisplyx

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes herbal preparations and medicines without a prescription.

Contraception, pregnancy and breast-feeding

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.

  • Use highly effective contraception while taking this medicine, and for at least one month after you finish treatment.
  • Do not take Kisplyx if you are planning to become pregnant during your treatment. This is because it may seriously harm your baby.
  • If you become pregnant while being treated with Kisplyx, tell your doctor immediately. Your doctor will help you decide whether the treatment should be continued.
  • Do not breast-feed if you are taking Kisplyx. This is because the medicine passes into breast milk and may seriously harm your breastfed baby.

Driving and using machines

Kisplyx may cause side effects that can affect your ability to drive or use machines. Avoid driving or using machines if you feel dizzy or tired.

3. How to take Kisplyx

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

How much to take

  • The recommended daily dose of Kisplyx is 18 mg once a day (one 10 mg capsule and two 4 mg capsules) in combination with one 5 mg tablet of everolimus once a day.
  • If you have severe liver or kidney problems the recommended dose of Kisplyx is 10 mg once a day (1 capsule of 10 mg) in combination with one 5 mg tablet of everolimus once a day.
  • Your doctor may reduce your dose if you experience side effects.

Taking this medicine

  • You can take the capsules with or without food.
  • Swallow the capsules whole with water or dissolved. To dissolve them, pour a tablespoon of water or apple juice into a small glass and put the capsules into the liquid without breaking or crushing them. Leave for at least 10 minutes then stir for at least 3 minutes to dissolve the capsule shells. Drink the mixture. After drinking, add the same amount of water or apple juice, swirl and swallow.
  • Take the capsules at about the same time each day.
  • Caregivers should not open capsules to avoid exposure to the contents of the capsule.

How long to takeKisplyx

You will usually carry on taking this medicine as long as you are getting benefit.

If you take more Kisplyx than you should

If you take more Kisplyx than you should, talk to a doctor or pharmacist straight away. Take the medicine pack with you.

If you forget to take Kisplyx

Do not take a double dose (two doses at the same time) to make up for a forgotten dose.

What to do if you forget to take your dose depends on how long it is until your next dose.

  • If it is 12 hours or more until your next dose: take the missed dose as soon as you remember. Then take the next dose at the normal time.
  • If it is less than 12 hours until your next dose: skip the missed dose. Then take the next dose at the normal time.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects may happen with this medicine.

Tell your doctor straight away if you notice any of the following side effects - you may need urgent medical treatment:

  • feeling numb or weak on one side of your body, severe headache, seizure, confusion, difficulty talking, vision changes or feeling dizzy - these may be signs of a stroke, bleeding in your brain, or the effect on your brain of a severe increase in blood pressure.
  • chest pain or pressure, pain in your arms, back, neck or jaw, being short of breath, rapid or irregular heart rate, coughing, bluish colour to lips or fingers, feeling very tired – these may be signs of a heart problem a blood clot in your lung or a leak of air from your lung into your chest so your lung cannot inflate.
  • severe pain in your belly (abdomen) - this may be due to a hole in the wall of your gut or a fistula (a hole in your gut which links through a tube-like passage to another part of your body or skin).
  • black, tarry, or bloody stools, or coughing up of blood - these may be signs of bleeding inside your body.
  • diarrhoea, feeling and being sick - these are very common side effects that can become serious if they cause you to become dehydrated, which can lead to kidney failure. Your doctor can give you medicine to reduce these side effects.

Tell your doctor straight away if you notice any of the side effects above.

Other side effects include:

Very common (may affect more than 1 in 10 people)

  • high or low blood pressure
  • loss of appetite or weight loss
  • feeling and being sick, constipation, diarrhoea, abdominal pain, indigestion
  • feeling very tired or weak
  • hoarse voice
  • swelling of the legs
  • rash
  • dry, sore, or inflamed mouth, odd taste sensation
  • joint or muscle pain
  • feeling dizzy
  • hair loss
  • bleeding (most commonly nose bleeds, but also other types of bleeding such as blood in the urine, bruising, bleeding from the gums or gut wall)
  • trouble sleeping
  • high levels of protein in the urine and urinary infections (increased frequency in urination and pain in passing urine)
  • headache and back pain
  • redness, soreness and swelling of the skin on the hands and feet (hand-foot syndrome)
  • changes in blood test results for potassium levels (low), calcium levels (low), cholesterol (high) and thyroid stimulating hormone (high)
  • underactive thyroid (tiredness, weight gain, constipation, feeling cold, dry skin)
  • low levels of platelets in the blood which may lead to bruising and difficulty in wound healing

Common (may affect up to 1 in 10 people)

  • loss of body fluids (dehydration)
  • heart palpitations
  • dry skin, thickening and itching of the skin
  • feeling bloated or having gas in the bowel
  • heart problems or blood clots in the lungs (difficulty breathing, chest pain) or other organs
  • feeling unwell
  • stroke
  • inflammation of the gallbladder
  • anal fistula (a small channel that forms between the anus and the surrounding skin)
  • changes in blood test results for liver enzymes, white blood cells (low), blood magnesium (low)
  • changes in blood test results for kidney function and kidney failure
  • increase in lipase and amylase (enzymes involved in digestion)

Uncommon (may affect up to 1 in 100 people)

  • painful infection or irritation near the anus
  • mini-stroke
  • liver damage
  • severe pain in the upper left part of the belly (abdomen) which may be associated with fever, chills, nausea and vomiting
  • inflammation of the pancreas
  • wound healing problems
  • severe pain in the back, chest or abdomen associated with tearing in the wall of the aorta and internal bleeding

Not Known (the following side effects have been reported since the marketing of lenvatinib but the frequency for them to occur is not known)

  • other types of fistulae (an abnormal connection between different organs in the body or from the skin to an underlying structure such as throat and windpipe). Symptoms would depend on where the fistula is located. Talk to your doctor if you experience any new or unsual symptoms such as coughing when swallowing.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme: 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 Kisplyx

  • 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 and blister after ‘EXP’. The expiry date refers to the last day of that month.
  • Do not store above 25°C. Store in the original blister in order to protect from moisture.
  • 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 Kisplyx contains

  • The active substance is lenvatinib.
    • Kisplyx 4 mg hard capsules: - Each hard capsule contains 4 mg of lenvatinib (as mesilate).
    • Kisplyx 10 mg hard capsules: - Each hard capsule contains 10 mg of lenvatinib (as mesilate).
  • The other ingredients are calcium carbonate, mannitol, microcrystalline cellulose, hydroxypropylcellulose, low-substituted hydroxypropyl cellulose, talc. The capsule shell contains hypromellose, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172). The printing ink contains shellac, black iron oxide (E172), potassium hydroxide, propylene glycol.

What Kisplyx looks like and contents of the pack

  • Kisplyx 4 mg hard capsule: yellowish red body and yellowish red cap, approximately 14.3 mm in length, marked in black ink with “Є” on the cap, and “LENV 4 mg” on the body.
  • Kisplyx 10 mg hard capsule: yellow body and yellowish red cap, approximately 14.3 mm in length, marked in black ink with “Є” on the cap, and “LENV 10 mg” on the body.
  • The capsules come in blisters of polyamide/aluminium/PVC with a push through aluminium foil lidding in cartons of 30 capsules.

Marketing Authorisation Holder

Eisai GmbH
Lyoner Straße 36
60528 Frankfurt am Main
Germany

Manufacturer

Eisai Manufacturing Ltd
Mosquito Way
Hatfield
Herts
AL10 9SN
United Kingdom

Or

Eisai GmbH
Lyoner Straße 36
60528 Frankfurt am Main
Germany

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

United Kingdom
Eisai Europe Ltd.
Tel: + 44 (0) 208 600 1400

This leaflet was last revised in 02/2019

Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.