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 can be viewed in PDF format using the link above.

The text only version may be available from RNIB in large print, Braille or audio CD. For further information call RNIB Medicine Leaflet Line on 0800 198 5000. The product code(s) for this leaflet are: EU/1/15/1002/002, EU/1/15/1002/001.

Lenvima 4mg and 10mg hard capsules

Package leaflet: Information for the user

LENVIMA 4 mg hard capsules

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

1. What LENVIMA is and what it is used for

What LENVIMA is

LENVIMA is a medicine that contains the active substance lenvatinib. It is used to treat progressive or advanced thyroid cancer in adults when radioactive iodine treatment has not helped to stop the disease.

How LENVIMA works

LENVIMA 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 LENVIMA 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 LENVIMA

Do not take LENVIMA 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 LENVIMA if you:

  • have high blood pressure
  • are a woman able to become pregnant (see the section below on Contraception, pregnancy and breast-feeding)
  • have a history of heart problems or strokes
  • have liver or kidney problems
  • have had recent surgery or radiotherapy
  • are over 75 years
  • 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 LENVIMA, 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 LENVIMA. You may need to have additional treatment with other medicines, to take a lower dose of LENVIMA, or to take extra care due to an increased risk of side effects.

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

Children and adolescents

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

Other medicines and LENVIMA

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.

  • If you could become pregnant, use highly effective contraception while taking this medicine, and for at least one month after you finish treatment. Because it is not known if LENVIMA can reduce the effect of the oral contraceptive pill, if this is your normal method of contraception you should ensure you also add a barrier method such as the cap or condoms if you have sex during treatment of LENVIMA.
  • Do not take LENVIMA 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 LENVIMA, tell your doctor immediately. Your doctor will help you decide whether the treatment should be continued.
  • Do not breast-feed if you are taking LENVIMA. This is because the medicine passes into breast milk and may seriously harm your breastfed baby.

Driving and using machines

LENVIMA 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 LENVIMA

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 dose of LENVIMA is usually 24 mg once a day (2 capsules of 10 mg and 1 capsule of 4 mg).
  • If you have severe liver or kidney problems the recommended dose is 14 mg once a day (1 capsule of 10 mg and 1 capsule of 4 mg).
  • Your doctor may reduce your dose if you have problems with side effects.

Taking this medicine

  • You can take the capsules with or without food.
  • Swallow the capsules whole with water.
  • Take the capsules at about the same time each day.
  • Caregivers should not open the capsules to avoid exposure to the contents of the capsule.

How long to take LENVIMA

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

If you take more LENVIMA than you should

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

If you forget to take LENVIMA

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 on 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 or a blood clot in your lung.
  • 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 sick 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
  • changes in urine tests for protein (high) 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) and calcium levels (low)
  • 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
  • underactive thyroid (tiredness, weight gain, constipation, feeling cold, dry skin)
  • heart problems or blood clots in the lungs (difficulty breathing, chest pain) or other organs
  • feeling unwell
  • inflammation of the gallbladder
  • stroke
  • anal fistula (a small channel that forms between the anus and the surrounding skin)
  • changes in blood test results for liver, kidney, white blood cells (low), blood sodium and magnesium (low), cholesterol (high) and thyroid stimulating hormone (high)
  • 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

Not Known (the following side effects have been reported since the marketing of LENVIMA 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 an organ to the skin and 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. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store LENVIMA

  • 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 on each 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 LENVIMA contains

  • The active substance is lenvatinib.
    • LENVIMA 4 mg hard capsules: - Each hard capsule contains 4 mg of lenvatinib (as mesilate).
    • LENVIMA 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 LENVIMA looks like and contents of the pack

  • The 4 mg capsule is a 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.
  • The 10 mg capsule is a 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 Europe Limited
European Knowledge Centre
Mosquito Way
Hatfield
Herts
AL10 9SN
United Kingdom

Manufacturer

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

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 03/2017.

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