What Lenvima 4mg and 10mg Hard Capsules is used for and how to use it
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Lenvima 4mg and 10mg Hard Capsules - Consumer Medicine Information

Manufacture: Eisai Inc.
Country: Great Britain
Condition: Cancer, Cancer, Breast (Breast Cancer), Renal Cell Carcinoma, Thyroid Cancer
Class: Multikinase inhibitors, VEGF/VEGFR inhibitors
Form: Capsules
Ingredients: lenvatinib, calcium carbonate, mannitol, microcrystalline cellulose, hydroxypropylcellulose, low-substituted hydroxypropyl cellulose,talc

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 growth of cells and the development of new blood vessels that supply them. 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 grownd help to cut off the blood supply that the cancer needs.

What you Need to Know Before you Take Lenvima

Do not Take Lenvima if

  • you are allergic to lenvatinib or any of the other ingredie nts of this medicine (listed in section Contents of the pack and other information).
  • you ar e breast-feeding (see the section below on Contraception, pre gnancy and breast-feedin g).

Warnings and Precaut Ions

Talk to your doctor before taking LENVIMA if you

  • have high blood pressure
  • are a woman able to become pregnant (see the section b elow 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

Before taking LENVIMA, your doctor will talk to you about:

  • side effects that your doctor will need to test for (high blood pressure, early signs of kidney or liver damage, heart problems, and the level of salt [low] and thyroid stimulating hormone [high] in your blood)
  • side effects that you need to tell your doctor about straight away (see section Possible side effects on possible side effects).

Tell your doctor if any of these affect you. You may need 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 any of the above applies to you (or 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.

Contraception, Pregnancy and Breastfeeding

  • 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 with 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 breastfeed if you are taking LENVIMA. This is because the medicine may seriously harm your 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.

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 them at about the same time each day.
  • Caregivers should 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

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.

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

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 and 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
  • swelling and inflammation of the joints; and stiff muscles, bones and joints
  • feeling dizzy
  • hair loss
  • bleeding (most commonly nose bleeds, but may include bleeding from other sites 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)
  • pain – muscle, joint, headache, back
  • 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)
  • bruising and difficulty in wound healing - signs of low level of platelets in the blood

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
  • heart problems or blood clots in the lungs (difficulty breathing, chest pain) or other organs
  • feeling unwell
  • 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), and thyroid stimulating hormone (high)
  • kidney failure

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

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 national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

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.

Contents of the Pack and Other Information

What Lenvima Contains

  • The active substance is lenvatinib. Each hard capsule contains either 4 mg or 10 mg of lenvatinib (as mesyilate).
  • 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

E-mail:EUmedinfo@eisai.net

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:

België/Belgique/Belgien
Eisai SA/NV
Tél/Tel: + 32 (0) 2 502 58 04

България
Eisai Europe Ltd.
Teл .: +44 (0)20 8600 1400
(Обединено кралство)

Česká republika
Eisai GesmbH organizačni složka
Tel.: + 420 242 485 839

Danmark
Eisai AB
Tlf: + 46 (0) 8 501 01 600
(Sverige)

Deutschland
Eisai GmbH
Tel: + 49 (0) 69 66 58 50

Eesti
Eisai Europe Ltd.
Tel: + 44 (0) 208 600 1400
(Ühendkuningriik)

Ελλάδα
Eisai Europe Ltd.
Tel: + 44 (0) 208 600 1400
(Ηνωμένο Βασίλειο)

España
Eisai Farmacéutica, S.A.
Tel: + (34) 91 455 94 55

France
Eisai SAS
Tél: + (33) 1 47 67 00 05

Lietuva
Eisai Europe Ltd.
Tel. + 44 (0) 208 600 1400
(Jungtinė Karalystė)

Luxembourg/Luxemburg
Eisai SA/NV
Tél/Tel: + 32 (0) 2 502 58 04
(Belgique/Belgien)

Magyarország
Eisai Europe Ltd.
Tel.: + 44 (0) 20 8600 1400
(Egyesült Királyság)

Malta
Eisai Europe Ltd.
Tel: +44 (0) 20 8600 1400
(United Kingdom)

Nederland
Eisai B.V.
Tél/Tel: + 31 (0) 900 575 3340

NorgeEisai AB
Tlf: + 46 (0) 8 501 01 600
(Sverige)

Österreich
Eisai GesmbH
Tel: + 43 (0) 1 535 1980-0

Polska
Eisai Europe Ltd.
Tel.: + 44 (0) 208 600 1400
(Wielka Brytania)

Portugal
Eisai Farmacêutica, Unipessoal Lda
Tel: + 351 214 875 540

Hrvatska
Eisai Europe Ltd.
Tel : + 44 (0) 20 8600 1400
(Velika Britanija)

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

Ísland
Eisai AB
Sími: + 46 (0) 8 501 01 600
(Svíþjóð)

Italia
Eisai S.r.l.
Tel: + 39 02 5181401

Κύπρος
Eisai Europe Ltd.
Τηλ: +44 (0) 20 8600 1400
(Ηνωμένο Βασίλειο)

Latvija
Eisai Europe Ltd.
Tel: +44 (0) 20 8600 1400
(Anglija)

România
Eisai Europe Ltd.
Tel: +44 (0) 20 8600 1400
(Marea Britanie)

Slovenija
Eisai Europe Ltd.
Tel: +44 (0) 20 8600 1400
(Velika Britanija)

Slovenská republika
Eisai GesmbH organizační složka
Tel.: +420 242 485 839
(Česká republika)

Suomi/Finland
Eisai AB
Puh/Tel: + 46 (0) 8 501 01 600
(Ruotsi/Sverige)

Sverige
Eisai AB
Tel: + 46 (0) 8 501 01 600

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

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