Sutent

Helstu upplýsingar

  • Heiti vöru:
  • Sutent
  • Lyf við lungum:
  • Mannfólk
  • Lyfjaform:
  • Allópatísk lyf

Skjöl

Staðsetning

  • Fáanlegt í:
  • Sutent
    Evrópusambandið
  • Tungumál:
  • enska

Meðferðarupplýsingar

  • Meðferðarhópur:
  • Antineoplastic agents,
  • Lækningarsvæði:
  • Gastrointestinal Stromal Tumors, Carcinoma, Renal Cell, Neuroendocrine Tumors
  • Ábendingar:
  • Gastrointestinal stromal tumour (GIST), Sutent is indicated for the treatment of unresectable and/or metastatic malignant gastrointestinal stromal tumour (GIST) in adults after failure of imatinib mesilate treatment due to resistance or intolerance.Metastatic renal cell carcinoma (MRCC), Sutent is indicated for the treatment of advanced/metastatic renal cell carcinoma (MRCC) in adults.Pancreatic neuroendocrine tumours (pNET), Sutent is indicated for the treatment of unresectable or metastatic, well-differentiated pancreatic neuroendocrine tumours with disease progression in adults., Experience with Sutent as first-line treatment is limited (see section 5.1).,
  • Vörulýsing:
  • Revision: 36

Staða

  • Heimild:
  • EMA - European Medicines Agency
  • Leyfisstaða:
  • Authorised
  • Leyfisnúmer:
  • EMEA/H/C/000687
  • Leyfisdagur:
  • 18-07-2006
  • EMEA númer:
  • EMEA/H/C/000687
  • Síðasta uppfærsla:
  • 23-03-2019

Opinber matsskýrsla

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Telephone

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Facsimile

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Send a question via our website

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© European Medicines Agency, 2014. Reproduction is authorised provided the source is acknowledged.

EMA/487080/2014

EMEA/H/C/000687

EPAR summary for the public

Sutent

sunitinib

This is a summary of the European public assessment report (EPAR) for Sutent. It explains how the

Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in

favour of granting a marketing authorisation and its recommendations on the conditions of use for

Sutent.

What is Sutent?

Sutent is a medicine that contains the active substance sunitinib. It is available as capsules (12.5 mg,

25 mg, 37.5 mg and 50 mg).

What is Sutent used for?

Sutent is used to treat adults with the following types of cancer:

gastrointestinal stromal tumour (GIST), a type of cancer of the stomach and bowel where there is

uncontrolled growth of cells in the supporting tissues of these organs. Sutent is used in patients

with GISTs that cannot be removed with surgery or have spread to other parts of the body. It is

used after treatment with imatinib (another cancer medicine) has failed;

metastatic renal cell carcinoma, a type of kidney cancer, that has spread to other parts of the

body;

pancreatic neuroendocrine tumours (tumours of the hormone-producing cells in the pancreas) that

have spread or cannot be removed with surgery. Sutent is used if the disease is getting worse and

the tumour cells are well-differentiated (similar to normal cells in the pancreas).

The medicine can only be obtained with a prescription.

Sutent

EMA/487080/2014

Page 2/3

How is Sutent used?

Treatment with Sutent should be started by doctors who have experience in administering cancer

medicines.

For GIST and metastatic renal cell carcinoma, Sutent is given in six-week cycles, at a dose of 50 mg

once a day for four weeks, followed by a two-week ‘rest period’. The dose can be adjusted according to

the patient’s response to the treatment, but should be kept within the range of 25 to 75 mg.

For pancreatic neuroendocrine tumours, Sutent is given at a dose of 37.5 mg once a day without a rest

period. This dose may also be adjusted.

How does Sutent work?

The active substance in Sutent, sunitinib, is a protein kinase inhibitor. This means that it blocks some

specific enzymes known as protein kinases. These enzymes can be found in some receptors at the

surface of cancer cells, where they are involved in the growth and spread of cancer cells and in the

blood vessels that supply the tumours, where they are involved in the development of new blood

vessels. By blocking these enzymes, Sutent can reduce the growth and spread of the cancer and cut

off the blood supply that keeps cancer cells growing.

How has Sutent been studied?

Sutent was compared with placebo (a dummy treatment) in 312 patients with GIST whose previous

treatment with imatinib had failed and in 171 patients with worsening pancreatic neuroendocrine

tumours that could not be removed with surgery. Sutent was also compared with another cancer

medicine, interferon alfa, in 750 patients with metastatic renal cell carcinoma whose cancer had not

been treated before.

The main measure of effectiveness in all of the studies was how long the patients lived without their

tumours getting worse.

What benefit has Sutent shown during the studies?

Sutent was more effective than placebo in treating GIST and pancreatic neuroendocrine tumours.

Patients with GIST taking Sutent lived for an average of 26.6 weeks without the disease getting worse,

compared with 6.4 weeks in the patients taking placebo. For pancreatic neuroendocrine tumours the

figures were 11.4 months in the Sutent group and 5.5 months in the placebo group.

In metastatic renal cell carcinoma, patients taking Sutent lived for an average of 47.3 weeks without

their disease worsening, compared with 22.0 weeks in the patients receiving interferon alfa.

What is the risk associated with Sutent?

The most common side effects with Sutent (seen in more than 1 in 10 patients) include fatigue

(tiredness), gastrointestinal disorders (such as diarrhoea, feeling sick, inflammation of the lining of the

mouth, indigestion and vomiting), respiratory (such as shortness of breath and cough) and skin

disorders (such as skin discoloration, dryness of the skin and rash), hair color changes, dysgeusia

(taste disturbances), epistaxis (nosebleeds), loss of appetite, hypertension (high blood pressure),

palmar-plantar erythrodysaesthesia syndrome (rash and numbness on the palms and soles),

hypothyroidism (an underactive thyroid gland), insomnia (difficulty falling and staying asleep),

dizziness, headache, arthralgia (joint pain), neutropenia (low levels of neutrophils, a type of white

Sutent

EMA/487080/2014

Page 3/3

blood cell), thrombocytopenia (low blood platelet counts), anaemia (low red blood cell counts), and

leucopenia (low white blood cell counts).

The most serious side effects reported with Sutent include heart and kidney failure, pulmonary

embolism (clot in a blood vessel supplying the lungs), gastrointestinal perforation (holes in the wall of

the gut), and internal haemorrhages (bleeding).

For the full list of all side effects and restrictions with Sutent, see the package leaflet.

Why has Sutent been approved?

The CHMP decided that Sutent’s benefits are greater than its risks and recommended that it be given

marketing authorisation.

Sutent was originally given ‘conditional approval’ because there was more evidence to come about the

medicine, in particular in the treatment of renal cell carcinoma. As the company has supplied the

additional information necessary, the authorisation has been switched from conditional to full approval.

What measures are being taken to ensure the safe and effective use of

Sutent?

A risk management plan has been developed to ensure that Sutent is used as safely as possible. Based

on this plan, safety information has been included in the summary of product characteristics and the

package leaflet for Sutent, including the appropriate precautions to be followed by healthcare

professionals and patients.

Other information about Sutent

The European Commission granted a conditional marketing authorisation valid throughout the

European Union for Sutent on 19 July 2006. This was switched to a full marketing authorisation on 11

January 2007.

The full EPAR for Sutent can be found on the Agency’s website

ema.europa.eu/Find medicine/Human

medicines/European Public Assessment Reports. For more information about treatment with Sutent,

read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

This summary was last updated in 08-2014.

Upplýsingar um fylgiseðil sjúklinga: samsetning, vísbendingar, aukaverkanir, skammtar, milliverkanir, aukaverkanir, meðgöngu, brjóstagjöf

B. PACKAGE LEAFLET

Package leaflet: Information for the user

Sutent 12.5 mg hard capsules

Sutent 25 mg hard capsules

Sutent 37.5 mg hard capsules

Sutent 50 mg hard capsules

sunitinib

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. This includes any possible side effects not

listed in this leaflet. See section 4.

What is in this leaflet

What Sutent is and what it is used for

What you need to know before you take Sutent

How to take Sutent

Possible side effects

How to store Sutent

Contents of the pack and other information

1.

What Sutent is and what it is used for

Sutent contains the active substance sunitinib, which is a protein kinase inhibitor. It is

used to

treat cancer by preventing the activity of a special group of proteins which are known to be

involved in the growth and spread of cancer cells.

Sutent is used to treat adults with the following types of cancer:

Gastrointestinal stromal tumour (GIST), a type of cancer of the stomach and bowel, where

imatinib (another anticancer medicine) no longer works or you cannot take imatinib.

Metastatic renal cell carcinoma (MRCC), a type of kidney cancer that has spread to other

parts of the body.

Pancreatic neuroendocrine tumours (pNET) (tumours of the hormone-producing cells in

the pancreas) that have progressed or cannot be removed with surgery.

If you have any questions about how Sutent works or why this medicine has been prescribed for

you, ask your doctor.

2.

What you need to know before you take Sutent

Do not take Sutent:

If you are allergic to sunitinib or any of the other ingredients of Sutent (listed in section

Warnings and precautions

Talk to your doctor before taking Sutent:

-

If you have high blood pressure.

Sutent can raise blood pressure. Your doctor may

check your blood pressure during treatment with Sutent, and you may be treated with

medicines to reduce the blood pressure, if needed.

If you have or have had blood disease, bleeding problems, or bruising.

Treatment

with Sutent may lead to a higher risk of bleeding or lead to changes in the number of

certain cells in the blood which may lead to

anaemia or affect the ability of your blood to

clot. If you are taking warfarin or acenocoumarole, medicines which thin the blood to

prevent blood clots, there may be a greater risk of bleeding. Tell your doctor if you have

any bleeding while on treatment with Sutent.

If you have heart problems.

Sutent can cause heart problems. Tell your doctor if you

feel very tired, are short of breath, or have swollen feet and ankles.

If you have abnormal heart rhythm changes.

Sutent can cause abnormality of your

heart rhythm. Your doctor may obtain electrocardiograms to evaluate for these problems

during your treatment with Sutent. Tell your doctor if you feel dizzy, faint, or have

abnormal heartbeats while taking Sutent.

If you have had a recent problem with blood clots in your veins and/or arteries

(types of blood vessels), including stroke, heart attack, embolism, or thrombosis.

Call

your doctor immediately if you get symptoms such as chest pain or pressure, pain in your

arms, back, neck or jaw, shortness of breath, numbness or weakness on 1 side of your

body, trouble talking, headache, or dizziness while on treatment with Sutent.

If you have been diagnosed with an enlargement or "bulge" of the large blood aortic

vessel known as aortic aneurysm.

If

you have experienced a previous episode of a tear in the aortic wall known as

aortic dissection.

If you have or have had damage to the smallest blood vessels known as thrombotic

microangiopathy (TMA).

Tell your doctor if you develop fever, fatigue, tiredness,

bruising, bleeding, swelling, confusion, vision loss, and seizures.

If you have thyroid glands problems.

Sutent can cause thyroid gland problems. Tell

your doctor if you get tired more easily, generally feel colder than other people, or your

voice deepens whilst taking Sutent. Your thyroid function should be checked before you

take Sutent and regularly while you are taking it. If your thyroid gland is not producing

enough thyroid hormone, you may be treated with thyroid hormone replacement.

-

If you have or have had pancreatic or gallbladder disorders.

Tell your doctor if you

develop any of the following signs and symptoms: pain in the area of the stomach (upper

abdomen), nausea, vomiting, and fever. These may be caused by inflammation of the

pancreas

or gallbladder.

If you have or have had liver problems.

Tell your doctor if you develop any of the

following signs and symptoms of liver problems during Sutent treatment: itching, yellow

eyes or skin, dark urine, and pain or discomfort in the right upper stomach area. Your

doctor should do blood tests to check your liver function before and during treatment with

Sutent, and as clinically indicated.

If you have or have had kidney problems.

Your doctor will monitor your kidney

function.

If you are going to have surgery or if you had an operation recently.

Sutent may

affect the way your wounds heal. You will usually be taken off Sutent if you are having

an operation. Your doctor will decide when to start Sutent again.

You may be advised to have a dental check-up before you start treatment with

Sutent.

If you have or have had pain in the mouth, teeth and/or jaw, swelling or sores inside

the mouth, numbness or a feeling of heaviness in the jaw, or loosening of a tooth, tell

your doctor and dentist immediately.

If you need to undergo an invasive dental treatment or dental surgery, tell your dentist

that you are being treated with Sutent in particular when you are also receiving or

have received intravenous bisphosphonates. Bisphosphonates are medicines used to

prevent bone complications that may have been given for another medical condition.

If you have or have had skin and subcutaneous tissue disorders.

While you are on this

medicine "pyoderma gangrenosum" (painful skin ulceration) or “necrotising fasciitis”

(rapidly spreading infection of the skin/soft tissue that may be life-threatening) may

occur. Contact your doctor immediately if symptoms of infection occur around a skin

injury, including fever, pain, redness, swelling, or drainage of pus or blood. This event is

generally reversible after sunitinib discontinuation. Severe skin rashes (Stevens-Johnson

syndrome, toxic epidermal necrolysis, erythema multiforme) have been reported with the

use of sunitinib, appearing initially as reddish target-like spots or circular patches often

with central blisters on the trunk. The rash may progress to widespread blistering or

peeling of the skin and may be life-threatening. If you develop a rash or these skin

symptoms, seek immediate advice from a doctor.

If you have or have had seizures.

Notify your doctor as soon as possible if you have

high blood pressure, headache, or loss of sight.

If you have diabetes.

Blood sugar levels in diabetic patients should be checked regularly

in order to assess if antidiabetic medicine’s dosage needs to be adjusted to minimise the

risk of low blood sugar. Notify your doctor as soon as possible if you experience any

signs and symptoms of low blood sugar (fatigue, palpitations, sweating, hunger and loss

of consciousness).

Children and adolescents

Sutent is not recommended for people aged under 18.

Other medicines and Sutent

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other

medicines, including medicines obtained without a prescription and even those not prescribed.

Some medicines can affect the levels of Sutent in your body. You should inform your doctor if

you are taking medicines containing the following active substances:

ketoconazole, itraconazole – used to treat fungal infections

erythromycin, clarithromycin, rifampicin –used to treat infections

ritonavir –used to treat HIV

dexamethasone – a corticosteroid used for various conditions (such as allergic/breathing

disorders or skin diseases)

phenytoin, carbamazepine, phenobarbital – used to treat epilepsy and other neurological

conditions

herbal preparations containing St. John’s Wort (

Hypericum perforatum

) – used to treat

depression and anxiety

Sutent with food and drink

You should avoid drinking grapefruit juice while on treatment with Sutent.

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 might get pregnant, you should use a reliable method of contraception during treatment

with Sutent.

If you are breast-feeding, tell your doctor. You should not breast-feed during treatment with

Sutent.

Driving and using machines

If you experience dizziness or you feel unusually tired, take special care when driving or using

machines.

3.

How to take Sutent

Always take this medicine exactly as your doctor has told you. Check with your doctor if you

are not sure.

Your doctor will prescribe a dose that is right for you, depending on the type of cancer to be

treated. If you are being treated for:

GIST or MRCC: the usual dose is 50 mg once daily taken for 28 days (4 weeks),

followed by 14 days (2 weeks) of rest (no medicine), in 6-week cycles.

pNET: the usual dose is 37.5 mg once daily without a rest period.

Your doctor will determine the appropriate dose you need to take, as well as if and when you

need to stop treatment with Sutent.

Sutent can be taken with or without food.

If you take more Sutent

than you should

If you have accidentally taken too many capsules, talk to your doctor straight away. You may

require medical attention.

If you forget to take Sutent

Do not take a double dose to make up for a forgotten dose.

4.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

You must immediately contact your doctor if you experience any of those serious side effects

(see also

What you need to know before you take Sutent

Heart problems.

Tell your doctor if you feel very tired,

are short of breath, or have swollen feet

and ankles. These may be symptoms of heart problems that may include heart failure and heart

muscle problems (cardiomyopathy).

Lung or breathing problems.

Tell your doctor if you develop cough, chest pain, sudden onset

of shortness of breath, or coughing up blood. These may be symptoms of a condition called

pulmonary embolism that occurs when blood clots travel to your lungs.

Kidney disorders.

Tell your doctor if you experience

altered frequency or absence of urination

which may be symptoms of kidney failure.

Bleeding.

Tell your doctor if you have any of these symptoms or a serious bleeding problem

during treatment with Sutent: painful, swollen stomach (abdomen); vomiting blood; black,

sticky stools; bloody urine; headache or change in your mental status; coughing up of blood or

bloody sputum from the lungs or airway.

Tumour destruction leading to hole in the intestine.

Tell your doctor if you have severe

abdominal pain, fever, nausea, vomiting, blood in your stool, or changes in bowel habits.

Other side effects with Sutent may include:

Very common: may affect more than 1 in 10 people

Reduction in the number of platelets, red blood cells and/or white blood cells (e.g.

neutrophils).

Shortness of breath.

High blood pressure.

Extreme tiredness, loss of strength.

Swelling caused by fluid under the skin and around the eye, deep allergic rash.

Mouth pain/irritation, mouth sores/inflammation/dryness, taste disturbances, upset

stomach, nausea, vomiting, diarrhoea, constipation, abdominal pain/swelling,

loss/decrease of appetite.

Decreased activity of thyroid gland (hypothyroidism).

Dizziness.

Headache.

Nose bleeding.

Back pain, joint pain.

Pain in arms and legs.

Yellow skin/skin discoloration, excess pigmentation of the skin, hair colour change, rash

on the palms of the hands and soles of the feet, rash, dryness of the skin.

Cough.

Fever.

Difficulty in falling asleep.

Common: may affect up to 1 in 10 people

Blood clots in the blood vessels.

Deficiency of blood supply to the heart muscle, due to obstruction or constriction of the

coronary arteries.

Chest pain.

Decreased in the amount of blood pumped by the heart.

Fluid retention including around the lungs.

Infections.

Complication of severe infection (infection is present in the bloodstream) that can lead to

tissue damage, organ failure, and death.

Decreased blood sugar level (see section 2)..

Loss of protein in the urine sometime resulting in swelling.

Influenza-like syndrome.

Abnormal blood tests including pancreatic and liver enzymes.

High level of uric acid in the blood.

Haemorrhoids, pain in the rectum, gingival bleeding, difficulty in swallowing or inability

to swallow.

Burning or painful sensation in the tongue, inflammation of the digestive tract lining,

excessive gas in the stomach or intestine.

Weight loss.

Musculoskeletal pain (pain in muscles and bones), muscular weakness, muscular fatigue,

muscle pain, muscle spasms.

Nasal dryness, congested nose.

Excessive tear flow.

Abnormal sensation of the skin, itching, flaking and inflammation of the skin, blisters,

acne, nail discolouration, hair loss.

Abnormal sensations in extremities.

Abnormally decreased/increased sensitivity, particularly to touch.

Acid heartburn.

Dehydration.

Hot flushes.

Abnormally coloured urine.

Depression.

Chills.

Uncommon: may affect up to 1 in 100 people

Life-threatening infection of the soft tissue including the ano-genital region (see section

Stroke.

Heart attack caused by an interrupted or decreased blood supply to the heart.

Changes in the electrical activity or abnormal rhythm of the heart.

Fluid around the heart (pericardial effusion).

Liver failure.

Pain in the stomach (abdomen) caused by inflammation of the pancreas.

Tumour destruction leading to hole in the intestine (perforation).

Inflammation (swelling and redness) of the gallbladder with or without associated

gallstones.

Abnormal tube like passage from one normal body cavity to another body cavity or the

skin.

Pain in the mouth, teeth and/or jaw, swelling or sores inside the mouth, numbness or a

feeling of heaviness in the jaw, or loosening of a tooth. These could be signs and

symptoms of bone damage in the jaw (osteonecrosis), see section 2.

Overproduction of thyroid hormones which increases the amount of energy the body uses

at rest.

Problems with wound healing after surgery.

Increased blood level of enzyme (creatine phosphokinase) from muscle.

Excessive reaction to an allergen including hay fever, skin rash, itchy skin, hives,

swelling of body parts, and trouble breathing.

Inflammation of the colon (colitis, colitis ischaemic).

Rare: may affect up to 1 in 1,000 people

Severe reaction of the skin and/or mucous membranes (Stevens-Johnson syndrome, toxic

epidermal necrolysis, erythema multiforme).

Tumour lysis syndrome (TLS) – TLS consists of a group of metabolic complications that

can occur during treatment of cancer. These complications are caused by the break-down

products of dying cancer cells and may include the following: nausea, shortness of breath,

irregular heartbeat, muscular cramps, seizure, clouding of urine and tiredness associated

with abnormal laboratory test results (high potassium, uric acid and phosphorous levels

and low calcium levels in the blood) that can lead to changes in kidney function and acute

renal failure.

Abnormal muscle breakdown which can lead to kidney problems (rhabdomyolysis).

Abnormal changes in the brain that can cause a collection of symptoms including

headache, confusion, seizures, and vision loss (reversible posterior leukoencephalopathy

syndrome).

Painful skin ulceration (pyoderma gangrenosum).

Inflammation of the liver (hepatitis).

Inflammation of the thyroid gland.

Damage to the smallest blood vessels known as thrombotic microangiopathy (TMA).

Not known (frequency cannot be estimated from available data):

An enlargement or "bulge" of the aortic vessel or a tear in the aortic wall (aortic

aneurysms and dissections).

Reporting of side effects

If you get any side effects, talk to your doctor. 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.

5.

How to store Sutent

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

Do not use this medicine after the expiry date which is stated on carton, bottle and blister

foil after “EXP”. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

Do not use this medicine if you notice that the pack is damaged or shows 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.

6.

Contents of the pack and other information

What Sutent contains

Sutent 12.5 mg hard capsules

The active substance is sunitinib. Each capsule contains sunitinib malate equivalent to 12.5 mg

sunitinib. The other ingredients are:

Capsule content:

mannitol (E421), croscarmellose sodium, povidone (K-25), and

magnesium stearate.

Capsule shell:

gelatin, red iron oxide (E172), and titanium dioxide (E171).

Printing ink:

shellac, propylene glycol, sodium hydroxide, povidone and titanium dioxide

(E171).

Sutent 25 mg hard capsules

The active substance is sunitinib. Each capsule contains sunitinib malate equivalent to 25 mg.

The other ingredients are:

Capsule content:

mannitol, croscarmellose sodium, povidone (K-25), and magnesium

stearate.

Capsule shell:

gelatin, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide

(E172), black iron oxide (E172).

Printing ink:

shellac, propylene glycol, sodium hydroxide, povidone, and titanium

dioxide (E171).

Sutent 37.5 mg hard capsules

The active substance is sunitinib. Each capsule contains sunitinib malate equivalent to 37.5 mg.

The other ingredients are:

Capsule content:

mannitol, croscarmellose sodium, povidone (K-25), and magnesium

stearate.

Capsule shell:

gelatin, titanium dioxide (E171), yellow iron oxide (E172).

Printing ink:

shellac, propylene glycol, potassium hydroxide, black iron oxide (E172).

Sutent 50 mg hard capsules

The active substance is sunitinib. Each capsule contains sunitinib malate equivalent to 50 mg.

The other ingredients are:

Capsule content:

mannitol, croscarmellose sodium, povidone (K-25), and magnesium

stearate.

Capsule shell:

gelatin, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide

(E172), and black iron oxide (E172).

Printing ink:

shellac, propylene glycol, sodium hydroxide, povidone, and titanium

dioxide (E171).

What Sutent looks like and contents of the pack

Sutent 12.5 mg is supplied as hard gelatin capsules with orange cap and orange body, printed

with white ink “Pfizer” on the cap, “STN 12.5 mg” on the body, containing yellow to orange

granules.

Sutent 25 mg is supplied as hard gelatin capsules with caramel cap and orange body, printed

with white ink “Pfizer” on the cap, “STN 25 mg” on the body, containing yellow to orange

granules.

Sutent 37.5 mg is supplied as hard gelatin capsules with yellow cap and yellow body, printed

with black ink “Pfizer” on the cap, “STN 37.5 mg” on the body, containing yellow to orange

granules.

Sutent 50 mg is supplied as hard gelatin capsules with caramel cap and caramel body, printed

with white ink “Pfizer” on the cap, “STN 50 mg” on the body, containing yellow to orange

granules.

It is available in plastic bottles of 30 capsules and in perforated unit dose blisters containing

28 x 1 capsules.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Pfizer Europe MA EEIG

Boulevard de la Plaine 17

1050 Bruxelles

Belgium

Manufacturer

Pfizer Italia S.r.l.

Via del Commercio – Zona Industriale

63100 Marino del Tronto (Ascoli Piceno)

Italy

For any information about this medicine, please contact the local representative of the

Marketing Authorisation Holder:

Belgique / België /Belgien

Pfizer S.A. / N.V.

Tél/Tel: +32 (0)2 554 62 11

Lietuva

Pfizer Luxembourg SARL filialas Lietuvoje

Tel. + 370 52 51 4000

България

Пфайзер Люксембург САРЛ, Клон България

Тел.: +359 2 970 4333

Luxembourg/Luxemburg

Pfizer S.A.

Tél/Tel: +32 (0)2 554 62 11

Česká republika

Pfizer PFE, spol. s r.o.

Tel.: +420 283 004 111

Magyarország

Pfizer Kft.

Tel.: +36-1-488-37-00

Danmark

Pfizer ApS

Tlf: +45 44 20 11 00

Malta

V.J. Salomone Pharma Ltd.

Tel. +356 21220174

Deutschland

Pfizer Pharma GmbH

Tel: +49 (0)30 550055 51000

Nederland

Pfizer BV

Tel: +31 (0)10 406 43 01

Eesti

Pfizer Luxembourg SARL Eesti filiaal

Tel.: +372 666 7500

Norge

Pfizer Norge AS

Tlf: +47 67 52 61 00

Ελλάδα

Pfizer Ελλάς A.E.

λ: +30 210 6785 800

Österreich

Pfizer Corporation Austria Ges.m.b.H.

Tel: +43 (0)1 521 15-0

España

Pfizer, S.L.

Tél: +34 91 490 99 00

Polska

Pfizer Polska Sp.z.o.o

Tel.:+48 22 335 61 00

France

Pfizer

Tél: +33 (0)1 58 07 34 40

Portugal

Pfizer Biofarmacêutica, Sociedade Unipessoal Lda

Tel: +351 21 423 5500

Hrvatska

Pfizer Croatia d.o.o.

Tel: + 385 1 3908 777

România

Pfizer Romania S.R.L.

Tel: +40 (0) 21 207 28 00

Ireland

Pfizer Healthcare Ireland

Tel: 1800 633 363 (toll free)

+44 (0)1304 616161

Slovenija

Pfizer Luxembourg SARL

Pfizer, podružnica za svetovanje s področja

farmacevtske dejavnosti, Ljubljana

Tel.: + 386 (0)1 52 11 400

Ísland

Icepharma hf.

Sími: +354 540 8000

Slovenská republika

Pfizer Luxembourg SARL, organizačná zložka

Tel.: + 421 2 3355 5500

Italia

Pfizer S.r.l.

Tel: +39 06 33 18 21

Suomi/Finland

Pfizer Oy

Puh./Tel: +358 (0)9 43 00 40

Kύπρος

Pfizer Ελλάς A.E. (Cyprus Branch)

Tηλ.:+ 357 22 817690

Sverige

Pfizer Innovations AB

Tel: +46 (0)8 550 520 00

Latvija

Pfizer Luxembourg SARL filiāle

Latvijā

Tel.: + 371 670 35 775

United Kingdom

Pfizer Limited

Tel: +44 (0) 1304 616161

This leaflet was last revised in {MM/YYYY}.

Detailed information on this medicine is available on the European Medicine Agency website:

http://www.ema.europa.eu.

ANNEX IV

SCIENTIFIC CONCLUSIONS AND GROUNDS FOR THE VARIATION TO THE

TERMS OF THE MARKETING

AUTHORISATION(S)

Scientific conclusions

Taking into account the PRAC Assessment Report on the PSUR(s) for sunitinib, the

scientific conclusions of CHMP are as follows:

Twelve cases of aortic dissection and aneurysm with a possible causal relationship to sunitinib

have been retrieved cumulatively. Based on the evidence from literature, case reports,

pathophysiologic mechanisms considering also some cases occurring in patients without

hypertension, the fatal outcome observed in 26 cases and overall the severity of the ADR, the

product information should be updated to reflect the risk.

A cumulative review of cases related to colitis retrieved 7 cases from clinical trials data and

82 cases from post-marketing for which a causal relationship between the event and sunitinib

could not be excluded. Similarly, a search performed on EV database revealed a total of

81 cases (spontaneous and from studies) cumulatively reported. A disproportionality analysis

used to evaluate the dataset revealed a positive RORs. Finally, colitis and inflammatory bowel

disease are listed for other multi-targeted tyrosine kinase inhibitors with similar targets as

sunitinib.

As a result, sections 4.4 and 4.8 of the Summary of Products Characteristics (SmPC) should be

updated to add ‘aortic aneurysms and dissections’ to the list of adverse reactions with a

frequency not known and to introduce a relevant warning. In addition, section 4.8 of the SmPC

should be updated to add the adverse reactions ‘colitis’ and ‘ischaemic colitis’ with a

frequency uncommon.

The CHMP agrees with the scientific conclusions made by the PRAC.

Grounds for the variation to the terms of the marketing authorisation(s)

On the basis of the scientific conclusions for sunitinib the CHMP is of the opinion that the

benefit-risk balance of the medicinal product(s) containing sunitinib is unchanged subject to

the proposed changes to the product information.

The CHMP recommends that the terms of the marketing authorisation(s) should be varied.