Sorafenib Accord: detailed information

Package leaflet: Information for the patient

Sorafenib Accord 200 mg film-coated tablets

sorafenib
Please 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 questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any adverse reactions, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Sorafenib Accord is and what it is used for
What you need to know before taking Sorafenib Accord
How to take Sorafenib Accord
Possible side effects
How to store Sorafenib Accord
Contents of the pack and other information

1. What Sorafenib Accord is and what it is used for

Sorafenib Accord is used to treat hepatocellular carcinoma.
Sorafenib Accord is also used to treat kidney cancer (advanced renal cell carcinoma) when it has reached an advanced stage and when standard therapy has failed to control it or is considered unsuitable.
Sorafenib Accord is used to treat thyroid cancer (differentiated thyroid carcinoma).
Sorafenib Accord is a so-called multikinase inhibitor. It works by slowing down the rate of growth of tumour cells and by blocking the blood supply that allows tumour cells to grow.

2. What you should know before taking Sorafenib Accord

Do not take Sorafenib Accord

if you are allergic to sorafenib or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before taking Sorafenib Accord.
Take special care with Sorafenib Accord, especially if

skin problems occur. Sorafenib Accord may cause rashes and skin reactions, particularly on the hands and feet. These effects can usually be managed by your doctor. Otherwise, your doctor may suspend or completely discontinue treatment.
you have high blood pressure. Sorafenib Accord may increase blood pressure; your doctor will monitor your blood pressure regularly and may prescribe medication to manage high blood pressure.
you have or have had an aneurysm (a weakened and dilated blood vessel wall) or a tear in the wall of a blood vessel.
you have diabetes. Blood glucose levels should be monitored regularly in diabetic patients to assess whether the dose of anti-diabetic medication needs adjustment, in order to minimize the risk of low blood sugar levels.
you have bleeding problems or are taking warfarin or fenprocouone. Treatment with Sorafenib Accord may increase the risk of bleeding. If you are taking warfarin or fenprocumone—medicines that thin the blood to prevent clot formation—there may be an increased risk of bleeding.
you have chest pain or heart problems. Your doctor may decide to suspend or completely discontinue treatment.
you have a heart disorder, such as an electrical conduction abnormality known as “QT interval prolongation.”
you are scheduled for or have recently undergone surgery. Sorafenib Accord may affect wound healing. If you are about to undergo surgery, your treatment with Sorafenib Accord will likely be suspended. Your doctor will decide when to restart it.
you are receiving treatment with irinotecan or docetaxel, which are also anticancer medicines. Sorafenib Accord may enhance the effects of these medicines, particularly their adverse effects.
you are taking neomycin or other antibiotics. The effectiveness of Sorafenib Accord may be reduced.
you have severe liver impairment. You may experience worsening of adverse effects while taking this medicine.
you have reduced kidney function. Your doctor will monitor your fluid and electrolyte balance.
Fertility. Sorafenib Accord may reduce fertility in both men and women. If this is a concern, discuss it with your doctor.
Gastrointestinal perforation may occur during treatment (see section 4: Possible side effects). In such cases, your doctor will discontinue treatment.
if you have thyroid cancer, your doctor will monitor calcium and thyroid hormone levels in your blood.
If you experience any of the following symptoms, contact your doctor immediately, as they may indicate a potentially life-threatening condition: nausea, shortness of breath, irregular heartbeat, muscle cramps, seizures, cloudy urine, and fatigue. These symptoms may be caused by a series of metabolic complications that can occur during cancer treatment due to the breakdown products of killed tumor cells (tumor lysis syndrome, TLS), which may lead to impaired kidney function and acute kidney failure (see also section 4: Possible side effects).

Inform your doctor if any of these conditions apply to you. You may require treatment for these conditions, or your doctor may adjust your dose of Sorafenib Accord, or discontinue treatment altogether (see also section 4: Possible side effects).
Children and adolescents
Sorafenib has not yet been studied in children and adolescents.
Other medicines and Sorafenib Accord
Some medicines may affect Sorafenib Accord or be affected by it. Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines:

Rifampicin, neomycin, or other medicines used to treat infections (antibiotics)
Hypericum perforatum, also known as “St. John’s wort,” a herbal remedy for depression
Phenytoin, carbamazepine, or phenobarbital, treatments for epilepsy and other conditions
Dexamethasone, a corticosteroid used for various diseases
Warfarin or fenprocumone, anticoagulants used to prevent blood clots
Doxorubicin, capecitabine, docetaxel, paclitaxel, and irinotecan, used in the treatment of cancers
Digoxin, used in the treatment of mild to moderate heart failure

Pregnancy and breastfeeding
Avoid becoming pregnant while being treated with Sorafenib Accord. If you are of childbearing age, you must use an effective method of contraception during treatment with Sorafenib Accord.
If you become pregnant while being treated with Sorafenib Accord, inform your doctor immediately; your doctor will decide whether treatment should continue or be discontinued.
You must not breastfeed during treatment with Sorafenib Accord, as this medicine may interfere with the growth and development of the infant.
Driving and using machines
There are no known reasons to believe that Sorafenib Accord affects the ability to drive vehicles or operate machinery.
Sorafenib Accord contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e., essentially “sodium-free”.

3. How to take Sorafenib Accord

The recommended dose of Sorafenib Accord in adults is two 200 mg tablets twice daily.
This corresponds to a daily dose of 800 mg, or four tablets per day.
Take the Sorafenib Accord tablets with a glass of water, on an empty stomach or with food low or
moderately high in fat. Do not take this medicine with high-fat meals, as these may reduce its efficacy.
If you plan to eat a high-fat meal, take the tablets at least 1 hour before or 2 hours after the meal.
Always take this medicine exactly as instructed by your doctor. If you have any doubts, consult your
doctor or pharmacist.
It is important to take this medicine approximately at the same time each day to maintain a constant
concentration in the blood.
This medicine is usually taken for as long as clinical benefit is observed and intolerable side effects
are not experienced.
If you take more Sorafenib Accord than you should
Inform your doctor immediately if you, or anyone else, have taken more than the prescribed dose.
Taking too much Sorafenib Accord may make side effects more likely or more severe, especially
diarrhoea and skin reactions. Your doctor may instruct you to stop taking this medicine.
If you forget to take Sorafenib Accord
If you forget to take a dose, take it as soon as you remember. If it is almost time for your next dose,
skip the missed dose and take the next dose at the usual time. 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 everyone gets them. This medicine may also alter the results of certain blood tests.

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

diarrhoea
feeling unwell (nausea)
feeling weak or tired (fatigue)
pain (including mouth, abdominal pain, headache, bone pain, pain at tumour site)
hair loss (alopecia)
redness or pain on the palms of the hands or soles of the feet (hand-foot skin reaction)
itching or skin rash
vomiting
bleeding (including brain haemorrhage, intestinal wall bleeding, respiratory tract bleeding; haemorrhage)
high blood pressure, or increase in blood pressure (hypertension)
infections
loss of appetite (anorexia)
constipation
joint pain (arthralgia)
fever
weight loss
dry skin

Common side effects: (may affect up to 1 in 10 people)

flu-like illness
indigestion (dyspepsia)
difficulty swallowing (dysphagia)
inflammation or dryness of the mouth, tongue pain (stomatitis and mucosal inflammation)
low levels of calcium in the blood (hypocalcaemia)
low levels of potassium in the blood (hypokalaemia)
low levels of glucose in the blood (hypoglycaemia)
muscle pain (myalgia)
disturbances in sensation of fingers and toes, including tingling and numbness (peripheral sensory neuropathy)
depression
erection problems (impotence)
voice changes (dysphonia)
acne
inflamed, dry or peeling skin (dermatitis, skin desquamation)
heart failure
heart attack (myocardial infarction) or chest pain
tinnitus (ringing in the ears)
kidney failure
high levels of protein in the urine (proteinuria)
general weakness or loss of strength (asthenia)
reduced number of white blood cells (leucopenia and neutropenia)
reduced number of red blood cells (anaemia)
low platelet count in the blood (thrombocytopenia)
inflammation of hair follicles (folliculitis)
reduced thyroid activity (hypothyroidism)
low levels of sodium in the blood (hyponatraemia)
changes in taste sensation (dysgeusia)
redness of the face and often other areas of the skin (flushing)
runny nose (rhinorrhoea)
heartburn (gastro-oesophageal reflux disease)
skin tumour (keratoacanthoma/squamous cell carcinoma of the skin)
thickening of the outer layer of the skin (hyperkeratosis)
sudden involuntary muscle contraction (muscle spasms)

Uncommon side effects: (may affect up to 1 in 100 people)

inflammation of the stomach (gastritis)
stomach (abdominal) pain due to pancreatitis, inflammation of the gallbladder and/or bile ducts
yellowing of the skin or eyes (jaundice) caused by high levels of bile pigments (hyperbilirubinaemia)
allergic-type reactions (including skin reactions and hives)
dehydration
breast enlargement (gynaecomastia)
difficulty breathing (lung disease)
eczema
overactivity of the thyroid gland (hyperthyroidism)
multiple skin rashes (erythema multiforme)
unusually high blood pressure
gastrointestinal perforation
reversible swelling in the back part of the brain which may be associated with headache, altered consciousness, seizures and visual symptoms, including loss of vision (reversible posterior leucoencephalopathy syndrome)
sudden, severe allergic reaction (anaphylactic reaction)

Rare side effects: (may affect up to 1 in 1,000 people)

allergic reaction with swelling of the skin (e.g. face, tongue) which may cause difficulty in breathing and swallowing (angioedema)
abnormal heart rhythm (QT prolongation)
inflammation of the liver, which may lead to nausea, vomiting, abdominal pain and jaundice (drug-induced hepatitis)
appearance of a sunburn-like rash on skin previously exposed to radiotherapy, which may be severe (radiation recall dermatitis)
severe skin and/or mucous membrane reactions which may include painful blisters and fever, with shedding of large areas of skin (Stevens-Johnson syndrome and toxic epidermal necrolysis)
abnormal muscle damage which may lead to kidney problems (rhabdomyolysis)
kidney damage causing loss of large amounts of protein in the urine (nephrotic syndrome)
inflammation of blood vessels in the skin which may appear as a rash (leucocytoclastic vasculitis)

Side effects not known:
frequency cannot be estimated from the available data

impaired brain function which may be associated with, for example, drowsiness, behavioural changes, or confusion (encephalopathy)
dilation and weakening of the wall of a blood vessel or a tear in the wall of a blood vessel (arterial aneurysms and dissections)
nausea, shortness of breath, irregular heartbeat, muscle cramps, seizures, cloudy urine and fatigue [tumour lysis syndrome (TLS)] (see section 2)

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system referred to in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Sorafenib Accord

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after Exp. and on each blister after EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Sorafenib Accord contains

The active substance is sorafenib. Each film-coated tablet contains 200 mg of sorafenib (as tosylate).
The other components are: Tablet core: croscarmellose sodium, microcrystalline cellulose, hypromellose, sodium lauryl sulfate, and magnesium stearate. See section 2 “Sorafenib Accord contains sodium”.

Tablet coating: hypromellose (E464), macrogol (E1521), titanium dioxide (E171), and red iron
oxide (E172)
Description of the appearance of Sorafenib Accord and contents of the pack
The 200 mg film-coated tablets of Sorafenib Accord are red, round, biconvex, with bevelled edges, 12.0 mm in diameter, marked with “H1” on one side and smooth on the other.
Aluminium-aluminium single-dose perforated blisters, packs of 112x1 film-coated tablets in cardboard
box.
Marketing Authorisation Holder
Accord Healthcare S.L.U.
World Trade Center, Moll de Barcelona, s/n
Edifici Est, 6 Planta
08039 Barcelona
Spain
Manufacturer
Accord Healthcare Polska Sp. z o.o.
ul. Lutomierska 50
95-200, Pabianice
Poland
Pharmadox Healthcare Limited
KW20A Kordin Industrial Estate
Paola PLA 3000
Malta
Accord Healthcare B.V.
Winthontlaan 200,
3526 KV Utrecht
The Netherlands
For further information about this medicinal product, please contact the local representative of the
Marketing Authorisation Holder:
AT / BE / BG / CY / CZ / DE / DK / EE / FI / FR / HR / HU / IE / IS / IT / LT / LV / LU / MT / NL
/ NO / PT / PL / RO / SE / SI / SK / ES
Accord Healthcare S.L.U.
Tel: +34 93 301 00 64
EL
Win Medica A.E.
Tel: +30 210 7488 821
Other sources of information
More detailed information on this medicinal product is available on the website of the European
Medicines Agency: http://www.ema.europa.eu .