Nexavar
Italy
Table of Contents
Package leaflet: Information for the user
Nexavar 200 mg film-coated tablets
sorafenib
Please read all of this leaflet carefully before 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 others, even if their symptoms are the same as yours, as it may be harmful.
- If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.
Contents of this leaflet:
- What Nexavar is and what it is used for
- What you need to know before taking Nexavar
- How to take Nexavar
- Possible side effects
- How to store Nexavar
- Contents of the pack and other information
1. What Nexavar is and what it is used for
Nexavar is used for the treatment of hepatocellular carcinoma.
Nexavar is also used in the treatment of kidney cancer (advanced renal cell carcinoma) when
it is in an advanced stage and when standard therapy has not been effective in stopping it or is
considered unsuitable.
Nexavar is used for the treatment of thyroid cancer (differentiated thyroid carcinoma).
Nexavar is a so-called multikinase inhibitor. It works by slowing down the growth rate of tumor
cells and blocking the blood supply that enables tumor cells to grow.
2. What you need to know before taking Nexavar
Do not take Nexavar
- 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 Nexavar.
Be especially careful with Nexavar, particularly if
-
you develop skin problems. Nexavar can cause rashes and skin reactions, especially on the hands and feet. These effects can usually be managed by your doctor. Otherwise, your doctor may suspend or completely stop treatment.
-
you have high blood pressure. Nexavar can cause an increase in blood pressure; your doctor will monitor your blood pressure regularly and may prescribe medication to treat high blood pressure.
-
you have or have had an aneurysm (a bulging and weakening of a blood vessel wall) or a tear in the wall of a blood vessel.
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you have diabetes. In diabetic patients, blood glucose levels should be monitored regularly to assess whether the dose of anti-diabetic medication needs to be adjusted to minimize the risk of low blood sugar levels.
-
you have bleeding problems or are taking warfarin or fenprocoumon. Treatment with Nexavar may increase the risk of bleeding. If you are taking warfarin or fenprocoumon, 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 stop treatment.
-
you have a heart disorder, such as an electrical conduction abnormality known as "QT interval prolongation".
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you are about to undergo or have recently undergone surgery. Nexavar may affect wound healing. If you are scheduled for surgery, your treatment with Nexavar will likely be stopped temporarily. Your doctor will decide when to restart it.
-
you are being treated with irinotecan or docetaxel, which are also anticancer medicines. Nexavar may increase the effects and, in particular, the side effects of these medicines.
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you are taking neomycin or other antibiotics. The effectiveness of Nexavar may be reduced.
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you have severe liver impairment. You may experience a worsening of side effects when taking this medicine.
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you have reduced kidney function. Your doctor will monitor your fluid and electrolyte balance.
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Fertility. Nexavar may reduce fertility in both men and women. If you are concerned about this, discuss it with your doctor.
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Gastrointestinal perforation may occur during treatment (see section 4: Possible side effects). In such a case, your doctor will stop treatment.
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if you have a thyroid tumor, your doctor will monitor calcium and thyroid hormone levels in your blood.
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if you experience any of the following symptoms, contact your doctor immediately, as this could be 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 tumor treatment due to the breakdown products of dying 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 Nexavar or stop treatment altogether (see also section 4: Possible side effects).
Children and adolescents
Nexavar has not yet been studied in children and adolescents.
Other medicines and Nexavar
Some medicines may affect Nexavar or be affected by it. Inform your doctor or pharmacist if you are taking, have recently taken, or might take any of the medicines listed below or any other medicine, including those without a prescription:
- 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 fenprocoumon, anticoagulants used to prevent blood clots
- Doxorubicin, capecitabine, docetaxel, paclitaxel, and irinotecan, used in the treatment of cancer
- Digoxin, used in the treatment of mild to moderate heart failure
Pregnancy and breastfeeding
Avoid becoming pregnant while being treated with Nexavar. If you are of childbearing age, you must use an effective method of contraception during treatment with Nexavar. If you become pregnant while taking Nexavar, inform your doctor immediately; they will decide whether treatment should continue or be stopped.
You must not breastfeed during treatment with Nexavar, 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 Nexavar affects the ability to drive vehicles or operate machinery.
Nexavar contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e., essentially "sodium-free".
3. How to take Nexavar
The recommended dose of Nexavar in adults is two 200 mg tablets twice daily.
This corresponds to a daily dose of 800 mg, or four tablets per day.
Take Nexavar tablets with a glass of water, on an empty stomach or with low- to medium-fat food. Do not take this medicine with high-fat meals, as they may reduce its effectiveness. 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 your doctor has instructed. If you have any doubts, consult your doctor or pharmacist.
It is important to take this medicine at approximately the same time each day to maintain a constant concentration in the blood.
This medicine is usually taken for as long as you are deriving clinical benefit and are not experiencing intolerable side effects.
If you take more Nexavar than you should
Inform your doctor immediately if you, or anyone else, have taken more than the prescribed dose. Taking too much Nexavar increases the likelihood or severity of side effects, especially diarrhoea and skin reactions. Your doctor may instruct you to stop taking this medicine.
If you forget to take Nexavar
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 tablet.
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:
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, cancer-related pain)
- hair loss (alopecia)
- redness or pain on the palms of the hands or soles of the feet (hand-foot skin reaction)
- itching or rash
- vomiting
- bleeding (including brain haemorrhage, intestinal wall bleeding, and respiratory tract bleeding)
- high blood pressure, or increase in blood pressure (hypertension)
- infections
- loss of appetite (anorexia)
- constipation
- joint pain (arthralgia)
- fever
- weight loss
- dry skin
Common:
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)
- reduction in the number of white blood cells (leucopenia and neutropenia)
- reduction in the number of red blood cells (anaemia)
- low number of platelets in the blood (thrombocytopenia)
- inflammation of hair follicles (folliculitis)
- reduced activity of the thyroid gland (hypothyroidism)
- low levels of sodium in the blood (hyponatraemia)
- changes in taste (dysgeusia)
- redness of the face and often other areas of the skin (flushing)
- runny nose (rhinorrhoea)
- heartburn (gastroesophageal reflux disease)
- skin tumour (keratoacanthoma/squamous cell carcinoma)
- thickening of the outer layer of the skin (hyperkeratosis)
- sudden involuntary muscle contraction (muscle spasms)
Uncommon:
may affect up to 1 in 100 people
- inflammation of the stomach (gastritis)
- stomach pain (abdomen) 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 (hyperbilirubinemia)
- allergic-type reactions (including skin reactions and urticaria)
- dehydration
- breast enlargement (gynaecomastia)
- difficulty breathing (lung disease)
- eczema
- overactivity of the thyroid gland (hyperthyroidism)
- multiple skin rashes (erythema multiforme)
- 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 leukoencephalopathy syndrome)
- sudden, severe allergic reaction (anaphylactic reaction)
Rare:
may affect up to 1 in 1,000 people
- allergic reaction with swelling of the skin (e.g. face, tongue) which may cause difficulty 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 on previously radiotherapy-exposed skin of a sunburn-like rash, which may be severe (radiation recall dermatitis)
- severe skin and/or mucosal 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)
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 (aneurysms and arterial dissections)
- nausea, shortness of breath, irregular heartbeat, muscle cramps, seizures, cloudy urine and tiredness [tumour lysis syndrome (TLS)] (see section 2).
Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store Nexavar
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.
Do not store this medicine above 25°C.
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 Nexavar 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.
Tablet coating: hypromellose, macrogol, titanium dioxide (E 171) and red iron oxide (E 172).
Description of the appearance of Nexavar and contents of the pack
The 200 mg film-coated tablets of Nexavar are red, round, biconvex, with the Bayer cross on one side and "200" on the other.
They are available in cartons containing 112 tablets, packed in four transparent calendar blisters with 28 tablets each.
Marketing Authorization Holder
Bayer AG
51368 Leverkusen
Germany
Manufacturer
Bayer AG
Kaiser-Wilhelm-Allee
51368 Leverkusen
Germany
For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder.
België/Belgique/Belgien Lietuva
Bayer SA-NV UAB Bayer
Tél/Tel: +32-(0)2-535 63 11 Tel. +37 05 23 36 868
България Luxembourg/Luxemburg
Байер България ЕООД Bayer SA-NV
Тел.: +359 (0)2 424 72 80 Tél/Tel: +32-(0)2-535 63 11
Česká republika Magyarország
Bayer s.r.o. Bayer Hungária KFT
Tel: +420 266 101 111 Tel:+36 14 87-41 00
Danmark Malta
Bayer A/S Alfred Gera and Sons Ltd.
Tlf: +45 45 23 50 00 Tel: +35 621 44 62 05
Deutschland Nederland
Bayer Vital GmbH Bayer B.V.
Tel: +49 (0)214-30 513 48 Tel: +31-(0)23-799 1000
Eesti Norge
Bayer OÜ Bayer AS
Tel: +372 655 8565 Tlf: +47 23 130 500
Ελλάδα Österreich
Bayer Ελλάς ΑΒΕΕ Bayer Austria Ges.m.b.H.
Τηλ: +30 210 61 87 500 Tel: +43-(0)1-711 46-0
España Polska
Bayer Hispania S.L. Bayer Sp. z o.o.
Tel: +34-93-495 65 00 Tel: +48 22 572 35 00
France Portugal
Bayer HealthCare Bayer Portugal, Lda.
Tél (N° vert): +33-(0)800 87 54 54 Tel: +351 21 416 42 00
Hrvatska România
Bayer d.o.o. SC Bayer SRL
Tel: +385-(0)1-6599 900 Tel: +40 21 529 59 00
Ireland Slovenija
Bayer Limited Bayer d. o. o.
Tel: +353 1 216 3300 Tel: +386 (1) 58 14 400
Ísland Slovenská republika
Icepharma hf. Bayer spol. s r.o.
Sími: +354 540 8000 Tel. +421 2 59 21 31 11
Italia Suomi/Finland
Bayer S.p.A. Bayer Oy
Tel: +39 02 397 81 Puh/Tel: +358 20 785 21
Κύπρος Sverige
NOVAGEM Limited Bayer AB
Τηλ: +357 22 48 38 58 Tel: +46 (0) 8 580 223 00
Latvija United Kingdom (Northern Ireland)
SIA Bayer Bayer AG
Tel: +371 67 84 55 63 Tel: +44-(0)118 206 3000
More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu