200 mg film-coated tablets
sorafenib
What Nexavar is and what it is used for
Nexavar is used to treat liver cancer (hepatocellular carcinoma).
Nexavar is also used to treat kidney cancer (advanced kidney cell cancer) at an advanced stage when standard treatment has not been able to stop your disease or is not considered appropriate.
Nexavar is used to treat thyroid cancer (differentiated thyroid cancer).
Nexavar is a so-called multikinase inhibitor. The drug works by reducing the growth of cancer cells and by reducing the blood flow that allows cancer cells to grow.
What you need to know before you take Nexavar
Do not take Nexavar
- if you are allergic to sorafenib or any of the other ingredients of this medicine (listed in section 6).
Warnings and cautions
Talk to your doctor or pharmacist before taking Nexavar.
Take special care with Nexavar
- If you have skin problems . Nexavar can cause rashes and skin reactions, especially on the hands and feet. These can usually be treated by your doctor. If not, it may mean that your doctor prescribes a break in treatment or that it is stopped completely.
- If you have high blood pressure . Nexavar may raise blood pressure . Your doctor will usually want to check your blood pressure and possibly treat high blood pressure .
- If you have or have had an aneurysm (enlargement and weakening of a vessel wall) or a rupture in a vessel wall.
- If you have diabetes . The blood sugar level in diabetic patients should be checked regularly to assess whether the dose of one of the diabetes medicines needs to be adjusted, in order to minimize the risk of low blood sugar.
- If you have bleeding problems , or if you are being treated with warfarin or fenprocoumon. Treatment with Nexavar may lead to an increased risk of bleeding. If you are being treated with warfarin or fenprocoumon, medicines that thin the blood, there may be an increased risk of bleeding.
- If you get chest pain or heart problems . Your doctor may decide to stop the treatment or stop it altogether.
- If you have a heart rhythm disorder , such as abnormal electrical conduction in the heart’s conduction system, so-called “extension of the QT interval”.
- If you are going to have an operation, or if you have recently had an operation. Nexavar may affect your wound healing. Usually, a break in the Nexavar treatment will be made if you are going to have surgery. Your doctor will decide when treatment can start again.
- If you are taking irinotecan or are being treated with docetaxel, which are also medicines for cancer. Nexavar can increase the effect, and especially the side effects , of these medicines.
- If you are taking Neomycin or other antibiotics . The effect of Nexavar may be reduced.
- If you have severe hepatic impairment. You may experience more severe side effects when taking this medicine.
- If you have impaired kidney function. Your doctor will check your fluid and salt balance (electrolyte balance).
- Fertility . Nexavar may reduce fertility in both men and women. If you are worried, talk to your doctor.
- Holes in the intestinal wall ( gastrointestinal perforation ) may occur during treatment (see section 4: Possible side effects ) . If this happens, your doctor will want to stop the treatment.
- If you have thyroid cancer. Your doctor will check the level of calcium and thyroid hormone in the blood.
Tell your doctor if any of the above apply to you. You may need treatment for the problem or your doctor may decide to change the dose of Nexavard, or stop treatment altogether (see also section 4: Possible side effects ).
Children and young people
Nexavar has not yet been tested in children and adolescents.
Other medicines and Nexavar
Nexavar may affect or be affected by other medicines. Tell your doctor or pharmacist if you are taking, have recently taken, or might take any of the following products or other medicines, including medicines obtained without a prescription:
- Rifampicin, Neomycin or other medicines that treat infection ( antibiotics )
- St. John’s wort , a natural remedy for depression
- Phenytoin , carbamazepine or phenobarbital, treatment used in epilepsy and other diseases
- Dexamethasone, a corticosteroid used in various medical conditions
- Warfarin or fenprocoumon, blood thinners used to treat blood clots
- Doxorubicin, capecitabine, docetaxel, paclitaxel and irinotecan, which are cancer drugs
- Digoxin , a treatment for mild to moderate heart failure
Pregnancy and breastfeeding
Avoid getting pregnant while you are being treated with Nexavar. If you are likely to become pregnant, use a safe contraceptive during treatment. If you become pregnant during treatment with Nexavar, talk to your doctor immediately, who will decide whether to continue treatment.
You must not breastfeed your baby during treatment with Nexavar as this medicine may affect the growth and development of your baby.
Driving and using machines
There is no evidence that Nexavar affects the ability to drive or use machines.
Nexavar contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per dose, ie essentially ‘sodium-free’. is next to “sodium-free”.
How to take Nexavar
The recommended dose of one of Nexavar tablets for adults is 2 x 200 mg twice daily.
This is the same as a daily dose of 800 mg or 4 tablets daily.
Swallow the Nexavar tablets with a glass of water, either without food or with a low-fat meal. Do not take this medicine with a high-fat meal as it may reduce the effect of Nexavar. 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 told you. Ask your doctor or pharmacist if you are unsure.
It is important to take this medicine at about the same time each day so that there is the same amount of medicine in your blood at all times.
You will usually be treated with this medicine as long as you benefit from the treatment and do not suffer from unacceptable side effects.
If you take more Nexavar than you should
Talk to your doctor immediately if you (or anyone else) have taken more than the prescribed dose. Taking too much Nexavar causes a greater risk of side effects or more pronounced side effects, especially diarrhea and skin reactions. Your doctor may advise 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 near the time of the next dose, ignore the missed dose and continue as previously prescribed.
Do not take a double dose to make up for a single forgotten dose.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. This medicine may also affect the results of certain blood tests.
Very common: may affect more than 1 user in 10
- diarrhea
- nausea
- feeling of abnormal weakness or fatigue (fatigue)
- pain (including pain in the mouth, abdominal pain, headache, pain in the bones and bones, tumor pain)
- hair loss ( alopecia )
- redness or pain in hands or soles of the feet (hand-foot-skin reaction)
- itching or rash
- vomiting
- bleeding (including bleeding in the brain, intestines and airways)
- high blood pressure or increase in blood pressure ( hypertension )
- infection is
- loss of appetite ( anorexia )
- constipation
- joint pain ( arthralgia )
- fever
- weight loss
- dry skin
Common: may affect up to 1 in 10 users
- flu-like illness
- indigestion ( dyspepsia )
- difficulty swallowing ( dysphagia )
- inflamed or dry mouth, pain in the tongue ( stomatitis and mucositis)
- low levels of calcium in the blood ( hypocalcaemia )
- low levels of potassium in the blood ( hypokalaemia )
- low blood sugar levels ( hypoglycaemia )
- muscle pain ( myalgia )
- altered sensation in fingers and toes, including tingling and numbness ( peripheral sensory neuropathy )
- Depression
- erection problem ( impotence )
- voice change ( dysphonia )
- acne
- inflamed, dry or scaly skin ( dermatitis , skin desquamation)
- heart failure
- heart attack (heart attack) or chest pain
- tinnitus (ringing sound in the ears)
- kidney failure
- abnormally high levels of protein in the urine ( proteinuria )
- pronounced weakness or weakness ( asthenia )
- decreased white blood cell count ( leukopenia and neutropenia )
- decreased number of red blood cells ( anemia )
- decreased platelet count ( thrombocytopenia )
- inflammation of hair follicles ( folliculitis )
- hypothyroidism _
- low level of sodium in the blood ( hyponatremia )
- taste changes ( dysgeusia )
- redness of the face and often other skin areas (swelling)
- runny nose ( rhinorrhea )
- heartburn ( gastroesophageal reflux )
- skin cancer (keratoacanthoma or squamous cell carcinoma of the skin)
- thickening of the outer layer of skin ( hyperkeratosis )
- sudden, involuntary muscle contractions (muscle spasms)
Uncommon: may affect up to 1 in 100 people
- inflamed gastric mucosa ( gastritis )
- abdominal pain caused by inflammation of the pancreas, inflammation of the gallbladder and / or bile ducts
- yellow skin or yellow whites of the eyes (jaundice) caused by elevated levels of bile pigment (hyperbilirubinemia)
- allergy-like reactions (including skin reaction and hives)
- dehydration
- enlarged breasts ( gynecomastia )
- breathing difficulties ( lung disease )
- eczema
- increased thyroid function (hyperthyroidism)
- skin rash with blisters (erythema multiforme)
- abnormally high blood pressure
- hole in the intestinal wall ( gastrointestinal perforation )
- temporary swelling of the back of the brain which can cause headaches, altered consciousness, seizures and changes in vision including vision loss ( reversible posterior leukoencephalopathy)
- sudden, severe allergic reaction ( anaphylactic reaction )
Rare:
can occur in up to 1 in 1,000 users
- allergic reaction with swelling of the skin (eg on the face, on the tongue) which may lead to difficulty breathing or swallowing ( angioedema )
- abnormal heart rhythm ( QT prolongation)
- inflammation of the liver that can lead to nausea, vomiting, abdominal pain and jaundice (drug-induced hepatitis )
- sunburn-like rash that can occur on skin that has previously been exposed to radiation therapy and that can become serious (“radiation recall” – dermatitis )
- severe reactions in the skin and / or mucous membranes that can cause painful blisters and fever, as well as skin that loosens ( Stevens-Johnson syndrome and toxic epidermal necrolysis )
- abnormal muscle breakdown that can lead to kidney problems ( rhabdomyolysis )
- damage to the kidneys that leads to the leakage of large amounts of protein ( nephrotic syndrome )
- inflammation of the blood vessels in the skin that can result in rash (leukocytoclastic vasculitis ) .
No known frequency: can not be calculated from the available data
- Impairment of brain function that can be linked to e.g. drowsiness, behavioral changes or confusion ( encephalopathy )
- An enlargement and weakening of a vessel wall or a rupture in a vessel wall ( aneurysms and arterial dissections) .
How to store Nexavar
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 each blister after EXP. The expiration date is the last day of the specified month.
This medicine should not be stored above 25 ° C.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the pack and other information
Content declaration
- The active substance is sorafenib. Each film-coated tablet contains 200 mg sorafenib (as tosylate).
- Other ingredients are:Tablet core: Croscarmellose sodium, microcrystalline cellulose, hypromellose, sodium lauryl sulphate, magnesium stearate.Tablet cover: Hypromellose, macrogol, titanium dioxide (E 171), red iron oxide (E 172).
What the medicine looks like and contents of the pack
Nexavar 200 mg film-coated tablets are red and round, marked with the Bavarian cross on one side and “200” on the other side. They are available in calendar packs of 112 tablets: four transparent blister packs with 28 tablets in each.
Marketing Authorisation Holder
Bayer AG
51368 Leverkusen
Germany
Manufacturer
Bayer AG
Kaiser-Wilhelm-Allee
51368 Leverkusen
Germany
Bayer HealthCare Manufacturing Srl.
Via Delle Groaned, 126
20024 Garbagnate Milanese
Italy