What Rafenex is and what it is used for?
Rafenex is used to treat liver cancer (hepatocellular carcinoma).
Rafenex is also used to treat kidney cancer (advanced renal cell carcinoma) at an advanced stage when standard therapy has not helped to stop your disease or is considered unsuitable.
Rafenex is used to treat thyroid cancer (differentiated thyroid carcinoma).
Rafenex is a so-called multikinase inhibitor. It works by slowing down the rate of growth of cancer cells and cutting off the blood supply that keeps cancer cells growing.
Before you take Rafenex
Do not take Rafenex
Warnings and precautions
Talk to your doctor or pharmacist before taking Rafenex.
Take special care with Rafenex:
Children and adolescents
Children and adolescents have not yet been tested with Rafenex.
Other medicines and Rafenex
Some medicines may affect Rafenex, or be affected by it. Tell your doctor or pharmacist if you are taking, have recently taken or might take anything in this list or any other medicines, including medicines obtained without a prescription:
Rifampicin, Neomycin or other medicines used to treat infections (antibiotics)
St John’s wort, a herbal treatment for depression
Phenytoin, carbamazepine or phenobarbital, treatments for epilepsy and other conditions
Dexamethasone, a corticosteroid used for various conditions
Warfarin or phenprocoumon, anticoagulants used to prevent blood clots
Doxorubicin, capecitabine, docetaxel, paclitaxel and irinotecan, which are cancer treatments
Digoxin, a treatment for mild to moderate heart failure
Pregnancy and breast-feeding
Avoid becoming pregnant while being treated with Rafenex. If you could become pregnant use adequate contraception during treatment. If you become pregnant while being treated with Rafenex, immediately tell your doctor who will decide if the treatment should be continued.
You must not breast-feed your baby during Rafenex treatment, as this medicine may interfere with the growth and development of your baby.
Driving and using machines
There is no evidence that Rafenex will affect the ability to drive or to operate machines.
How to take Rafenex?
The recommended dose of Rafenex in adults is 2 x 200 mg tablets, twice daily.
This is equivalent to a daily dose of 800 mg or four tablets a day.
Swallow Rafenex tablets with a glass of water, either without food or with a low-fat or moderate fat meal. Do not take this medicine with high fat meals, as this may make Rafenex less effective. If you intend to have 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 to. Check with your doctor or pharmacist if you are not sure.
It is important to take this medicine at about the same times each day, so that there is a steady amount in the bloodstream.
You will usually carry on taking this medicine as long as you are getting clinical benefits, and not suffering unacceptable side effects.
If you take more Rafenex than you should
Tell your doctor straight away if you (or anyone else) have taken more than your prescribed dose. Taking too much Rafenex makes side effects more likely or more severe, especially diarrhea and skin reactions. Your doctor may tell you to stop taking this medicine.
If you forget to take Rafenex
If you have missed a dose, take it as soon as you remember. If it is nearly time for the next dose, forget about the missed one and carry on as normal. Do not take a double dose to make up for forgotten individual doses.
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 some blood tests.
Very common side effects (may affect more than 1 in 10 people):
Diarrhea, feeling sick (nausea), feeling weak or tired (fatigue),pain (including mouth pain, abdominal pain, headache, bone pain, tumor pain), hair loss (alopecia), flushed or painful palms or soles (hand foot skin reaction), itching or rash, throwing up (vomiting), bleeding (including bleeding in the brain, gut wall and respiratory tract; hemorrhage), High blood pressure, or increases 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), inflamed or dry mouth, tongue pain (stomatitis and mucosal inflammation), low calcium levels in the blood (hypocalcaemia), low potassium levels in the blood (hypokalemia), low blood sugar level (hypoglycemia), muscle pain (myalgia), disturbed sensations in fingers and toes, including tingling or numbness (peripheral sensory neuropathy), depression, erection problems (impotence), altered voice (dysphonia), acne, inflamed, dry or scaly skin that sheds (dermatitis, skin desquamation), heart failure, heart attack (myocardial infarction) or chest pain, tinnitus (ringing sound in the ear), kidney failure, abnormally high levels of protein in the urine (proteinuria), general weakness or loss of strength (asthenia), decrease in the number of white blood cells (leucopenia and neutropenia), decrease in the number of red blood cells (anemia), low number of platelets in the blood (thrombocytopenia), inflammation of hair follicles (folliculitis), underactive thyroid gland (hypothyroidism), low sodium levels in the blood (hyponatremia), distortion of the sense of taste (dysgeusia), red in the face and often other areas of the skin (flushing), runny nose (rhinorrhea), heartburn (gastro esophageal reflux disease), skin cancer (keratoacanthomas/squamous cell cancer of the skin), a thickening of the outer layer of the skin (hyperkeratosis), a sudden, involuntary contraction of a muscle (muscle spasms).
Uncommon side effects (may affect up to 1 in 100 people):
Inflamed stomach lining (gastritis), pain in the tummy (abdomen) caused by pancreatitis, inflammation of the gall bladder and/or bile ducts, yellow skin or eyes (jaundice) caused by high levels of bile pigments (hyperbilirubinemia), allergic like reactions (including skin reactions and hives), dehydration, enlarged breasts (gynecomastia), breathing difficulty (lung disease), eczema, overactive thyroid gland (hyperthyroidism), multiple skin eruptions (erythema multiform), abnormally high blood pressure, holes in the gut wall (gastrointestinal perforation), reversible swelling in the rear part of the brain that can be associated with headache, altered consciousness, fits and visual symptoms including visual loss (reversible posterior leukoencephalopathy), a 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) that may cause difficulty in breathing or swallowing (angioedema), abnormal heart rhythm (qt prolongation), inflammation of the liver, which may lead to nausea, vomiting, abdominal pain, and jaundice (drug induced hepatitis), a sunburn-like rash that may occur on skin that has previously been exposed to radiotherapy and can be severe (radiation recall dermatitis), serious reactions of the skin and/or mucous membranes which may include painful blisters and fever, including extensive detachment of the skin (stevens-johnson syndrome and toxic epidermal necrolysis), abnormal muscle breakdown which can lead to kidney problems (rhabdomyolysis), damage of the kidney causing them to leak large amounts of protein (nephrotic syndrome), inflammation of the vessels in the skin which may result in rash (leucocytoclastic vasculitis).
Not known side effects (frequency cannot be estimated from the available data):
Impaired brain function that can be associated with e.g. Drowsiness, behavioral changes, or confusion (encephalopathy), an enlargement and weakening of a blood vessel wall or a tear in a blood vessel wall (aneurysms and artery dissections).
You might have any of these symptoms and/or conditions. You must tell your doctor as soon as possible when you start experiencing any of these side effects.
How to store Rafenex?
Keep out of the reach of children.
Store below 30°C. Protect from light and moisture.
Do not use this medicine after the expiry date which is stated on the label and carton.
The medicine 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.
Further information
What Rafenex contains?
The active substance is sorafenib (as tosylate). Each film-coated tablet contains sorafenib (as tosylate) 200 mg.
The other ingredients are: Calcium Carbonate, Magnesium Oxide, Croscarmellose Sodium, Hypromellose, Sodium Lauryl Sulfate, Magnesium Stearate.
What Rafenex looks like and contents of the pack?
Rafenex film-coated tablets are Brown, round, biconvex.
Rafenex is available in the boxes of 6 blisters, each one containing 10 tablets.