Sorafenib Mylan – Sorafenib uses, dose and side effects


Sorafenib Mylan

200 mg film-coated tablets

What Sorafenib Mylan is and what it is used for

Sorafenib Mylan is used to treat liver cancer ( hepatocellular cancer ).

Sorafenib Mylan is also used to treat kidney cancer ( advanced renal cell cancer ) in an advanced stage when standard treatment has not been able to stop your disease or is not considered suitable.

Sorafenib Mylan is a so-called multikinase inhibitor. The medicine works by reducing the growth of cancer cells and by reducing the blood flow that allows cancer cells to grow.

The sorafenib contained in Sorafenib Mylan may also be approved to treat other diseases not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.

What you need to know before you take Sorafenib Mylan

Do not take Sorafenib Mylan

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

Warnings and precautions

Talk to your doctor or pharmacist before taking Sorafenib Mylan.

Take special care with Sorafenib Mylan

  • If you have skin problems. Sorafenib Mylan can cause rashes and skin reactions, especially on the hands and feet. These can usually be treated by your doctor. If not, this may mean that your doctor prescribes a pause in the treatment or that it is stopped altogether.
  • If you have high blood pressure. Sorafenib Mylan can raise blood pressure et. 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. Blood sugar levels in diabetic patients should be checked regularly to assess whether the dose of diabetes medication needs to be adjusted, to minimize the risk of low blood sugar.
  • If you develop bleeding problems, or if you are treated with warfarin or phenprocoumon. Treatment with Sorafenib Mylan may lead to an increased risk of bleeding. If you are treated with warfarin or phenprocoumon, medicines that thin the blood, this may mean an increased risk of bleeding.
  • If you get chest pains or heart problems. Your doctor may decide to pause 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 “prolongation of the QT interval”.
  • If you are about to undergo an operation, or if you have recently had an operation. Sorafenib Mylan may affect your wound healing. Usually, a break in Sorafenib Mylan treatment will be made if you are going to have surgery. Your doctor will decide when treatment with Sorafenib Mylan can start again.
  • If you take irinotecan or are treated with docetaxel, which is also medicines against cancer. Sorafenib Mylan can increase the effect, and especially the side effects, of these medicines.
  • If you take Neomycin or other antibiotics. The effect of Sorafenib Mylan may be reduced.
  • If you have severely impaired liver function. You may experience stronger side effects when taking this medication.
  • If you have reduced kidney function. Your doctor will check your fluid and salt balance (electrolyte balance).
  • FertilitySorafenib Mylan can 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.

Tell your doctor if any of the above applies to you. You may need treatment for the symptoms or your doctor may decide to change the Sorafenib Myland dose, or stop the treatment altogether (see also section 4: Possible side effects ).

Children and young people

Sorafenib Mylan has not yet been tested in children and adolescents.

Other medicines and Sorafenib Mylan

Sorafenib Mylan can 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 over-the-counter medicines:

  • Rifampicin, Neomycin, or other drugs 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 phenprocoumon, blood thinners used to prevent blood clots
  • Doxorubicin, capecitabine, docetaxel, paclitaxel and irinotecan , which are cancer medicines
  • Digoxin, a treatment for mild to moderate heart failure

Pregnancy and breastfeeding

Avoid becoming pregnant while you are being treated with Sorafenib Mylan. If you can become pregnant, use a safe method of contraception during treatment. If you become pregnant during treatment with Sorafenib Mylan, talk to your doctor immediately, who will decide whether treatment should be continued.

You must not breastfeed your baby during treatment with Sorafenib Mylan as this medicine may affect your baby’s growth and development.

Driving ability and use of machinery

There is no indication that Sorafenib Mylan affects the ability to drive or use machines.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with your doctor or pharmacist if you are unsure.

Sorafenib Mylan contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per dose, i.e. is almost “sodium-free”.

How to take Sorafenib Mylan

Always take this medicine as directed by your doctor or pharmacist. Ask your doctor or pharmacist if you are unsure.

The recommended dose of one of Sorafenib Mylan 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 Sorafenib Mylan 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 Sorafenib Mylan. If you intend to eat a high-fat meal, take the tablets at least 1 hour before or 2 hours after the meal.

It is important to take this medicine at about the same time every day so that there is the same amount of medicine in the blood all the time.

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 have taken too much Sorafenib Mylan

Talk to your doctor straight away if you (or anyone else) have taken more than the prescribed dose. Taking too much Sorafenib Mylan 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 have ingested too much medicine or if, for example, a child has ingested the medicine by mistake, immediately contact a doctor or hospital for an assessment of the risk and advice.

If you forget to take Sorafenib Mylan

If you have forgotten to take a dose, take it as soon as you remember. If it is close to the time for the next dose, ignore the missed dose and continue as previously prescribed.

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

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. This medicine can also affect the results of some blood tests.

Very common:

may affect more than 1 in 10 users

  • diarrhea
  • nausea
  • feeling abnormally weak or tired ( fatigue )
  • pain (including mouth pain, abdominal pain, headache, bone and bone pain, tumor pain)
  • hair loss ( alopecia )
  • redness or pain in the hands or soles of the feet (hand-foot skin reaction)
  • itching or rash
  • vomiting
  • bleeding (including bleeding in the brain, gut, and respiratory tract)
  • high blood pressure or increase in blood pressure et ( hypertension )
  • infection _
  • loss of appetite ( anorexia )
  • constipation
  • joint pain ( arthralgia )
  • fever
  • weight loss
  • dry skin


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 ( hypocalcemia )
  • low levels of potassium in the blood ( hypokalemia )
  • low blood sugar levels ( hypoglycemia )
  • muscle pain ( myalgia )
  • altered sensation in fingers and toes, including tingling and numbness ( peripheral sensory neuropathy )
  • Depression
  • erectile dysfunction ( impotence )
  • voice change ( dysphonia )
  • acne
  • inflamed, dry, or scaly skin ( dermatitis, skin desquamation)
  • heart failure
  • heart attack (myocardial infarction) or chest pain
  • tinnitus ( ringing in the ears )
  • kidney failure
  • abnormally high levels of protein in the urine ( proteinuria )
  • pronounced weakness or powerlessness ( asthenia )
  • decreased number of white blood cells ( leukopenia and neutropenia )
  • reduced number of red blood cells ( anemia )
  • decreased number of blood platelets ( thrombocytopenia )
  • inflammation of hair follicles ( folliculitis )
  • reduced thyroid function (hypothyroidism)
  • low level of sodium in the blood ( hyponatremia )
  • taste changes ( dysgeusia )
  • redness of the face and often other skin areas (hemorrhage)
  • runny nose ( rhinorrhea )
  • heartburn ( gastroesophageal reflux )
  • skin cancer (keratoacanthoma or squamous cell carcinoma of the skin)
  • thickening of the outermost skin layer ( hyperkeratosis )
  • sudden, involuntary muscle contractions (muscle spasms)

Less common:

may affect up to 1 in 100 users

  • inflamed stomach lining ( gastritis )
  • pain in the stomach 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 increased levels of bile pigment (hyperbilirubinemia)
  • allergy-like reactions (including skin reactions 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 headache, altered level of consciousness, convulsions, and vision changes including vision loss ( reversible posterior leukoencephalopathy)
  • sudden, severe allergic reaction ( anaphylactic reaction )


may affect up to 1 in 1,000 users

  • allergic reaction with swelling of the skin (e.g. on the face, on the tongue) which can lead to difficulty breathing or swallowing ( angioedema )
  • abnormal heart rhythm ( QT prolongation)
  • inflammation of the liver which can lead to nausea, vomiting, stomach pain, and jaundice (drug-induced hepatitis ).
  • sunburn-like rash that can appear on skin that has previously been exposed to radiation treatment and that can become severe (“radiation recall” dermatitis )
  • serious reactions in the skin and/or mucous membranes that can cause painful blisters and fever, as well as skin peeling ( Stevens-Johnson syndrome and toxic epidermal necrolysis )
  • abnormal muscle breakdown that can lead to kidney problems ( rhabdomyolysis )
  • damage to the kidneys that causes them to leak large amounts of protein ( nephrotic syndrome )
  • inflammation of the blood vessels in the skin which may result in a rash (leukocytoclastic vasculitis ).

Has been reported:

occurs in an unknown number of users

  • Impairment of brain function which 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 Sorafenib Mylan

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

Use before the expiry date which is stated on the carton and blister after EXP. The expiration date is the last day of the specified month.

Store at a maximum of 30 ºC.

Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.

Contents of the packaging and other information

Contents declaration

  • The active substance is sorafenib. Each film-coated tablet contains 200 mg of sorafenib (as tosylate).
  • Other ingredients are:
    Tablet core : hypromellose 2910 (E464), croscarmellose sodium (E468), microcrystalline cellulose (E460), magnesium stearate (E470b), sodium lauryl sulfate (E514).
    Tablet coating : Hypromellose 2910 (E464), titanium dioxide (E 171), macrogol (E1521), red iron oxide (E 172).

Appearance and package sizes of the medicine

Sorafenib Mylan 200 mg film-coated tablets are red-brown, round, biconvex film-coated tablets debossed with “200” on one side and plain on the other side with a tablet diameter of 12.0 mm ± 5%.

They are supplied in packs of 112 film-coated tablets in aluminium-PVC/PE/PVDC blisters.

They are supplied in packs of 112 x 1 film-coated tablet in aluminum PVC/PE/PVDC perforated unit dose blisters.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer


Remedica Ltd

Aharnon Street, Limassol Industrial Estate,

3056 Limassol, Cyprus

PharOS MT Ltd.

HF62X, Hal Far Industrial Estate

BBG3000 Birzebbugia


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