Sorafenib Viatris 200 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Sorafenib Viatris 200 mg film-coated tablets EFG

sorafenib

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as 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 and must not be given to other people, even if they have the same symptoms as you. It may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Sorafenib Viatris is and what it is used for
2. What you need to know before taking Sorafenib Viatris
3. How to take Sorafenib Viatris
4. Possible side effects
5. How to store Sorafenib Viatris
6. Contents of the pack and other information

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

This medicine is used in the treatment of liver cancer (hepatocellular carcinoma).

This medicine is also used in the treatment of advanced renal cell cancer (advanced renal cell carcinoma) when standard treatment has not been effective in stopping the progression of the disease or is considered inappropriate.

This medicine is used in the treatment of thyroid cancer (differentiated thyroid carcinoma).

This medicine is a multikinase inhibitor. It works by slowing down the growth rate of cancer cells and by interrupting the blood supply that supports the growth of cancer cells.

2. What you need to know before starting to take Sorafenib Viatris

Do not take Sorafenib Viatris

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

Warnings and precautions

Talk to your doctor or pharmacist before starting to take this medicine.

Take special care with Sorafenib Viatris

• If you experience skin problems. This medicine may cause rashes and skin reactions, especially on the hands and feet. Your doctor can usually manage these conditions. Otherwise, your doctor may temporarily or permanently discontinue treatment.
• If you have high blood pressure (hypertension). This medicine may increase blood pressure. Your doctor will monitor your blood pressure and may prescribe medication to treat hypertension.
• If you have or have had an aneurysm (a bulge and weakening in the wall of a blood vessel) or a tear in the wall of a blood vessel.
• If you have diabetes. Blood sugar levels in diabetic patients should be monitored regularly to determine whether adjustment of antidiabetic medication dosage is needed to minimize the risk of low blood sugar.
• If you have bleeding disorders or are taking warfarin or fenprocoumon. Treatment with this medicine may increase the risk of bleeding. If you are taking warfarin or fenprocoumon, medicines that thin the blood to prevent blood clots, you may have an increased risk of bleeding.
• If you have chest pain or heart problems. Your doctor will decide whether to temporarily or permanently discontinue treatment.
• If you have a heart disorder, such as an abnormal electrical signal known as "QT interval prolongation."
• If you are scheduled for surgery or have recently undergone surgery. This medicine may affect wound healing. You should normally stop taking this medicine before undergoing surgery.

Your doctor will decide when to restart treatment with this medicine.

• If you are taking irinotecan or docetaxel, which are also anticancer medicines.

This medicine may enhance the effects and, in particular, the adverse effects of these medicines.

• If you are taking neomycin or other antibiotics. The effect of this medicine may be reduced.
• If you have severe liver impairment. You may experience more severe adverse effects when taking this medicine.
• If you have kidney impairment. Your doctor will monitor your fluid and electrolyte balance.
• Fertility. This medicine may reduce male and female fertility. If this applies to you, consult your doctor.
• During treatment, holes in the intestinal wall (gastrointestinal perforation) may occur (see section 4: Possible side effects). In such a case, your doctor will discontinue treatment.
• If you have thyroid cancer. Your doctor will monitor blood levels of calcium and thyroid hormones.
• If you experience the following symptoms, contact your doctor immediately, as this may be a potentially life-threatening condition: nausea, difficulty breathing, irregular heartbeat, muscle cramps, seizures, cloudy urine, and fatigue. The cause may be a set of metabolic complications that can occur during cancer treatment as a result of breakdown products from dying cancer cells [tumor lysis syndrome (TLS)], which may lead to changes in kidney function and acute kidney failure (see also section 4: Possible side effects).

Talk to your doctor if any of these situations apply to you. Treatment may be required, or your doctor may decide to adjust your dose or permanently discontinue treatment (see also section 4: Possible side effects).

Children and adolescents

This medicine has not yet been studied in children and adolescents.

Other medicines and Sorafenib Viatris

Some medicines may interact with this medicine or be affected by it. Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any of the medicines listed below, or any other medicine, including those obtained without a prescription:

• Rifampicin, neomycin, or other medicines used to treat infections (antibiotics)
• St. John’s wort, a herbal remedy used for depression
• Phenytoin, carbamazepine, or phenobarbital, treatments for epilepsy and other conditions
• Dexamethasone, a corticosteroid used in various conditions
• Warfarin or fenprocoumon, 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 breastfeeding

Avoid becoming pregnant during treatment with sorafenib. If you are able to become pregnant, use effective contraception during treatment. If you become pregnant while taking this medicine, inform your doctor immediately. Your doctor will decide whether treatment should continue.

You must not breastfeed during treatment with sorafenib, as this medicine may interfere with your baby's growth and development.

Driving and using machines

There are no indications that this medicine affects the ability to drive or use machines.

Sorafenib Viatris contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per dose unit; hence, it is essentially "sodium-free".

3. How to take Sorafenib Viatris

Follow exactly the instructions for the use of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended dose of Sorafenib Viatris in adults is two 200 mg tablets twice daily.

This corresponds to a daily dose of 800 mg or four tablets per day.

Sorafenib Viatris tablets should be taken with a glass of water on an empty stomach or with a low- to moderate-fat meal. Do not take this medicine with a high-fat meal, as this reduces the effectiveness of the medicine. If you plan to eat a high-fat meal, you should take the sorafenib tablets at least 1 hour before or 2 hours after the meal.

It is important to take this medicine at the same time each day to maintain a stable level in the bloodstream.

You will usually continue taking this medicine for as long as you are obtaining clinical benefit and do not experience unacceptable side effects.

If you take more Sorafenib Viatris than you should

Contact your doctor immediately if you (or anyone else) have taken more than the prescribed dose. Taking too much of this medicine increases the likelihood or severity of adverse effects, especially diarrhea or skin problems. Your doctor may instruct you to stop taking this medicine.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Sorafenib Viatris

If you miss a dose, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and continue with your regular schedule. Do not take a double dose to make up for a forgotten dose.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them. This medicine may also affect some laboratory test results.

Very common:

may affect more than 1 in 10 people

• diarrhea
• nausea
• feeling of weakness or tiredness (fatigue)
• pain (including oral pain, abdominal pain, headache, bone pain, tumor pain)
• hair loss (alopecia)
• red or painful palms and soles (hand-foot skin reaction)
• itching or rash (pruritus or exanthem)
• vomiting
• bleeding (including bleeding in the brain, intestinal wall, and respiratory tract)
• high 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)
• inflamed or dry mouth, tongue pain (stomatitis and mucosal inflammation)
• low levels of calcium in the blood (hypocalcemia)
• low levels of potassium in the blood (hypokalemia)
• low levels of blood sugar (hypoglycemia)
• muscle pain (myalgia)
• disturbances in sensation in fingers and toes, including tingling or numbness (peripheral sensory neuropathy)
• depression
• erection problems (impotence)
• voice changes (dysphonia)
• acne
• inflamed, dry, or scaly skin, peeling 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)
• general weakness or loss of strength (asthenia)
• decreased number of white blood cells (leukopenia and neutropenia)
• decreased number of red blood cells (anemia)
• low platelet count in the blood (thrombocytopenia)
• inflammation of hair follicles (folliculitis)
• underactive thyroid gland (hypothyroidism)
• low levels of sodium in the blood (hyponatremia)
• distortion of taste sensation (dysgeusia)
• redness of the face and often other areas of the skin (flushing)
• runny nose (rhinorrhea)
• heartburn (gastroesophageal reflux disease)
• skin cancer (keratoacanthoma/squamous cell skin cancer)
• thickening of the outer layer of the skin (hyperkeratosis)
• sudden, involuntary muscle contractions (muscle spasms)

Uncommon:

may affect up to 1 in 100 people

• inflammation of the stomach lining (gastritis)
• abdominal pain caused by pancreatitis, inflammation of the gallbladder and/or bile ducts
• yellowing of the skin or eyes (jaundice) due to elevated levels of bile pigments (hyperbilirubinemia)
• allergic-type reactions (including skin reactions and hives)
• dehydration
• breast enlargement (gynecomastia)
• difficulty breathing (lung disease)
• eczema
• overactive thyroid gland (hyperthyroidism)
• multiple skin rashes (erythema multiforme)
• abnormally high blood pressure
• perforation of the intestinal wall (gastrointestinal perforation)
• reversible inflammation of the posterior 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) that may cause difficulty breathing or swallowing (angioedema)
• abnormal heart rhythm (QT prolongation)
• liver inflammation that may lead to nausea, vomiting, abdominal pain, and yellowing of the skin (drug-induced hepatitis)
• a rash resembling a sunburn, which may occur on skin previously exposed to radiation therapy and may be severe (radiation recall dermatitis)
• severe skin and/or mucous membrane reactions that may include painful blisters or fever, including extensive peeling of the skin (Stevens-Johnson syndrome and toxic epidermal necrolysis)
• abnormal muscle breakdown that may lead to kidney problems (rhabdomyolysis)
• kidney damage causing loss of large amounts of protein (nephrotic syndrome)
• inflammation of blood vessels in the skin that may cause a rash (leukocytoclastic vasculitis)

Frequency not known:

frequency cannot be estimated from the available data

• impaired brain function that may be associated with, for example, drowsiness, behavioral changes, or confusion (encephalopathy)
• enlargement and weakening of a blood vessel wall or tearing of a blood vessel wall (aneurysms and arterial dissections)
• nausea, difficulty breathing, irregular heartbeat, muscle cramps, seizures, cloudy urine, and fatigue (tumor lysis syndrome [TLS]) (see section 2)

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Sorafenib Viatris

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

Do not use this medicine after the expiry date stated on the carton and blister after CAD or EXP. The expiry date refers to the last day of the month indicated.

Do not store above 30°C.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Sorafenib Viatris

• The active substance is sorafenib. Each film-coated tablet contains 200 mg of sorafenib (as tosylate).
• The other components are:

Tablet core: hypromellose 2910 (E464), sodium croscarmellose (E468), microcrystalline cellulose (E460), magnesium stearate (E470b), sodium lauryl sulfate (E514).

Tablet coating: hypromellose 2910 (E464), titanium dioxide (E171), macrogol (E1521), iron oxide red (E172). See Section 2 “Sorafenib Viatris contains sodium”.

What Sorafenib Viatris looks like and contents of the pack

Sorafenib Viatris are red-brown, round, biconvex, film-coated tablets marked with “200” on one side and smooth on the other, with a diameter of 12 mm.

Pack presentation of 112 film-coated tablets in aluminum-PVC/PE/PVDC blisters.

Pack presentation of 112 × 1 film-coated tablets in single-dose perforated unit-dose aluminum-PVC/PE/PVDC blisters.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Viatris Limited
Damastown Industrial Park
Mulhuddart, Dublin 15
Dublin
Ireland

Manufacturer:

Remedica Ltd
Aharnon Street, Limassol Industrial Estate
Limassol 3056
Cyprus

Or

PharOS MT Ltd.
HF62X, Hal Far Industrial Estate
BBG3000 Birzebbugia
Malta

Further information on this medicinal product is available from the local representative of the Marketing Authorization Holder:

Viatris Pharmaceuticals, S.L.U.
C/ General Aranaz, 86
28027 - Madrid
Spain

This medicinal product is authorized in the European Economic Area member states under the following names:

Germany Sorafenib Mylan 200 mg Film tablets
Bulgaria Sorafenib Mylan
Croatia Sorafenib Viatris 200 mg film-coated tablets
Denmark Sorafenib Viatris
Spain Sorafenib Viatris 200 mg film-coated tablets EFG
Finland Sorafenib Viatris
France Sorafénib Viatris 200 mg, comprimé pelliculé
Iceland Sorafenib Viatris
Italy Sorafenib Mylan 200 mg compresse rivestite con film
Norway Sorafenib Viatris
Poland Sorafenib Mylan
Portugal Sorafenib Mylan
United Kingdom Sorafenib 200 mg film-coated tablets
Czech Republic Sorafenib Viatris
Romania Sorafenib Viatris 200 mg comprimate filmate
Sweden Sorafenib Mylan

Date of the most recent review of this leaflet: July 2024

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) (https://www.aemps.gob.es/)