Package Insert: Information for the Patient

Sorafenib Viatris 200mg Film-Coated Tablets

sorafenib

Read this entire package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you and should not be given to others who may have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section4.

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

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

3.How to take Sorafenib Viatris

4.Possible adverse effects

5.Storage of Sorafenib Viatris

6.Contents of the package and additional information

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

This medication is also used in the treatment of advanced kidney cancer(advanced renal cell carcinoma)when standard treatment has not been able to slow down the disease or is considered inappropriate.

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

This medication is amulti-tyrosine kinase inhibitor. It acts by slowing down the growth rate of cancer cells and interrupting the blood supply that allows cancer cells to grow.

Do not take Sorafenib Viatris

• If you are allergicto sorafenib or to any of the other ingredients of this medication (listed in section6).

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medication.

Be especially careful with Sorafenib Viatris

• If you experience skin problems.This medication may cause rashes and skin reactions, especially on hands and feet. Your doctor may normally treat these conditions. Otherwise, your doctor may temporarily or completely stop treatment.
• If you have hypertension.This medication 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(an enlargement and weakening of a blood vessel wall)or a tear in the wall of a blood vessel.
• If you have diabetes.Patients with diabetes should have their blood sugar levels regularly monitored to assess whether a dose adjustment of antidiabetic medication is necessary to minimize the risk of low blood sugar levels.
• If you have bleeding problems or are taking warfarin or fenprocoumon.Treatment with this medication may increase the risk of bleeding. If you are taking warfarin or fenprocoumon, medications that thin the blood to prevent blood clots, you may be at higher risk of bleeding.
• If you have chest pain or heart problems.Your doctor will decide whether to temporarily or completely stop treatment.
• If you have a heart condition,such as an abnormal electrical signal called “prolongation of the QT interval.”
• If you are about to undergo surgery or have recently undergone surgery.This medication may affect wound healing. Normally, you should stop taking this medication before undergoing surgery.

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

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

This medication may increase the effects and, in particular, the adverse effects of these medications.

• If you are taking neomycin or other antibiotics.The effect of this medication may be reduced.
• If you have severe liver failure.You may experience more severe adverse effects when taking this medication.
• If you have kidney problems.Your doctor will monitor your fluid and electrolyte balance.
• Fertility.This medication may reduce male and female fertility. If this applies to you, consult your doctor.
• During treatment, perforation of the intestinal walls(gastrointestinal perforation)(see section4: Possible side effects). If this occurs, your doctor will stop treatment.
• If you have thyroid cancer.Your doctor will monitor your blood calcium and thyroid hormone levels.
• If you experience the following symptoms, contact your doctor immediately, as they may be life-threatening:nausea, difficulty breathing, irregular heartbeats, 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 the breakdown products of dying cancer cells [tumor lysis syndrome (TLS)] and may cause changes in kidney function and acute kidney failure (see also section 4: Possible side effects).

Consult your doctor if any of these aspects affect you.Your doctor may need to treat them or decide to modify your dose of this medication or completely stop treatment (see also section4: Possible side effects).

Children and adolescents

No studies have been conducted with this medication in children and adolescents.

Other medications and Sorafenib Viatris

Some medications affect this medication or may be affected by it. Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any of the medications listed below or any other medication, including those purchased without a prescription:

• Rifampicin, neomycin, or other medications used to treat infections(antibiotics)
• St. John's Wort, a herbal remedy fordepression
• Phenobarbital, carbamazepine, or phenytoin, treatments forepilepsyand other conditions
• Dexamethasone, acorticosteroidused in various conditions
• Warfarin or fenprocoumon, anticoagulants used toprevent blood clots
• Doxorubicin, capecitabine, docetaxel, paclitaxel, and irinotecan, which areanticancer medications
• Digoxin, a treatment formild or moderate heart failure

Pregnancy and breastfeeding

Avoid becoming pregnant during treatment with sorafenib.If you can become pregnant, use suitable contraceptive methods during treatment. If you become pregnant during treatment, inform your doctor immediately, who will decide whether to continue treatment.

Do not breastfeed your baby during treatment with sorafenib, as this medication may interfere with your baby's growth and development.

Driving and operating machinery

No studies have shown that this medication affects your ability to drive or operate machinery.

Sorafenib Viatris contains sodium

This medication contains less than 1mmol of sodium (23mg) per dose; it is essentially “sodium-free.”

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended dose of Sorafenib Viatris in adults is two 200 mg tablets, taken twice a day.

This is equivalent to a daily dose of 800 mg or four tablets a day.

Sorafenib Viatris tablets should be taken with a glass of water outside of meals or with a meal low or moderate in fat. Do not take this medication with a meal high in fat, as this reduces the effectiveness of this medication. If you plan to take a meal high in fat, take the Sorafenib tablets at least 1 hour before or 2 hours after the meal.

It is essential to take this medication at the same time every day to maintain a stable amount in the bloodstream.

Normally, you will continue taking this medication as long as it provides clinical benefits and you do not experience unacceptable side effects.

If you take more Sorafenib Viatris than you should

Consult your doctor immediatelyif you (or anyone else) have taken a dose higher than prescribed. Taking too much of this medication increases the likelihood of adverse effects or more severe effects, especially diarrhea or skin problems. Your doctor may instruct you to stop taking this medication.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Sorafenib Viatris

If you have missed a dose, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and continue as usual. Do not take a double dose to compensate for the missed dose.

Like all medicines, this medicine can cause side effects, although not everyone will experience 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 fatigue(fatigue)
• pain (including mouth pain, abdominal pain, headache, bone pain, tumor pain)
• hair loss(alopecia)
• redness or pain on palms and soles of feet(hand-foot syndrome)
• pruritus or exanthema
• vomiting
• bleeding (including intracranial hemorrhage, intestinal wall hemorrhage, and respiratory tract hemorrhage)
• hypertension or increased blood pressure(hypertension)
• infections
• loss of appetite(anorexia)
• constipation
• joint pain(arthralgias)
• 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 calcium levels in the blood(hypocalcemia)
• low potassium levels in the blood(hypokalemia)
• low blood sugar(hypoglycemia)
• muscle pain(myalgias)
• alterations in sensitivity in fingers and toes, including numbness or tingling(peripheral sensory neuropathy)
• depression
• erectile dysfunction(impotence)
• voice alteration(dysphonia)
• acne
• inflamed, dry, or scaly skin that peels(dermatitis, skin peeling)
• heart failure
• heart attack(myocardial infarction)or chest pain
• tinnitus(ringing in the ears)
• kidney insufficiency
• abnormally high levels of protein in the urine(proteinuria)
• general weakness or loss of strength(asthenia)
• decrease in the number of white blood cells(leukopenia and neutropenia)
• decrease in the number of red blood cells(anemia)
• low platelet count in the blood(thrombocytopenia)
• inflammation of hair follicles(folliculitis)
• underactive thyroid gland(hypothyroidism)
• low sodium levels in the blood(hyponatremia)
• distortion of taste(dysgeusia)
• redness of the face and often other areas of the skin(flushing)
• nasal secretion(rhinorrhea)
• pyrosis(gastroesophageal reflux disease)
• skin cancer(squamous cell carcinoma)
• 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 wall(gastritis)
• abdominal pain caused by pancreatitis, inflammation of the gallbladder and/or bile ducts
• yellow skin or eyes(jaundice)caused by elevated levels of bile pigments(hyperbilirubinemia)
• allergic reactions (including skin reactions and rashes)
• dehydration
• breast enlargement(gynecomastia)
• difficulty breathing(pulmonary disease)
• eczema
• overactive thyroid gland(hyperthyroidism)
• multiple skin eruptions(erythema multiforme)
• abnormally high blood pressure
• perforation of the intestinal wall(gastrointestinal perforation)
• reversible inflammation of the back of the brain, which may be associated with headache, altered consciousness, seizures, and visual symptoms including loss of vision(reversible posterior leukoencephalopathy syndrome)
• severe, sudden allergic reaction(anaphylactic reaction)

Rare:

may affect up to 1 in 1,000 people

• allergic reaction with skin swelling (e.g., face, tongue) that may cause difficulty breathing or swallowing(angioedema)
• abnormal heart rhythm(prolonged QT interval)
• inflammation of the liver that may lead to nausea, vomiting, abdominal pain, and yellowing of the skin(drug-induced hepatitis)
• a rash with a sunburn-like appearance, which may occur on skin that has been exposed to radiation therapy and may be severe(radiation dermatitis)
• severe skin and/or mucous membrane reactions that may include painful blisters or fever, including extensive skin peeling(Stevens-Johnson syndrome and toxic epidermal necrolysis)
• abnormal muscle breakdown that may lead to kidney problems(rhabdomyolysis)
• kidney damage that causes large amounts of protein to be lost(nephrotic syndrome)
• inflammation of skin blood vessels that may cause a rash(leukocytoclastic vasculitis)

Frequency not known:

the frequency cannot be estimated from available data

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

Reporting of adverse reactions

If you experience any type of adverse reaction, consult your doctor or pharmacist, even if it is a possible adverse reaction that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting adverse reactions, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration datethat appears on the box and on the blister pack after CAD or EXP. The expiration date is the last day of the month indicated.

Do not store at a temperature above 30°C.

Medications should not be disposed of through drains or in the trash. Dispose of the containers and medications you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Sorafenib Viatris

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

Core of the tablet: hypromellose2910 (E464), croscarmellose sodium (E468), microcrystalline cellulose (E460), magnesium stearate (E470b), sodium lauryl sulfate (E514).

Film coating of the tablet: hypromellose2910 (E464), titanium dioxide (E171), macrogol (E1521), iron oxide red (E172).See Section 2 “Sorafenib Viatris contains sodium”.

Appearance of Sorafenib Viatris and packaging contents

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

Presentation in a pack of 112 film-coated tablets in aluminum-PVC/PE/PVDC blisters.

Presentation in a pack of 112×1 film-coated tablet in perforated unit dose aluminum-PVC/PE/PVDC blisters.

Only some 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

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

This medicine is authorized in the member states of the European Economic Area with the following names:

GermanySorafenib Mylan 200mg Filmtabletten

BulgariaSorafenib Mylan

CroatiaSorafenib Viatris 200mg filmom obložene tablete

DenmarkSorafenib Viatris

SpainSorafenib Viatris 200mg comprimidos recubiertos con película EFG

FinlandSorafenib Viatris

FranceSorafénib Viatris 200mg, comprimé pelliculé

IcelandSorafenib Viatris

ItalySorafenib Mylan 200mg compresse rivestite con film

NorwaySorafenib Viatris

PolandSorafenib Mylan

PortugalSorafenib Mylan

United KingdomSorafenib 200mg film-coated tablets

Czech RepublicSorafenib Viatris

RomaniaSorafenib Viatris 200mg comprimate filmate

SwedenSorafenib Mylan

Last review date of this leaflet: July 2024

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (https://www.aemps.gob.es/)