Patient Medication Information: uses, side effects, how to take - Nexavar
Serious Warnings and Precautions box:
What NEXAVAR is used for:
NEXAVAR is used in adults to treat:
- liver cancer (hepatocellular carcinoma) which cannot be removed by surgery.
- advanced kidney cancer (renal cell carcinoma). NEXAVAR is to be used when standard therapy did not help or is not considered suitable.
This drug should be prescribed and managed only by a healthcare professional experienced in anticancer drugs. You may experience the following serious side effects when taking NEXAVAR:
|
- thyroid cancer (differentiated thyroid carcinoma) in patients who are no longer responding to radioactive iodine therapy.
How NEXAVAR works:
NEXAVAR is a multikinase inhibitor. It works by:
- slowing down the growth and spread of cancer cells
- stopping/cutting off the development of new blood vessels that supply the tumours
The ingredients in NEXAVAR are:
Medicinal ingredients: Sorafenib tosylate
Non-medicinal ingredients: croscarmellose sodium, ferric oxide red, hydroxypropylmethyl cellulose, macrogol, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate, and titanium dioxide.
NEXAVAR comes in the following dosage form:
Tablet (film-coated): 200 mg sorafenib (as sorafenib tosylate)
Do not use NEXAVAR if:
You are allergic to sorafenib tosylate or any of the other ingredients of NEXAVAR.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take NEXAVAR. Talk about any health conditions or problems you may have, including if you:
- are going to have surgery, or a dental procedure, or if you had an operation recently. NEXAVAR might affect the way your wounds heal. You will usually be taken off NEXAVAR if you are having an operation. Your healthcare professional will decide when to start with NEXAVAR again.
- have kidney problems (in addition to cancer).
- have a personal history of fainting spells.
- have thyroid cancer. Your thyroid gland may become underactive or overactive while you take NEXAVAR. Your healthcare professional will monitor your calcium and thyroid hormone levels with blood tests.
Other warnings you should know about:
Abnormal electrical signal in the heart (QT Interval Prolongation):
- Taking NEXAVAR may cause changes in the electrical system of your heart. QT interval prolongation can lead to a life threatening condition called Torsade de Pointes. If untreated, Torsade de Pointes can lead to sudden death.
- Your healthcare professional will use an electrocardiogram (ECG) to measure your heart condition.
You are at a greater risk of developing Torsade de Pointes if you have the following risk factors. Speak to your healthcare professional if you:
- are female;
- 65 years of age or older;
- have QT/QTc prolongation or a family history of QT/QTc prolongation;
- have a family history of sudden cardiac death in those older than 50 years of age;
- have had a history of heart problems (i.e. irregular heartbeats);
- have electrolyte disturbances (e.g. low blood potassium or magnesium levels) or conditions that could lead to electrolyte disturbances (e.g. vomiting, diarrhea, dehydration);
- have experienced sudden brain problems (e.g. strokes, bleeding and trauma)
- have nutrient deficiencies or diabetes;
- have damaged nerves;
- Speak to your healthcare professional immediately if you experience any of the symptoms of a possible heart rhythm problem. See the ‘Possible side effects from using NEXAVAR:’ section below for more information
Check-ups and testing: You will have regular visits with your healthcare professional during treatment with NEXAVAR to monitor your health. They will:
- Check your blood pressure.
- Check your heart by using an Electrocardiogram (ECGs).
- Do blood tests to check your liver, heart, thyroid and blood health.
Pregnancy, contraception and breastfeeding:
- Avoid becoming pregnant while taking NEXAVAR. It may harm your unborn baby.
- Use highly effective birth control if you can get pregnant while taking NEXAVAR and for 2 weeks after your last dose.
- Tell your healthcare professional right away if you become pregnant or think you are pregnant during treatment with NEXAVAR.
- It is not known if NEXAVAR passes into breast milk. Do not breastfeed during treatment with NEXAVAR. Talk to your healthcare professional about the best way to feed your baby during this time.
Fertility: Treatment with NEXAVAR may affect the ability in both men and women to have children.
Tumour lysis syndrome (TLS):
- Taking NEXAVAR may cause tumour lysis syndrome (the sudden, rapid death of cancer cells due to the treatment). This can lead to death.
You are at a greater risk of developing tumour lysis syndrome if you have the following risk factors. Speak to your healthcare professional if you:
- have a lot of cancer in your body
- had kidney problems before you started your treatment with NEXAVAR
- have urine problems
- are dehydrated
- have low blood pressure
- Your healthcare professional will monitor your condition and treat you if needed.
- See the ‘What are possible side effects from using NEXAVAR?’ section below for more information
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with NEXAVAR:
- Antibiotics such as rifampin and neomycin
- St John’s Wort, an herbal treatment for depression
- Phenytoin, carbamazepine, dexamethasone or phenobarbital, treatments for epilepsy and other conditions
- Warfarin, an anticoagulant used to prevent blood clots. If you are taking warfarin, you may be at a greater risk of bleeding while taking NEXAVAR
- Medicines that treat cancers. Such as doxorubicin, docetaxel, irinotecan, paclitaxel, carboplatin, capecitabine, and cisplatin
- Drugs to treat heart rhythm disturbances
- Antidepressants
- Antipsychotics
- Painkillers
- Drugs to treat nausea and vomiting
- Diuretics (water pills)
How to take NEXAVAR:
- Take exactly as your healthcare professional has told you. Check with your doctor or pharmacist if you are not sure.
- Swallow tablets with a glass of water.
Take NEXAVAR without food or with a low to moderate fat content meal.
- Take NEXAVAR at about the same time each day.
Usual adult dose:
Take two 200 mg tablets twice a day.
Overdose:
| If you think you, or a person you are caring for, have taken too much NEXAVAR, contact a healthcare professional, hospital emergency department, regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no signs or symptoms. |
Missed Dose:
If you missed a dose of this medication, take it as soon as you remember. But if it is almost time for your next dose, skip the missed dose and continue with your next scheduled dose. Go back to the regular dosing schedule. Do not take two doses at the same time.
Possible side effects from using NEXAVAR:
These are not all the possible side effects you may have when taking NEXAVAR. If you experience any side effects not listed here, tell your healthcare professional.
- a sudden, uncontrollable tightening of a muscle
- acne
- breathlessness
- change in the sense of taste
- constipation
- dehydration
- depression
- diarrhea (frequent and/or loose bowel movements)
- erection problems (impotence)
- feeling sick - nausea and/or vomiting
- feeling weak or tired
- flu-like illness
- flushing
- hair loss
- heartburn
- indigestion
- inflamed, dry or scaly skin that sheds
- inflamed or dry mouth, tongue pain
- inflammation (swelling/redness) at the base of hairs
- loss of appetite
- pain (including mouth, abdominal, headache, muscle, bone pain)
- persistent runny nose
- rash including hives, redness or itching of your skin
- stomach pain
- voice hoarseness, voice changes
- weight loss
NEXAVAR can cause abnormal blood test results. Your healthcare professional will do blood tests during your treatment. These will tell your healthcare professional how NEXAVAR is affecting your blood, heart, thyroid, and liver.
Serious side effects and what to do about them:
| Frequency / Side Effect / Symptom | Talk with your healthcare professional | Stop taking this drug and get immediate medical help | |
|---|---|---|---|
| Frequency / Side Effect / Symptom | Talk with your healthcare professional | Stop taking this drug and get immediate medical help | |
| Frequency / Side Effect / Symptom | Talk with your healthcare professional | Stop taking this drug and get immediate medical help | |
| Frequency / Side Effect / Symptom | Talk with your healthcare professional | Stop taking this drug and get immediate medical help | |
| Only if severe | In all cases | ||
| Only if severe | In all cases | ||
| Only if severe | In all cases | ||
| Only if severe | In all cases | ||
| VERY COMMON | |||
| Hand-Foot syndrome (skin reaction): Flushed, redness, pain, swelling or blistering on the palms or soles of your feet | ✓ | ||
| Bleeding (hemorrhage): bleeding from the mouth, nose, stomach or gut, rectum (back passage), blood in stool, lungs or windpipe, coughing up blood, bleeding nail beds and blood blisters | ✓ | ||
| Increase in blood pressure | ✓ | ||
| Fever | ✓ | ||
| Infection: fever, chills, flu-like symptoms | ✓ | ||
| COMMON | |||
| Neuropathy (nerve problems): Numbness, tingling or pain in your hands and feet | ✓ | ||
| Difficulty swallowing | ✓ | ||
| Infection/inflammation of the gallbladder and/or bile ducts: severe abdominal pain, nausea, vomiting | ✓ | ||
| Kidney failure: decrease in the amount of urine, blood in urine, swelling in ankles, lack of appetite | ✓ | ||
| Skin cancer: changes in the appearance of skin or skin growths | ✓ | ||
| Underactive thyroid gland (hypothyroidism): feeling tired, weight gain, constipation, feeling more cold than usual, hair loss, depression | ✓ | ||
| Decreased blood flow to the heart (angina): sudden chest pain, pressure or discomfort, feeling faint, feeling anxious, shortness of breath, irregular heartbeat, nausea, or sudden heavy sweating. | ✓ | ||
| Heart failure (heart does not pump blood as well as it should): shortness of breath, fatigue and weakness, swelling in ankles, legs and feet, cough, fluid retention, lack of appetite, nausea, rapid or irregular heartbeat, reduced ability to exercise. | ✓ | ||
| Heart Attack: severe chest pain, shortness of breath, cold sweat, etc. | ✓ | ||
| UNCOMMON | |||
| Eczema: dry, redness or itching of your skin | ✓ | ||
| Multiple skin eruptions | ✓ | ||
| Inflammation of the lung: breathing problems, shortness of breath, cough, fatigue | ✓ | ||
| RARE | |||
| Inflammation of the liver: generally feeling unwell, fever nausea, vomiting, loss of appetite, itching all over the body, yellowing of the skin or eyes, light coloured feces, dark urine | ✓ | ||
| Increase in thyroid activity: nervousness, fast heart beat, anxiety, sweating and weight loss | ✓ | ||
| Severe skin condition: rash, skin peeling and sores of the mucous membranes (e.g. mouth, genitals) | ✓ | ||
| Inflammation of skin previously exposed to radiation: skin redness, blisters or pimples, may itch, burn and sting. | ✓ | ||
| Severe allergic reaction: flushing, rashes, hives, itching, swelling, breathing difficulty, dizziness, chest discomfort, and swelling of the tissues underneath the skin often affecting the eyes, lips and throat (angioedema) | ✓ | ||
| Muscle problems: unexplained muscle injury, such as muscle cramps, pain, tenderness, stiffness, weakness, spasm. This may lead to serious kidney problems | ✓ | ||
| Life-threatening or fatal interstitial lung disease (diseases that inflame or scar lung tissue): shortness of breath and coughing | ✓ | ||
| VERY RARE | |||
| Artery Dissection (separation of the layers of the arterial wall): sudden severe pain in the back, chest or abdomen | ✓ | ||
| Artery Aneurysm (a bulge in the wall of any artery including in the chest, arms, legs, heart and brain): symptoms will differ by the site. They can be cough, coughing up blood. Strong pain high in your neck or in your back when you didn’t hurt yourself. Problems swallowing. Hoarse voice. Unusual pulsing in your chest or abdomen. | ✓ | ||
| UNKNOWN | |||
| Inflammation of small blood vessels in the skin: painful, itchy rash, redness of the skin (erythema), and small blood spots under the skin (leukocytoclastic vasculitis). | ✓ | ||
| Tumour lysis syndrome (the sudden, rapid death of cancer cells due to the treatment): nausea, shortness of breath, irregular heartbeat, heart rhythm disturbances, lack of urination, clouding of urine, muscle spasms or twitching, tiredness and/or joint pain, severe muscle weakness, and seizures. Metabolic disorders (kidney failure, abnormal heartbeat) and abnormal blood tests due to rapid breakdown of cancer cells. | ✓ | ||
| Thrombotic Microangiopathies (clots in small blood vessels): bleeding, bruising, weakness, confusion, fever, chills, nausea, vomiting, diarrhea, low or no urine output | ✓ |
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice. |
Storage:
Store at room temperature between 15oC-30oC in a dry place.
Do not use the tablets after the expiry date. This is shown on the bottle and blister cards.
Keep out of the reach and sight of children and pets.
This medicine does not need any other special storage conditions.
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.
If you want more information about NEXAVAR:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website: https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html; the manufacturer’s website http://www.bayer.ca, or by calling 1-800-265-7382 or canada.medinfo@bayer.com.
Bayer Inc. 2920 Matheson Boulevard East Mississauga, Ontario L4W 5R6 Canada |
Date of Authorization: 2025-06-05
© 2025, Bayer Inc.
® TM see www.bayer.ca/tm-mc