Sorafenib Sandoz
Sorafenib Sandoz is used to treat certain types of liver, kidney, and thyroid cancer by slowing cancer growth and reducing blood flow to tumors.
Form
tabletti, kalvopäällysteinen
Strength
200 mg
Active Ingredient
Sorafenib tosilate
Manufacturer
Sandoz A/S
How to Use
Dosage
The usual dose for adults is two 200 mg tablets, taken twice a day.
Method
Swallow the tablets whole with a glass of water, with or without a low-fat meal. Do not take with high-fat meals. If you eat a high-fat meal, take the tablets at least 1 hour before or 2 hours after the meal. Take at the same time each day to keep the medicine level steady in your body.
Important
The maximum daily dose is 800 mg, which is 4 tablets.
Possible Side Effects
COMMON
- •Diarrhea
- •Nausea
- •Feeling weak or tired (fatigue)
- •Pain (including mouth pain, stomach pain, headache, bone pain, tumor pain)
- •Hair loss (alopecia)
- •Redness or pain in hands or feet (hand-foot skin reaction)
- •Itching or rash
- •Vomiting
- •Bleeding (including in the brain, bowel wall, and airways)
- •High blood pressure or increased blood pressure (hypertension)
- •Infections
- •Loss of appetite (anorexia)
- •Constipation
- •Joint pain (arthralgia)
- •Fever
- •Weight loss
- •Dry skin
COMMON
- •Flu-like symptoms
- •Indigestion (dyspepsia)
- •Difficulty swallowing (dysphagia)
- •Inflamed or dry mouth, tongue pain (stomatitis and mucositis)
- •Low calcium levels in the blood (hypocalcemia)
- •Low potassium levels in the blood (hypokalemia)
- •Low blood sugar levels (hypoglycemia)
- •Muscle pain (myalgia)
- •Numbness or tingling in fingers and toes (peripheral sensory neuropathy)
- •Depression
- •Erectile dysfunction (impotence)
- •Voice changes (dysphonia)
- •Acne
- •Inflamed, dry, or peeling skin (dermatitis, skin desquamation)
- •Heart failure
- •Heart attack (myocardial infarction) or chest pain
- •Ringing in the ears (tinnitus)
- •Kidney failure
- •Abnormally high protein levels in urine (proteinuria)
- •General weakness or lack of strength (asthenia)
- •Decreased white blood cell count (leukocytopenia and neutropenia)
- •Decreased red blood cell count (anemia)
- •Low platelet count (thrombocytopenia)
- •Hair follicle inflammation (folliculitis)
- •Underactive thyroid (hypothyroidism)
- •Low sodium levels in the blood (hyponatremia)
- •Taste changes (dysgeusia)
- •Redness of the face and often other body parts (flushing)
- •Runny nose (rhinorrhea)
- •Heartburn (gastroesophageal reflux disease)
- •Skin cancer (keratoacanthoma / squamous cell carcinoma)
- •Thickening of the outer layer of skin (hyperkeratosis)
- •Sudden, involuntary muscle spasm
RARE
- •Stomach lining inflammation (gastritis)
- •Abdominal pain due to pancreas, gallbladder, or bile duct inflammation
- •Yellow skin or eyes due to high bile pigment levels in blood (hyperbilirubinemia)
- •Allergic reactions (including allergic rash and hives)
- •Dehydration
- •Enlarged breasts (gynecomastia)
- •Difficulty breathing (lung disease)
- •Rash
- •Overactive thyroid (hyperthyroidism)
- •Erythema multiforme (a type of skin rash)
- •Abnormally high blood pressure
- •Holes in the bowel wall (gastrointestinal perforation)
- •Swelling in the back of the brain, causing headache, confusion, seizures, or vision problems including blindness (posterior reversible leukoencephalopathy, PRES)
- •Sudden, severe allergic reaction (anaphylactic reaction)
RARE
- •Allergic reaction with swelling of the skin (e.g., face, tongue), leading to breathing or swallowing difficulties (angioedema)
- •Abnormal heart rhythm (QT prolongation)
- •Liver inflammation, causing nausea, vomiting, abdominal pain, and jaundice (drug-induced hepatitis)
- •Sunburn-like rash that may appear on skin previously exposed to radiation, potentially severe ('radiation recall' dermatitis)
- •Severe skin and/or mucous membrane reactions, with painful blisters, fever, and extensive skin peeling (Stevens-Johnson syndrome and toxic epidermal necrolysis)
- •Muscle damage that can lead to kidney failure (rhabdomyolysis)
- •Kidney damage where kidneys leak large amounts of protein (nephrotic syndrome)
- •Inflammation of blood vessels in the skin, causing a rash (leukocytoclastic vasculitis)
- •Impaired brain function, possibly with drowsiness, behavioral changes, or confusion (encephalopathy)
- •Bulging and weakening of a blood vessel wall, or a tear in a blood vessel wall (aneurysms and arterial dissections)
- •Nausea, shortness of breath, irregular heartbeat, muscle cramps, seizures, cloudy urine, and fatigue (tumor lysis syndrome, TLS)
Important Warnings
- Do not take this medicine if you are allergic to sorafenib or any other ingredient in this medicine.
- Tell your doctor if you have skin problems like a rash on your hands and feet.
- Tell your doctor if you have high blood pressure, as it may need to be treated.
- Tell your doctor if you have or have had an aneurysm (a bulging or weak blood vessel wall) or a tear in a blood vessel wall.
- If you have diabetes, your blood sugar levels must be checked regularly.
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- Tell your doctor if you have bleeding problems or if you are taking blood thinners like warfarin.
- Tell your doctor if you experience chest pain or heart problems, as treatment may need to be paused or stopped.
- Tell your doctor if you have an abnormal heart rhythm, such as a prolonged QT interval.
- If you are having surgery or have recently had surgery, treatment may need to be paused.
- Tell your doctor if you are taking other cancer medicines like irinotecan or docetaxel, as Sorafenib Sandoz can make their effects or side effects stronger.
- Tell your doctor if you are taking neomycin or other antibiotics, as this may reduce the effect of Sorafenib Sandoz.
- Tell your doctor if you have severe liver problems, as side effects might be stronger.
- Tell your doctor if you have reduced kidney function, as your fluid and salt balance will need to be monitored.
- This medicine may affect fertility in both men and women. Discuss any concerns with your doctor.
- Tell your doctor if you experience holes in your digestive tract (gastrointestinal perforation).
- If you have thyroid cancer, your doctor will monitor your calcium and thyroid hormone levels.
- Seek immediate medical attention if you have nausea, shortness of breath, irregular heartbeat, muscle cramps, seizures, cloudy urine, and fatigue, as these can be life-threatening symptoms (Tumor Lysis Syndrome).