Nexavar

Generic Name: sorafenib (Oral route)

soe-RAF-e-nib

Commonly used brand name(s)

In the U.S.

• Nexavar

Available Dosage Forms:

• Tablet

Therapeutic Class: Antineoplastic Agent

Uses For Nexavar

Sorafenib is an anticancer medicine that is used to treat adults with kidney cancer (advanced renal cell carcinoma) and liver cancer that cannot be treated with surgery.

This medicine is available only with your doctor's prescription.

Before Using Nexavar

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of sorafenib in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of sorafenib in the elderly. However, elderly patients are more likely to be sensitive and may require a lower dose.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	D	Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Cisapride


• Dronedarone


• Fluconazole


• Levomethadyl


• Mesoridazine


• Pimozide


• Posaconazole


• Saquinavir


• Sparfloxacin


• Thioridazine


• Ziprasidone

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Alfuzosin


• Amiodarone


• Amitriptyline


• Amoxapine


• Apomorphine


• Arsenic Trioxide


• Asenapine


• Astemizole


• Azithromycin


• Chloroquine


• Chlorpromazine


• Ciprofloxacin


• Citalopram


• Clarithromycin


• Clomipramine


• Clozapine


• Crizotinib


• Dasatinib


• Desipramine


• Disopyramide


• Dofetilide


• Dolasetron


• Droperidol


• Erythromycin


• Flecainide


• Gatifloxacin


• Gemifloxacin


• Granisetron


• Halofantrine


• Haloperidol


• Ibutilide


• Iloperidone


• Imipramine


• Lapatinib


• Levofloxacin


• Lopinavir


• Lumefantrine


• Mefloquine


• Methadone


• Moxifloxacin


• Neomycin


• Nilotinib


• Norfloxacin


• Nortriptyline


• Octreotide


• Ofloxacin


• Ondansetron


• Paliperidone


• Pazopanib


• Perflutren Lipid Microsphere


• Procainamide


• Prochlorperazine


• Promethazine


• Propafenone


• Protriptyline


• Quetiapine


• Quinidine


• Quinine


• Ranolazine


• Salmeterol


• Sodium Phosphate


• Sodium Phosphate, Dibasic


• Sodium Phosphate, Monobasic


• Solifenacin


• Sotalol


• Sunitinib


• Telavancin


• Telithromycin


• Terfenadine


• Tetrabenazine


• Toremifene


• Trazodone


• Trifluoperazine


• Trimipramine


• Vandetanib


• Vardenafil


• Vemurafenib


• Voriconazole

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Docetaxel


• Doxorubicin


• Irinotecan


• Warfarin

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Bleeding problems or


• Heart disease or


• Hypertension (high blood pressure) or


• Stomach or bowel problems (e.g., perforation)—Use with caution. May make these conditions worse.

• Congestive heart failure or


• Electrolyte imbalance (e.g., high or low calcium, magnesium, or potassium) or


• Heart rhythm problems (e.g., QT prolongation, slow heartbeat)—Use with caution. May increase risk for more serious side effects.

• Heart rhythm problem (congenital long QT syndrome)—Should not be used in patients with this condition.

• Kidney disease, severe (requires dialysis) or


• Liver disease, severe—Use with caution. This medicine has not been studied in patients with these conditions.

• Squamous cell lung cancer—Should not be used in combination with certain cancer medicines (e.g., carboplatin, paclitaxel, Paraplatin®, or Taxol®) in patients with this condition.

Proper Use of Nexavar

Medicines used to treat cancer are very strong and can have many side effects. Before using this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.

Take this medicine exactly as directed even if you feel well. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.

Swallow the tablet whole with water. Do not crush, break, or chew it.

Take the tablet on an empty stomach, at least 1 hour before or 2 hours after a meal.

This medicine comes with a patient information insert. It is very important that you read and understand this information. Be sure to ask your doctor about anything you do not understand.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):
  
  • For kidney cancer:
    
    • Adults—400 milligrams (mg) two times a day. Your doctor may adjust your dose as needed.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  
  • For liver cancer:
    
    • Adults—400 milligrams (mg) two times a day. Your doctor may adjust your dose as needed.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  

Missed Dose

If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using Nexavar

If you will be taking this medicine for a long time, it is very important that your doctor check you at regular visits for any problems or unwanted effects that may be caused by this medicine.

Your blood pressure should be checked weekly, especially during the first six weeks of starting this medicine. Your doctor may need to treat you if you develop high blood pressure while you are using this medicine. Symptoms of high blood pressure are blurred vision, dizziness, nervousness, headache, pounding in the ears, or a slow or fast heartbeat.

Using this medicine while you are pregnant can harm your unborn baby. Men and women should use an effective form of birth control during treatment with sorafenib and for at least 2 weeks after stopping treatment. If you think you have become pregnant while using this medicine, tell your doctor right away.

This medicine may cause a serious skin problem called hand-foot syndrome. Check with your doctor right away if you have a skin rash or any redness, pain, swelling, or blisters on the palms of your hands or the soles of your feet. If you get this skin problem, your doctor may adjust the dose or stop treatment for a short time.

Sorafenib may cause serious heart problems. Stop using this medicine and check with your doctor right away if you are having chest pain or discomfort; nausea; pain or discomfort in your arms, jaw, back or neck; shortness of breath; sweating; or vomiting.

Stop using this medicine and check with your doctor right away if you start having severe abdominal or stomach burning, cramps, or pains; bloody or black, tarry stools; trouble breathing; heartburn; indigestion; nausea; or vomiting of material that looks like coffee grounds. These could be symptoms of a serious bowel problem.

This medicine may increase your chance of bleeding and cause delay in wound healing. To help with this problem, stay away from rough sports or other situations where you could be bruised, cut, or injured. Brush and floss your teeth gently. Be careful when using sharp objects, including razors and fingernail clippers.

This medicine can cause changes in heart rhythms, such as a condition called QT prolongation. It may change the way your heart beats and cause fainting or serious side effects in some patients. Contact your doctor right away if you have any symptoms of heart rhythm problems, such as fast, pounding, or irregular heartbeats.

Make sure any doctor who treats you knows that you are using this medicine. You may need to stop using this medicine several days before having surgery.

Before you have any medical tests, tell the medical doctor in charge that you are taking this medicine. The results of some tests may be affected by this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (e.g., St. John's wort) or vitamin supplements.

Nexavar Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

• Abdominal or stomach pain


• bleeding gums


• bloating of the abdomen or stomach


• blood in the urine or stools


• blurred vision


• clay-colored stools


• coughing up blood


• dark urine


• difficulty with breathing or swallowing


• dizziness


• headache


• increased menstrual flow or vaginal bleeding


• light-colored stools


• nausea and vomiting


• nervousness


• nosebleeds


• paralysis


• pounding in the ears


• prolonged bleeding from cuts


• red or black, tarry stools


• red or dark brown urine


• shortness of breath


• slow or fast heartbeat


• vomiting of blood


• yellow eyes or skin

Less common

• Bone pain


• chest pain or discomfort


• chills


• clammy skin


• confusion


• constipation


• convulsions (seizures)


• cough


• decreased urine production


• depressed mood


• difficulty with moving


• dry skin and hair


• enlarged pupils


• feeling cold


• fever


• hair loss


• hearing loss


• hives


• hoarseness or husky voice


• increased sensitivity of the eyes to light


• increased sweating, possibly with fever or cold


• increased thirst


• indigestion


• itching


• joint pain


• loss of appetite


• lower back or side pain


• muscle cramps and stiffness


• muscle pain


• pain or discomfort in the arms, jaw, back, or neck


• painful or difficult urination


• pains in the stomach, side, or abdomen, possibly radiating to the back


• pale skin


• pinpoint red spots on the skin


• reddening of the skin, especially around the ears


• ringing, buzzing, or other unexplained noise in the ears that continues


• severe chest pain


• severe headache


• sore throat


• sores, ulcers, or white spots on the lips or in the mouth


• stiff or sore neck


• stomach discomfort, upset, or pain


• sweating


• swelling of the ankles or hands


• swelling of the eyes, face, or inside of the nose


• swollen glands


• swollen joints


• trouble breathing with exertion


• unpleasant breath odor


• unusual bleeding or bruising


• unusual tiredness or weakness


• weight gain

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Blistering, peeling, redness, and/or swelling of the palms of the hands or bottom of the feet


• burning, tingling, numbness or pain in the hands, arms, feet, or legs


• diarrhea


• numbness, pain, tingling, or unusual sensations in palms of the hands or bottom of the feet


• sensation of pins and needles


• stabbing pain


• thinning of the hair


• tightness in the chest


• weight loss


• wheezing

Less common

• Acid or sour stomach


• acne


• belching


• blistering, peeling, or loosening of the skin


• burning feeling in the chest or stomach


• burning, itching, and pain in hairy areas


• cracked lips


• cracks in the skin


• decreased appetite


• decreased interest in sexual intercourse


• discouragement


• dry mouth


• fainting


• feeling of warmth


• feeling sad or empty


• flushing or red skin


• gas


• general feeling of discomfort or illness


• heartburn


• inability to have or keep an erection


• increase in heart rate


• irritability


• lack or loss of strength


• lightheadedness


• loss in sexual ability, desire, drive, or performance


• loss of ability to use or understand speech or language


• loss of heat from the body


• loss of interest or pleasure


• mouth pain


• pus at the root of the hair


• rapid breathing


• red face, neck, arms, and occasionally, upper chest


• red, irritated eyes


• red, swollen skin


• runny nose


• scaly skin


• shivering


• skin rash that is encrusted, scaly, and oozing


• sunken eyes


• swelling of the breasts or breast soreness in both men and women


• swelling or inflammation of the mouth


• tenderness in the stomach area


• thirst


• trouble concentrating


• trouble sleeping


• unusually warm skin


• wrinkled skin

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Nexavar side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More Nexavar resources

• Nexavar Side Effects (in more detail)
• Nexavar Dosage
• Nexavar Use in Pregnancy & Breastfeeding
• Nexavar Drug Interactions
• Nexavar Support Group
• 3 Reviews for Nexavar - Add your own review/rating

• Nexavar Prescribing Information (FDA)


• Nexavar Consumer Overview


• Nexavar Monograph (AHFS DI)


• Nexavar MedFacts Consumer Leaflet (Wolters Kluwer)


• Sorafenib Professional Patient Advice (Wolters Kluwer)

Compare Nexavar with other medications

• Hepatic Tumor
• Hepatocellular Carcinoma
• Renal Cell Carcinoma
• Thyroid Cancer