1 What is NexAVAR?

Brand: NexAVAR

Generic: Sorafenib

NexAVAR is an antineoplastic drug used for the treatment of advanced renal cell carcinoma, hepatocellular carcinoma, and metastatic, progressive, differentiated thyroid carcinoma.

This drug interferes with the growth of cancer cells by inhibiting several tyrosine kinases. This drug requires a prescription.

2 What to Know Before Using

If you are about to start NexAVAR, speak with your doctor about what you need to know. Inform your healthcare provider for any allergic reactions to these drugs or any other drugs, foods, dyes, preservatives, or animals. Carefully read the label of non-prescription drugs for any possible allergic reaction or contraindications.

Studies in children regarding the correlation of age to the effects of sorafenib have not been performed while safety and efficacy have not been established. Studies in the elderly have not reported any geriatric-specific problems that would limit the utility of sorafenib.

Adjustments in the dose of the elderly may be required since they are more likely to be sensitive to this drug. Risks to fetuses have been reported in studies of pregnant of women but these may be outweighed by the benefits of therapy in a life threatening situation or a serious disease.

Infant risk is still undetermined when using this drug during breastfeeding. Discuss with your healthcare professional about the potential risks and benefits of taking this drug while breastfeeding.

Drugs should not be taken together to prevent any interactions but in necessary cases inquire your healthcare provider regarding the adjustments in dosage or any other necessary precautions to prevent any unwanted side effects.

Inform your healthcare professional if you are taking any other drugs such as Cytochrome P450 Inducers, Cytochrome P450 Inhibitors, Neomycin, or drugs that increase Gastric pH.

Intake of specific food or using alcohol or tobacco with this drug is associated with an increased risk of certain side effects.

Your healthcare professional can give you special instructions about the use of food, alcohol, or tobacco. Inform your doctor if you have any other medical problems such as bleeding problems, heart disease, hepatitis, hypertension, stomach or bowel perforation, congestive heart failure, electrolyte imbalance, or heart rhythm problems.

3 Proper Usage

To use NexAVAR properly, you must follow all instructions given by your doctor. Cancer drugs are very strong and can have many side effects. To prevent any side effects, take this drug exactly as directed on the label or as prescribed by your healthcare professional.

The tablet must be swallowed whole with water. Crushing, breaking, or chewing it is not recommended. This drug must be taken on an empty stomach, at least 1 hour before or 2 hours after a meal.

The dose of this drug will be variable for different patients. The directions on the label or the prescription by your healthcare professional should be followed. The dosage of this drug you take depends on the medical problem for which you are using this drug.

Adults with kidney or thyroid or liver cancer are given 400 milligrams two times per day. Your healthcare professional may adjust your dose if necessary. Use and dose in children must be determined by your healthcare professional.

A missed dose should be taken as soon as possible. However, skip the missed dose and go back to your regular dosing schedule if it is almost time for your next dose.

Store the drug in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing. Keep out of the reach of children.

Dispose any outdated or expired drugs and ask your healthcare professional for the proper disposal of the drugs.

4 Precautions to Take

In using NexAVAR, you must be careful and take some precautions as advised by your doctor. Regular visits should be made to your healthcare provider to track your progress and to monitor the effectiveness of the drug.

This drug has teratogenic potential and it is recommended to use an effective form of birth control during therapy and for at least 2 weeks after the last dose.

Inform your healthcare professional immediately if you think you have become pregnant while using this drug. It is recommended to monitor your blood pressure weekly, especially during the first 6 weeks after starting this drug.

Consult with your healthcare professional if you have symptoms of hypertension such as:

  • Blurred vision
  • Dizziness
  • Nervousness
  • Headache
  • Pounding in the ears, or a slow or fast heartbeat

Check with your healthcare professional immediately if you have symptoms of skin reactions such as:

  • Redness, blistering, peeling or loosening of the skin
  • Red skin lesions
  • Redness, pain, swelling, or blisters on the palms of your hands or soles of your feet
  • Severe acne or skin rash
  • Sores or ulcers on the skin, or fever
  • or Chills while you are using this drug

Check with your healthcare professional immediately if you are having symptoms of a heart problem such as:

Check with your healthcare professional immediately if you have symptoms of a serious bowel problem such as:

  • Severe burning
  • Cramps, or pain in the stomach area
  • Bloody or black, tarry stools
  • Trouble breathing
  • Heartburn
  • Indigestion
  • Nausea, or vomiting of material that looks like coffee grounds

Chance of bleeding and delay in wound healing may be increased by this drug. It is recommended to avoid rough sports or other situations where you could be bruised, cut, or injured.

Your teeth must be brushed and flossed gently. Care must be given in using sharp objects, including razors and fingernail clippers.

Contact your healthcare professional immediately if you have any symptoms of heart rhythm problems, such as fast, pounding, or irregular heartbeats.

Check with your healthcare professional immediately if you have symptoms of hepatitis such as:

  • Pain or tenderness in the upper stomach
  • Pale stools
  • Dark urine
  • Loss of appetite
  • Nausea
  • Vomiting
  • Yellow eyes or skin

Inform any healthcare professional who treats you that you are using this drug. You may be advised to stop using this drug several days before having surgery or any medical tests.

Consult with your healthcare professional before taking any other prescription or nonprescription drugs, and herbal or vitamin supplements.

5 Potential Side Effects

As with many medications, there are several potential side effects associated with NexAVAR. Side effects may vary for each individual and prompt medical attention should be given if they occur. 

Seek advice from your healthcare professional immediately if you experience any unusual symptoms such as:

  • 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
  • Slow or fast heartbeat
  • Vomiting of blood
  • Yellow eyes or skin
  • Bone pain
  • Chest pain or discomfort
  • Chills
  • Clammy skin
  • Confusion
  • Constipation
  • Convulsions
  • 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 or upset
  • 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
  • Blistering, peeling, or loosening of the skin
  • Diarrhea
  • Large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • Red skin lesions
  • Often with a purple center, or red, irritated eyes

Some side effects may occur that usually do not need medical attention. As your body adjusts to the drug, the side effects will slowly disappear. Ask your healthcare professional about ways to prevent or reduce some of these side effects.

If any of the following side effects persists or are inconvenient, or if you notice any other effects, or if you have any questions about them, consult with your health care professional. Report any side effects to the FDA hotline at 1-800-FDA-1088.

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