Votrient

Votrient is a tyrosine kinase inhibitor that is used for the treatment of advanced renal cell carcinoma, and advanced soft tissue sarcoma in patients who have received other cancer treatments.

This drug interferes with the growth and angiogenesis of cancer cells. Discuss with your healthcare professional about the potential risks and benefits of taking this drug before beginning treatment with it. This drug requires a prescription.

Before using Votrient, you must know all about the risks and complications associated with it. 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 pazopanib have not been performed while safety and efficacy have not been established.

Studies in the elderly have not demonstrated any geriatric-specific problems that would limit the utility of pazopanib. Adjustments in the dose of the elderly may be required since they are more likely to have age-related liver problems.

Risks to the fetus have been reported in studies of pregnant 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:

• Drugs that raise gastric pH
• Simvastatin
• Drugs that inhibit transporters
• CYP substrates
• CYP3A4 inducers
• CYP3A4 inducers
• Drugs that inhibit or induce Cytochrome P450 3A4 enzymes

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 healthcare provider for any other medical problems such as:

• Angina
• Blood clotting problems
• Congestive heart failure
• Gilbert syndrome
• Heart attack
• Heart disease
• Heart rhythm problems
• Hypertension
• Hypothyroidism
• Lung problems
• Stomach or bowel problems
• Stroke
• Transient ischemic attack
• Infection
• Liver disease

Proper usage of Votrient requires strict adherence to your doctor’s orders. It is recommended to take this drug on an empty stomach, at least 1 hour before or 2 hours after a meal. The tablet must be swallowed whole. Breaking, crushing, or chewing the drug is not recommended.

Grapefruit products are contraindicated with this drug, as these may change the amount of drug that is absorbed in the body. 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 late-stage kidney cancer and advanced soft tissue sarcoma are given 800 milligrams once 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.

Before using Votrient, there are some precautions you must take. Regular visits should be made to your healthcare provider to track your progress and to monitor the effectiveness of the drug.

Unwanted effects can be screened using blood tests. Your blood pressure will be regularly monitored during treatment with this drug. Your healthcare professional may need to treat you if you develop high blood pressure.

Your blood pressure will be regularly monitored during treatment with this drug. Your healthcare professional may need to treat you if you develop high blood pressure.

Symptoms of high blood pressure are:

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

This drug has teratogenic potential and it is recommended to use an effective form of birth control to keep from getting pregnant. Inform your healthcare professional immediately if you think you have become pregnant while using the drug.

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

• Stomach pain or tenderness
• Clay-colored stools
• Dark urine
• Decreased appetite
• Fever
• Headache
• Itching
• Loss of appetite
• Nausea and vomiting
• Skin rash
• Swelling of the feet or lower legs
• Unusual tiredness or weakness
• Yellow eyes or skin

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

If you are rapidly gaining weight, having shortness of breath, chest pain or discomfort, extreme tiredness or weakness, irregular breathing, irregular heartbeat, or excessive swelling of the hands, wrist, ankles, or feet, check with your healthcare professional immediately for the possibility of a heart problem.

This drug may cause thrombocytopenia which can increase your chance of bleeding and cause a delay in wound healing. Rough sports or other situations where you could be bruised, cut, or injured should be avoided. Your teeth should be brushed and flossed gently. Be careful when using sharp objects, including razors and fingernail clippers.

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

• New chest pain
• Troubled breathing
• Leg pain
• Swelling of the arms, hands, legs, or feet
• A cool or pale arm or leg

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

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

Inform your healthcare professional immediately if you have symptoms of a serious lung condition such as:

• Cough
• Fever
• Chest pain
• Trouble breathing with this drug

Check with your healthcare professional immediately if you have symptoms of reversible posterior leukoencephalopathy syndrome such as:

• Headaches
• Seizures
• Extreme drowsiness
• Confusion
• Vision problems with this drug

Inform any healthcare professional who treats you that you are using this drug. You may need to stop using it at least 7 days before having surgery.

Call your healthcare professional immediately if you have symptoms of an infection such as:

• A persistent cough
• Weight loss
• Night sweats
• Fever
• Chills
• Flu-like symptoms, such as:
  • A runny or stuffy nose,
  • Headache
  • Blurred vision
  • Feel generally ill

This drug may cause diarrhea, and in some cases, it can be severe. Check with your healthcare professional before you take any drugs to treat diarrhea as these may make the diarrhea worse or make it last longer.

Check with your healthcare professional if you have any questions about this or if mild diarrhea continues or gets worse.

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

As with many medications, there are several potential side effects associated with Votrient. 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 or tenderness
• Black, tarry stools
• Bleeding gums
• Blood in the urine or stools
• Blurred vision
• Chest pain
• Chills
• Clay-colored stools
• Cloudy urine
• Constipation
• Cough
• Coughing up blood
• Dark urine
• Decreased appetite
• Depressed mood
• Difficulty with breathing or swallowing
• Dizziness
• Dry skin and hair
• Feeling cold
• Fever
• Hair loss
• Headache
• Hoarseness or husky voice
• Increased menstrual flow or vaginal bleeding
• Itching or skin rash
• Loss of appetite
• Lower back or side pain
• Muscle cramps and stiffness
• Nausea and vomiting
• Nervousness
• Nosebleeds
• Painful or difficult urination
• Pale skin
• Paralysis
• Pinpoint red spots on the skin
• Pounding in the ears
• Prolonged bleeding from cuts
• Red or black, tarry stools
• Red or dark brown urine
• Redness
• Swelling, or pain of the skin
• Scaling of the skin on the hands and feet
• Slow or fast heartbeat
• Sore throat
• Sores
• Ulcers, or white spots on the lips or in the mouth
• Swelling of the feet or lower legs
• Swollen glands
• Tingling of the hands and feet
• Ulceration of the skin
• Unusual bleeding or bruising
• Unusual tiredness or weakness
• Weight gain
• Yellow eyes or skin
• Bleeding from rectum or bloody stools
• Bloody nose
• Chest discomfort
• Confusion
• Fainting
• Irregular or slow heart rate
• Numbness or tingling in the face, arms, or legs
• Pain or discomfort in the shoulders, arms, jaw, back, or neck
• Sweating
• Swelling or puffiness of the face
• Trouble speaking
• Thinking
• or Walking

Some side effects may occur that usually do not need medical attention. As your body adjusts to the medicine, 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.