Severe and fatal hepatotoxicity has been observed in clinical studies. Monitor hepatic function and interrupt, reduce, or discontinue dosing as recommended .
Commonly used brand name(s):
In the U.S.
Available Dosage Forms:
Therapeutic Class: Antineoplastic Agent
Pharmacologic Class: Tyrosine Kinase Inhibitor
Pazopanib is an anticancer medicine that is used to treat adults with kidney cancer (advanced renal cell carcinoma).
Pazopanib interferes with the growth of cancer cells, which are eventually destroyed. Since the growth of normal body cells may also be affected by pazopanib, other effects will also occur. Some of these may be serious and must be reported to your doctor. Other effects, like hair loss, may not be serious but may cause concern. Some effects may not occur for months or years after the medicine is used.
Before you begin treatment with pazopanib, you and your doctor should talk about the good pazopanib will do as well as the risks of using it.
pazopanib is available only with your doctor's prescription.
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 pazopanib, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to pazopanib 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.
Appropriate studies have not been performed on the relationship of age to the effects of pazopanib in the pediatric population. Safety and efficacy have not been established.
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of pazopanib in the elderly. However, elderly patients may be more sensitive to the effects of pazopanib than younger adults, and are more likely to have age-related liver problems, which may require caution for patients receiving pazopanib.
|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.|
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.
Using pazopanib 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.
Using pazopanib 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.
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.
Using pazopanib with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use pazopanib, or give you special instructions about the use of food, alcohol, or tobacco.
The presence of other medical problems may affect the use of pazopanib. Make sure you tell your doctor if you have any other medical problems, especially:
Take pazopanib only as directed by your doctor to benefit your condition as much as possible. 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.
pazopanib should come with a medication guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.
It is best to take pazopanib on an empty stomach, at least one hour before or 2 hours after a meal.
Swallow the tablets whole. Do not break, crush, or chew it.
The dose of pazopanib 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 pazopanib. 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.
If you miss a dose of pazopanib, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
If you miss a dose or forget to use it, and it is less than 12 hours since your last dose, wait and take your next dose at the normal time. Do not use extra medicine to make up for a missed dose.
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.
If you will be taking pazopanib 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 pazopanib. Blood and urine tests may be needed to check for unwanted effects.
Using pazopanib while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.
Liver problems may occur while you are using pazopanib. Stop using pazopanib and check with your doctor right away if you are having more than one of these symptoms: abdominal or 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; or yellow eyes or skin.
pazopanib 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.
You will also need to have your blood pressure measured before starting pazopanib and while you are using it. If you notice any change to your recommended blood pressure, call your doctor right away. If you have questions about this, talk to your doctor.
pazopanib may increase your chance of bleeding. 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.
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.
Make sure any doctor who treats you knows that you are using pazopanib. You may need to stop using pazopanib several days before having surgery.
pazopanib may cause diarrhea, and in some cases it can be severe. Do not take any medicine to treat diarrhea without first checking with your doctor. Diarrhea medicines may make the diarrhea worse or make it last longer. If you have any questions about this or if mild diarrhea continues or gets worse, check with your doctor.
Grapefruits and grapefruit juice may increase the effects of pazopanib by increasing the amount of pazopanib in your body. You should not eat grapefruit or drink grapefruit juice while you taking pazopanib.
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 or vitamin supplements.
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
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
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.
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