Votrient

Generic Name: pazopanib (Oral route)

paz-OH-pa-nib

Oral route(Tablet)

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.

• Votrient

Available Dosage Forms:

• Tablet

Therapeutic Class: Antineoplastic Agent

Pharmacologic Class: Tyrosine Kinase Inhibitor

Uses For Votrient

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 this medicine will do as well as the risks of using it.

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

Before Using Votrient

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 pazopanib 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 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.

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


• Mesoridazine


• Pimozide


• Posaconazole


• Sparfloxacin


• Thioridazine

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.

• Alfentanil


• Alfuzosin


• Amiodarone


• Amitriptyline


• Amoxapine


• Apomorphine


• Arsenic Trioxide


• Asenapine


• Astemizole


• Atazanavir


• Azithromycin


• Carbamazepine


• Chloroquine


• Chlorpromazine


• Ciprofloxacin


• Citalopram


• Clarithromycin


• Clomipramine


• Clozapine


• Crizotinib


• Cyclosporine


• Dasatinib


• Desipramine


• Disopyramide


• Dofetilide


• Dolasetron


• Droperidol


• Ergotamine


• Erythromycin


• Fentanyl


• Flecainide


• Fluconazole


• Gatifloxacin


• Gemifloxacin


• Granisetron


• Halofantrine


• Haloperidol


• Ibutilide


• Iloperidone


• Imipramine


• Indinavir


• Itraconazole


• Ketoconazole


• Lapatinib


• Levofloxacin


• Lumefantrine


• Mefloquine


• Methadone


• Moxifloxacin


• Nefazodone


• Nelfinavir


• Nilotinib


• Norfloxacin


• Nortriptyline


• Octreotide


• Ofloxacin


• Ondansetron


• Paclitaxel


• Paliperidone


• Perflutren Lipid Microsphere


• Procainamide


• Prochlorperazine


• Promethazine


• Propafenone


• Protriptyline


• Quetiapine


• Quinidine


• Quinine


• Ranolazine


• Rifampin


• Ritonavir


• Salmeterol


• Saquinavir


• Sirolimus


• Sodium Phosphate


• Sodium Phosphate, Dibasic


• Sodium Phosphate, Monobasic


• Solifenacin


• Sorafenib


• Sotalol


• Sunitinib


• Tacrolimus


• Telavancin


• Telithromycin


• Terfenadine


• Tetrabenazine


• Toremifene


• Trazodone


• Trifluoperazine


• Trimipramine


• Vandetanib


• Vardenafil


• Vemurafenib


• Voriconazole


• Ziprasidone

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. 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 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 this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• food


• Grapefruit Juice

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:

• Angina (severe chest pain), history of or


• Gilbert's syndrome (a genetic liver disease) or


• Heart attack, history of or


• Heart disease or


• Heart rhythm problems (e.g., QT prolongation), history of or


• Hypertension (high blood pressure) or


• Hypothyroidism (underactive thyroid) or


• Stomach or bowel problems (e.g., fistula, perforation, tear) or


• Stroke, history of—Use with caution. May make these conditions worse.

• Bleeding problems or


• Hemoptysis (coughing up of blood), history of or


• Stomach bleeding (last 6 months)—It is not known if pazopanib will work in patients with these conditions.

• Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of Votrient

Take this medicine 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.

This medicine 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 this medicine 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.

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 late-stage kidney cancer:
    
    • Adults—800 milligrams (mg) once a day.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  

Missed Dose

If you miss a dose of this medicine, 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.

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 Votrient

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. Blood and urine tests may be needed to check for unwanted effects.

Using this medicine 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 this medicine. Stop using this medicine 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.

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.

You will also need to have your blood pressure measured before starting this medicine 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.

This medicine 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 this medicine. You may need to stop using this medicine several days before having surgery.

This medicine 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 this medicine in your body. You should not eat grapefruit or drink grapefruit juice while you taking 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 or vitamin supplements.

Votrient 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 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


• 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


• shortness of breath


• skin rash


• 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

Less common

• Bleeding from rectum or bloody stools


• blood in the urine


• bloody nose


• chest pain or discomfort


• confusion


• coughing or spitting up blood


• fainting


• irregular heartbeat


• 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. 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

• Change in hair color


• change in taste


• decreased weight


• diarrhea


• hair loss


• lack or loss of strength


• loss of taste


• thinning of the hair


• weight loss

Less common

• Acid or sour stomach


• belching


• heartburn


• indigestion


• stomach discomfort, upset, or pain

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: Votrient side effects (in more detail)

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More Votrient resources

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

• Votrient Prescribing Information (FDA)


• Votrient Consumer Overview


• Votrient Monograph (AHFS DI)


• Votrient MedFacts Consumer Leaflet (Wolters Kluwer)


• Pazopanib Professional Patient Advice (Wolters Kluwer)

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