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Votrient

Last reviewed on RxList: 7/3/2017
Votrient Side Effects Center

Last reviewed on RxList 7/3/2017

Votrient (pazopanib) is a tyrosine kinase inhibitor used to treat kidney cancer, and it may also be used to treat certain other types of cancer (soft tissue sarcoma). Common side effects of Votrient include:

  • headache,
  • loss of appetite,
  • weight loss,
  • altered sense of taste,
  • nausea and vomiting (may be severe),
  • diarrhea,
  • numbness/tingling/redness in hands/feet,
  • changes in hair or skin color,
  • joint or muscle pain,
  • feeling tired/weak,
  • fatigue,
  • high blood pressure (hypertension),
  • tumor pain,
  • stomach or abdominal pain,
  • shortness of breath,
  • peeling rash,
  • cough,
  • swelling of extremities,
  • mouth sores,
  • hair loss,
  • dizziness,
  • swelling of the mouth or lips, or
  • chest pain.

Many people have more frequent/loose stools or diarrhea while taking Votrient. Diarrhea can cause a serious loss of body water (dehydration). Tell your doctor if you develop signs of dehydration (such as extreme thirst, decreased urination, muscle cramps, weakness, or fainting). Votrient may cause high blood pressure. Temporary hair loss and/or change in hair or skin color may occur. Normal hair growth should return after treatment with Votrient has ended.

The recommended dose of Votrient is 800 mg orally once daily without food (at least 1 hour before or 2 hours after a meal). Votrient may interact with other drugs that can cause bleeding/bruising such as antiplatelet drugs, NSAIDs, aspirin, or blood thinners. It can also interact with azole antifungals, antidepressants, antibiotics, rifamycins, St. John's wort, seizures medications, HIV medicines, and other drugs that can affect the heart rhythm (QT prolongation), including amiodarone, dofetilide, pimozide, procainamide, quinidine, or sotalol. Tell your doctor all medications and supplements you use. Votrient is not recommended for use during pregnancy. It may harm a fetus. Discuss birth control with your doctor. If you become pregnant or think you may be pregnant, tell your doctor. It is unknown if this medication passes into breast milk. Consult your doctor before breastfeeding.

Our Votrient (pazopanib) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Votrient Consumer Information

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using pazopanib and call your doctor at once if you have a serious side effect such as:

  • slow healing of a wound or surgical incision;
  • dizziness, fainting, fast or pounding heartbeat;
  • fever, chills, easy bruising, flu symptoms, sores in your mouth and throat;
  • feeling short of breath (even with mild exertion), swelling, rapid weight gain;
  • bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;
  • nosebleed, bleeding gums;
  • any wound that will not heal;
  • nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • sudden numbness or weakness (especially on one side of the body), sudden severe headache, confusion, problems with vision, speech, or balance;
  • seizures (convulsions);
  • sudden cough, wheezing, rapid breathing, coughing up blood;
  • chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
  • pain, swelling, warmth, or redness in one or both legs; or
  • dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, chest pain, shortness of breath, uneven heartbeats, seizure).

Less serious side effects may include:

  • mild nausea or vomiting, diarrhea;
  • weight loss;
  • changes in hair or skin color;
  • joint or muscle pain;
  • tumor pain, mild headache; or
  • unusual or unpleasant taste in your mouth.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Votrient (Pazopanib Tablets)

Votrient Professional Information

SIDE EFFECTS

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Potentially serious adverse reactions with VOTRIENT included:

Renal Cell Carcinoma

The safety of VOTRIENT has been evaluated in 977 patients in the monotherapy trials which included 586 patients with RCC at the time of NDA submission. With a median duration of treatment of 7.4 months (range: 0.1 to 27.6), the most commonly observed adverse reactions ( ≥ 20%) in the 586 patients were diarrhea, hypertension, hair color change, nausea, fatigue, anorexia, and vomiting.

The data described below reflect the safety profile of VOTRIENT in 290 RCC patients who participated in a randomized, double-blind, placebo-controlled trial [see Clinical Studies]. The median duration of treatment was 7.4 months (range: 0 to 23) for patients who received VOTRIENT and 3.8 months (range: 0 to 22) for the placebo arm. Forty-two percent of patients on VOTRIENT required a dose interruption. Thirty-six percent of patients on VOTRIENT were dose reduced. Table 1 presents the most common adverse reactions occurring in ≥ 10% of patients who received VOTRIENT.

Table 1: Adverse Reactions Occurring in ≥ 10% of Patients with RCC Who Received VOTRIENT

Adverse Reactions VOTRIENT
(N = 290)
Placebo
(N = 145)
All Gradesa % Grade 3 % Grade 4 % All Gradesa % Grade 3 % Grade 4 %
Diarrhea 52 3 < 1 9 < 1 0
Hypertension 40 4 0 10 < 1 0
Hair color changes 38 < 1 0 3 0 0
Nausea 26 < 1 0 9 0 0
Anorexia 22 2 0 10 < 1 0
Vomiting 21 2 < 1 8 2 0
Fatigue 19 2 0 8 1 1
Asthenia 14 3 0 8 0 0
Abdominal pain 11 2 0 1 0 0
Headache 10 0 0 5 0 0
aNational Cancer Institute Common Terminology Criteria for Adverse Events, version 3.

Other adverse reactions observed more commonly in patients treated with VOTRIENT than placebo and that occurred in < 10% (any grade) were alopecia (8% versus < 1%), chest pain (5% versus 1%), dysgeusia (altered taste) (8% versus < 1%), dyspepsia (5% versus < 1%), dysphonia (4% versus < 1%), facial edema (1% versus 0%), palmar-plantar erythrodysesthesia (hand-foot syndrome) (6% versus < 1%), proteinuria (9% versus 0%), rash (8% versus 3%), skin depigmentation (3% versus 0%), and weight decreased (9% versus 3%).

Additional adverse reactions from other clinical trials in RCC patients treated with VOTRIENT are listed below:

Musculoskeletal and Connective Tissue Disorders: Arthralgia, muscle spasms.

Table 2 presents the most common laboratory abnormalities occurring in > 10% of patients who received VOTRIENT and more commonly ( ≥ 5%) in patients who received VOTRIENT versus placebo.

Table 2: Selected Laboratory Abnormalities Occurring in > 10% of Patients with RCC Who Received VOTRIENT and More Commonly ( ≥ 5%) in Patients Who Received VOTRIENT versus Placebo

Parameters VOTRIENT
(N = 290)
Placebo
(N = 145)
All Grades a % Grade 3 % Grade 4 % All Grades a % Grade 3 % Grade 4 %
Hematologic
  Leukopenia 37 0 0 6 0 0
  Neutropenia 34 1 < 1 6 0 0
  Thrombocytopenia 32 < 1 < 1 5 0 < 1
  Lymphocytopenia 31 4 < 1 24 1 0
Chemistry
  ALT increased 53 10 2 22 1 0
  AST increased 53 7 < 1 19 < 1 0
  Glucose increased 41 < 1 0 33 1 0
  Total bilirubin increased 36 3 < 1 10 1 < 1
  Phosphorus decreased 34 4 0 11 0 0
  Sodium decreased 31 4 1 24 4 0
  Magnesium decreased 26 < 1 1 14 0 0
  Glucose decreased 17 0 < 1 3 0 0
aNational Cancer Institute Common Terminology Criteria for Adverse Events, version 3.

Soft Tissue Sarcoma

The safety of VOTRIENT has been evaluated in 382 patients with advanced soft tissue sarcoma, with a median duration of treatment of 3.6 months (range: 0 to 53). The most commonly observed adverse reactions ( ≥ 20%) in the 382 patients were fatigue, diarrhea, nausea, decreased weight, hypertension, decreased appetite, vomiting, tumor pain, hair color changes, musculoskeletal pain, headache, dysgeusia, dyspnea, and skin hypopigmentation.

The data described below reflect the safety profile of VOTRIENT in 240 patients who participated in a randomized, double-blind, placebo-controlled trial [see Clinical Studies]. The median duration of treatment was 4.5 months (range: 0 to 24) for patients who received VOTRIENT and 1.9 months (range: 0 to 24) for the placebo arm. Fifty-eight percent of patients on VOTRIENT required a dose interruption. Thirty-eight percent of patients on VOTRIENT had their dose reduced. Seventeen percent of patients who received VOTRIENT discontinued therapy due to adverse reactions. Table 3 presents the most common adverse reactions occurring in ≥ 10% of patients who received VOTRIENT.

Table 3: Adverse Reactions Occurring in ≥ 10% of Patients with STS Who Received VOTRIENT

Adverse Reactions VOTRIENT
(N = 240)
Placebo
(N = 123)
All Gradesa % Grade 3 % Grade 4 % All Gradesa % Grade 3 % Grade 4 %
Fatigue 65 13 1 48 4 1
Diarrhea 59 5 0 15 1 0
Nausea 56 3 0 22 2 0
Weight decreased 48 4 0 15 0 0
Hypertension 42 7 0 6 0 0
Appetite decreased 40 6 0 19 0 0
Hair color changes 39 0 0 2 0 0
Vomiting 33 3 0 11 1 0
Tumor pain 29 8 0 21 7 2
Dysgeusia 28 0 0 3 0 0
Headache 23 1 0 8 0 0
Musculoskeletal pain 23 2 0 20 2 0
Myalgia 23 2 0 9 0 0
Gastrointestinal pain 23 3 0 9 4 0
Dyspnea 20 5 < 1 17 5 1
Exfoliative rash 18 < 1 0 9 0 0
Cough 17 < 1 0 12 < 1 0
Peripheral edema 14 2 0 9 2 0
Mucositis 12 2 0 2 0 0
Alopecia 12 0 0 1 0 0
Dizziness 11 1 0 4 0 0
Skin disorderb 11 2 0 1 0 0
Skin hypopigmentation 11 0 0 0 0 0
Stomatitis 11 < 1 0 3 0 0
Chest pain 10 2 0 6 0 0
aNational Cancer Institute Common Terminology Criteria for Adverse Events, version 3.
b27 of the 28 cases of skin disorder were palmar-plantar erythrodysesthesia.

Other adverse reactions observed more commonly in patients treated with VOTRIENT that occurred in ≥ 5% of patients and at an incidence of more than 2% difference from placebo included insomnia (9% versus 6%), hypothyroidism (8% versus 0%), dysphonia (8% versus 2%), epistaxis (8% versus 2%), left ventricular dysfunction (8% versus 4%), dyspepsia (7% versus 2%), dry skin (6% versus < 1%), chills (5% versus 1%), vision blurred (5% versus 2%), and nail disorder (5% versus 0%).

Table 4 presents the most common laboratory abnormalities occurring in > 10% of patients who received VOTRIENT and more commonly ( ≥ 5%) in patients who received VOTRIENT versus placebo.

Table 4: Selected Laboratory Abnormalities Occurring in > 10% of Patients with STS Who Received VOTRIENT and More Commonly ( ≥ 5%) in Patients Who Received VOTRIENT vers us Placebo

Parameters VOTRIENT
(N = 240)
Placebo
(N = 123)
All Grades a % Grade 3 % Grade 4 % All Grades a % Grade 3 % Grade 4 %
Hematologic
  Leukopenia 44 1 0 15 0 0
  Lymphocytopenia 43 10 0 36 9 2
  Thrombocytopenia 36 3 1 6 0 0
  Neutropenia 33 4 0 7 0 0
Chemistry
  AST increased 51 5 3 22 2 0
  ALT increased 46 8 2 18 2 1
  Glucose increased 45 < 1 0 35 2 0
  Albumin decreased 34 1 0 21 0 0
  Alkaline phosphatase increased 32 3 0 23 1 0
  Sodium decreased 31 4 0 20 3 0
  Total bilirubin increased 29 1 0 7 2 0
  Potassium increased 16 1 0 11 0 0
aNational Cancer Institute Common Terminology Criteria for Adverse Events, version 3.

Diarrhea

Diarrhea occurred frequently and was predominantly mild to moderate in severity in both the RCC and STS clinical trials. Patients should be advised how to manage mild diarrhea and to notify their healthcare provider if moderate to severe diarrhea occurs so appropriate management can be implemented to minimize its impact.

Lipase Elevations

In a single-arm RCC trial, increases in lipase values were observed for 27% (48/181) of patients. Elevations in lipase as an adverse reaction were reported for 4% (10/225) of patients and were Grade 3 for 6 patients and Grade 4 for 1 patient. In the RCC trials of VOTRIENT, clinical pancreatitis was observed in < 1% (4/586) of patients.

Pneumothorax

Two of 290 patients treated with VOTRIENT and no patient on the placebo arm in the randomized RCC trial developed a pneumothorax. In the randomized trial of VOTRIENT for the treatment of STS, pneumothorax occurred in 3% (8/240) of patients treated with VOTRIENT and in no patients on the placebo arm.

Bradycardia

In the randomized trial of VOTRIENT for the treatment of RCC, bradycardia based on vital signs ( < 60 beats per minute) was observed in 19% (52/280) of patients treated with VOTRIENT and in 11% (16/144) of patients on the placebo arm. Bradycardia was reported as an adverse reaction in 2% (7/290) of patients treated with VOTRIENT compared with < 1% (1/145) of patients treated with placebo. In the randomized trial of VOTRIENT for the treatment of STS, bradycardia based on vital signs ( < 60 beats per minute) was observed in 19% (45/238) of patients treated with VOTRIENT and in 4% (5/121) of patients on the placebo arm. Bradycardia was reported as an adverse reaction in 2% (4/240) of patients treated with VOTRIENT compared with < 1% (1/123) of patients treated with placebo.

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of VOTRIENT. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate the frequency or establish a causal relationship to drug exposure.

Eye Disorders: Retinal detachment/tear.

Gastrointestinal Disorders: Pancreatitis.

Read the entire FDA prescribing information for Votrient (Pazopanib Tablets)

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© Votrient Patient Information is supplied by Cerner Multum, Inc. and Votrient Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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