Votrient Side Effects: Weight Loss, Nausea, High Blood Pressure. Last April, the Food and Drug Administration (FDA) approved the use of the drug Votrient (generic name: pazopanib) to treat “patients with advanced soft tissue sarcoma who have previously received chemotherapy”.
Reports, such as a Daily Mail story, claim that Votrient has less burdensome side effects but it is still very important to familiarize ourselves with what these side effects are.
According to the FDA’s press release the most common Votrient side effects are as follows: fatigue, diarrhea, nausea, weight loss, high blood pressure, decreased appetite, vomiting, tumor and muscle pain, hair color changes, headache, a distorted sense of taste, shortness of breath, and skin discoloration.
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As for less common but more serious Votrient side effects, the medication guide issued by the drug manufacturer, GlaxoSmithKline, and approved by the FDA mentions the following:
- irregular or fast heartbeat or fainting
- heart failure. This is a condition where your heart does not pump as well as it should and may cause you to have shortness of breath.
- heart attack or stroke. Heart attack and stroke can happen with and may cause death.
- blood clots. Blood clots may form in a vein, especially in your legs (deep vein 112 thrombosis or DVT). Pieces of a blood clot may travel to your lungs (pulmonary 113 embolism). This may be life threatening and cause death.
- bleeding problems. These bleeding problems may be severe and cause death.
- tear in your stomach or intestinal wall (perforation) or an abnormal connection between two parts of your gastrointestinal tract (fistula).
- Reversible Posterior Leukoencephalopathy (RPLS). RPLS is a condition that can happen while taking VOTRIENT that may cause death.
- high blood pressure. High blood pressure can happen with VOTRIENT, including a sudden and severe rise in blood pressure which may be life threatening. These blood pressure increases usually happen in the first several months of treatment. Your blood pressure should be well controlled before you start taking VOTRIENT. Your healthcare provider should begin checking your blood pressure within 1 week of you starting VOTRIENT and often during treatment to make sure that your blood pressure is well controlled. Have someone call your healthcare provider or get medical help right away for you, if you get symptoms of a severe increase in blood pressure, including: severe chest pain, severe headache, blurred vision, confusion, nausea and vomiting, severe anxiety, shortness of breath, seizures, or you pass out (become unconscious).
- thyroid problems. Your healthcare provider should check you for this during treatment with VOTRIENT.
- protein in your urine. Your healthcare provider will check you for this problem. If there is too much protein in your urine, your healthcare provider may tell you to stop taking VOTRIENT.
- serious infections. Serious infections can happen with VOTRIENT and can cause death.
- collapsed lung (pneumothorax). A collapsed lung can happen with VOTRIENT. Air may get trapped in the space between your lung and chest wall. This may cause you to have shortness of breath.
Now, the most important thing that you should know about Votrient side effects according to the medication guide issued by its manufacturer is that VOTRIENT can cause serious liver problems which can lead to death.
That’s why your healthcare provider should conduct blood tests to check your liver before you start medication and while you are taking VOTRIENT. A patient should also tell his/her healthcare provider immediately if he/she has any of the following signs of liver problems during treatment with VOTRIENT:
- yellowing of your skin or the whites of your eyes (jaundice)
- dark urine
- nausea or vomiting
- loss of appetite
- pain on the right side of your stomach area (abdomen)
- bruise easily
If you do develop liver problems during treatment, your healthcare provider may need to prescribe a lower dose of VOTRIENT for you or tell you to stop taking the drug altogether.
How should you take Votrient? Here’s what the medication guide advises you to do:
- Take VOTRIENT exactly as your healthcare provider tells you. Your healthcare provider will tell you how much VOTRIENT to take. Your healthcare provider may change your dose.
- Take VOTRIENT on an empty stomach, at least 1 hour before or 2 hours after food.
- Do not crush VOTRIENT tablets.
- Do not eat grapefruit or drink grapefruit juice during treatment with VOTRIENT. Grapefruit products may increase the amount of VOTRIENT in your body.
- If you miss a dose, take it as soon as you remember. Do not take it if it is close (within 12 hours) to your next dose. Just take the next dose at your regular time. Do not take more than 1 dose of VOTRIENT at a time.
- Your healthcare provider will test your urine, blood, and heart before you start and while you take VOTRIENT.
- Tell your healthcare provider if you plan to have surgery while taking VOTRIENT. You will need to stop taking VOTRIENT at least 7 days before surgery because VOTRIENT may affect healing after surgery.
Is Votrient effective? In its news release announcing its approval of Votrient, the FDA has this to say about the effectiveness of the drug for patients with advanced soft tissue sarcoma:
The safety and effectiveness of Votrient was evaluated in a single clinical study in 369 patients with advanced soft tissue sarcoma who had received prior chemotherapy. Patients were randomly selected to receive Votrient or a placebo. The study was designed to measure the length of time a patient lived without the cancer progressing (progression-free survival). The disease did not progress for a median of 4.6 months for patients receiving Votrient, compared with 1.6 months for those receiving the placebo.
Votrient Side Effects: Weight Loss, Nausea, High Blood Pressure posted 12 June 2012. Last update on 27 April 2017.