Precautions
Sep 01, 2021 · Votrient stays in your system for approximately 5 to 6.5 days. This estimate is based on the half-life of Votrient which is about 31 hours and experts agree that it takes up to 5 half-lives for a drug without active metabolites to be completely removed from the body.
How long does Votrient last in clinical trials?
Votrient side effects are often predictable in terms of their onset, duration, and severity. Votrient side effects are almost always reversible and will go away after therapy is complete. ... Before starting Votrient treatment, make sure you tell your doctor about any other medications you are taking (including prescription, over-the-counter ...
What is the duration of treatment for Votrient in HIV infection?
Mainstream access to the drug has only been about three years. There is still a lot they do not know about Votrient. Every time I visit my Oncologist I am always asked if I am experiencing anything unusual. When I was diagnosed, I was informed by my Oncologist that Votrient generally works for only about a year.
What is the recommended dosage of Votrient?
May 05, 2022 · 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.
Is Votrient a chemotherapy treatment?
26 . with VOTRIENT and for 2 weeks after your last dose of VOTRIENT. Talk to your healthcare provider about types of birth control that may be right for you during this time.
How long is Votrient effective?
Does Votrient shrink tumors?
Can you drink alcohol while taking Votrient?
When is the best time to take Votrient?
How fast does sarcoma grow?
What are the side effects of Votrient?
Does Votrient cause hair loss?
Can Votrient cause blood clots?
What is Votrient used to treat?
Does Votrient suppress your immune system?
Who manufactures Votrient?
How do you take Votrient?
How long does Votrient stay in your system?
Votrient stays in your system for approximately 5 to 6.5 days. This estimate is based on the half-life of Votrient which is about 31 hours and expe...
Does Votrient cure cancer or shrink tumors?
Votrient is not a cure for cancer, but it does increase progression-free survival – this is the length of time during and after treatment that a pa...
Is Votrient immunotherapy?
Votrient is not an immunotherapy medicine. It is known as a targeted drug therapy used to treat cancer. Targeted drug therapies affect the areas of...
Is Votrient a chemotherapy treatment?
No, Votrient is not a chemotherapy treatment but it is an oral drug used to treat cancer. It is considered a targeted drug therapy. Targeted drug t...
Is votrient safe for children?
It is not known if Votrient is effective in treating certain soft tissue sarcomas or certain gastrointestinal tumors. It is not known if Votrient is safe and effective in children under 18 years of age.
How long after vasectomies can you use condoms?
Advise males (including those who have had vasectomies) with female partners of reproductive potential to use condoms during treatment with Votrient and for at least 2 weeks after the last dose.
Can adverse reaction rates be directly compared with rates in the clinical trials of another drug?
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.
What Votrient Is Used For
Votrient is used for the treatment of advanced renal cell carcinoma Note: If a drug has been approved for one use, physicians may elect to use this same drug for other problems if they believe it may be helpful.
How Votrient Is Given
The amount of Votrient that you will receive depends on many factors, including your general health or other health problems, and the type of cancer or condition you have. Your doctor will determine your exact Votrient dosage and schedule.
Precautions
Before starting Votrient treatment, make sure you tell your doctor about any other medications you are taking (including prescription, over-the-counter, vitamins, herbal remedies, etc.). While taking Votrient, ask your doctor before you take aspirin or products containing aspirin.
Self-Care Tips
While taking Votrient, drink at least two to three quarts of fluid every 24 hours, unless you are instructed otherwise.
Monitoring and Testing
You will be checked regularly by your doctor while you are taking Votrient to monitor side effects and check your response to therapy. Periodic blood work will be obtained to monitor your complete blood count (CBC) as well as the function of other organs (such as your kidneys and liver).
How Votrient Works
Votrient is not a chemotherapy drug but one of many "targeted therapies." Targeted therapy is the result of about 100 years of research dedicated to understanding the differences between cancer cells and normal cells.
Can you take a lower dose of votrient?
have or had liver problems. You may need a lower dose of VOTRIENT, or your healthcare provider may prescribe a different medicine to treat your advanced renal cell cancer or advanced soft tissue sarcoma.
What are the side effects of votrient?
Side effects of Votrient include: hives, difficulty breathing, swelling of your face, lips, tongue, or throat, unusual bleeding or bruising, slow healing of a wound or surgical incision, any wound that will not heal, sudden chest pain or discomfort, wheezing,
What is a votrient?
Votrient is a prescription medicine used to treat the symptoms of Soft Tissue Sarcomas and Advanced Renal Cell Carcinoma. Votrient may be used alone or with other medications. Votrient belongs to a class of drugs called Antineoplastics, Tyrosine Kinase Inhibitor; Antineoplastics, VEGF Inhibitor.
Is votrient a VEGF inhibitor?
Votrient belongs to a class of drugs called Antineoplastics, Tyrosine Kinase Inhibitor; Antineoplastics, VEGF Inhibitor. It is not known if Votrient is safe and effective in children.
Can adverse reaction rates be directly compared with rates in the clinical trials of another drug?
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.
Is votrient safe for children?
It is not known if VOTRIENT is effective in treating certain soft tissue sarcomas or certain gastrointestinal tumors. It is not known if VOTRIENT is safe and effective in children under 18 years of age.
Can you give a votrient to other people?
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use VOTRIENT for a condition for which it was not prescribed. Do not give VOTRIENT to other people even if they have the same symptoms that you have. It may harm them.
How long can you take votrient without food?
VOTRIENT must be taken without food at least 1 hour before or 2 hours after a meal. Do not crush tablets due to the potential for increased rate of absorption, which may affect systemic exposure. If a dose is missed, it should not be taken if it is less than 12 hours until the next dose.
Can you use a votrient with CYP3A4?
VOTRIENT should not be used in patients who cannot avoid chronic use of CYP3A4 inducers. Concomitant treatment with strong inhibitors of P-glycoprotein (PgP) or breast cancer resistance protein (BCRP) should be avoided due to risk of increased exposure to pazopanib.
When does HTN occur?
HTN occurs early in the course of treatment (approximately 40% of cases occurred by Day 9, and 90% of cases occurred in the first 18 weeks). Do not initiate VOTRIENT in patients with uncontrolled HTN.
Can a votrient cause organ damage?
VOTRIENT may potentially cause serious adverse effects on organ development in pediatric patients , particularly in patients younger than 2 years of age. Embryo-Fetal Toxicity: VOTRIENT can cause fetal harm when administered to a pregnant woman based on animal reproduction studies and its mechanism of action.
How long after eating can you take pazopanib?
Daily dose should not exceed 800 mg. VOTRIENT must be taken without food at least 1 hour before or 2 hours after a meal. Do not crush tablets due to the potential for increased rate of absorption, which may affect systemic exposure.
Indications and Usage
Pazopanib is used to treat certain types of cancer (kidney, soft tissue sarcoma).
May Treat: Renal cell carcinoma · Soft or connective tissue sarcoma
Drug Class: Antineoplastic - Protein-Tyrosine Kinase Inhibitors
Availability: Prescription Required
Pregnancy: Consult your doctor. This medication may be harmful to an unborn child.
Lactation: This drug should not be given to breastfeeding mothers
May Treat: Renal cell carcinoma · Soft or connective tissue sarcoma
Drug Class: Antineoplastic - Protein-Tyrosine Kinase Inhibitors
Availability: Prescription Required
Pregnancy: Consult your doctor. This medication may be harmful to an unborn child.
Lactation: This drug should not be given to breastfeeding mothers
Alcohol: Avoid intake while taking this medication
Driving: May cause drowsiness or dizziness. Use caution
Manufacturer: NOVARTIS
- Before use, important to read the Medication Guide
- Do not take while breast feeding or when pregnant
- Call MD if new abdominal pain/yellowing eyes/skin
- Before use, important to read the Medication Guide
- Do not take while breast feeding or when pregnant
- Call MD if new abdominal pain/yellowing eyes/skin
- Swallow whole tablet. Do not break, chew or crush.
- Lab tests may be ordered to monitor therapy
- Tell doctor if fainting or faintness occurs.
- Report severe diarrhea or abdominal pain to Dr.
- Watch for bleeding, heart attack or stroke signs.
Dosage and Administration
Dosage Forms and Strengths
Warnings and Precautions
Adverse Reactions
Drug Interactions
- Recommended Dosage
The recommended dosage of Votrient is 800 mg (four 200 mg tablets) orally once daily without food (at least 1 hour before or 2 hours after a meal) until disease progression or unacceptable toxicity [see Clinical Pharmacology (12.3)]. The dosage should be modified for hepatic impairme… - Dosage Modifications for Adverse Reactions
Table 1 summarizes the recommended dose reductions. Permanently discontinue Votrient in patients unable to tolerate the second dose reduction. Table 2 summarizes the recommended dosage modifications for adverse reactions.
Use in Specific Populations
- Tablets: 200 mg, modified capsule-shaped, gray or pink, film-coated with ‘GS JT’ debossed on one side.
Overdosage
- Hepatic Toxicity
Hepatotoxicity, manifested as increases in ALT, aspartate aminotransferase (AST) and bilirubin, occurred in patients who received Votrient. This hepatotoxicity can be severe and fatal. Patients older than 65 years are at greater risk for hepatotoxicity [see Use in Specific Populations (8.5)]. … - QT Prolongation and Torsades de Pointes
In the RCC trials, 558/586 patients were subject to routine electrocardiogram (ECG) monitoring and QT prolongation ≥ 500 msec was identified in 2% of these 558 patients. In monotherapy trials, torsades de pointes occurred in < 1% of 977 patients who received Votrient. In the randomized R…
Description
- The following clinically significant adverse reactions are elsewhere in the labeling: 1. Hepatic Toxicity [see Warnings and Precautions (5.1)] 2. QT Prolongation and Torsades de Pointes [see Warnings and Precautions (5.2)] 3. Cardiac Dysfunction [see Warnings and Precautions (5.3)] 4. Hemorrhagic Events [see Warnings and Precautions (5.4)] 5. Arterial Thromboembolic Events [s…
Clinical Pharmacology
- Effect of Other Drugs on Votrient
Strong CYP3A4 Inhibitors Coadministration of pazopanib with strong inhibitors of CYP3A4 increases pazopanib concentrations [see Clinical Pharmacology (12.3)]. Avoid coadministration of Votrient with strong CYP3A4 inhibitors and consider an alternate concomitant medication wit… - Effects of Votrient on Other Drugs
CYP Substrates Coadministration of Votrient with agents with narrow therapeutic windows that are metabolized by CYP3A4, CYP2D6, or CYP2C8 may result in inhibition of the metabolism of these products and create the potential for serious adverse reactions. The concomitant use of V…