Zytiga and prednisone. Use of prednisone with abiraterone acetate in metastatic castration-resistant prostate cancer
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Use of prednisone with abiraterone acetate in metastatic castration-resistant prostate cancer.
Abiraterone Plus Prednisone in Prostate Cancer - The ASCO Post - Publication types
Metastatic means the cancer has spread to other parts of the body. Both of these cancers are considered advanced. Testosterone usually plays a role in stimulating prostate cancer growth.
Prostate cancer is considered castration-resistant if the cancer continues to grow or spread even with therapy or surgery to lower testosterone levels. High-risk castration-sensitive cancer still responds to lowered testosterone levels but requires more aggressive treatment.
Zytiga contains the drug abiraterone acetate. Reduced levels of male hormones, such as testosterone, help slow or stop the growth of prostate cancer cells. Zytiga comes as an oral tablet that you take once a day. In clinical studies of men with metastatic CRPC, taking Zytiga with prednisone in addition to standard hormone therapy prolonged life by about 4. This means that they lived for three years after they started taking the drug.
This was compared to standard therapy. Zytiga is a brand-name medication that contains abiraterone acetate. Zytiga comes as a mg tablet and a mg tablet. A generic version of the mg tablet of abiraterone acetate is available. Zytiga can cause mild or serious side effects. The following list contains some of the key side effects that you may have while taking Zytiga. This list does not include all possible side effects.
For more information on the possible side effects of Zytiga, talk with your doctor or pharmacist. They can give you tips on how to deal with any side effects that may be bothersome. Most of these side effects may go away within a few days or a couple of weeks.
Your doctor will monitor you for these side effects at regularly scheduled office visits. Call your doctor right away if you have serious side effects. You may wonder how often certain side effects occur with this drug, or whether certain side effects pertain to it. Liver damage, severe liver toxicity when harmful levels of the drug build up in your liverand liver failure were reported as side effects in clinical studies of Zytiga. Liver damage typically occurs during the first three months after starting Zytiga.
Six percent of people who took Zytiga in clinical trials had serious liver damage, based on liver function tests. Your doctor will test your liver function before you start taking Zytiga and during your treatment. If these levels are too high, you may need to take a lower dose of Zytiga or stop treatment. If you have moderate liver damage before you begin taking Zytiga, your doctor will start you on a lower dose of Zytiga.
Symptoms of a UTI include feeling a burning sensation when you urinate, having to urinate often, and feeling that you have to urinate right away. If you have these symptoms, tell your doctor. You may need an antibiotic to help prevent the infection from spreading. Some people in clinical studies of Zytiga had side effects involving their kidneys, including:. Some of these kidney effects may be related to a UTI, but they may not. If you have any of these symptoms, talk with your doctor about possible treatment options.
But some people may lose weight because of some of the side effects of Zytiga, including diarrhea, nausea, vomiting, and upset stomach. These side effects may prevent these people from eating on a regular schedule. These side effects may also prevent their bodies from taking in enough nutrients.
Weight loss is commonly one of the first signs of cancer, according to the American Cancer Society. During cancer treatment, people may lose weight for many reasons, including medication side effects, depression, and loss of appetite. Also, unexplained weight loss and muscle loss, called cachexia, is often seen during late-stage cancer due to poor food intake or poor food absorption. Lastly, weight loss can be a symptom of liver damage or liver failure, which has been reported as a side effect in Zytiga clinical studies.
They can help create a diet plan that provides all the vitamins, minerals, and calories you need. They can also refer you to a dietitian or nutritionist specially trained to help people with cancer. As with all medications, the cost of Zytiga can vary.
Your actual cost will depend on your insurance plan, your location, and the pharmacy you use. If you need financial support to pay for Zytiga, or if you need help understanding your insurance coverage, help is available. Janssen Biotech, Inc. Typically, your doctor will start you on the usual dosage. Your doctor will ultimately prescribe the smallest dosage that provides the desired effect. The following information describes dosages that are commonly used or recommended.
However, be sure to take the dosage your doctor prescribes for you. Your doctor will determine the best dosage to suit your needs. The usual recommended dose for metastatic castration-resistant prostate cancer is 1, mg of Zytiga taken once a day. The dosage may be taken as two mg tablets or four mg tablets. With your Zytiga dose, you will also take 5 mg of prednisone by mouth twice a day.
The usual recommended dose for metastatic high-risk castration-sensitive prostate cancer is 1, mg of Zytiga taken once a day. This dosage may also be taken as two mg tablets or four mg tablets. With your Zytiga dose, you will also take 5 mg of prednisone by mouth once a day. If you have moderately severe liver disease, the recommended dosage is mg of Zytiga taken once a day. If you miss a dose of Zytiga or prednisone, take a dose the next day at the regular time.
Taking more than one dose of Zytiga or prednisone can increase your risk for side effects. It depends. Your doctor may want you to continue your Zytiga treatment on a long-term basis if the drug is effective works well and safe for you. Zytiga may also be used off-label for other conditions.
Metastatic prostate cancer is cancer that has spread from the prostate to other areas in the body. For either type of cancer, Zytiga is used with prednisone, a corticosteroid that helps lessen certain side effects.
Zytiga is also taken with other hormone therapy called androgen deprivation therapy ADTwhich further reduces male hormone levels. Examples of ADT options include:. An alternative to ADT medication is bilateral orchiectomy surgical removal of the testicleswhich also lowers testosterone levels. Zytiga may be used off-label for other uses. But the American Urological Association recommends Zytiga as an option for people if all of the following apply:.
But people with nonmetastatic prostate cancer did go longer without having a significant change in cancer growth or needing to change therapy.
There are other drugs available that can treat your condition. Some may be better suited for you than others. You may wonder how Zytiga compares to other medications that are prescribed for similar uses. Here we look at how Zytiga and Xtandi are alike and different. Both drugs decrease the activity of male hormones but work in slightly different ways.
Zytiga blocks the production of certain male hormones. Xtandi helps prevent male hormones from attaching to their receptors proteins on prostate cancer cells. In both cases, the drugs help stop the spread of prostate cancer. Castration-resistant cancer continues to spread despite the use of drugs that lower male hormone levels.
Metastatic prostate cancer has spread from the prostate to other areas in the body. CSPC still responds to hormone therapy. Nonmetastatic prostate cancer has not spread to other parts of the body yet. Both drugs are taken along with other hormone therapy or following surgery to remove your testicles. This helps further reduce the effects of androgens male hormones such as testosterone on cancer cells.
The usual dosage is 1, mg once a day. You should take Zytiga without food on an empty stomach. You take Zytiga along with prednisone, a corticosteroid that helps reduce certain side effects. Xtandi comes as a mg capsule.
The usual dosage is mg once a day. You can take it with or without food. You may also need a lower dose of Zytiga if you have liver disease.
Zytiga and Xtandi work in slightly different ways, so they have some similar and some different side effects. Below are examples of these side effects. These lists contain examples of more common side effects that can occur with Zytiga, Xtandi, or with both drugs when taken individually.
These lists contain examples of serious side effects that can occur with Zytiga, Xtandi, or with both drugs when taken individually. Zytiga and Xtandi are both brand-name drugs.
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The adrenal glands and prostate cancer cells themselves also make male hormones in small amounts. Zytiga helps prevent these secondary areas of the body from producing testosterone. But Zytiga has caused liver toxicity dangerous levels of the drug that build up in the liver in some people.
Drinking too much alcohol may increase the risk of liver damage in people who are taking Zytiga. Zytiga can interact with several other medications.
It can also interact with certain supplements and foods. Different interactions can cause different effects. For instance, some interactions can affect how well a drug works, while others can increase the number of side effects or make them more severe.
Below is a list of medications that can interact with Zytiga. This list does not contain all drugs that may interact with Zytiga. Before taking Zytiga, talk with your doctor and pharmacist. Tell them about all prescription, over-the-counter, and other drugs you take. Also tell them about any vitamins, herbs, and supplements you use.
Sharing this information can help you avoid potential interactions. If you have questions about drug interactions that may affect you, ask your doctor or pharmacist. In a clinical study , people who took Zytiga with Xofigo had a greater risk for bone fractures and death.
If you have questions about Xofigo, talk with your doctor. Provenge is a type of vaccine that makes your immune system more active in fighting prostate cancer. An immune system response shows that Provenge is working. The results of this study were similar in people who took Zytiga with Provenge and in people who used Zytiga after taking Provenge. Instead, the guidelines recommended taking one drug or the other as a possible treatment. Taking Zytiga with certain seizure medications can increase how quickly your body gets rid of Zytiga.
This can lower the amount of Zytiga in your body and make the drug less effective not work as well. Examples of these seizure medications include:. In some instances, your doctor may want you to take Zytiga with one of these seizure medications.
Taking Zytiga with certain tuberculosis medications can increase how quickly your body gets rid of Zytiga. This may make Zytiga less effective not work as well by lowering the amount of the drug in your body. Examples of these tuberculosis medications include:. In some instances, your doctor may want you to take Zytiga with one of these tuberculosis medications.
Taking Zytiga with drugs that are metabolized broken down by the enzyme CYP2D6 can increase the levels of those drugs in your body. An enzyme is a protein that causes chemical reactions in your body. This is because Zytiga blocks CYP2D6 from breaking down those drugs the way the enzyme normally would. Higher levels of these drugs may increase your risk for side effects. You may need a lower dose of Zytiga or an alternative for the other medication.
Taking Zytiga with drugs that are metabolized broken down by the protein CYP2C8 can increase the levels of those drugs in your body. This is because Zytiga blocks CYP2C8 from breaking down those drugs the way the protein normally would. Higher levels of these drugs can increase your risk for side effects. You may need an alternative to that medication or a lower dose of Zytiga.
Taking Zytiga with St. This is because St. Low levels of Zytiga can decrease how well it will work for you. In some instances, your doctor may want you to take Zytiga and St. Eating food when you take the drug will increase the amount of Zytiga that your body absorbs takes in at one time.
This increases your risk for side effects. Take Zytiga either one hour before a meal or two hours after a meal. However, according to current treatment guidelines , taking Zytiga with food may be an option. Talk with your doctor if you have questions.
Take Zytiga once a day, either one hour before a meal or two hours after a meal. Taking the medication at the same time each day can help you remember your dose. Take Zytiga on an empty stomach, either one hour before a meal or two hours after a meal. Taking Zytiga on an empty stomach helps decrease your risk for side effects. Zytiga contains the drug abiraterone acetate, which is used to treat two types of metastatic prostate cancer:.
Both of these methods decrease testosterone levels. Androgens male hormones such as testosterone encourage prostate cancer cells to grow. Zytiga belongs to a class of medications called androgen biosynthesis inhibitors. These drugs inhibit block the production of androgens. Specifically, Zytiga blocks the activity of an enzyme a protein that causes chemical reactions in the body called CYP The CYP17 enzyme is involved in the production of testosterone and other male hormones. These hormones are made in the testicles, the adrenal glands, and prostate cancer cells.
Zytiga decreases the amount of testosterone that prompts cancer to grow. But drugs like Zytiga that affect steroid hormones may start to lower testosterone levels in days to weeks. In animal studies , taking Zytiga while pregnant had harmful and fatal effects on offspring.
Women who are pregnant or may become pregnant must wear protective gloves while handling Zytiga mg uncoated tablets or damaged Zytiga mg coated tablets. Unprotected exposure to the drug may harm the developing baby. If men who are taking Zytiga are sexually active with a pregnant woman, they should use a condom during treatment and for three weeks after the final dose. If they have female partners who can become pregnant, the couple should use two forms of birth control for example, condoms and oral birth control pills.
In animal studies , males who were given Zytiga had reduced fertility ability to make a woman pregnant. This effect was reversible after 16 weeks following the last dose.
They may recommend that you either stop breastfeeding or take a drug other than Zytiga. According to current treatment guidelines , Zytiga is a treatment option for people whose cancer got worse while taking Xtandi or after taking Xtandi. On the other hand, Xtandi is a treatment option for people whose cancer got worse while taking Zytiga or after taking Zytiga. Some of these side effects include high blood pressure, low potassium levels, and edema swelling, typically in your hands, legs, and feet.
In another clinical study involving older adults, Zytiga was taken with either prednisone or prednisolone. These combinations were found to be safe and effective for treating metastatic prostate cancer when taken with standard hormone therapy. And in another study , switching from prednisone to dexamethasone a corticosteroid similar to prednisone was safe for people with advanced cancer. A small clinical study found that some people may be able to take Zytiga without prednisone.
Some doctors may also prescribe a different corticosteroid, such as prednisolone, methylprednisolone, or dexamethasone, that you take with Zytiga. Prescribing a different corticosteroid than the one the Food and Drug Administration FDA approved is considered off-label use. Zytiga is a type of hormone therapy that helps fight prostate cancer. It works by reducing the amount of male hormones in the body. Chemotherapy drugs, such as docetaxel Taxotere or cabazitaxel Jevtana , work differently from hormone therapy drugs.
Chemotherapy drugs attack many different types of rapidly growing cells in the body, including cancer cells. But the drugs also attack newly forming blood cells, hair follicle cells, and cells on the linings of the mouth and intestines.
Chemotherapy drugs typically have many side effects because of how they affect the body. Hormone therapy is usually a first-choice therapy for treating prostate cancer. Chemotherapy can be used with hormone therapy or by itself to treat late-stage cancer.
You and your doctor will discuss how effective and safe Zytiga is for you. You will likely take Zytiga for as long as it helps prevent cancer from growing and for as long as you can handle the side effects. This may be anywhere from months to years. Zytiga helps slow or stop the growth of prostate cancer by decreasing the amount of testosterone and other male hormones in your body.
Zytiga lowers testosterone levels by blocking the production of other steroids that help create testosterone. It also lowers the levels of another important male hormone called dihydrotestosterone.
Life expectancy the number of years you will likely live is based on several factors. These include your age, overall health status, the stage how advanced your cancer is, and other factors. Life expectancy is different for every person. The number of years you will likely live will help guide therapy options for your prostate cancer.
In clinical studies , people with metastatic castration-resistant prostate cancer who took Zytiga lived about 4. Before taking Zytiga, talk with your doctor about your health history. Zytiga may not be right for you if you have certain medical conditions.
These include:. Zytiga may cause serious heart problems such as heart attack or stroke and death. Before you start taking Zytiga, talk with your doctor about your history of heart disease. This includes heart failure, arrhythmia abnormal heart rhythm , and heart attack.
Your doctor will check you for heart disease, as well as for high blood pressure, low potassium levels, and fluid retention see below. Zytiga may not be right for people with a very high risk for serious heart problems. Zytiga can cause hypertension high blood pressure , which increases your risk for heart problems such as heart attack or stroke. Your doctor will check your blood pressure before you start Zytiga and at least once a month while you take the drug.
Zytiga can decrease blood levels of potassium. This is an important electrolyte a mineral that your body needs for proper nerve, muscle, and heart function. Your doctor will check your potassium levels before you start Zytiga and at least once a month while you take the drug. Before starting Zytiga, tell your doctor about any swelling that you have. They will check to see if the swelling is caused by a disease that should be treated before you start taking Zytiga. Zytiga and prednisone a corticosteroid drug that you take with Zytiga have been linked to adrenal problems.
Adrenal glands make and release hormones. The link was very strong in people who were under stress, had an infection, or stopped corticosteroid therapy. They may monitor you more closely for side effects or recommend an alternate therapy. They may monitor you more closely while you take Zytiga. Zytiga has been linked to liver damage, hepatitis, liver failure, and death. People who had liver disease or liver problems in the past have a greater risk of liver damage if they take Zytiga.
Your doctor will check how your liver is working before you start Zytiga. If you develop liver problems during treatment, you may need to stop taking Zytiga for a time or take a lower dose. People with moderate liver disease should start with a lower dose of Zytiga. Taking more than the recommended dosage of Zytiga can increase your risk for common and serious side effects. This list does not include all possible overdose symptoms. You can also call the American Association of Poison Control Centers at or use their online tool.
But if your symptoms are severe, call or go to the nearest emergency room right away. When you get Zytiga from the pharmacy, the pharmacist will add an expiration date to the label on the bottle. This date is typically one year from the date they dispensed the medication.
The expiration date helps guarantee the effectiveness of the medication during this time. If you have unused medication that has gone past the expiration date, talk with your pharmacist about whether you might still be able to use it. How long a medication remains good can depend on many factors, including how and where you store the medication.
This helps prevent others, including children and pets, from taking the drug by accident. It also helps keep the drug from harming the environment. The FDA website provides several useful tips on medication disposal.
You can also ask your pharmacist for information on how to dispose of your medication. Zytiga is approved by the Food and Drug Administration FDA to be used in combination with prednisone for the treatment of metastatic castration-resistant prostate cancer and metastatic high-risk castration-sensitive prostate cancer.
Zytiga contains the prodrug abiraterone acetate, which is an androgen biosynthesis inhibitor. Inhibition of the CYP17 enzyme decreases production of the testosterone precursors dehydroepiandrosterone DHEA and androstenedione, which ultimately lowers the levels of serum testosterone and dihydroxy testosterone. Maximum plasma concentrations are reached two hours after oral administration of Zytiga.
Meal fat composition significantly alters systemic exposure, so Zytiga should be taken on an empty stomach. Zytiga is highly bound to plasma proteins albumin and alpha-1 acid glycoprotein and is metabolized via non-CYP mediated hydrolysis. Terminal half-life is approximately 12 hours.
Hepatic impairment prolongs exposure see dosing adjustment recommendations. Note: Men with female partners of reproductive potential should use effective contraception during Zytiga treatment and for three weeks after the final dose. Keep out of reach of children. Alcohol consumption may affect the risk of prostate cancer, but more research is necessary to confirm this.
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Medical News Today. Health Conditions Discover Tools Connect. Zytiga abiraterone acetate. What is Zytiga? Zytiga generic. Zytiga side effects. Zytiga cost. Zytiga dosage. Zytiga uses. Alternatives to Zytiga.
Zytiga vs. Zytiga and prednisone. Zytiga use with other drugs. Zytiga and alcohol. Zytiga interactions. In patients resuming treatment, serum transaminases and bilirubin must be monitored at a minimum of every 2 weeks for 3 months and monthly thereafter. Concomitant use of abiraterone with strong CYP3A4 inducers eg, phenytoin, carbamazepine, rifampin, rifabutin, rifapentine, phenobarbital should be avoided. If concomitant use cannot be avoided, the abiraterone dosing frequency should be increased to twice a day during coadministration eg, from 1, mg once daily to 1, mg twice daily.
If the strong CYP3A4 inducer is discontinued, the abiraterone dose should be reduced to the previous dose and frequency. Concomitant use of abiraterone with substrates of CYP2D6 with a narrow therapeutic index eg, thioridazine should also be avoided.
If alternative treatments cannot be used, dose reduction of the concomitant CYP2D6 substrate drug should be considered. Patients with cardiovascular disease must be closely monitored, with hypertension being controlled and hypokalemia corrected before treatment.
Blood pressure, serum potassium, and symptoms of fluid retention must be monitored at least monthly. Patients should be monitored for symptoms and signs of adrenocortical insufficiency; increased dosage of corticosteroids may be indicated before, during, and after stressful situations. Liver function must be regularly monitored, as previously discussed, and abiraterone dosing should be modified, interrupted, or discontinued as recommended.
Abiraterone is contraindicated during pregnancy. Food and Drug Administration: FDA approves abiraterone acetate in combination with prednisone for high-risk metastatic castration-sensitive prostate cancer. Available at www. Accessed July 6, Zytiga abiraterone acetate tablets prescribing information, Janssen Pharmaceutical Companies, February N Engl J Med , Toggle navigation.
All rights reserved. Conference European Association of Urology Congress. Abiraterone acetate plus prednisone should be considered as the first treatment choice for patients with newly diagnosed metastatic castration-resistant prostate cancer if fatigue is a concern.
Abiraterone acetate Zytiga plus prednisone should be considered as the first treatment choice for patients with newly diagnosed metastatic castration-resistant prostate cancer mCRPC if fatigue is a concern.
Results showed that abiraterone plus prednisone was associated with the highest increase in quality of life QoLwhile enzalutamide was associated with the highest incidence of increased fatigue in patients, according to Klara Kvorning Ternov, a clinical assistant in the Department of Urology at Herlev and Gentofte Hospital in Herlev, Denmark. However, abiraterone plus prednisone was associated with higher increases in weight, body mass index, visceral fat, and glycated hemoglobin, as well as the highest incidence of type 2 diabetes, Ternov said.
Additionally, enzalutamide was associated with negative changes in cholesterol, including higher increases in low-density lipoprotein LDL cholesterol, and lower increases in high-density lipoprotein HDL cholesterol. Patients included on the study were those with mCRPC who experienced disease progression, despite undergoing treatment with androgen deprivation therapy, Ternov noted.
The primary end point of the trial was to examine changes in fatigue and QoL from baseline to week 12 of treatment, and secondary end points included changes in all components of metabolic syndrome, including insulin resistance, lipids, blood pressure, and fat distribution, Ternov said.
Additional outcome measures included treatment differences in changed QoL, weight, body composition assessed with dual x-ray absorptiometry, glycated hemoglobin, and cholesterols and incidence of type 2 diabetes mellitus.
The follow-up time was 12 weeks. July 12, Courtney Marabella. Fatigue, quality-of-life and metabolic changes in men treated with enzalutamide versus abiraterone plus prednisone for metastatic castration-resistant prostate cancer HEAT : a randomised trial.
Abstract P
Abiraterone acetate in combination with prednisone or prednisolone at a low dose of 5 mg twice daily has been shown to improve survival of mCRPC patients. Abiraterone acetate, a prodrug of the CYP17A1 inhibitor abiraterone that blocks androgen biosynthesis, is approved for treatment of patients. Abiraterone acetate in combination with prednisone or prednisolone at a low dose of 5 mg twice daily has been shown to improve survival of mCRPC patients. CHICAGO — The addition of abiraterone acetate with prednisone to standard hormonal therapy led to a 38% lower risk for death in men with. EARLY IN , abiraterone acetate tablets (Zytiga) in combination with prednisone were approved for the treatment of metastatic high-risk. In animal studiestaking Zytiga while pregnant had harmful and fatal effects on offspring. As with all medications, the cost of Zytiga can vary. Quick Links. Reduced levels of male hormones, such as testosterone, help slow or stop the growth of prostate cancer cells. Zytiga and Casodex work in different ways in the body. We searched PubMed to identify safety concerns regarding glucocorticoid use, placing a focus on longitudinal studies in autoimmune and inflammatory diseases and cancer. There are currently no generic forms of Yonsa, but there is a generic form of Zytiga available.Abiraterone acetate, a prodrug of the CYP17A1 inhibitor abiraterone that blocks androgen biosynthesis, is approved for treatment of patients with metastatic castration-resistant prostate cancer mCRPC in combination with prednisone or prednisolone 5 mg twice daily. This review evaluates the basis for the effects of prednisone on mineralocorticoid-related adverse events that arise because of CYP17A1 inhibition with abiraterone. Coadministration with the recommended dose of glucocorticoid compensates for abiraterone-induced reductions in serum cortisol and blocks the compensatory increase in adrenocorticotropic hormone seen with abiraterone.
Consequently, 5 mg prednisone twice daily serves as a glucocorticoid replacement therapy when coadministered with abiraterone acetate, analogous to use of glucocorticoid replacement therapy for certain endocrine disorders. We searched PubMed to identify safety concerns regarding glucocorticoid use, placing a focus on longitudinal studies in autoimmune and inflammatory diseases and cancer.
Although glucocorticoids are often used to manage tumor-related symptoms or to prevent treatment-related toxicity, available evidence suggests that prednisone and dexamethasone might also offer modest therapeutic benefit in mCRPC. Given recent improvements in survival achieved for mCRPC with novel agents in combination with prednisone, the risks of these recommended glucocorticoid doses must be balanced with the benefits shown for these regimens. Abstract Abiraterone acetate, a prodrug of the CYP17A1 inhibitor abiraterone that blocks androgen biosynthesis, is approved for treatment of patients with metastatic castration-resistant prostate cancer mCRPC in combination with prednisone or prednisolone 5 mg twice daily.
Publication types Research Support, Non-U. Gov't Review.
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