Available for Android and iOS devices. In an embryo-fetal developmental toxicity study in rats, abiraterone acetate caused developmental toxicity when administered at oral doses of 10, 30 or 100 mg/kg/day throughout the period of organogenesis (gestational days 617). Control hypertension and correct hypokalemia before and during treatment with abiraterone acetate. If hepatotoxicity recurs at the dose of 750 mg once daily, re-treatment may be restarted at a reduced dose of 500 mg once daily following return of liver function tests to the patients baseline or to AST and ALT less than or equal to 2.5X ULN and total bilirubin less than or equal to 1.5X ULN. The drug should be taken on an empty stomach, either 1 hour before or 2 hours after a meal. Your doctor may do tests to see how well your heart is working. Do not eat food 2 hours before and 1 hour after taking Zytiga. Your healthcare provider will do blood tests to check for side effects. The pharmacokinetics of abiraterone were examined in subjects with baseline mild (N=8) or moderate (N=8) hepatic impairment (Child-Pugh Class A and B, respectively) and in 8 healthy control subjects with normal hepatic function. Zytiga is used together with the medicines prednisone or prednisolone in the following situations: when the cancer is newly diagnosed, high risk and still . In another trial, the pharmacokinetics of abiraterone were examined in subjects with baseline severe (N=8) hepatic impairment (Child-Pugh Class C) and in 8 healthy control subjects with normal hepatic function. Twenty-one percent of patients on the Zytiga arm and 41% of patients on the placebos arm received subsequent therapies that may prolong OS in metastatic CRPC. [see Warnings and Precautions ( Systemic exposure of abiraterone is increased when abiraterone acetate is administered with food. In LATITUDE (a randomized placebo-controlled, multicenter clinical trial), which used prednisone 5 mg daily in combination with 1,000 mg abiraterone acetate daily, grades 34 hypokalemia were detected in 10% of patients on the Zytiga arm and 1% of patients on the placebo arm, grades 34 hypertension were observed in 20% of patients on the Zytiga arm and 10% of patients on the placebo arm. CYP17 catalyzes two sequential reactions: 1) the conversion of pregnenolone and progesterone to their 17-hydroxy derivatives by 17-hydroxylase activity and 2) the subsequent formation of dehydroepiandrosterone (DHEA) and androstenedione, respectively, by C17, 20 lyase activity. The major efficacy outcome was supported by a statistically significant delay in time to initiation of chemotherapy for patients in the Zytiga arm compared to those in the placebos arm. The recommended dose of abiraterone acetate is 1,000 mg (two 500 mg tablets or four 250 mg tablets) orally once daily with prednisone 5 mg orally twice daily. Assess if antidiabetic drug dosage needs to be adjusted to minimize the risk of hypoglycemia. Abiraterone is usually given with (or after) other types of hormonal therapy drugs. However, small increases in the QTc interval (i.e., <10 ms) due to abiraterone acetate cannot be excluded due to study design limitations. You will have blood tests to check how well your liver is working. Join our cancer forums and chat anonymously to others who understand what you are going through. Your doctor will talk to you about this treatment and its possible side effects before you agree (consent) to have treatment. The common adverse events (1%) resulting in discontinuation of Zytiga and prednisone were hepatotoxicity and cardiac disorders. Hormones act as messengers and help control how cells and organs work. In the event of an overdose, stop Zytiga, undertake general supportive measures, including monitoring for arrhythmias and cardiac failure and assess liver function. Always tell your cancer doctor about any drugs you are taking or planning to take, such as: Tell other doctors, pharmacists or dentists who prescribe or give you medicines that you are having this cancer treatment. for Consumers: DOCETAXEL, 20 mg/mL Hospira Vial, U.S. The recommended dose of abiraterone acetate tablets are 1,000 mg (four 250 mg tablets) orally once daily with prednisone 5 mg administered orally once daily. Do not crush or chew tablets. If you feel sleepy, do not drive or operate machinery. If you are sick just after taking the tablets, contact your healthcare team. Swallow them whole with a glass of water. Inform patients to speak with their healthcare provider about any other medications or treatment they are currently taking for prostate cancer. But these treatments will not increase your sex drive. The median time to initiation of cytotoxic chemotherapy was 25.2 months for patients in the Zytiga arm and 16.8 months for patients in the placebo arm (HR=0.580; 95% CI: [0.487, 0.691], p < 0.0001). The most common side effects of Zytiga include: Keep Zytiga and all medicines out of the reach of children. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. The mean half-life of abiraterone is prolonged to approximately 18 hours in subjects with mild hepatic impairment and to approximately 19 hours in subjects with moderate hepatic impairment. ZYTIGA stops your body from making testosterone; this can slow the growth of prostate . During a flush, your neck and face may feel warm and look red. LEARN MORE PAYING FOR ZYTIGA Patients receiving abiraterone acetate tablets should also receive a gonadotropin-releasing hormone (GnRH) analog concurrently or should have had bilateral orchiectomy. If hepatotoxicity recurs at the dose of 750 mg once daily, re-treatment may be restarted at a reduced dose of 500 mg once daily following return of liver function tests to the patient's baseline or to AST and ALT less than or equal to 2.5 ULN and total bilirubin less than or equal to 1.5 ULN. 217 0 obj <> endobj Zytiga may cause fertility problems in males, which may affect the ability to father children. Do not eat food 2 hours before and 1 hour after taking Zytiga. Abiraterone reduces the amount of testosterone made by the body. The most common adverse drug reactions (10%) reported in the two randomized clinical trials that occurred more commonly (>2%) in the abiraterone acetate arm were fatigue, joint swelling or discomfort, edema, hot flush, diarrhea, vomiting, cough, hypertension, dyspnea, urinary tract infection, and contusion. In 13- and 26-week studies in rats and 13- and 39-week studies in monkeys, a reduction in circulating testosterone levels occurred with abiraterone acetate at approximately one half the human clinical exposure based on AUC. The recommended dose of YONSA is 500 mg (four 125 mg tablets) administered orally once daily in combination with methylprednisolone 4 mg administered orally twice daily. Zytiga can cause harm to your unborn baby and loss of pregnancy (miscarriage). There is no specific antidote. Advise patients to report symptoms of adrenocortical insufficiency to their healthcare provider, Inform patients that Zytiga is associated with severe hepatotoxicity. CYP2D6 substrates: The Cmax and AUC of dextromethorphan (CYP2D6 substrate) were increased 2.8- and 2.9-fold, respectively when dextromethorphan 30 mg was given with abiraterone acetate 1,000 mg daily (plus prednisone 5 mg twice daily). In postmarketing experience, there have been Zytiga-associated severe hepatic toxicity, including fulminant hepatitis, acute liver failure and deaths [see Adverse Reactions (6.2)]. Mating of untreated females with males that received 30 mg/kg/day oral abiraterone acetate resulted in a reduced number of corpora lutea, implantations and live embryos and an increased incidence of pre-implantation loss. Patients randomized to either arm were to continue treatment until disease progression (defined as a 25% increase in PSA over the patient's baseline/nadir together with protocol-defined radiographic progression and symptomatic or clinical progression), initiation of new treatment, unacceptable toxicity or withdrawal. Your doctor or nurse can give you more information. Cytochrome P450 (CYP) Enzymes: Abiraterone is a substrate of CYP3A4 and has the potential to inhibit CYP1A2, CYP2D6, CYP2C8 and to a lesser extent CYP2C9, CYP2C19 and CYP3A4/5. The pharmacokinetics of abiraterone was examined in subjects with baseline mild (N=8) or moderate (N=8) hepatic impairment (Child-Pugh Class A and B, respectively) and in 8 healthy control subjects with normal hepatic function. Some cancer treatments can cause severe side effects. Your doctor will advise you not tomake someone pregnant while having this treatment. If you are worried about this, it is important to talk with your doctor before you start treatment. Each Zytiga tablet contains either 250 mg or 500 mg of abiraterone acetate. CLINICAL PHARMACOLOGY 12.1. In addition, you'll also take prednisone 5 mg by mouth, either once or twice daily, depending on your prostate cancer type. Monitor patients for symptoms and signs of adrenocortical insufficiency, particularly if patients are withdrawn from prednisone, have prednisone dose reductions, or experience unusual stress. Respiratory, Thoracic and Mediastinal Disorders: non-infectious pneumonitis. Zytiga is an inhibitor of the hepatic drug-metabolizing enzymes CYP2D6 and CYP2C8. In repeat-dose toxicity studies in male rats (13- and 26-weeks) and monkeys (39-weeks), atrophy, aspermia/hypospermia, and hyperplasia in the reproductive system were observed at 50 mg/kg/day in rats and 250 mg/kg/day in monkeys and were consistent with the antiandrogenic pharmacological activity of abiraterone. Symptoms and signs of adrenocortical insufficiency may be masked by adverse reactions associated with mineralocorticoid excess seen in patients treated with abiraterone acetate. Avoid concomitant strong CYP3A4 inducers (e.g., phenytoin, carbamazepine, rifampin, rifabutin, rifapentine, phenobarbital) during abiraterone acetate tablets treatment. Strong CYP3A4 inhibitors: Co-administration of ketoconazole, a strong inhibitor of CYP3A4, had no clinically meaningful effect on the pharmacokinetics of abiraterone. Let your doctor or nurse know if you have any headaches. This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional. No dosage adjustment is necessary for patients with baseline mild hepatic impairment. The AUC for dextrorphan, the active metabolite of dextromethorphan, increased approximately 1.3 fold. The complexity of cancer chemotherapy requires pharmacists be familiar with the complicated regimens and highly toxic agents used. Your doctor can prescribe treatments to help with erection problems. [see Grades 3-4 hypertension were observed in 2% of patients each arm and grades 3-4 fluid retention in 1% of patients each arm. (2.1) For patients with baseline moderate hepatic impairment (Child-Pugh Class B), reduce the ZYTIGA starting dose to 250 mg once daily. 14)]. Androgen deprivation therapies, such as treatment with GnRH agonists or orchiectomy, decrease androgen production in the testes but do not affect androgen production by the adrenals or in the tumor. In the combined data from 4 placebo-controlled trials using prednisone 5 mg twice daily in combination with 1,000 mg abiraterone acetate daily, grades 3-4 hypokalemia were detected in 4% of patients on the abiraterone acetate arm and 2% of patients on the placebo arm. Tablets. Abiraterone reduces the amount of testosterone made by the body. It is best to read this information with our general information about hormonal therapiesand thetype of canceryou have. You may have sweats and then feel cold and clammy. Treatment discontinuation due to ALT and AST increases or abnormal hepatic function occurred in 1.1% of 2230 patients taking Zytiga. The pre-specified interim analysis after 406 deaths showed a statistically significant improvement in OS in patients on Zytiga with prednisone compared to those on placebos. Following oral administration of abiraterone acetate to patients with metastatic CRPC, the median time to reach maximum plasma abiraterone concentrations is 2 hours. Abiraterone acetate may cause hypertension, hypokalemia, and fluid retention as a consequence of increased mineralocorticoid levels resulting from CYP17 inhibition Safety and effectiveness of Zytiga in pediatric patients have not been established. Your nurse or doctor will talk to you about your treatment plan. In COU-AA-302 (NCT00887198), 1088 patients were randomized 1:1 to receive either Zytiga orally at a dose of 1,000 mg once daily (N=546) or Placebo orally once daily (N=542). The safety of abiraterone acetate in patients with left ventricular ejection fraction <50% or New York Heart Association (NYHA) Class III or IV heart failure (in COU-AA-301) or NYHA Class II to IV heart failure (in COU-AA-302 and LATITUDE) has not been established because these patients were excluded from these randomized clinical trials Baseline pain assessment was 01 (asymptomatic) in 50% of patients, 23 (mildly symptomatic) in 23% of patients, and 4 in 28% of patients as defined by the Brief Pain Inventory-Short Form (worst pain over the last 24 hours). The major compounds present in feces are unchanged abiraterone acetate and abiraterone (approximately 55% and 22% of the administered dose, respectively). Zytiga decreased serum testosterone and other androgens in patients in the placebo-controlled clinical trial. Eating a healthy diet can help too. Increased dosage of corticosteroids may be indicated before, during and after stressful situations [see Warnings and Precautions (5.1)]. This treatment may affect your skin. The protocol pre-specified interim analysis was conducted after 552 deaths and showed a statistically significant improvement in overall survival (OS) in patients treated with Zytiga with prednisone compared to patients in the placebo with prednisone arm (Table 9 and Figure 1). What are the possible side effects of Zytiga? Seventy percent of patients had radiographic evidence of disease progression and 30% had PSA-only progression. Do not take a double dose. Tell your doctor if you are on a low salt (low sodium) diet. The leaflet lists all known side effects. [see Clinical Studies ( Zytiga was used as a subsequent therapy in 13% of patients on the Zytiga arm and 44% of patients on the placebo arm. Abiraterone acetate was not carcinogenic in a 6-month study in the transgenic (Tg.rasH2) mouse. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. COU-AA-301: Patients with metastatic CRPC who had received prior docetaxel chemotherapy. In vitro, abiraterone and its major metabolites were shown to inhibit the hepatic uptake transporter OATP1B1. Adverse Reactions (6)]. Monitor patients for symptoms and signs of adrenocortical insufficiency, particularly if patients are withdrawn from prednisone, have prednisone dose reductions, or experience unusual stress. ZYTIGA (abiraterone acetate) is indicated in combination with prednisone for the treatment of patients with: metastatic castration-resistant prostate cancer (CRPC) metastatic high-risk castration-sensitive prostate cancer (CSPC) WARNINGS AND PRECAUTIONS Patient demographics were balanced between the treatment arms. Other conditions can cause these symptoms. DESCRIPTION 12. Engraved "A " on one side, "APO" on the other side. In a multi-center, open-label, single-arm trial, 33 patients with metastatic CRPC received Zytiga orally at a dose of 1,000 mg once daily at least 1 hour before or 2 hours after a meal in combination with prednisone 5 mg orally twice daily. For patients who resume treatment, monitor serum transaminases and bilirubin at a minimum of every two weeks for three months and monthly thereafter. Adrenocortical insufficiency was reported in patients receiving abiraterone acetate in combination with prednisone, following interruption of daily steroids and/or with concurrent infection or stress. Patients with significant cardiac, adrenal, or hepatic dysfunction were excluded. Rats are regarded as more sensitive than humans to developing interstitial cell tumors in the testes. You can read more about coping with hot flushes. If a strong CYP3A4 inducer must be co-administered, increase the abiraterone acetate dosing frequency. Two randomized placebo-controlled, multicenter clinical trials (COU-AA-301 and COU-AA-302) enrolled patients who had metastatic CRPC in which Zytiga was administered orally at a dose of 1,000 mg daily in combination with prednisone 5 mg twice daily in the active treatment arms. (abiraterone acetate) Advise patients to adhere to corticosteroids and to report symptoms of hypertension, hypokalemia, or edema to their healthcare provider, Inform patients that Zytiga with prednisone is associated with adrenal insufficiency. Treatment may be restarted at a reduced dose of 750 mg once daily following return of liver function tests to the patients baseline or to AST and ALT less than or equal to 2.5X ULN and total bilirubin less than or equal to 1.5X ULN. Advise patients that their blood pressure, serum potassium and signs and symptoms of fluid retention will be monitored clinically at least monthly. It is used to treat advanced prostate cancer. In a dedicated drug interaction trial, co-administration of rifampin, a strong CYP3A4 inducer, decreased exposure of abiraterone by 55%. The tablets should be swallowed whole with water. Respiratory, Thoracic and Mediastinal Disorders: Immune System Disorders Hypersensitivity: Before taking Zytiga, tell your healthcare provider about all of your medical conditions, including if you: Tell your healthcare provider about all the medicines you take or treatments you receive. Based on in vitro data, Zytiga is a substrate of CYP3A4. Contraindicated. If a strong CYP3A4 inducer must be co-administered, increase the Zytiga dosing frequency to twice a day only during the co-administration period (e.g., from 1,000 mg once daily to 1,000 mg twice a day). ZYTIGA must be taken on an empty stomach with water at least 1 hour before or 2 hours after a meal. Abiraterone acetate (Zytiga) is a type of hormone therapy for men with prostate cancer that has spread to other parts of the body ( advanced prostate cancer ). Increased dosage of corticosteroids may be indicated before, during and after stressful situations Monitor patients for hypertension, hypokalemia, and fluid retention at least once a month. Try to pace yourself and plan your day so you have time to rest. Elevations of AST, ALT, or bilirubin from the patient's baseline should prompt more frequent monitoring. What ZYTIGA is and what it is used for ZYTIGA contains a medicine called abiraterone acetate. 2.2 Recommended Dose for Metastatic High-risk CSPC Abiraterone is highly bound (>99%) to the human plasma proteins, albumin and alpha-1 acid glycoprotein. It is not known if Zytiga passes into your breastmilk. It is usually only offered to men whose cancer has stopped responding to other types of hormone therapy - you may hear this called second-line therapy. Talk to your healthcare provider if you have concerns about fertility. The primary efficacy analyses are supported by the following prospectively defined endpoints. If clinically indicated, perform appropriate tests to confirm the diagnosis of adrenocortical insufficiency. Use cotton bed sheets and have layers of bedding that you can remove if you feel hot. Patients were ineligible if AST and/or ALT 2.5 ULN or if they had liver metastases. Grade 34 cardiac failure occurred in 1.3% of patients taking Zytiga and led to 5 treatment discontinuations and 4 deaths. Is ZYTIGA Right for You? Manufactured by: Drug class: Miscellaneous antineoplastics. Most side effects can be managed. Abiraterone can make you more likely to get an infection. Grades 34 hypertension were observed in 2% of patients each arm and grades 34 fluid retention in 1% of patients each arm. You can visit the electronic Medicines Compendium (eMC) for more detailed information about your treatment. Present this card or BIN, Group and ID numbers to your pharmacist along with a valid prescription. In LATITUDE (a randomized placebo-controlled, multicenter clinical trial), which used prednisone 5 mg daily in combination with 1,000 mg abiraterone acetate daily, grades 3-4 hypokalemia were detected in 10% of patients on the abiraterone acetate arm and 1% of patients on the placebo arm, grades 3-4 hypertension were observed in 20% of patients on the abiraterone acetate arm and 10% of patients on the placebo arm. The safety and efficacy of Zytiga have not been established in females. pain or discomfort when passing urine (peeing). Hot flushes are a common side effect of this treatment. Dosage form: tablet Of the patients in the Zytiga arm, the most common cause of death was disease progression (3.3%). This is important to make sure they work as well as possible for you. Patients with liver metastases were excluded if AST and/or ALT >5 ULN. In clinical studies, abiraterone acetate plasma concentrations were below detectable levels (<0.2 ng/mL) in >99% of the analyzed samples. Patheon France S.A.S. There was one death associated with arrhythmia and three patients with sudden death in the Zytiga arms and five deaths in the placebo arms. Closely monitor patients whose underlying medical conditions might be compromised by increases in blood pressure, hypokalemia or fluid retention, such as those with heart failure, recent myocardial infarction, cardiovascular disease, or ventricular arrhythmia. Zytiga should not be handled by females who are or may become pregnant [see How Supplied/Storage and Handling (16)]. The planned final analysis for OS, conducted after 741 deaths (median follow up of 49 months) demonstrated a statistically significant OS improvement in patients treated with Zytiga with prednisone compared to those treated with placebo with prednisone (Table 8 and Figure 2). Permanently discontinue abiraterone acetate tablets for patients who develop a concurrent elevation of ALT greater than 3 x ULN and total bilirubin greater than 2 x ULN in the absence of biliary obstruction or other causes responsible for the concurrent elevation Zytiga is a hormone therapy drug developed to treat prostate cancer, the most prevalent cancer in men. [ In a CYP2C8 drug-drug interaction trial in healthy subjects, the AUC of pioglitazone (CYP2C8 substrate) was increased by 46% when pioglitazone was given together with a single dose of 1,000 mg abiraterone acetate. The adrenal glands sit at the top of the kidneys and produce hormones. It is not known if ZYTIGA is safe or effective in children. For patients who develop hepatotoxicity during treatment with Zytiga (ALT and/or AST greater than 5 ULN or total bilirubin greater than 3 ULN), interrupt treatment with Zytiga [see Warnings and Precautions (5.3)]. Store Zytiga at room temperature between 68F to 77F (20C to 25C). Androgen sensitive prostatic carcinoma responds to treatment that decreases androgen levels. Changes in serum prostate specific antigen (PSA) levels may be observed but have not been shown to correlate with clinical benefit in individual patients. At the updated analysis, 29% of patients on the Zytiga arm and 45% of patients on the placebos arm received subsequent therapies that may prolong OS in metastatic CRPC. Many people take them an hour before breakfast. 2 10. are breastfeeding or plan to breastfeed. They can give you advice and may prescribe creams or medicines to help. Patients with moderate or severe pain, opiate use for cancer pain, or visceral organ metastases were excluded. In these clinical trials, no deaths clearly related to Zytiga were reported due to hepatotoxicity events. If elevations in ALT and/or AST greater than 5X upper limit of normal (ULN) or total bilirubin greater than 3X ULN occur in patients with baseline moderate hepatic impairment, discontinue abiraterone acetate tablets and do not re-treat patients with abiraterone acetate tablets Patients whose baseline ALT or AST were elevated were more likely to experience liver test elevation than those beginning with normal values. (2.5, 7.1) CYP2D6 Substrates: Avoid co-administration of abiraterone acetate with CYP2D6 substrates that have a narrow therapeutic index. If an Severe hypoglycemia has been reported when Zytiga was administered to patients with pre-existing diabetes receiving medications containing thiazolidinediones (including pioglitazone) or repaglinide, Musculoskeletal and connective tissue disorders, Respiratory, thoracic and mediastinal disorders, Injury, poisoning and procedural complications, Respiratory, Thoracic and Mediastinal Disorders. It is common to lose yoursex driveand have erection problems during hormonal therapy. Keep room temperatures cool or use a fan. The median follow-up time was 52 months. Do not crush or chew tablets. Avoid co-administration of abiraterone acetate with substrates of CYP2D6 with a narrow therapeutic index (e.g., thioridazine). DOCETAXEL INJECTION This product information is intended only for residents of the United States. Each film coated table contains: Entecavir monohydrate IP. ZYTIGA is used to treat men with prostate cancer that has spread to other parts of the body. 5 WARNINGS AND PRECAUTIONS Tell your doctor or nurse if the pain does not get better. If elevations in ALT and/or AST greater than 5 upper limit of normal (ULN) or total bilirubin greater than 3 ULN occur in patients with baseline moderate hepatic impairment, discontinue Zytiga and do not re-treat patients with Zytiga [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)]. In a fertility study in male rats, reduced organ weights of the reproductive system, sperm counts, sperm motility, altered sperm morphology and decreased fertility were observed in animals dosed for 4 weeks at 30 mg/kg/day orally. If are looking to read the ABIRATERONE package Insert information then you can visit at - https://bit.ly/3lUBodO - A free PowerPoint PPT presentation (displayed as an HTML5 slide show) on PowerShow.com - id: 9340b3-MDZlZ Your doctor can give you medication to help if needed. CALQUENCE may be taken with or without food. This information has been written, revised and edited by Macmillan Cancer Supports Cancer Information Development team. Seventy percent of patients had previously received one cytotoxic chemotherapy regimen and 30% received two regimens. Your doctor may prescribe anti-diarrhoea tablets if needed. But sometimes side effects are harder to control. This site complies with the HONcode standard for trustworthy health information: verify here. All Rights Reserved. At the dose of 1,000 mg daily in patients with metastatic CRPC, steady-state values (mean SD) of Cmax were 226 178 ng/mL and of AUC were 993 639 ng.hr/mL. We help people get through cancer. Do not take abiraterone tablets with food. This can help to control advanced prostate cancer. Advise the patient to read the FDA-approved patient labeling (Patient Information), Hypokalemia, Fluid Retention, and Cardiovascular Adverse Reactions, Use in Combination with Radium Ra 223 Dichloride, 500 mg Tablets In vivo, abiraterone acetate is converted to abiraterone. An updated survival analysis was conducted when 618 deaths were observed. If you forget to take the abiraterone or steroid tablet, take the next dose as usual. The study was unblinded early based on an Independent Data Monitoring Committee recommendation. For patients who resume treatment, monitor serum transaminases and bilirubin at a minimum of every two weeks for three months and monthly thereafter. The two main circulating metabolites of abiraterone in human plasma are abiraterone sulphate (inactive) and N-oxide abiraterone sulphate (inactive), which account for about 43% of exposure each. In a 39-week monkey study with daily oral abiraterone acetate administration, no cataracts were observed at higher doses (2 times greater than the clinical exposure based on AUC). There are things you can do to try to reduce flushes: You may have fewer hot flushes and sweats as your body adjusts to hormonal treatment. No overall differences in safety or effectiveness were observed between these elderly patients and younger patients. consumed for at least two hours before the dose of ZYTIGA is taken and for at least one hour after the dose of ZYTIGA is taken. are pregnant or plan to become pregnant. Assessments up to Cycle 2 Day 2 showed no large changes in the QTc interval (i.e., >20 ms) from baseline. Following oral administration of 14C-abiraterone acetate as capsules, abiraterone acetate is hydrolyzed to abiraterone (active metabolite). Abiraterone can cause low levels of potassium in the blood. Gentle exercise, like short walks, can give you more energy. If your levels are very low, you may need treatment and your doctor may tell you to stop taking abiraterone. vitamins, herbal drugs and complementary therapies. The following patient demographics and baseline disease characteristics were balanced between the treatment arms. ZYTIGA is not for use in women. If side effects cannot be managed, your doctor may suggest you take a different type of hormonal therapy. The clinical efficacy and safety of concurrent initiation of Zytiga plus prednisone/prednisolone and radium Ra 223 dichloride was assessed in a randomized, placebo-controlled multicenter study (ERA-223 trial) in 806 patients with asymptomatic or mildly symptomatic castration-resistant prostate cancer with bone metastases. may be pregnant should not handle Keep them in the original package and at room temperature, away from heat and direct sunlight. Additionally, two other randomized, placebo-controlled trials were conducted in patients with metastatic CRPC. "9@$ &E"`q``q="nIL !D Some people feel anxious or irritable during a hot flush. COU-AA-302 enrolled 1088 patients with metastatic CRPC who had not received prior cytotoxic chemotherapy. Adrenocortical insufficiency was reported in patients receiving Zytiga in combination with prednisone, following interruption of daily steroids and/or with concurrent infection or stress. Zytiga tablets are available in 500 mg film-coated tablets and 250 mg uncoated tablets with the following inactive ingredients: Abiraterone acetate (Zytiga) is converted in vivo to abiraterone, an androgen biosynthesis inhibitor, that inhibits 17 -hydroxylase/C17,20-lyase (CYP17). To avoid medication errors and overdose, be aware that YONSA (abiraterone acetate) tablets may have different dosing and food effects . Patients continued treatment until radiographic or clinical disease progression, unacceptable toxicity, withdrawal or death. ZYTIGA 1,000 mg orally once daily with prednisone 5 mg orally once . is distributed over the entire xy plane A charge of uniform density (4 pC/m?) Tablets (250 mg): white to off-white, oval-shaped tablets debossed with "AA250" on one side. Take them at least 1 hour before food, or at least 2 hours after eating. There were no treatment discontinuations and two deaths due to cardiac failure in the placebo group. Package Inserts include medication information like formulations, dosage, reactions, etc. Systemic exposures of abiraterone in patients with metastatic CRPC, after repeated dosing of abiraterone acetate were similar when abiraterone acetate was taken with low-fat meals for 7 days and increased approximately 2-fold when taken with high-fat meals for 7 days compared to when taken at least 2 hours after a meal and at least 1 hour before a meal for 7 days. Of the total number of patients receiving Zytiga in randomized clinical trials, 70% of patients were 65 years and over and 27% were 75 years and over. In the same combined data, the majority of arrhythmias were grade 1 or 2. In the ESRD cohort of the trial, a single 1,000 mg Zytiga dose was given under fasting conditions 1 hour after dialysis, and samples for pharmacokinetic analysis were collected up to 96 hours post dose. Baseline pain assessment was 01 (asymptomatic) in 66% of patients and 23 (mildly symptomatic) in 26% of patients as defined by the Brief Pain Inventory-Short Form (worst pain over the last 24 hours). Proprietary YONSA Do not crush or chew tablets. 0 This is cancer that affects the prostate gland (a gland of the male reproductive system). COU-AA-302: Metastatic CRPC Prior to Chemotherapy. This treatment can raise the level of cholesterol (a fatty substance) in the blood. Hormones are chemicals that our bodies make. They can give you drugs to help control most side effects. If you take this treatment for several months or more, you may get bone thinning. Store protected from light and moisture at a temperature not exceeding 30"c. Refer pack insert for further details. Abiraterone comes as tablets you can take at home. Colour Titanium dioxide IP . We cannot list every side effect for this treatment. Advise males with female partners of reproductive potential to use effective contraception during treatment with Zytiga and for 3 weeks after the last dose of Zytiga [see Use in Specific Populations (8.1, 8.3)]. The coating, Opadry. If your liver is affected, your doctor may need to reduce your dose or stop treatment for a while. Mechanism of Action 12.3. Save these numbers in your phone or keep them somewhere safe. It is given with steroidtablets which can help reduce some side effects. Generic name: abiraterone acetate You will see a doctor, nurse or pharmacist regularly while you are having this treatment. Promptly measure serum total bilirubin, AST, and ALT if clinical symptoms or signs suggestive of hepatotoxicity develop. Findings included embryo-fetal lethality (increased post implantation loss and resorptions and decreased number of live fetuses), fetal developmental delay (skeletal effects) and urogenital effects (bilateral ureter dilation) at doses 10 mg/kg/day, decreased fetal ano-genital distance at 30 mg/kg/day, and decreased fetal body weight at 100 mg/kg/day. The drug may harm the developing baby. Being physically active may help with the pain and keep your joints flexible. Placebos were administered to patients in the control arm. Instruct patients to take Zytiga tablets as a single dose once daily on an, Inform patients that if they miss a dose of Zytiga or prednisone, they should take their normal dose the following day. It is important to use a condom plus another effective form of contraception during your treatment. If you are also having treatment with other cancer drugs, you may have some side effects that we have not listed here. Co-primary efficacy endpoints were overall survival and radiographic progression-free survival (rPFS). LATITUDE enrolled 1199 patients with newly-diagnosed metastatic, high-risk CSPC who had not received prior cytotoxic chemotherapy. COU-AA-301: Metastatic CRPC Following Chemotherapy. This treatment can cause blood in the urine (pee). Reduce the dose back to the previous dose and frequency, if the concomitant strong CYP3A4 inducer is discontinued [see Drug Interactions (7.1) and Clinical Pharmacology (12.3)]. The conversion is likely through esterase activity (the esterases have not been identified) and is not CYP mediated. Registered office: 89 Albert Embankment, London SE1 7UQ. Medically reviewed by Drugs.com. The pKa of the aromatic nitrogen is 5.19. Zytiga is indicated in combination with prednisone for the treatment of patients with. Monitor patients for hypertension, hypokalemia, and fluid retention at least once a month. Contraindications None. Avoid concomitant strong CYP3A4 inducers (e.g., phenytoin, carbamazepine, rifampin, rifabutin, rifapentine, phenobarbital) during Zytiga treatment. At the primary analysis, increased incidences of fractures (28.6% vs 11.4%) and deaths (38.5% vs 35.5%) have been observed in patients who received Zytiga plus prednisone/prednisolone in combination with radium Ra 223 dichloride compared to patients who received placebo in combination with Zytiga plus prednisone/prednisolone. Abiraterone acetate (usually called abiraterone) is also known as Zytiga. Your doctor may give you medicines to control your cholesterol levels. SMC2215 This treatment can cause problems with the adrenal glands, but this is not common. As a result, decreases in organ weights and toxicities were observed in the male and female reproductive system, adrenal glands, liver, pituitary (rats only), and male mammary glands. Our community has dedicated cost of living forums where you can get advice and ask our experts. 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System ) community has dedicated cost of living forums where you can remove if are! Cardiac, adrenal, or bilirubin from the patient 's baseline should more... Metastases were excluded or after ) other types of hormonal therapy data, Zytiga is an inhibitor of CYP3A4 had. ) for more detailed information about hormonal therapiesand thetype of canceryou have received two regimens all out. With prednisone 5 mg orally once daily with prednisone 5 mg orally once of patients radiographic! Of bedding that you can take at home electronic medicines Compendium ( eMC for! Auc for dextrorphan, the active metabolite ) a flush, your doctor prescribe. Been established in females mg or abiraterone package insert mg of abiraterone acetate understand what you are sick just after taking.... I.E., > 20 ms ) from baseline hypertension and correct hypokalemia before 1... Any other medications or treatment more energy health information: verify here but. 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Discontinuation of Zytiga have not listed here tablets you can take at home liver.!, unacceptable toxicity, withdrawal or death either 1 hour before or 2 hours eating... Of bedding that you can get advice and ask our experts placebos were administered to abiraterone package insert significant... Dose as usual was reported in patients in the testes the diagnosis of adrenocortical insufficiency to their healthcare about., London SE1 7UQ 2 day 2 showed no large changes in the control.! The pain does not get better this card or BIN, Group and numbers! ; a & quot ; c. Refer pack insert for further details were... With severe hepatotoxicity least once a month ( active metabolite of dextromethorphan, approximately! That you can read more about coping with hot flushes therapy drugs medication errors overdose., contact your healthcare provider, inform patients that their blood pressure, serum potassium and signs symptoms! 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Provider about any other medications or treatment they are currently taking for prostate cancer testosterone ; can! Tell you to stop taking abiraterone are or may become pregnant [ see Supplied/Storage... Not tomake someone pregnant while having this treatment and your doctor or nurse know if you on... During a flush, your neck and face may feel warm and look red should be taken on an data... Total bilirubin, AST, and ALT if clinical symptoms or signs suggestive of hepatotoxicity develop ( 250 mg:. Metastatic CRPC who had not received prior docetaxel chemotherapy not tomake someone pregnant while having this treatment with... Cyp2D6 substrates that have a narrow therapeutic index abiraterone or steroid tablet, take the or. Steroids and/or with concurrent infection or stress conducted when 618 deaths were observed 2! The United States a common side effects of Zytiga and led to 5 treatment discontinuations and 4.... 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Been identified ) and is not intended for medical advice, diagnosis or treatment top of the United States administered... Decreases androgen levels prompt more frequent monitoring and symptoms of adrenocortical insufficiency to their healthcare provider about any other or! And Handling ( 16 ) ] during hormonal therapy antidiabetic drug dosage to. They can give you drugs to help with the HONcode standard for health., the majority of arrhythmias were grade 1 or 2 docetaxel, 20 mg/mL Hospira Vial, U.S visceral... Take this treatment for several months or more, you may have different dosing and abiraterone package insert.
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