Zytiga

Zytiga

abiraterone

Manufacturer:

Janssen

Distributor:

Zuellig Pharma
Full Prescribing Info
Contents
Abiraterone acetate.
Description
Each tablet contains lactose 189 mg and sodium 6.8 mg. It also contains the following excipients: Lactose monohydrate, cellulose, microcrystalline, croscarmellose sodium, povidone, sodium laurylsulfate, magnesium stearate, silica, colloidal anhydrous.
Action
Pharmacotherapeutic Group: Endocrine therapy, other hormone antagonists and related agents. ATC Code: L02BX03.
Pharmacodynamics: Zytiga decreases serum testosterone and other androgens to levels lower than those achieved by the use of LHRH agonists alone or by orchiectomy. This results from the selective inhibition of the CYP17 enzyme required for androgen biosynthesis. Prostate specific antigen (PSA) serves as a biomarker in patients with prostate cancer. In a phase 3 clinical study of patients who failed prior chemotherapy with taxanes, 38% of patients treated with Zytiga, versus 10% of patients treated with placebo, had at least a 50% decline from baseline in PSA levels.
Mechanism of action: Abiraterone acetate is converted in vivo to abiraterone, an androgen biosynthesis inhibitor. Specifically, abiraterone selectively inhibits the enzyme 17α-hydroxylase/C17,20-lyase (CYP17). This enzyme is expressed in and is required for androgen biosynthesis in testicular, adrenal and prostatic tumour tissues. CYP17 catalyses the conversion of pregnenolone and progesterone into testosterone precursors, DHEA and androstenedione, respectively, by 17α-hydroxylation and cleavage of the C17,20 bond. CYP17 inhibition also results in increased mineralocorticoid production by the adrenals (see Precautions).
Androgen-sensitive prostatic carcinoma responds to treatment that decreases androgen levels. Androgen deprivation therapies eg, treatment with LHRH agonists or orchiectomy, decrease androgen production in the testes but do not affect androgen production by the adrenals or in the tumour. Treatment with Zytiga decreases serum testosterone to undetectable levels (using commercial assays) when given with LHRH agonists (or orchiectomy).
Clinical Efficacy and Safety: Efficacy was established in a randomised placebo-controlled multicentre phase 3 clinical study of patients with metastatic advanced prostate cancer (castration resistant prostate cancer) who had received prior chemotherapy containing a taxane. Enrolled patients had received prior docetaxel. Patients were not required to show disease progression on docetaxel, as toxicity from this chemotherapy may have led to discontinuation. Patients were using an LHRH agonist or were previously treated with orchiectomy (N=1195). In the active treatment arm, Zytiga was administered at a dose of 1000 mg daily in combination with low dose prednisone or prednisolone 5 mg twice daily (N=797). Control patients received placebo and low dose prednisone or prednisolone 5 mg twice daily (N=398).
Changes in either radiographic findings or PSA serum concentration independently do not always predict clinical benefit. Therefore, in this study it was recommended that patients be maintained on their study treatments until there was PSA progression (confirmed 25% increase over the patient's baseline/nadir) together with protocol-defined radiographic progression and symptomatic or clinical progression. Patients with prior ketoconazole treatment for prostate cancer were excluded from this study. The primary efficacy endpoint was overall survival.
The median age of enrolled patients was 69 years (range 39-95). The number of patients treated with Zytiga by racial group was Caucasian 737 (93.2%), Black 28 (3.5%), Asian 11 (1.4%) and other 14 (1.8%). Eleven percent of patients enrolled had an ECOG performance score of 2; 70% had radiographic evidence of disease progression with or without PSA progression; 70% had received one prior cytotoxic chemotherapy and 30% received two. Liver metastasis was present in 11% of patients treated with Zytiga.
In a planned analysis conducted after 552 deaths were observed, 42% (333 of 797) of patients treated with Zytiga compared with 55% (219 of 398) of patients treated with placebo, had died. A statistically significant improvement in median overall survival was seen in patients treated with Zytiga. (See Table 1).

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At all evaluation time points after the initial few months of treatment, a higher proportion of patients treated with Zytiga remained alive, compared with the proportion of patients treated with placebo (see Figure 1).

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Subgroup survival analyses showed a consistent survival benefit for treatment with Zytiga (see Figure 2).

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In addition to the observed improvement in overall survival, all secondary study endpoints favoured Zytiga and were statistically significant after adjusting for multiple testing as follows: Patients receiving Zytiga demonstrated a significantly higher total PSA response rate (defined as a ≥50% reduction from baseline), compared with patients receiving placebo, 38% versus 10%, p<0.0001.
The median time to PSA progression was 10.2 months for patients treated with Zytiga and 6.6 months for patients treated with placebo (HR=0.58; 95% CI: [0.462; 0.728], p<0.0001).
The median radiographic progression-free survival was 5.6 months for patients treated with Zytiga and 3.6 months for patients who received placebo (HR=0.673; 95% CI: [0.585; 0.776], p<0.0001).
Pain: The proportion of patients with pain palliation was statistically significantly higher in the Zytiga group than in the placebo group (44% versus 27%, p=0.0002). A responder for pain palliation was defined as a patient who experienced at least a 30% reduction from baseline in the BPI-SF worst pain intensity score over the last 24 hrs without any increase in analgesic usage score observed at 2 consecutive evaluations four weeks apart. Only patients with a baseline pain score of ≥4 and at least 1 post-baseline pain score were analysed (N=512) for pain palliation.
A lower proportion of patients treated with Zytiga had pain progression compared to patients taking placebo at 6 (22% versus 28%), 12 (30% versus 38%) and 18 months (35% versus 46%). Pain progression was defined as an increase from baseline of ≥30% in the BPI-SF worst pain intensity score over the previous 24 hrs without a decrease in analgesic usage score observed at 2 consecutive visits, or an increase of ≥30% in analgesic usage score observed at 2 consecutive visits. The time to pain progression at the 25th percentile was 7.4 months in the Zytiga group, versus 4.7 months in the placebo group.
Skeletal-Related Events: A lower proportion of patients in the Zytiga group had skeletal-related events compared with the placebo group at 6 months (18% versus 28%), 12 months (30% versus 40%) and 18 months (35% versus 40%). The time to 1st skeletal-related event at the 25th percentile in the Zytiga group was twice that of the control group at 9.9 months versus 4.9 months. A skeletal-related event was defined as a pathological fracture, spinal cord compression, palliative radiation to bone or surgery to bone.
Pharmacokinetics: Following administration of abiraterone acetate, the pharmacokinetics of abiraterone and abiraterone acetate have been studied in healthy subjects, patients with metastatic advanced prostate cancer and subjects without cancer with hepatic or renal impairment. Abiraterone acetate is rapidly converted in vivo to abiraterone, an androgen biosynthesis inhibitor (see Pharmacology under Actions).
Absorption: Following oral administration of abiraterone acetate in the fasting state, the time to reach maximum plasma abiraterone concentration is approximately 2 hrs.
Administration of abiraterone acetate with food, compared with administration in a fasted state, results in up to a 10-fold (AUC) and up to a 17-fold (Cmax) increase in mean systemic exposure of abiraterone, depending on the fat content of the meal. Given the normal variation in the content and composition of meals, taking Zytiga with meals has the potential to result in highly variable exposures. Therefore, Zytiga must not be taken with food. It should be taken at least 2 hrs after eating and no food should be eaten for at least 1 hr after taking Zytiga. The tablets should be swallowed whole with water (see Dosage & Administration).
Distribution: The plasma protein binding of 14C-abiraterone in human plasma is 99.8%. The apparent volume of distribution is approximately 5630 one, suggesting that abiraterone extensively distributes to peripheral tissues.
Biotransformation: Following oral administration of 14C-abiraterone acetate as capsules, abiraterone acetate is hydrolysed to abiraterone, which then undergoes metabolism including sulphation, hydroxylation and oxidation primarily in the liver. The majority of circulating radioactivity (approximately 92%) is found in the form of metabolites of abiraterone. Of 15 detectable metabolites, 2 main metabolites, abiraterone sulphate and N-oxide abiraterone sulphate, each represents approximately 43% of total radioactivity.
Elimination: The mean t½ of abiraterone in plasma is approximately 15 hrs based on data from healthy subjects. Following oral administration of 14C-abiraterone acetate 1000 mg, approximately 88% of the radioactive dose is recovered in faeces and approximately 5% in urine. The major compounds present in faeces are unchanged abiraterone acetate and abiraterone (approximately 55% and 22% of the administered dose, respectively).
Patients with Hepatic Impairment: The pharmacokinetics of abiraterone acetate was examined in subjects with preexisting mild or moderate hepatic impairment (Child-Pugh Class A and B, respectively) and in healthy control subjects. Systemic exposure to abiraterone after a single oral 1000-mg dose increased by approximately 11% and 260% in subjects with mild and moderate preexisting hepatic impairment, respectively. The mean t½ of abiraterone is prolonged to approximately 18 hrs in subjects with mild hepatic impairment and to approximately 19 hrs in subjects with moderate hepatic impairment. No dose adjustment is necessary for patients with preexisting mild hepatic impairment. Zytiga should not be used in patients with preexisting moderate or severe hepatic impairment (see Dosage & Administration).
For patients who develop hepatotoxicity during treatment, suspension of treatment and dose adjustment may be required (see Dosage & Administration).
Patients with Renal Impairment: The pharmacokinetics of abiraterone acetate was compared in patients with end-stage renal disease on a stable haemodialysis schedule versus matched control subjects with normal renal function. Systemic exposure to abiraterone after a single oral 1000-mg dose did not increase in subjects with end-stage renal disease on dialysis. Administration in patients with renal impairment, including severe renal impairment, does not require dose reduction. However, there is no clinical experience in patients with prostate cancer and severe renal impairment. Caution is advised in these patients.
Toxicology: Preclinical Safety Data: Developmental or reproductive toxicology studies were not conducted with abiraterone acetate; however, in all animal toxicity studies, circulating testosterone levels were significantly reduced. As a result, reduction in organ weights and morphological and/or histopathological changes in the reproductive organs, and the adrenal, pituitary and mammary glands were observed. All changes showed complete or partial reversibility. The changes in the reproductive organs and androgen-sensitive organs are consistent with the pharmacology of abiraterone. All treatment-related hormonal changes reversed or were shown to be resolving after a 4-week recovery period. Zytiga is contraindicated in pregnancy (see Contraindications).
Aside from reproductive organ changes seen in all animal toxicology studies, nonclinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity and genotoxicity. Carcinogenicity studies were not conducted.
Indications/Uses
In combination with prednisone or prednisolone for the treatment of metastatic castration resistant prostate cancer in adult men whose disease has progressed after a docetaxel-based chemotherapy regimen.
Dosage/Direction for Use
Recommended Dose: 1000 mg (Four 250 mg tablets) as a single daily dose that must not be taken with food (see Administration as follows). Taking the tablets with food increases systemic exposure to abiraterone (see Interactions, and Pharmacokinetics under Actions).
Zytiga is to be taken with low dose prednisone or prednisolone. The recommended dose of prednisone or prednisolone is 10 mg daily.
Serum transaminases should be measured prior to starting treatment, every 2 weeks for the first 3 months of treatment and monthly thereafter. Blood pressure, serum potassium and fluid retention should be monitored monthly.
In the event of a missed daily dose of either Zytiga, prednisone or prednisolone, treatment should be resumed the following day with the usual daily dose.
Hepatotoxicity: For patients who develop hepatotoxicity during treatment [alanine aminotransferase (ALT) increases above 5 times the upper limit of normal (ULN)], treatment should be withheld immediately. Re-treatment following return of liver function tests to the patient's baseline may be given at a reduced dose of 500 mg (2 tablets) once daily. For patients being re-treated, serum transaminases should be monitored at a minimum of every 2 weeks for 3 months and monthly thereafter. If hepatotoxicity recurs at the reduced dose of 500 mg daily, treatment should be discontinued.
If patients develop severe hepatotoxicity (ALT 20 times the upper limit of normal) anytime while on therapy, treatment should be discontinued and patients should not be re-treated.
Hepatic Impairment: No dose adjustment is necessary for patients with preexisting mild hepatic impairment, Child-Pugh Class A.
Moderate hepatic impairment (Child-Pugh Class B) has been shown to increase the systemic exposure to abiraterone by approximately 4-fold following single oral doses of abiraterone acetate 1000 mg (see Pharmacokinetics under Actions). There are no data on the clinical safety and efficacy of multiple doses of abiraterone acetate when administered to patients with moderate or severe hepatic impairment (Child-Pugh Class B or C). No dose adjustment can be predicted and Zytiga should be avoided in these patients.
Renal Impairment: No dose adjustment is necessary for patients with renal impairment. However, there is no clinical experience in patients with prostate cancer and severe renal impairment. Caution is advised in these patients.
Paediatric Population: There is no relevant use of this medicinal product in the paediatric population, as prostate cancer is not present in children and adolescents.
Administration: Zytiga should be taken at least 2 hrs after eating and no food should be eaten for at least 1 hr after taking the tablets. Zytiga is to be administered orally. These should be swallowed whole with water.
Overdosage
There have been no reports of overdose during clinical studies.
There is no specific antidote. In the event of an overdose, administration should be withheld and general supportive measures undertaken, including monitoring for arrhythmias, hypokalaemia and for signs and symptoms of fluid retention. Liver function also should be assessed.
Contraindications
Hypersensitivity to the abiraterone acetate or to any of the excipients of Zytiga (see Description for the list of Excipients).
Women who may potentially be pregnant (see Use in pregnancy & lactation).
Special Precautions
Hypertension, Hypokalaemia and Fluid Retention Due to Mineralocorticoid Excess: The phase 3 study conducted with Zytiga excluded patients with uncontrolled hypertension, clinically significant heart disease as evidenced by myocardial infarction or arterial thrombotic events in the past 6 months, severe or unstable angina or New York Heart Association Class III or IV heart disease or cardiac ejection fraction measurement of <50%. Zytiga should be used with caution in patients with a history of cardiovascular disease. Safety in patients with left ventricular ejection fraction <50% or NYHA Class III or IV heart failure has not been established. Before treatment hypertension must be controlled and hypokalaemia must be corrected.
Zytiga may cause hypertension, hypokalaemia and fluid retention (see Adverse Reactions) as a consequence of increased mineralocorticoid levels resulting from CYP17 inhibition (see Actions). Co-administration of a corticosteroid suppresses adrenocorticotropic hormone (ACTH) drive, resulting in a reduction in incidence and severity of these adverse reactions. Caution is required in treating patients whose underlying medical conditions might be compromised by increases in blood pressure, hypokalaemia (eg, those on cardiac glycosides) or fluid retention (eg, those with heart failure), severe or unstable angina pectoris, recent myocardial infarction or ventricular arrhythmia and those with severe renal impairment. Blood pressure, serum potassium and fluid retention should be monitored before treatment and at least monthly thereafter.
Hepatotoxicity: Marked increases in liver enzymes leading to treatment discontinuation or dose modification occurred in controlled clinical studies (see Adverse Reactions). Serum transaminase levels should be measured prior to starting treatment, every 2 weeks for the 1st 3 months of treatment and monthly thereafter. If clinical symptoms or signs suggestive of hepatotoxicity develop, serum transaminases, in particular serum ALT, should be measured immediately. If at any time the ALT rises >5 times the upper limit of normal (ULN), treatment should be interrupted immediately and liver function closely monitored.
Re-treatment may take place only after return of liver function tests to the patient's baseline and at a reduced dose level (see Dosage & Adminstration).
If patients develop severe hepatotoxicity (ALT 20 times the ULN) anytime while on therapy, treatment should be discontinued and patients should not be re-treated.
Patients with active or symptomatic viral hepatitis were excluded from clinical trials; thus, there are no data to support the use of Zytiga in this population.
Corticosteroid Withdrawal and Coverage of Stress Situations: Caution is advised and monitoring for adrenocortical insufficiency should occur if patients are withdrawn from prednisone or prednisolone. If Zytiga is continued after corticosteroids are withdrawn, patients should be monitored for symptoms of mineralocorticoid excess.
In patients on prednisone or prednisolone who are subjected to unusual stress, an increased dose of corticosteroids may be indicated before, during and after the stressful situation.
Bone Density: Decreased bone density may occur in men with metastatic advanced prostate cancer (castration resistant prostate cancer). The use of Zytiga in combination with a glucocorticoid could increase this effect.
Prior Use of Ketoconazole: Lower rates of response might be expected in patients previously treated with ketoconazole for prostate cancer.
Intolerance to Excipients: Zytiga contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take Zytiga. Zytiga also contains more than 1 mmol (or 27.2 mg) sodium per dose of 4 tablets. To be taken into consideration by patients on a controlled sodium diet.
Effects on the Ability to Drive or Operate Machinery: Zytiga has no or negligible influence on the ability to drive or use machines.
Use in pregnancy & lactation: Women of Childbearing Potential: There are no human data on the use of Zytiga in pregnancy and it is not for use in women of childbearing potential. Maternal use of a CYP17 inhibitor is expected to produce changes in hormone levels that could affect development of the foetus.
Contraception in Males and Females: It is not known whether abiraterone or its metabolites are present in semen. A condom is required if the patient is engaged in sexual activity with a pregnant woman. If the patient is engaged in sex with a woman of childbearing potential, a condom is required along with another effective contraceptive method.
Pregnancy: Zytiga is not for use in women. Abiraterone acetate is contraindicated in women who are or may potentially by pregnant (see Pharmacology: Toxicology: Preclinical Safety Data under Actions and Contraindications).
Breastfeeding: Zytiga is not for use in women. It is not known if either abiraterone acetate or its metabolites are excreted in human milk.
Use In Pregnancy & Lactation
Women of Childbearing Potential: There are no human data on the use of Zytiga in pregnancy and it is not for use in women of childbearing potential. Maternal use of a CYP17 inhibitor is expected to produce changes in hormone levels that could affect development of the foetus.
Contraception in Males and Females: It is not known whether abiraterone or its metabolites are present in semen. A condom is required if the patient is engaged in sexual activity with a pregnant woman. If the patient is engaged in sex with a woman of childbearing potential, a condom is required along with another effective contraceptive method.
Pregnancy: Zytiga is not for use in women. Abiraterone acetate is contraindicated in women who are or may potentially by pregnant (see Pharmacology: Toxicology: Preclinical Safety Data under Actions and Contraindications).
Breastfeeding: Zytiga is not for use in women. It is not known if either abiraterone acetate or its metabolites are excreted in human milk.
Adverse Reactions
Summary of the Safety Profile: The most common adverse reactions seen are peripheral oedema, hypokalaemia, hypertension and urinary tract infection.
Zytiga may cause hypertension, hypokalaemia and fluid retention as a pharmacodynamic consequence of its mechanism of action. In a phase 3 study, anticipated mineralocorticoid adverse reactions were seen more commonly in patients treated with Zytiga than in patients treated with placebo: Hypokalaemia 17% versus 8%, hypertension 9% versus 7% and fluid retention (peripheral oedema) 25% versus 17%, respectively. In patients treated with Zytiga, CTCAE (version 3) Grades 3 and 4 hypokalaemia and CTCAE (version 3) Grades 3 and 4 hypertension were observed in 4% and 1% of patients, respectively. Mineralocorticoid reactions generally were able to be successfully managed medically. Concomitant use of a corticosteroid reduces the incidence and severity of these adverse reactions (see Precautions).
Tabulated Summary of Adverse Reactions: In studies of patients with metastatic advanced prostate cancer who were using a luteinising hormone-releasing hormone (LHRH) agonist, or were previously treated with orchiectomy, Zytiga was administered at a dose of 1000 mg daily in combination with low dose of prednisone or prednisolone (10 mg daily). Patients were intolerant to or had failed up to 2 prior chemotherapy regimens, one of which contained a taxane (see Table 2).

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*Cardiac failure also includes congestive heart failure, left ventricular dysfunction and ejection fraction decreased.
**Fractures includes all fractures with the exception of pathological fracture.
The following CTCAE (version 3.0). Grade 3 adverse reactions occurred in patients treated with ZYTIGA: Hypokalaemia 3%; urinary tract infection 2%; peripheral oedema, increased alanine aminotransferase, hypertension, cardiac failure and atrial fibrillation and fractures, 1% each. CTCAE (version 3.0). Grade 3 hypertriglyceridaemia and angina pectoris occurred in <1% of patients. CTCAE (version 3.0). Grade 4 peripheral oedema, hypokalaemia, urinary tract infection, cardiac failure and fractures occurred in <1% of patients.
Description of Selected Adverse Reactions: Cardiovascular Reactions: The phase 3 study excluded patients with uncontrolled hypertension, clinically significant heart disease as evidenced by myocardial infarction or arterial thrombotic events in the past 6 months, severe or unstable angina or New York Heart Association Class III or IV heart disease or cardiac ejection fraction measurement of <50%. All patients enrolled (both active and placebo-treated patients) were concomitantly treated with androgen deprivation therapy, predominantly with the use of LHRH agonists, which has been associated with diabetes, myocardial infarction, cerebrovascular accident and sudden cardiac death. Cardiovascular adverse reactions in the phase 3 study occurred in 11% of patients who received Zytiga and in 7% of patients who received placebo.
Hepatotoxicity: Hepatotoxicity with elevated ALT, aspartate transaminase (AST) and total bilirubin has been reported in patients treated with Zytiga. Across all clinical studies, liver function test elevations (ALT or AST increases of >5 x ULN or bilirubin increases >1.5 x ULN) were reported in approximately 2% of patients who received Zytiga, typically during the first 3 months after starting treatment. In the phase 3 clinical study, patients whose baseline ALT or AST were elevated were more likely to experience liver function test elevations than those beginning with normal values. When elevations of either ALT or AST >5 x ULN, or elevations in bilirubin >3 x ULN were observed, Zytiga was withheld or discontinued. In 2 instances marked increases in liver function tests occurred. These 2 patients with normal baseline hepatic function, experienced ALT or AST elevations 15-40 x ULN and bilirubin elevations 2-6 x ULN. Upon discontinuation of Zytiga, both patients had normalisation of their liver function tests and 1 patient was re-treated without recurrence of the elevations.
In clinical trials, the risk for hepatotoxicity was mitigated by exclusion of patients with active or symptomatic hepatitis or baseline ALT and AST ≥2.5 x ULN in the absence of liver metastases and >5 x ULN if liver metastases were present. Abnormal liver function tests developing in patients participating in clinical trials were vigorously managed by requiring treatment interruption and permitting re-treatment only after return of liver function tests to the patient's baseline. Patients with elevations of ALT or AST >20 x ULN were not re-treated. The safety of re-treatment in such patients is unknown. The mechanism for hepatotoxicity is not understood.
Drug Interactions
Administration with food significantly increases the absorption of abiraterone acetate. The efficacy and safety of Zytiga given with food have not been established. Zytiga must not be taken with food.
In a study to determine the effects of abiraterone acetate (plus prednisone) on a single dose of the CYP2D6 substrate dextromethorphan, the systemic exposure (AUC) of dextromethorphan was increased approximately 2.9 fold. The AUC24 for dextrorphan, the active metabolite of dextromethorphan, increased approximately 33%.
Caution is advised when Zytiga is administered with drugs activated by or metabolised by CYP2D6, particularly with drugs that have a narrow therapeutic index. Dose reduction of drugs with a narrow therapeutic index that are metabolised by CYP2D6 should be considered. Examples of drugs metabolised by CYP2D6 include metoprolol, propranolol, desipramine, venlafaxine, haloperidol, risperidone, propafenone, flecanide, codeine, oxycodone and tramadol (the latter 3 products requiring CYP2D6 to form their active analgesic metabolites).
Based on in vitro data, Zytiga is an inhibitor of the hepatic drug-metabolizing enzyme CYP2C8. Examples of drugs metabolised by CYP2C8 include paclitaxel and repaglinide. There are no clinical data on the use of Zytiga with drugs that are substrates of CYP2C8.
Based on in vitro data, Zytiga is a substrate of CYP3A4. The effects of strong CYP3A4 inhibitors (eg, ketoconazole, itraconazole, clarithromycin, atazanavir, nefazodone, saquinavir, telithromycin, ritonavir, indinavir, nelfinavir, voriconazole) or inducers (eg, phenytoin, carbamazepine, rifampicin, rifabutin, rifapentine, phenobarbital) on the pharmacokinetics of abiraterone have not been evaluated, in vivo. Strong inhibitors and inducers of CYP3A4 during treatment are to be avoided or used with caution.
Caution For Usage
Based on its mechanism of action, Zytiga may harm a developing foetus; therefore, women who are pregnant or may be pregnant should not handle Zytiga without protection eg, gloves. Any unused product or waste material should be disposed of in accordance with local requirements.
Storage
Store below 30°C.
ATC Classification
L02BX03 - abiraterone ; Belongs to the class of other hormone antagonists and related agents. Used in the treatment of metastatic castration-resistant prostate cancer.
Presentation/Packing
Tab 250 mg (white to off-white, oval, debossed with 'AA250' on 1 side) x 120's.
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