Abiraterone Acetate (Abiraterone Acetate)

Trade Name : Abiraterone Acetate

Teva Pharmaceuticals USA, Inc.

TABLET, FILM COATED

Strength 250 mg/1

Storage and handling for Abiraterone Acetate

ABIRATERONE ACETATE Cytochrome P450 17A1 Inhibitors [MoA],Cytochrome P450 17A1 Inhibitor [EPC],Cytochrome P450 2D6 Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA]

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Abiraterone Acetate (Abiraterone Acetate) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials. Click to know price. Read less

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About GNH

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Abiraterone acetate tablets are indicated in combination with prednisone for the treatment of patients with
Abiraterone acetate tablets areu00a0a CYP17 inhibitor indicated in combination with prednisone for the treatment of patients with

metastatic castration-resistant prostate cancer (CRPC). ()n

Metastatic castration-resistant prostate cancer:
Patients receiving abiraterone acetate tablets should also receive a gonadotropin-releasing hormone (GnRH) analog concurrently or should have had bilateral orchiectomy. Abiraterone acetate tablets must be taken on an empty stomach with water at least 1 hour before or 2 hours after a meal. Do not crush or chew tablets. ()
Dose Modification:

Tablets (250 mg): white, modified, oval-shaped, unscored, film-coated tablets, debossed with u201cTEVAu201d on one side and u201c1125u201d on the other side.

Film-Coated Tablet 250 mg ()

None.
None

No data

Mineralocorticoid excess: Closely monitor patients with cardiovascular disease. Control hypertension and correct hypokalemia before treatment. Monitor blood pressure, serum potassium and symptoms of fluid retention at least monthly.u00a0()
Adrenocortical insufficiency: Monitor for symptoms and signs of adrenocortical insufficiency. Increased dosage of corticosteroids may be indicated before, during and after stressful situations. ()
Hepatotoxicity: Can be severe and fatal. Monitor liver function and modify, interrupt, or discontinue abiraterone acetate dosing as recommended. ()
Increased fractures and mortality in combination with radium Ra 223 dichloride: Use of abiraterone acetate plus prednisone/prednisolone in combination with radium Ra 223 dichloride is not recommended. ()
Embryo-Fetal Toxicity: Abiraterone acetate can cause fetal harm. Advise males with female partners of reproductive potential to use effective contraception. (, , )

The following are discussed in more detail in other sections of the labeling:
The most common adverse reactions (u226510%) are fatigue, arthralgia, hypertension, nausea, edema, hypokalemia, hot flush, diarrhea, vomiting, upper respiratory infection, cough, and headache. ()
The most common laboratory abnormalities (>20%) are anemia, elevated alkaline phosphatase, hypertriglyceridemia, lymphopenia, hypercholesterolemia, hyperglycemia, and hypokalemia. ()
To report SUSPECTED ADVERSE REACTIONS, contact Teva Pharmaceuticals USA, Inc. at 1-888-838-2872 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

No data

CYP3A4 Inducers: Avoid concomitant strong CYP3A4 inducers during abiraterone acetate treatment. If a strong CYP3A4 inducer must be coadministered, increase the abiraterone acetate dosing frequency. (,u00a0)
CYP2D6 Substrates: Avoid coadministration of abiraterone acetate with CYP2D6 substrates that have a narrow therapeutic index. If an alternative treatment cannot be used, exercise caution and consider a dose reduction of the concomitant CYP2D6 substrate. ()

No data

Do not use abiraterone acetate in patients with baseline severe hepatic impairment (Child-Pugh Class C). ()

Human experience of overdose with abiraterone acetate tablets is limited.
There is no specific antidote. In the event of an overdose, stop abiraterone acetate tablets, undertake general supportive measures, including monitoring for arrhythmias and cardiac failure and assess liver function.

Abiraterone acetate, USP, the active ingredient of Abiraterone Acetate Tablets, USP is the acetyl ester of abiraterone. Abiraterone is an inhibitor of CYP17 (17u03b1-hydroxylase/C17,20-lyase). Each Abiraterone Acetate Tablet USP contains 250 mg of abiraterone acetate, USP. Abiraterone acetate, USP is designated chemically as (3u03b2)-17-(3-pyridinyl)androsta-5,16-dien-3-yl acetate and its structure is:
CHNOM.W. 391.55
Abiraterone acetate, USP is a white to off-white, non-hygroscopic, crystalline powder. Abiraterone acetate, USP is a lipophilic compound with an octanol-water partition coefficient of 5.12 (Log P) and is practically insoluble in water. The pKa of the aromatic nitrogen is 5.19.
Abiraterone Acetate Tablets, USP are available as 250 mg film-coated tablets with the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol (part hydrolyzed), povidone, sodium lauryl sulfate, talc, and titanium dioxide.

No data

No data

The efficacy and safety of abiraterone acetate with prednisone was established in three randomized placebo-controlled international clinical studies. All patients in these studies received a GnRH analog or had prior bilateral orchiectomy. Patients with prior ketoconazole treatment for prostate cancer and a history of adrenal gland or pituitary disorders were excluded from these trials. Concurrent use of spironolactone was not allowed during the study period.
COU-AA-301: Patients with metastatic CRPC who had received prior docetaxel chemotherapy
In COU-AA-301 (NCT00638690), a total of 1195 patients were randomized 2:1 to receive either abiraterone acetate orally at a dose of 1,000 mg once daily in combination with prednisone 5 mg orally twice daily (N=797) or placebo once daily plus prednisone 5 mg orally twice daily (N=398). Patients randomized to either arm were to continue treatment until disease progression (defined as a 25% increase in PSA over the patientu2019s baseline/nadir together with protocol-defined radiographic progression and symptomatic or clinical progression), initiation of new treatment, unacceptable toxicity or withdrawal.
The following patient demographics and baseline disease characteristics were balanced between the treatment arms. The median age was 69 years (range 39 to 95) and the racial distribution was 93% Caucasian, 3.6% Black, 1.7% Asian, and 1.6% Other. Eighty-nine percent of patients enrolled had an ECOG performance status score of 0 to 1 and 45% had a Brief Pain Inventory-Short Form score of u22654 (patientu2019s reported worst pain over the previous 24 hours). Ninety percent of patients had metastases in bone and 30% had visceral involvement. Seventy percent of patients had radiographic evidence of disease progression and 30% had PSA-only progression. Seventy percent of patients had previously received one cytotoxic chemotherapy regimen and 30% received two regimens.
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 abiraterone acetate with prednisone compared to patients in the placebo with prednisone arm (Table 9 and Figure 1). An updated survival analysis was conducted when 775 deaths (97% of the planned number of deaths for final analysis) were observed. Results from this analysis were consistent with those from the interim analysis (Table 7).
COU-AA-302: Patients with metastatic CRPC who had not received prior cytotoxic chemotherapy
In COU-AA-302 (NCT00887198), 1088 patients were randomized 1:1 to receive either abiraterone acetate orally at a dose of 1,000 mg once daily (N=546) or Placebo orally once daily (N=542). Both arms were given concomitant prednisone 5 mg twice daily. Patients continued treatment until radiographic or clinical (cytotoxic chemotherapy, radiation or surgical treatment for cancer, pain requiring chronic opioids, or ECOG performance status decline to 3 or more) disease progression, unacceptable toxicity or withdrawal. Patients with moderate or severe pain, opiate use for cancer pain, or visceral organ metastases were excluded.
Patient demographics were balanced between the treatment arms. The median age was 70 years. The racial distribution of patients treated with abiraterone acetate was 95% Caucasian, 2.8% Black, 0.7% Asian and 1.1% Other. The ECOG performance status was 0 for 76% of patients, and 1 for 24% of patients. Co-primary efficacy endpoints were overall survival and radiographic progression-free survival (rPFS). Baseline pain assessment was 0 to 1 (asymptomatic) in 66% of patients and 2 to 3 (mildly symptomatic) in 26% of patients as defined by the Brief Pain Inventory-Short Form (worst pain over the last 24 hours).
Radiographic progression-free survival was assessed with the use of sequential imaging studies and was defined by bone scan identification of 2 or more new bone lesions with confirmation (Prostate Cancer Working Group 2 criteria) and/or modified Response Evaluation Criteria In Solid Tumors (RECIST) criteria for progression of soft tissue lesions. Analysis of rPFS utilized centrally-reviewed radiographic assessment of progression.
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 abiraterone acetate with prednisone compared to those treated with placebo with prednisone (Table 8 and Figure 2). Sixty-five percent of patients on the abiraterone acetate arm and 78% of patients on the placebo arm used subsequent therapies that may prolong OS in metastatic CRPC. Abiraterone acetate was used as a subsequent therapy in 13% of patients on the abiraterone acetate arm and 44% of patients on the placebo arm.
NR=Not reached
The median time to opiate use for prostate cancer pain was not reached for patients receiving abiraterone acetate and was 23.7 months for patients receiving placebo (HR = 0.686; 95% CI: [0.566, 0.833], p = 0.0001). The time to opiate use result was supported by a delay in patient reported pain progression favoring the abiraterone acetate arm.

Abiraterone Acetate Tablets USP, 250 mg are white, modified, oval-shaped, unscored, film-coated tablets, debossed with u201cTEVAu201d on one side and u201c1125u201d on the other side.
Abiraterone Acetate Tablets USP, 250 mg are available in bottles of 120 (NDC 0093-1125-89).n
Storage and Handling
Store at 20u00b0C to 25u00b0C (68u00b0F to 77u00b0F); excursions permitted in the range from 15u00b0C to 30u00b0C (59u00b0F to 86u00b0F) [see USP Controlled Room Temperature].
Keep this and all medications out of the reach of children.
Based on its mechanism of action, abiraterone acetate tablets may harm a developing fetus. Women who are pregnant or women who may be pregnant should not handle abiraterone acetate tablets if broken, crushed, or damaged without protection, e.g., gloves n .

Advise the patient to read the FDA-approved patient labeling (Patient Information)
Hypokalemia, Fluid Retention, and n- Cardiovascular Adverse Reactions
Adrenocortical Insufficiency
Hepatotoxicity
Use in Combination with Radium Ra 223 Dichloride
Dosing and Administration
Embryo-Fetal Toxicity
Infertility
Teva Pharmaceutical Ind. Ltd.n- Teva Pharmaceuticals USA, Inc.
Rev. D 6/2019

This Patient Information has been approved by the U.S. Food and Drug Administration.u00a0 u00a0 u00a0 u00a0 u00a0Rev. D 6/2019

NDCn- 1125
Abiraterone Acetate Tablets USP
250 mg
Warning: Women who are or may be pregnant should not handle abiraterone acetate tablets without gloves (see package insert).
Rx only
120 TABLETS
TEVA

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