Zytiga:

• Treatment of metastatic castration-resistant prostate cancer (in combination with prednisone).

Zytiga:

• Treatment of metastatic high-risk castration-sensitive prostate cancer (in combination with prednisone).

Yonsa:

• Treatment of metastatic castration-resistant prostate cancer (in combination with methylprednisolone).

Contraindicated in:

• Severe hepatic impairment
• Concurrent use of radium Ra 223 dichloride (↑ risk of fractures and mortality).

Use Cautiously in:

• HF, recent MI, other cardiovascular disease, ventricular arrhythmias
• Electrolyte abnormalities or hypertension (correct/treat prior to initiation)
• Moderate hepatic impairment
• Stress, infection, trauma, acute disease process (may result in adrenocortical insufficiency requiring additional corticosteroids)
• Rep: Men with female partners of reproductive potential.

CV: hypertension, QT interval prolongation (in presence of hypokalemia), arrhythmia, edema, TORSADES DE POINTES (IN PRESENCE OF HYPOKALEMIA).

Derm: hot flush.

Endo: adrenocortical insufficiency (due to concurrent corticosteroid), hypoglycemia.

F and E: hypokalemia.

GI: diarrhea, dyspepsia, HEPATOTOXICITY.

GU: ↓ fertility, nocturia, urinary frequency.

MS: fracture, joint pain/discomfort.

Resp: cough.

Drug-Drug:

• May ↑ levels of and risk of toxicity from CYP2D6 substrates, including thioridazine and dextromethorphan; if concurrent use necessary, ↓ dose of CYP2D6 substrate. may be required.
• May ↑ levels of and risk of toxicity from CYP2C8 substrates, including pioglitazone; if concurrent use necessary, ↓ dose of CYP2C8 substrate may be required.
• Strong CYP3A4 inducers, including carbamazepine, phenobarbital, phenytoin, rifabutin, rifapentine, or rifampin may ↓ levels and effectiveness; avoid concurrent use.
• May ↑ risk of hypoglycemia when used with pioglitazone or repaglinide.

(Generic available)

• Tablets (Zytiga): 250 mg; 500 mg;
• Tablets (Yonsa): 125 mg;

Zytiga and Yonsa are not interchangeable.

Zytiga

• PO (Adults): 1000 mg once daily; Concurrent use with strong CYP3A4 inducer: 1000 mg twice daily.

Yonsa

• PO (Adults): 500 mg once daily; Concurrent use with strong CYP3A4 inducer: 500 mg twice daily.

Yonsa, Zytiga

• Inhibits the enzyme 17α-hydroxylase/C17,20–lyase (CYP17), which is required for androgen production. May also result in increased mineralocortocoid production.

• Decreased androgen production with decreased spread of androgen-sensitive prostate cancer.

Therapeutic Classification: antineoplastics

Pharmacologic Classification: enzyme inhibitors

Absorption: Hydrolyzed to its active compound following oral administration.

Distribution: Widely distributed to tissues.

Protein Binding: >99%.

Metabolism/Excretion: Metabolized by esterases to inactive compounds; eliminated primarily in feces as unchanged drug and metabolites; 5% excreted in urine.

Half-life: 12 hr.

(plasma concentrations)

• Instruct patient to take medications as directed and not to stop abiraterone, prednisone or methylprednisolone, or gonadotropin-releasing hormone analog without consulting health care professional. If a dose is missed, take the following day. If more than 1 dose is missed, consult health care professional. Do not share medication with others, even if they have the same symptoms; may be dangerous. Advise patient to read Patient Information before starting therapy and with each Rx refill in case of changes.
• Advise patient to notify health care professional if signs and symptoms of high blood pressure, low potassium, and fluid retention (dizziness, fast heartbeats, feel faint or lightheaded, headache, confusion, muscle weakness, pain in legs, swelling in legs or feet), adrenal insufficiency, or hepatotoxicity (yellowing of skin and eyes, dark urine, pain in upper right quadrant, severe nausea or vomiting, difficulty concentrating, disorientation, confusion) occur or of side effects that are bothersome or persistent.
• Advise parents to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult with health care professional before taking other medications.
• Rep: Male patients should use a condom and another form of contraception during sex with a women of reproductive potential during and for 3 wk after therapy. Pregnant women and women of reproductive potential should not touch tablets without wearing gloves. May impair reproductive function and fertility in males of reproductive potential.
• Explain need for continued follow-up exams and lab tests to assess possible side effects.

a-bi-RA-te-rone

NDC Code^*

• 0093- Teva Pharmaceuticals USA, Inc.
  • 0093-1125- Abiraterone Acetate
    • 0093-1125-89- 120 TABLET, FILM COATED in 1 BOTTLE (0093-1125-89)

• 0143- Hikma Pharmaceuticals USA Inc.
  • 0143-9597- Abiraterone
    • 0143-9597-21- 120 TABLET in 1 BOTTLE (0143-9597-21)

• 0378- Mylan Pharmaceuticals Inc.
  • 0378-6920- Abiraterone Acetate
    • 0378-6920-78- 120 TABLET in 1 BOTTLE, PLASTIC (0378-6920-78)

• 42291- AvKARE, Inc.
  • 42291-024- Abiraterone Acetate
    • 42291-024-12- 120 TABLET in 1 BOTTLE (42291-024-12)

• 47335- Sun Pharmaceutical Industries, Inc.
  • 47335-401- YONSA
    • 47335-401-81- 120 TABLET in 1 BOTTLE, PLASTIC (47335-401-81)

• 51407- Golden State Medical Supply Inc.
  • 51407-181- Abiraterone Acetate
    • 51407-181-12- 120 TABLET in 1 BOTTLE, PLASTIC (51407-181-12)

• 57894- Janssen Biotech, Inc.
  • 57894-150- Zytiga
    • 57894-150-12- 120 TABLET in 1 BOTTLE (57894-150-12)

• 57894- Janssen Biotech, Inc.
  • 57894-155- Abiraterone acetate
    • 57894-155-12- 120 TABLET in 1 BOTTLE (57894-155-12)

• 57894- Janssen Biotech, Inc.
  • 57894-195- Zytiga
    • 57894-195-06- 60 TABLET, FILM COATED in 1 BOTTLE (57894-195-06)

• 57894- Janssen Biotech, Inc.
  • 57894-195- Zytiga
    • 57894-195-15- 60 TABLET, FILM COATED in 1 BOTTLE (57894-195-15)

• 57894- Janssen Biotech, Inc.
  • 57894-199- Abiraterone acetate
    • 57894-199-06- 60 TABLET, FILM COATED in 1 BOTTLE (57894-199-06)

• 60505- Apotex Corp.
  • 60505-4327- Abiraterone Acetate
    • 60505-4327-1- 120 TABLET in 1 BOTTLE (60505-4327-1)

• 60505- Apotex Corp.
  • 60505-4327- Abiraterone Acetate
    • 60505-4327-3- 360 TABLET in 1 BOTTLE (60505-4327-3)

• 60687- American Health Packaging
  • 60687-455- Abiraterone Acetate
    • 60687-455-21- 30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-455-21) > 1 TABLET in 1 BLISTER PACK (60687-455-11)

• 64679- Wockhardt USA LLC.
  • 64679-021- Abiraterone acetate
    • 64679-021-01- 120 TABLET in 1 BOTTLE (64679-021-01)

• 64980- Rising Pharmaceuticals, Inc.
  • 64980-418- Abiraterone acetate
    • 64980-418-12- 120 TABLET in 1 BOTTLE (64980-418-12)

• 69238- Amneal Pharmaceuticals NY LLC
  • 69238-1165- Abiraterone Acetate
    • 69238-1165-7- 120 TABLET in 1 BOTTLE (69238-1165-7)

• 69539- MSN LABORATORIES PRIVATE LIMITED
  • 69539-049- Abiraterone
    • 69539-049-92- 120 TABLET in 1 BOTTLE (69539-049-92)

• 72205- Novadoz Pharmaceuticals LLC
  • 72205-030- Abiraterone
    • 72205-030-92- 120 TABLET in 1 BOTTLE (72205-030-92)