Zytiga Application Scope

Zytiga is a prescription drug used in combination with other medications to treat specific types of advanced prostate cancer. Its application scope has been expanded since its initial approval.

Zytiga Characteristics

Ingredients: Abiraterone Acetate
Properties: White to off-white, non-hygroscopic crystalline powder; CYP17 inhibitor
Packaging Specification: Film-coated tablets of 250 mg or 500 mg
Storage: Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F to 86°F)
Expiry Date: Refer to the expiration date printed on the packaging
Executive Standard: Complies with FDA and EMA regulations for oncology pharmaceuticals
Approval Number:
- FDA NDA 202379
- EMA EMEA/H/C/002303
Date of Revision: Latest revision: November 2024
Manufacturer: Janssen Biotech, Inc., a subsidiary of Johnson & Johnson

Guidelines for the Use of Zytiga

Dosage and Administration:
- Recommended Dose: The recommended dosage of Zytiga is 1,000 mg (e.g., four 250 mg tablets) taken orally once daily, in combination with prednisone (or prednisolone) 5 mg taken orally twice daily. For patients with baseline moderate hepatic impairment (Child-Pugh Class B), the recommended dose is reduced to 250 mg once daily.
- Administration: Zytiga must be taken on an empty stomach. No food should be consumed for at least 2 hours before and at least 1 hour after taking the medicine. The tablets should be swallowed whole with water. Do not crush or chew the tablets.
- Missed Dose: If a dose is missed, it should be taken as soon as remembered on an empty stomach. However, if the next scheduled dose is due soon, the missed dose should be skipped. Doubling the dose to make up for a missed dose is not recommended.
Adverse Reactions:
- Common Adverse Reactions:
  - Fatigue
  - Joint pain
  - Hot flashes
  - Diarrhea
  - Cough
  - Vomiting
  - Headache
  - High blood pressure
  - Swelling (edema)
  - Low blood potassium
  - High blood sugar
- Serious Adverse Reactions:
  - Liver toxicity (elevated ALT/AST)
  - Adrenal insufficiency
  - Cardiovascular events (e.g., heart failure, arrhythmias)
  - Mineralocorticoid excess (e.g., hypokalemia, hypertension)
Contraindications:
- Pregnancy: Zytiga may cause fetal harm; it is contraindicated in women who are or may become pregnant.
- Severe hepatic impairment: Contraindicated in patients with baseline severe hepatic impairment (Child-Pugh Class C).
- Hypersensitivity: Contraindicated in patients with known hypersensitivity to abiraterone acetate or any component of the formulation.
Precautions:
- Liver Function: Monitor liver enzymes (ALT, AST) and bilirubin levels regularly.
- Blood Pressure: Monitor blood pressure; antihypertensive treatment may be necessary.
- Electrolyte Imbalance: Monitor potassium levels; supplementation may be required.
- Cardiovascular Health: Assess for cardiovascular risk factors before initiating treatment.

Zytiga Interactions

CYP3A4 Inhibitors: Avoid concomitant use with strong CYP3A4 inhibitors (e.g., ketoconazole, ritonavir) as they may increase abiraterone exposure.
CYP3A4 Inducers: Avoid concomitant use with strong CYP3A4 inducers (e.g., rifampin, carbamazepine) as they may decrease abiraterone efficacy.
Other Medications: Inform healthcare providers of all concomitant medications, including over-the-counter drugs and supplements.

Note:

If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYue Medicine.
This content is for reference only. Prescription drugs must be used under a doctor’s guidance and purchased from authorized sources.