Talazoparib

EACH LUCITALA CAPSULE CONTAINS:
Talazoparib ………………… 0.1 mg

Talazoparib ………………… 0.25 mg

INDICATION

LuciTala is indicated for the treatment of adult patients with:

• Germline BRCA-mutated (gBRCAm), HER2-negative locally advanced or metastatic
  breast cancer, and
• Homologous recombination repair (HRR) gene-mutated metastatic castration-resistant
  prostate cancer (mCRPC), in combination with enzalutamide,
  who have no satisfactory alternative treatment options or whose disease has progressed
  following prior therapy.
  DOSAGE AND USE
  Recommended Dosage in Adult Patients:
• Breast Cancer: 1 mg orally once daily.
• mCRPC: 0.5 mg orally once daily in combination with enzalutamide.
  Treatment should be continued until disease progression or unacceptable toxicity.
  Capsules should be swallowed whole and must not be opened, crushed, or chewed.
  If a dose is missed or vomiting occurs, take the next dose at the scheduled time.

DOSAGE FORM AND STRENGTH

Capsules: 0.1 mg, hard hypromellose capsules, size 4, with orange cap and orange body.

STORAGE

Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to
86°F).
Keep medicine out of the reach of children.

WARNING AND PRECAUTION

• To be sold by retail on the prescription of a registered oncologist only, and used as
  directed by the physician.
• Monitor complete blood counts regularly during treatment.
• Myelodysplastic syndrome/acute myeloid leukemia (MDS/AML) has been reported in
  patients receiving talazoparib.

MANUFACTURED AND MARKETED BY

LUCIUS PHARMACEUTICALS (LAO) CO., LTD
No. 26, Thongmang Village,
Xaythany District,
Vientiane Capital, Laos