Palbociclib 125 mg capsules, 21 capsules — generic (Hetero, India) (Ibrance-equivalent) Zelboraf® active ingredient indications Inoperable or metastatic melanoma with the BRAF V600 mutation in adult patients - as monotherapy. +380996042415

Indications for use

Ibrance is indicated for the treatment of hormone receptor-positive (HR-positive), human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in combination with:

• letrozole as initial hormonal therapy in postmenopausal women;
• fulvestrant in women with disease progression after endocrine therapy.

Indications for use in combination with letrozole: Approved under accelerated approval based on progression-free survival. Full approval for this indication is possible only after verification and description of clinical benefit in a confirmatory trial.

Directions for Use

The recommended dose of Ibrance is one 125 mg capsule taken orally once daily for 21 consecutive days, followed by a 7-day break to create a complete 28-day cycle. Ibrance must be taken with food.

When co-administered with palbociclib, the recommended dose of letrozole is 2.5 mg once daily continuously for a 28-day cycle.