

Palbociclib (Ibrance) is indicated for the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in combination with: an aromatase inhibitor as initial endocrine-based therapy * fulvestrant in patients who have received prior therapy
Place of Origin
Germany
Product Usage
The recommended dose of Palbociclib (Ibrance) is a 125 mg capsule taken orally once daily for 21 consecutive days followed by 7 days off treatment to comprise a complete cycle of 28 days.
When coadministered with Palbociclib (Ibrance), an aromatase inhibitor should be administered according to the dose schedule reported in the Product Information for that aromatase inhibitor .
When coadministered with Palbociclib (Ibrance), the recommended dose of fulvestrant is 500 mg administered intramuscularly on Days 1, 15, 29 and once monthly thereafter. Please refer to the Product Information for fulvestrant.
Ingredients
Palbociclib (Ibrance) is supplied as hard gelatin capsules containing 75 mg of Palbociclib as the freebase and the following excipients: microcrystalline cellulose, lactose monohydrate, sodium starch glycolate, silicon dioxide and magnesium stearate.
The capsules are opaque and are differentiated by size, color and printing. The capsule shells contain gelatin, iron oxide red, iron oxide yellow and titanium dioxide and are printed with Opacode S-1-7085 white printing ink. The capsule shells consist of a light orange body/light orange cap (75 mg).
Warnings
Use of Palbociclib (Ibrance) is contraindicated in patients with hypersensitivity to Palbociclib or to any of the excipients.
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