Ibrance (Palbociclib) | Breast Cancer | HongKong DengYue

Palbociclib Application Scope

• Treatment of adult patients with hormone receptor (HR)-positive, HER2-negative advanced or metastatic breast cancer in combination with an aromatase inhibitor (initial therapy) or fulvestrant (after progression)

• Additionally approved with inavolisib and fulvestrant for endocrine-resistant, PIK3CA-mutated advanced breast cancer

 

Palbociclib Characteristics

• Ingredients:

  • Active: palbociclib

  • Other excipients: capsules contain gelatin, printing (“PBC 125” etc.), tablets are film-coated (detailed in EMA packaging info)

• Properties: A selective CDK4/6 kinase inhibitor that blocks G1 to S-phase cell cycle progression in HR+ breast cancer cells

• Packaging Specification:​

  • Capsules: Bottles of 21 capsules (75, 100, or 125 mg) labeled “PBC xx”

  • Tablets: Blister packs of 21 or 63 film‑coated tablets (75, 100, 125 mg), PVC/Al blisters

• Storage:

  • Store at 20–25 °C (68–77 °F); allowed variation 15–30 °C (59–86 °F)

  • Tablets should remain in original blister packaging to protect from moisture

• Expiry Date: ​Unkonwn

• Executive Standard: ​

  • U.S. FDA standards (NDA 207103, initial approval 2015, latest labeling 2025)

  • EMA marketing authorisation (e.g. PLGB 00057/1699), renewal in July 2021; text updated Jan 2025

• Approval Number:

  • U.S.: NDA 207103 (approved April 4, 2019 for updated indications)

  • EU: EU/1/16/1147 series (for different strengths)

• Date of Revision: ​Recent US label changes in April 2025; EU text revised January 2025

• Manufacturer: Pfizer Inc. (U.S., Ireland, Germany manufacturing)

Guidelines for the Use of Palbociclib

• Dosage and Administration:

  • Standard dosing: 125 mg once daily for 21 days, followed by 7 days off (28-day cycle); take with food

  • Can be taken with or without food for tablets; capsules require food

  • Dose adjustments for hepatic impairment: 75 mg daily in severe impairment (Child‑Pugh C); no adjustment in mild–moderate cases

  • Combination regimens:

    • With aromatase inhibitor (e.g., letrozole 2.5 mg daily)

    • With fulvestrant (500 mg on Days 1, 15, 29, then monthly)

    • With inavolisib + fulvestrant for PIK3CA-mutant disease

• Adverse Reactions:

  Common:

  • Neutropenia (most frequent), leukopenia, anemia, fatigue, nausea, diarrhea, infections, headache, thrombocytopenia, decreased appetite

  • Serious: Risk of febrile neutropenia, pulmonary embolism, fetal harm in pregnancy

• Contraindications: Hypersensitivity to palbociclib or any excipient

• Precautions:

  • Monitor CBC frequently due to neutropenia risk

  • Avoid in pregnancy; counsel on effective contraception

  • Caution in severe hepatic impairment; adjust dose accordingly

Interactions

• Drug Interactions:​

• CYP3A inhibitors (e.g., ketoconazole): may increase palbociclib exposure; avoid strong inhibitors

• CYP3A inducers (e.g., rifampin): may reduce exposure; avoid

• Sensitive CYP3A substrates: palbociclib may increase their levels—monitor or adjust dose

• Grapefruit: avoid due to CYP3A inhibition risk

 

Note:

• If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYue Medicine.
• It is only for internal discussion among medical staff and does not serve as a basis for medication. For specific medication guidelines, please consult the attending physician.