Generic Name and Formulations:
Palbociclib 75mg, 100mg, 125mg; caps.
- PALOMA-1 Update: Survival With Palbociclib Not Significantly Improved in ER+/HER2- Breast Cancer
- Pfizer Will Acquire Developer of Enzalutamide
- FDA Approves Palbociclib for HR+, HER2- Advanced Breast Cancer
- FDA-Approved Breast Cancer Drug Treatments
- Breast Cancer (Invasive) Treatment Regimens
- Breast Cancer (Recurrent or Metastatic) Treatment Regimens
Indications for IBRANCE:
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 in postmenopausal women; or fulvestrant in women with disease progression following endocrine therapy.
Swallow whole. Take with food. 125mg once daily for 21 consecutive days followed by 7 days off to complete a 28-day cycle, in combination with an aromatase inhibitor or with fulvestrant 500mg on Days 1, 15, 29, and once monthly thereafter (see each drug's full labeling for dosing/duration). In the combination with fulvestrant therapy: pre/perimenopausal women should be treated with LHRH agonists according to clinical practice standards. Dose modification for adverse reactions: First reduction: 100mg/day; Second dose reduction: 75mg/day; discontinue if <75mg/day required. Dose modification for hematologic or non-hematologic toxicities: see full labeling. Concomitant strong CYP3A inhibitors: avoid and consider alternative drug; if use necessary, reduce palbociclib dose to 75mg/day. Severe hepatic impairment (Child-Pugh Class C): 75mg once daily for 21 consecutive days followed by 7 days off to complete a 28-day cycle.
Monitor CBCs prior to initiation and at start of each cycle, as well as on Day 15 of first 2 cycles, and as clinically indicated. Interrupt, reduce dose, or delay starting treatment cycles if Grade 3 or 4 neutropenia develops. If maximum of Grade 1–2 neutropenia develops in first 6 cycles, monitor CBCs for subsequent cycles every 3 months, at start of each cycle, and as clinically indicated. Monitor for fever. Moderate or severe hepatic impairment. Renal impairment. Embryo-fetal toxicity. Use effective contraception during therapy and for at least 3 weeks (females) or 3 months (males) after last dose. Pregnancy; exclude status prior to initiation. Nursing mothers: not recommended (during and for 3 weeks after last dose).
Avoid concomitant strong CYP3A inhibitors (eg, clarithromycin, indinavir, itraconazole, ketoconazole, lopinavir/ritonavir, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telaprevir, telithromycin, voriconazole), grapefruit or grapefruit juice; if unavoidable, reduce dose (see Adults). Avoid concomitant strong CYP3A inducers (eg, phenytoin, rifampin, carbamazepine, enzalutamide, St. John’s wort). May potentiate midazolam or other CYP3A substrates with narrow therapeutic index (eg, alfentanil, cyclosporine, dihydroergotamine, ergotamine, everolimus, fentanyl, pimozide, quinidine, sirolimus, tacrolimus); reduce dose of these drugs.
Neutropenia, leukopenia, infections, fatigue, anemia, nausea, stomatitis, alopecia, diarrhea, thrombocytopenia, decreased appetite, vomiting, rash, asthenia, pyrexia; febrile neutropenia.
Sign Up for Free e-newsletters
Regimen and Drug Listings
GET FULL LISTINGS OF TREATMENT Regimens and Drug INFORMATION
|Head and Neck Cancer||Regimens||Drugs|
|Renal Cell Carcinoma||Regimens||Drugs|
Cancer Therapy Advisor Articles
- Immune Checkpoint Inhibitors for NSCLC: Current and Future Approaches
- Can A Consortium of Hospitals Help To Reduce Drug Prices?
- Clostridium Difficile Infection in Patients With Cancer — In the Clinic
- Erdafitinib Granted FDA Breakthrough Therapy Designation for Urothelial Carcinoma
- NSCLC: Stratifying Patients With Complex EGFR Mutations
- Confronting Racial Disparities in Prostate Cancer Survival Outcomes
- FDA Approves Front-Line Brentuximab Vedotin Plus Chemotherapy for Hodgkin Lymphoma
- NSCLC: Pretreatment Weight Loss May Be Linked to Socioeconomic Status
- Targeted and Immunotherapies for Metastatic Renal Cell Carcinoma
- Atezolizumab, Carboplatin, Nab-Paclitaxel Combination Prolongs PFS in NSCLC