Important Safety Information and Indications
Neutropenia was the most frequently reported adverse reaction in PALOMA-1 (75%) and PALOMA-3 (83%). In PALOMA-1, Grade 3 (57%) or 4 (5%) decreased neutrophil counts were reported in patients receiving IBRANCE plus letrozole. In PALOMA-3, Grade 3 (56%) or Grade 4 (11%) decreased neutrophil counts were reported in patients receiving IBRANCE plus fulvestrant. Febrile neutropenia has been reported in about 1% of patients exposed to IBRANCE. One death due to neutropenic sepsis was observed in PALOMA-3. Inform patients to promptly report any fever.
Monitor complete blood count prior to starting IBRANCE, at the beginning of each cycle, on Day 14 of first 2 cycles, and as clinically indicated. Dose interruption, dose reduction, or delay in starting treatment cycles is recommended for patients who develop Grade 3 or 4 neutropenia.
Pulmonary embolism (PE) has been reported at a higher rate in patients treated with IBRANCE plus letrozole in PALOMA-1 (5%) and in patients treated with IBRANCE plus fulvestrant in PALOMA-3 (1%) compared with no cases in patients treated either with letrozole alone or fulvestrant plus placebo. Monitor for signs and symptoms of PE and treat as medically appropriate.
Based on the mechanism of action, IBRANCE can cause fetal harm. Advise females of reproductive potential to use effective contraception during IBRANCE treatment and for at least 3 weeks after the last dose. IBRANCE may impair fertility in males and has the potential to cause genotoxicity. Advise male patients with female partners of reproductive potential to use effective contraception during IBRANCE treatment and for 3 months after the last dose. Advise females to inform their healthcare provider of a known or suspected pregnancy. Advise women not to breastfeed during IBRANCE treatment and for 3 weeks after the last dose because of the potential for serious adverse reactions in nursing infants.
The most common adverse reactions (≥10%) of any grade reported in PALOMA-1 of IBRANCE plus letrozole vs letrozole alone included neutropenia (75% vs 5%), leukopenia (43% vs 3%), fatigue (41% vs 23%), anemia (35% vs 7%), upper respiratory infection (31% vs 18%), nausea (25% vs 13%), stomatitis (25% vs 7%), alopecia (22% vs 3%), diarrhea (21% vs 10%), thrombocytopenia (17% vs 1%), decreased appetite (16% vs 7%), vomiting (15% vs 4%), asthenia (13% vs 4%), peripheral neuropathy (13% vs 5%), and epistaxis (11% vs 1%).
Grade 3/4 adverse reactions (≥10%) in PALOMA-1 reported at a higher incidence in the IBRANCE plus letrozole group vs the letrozole alone group included neutropenia (54% vs 1%) and leukopenia (19% vs 0%). The most frequently reported serious adverse events in patients receiving IBRANCE plus letrozole were pulmonary embolism (4%) and diarrhea (2%).
Lab abnormalities occurring in PALOMA-1 (all grades, IBRANCE plus letrozole vs letrozole alone) were decreased WBC (95% vs 26%), decreased neutrophils (94% vs 17%), decreased lymphocytes (81% vs 35%), decreased hemoglobin (83% vs 40%), and decreased platelets (61% vs 16%).
The most common adverse reactions (≥10%) of any grade reported in PALOMA-3 of IBRANCE plus fulvestrant vs fulvestrant plus placebo included neutropenia (83% vs 4%), leukopenia (53% vs 5%), infections (47% vs 31%), fatigue (41% vs 29%), nausea (34% vs 28%), anemia (30% vs 13%), stomatitis (28% vs 13%), headache (26% vs 20%), diarrhea (24% vs 19%), thrombocytopenia (23% vs 0%), constipation (20% vs 16%), vomiting (19% vs 15%), alopecia (18% vs 6%), rash (17% vs 6%), decreased appetite (16% vs 8%), and pyrexia (13% vs 5%).
Grade 3/4 adverse reactions (≥10%) in PALOMA-3 reported at a higher incidence in the IBRANCE plus fulvestrant group vs the fulvestrant plus placebo group included neutropenia (66% vs 1%) and leukopenia (31% vs 2%). The most frequently reported serious adverse reactions in patients receiving IBRANCE plus fulvestrant were infections (3%), pyrexia (1%), neutropenia (1%), and pulmonary embolism (1%).
Lab abnormalities occurring in PALOMA-3 (all grades, IBRANCE plus fulvestrant vs fulvestrant plus placebo) were decreased WBC (99% vs 26%), decreased neutrophils (96% vs 14%), anemia (78% vs 40%), and decreased platelets (62% vs 10%).
Avoid concurrent use of strong CYP3A inhibitors. If patients must be administered a strong CYP3A inhibitor, reduce the IBRANCE dose to 75 mg/day. If the strong inhibitor is discontinued, increase the IBRANCE dose (after 3-5 half-lives of the inhibitor) to the dose used prior to the initiation of the strong CYP3A inhibitor. Grapefruit or grapefruit juice may increase plasma concentrations of IBRANCE and should be avoided. Avoid concomitant use of strong CYP3A inducers. The dose of sensitive CYP3A substrates with a narrow therapeutic index may need to be reduced as IBRANCE may increase their exposure.
IBRANCE has not been studied in patients with moderate to severe hepatic impairment or in patients with severe renal impairment (CrCl <30 mL/min).
Indications
IBRANCE is indicated for the treatment of hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced or metastatic breast cancer in combination with:
  • letrozole as initial endocrine-based therapy in postmenopausal women, or
  • fulvestrant in women with disease progression following endocrine therapy
The indication in combination with letrozole is approved under accelerated approval based on progression-free survival (PFS). Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Access and Coverage

Access & Specialty Pharmacies
Coverage
Access for patients is a priority

Start now—help your patients gain access to IBRANCE

Pfizer Oncology is committed to ensuring your patients get the services they may need, regardless of their financial or health insurance status.

This section provides resources that can provide financial and access assistance to your eligible patients.*

Experience with IBRANCE continues to grow nationwide



*Limits, terms, and conditions apply to each offer.
Data current as of October 2016.

IBRANCE is available through specialty pharmacies

Specialty pharmacies offer a range of services to help patients access IBRANCE and are able to coordinate home delivery




Your specialty pharmacy:

  • Helps navigate an ever-more-complex insurance system
  • Verifies the patient’s coverage for IBRANCE and helps with prior authorization, if needed
  • Helps patients seek co-pay assistance, if needed
  • Schedules shipments of IBRANCE to the patient’s home
  • Bills the payer the cost of the product
  • Bills the patients for the remaining co-pay or co-insurance
  • Provides patients with information about IBRANCE
  • Answers questions about side effects
Letrozole and fulvestrant are dosed as described in their respective labels and should be prescribed separately.
IBRANCE + letrozole:
Efficacy and Safety Profile
IBRANCE + fulvestrant:
Efficacy and Safety Profile

REFERENCE
1. Data on file. Pfizer Inc, New York, NY.
Pfizer Co-Pay One Savings Program



No more than $10 a month for eligible, commercially insured patients*

The Pfizer Co-Pay One Savings Program offers eligible, commercially insured patients:
  • Reduced out-of-pocket cost with no more than $10 spent for a month’s supply of IBRANCE
  • Simple enrollment with no financial conditions, enrollment forms, or faxing
  • Co-pay savings upon activation
  • For more information, see your Pfizer Oncology representative, or visit www.PfizerCoPayOne.com/Pharmacist

*Limits, terms, and conditions apply. This offer is only available at participating pharmacies. This offer is not health insurance. No membership fees. See the full terms and conditions at www.PfizerCoPayOne.com/Pharmacist. For help in answering pharmacy process questions, call 1-855-612-1951. Pfizer Inc, 235 East 42nd Street, New York, NY 10017.

Support for your underinsured or uninsured patients



Pfizer RxPathways® connects patients with services that may help them get started on IBRANCE

Two online resources are available to help you, your staff, and your patients understand and get started with the program.
  • Begin the enrollment process for new patients
  • Check patients’ enrollment history
  • Verify patients’ benefits
  • Reorder medicine for enrolled patients
  • Track medicine shipments
  • Receive alerts that highlight important tasks and events
Pfizer RxPathways website: Access more information about RxPathways, download an application, or order program materials for your patients and/or to display in your waiting room. Pfizer RxPathways offers services for the:
  • Insured/underinsured
  • Uninsured
To learn more, reach out to your Pfizer Oncology representative, or call a Pfizer Rx Navigator at 1-877-744-5675, option 411.

Download resources to help you and your practice