Important Safety Information and Indications

Neutropenia was the most frequently reported adverse reaction in PALOMA-2 (80%) and PALOMA-3 (83%). In PALOMA-2, Grade 3 (56%) or 4 (10%) decreased neutrophil counts were reported in patients receiving IBRANCE plus letrozole. In PALOMA-3, Grade 3 (55%) or Grade 4 (11%) decreased neutrophil counts were reported in patients receiving IBRANCE plus fulvestrant. Febrile neutropenia has been reported in 1.8% of patients exposed to IBRANCE across PALOMA-2 and PALOMA-3. 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 15 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.

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-2 for IBRANCE plus letrozole vs placebo plus letrozole were neutropenia (80% vs 6%), infections (60% vs 42%), leukopenia (39% vs 2%), fatigue (37% vs 28%), nausea (35% vs 26%), alopecia (33% vs 16%), stomatitis (30% vs 14%), diarrhea (26% vs 19%), anemia (24% vs 9%), rash (18% vs 12%), asthenia (17% vs 12%), thrombocytopenia (16% vs 1%), vomiting (16% vs 17%), decreased appetite (15% vs 9%), dry skin (12% vs 6%), pyrexia (12% vs 9%), and dysgeusia (10% vs 5%).

The most frequently reported Grade ≥3 adverse reactions (≥5%) in PALOMA-2 for IBRANCE plus letrozole vs placebo plus letrozole were neutropenia (66% vs 2%), leukopenia (25% vs 0%), infections (7% vs 3%), and anemia (5% vs 2%).

Lab abnormalities of any grade occurring in PALOMA-2 for IBRANCE plus letrozole vs placebo plus letrozole were decreased WBC (97% vs 25%), decreased neutrophils (95% vs 20%), anemia (78% vs 42%), decreased platelets (63% vs 14%), increased aspartate aminotransferase (52% vs 34%), and increased alanine aminotransferase (43% vs 30%).

The most common adverse reactions (≥10%) of any grade reported in PALOMA-3 for IBRANCE plus fulvestrant vs placebo plus fulvestrant were 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%), diarrhea (24% vs 19%), thrombocytopenia (23% vs 0%), vomiting (19% vs 15%), alopecia (18% vs 6%), rash (17% vs 6%), decreased appetite (16% vs 8%), and pyrexia (13% vs 5%).

The most frequently reported Grade ≥3 adverse reactions (≥5%) in PALOMA-3 for IBRANCE plus fulvestrant vs placebo plus fulvestrant were neutropenia (66% vs 1%) and leukopenia (31% vs 2%).

Lab abnormalities of any grade occurring in PALOMA-3 for IBRANCE plus fulvestrant vs placebo plus fulvestrant were decreased WBC (99% vs 26%), decreased neutrophils (96% vs 14%), anemia (78% vs 40%), decreased platelets (62% vs 10%), increased aspartate aminotransferase (43% vs 48%), and increased alanine aminotransferase (36% vs 34%).

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:

  • an aromatase inhibitor as initial endocrine-based therapy in postmenopausal women, or
  • fulvestrant in women with disease progression following endocrine therapy

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 March 2017.

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