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.

Call 1-844-9-IBRANCE for more information or to speak with a Field Reimbursement Manager.

Experience with IBRANCE continues to grow nationwide



Data projected as of September 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
Aromatase inhibitors 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 Oncology Together offers a range of programs that provide patient financial assistance. We help connect patients with financial assistance options regardless of their insurance coverage.

Pfizer Co-Pay One Program



Eligible, commercially insured patients may pay as little as $0 per month. Limits, terms and conditions apply*

The Pfizer Co-Pay One Savings Program offers eligible, commercially insured patients:
  • Reduced out-of-pocket cost that may be as little as $0 for a month's supply of IBRANCE (limits, terms and conditions apply)*
  • 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.PfizerOncologyTogether.com

*Limits, terms, and conditions apply. The offer will be accepted only at participating pharmacies. This offer is not health insurance. No membership fees apply. For full terms and conditions please see www.PfizerOncologyTogether.com. For more information please call 1-844-9-IBRANCE, visit www.PfizerOncologyTogether.com or write: Pfizer Co-Pay One Savings Card, 2250 Perimeter Park Drive, Suite 300, Morrisville, NC 27560.

IBRANCE is covered by 98% of commercial plans and 100% of Medicare Part D plans1†
Data current as of June 2017.
Support for your underinsured or uninsured patients: Pfizer Oncology Together connects patients with services that may help them get started on IBRANCE

Help identifying resources for patients with Medicare/Medicare Part D, Medicaid, and other government insurance plans

Insurance counseling—Assistance with understanding insurance benefits

Independent charitable foundations—Help locating support for patients needing medication cost-sharing

Free medication—Helping eligible patients receive free Pfizer medication at no cost through the remainder of the calendar year§

Help identifying resources for patients who do not have any form of healthcare coverage

Help finding coverage—We will check patient eligibility for Medicaid or Medicare Part D low-income subsidies

Free medication or savings—Eligible patients receive up to a one-year supply of their medication for free||


To learn more, reach out to your Pfizer Oncology representative, or call a Care Champion at 1-844-9-IBRANCE


Download resources to help you and your practice

REFERENCE
1. Data on file. Pfizer Inc. New York, NY.