• Prescribing Information for Capsules
  • Prescribing Information for Tablets
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  • Dosing & Therapy Management

    IBRANCE is switching from capsules to tablets

    What you need to know: IBRANCE tablets

    Why is IBRANCE switching from capsules to tablets?

    As part of our ongoing commitment to patients, Pfizer routinely looks for opportunities to better address patient needs and preferences. The IBRANCE tablet formulation offers patients:

    • Increased flexibility: Patients can take IBRANCE tablets with or without food, and they can be coadministered with proton pump inhibitors (PPIs) or antacids
    • Dose tracking: Tablets come in weekly blister packs that are designed to help patients track their treatment cycles
    • Addresses dietary concerns: The tablet formulation does not contain lactose (dairy) or gelatin

    Please specify "IBRANCE tablets" on all IBRANCE prescriptions, so patients receive this formulation.

    No action should be needed on your patients’ part. There is no change to the active ingredient (palbociclib), available dosage strengths (125 mg, 100 mg, 75 mg), or dosing schedule. See below for some important differences of which you should be aware.

    Here’s what’s changing:

     Capsules and tablets shown are not actual size.

    If the individual NDC codes are unavailable for selection at your practice, you must specify the dosage and "IBRANCE tablets" on all IBRANCE prescriptions.

    FAQs about IBRANCE tablets

    When will my patients begin receiving IBRANCE in tablet form?

    In April 2020, IBRANCE switched from a capsule formulation to tablets with blister packaging. Please specify "IBRANCE tablets" when prescribing IBRANCE so your patients receive the tablet formulation.

    What are the differences between IBRANCE capsules and IBRANCE tablets?

    The formulations of IBRANCE are bioequivalent and contain the same active ingredient. However, IBRANCE tablets can be taken with or without food, are film-coated, and can be coadministered with PPIs or antacids.

    How will this transition affect the dosing for IBRANCE?

    The dosage strengths of IBRANCE will stay the same. You can continue prescribing 125 mg, 100 mg, and 75 mg doses but in tablet form. Each dosage strength of IBRANCE tablets is designed to look different—they vary in tablet shape, size, and/or color. The tablets will follow the same treatment schedule as the capsules—take one tablet of IBRANCE, once daily for 3 weeks on and 1 week off.

    What are the administration changes with IBRANCE tablets?​​​​​​​

    IBRANCE tablets can be taken with or without food and can be coadministered with PPIs or antacids. IBRANCE tablets should be swallowed whole. Patients should be advised not to crush, chew, or split the tablets before swallowing them.

    Will switching from capsules to tablets change the price of IBRANCE?

    Since launch in April 2020, the tablet formulation has had the same price as the capsules. There are financial assistance resources available to your patients, subject to the program's limits, terms, and conditions. Click here to learn more. 

    How does the packaging of IBRANCE tablets differ from the capsules?​​​​​​​

    While IBRANCE capsules were provided in bottles, the tablet formulation is dispensed in 3 weekly blister packs per month. The weekly blister packaging is designed to help patients keep track of their treatment cycles.

    Can my patients still use their pill caddies for the tablet formulation?​​​​​​​

    No, patients should be advised that tablets are NOT meant to be removed from their blister packs and transferred to caddies. Patients may continue to use their pill caddies if they are still receiving IBRANCE capsules.

    Are there any additional side effects or safety concerns with the IBRANCE tablets?​​​​​​​

    The efficacy and safety data in the tablet label are based on the clinical trials conducted with the capsule formulation. The benefit and risk profile of IBRANCE tablets is expected to be similar to that of the approved capsules.

    How should my patients store IBRANCE tablets?​​​​​​​

    IBRANCE should be stored at 68°F to 77°F (20°C to 25°C) in the original blister pack. Patients should be advised to keep IBRANCE tablets in the blister packs.

    If your patients have any questions or concerns about this formulation change, please direct them to IBRANCEtablets.com for more information.

    Efficacy data for IBRANCE + aromatase inhibitor

    Review the data

    Safety profile for IBRANCE + aromatase inhibitor

    Review the data

    Efficacy data for IBRANCE + fulvestrant

    Review the data

    Safety profile for IBRANCE + fulvestrant

    Review the data

    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.

    Severe, life-threatening, or fatal interstitial lung disease (ILD) and/or pneumonitis can occur in patients treated with CDK4/6 inhibitors, including IBRANCE when taken in combination with endocrine therapy. Across clinical trials (PALOMA-1, PALOMA-2, PALOMA-3), 1.0% of IBRANCE-treated patients had ILD/pneumonitis of any grade, 0.1% had Grade 3 or 4, and no fatal cases were reported. Additional cases of ILD/pneumonitis have been observed in the post-marketing setting, with fatalities reported.

    Monitor patients for pulmonary symptoms indicative of ILD/pneumonitis (e.g., hypoxia, cough, dyspnea). In patients who have new or worsening respiratory symptoms and are suspected to have developed pneumonitis, interrupt IBRANCE immediately and evaluate the patient. Permanently discontinue IBRANCE in patients with severe ILD or pneumonitis.

    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 to consider sperm preservation before taking IBRANCE. 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. 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.

    For patients with severe hepatic impairment (Child-Pugh class C), the recommended dose of IBRANCE is 75 mg. The pharmacokinetics of IBRANCE have not been studied in patients requiring hemodialysis

    Please see full Prescribing Information for IBRANCE capsules and tablets.

    IBRANCE (palbociclib) 125 mg capsules and tablets are indicated for the treatment of adult patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced or metastatic breast cancer (mBC) in combination with:

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

    INDICATIONS

    IBRANCE (palbociclib) 125 mg capsules and tablets are indicated for the treatment of adult patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced or metastatic breast cancer (mBC) in combination with:

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