Ibrance 100 mg Capsules

IBRANCE is a kinase inhibitor indicated: • for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in combination with: o an aromatase inhibitor as initial endocrine-based therapy ( 1.1 ); or o fulvestrant in patients with disease progression following endocrine therapy. …

• Recommended starting dose: 125 mg once daily taken with or without food for 21 days followed by 7 days off treatment. • Dosing interruption and/or dose reductions are recommended based on individual safety and tolerability
• Recommended Dosage The recommended dosage of IBRANCE is a 125 mg tablet taken orally once daily for 21 consecutive days followed by 7 days off treatment to comprise a complete cycle of 28 days
• IBRANCE tablet may be taken with or without food [see Clinical Pharmacology ]
• Advise patients to take their dose of IBRANCE at approximately the same time each day
• If the patient vomits or misses a dose, an additional dose should not be taken
• The next prescribed dose should be taken at the usual time
• IBRANCE tablets should be swallowed whole (do not chew, crush, or split them prior to swallowing)
• Tablets should not be ingested if they are broken, cracked, or otherwise not intact
• Pre/perimenopausal women treated with the combination IBRANCE plus an aromatase inhibitor or fulvestrant, IBRANCE plus inavolisib and fulvestrant therapy, or IBRANCE plus trastuzumab, with or without pertuzumab, plus endocrine therapy should also be treated with luteinizing hormone-releasing hormone (LHRH) agonists according to current clinical practice standards
• For men treated with combination IBRANCE plus aromatase inhibitor, IBRANCE plus inavolisib and fulvestrant therapy, or IBRANCE plus trastuzumab, with or without pertuzumab, plus endocrine therapy, consider treatment with an LHRH agonist according to current clinical practice standards. …

125 mg tablets: Oval, light purple, film-coated tablets debossed with "Pfizer" on one side and "PBC 125" on the other side. 100 mg tablets: Oval, green, film-coated tablets debossed with "Pfizer" on one side and "PBC 100" on the other side. 75 mg tablets: Round, light purple, film-coated tablets debossed with "Pfizer" on one side and "PBC 75" on the other side. Tablets: 125 mg, 100 mg, and 75 mg. …

• The safety and effectiveness of IBRANCE
• In pediatric patients have not been established
• The safety and effectiveness of IBRANCE were assessed but not established in three trials: one open-label trial [A5481092, (NCT03709680)] that included 98 pediatric patients 2 to

Of 444 patients who received IBRANCE in PALOMA-2, 181 patients (41%) were ≥65 years of age and 48 patients (11%) were ≥75 years of age. Of 347 patients who received IBRANCE in PALOMA-3, 86 patients (25%) were ≥65 years of age and 27 patients (8%) were ≥75 years of age. Of the 260 patients who received IBRANCE in PATINA, 41 patients (16%) were ≥65 years of age and 13 patients (5%) were ≥75 years of age. …

• Advise the patient to read the FDA-approved patient labeling (Patient Information)
• Myelosuppression/Infection • Advise patients to immediately report any signs or symptoms of myelosuppression or infection, such as fever, chills, dizziness, shortness of breath, weakness, or any increased tendency to bleed and/or to bruise [see Warnings and Precautions ]
• Interstitial Lung Disease/Pneumonitis • Advise patients to immediately report new or worsening respiratory symptoms [see Warnings and Precautions ]
• Drug Interactions • Grapefruit may interact with IBRANCE
• Patients should not consume grapefruit products while on treatment with IBRANCE. …

• None
• None

Palbociclib is primarily metabolized by CYP3A and sulfotransferase (SULT) enzyme SULT2A1. In vivo, palbociclib is a time-dependent inhibitor of CYP3A. • CYP3A Inhibitors: Avoid concurrent use of IBRANCE with strong CYP3A inhibitors. If the strong inhibitor cannot be avoided, reduce the IBRANCE dose. ( 2.2 , 7.1 ) • CYP3A Inducers: Avoid concurrent use of IBRANCE with strong CYP3A inducers. ( 7.2 ) • CYP3A Substrates: The dose of sensitive CYP3A4 substrates with narrow therapeutic indices may need to be reduced when given concurrently with IBRANCE. …

• Neutropenia: Monitor complete blood count prior to start of IBRANCE therapy and at the beginning of each cycle, as well as on Day 15 of the first 2 cycles, and as clinically indicated. ( 2.2 , 5.1 ) • Interstitial Lung Disease (ILD)/Pneumonitis: Severe and fatal cases of ILD/pneumonitis have been reported. Monitor for pulmonary symptoms of ILD/pneumonitis. Interrupt IBRANCE immediately in patients with suspected ILD/pneumonitis. Permanently discontinue IBRANCE if severe ILD/pneumonitis occurs. ( 5.2 ) • Embryo-Fetal Toxicity: IBRANCE can cause fetal harm. Advise patients of potential risk to a fetus and to use effective contraception. …

The following clinically significant adverse reactions are described elsewhere in the labeling: • Neutropenia [see Warnings and Precautions (5.1) ] • ILD/Pneumonitis [see Warnings and Precautions (5.2) ] Most common adverse reactions (incidence ≥20%) in combination with either letrozole or fulvestrant, including laboratory abnormalities, were white blood cell count decreased, neutrophils decreased, blood creatinine increased, hemoglobin decreased, platelets decreased, infections, aspartate aminotransferase increased, alanine aminotransferase increased, fatigue, nausea, stomatitis, diarrhea, and alopecia. …

8.1 Pregnancy Risk Summary Based on findings from animal studies and its mechanism of action, IBRANCE can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1) ] . There are no available data in pregnant women to inform the drug-associated risk. …

Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature] . Store in the original blister pack.

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.