FDA.reportPublic FDA data

Application 213091

Type
ANDA
Sponsor
DR REDDYS LABS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PALBOCICLIBPALBOCICLIBCAPSULE;ORAL75MGNoNo
002PALBOCICLIBPALBOCICLIBCAPSULE;ORAL100MGNoNo
003PALBOCICLIBPALBOCICLIBCAPSULE;ORAL125MGNoNo

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IbrancePALBOCICLIBU.S. Pharmaceuticals89a142d5-7e61-48bf-9e77-e2cd124c47922026-07-06Warnings, Adverse reactionsName fallback
IbrancePALBOCICLIBPfizer Laboratories Div Pfizer Incfecbdd7d-b729-41b5-9872-231b8fe104ce2026-07-02Warnings, Adverse reactionsName fallback
IbrancePALBOCICLIBPfizer Laboratories Div Pfizer Ince0e6412f-50b4-4fd4-9364-62818d121a072026-07-02Warnings, Adverse reactionsName fallback

Warnings cross-check#

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warnings and cautions

5 WARNINGS AND PRECAUTIONS • 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. ( 5.3 , 8.1 , 8.3 ) 5.1 Neutropenia Neutropenia was the most frequently reported adverse reaction in PALOMA-2 with an incidence of 80% and PALOMA-3 with an incidence of 83%. A Grade ≥3 decrease in neutrophil counts was reported in 66% of patients receiving IBRANCE plus letrozole in PALOMA-2 and 66% of patients receiving IBRANCE plus fulvestrant in PALOMA-3. In PALOMA-2 and PALOMA-3, the median time to first episode of any grade neutropenia was 15 days and the median duration of Grade ≥3 neutropenia was 7 days [see Adverse Reactions (6.1) ] . Neutropenia was the most frequently reported adverse reaction in PATINA with an incidence of 78%. Grade ≥3 neutropenia was reported in 61% of patients receiving IBRANCE in combination with trastuzumab, with or without pertuzumab, and endocrine therapy. Based on laboratory findings, 93% had a decrease in neutrophil counts including 47% with Grade 3 and 3.1% with Grade 4. The median time to first episode of any grade neutropenia was 22 days and the median duration of Grade ≥3 neutropenia events was 9 days [see Adverse Reactions (6.1) ] . Monitor complete blood counts prior to starting IBRANCE therapy and at the beginning of each cycle, as well as on Day 15 of the 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 [see Dosage and Administration (2.2) ] . 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. Febrile neutropenia has been reported in 0.8% of patients exposed to IBRANCE in the PATINA study. Physicians shoul...

Adverse reactions cross-check#

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adverse reactions

6 ADVERSE REACTIONS 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. ( 6.1 ) The most common adverse reactions (incidence ≥20%) in combination with inavolisib and fulvestrant, including laboratory abnormalities, were neutrophils decreased, hemoglobin decreased, fasting glucose increased, platelets decreased, lymphocytes decreased, stomatitis, diarrhea, calcium decreased, fatigue, potassium decreased, creatinine increased, alanine aminotransferase (ALT) increased, nausea, sodium decreased, magnesium decreased, rash, decreased appetite, COVID-19 infection, and headache. ( 6.1 ) The most common adverse reactions (incidence ≥20%) in combination with trastuzumab, with or without pertuzumab, and endocrine therapy, including laboratory abnormalities, were white blood cell decreased, neutrophil count decreased, creatinine increased, hemoglobin decreased, diarrhea, infections, platelet count decreased, stomatitis, aspartate aminotransferase increased, decreased calcium, alanine aminotransferase increased, decreased potassium, fatigue, alkaline phosphatase increased, nausea, asthenia, headache, rash, pruritus, and muscle spasms. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Studies Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. PALOMA-2: IBRANCE plus Letrozole Patients with estrogen receptor (ER)-positive, HER2-negative advanced or metastatic breast cancer for initial endocrine-based therapy The safety of IBRANCE plus letrozole was evaluated in a randomized, double-blind trial (PALOMA-2) i...

adverse reactions table

Table 4. Adverse Reactions (≥10%) in PALOMA-2Grading according to CTCAE 4.0. CTCAE=Common Terminology Criteria for Adverse Events; N=number of patients; N/A=not applicable;IBRANCE plus Letrozole (N=444)Placebo plus Letrozole (N=222)Adverse ReactionAll Grades %Grade 3 %Grade 4 %All Grades %Grade 3 %Grade 4 %Infections and infestations InfectionsInfections includes all reported preferred terms (PTs) that are part of the System Organ Class Infections and infestations.60Most common infections (≥1%) include: nasopharyngitis, upper respiratory tract infection, urinary tract infection, oral herpes, sinusitis, rhinitis, bronchitis, influenza, pneumonia, gastroenteritis, conjunctivitis, herpes zoster, pharyngitis, cellulitis, cystitis, lower respiratory tract infection, tooth infection, gingivitis, skin infection, gastroenteritis viral, respiratory tract infection, respiratory tract infection viral, and folliculitis.614230Blood and lymphatic system disorders Neutropenia Leukopenia Anemia Thrombocytopenia80392416562451101<1<1629110201000Metabolism and nutrition disorders Decreased appetite1510900Nervous system disorders Dysgeusia1000500Gastrointestinal disorders StomatitisStomatitis includes: aphthous stomatitis, cheilitis, glossitis, glossodynia, mouth ulceration, mucosal inflammation, oral pain, oral discomfort, oropharyngeal pain, and stomatitis. Nausea Diarrhea Vomiting303526161<11100001426191702110000Skin and subcutaneous tissue disorders Alopecia RashRash includes the following PTs: rash, rash maculo-papular, rash pruritic, rash erythematous, rash papular, dermatitis, dermatitis acneiform, and toxic skin eruption. Dry skin33Grade 1 events – 30%; Grade 2 events – 3%.1812N/A10N/A0016Grade 1 events – 15%; Grade 2 events – 1%.126N/A10N/A00General disorders and administration site conditions Fatigue Asthenia Pyrexia37171222000028129100000

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
68524ORIG2021-09-02