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TARO-PALBOCICLIB is a brand name for Palbociclib, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: 05/2025 4 DOSAGE AND ADMINISTRATION 05/2025 7 WARNINGS AND PRECAUTIONS 05/2025 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES ............................................................................................2 TABLE OF…
Verbatim from this product's HC label. Tap a section to expand.
05/2025 7 WARNINGS AND PRECAUTIONS 05/2025 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. 2 TABLE OF CONTENTS ...............................................................................................................
2 1 INDICATIONS ........................................................................................................................ 1 Pediatrics ..................................................................................................................
2 Geriatrics ................................................................................................................... 4 2 CONTRAINDICATIONS ...........................................................................................................
4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ...................................................................... 5 4 DOSAGE AND ADMINISTRATION...........................................................................................
1 Dosing Considerations............................................................................................... 2 Recommended Dose and Dosage Adjustment .......................................................... 4 Administration ..........................................................................................................
5 Missed Dose .............................................................................................................. 7 5 OVERDOSAGE .......................................................................................................................
8
). The median time to first episode of any grade neutropenia was 15 days, and the median duration of Grade ≥3 neutropenia was 7 days. 8% of patients across the palbociclib clinical trials. One patient treated with palbociclib plus fulvestrant died due to neutropenic sepsis.
Physicians should inform patients to promptly report any episodes of fever. Monitor complete blood count prior to the start of TARO-PALBOCICLIB therapy, at the beginning of each cycle, as well as on Day 15 of the first 2 cycles, and as clinically indicated (see 7 WARNINGS AND PRECAUTIONS, Monitoring and Laboratory Tests).
2 Recommended Dose and Dosage Adjustment). For patients who experience Grade 3 neutropenia, consider repeating complete blood count monitoring one week later. Other Hematologic Parameters Decreases in leukocytes and platelets were observed in patients treated with either palbociclib plus letrozole or palbociclib plus fulvestrant.
Grade 3 leukopenia was reported in 24% of palbociclib plus letrozole patients and in 30% of palbociclib plus fulvestrant patients. Decreased hemoglobin and lymphocytes were also observed in palbociclib plus letrozole-treated patients (see 8 ADVERSE REACTIONS).
In clinical trials with palbociclib, anemia and leukopenia were usually managed with temporary TARO-PALBOCICLIB (Palbociclib tablets) Product Monograph Page 11 of 49 Unclassified / Non classifié palbociclib discontinuation and/or dose reduction.
2 Recommended Dose and Dosage Adjustment).
Hepatic/Biliary/Pancreatic Hepatic Impairment:
The pharmacokinetics of palbociclib has been studied in subjects with hepatic impairment. No dose adjustment is required for patients with mild or moderate hepatic impairment (Child-Pugh classes A and B). 3 Pharmacokinetics). There are no efficacy and safety data available for palbociclib in breast cancer patients with hepatic impairment.
05/2025 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. 2 TABLE OF CONTENTS ...............................................................................................................
2 1 INDICATIONS ........................................................................................................................ 1 Pediatrics ..................................................................................................................
2 Geriatrics ................................................................................................................... 4 2 CONTRAINDICATIONS ...........................................................................................................
4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ...................................................................... 5 4 DOSAGE AND ADMINISTRATION...........................................................................................
1 Dosing Considerations............................................................................................... 2 Recommended Dose and Dosage Adjustment .......................................................... 4 Administration ..........................................................................................................
5 Missed Dose .............................................................................................................. 7 5 OVERDOSAGE .......................................................................................................................
8 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING .......................................... 8 7 WARNINGS AND PRECAUTIONS ............................................................................................ 1 Special Populations .................................................................................................
o Patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
TARO-PALBOCICLIB (Palbociclib tablets) Product Monograph Page 5 of 49 Unclassified / Non classifié
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Monitor patients for signs of toxicity. Immune Infections TARO-PALBOCICLIB may predispose patients to infections. Infections have been more frequently reported in patients treated with palbociclib plus letrozole (60%) and in patients treated with palbociclib plus fulvestrant (47%) than those treated in the respective comparator arms (42% and 31%, respectively).
Grade ≥3 infections occurred in 6% of patients treated with palbociclib plus letrozole and in 3% of patients treated with letrozole alone. Grade ≥3 infections occurred in 3% of patients treated with either palbociclib plus fulvestrant or placebo plus fulvestrant.
Monitor patients for signs and symptoms of infection and treat as medically appropriate (see 7 WARNINGS AND PRECAUTIONS, Monitoring and Laboratory Tests). Physicians should be aware of the increased risk of infection with TARO-PALBOCICLIB and should inform patients to promptly report any episodes of fever.
Monitoring and Laboratory Tests Patients treated with TARO-PALBOCICLIB should be monitored for signs and symptoms of myelosuppression and infection. 2 Recommended Dose and Dosage Adjustment). Monitor complete blood count prior to starting TARO-PALBOCICLIB therapy and at the beginning of each cycle, as well as on Day 15 of the first two cycles, and as clinically indicated.
For patients who experience Grade 3 neutropenia, consider repeating complete blood count monitoring one week later. 2 Recommended Dose and Dosage Adjustment).
Renal Renal Impairment:
The pharmacokinetics of palbociclib has been studied in subjects with renal impairment. No dose adjustments are required for patients with mild, moderate, or severe renal impairment. 3 Pharmacokinetics). There are no efficacy and safety data available for palbociclib in breast TARO-PALBOCICLIB (Palbociclib tablets) Product Monograph Page 12 of 49 Unclassified / Non classifié cancer patients with renal impairment.
Reproductive Health:
Female and Male Potential • Fertility No clinical data have been obtained on fertility in humans. 3 Pharmacokinetics, Special Populations and Conditions). Based on nonclinical safety findings in male reproductive tissues, male fertility may be impaired by treatment with TARO-PALBOCICLIB (see 16 NON- CLINICAL TOXICOLOGY, Reproductive and Developmental Toxicology).
Men should consider sperm preservation prior to beginning therapy with TARO-PALBOCICLIB. Because of the potential for genotoxicity, male patients with female partners of childbearing potential should use adequate contraceptive methods during therapy and for at least 97 days after completing therapy.
Respiratory Interstitial lung disease/pneumonitis Severe, life-threatening, or fatal interstitial lung disease (ILD)/pneumonitis can occur in patients treated with TARO-PALBOCICLIB when taken in combination with endocrine therapy. 1% had Grade 3 and no Grade 4 or fatal cases were reported.
Additional cases of ILD/pneumonitis have been observed in the post- […]
1 Pregnant Women ................................................................................................. 2 Breast-feeding ......................................................................................................
3 Pediatrics ............................................................................................................. 4 Geriatrics ..............................................................................................................
13 8 ADVERSE REACTIONS .......................................................................................................... 1 Adverse Reaction Overview ....................................................................................
2 Clinical Trial Adverse Reactions ............................................................................... 3 Less Common Clinical Trial Adverse Reactions ........................................................ 4 Abnormal Hematologic and Clinical Chemistry Findings .........................................
5 Post-Market Adverse Reactions .............................................................................. 20 9 DRUG INTERACTIONS..........................................................................................................
2 Drug Interactions Overview .................................................................................... 4 Drug-Drug Interactions ........................................................................................... 5 Drug-Food Interactions ...........................................................................................
6 Drug-Herb Interactions ........................................................................................... 7 Drug-Laboratory Test Interactions .......................................................................... 23 10 CLINICAL PHARMACOLOGY ...............................................................................................
1 Mechanism of Action ............................................................................................ 2 Pharmacodynamics ............................................................................................... 3 Pharmacokinetics ..................................................................................................
24 11 STORAGE, STABILITY AND DISPOSAL ................................................................................. 27 12 SPECIAL HANDLING INSTRUCTIONS...................................................................................
27 PART II: SCIENTIFIC INFORMATION ........................................................................................ 28 13 PHARMACEUTICAL INFORMATION....................................................................................
28 14 CLINICAL TRIALS ................................................................................................................ 1 Clinical Trials by Indication ....................................................................................
2 Comparative Bioavailability Studies ...................................................................... 39 15 MICROBIOLOGY ................................................................................................................
40 16 NON-CLINICAL TOXICOLOGY ............................................................................................. 40 17 SUPPORTING PRODUCT MONOGRAPHS ................................................................... 42 PATIENT MEDICATION INFORMATION ...................................................................................
43 TARO-PALBOCICLIB (Palbociclib tablets) […]