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PMS-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: 03/2025 4.1 Dosing considerations 03/2025 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.
1 Dosing Considerations Pre/perimenopausal women and men treated with the combination palbociclib plus aromatase inhibitor therapy, and pre/perimenopausal women treated with the combination palbociclib plus fulvestrant therapy should also be treated with LHRH agonists according to local clinical practice.
2 Recommended Dose and Dosage Adjustment The recommended dose of pms-PALBOCICLIB (palbociclib) 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.
pms-PALBOCICLIB is used in combination with an aromatase inhibitor or fulvestrant. For full dosing instructions of the selected aromatase inhibitor or fulvestrant, please consult the corresponding Product Monographs. Management of some adverse reactions may require temporary dose interruptions/delays and/or dose reductions, or permanent discontinuation of pms-PALBOCICLIB as per dose reduction schedules provided in Table 1, 2, and 3.
pms-PALBOCICLIB (Palbociclib) – Product Monograph Page 6 of 50 Table 1. pms-PALBOCICLIB Recommended Dose Modification for Adverse Events Dose Level Dose Recommended starting dose 125 mg/day First dose reduction 100 mg/day Second dose reduction 75 mg/day* *If further dose reduction below 75 mg/day is required, discontinue palbociclib treatment.
Table 2. Dose Modification and Management – Hematologic Toxicitiesa Monitor complete blood counts prior to the start of pms-PALBOCICLIB therapy and at the beginning of each cycle, as well as on Day 15 of the first 2 cycles, and as clinically indicated.
For patients who experience a maximum of Grade 1 or 2 neutropenia in the first 6 cycles, monitor complete blood counts for subsequent cycles, prior to the beginning of every third cycle, and as clinically indicated. CTCAE Grade Dose Modifications Grade 1 or 2 No dose adjustment is required.
Grade 3 Day 1 of cycle:
Withhold pms-PALBOCICLIB, repeat complete blood count monitoring within 1 week. When recovered to Grade ≤2, start the next cycle at the same dose.
Day 15 of first 2 cycles:
If Grade 3 on Day 15, continue pms-PALBOCICLIB at current dose to complete cycle and repeat complete blood count on Day 22. If Grade 4 on Day 22, see Grade 4 dose modification guidelines below. Consider dose reduction in cases of prolonged (>1 week) recovery from Grade 3 neutropenia or recurrent Grade 3 neutropenia on Day 1 of subsequent cycles.
). 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 pms-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 pms-PALBOCICLIB (Palbociclib) – Product Monograph Page 11 of 50 (see 8 ADVERSE REACTIONS).
In clinical trials with palbociclib, anemia and leukopenia were usually managed with temporary 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.
1 Dosing Considerations Pre/perimenopausal women and men treated with the combination palbociclib plus aromatase inhibitor therapy, and pre/perimenopausal women treated with the combination palbociclib plus fulvestrant therapy should also be treated with LHRH agonists according to local clinical practice.
2 Recommended Dose and Dosage Adjustment The recommended dose of pms-PALBOCICLIB (palbociclib) 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.
pms-PALBOCICLIB is used in combination with an aromatase inhibitor or fulvestrant. For full dosing instructions of the selected aromatase inhibitor or fulvestrant, please consult the corresponding Product Monographs. Management of some adverse reactions may require temporary dose interruptions/delays and/or dose reductions, or permanent discontinuation of pms-PALBOCICLIB as per dose reduction schedules provided in Table 1, 2, and 3.
pms-PALBOCICLIB (Palbociclib) – Product Monograph Page 6 of 50 Table 1. pms-PALBOCICLIB Recommended Dose Modification for Adverse Events Dose Level Dose Recommended starting dose 125 mg/day First dose reduction 100 mg/day Second dose reduction 75 mg/day* *If further dose reduction below 75 mg/day is required, discontinue palbociclib treatment.
Table 2. Dose Modification and Management – Hematologic Toxicitiesa Monitor complete blood counts prior to the start of pms-PALBOCICLIB therapy and at the beginning of each cycle, as well as on Day 15 of the first 2 cycles, and as clinically indicated.
For patients who experience a maximum of Grade 1 or 2 neutropenia in the first 6 cycles, monitor complete blood counts for subsequent cycles, prior to the beginning of every third cycle, and as clinically indicated. CTCAE Grade Dose Modifications Grade 1 or 2 No dose adjustment is required.
• 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.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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5 ºC and/or infection At any time: Withhold pms-PALBOCICLIB until recovery to Grade ≤2. Resume at the next lower dose.
Grade 4 At any time:
Withhold pms-PALBOCICLIB until recovery to Grade ≤2. Resume at the next lower dose. 0 CTCAE=Common Terminology Criteria for Adverse Events; LLN=lower limit of normal. , opportunistic infections). b Absolute neutrophil count (ANC): Grade 1: ANC < LLN - 1500/mm3; Grade 2: ANC 1000 - <1500/mm3; Grade 3: ANC 500 - <1000/mm3; Grade 4: ANC <500/mm3.
Table 3. pms-PALBOCICLIB Dose Modification and Management – Non-Hematologic Toxicities CTCAE Grade Dose Modifications Grade 1 or 2 No dose adjustment is required. Grade ≥3 non-hematologic toxicity (if persisting despite medical treatment) Withhold until symptoms resolve to: • Grade ≤1; • Grade ≤2 (if not considered a safety risk for the patient) Resume at the next reduced dose level.
0 CTCAE=Common Terminology Criteria for Adverse Events. 3 Pharmacokinetics, Special Populations and Conditions). Permanently discontinue pms-PALBOCICLIB in patients with severe interstitial lung disease (ILD) or pneumonitis (see 7 WARNINGS AND PRECAUTIONS, Respiratory).
Special populations Hepatic impairment:
No dose adjustment is required for patients with mild or moderate hepatic impairment (Child-Pugh classes A and B). 3 Pharmacokinetics).
Renal impairment:
No dose adjustment is required for patients with mild, moderate or severe renal impairment (creatinine clearance [CrCl] ≥15 mL/min). 3 Pharmacokinetics). 4 Administration pms-PALBOCICLIB tablets may be taken with or without food. Patients should be advised to take their dose at approximately the same time each day.
Continue the treatment as long as the patient is deriving clinical benefit from therapy. 5 Missed Dose pms-PALBOCICLIB (Palbociclib) – Product Monograph Page 8 of 50 If the patient vomits or misses a dose, an additional dose should not be taken that day.
The next prescribed dose should be taken at the usual time. pms-PALBOCICLIB tablets should be swallowed whole (do not chew, crush or split the tablets prior to swallowing). No tablet should be ingested if it is broken, cracked, or otherwise not intact.
Monitor patients for signs of toxicity. Immune Infections pms-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 pms-PALBOCICLIB and should inform patients to promptly report any episodes of fever.
Monitoring and Laboratory Tests Patients treated with pms-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 pms-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 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 pms-PALBOCICLIB (see 16 NON- CLINICAL TOXICOLOGY, Reproductive and Developmental Toxicology).
Men should consider sperm preservation prior to beginning therapy with pms-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 pms-PALBOCICLIB when taken in combination with endocrine therapy. 1% had Grade 3 and no Grade 4 or fatal cases were reported.
5 Post- Market Adverse Reactions), with fatalities reported. Patients […]
Grade 3 Day 1 of cycle:
Withhold pms-PALBOCICLIB, repeat complete blood count monitoring within 1 week. When recovered to Grade ≤2, start the next cycle at the same dose.
Day 15 of first 2 cycles:
If Grade 3 on Day 15, continue pms-PALBOCICLIB at current dose to complete cycle and repeat complete blood count on Day 22. If Grade 4 on Day 22, see Grade 4 dose modification guidelines below. Consider dose reduction in cases of prolonged (>1 week) recovery from Grade 3 neutropenia or recurrent Grade 3 neutropenia on Day 1 of subsequent cycles.
5 ºC and/or infection At any time: Withhold pms-PALBOCICLIB until recovery to Grade ≤2. Resume at the next lower dose.
Grade 4 At any time:
Withhold pms-PALBOCICLIB until recovery to Grade ≤2. Resume at the next lower dose. 0 CTCAE=Common Terminology Criteria for Adverse Events; LLN=lower limit of normal. , opportunistic infections). b Absolute neutrophil count (ANC): Grade 1: ANC < LLN - 1500/mm3; Grade 2: ANC 1000 - <1500/mm3; Grade 3: ANC 500 - <1000/mm3; Grade 4: ANC <500/mm3.
Table 3. pms-PALBOCICLIB Dose Modification and Management – Non-Hematologic Toxicities CTCAE Grade Dose Modifications Grade 1 or 2 No dose adjustment is required. Grade ≥3 non-hematologic toxicity (if persisting despite medical treatment) Withhold until symptoms resolve to: • Grade ≤1; • Grade ≤2 (if not considered a safety risk for the patient) Resume at the next reduced dose level.
0 CTCAE=Common Terminology Criteria for Adverse Events. 3 Pharmacokinetics, Special Populations and Conditions). Permanently discontinue pms-PALBOCICLIB in patients with severe interstitial lung disease (ILD) or pneumonitis (see 7 WARNINGS AND PRECAUTIONS, Respiratory).
Special populations Hepatic impairment:
No dose adjustment is required for patients with mild or moderate hepatic impairment (Child-Pugh classes A and B). 3 Pharmacokinetics).
Renal impairment:
No dose adjustment is required for patients with mild, moderate or severe renal impairment (creatinine clearance [CrCl] ≥15 mL/min). 3 Pharmacokinetics). 4 Administration pms-PALBOCICLIB tablets may be taken with or without food. Patients should be advised to take their dose at approximately the same time each day.
Continue the treatment as long as the patient is deriving clinical benefit from therapy. 5 Missed Dose pms-PALBOCICLIB (Palbociclib) – Product Monograph Page 8 of 50 If the patient vomits or misses a dose, an additional dose should not be taken that day.
The next prescribed dose should be taken at the usual time. pms-PALBOCICLIB tablets should be swallowed whole (do not chew, crush or split the tablets prior to swallowing). No tablet should be ingested if it is broken, cracked, or otherwise not intact.
5 OVERDOSAGE There is no known antidote for pms-PALBOCICLIB (palbociclib). The treatment of overdose of pms-PALBOCICLIB should consist of general supportive measures. For the most recent information in the management of a suspected drug overdose, contact your regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764-7669).
6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING Table 4. Dosage Forms, Strengths, Composition and Packaging Route of Administration Dosage Form / Strength/Composition Non-medicinal Ingredients Oral Tablets 75 mg, 100 mg, 125 mg Crospovidone, FD & C Blue #2 / Indigo Carmine Aluminum Lake, Hypromellose, Magnesium stearate, Microcrystalline cellulose, Succinic acid, Titanium dioxide, Triacetin, Iron oxide red (in 75 mg […]