Dosing Considerations
Pre/perimenopausal women treated with the combination IBRANCE plus fulvestrant therapy should also be treated with LHRH agonists according to local clinical practice.
Recommended Dose and Dosage Adjustment
The recommended dose of IBRANCE (palbociclib) is a 125 mg capsule or tablet taken orally once daily for 21 consecutive days followed by 7 days off treatment to comprise a complete cycle of 28 days.
IBRANCE capsules should be taken with food.
IBRANCE tablets may be taken with or without food.
Healthcare professionals should remind patients of the administration requirements with regards to food when dispensing the capsules, given the different recommended dosing instructions with respect to food for tablets and capsules.
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.
IBRANCE 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 IBRANCE as per dose reduction schedules provided in Table 5, 6 and 7.
| Dose Level | Dose |
|---|---|
| Recommended starting dose | 125 mg/day |
| First dose reduction | 100 mg/day |
| Second dose reduction | 75 mg/day* |
| |
Monitor complete blood counts prior to the 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. 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 IBRANCE, 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 IBRANCE 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. |
| Grade 3 neutropeniab with fever ≥38.5 ºC and/or infection | At any time: Withhold IBRANCE until recovery to Grade ≤2. Resume at the next lower dose. |
| Grade 4 | At any time: Withhold IBRANCE until recovery to Grade ≤2. Resume at the next lower dose. |
Grading according to CTCAE 4.0
| |
| 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:
Resume at the next reduced dose level. |
| Grading according to CTCAE 4.0 CTCAE=Common Terminology Criteria for Adverse Events. b. | |
No dose adjustments are required on the basis of age, gender, or body weight [see Special Populations].
Permanently discontinue IBRANCE in patients with severe interstitial lung disease (ILD) or pneumonitis (see WARNINGS AND PRECAUTIONS).
Missed Dose
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. IBRANCE capsules or tablets should be swallowed whole (do not chew, crush or open the capsules or split the tablets prior to swallowing). No capsule or tablet should be ingested if it is broken, cracked, or otherwise not intact.
Hepatic impairment: No dose adjustment is required for patients with mild or moderate hepatic impairment (Child-Pugh classes A and B). For patients with severe hepatic impairment (Child-Pugh class C), the recommended dose of IBRANCE is 75 mg once daily on Schedule 3/1 [see ACTION AND CLINICAL PHARMACOLOGY, Pharmacokinetics].
Renal impairment: No dose adjustment is required for patients with mild, moderate or severe renal impairment (creatinine clearance [CrCl] ≥15 mL/min). There are no data available in patients requiring hemodialysis [see ACTION AND CLINICAL PHARMACOLOGY, Pharmacokinetics].
)Dosing Considerations
Pre/perimenopausal women treated with the combination IBRANCE plus fulvestrant therapy should also be treated with LHRH agonists according to local clinical practice.
Recommended Dose and Dosage Adjustment
The recommended dose of IBRANCE (palbociclib) is a 125 mg capsule or tablet taken orally once daily for 21 consecutive days followed by 7 days off treatment to comprise a complete cycle of 28 days.
IBRANCE capsules should be taken with food.
IBRANCE tablets may be taken with or without food.
Healthcare professionals should remind patients of the administration requirements with regards to food when dispensing the capsules, given the different recommended dosing instructions with respect to food for tablets and capsules.
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.
IBRANCE 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 IBRANCE as per dose reduction schedules provided in Table 5, 6 and 7.
| Dose Level | Dose |
|---|---|
| Recommended starting dose | 125 mg/day |
| First dose reduction | 100 mg/day |
| Second dose reduction | 75 mg/day* |
| |
Monitor complete blood counts prior to the 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. 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 IBRANCE, 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 IBRANCE 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. |
| Grade 3 neutropeniab with fever ≥38.5 ºC and/or infection | At any time: Withhold IBRANCE until recovery to Grade ≤2. Resume at the next lower dose. |
| Grade 4 | At any time: Withhold IBRANCE until recovery to Grade ≤2. Resume at the next lower dose. |
Grading according to CTCAE 4.0
| |
| 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:
Resume at the next reduced dose level. |
| Grading according to CTCAE 4.0 CTCAE=Common Terminology Criteria for Adverse Events. b. | |
No dose adjustments are required on the basis of age, gender, or body weight [see Special Populations].
Permanently discontinue IBRANCE in patients with severe interstitial lung disease (ILD) or pneumonitis (see WARNINGS AND PRECAUTIONS).
Missed Dose
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. IBRANCE capsules or tablets should be swallowed whole (do not chew, crush or open the capsules or split the tablets prior to swallowing). No capsule or tablet should be ingested if it is broken, cracked, or otherwise not intact.
Hepatic impairment: No dose adjustment is required for patients with mild or moderate hepatic impairment (Child-Pugh classes A and B). For patients with severe hepatic impairment (Child-Pugh class C), the recommended dose of IBRANCE is 75 mg once daily on Schedule 3/1 [see ACTION AND CLINICAL PHARMACOLOGY, Pharmacokinetics].
Renal impairment: No dose adjustment is required for patients with mild, moderate or severe renal impairment (creatinine clearance [CrCl] ≥15 mL/min). There are no data available in patients requiring hemodialysis [see ACTION AND CLINICAL PHARMACOLOGY, Pharmacokinetics].
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