IBRANCE® capsules Dosage and Administration

(palbociclib)

2 DOSAGE AND ADMINISTRATION

2.1 Recommended Dose and Schedule

The recommended dose of IBRANCE is a 125 mg capsule taken orally once daily for 21 consecutive days followed by 7 days off treatment to comprise a complete cycle of 28 days. IBRANCE should be taken with food [see Clinical Pharmacology (12.3)].

Administer the recommended dose of an aromatase inhibitor when given with IBRANCE. Please refer to the Full Prescribing Information for the aromatase inhibitor being used.

When given with IBRANCE, the recommended dose of fulvestrant is 500 mg administered on Days 1, 15, 29, and once monthly thereafter. Please refer to the Full Prescribing Information of fulvestrant.

Patients should be encouraged 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 capsules should be swallowed whole (do not chew, crush, or open them prior to swallowing). Capsules 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 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 therapy, consider treatment with an LHRH agonist according to current clinical practice standards.

2.2 Dose Modification

The recommended dose modifications for adverse reactions are listed in Tables 1, 2, and 3.

Table 1. Recommended Dose Modification for Adverse Reactions
Dose LevelDose
*
If further dose reduction below 75 mg/day is required, discontinue.

Recommended starting dose

125 mg/day

First dose reduction

100 mg/day

Second dose reduction

75 mg/day*

Table 2. Dose Modification and Management – Hematologic Toxicities*
Grading according to CTCAE 4.0.
CTCAE=Common Terminology Criteria for Adverse Events; LLN=lower limit of normal.
*
Table applies to all hematologic adverse reactions except lymphopenia (unless associated with clinical events, e.g., opportunistic infections).
†
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.

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 every 3 months, prior to the beginning of a 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 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 neutropenia† 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.

Table 3. Dose Modification and Management – Non-Hematologic Toxicities
CTCAE GradeDose Modifications
Grading according to CTCAE 4.0.
CTCAE=Common Terminology Criteria for Adverse Events.

Grade 1 or 2

No dose adjustment is required.

Grade ≥3 non-hematologic toxicity (if persisting despite optimal medical treatment)

Withhold until symptoms resolve to:

•
Grade ≤1;
•
Grade ≤2 (if not considered a safety risk for the patient)

Resume at the next lower dose.

Permanently discontinue IBRANCE in patients with severe interstitial lung disease (ILD)/pneumonitis.

Refer to the Full Prescribing Information for coadministered endocrine therapy dose adjustment guidelines in the event of toxicity and other relevant safety information or contraindications.

Dose Modifications for Use With Strong CYP3A Inhibitors

Avoid concomitant use of strong CYP3A inhibitors and consider an alternative concomitant medication with no or minimal CYP3A inhibition. If patients must be coadministered a strong CYP3A inhibitor, reduce the IBRANCE dose to 75 mg once daily. If the strong inhibitor is discontinued, increase the IBRANCE dose (after 3 to 5 half-lives of the inhibitor) to the dose used prior to the initiation of the strong CYP3A inhibitor [see Drug Interactions (7.1) and Clinical Pharmacology (12.3)].

Dose Modifications for 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 for 21 consecutive days followed by 7 days off treatment to comprise a complete cycle of 28 days [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].

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Dosage and Administration

2 DOSAGE AND ADMINISTRATION

2.1 Recommended Dose and Schedule

The recommended dose of IBRANCE is a 125 mg capsule taken orally once daily for 21 consecutive days followed by 7 days off treatment to comprise a complete cycle of 28 days. IBRANCE should be taken with food [see Clinical Pharmacology (12.3)].

Administer the recommended dose of an aromatase inhibitor when given with IBRANCE. Please refer to the Full Prescribing Information for the aromatase inhibitor being used.

When given with IBRANCE, the recommended dose of fulvestrant is 500 mg administered on Days 1, 15, 29, and once monthly thereafter. Please refer to the Full Prescribing Information of fulvestrant.

Patients should be encouraged 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 capsules should be swallowed whole (do not chew, crush, or open them prior to swallowing). Capsules 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 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 therapy, consider treatment with an LHRH agonist according to current clinical practice standards.

2.2 Dose Modification

The recommended dose modifications for adverse reactions are listed in Tables 1, 2, and 3.

Table 1. Recommended Dose Modification for Adverse Reactions
Dose LevelDose
*
If further dose reduction below 75 mg/day is required, discontinue.

Recommended starting dose

125 mg/day

First dose reduction

100 mg/day

Second dose reduction

75 mg/day*

Table 2. Dose Modification and Management – Hematologic Toxicities*
Grading according to CTCAE 4.0.
CTCAE=Common Terminology Criteria for Adverse Events; LLN=lower limit of normal.
*
Table applies to all hematologic adverse reactions except lymphopenia (unless associated with clinical events, e.g., opportunistic infections).
†
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.

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 every 3 months, prior to the beginning of a 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 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 neutropenia† 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.

Table 3. Dose Modification and Management – Non-Hematologic Toxicities
CTCAE GradeDose Modifications
Grading according to CTCAE 4.0.
CTCAE=Common Terminology Criteria for Adverse Events.

Grade 1 or 2

No dose adjustment is required.

Grade ≥3 non-hematologic toxicity (if persisting despite optimal medical treatment)

Withhold until symptoms resolve to:

•
Grade ≤1;
•
Grade ≤2 (if not considered a safety risk for the patient)

Resume at the next lower dose.

Permanently discontinue IBRANCE in patients with severe interstitial lung disease (ILD)/pneumonitis.

Refer to the Full Prescribing Information for coadministered endocrine therapy dose adjustment guidelines in the event of toxicity and other relevant safety information or contraindications.

Dose Modifications for Use With Strong CYP3A Inhibitors

Avoid concomitant use of strong CYP3A inhibitors and consider an alternative concomitant medication with no or minimal CYP3A inhibition. If patients must be coadministered a strong CYP3A inhibitor, reduce the IBRANCE dose to 75 mg once daily. If the strong inhibitor is discontinued, increase the IBRANCE dose (after 3 to 5 half-lives of the inhibitor) to the dose used prior to the initiation of the strong CYP3A inhibitor [see Drug Interactions (7.1) and Clinical Pharmacology (12.3)].

Dose Modifications for 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 for 21 consecutive days followed by 7 days off treatment to comprise a complete cycle of 28 days [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].
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