The recommended dosage is taken orally once daily with food. Swallow tablets whole. Do not cut, crush, break or chew tablets. Continue treatment with BOSULIF until disease progression or intolerance to therapy.
Capsules may be swallowed whole. For patients who are unable to swallow a whole capsule(s), each capsule can be opened and the contents mixed with applesauce or yogurt. Mixing the capsule contents with applesauce or yogurt cannot be considered a substitute of a proper meal.
If a dose is missed beyond 12 hours, the patient should skip the dose and take the usual prescribed dose on the following day.
Dosage in Adult Patients with Newly-Diagnosed CP Ph+ CML
The recommended dosage of BOSULIF is 400 mg orally once daily with food.
Dosage in Adult Patients with CP, AP, or BP Ph+ CML with Resistance or Intolerance to Prior Therapy
The recommended dosage of BOSULIF is 500 mg orally once daily with food.
Dosage in Pediatric Patients with Newly-Diagnosed CP Ph+ CML or with CP Ph+ CML with Resistance or Intolerance to Prior Therapy
The recommended dose of BOSULIF for pediatric patients with newly-diagnosed CP Ph+ CML is 300 mg/m2 orally once daily with food and the recommended dosage for pediatric patients with CP Ph+ CML that is resistant or intolerant to prior therapy is 400 mg/m2 orally once daily with food and dose recommendations are provided in Table 1. As appropriate, the desired dose can be attained by combining different strengths of BOSULIF tablets or capsules.
BSA* | Newly-Diagnosed Recommended Dose (Once Daily) | Resistant or Intolerant Recommended Dose (Once Daily) |
< 0.55 m2 | 150 mg | 200 mg |
0.55 to < 0.63 m2 | 200 mg | 250 mg |
0.63 to < 0.75 m2 | 200 mg | 300 mg |
0.75 to < 0.9 m2 | 250 mg | 350 mg |
0.9 to < 1.1 m2 | 300 mg | 400 mg |
≥ 1.1 m2 | 400 mg† | 500 mg† |
Preparation Instructions for BOSULIF Capsules Mixed with Applesauce or Yogurt
For patients who are unable to swallow capsules, the contents of the capsules can be mixed with applesauce or yogurt. Remove the required number of capsules from the container to prepare the dose as instructed and the amount of either room temperature applesauce or yogurt in a clean container. Carefully open each capsule, add the entire capsule content of each capsule into the applesauce or yogurt, then mix the entire dose into the applesauce or yogurt. Patients should immediately consume the full mixture in its entirety, without chewing. Do not store the mixture for later use. If the entire preparation is not swallowed do not take an additional dose. Wait until the next day to resume dosing.
Dose | Volume of Applesauce or Yogurt |
100 mg | 10 mL (2 teaspoons) |
150 mg | 15 mL (3 teaspoons) |
200 mg | 20 mL (4 teaspoons) |
250 mg | 25 mL (5 teaspoons) |
300 mg | 30 mL (6 teaspoons) |
350 mg | 30 mL (6 teaspoons) |
400 mg | 35 mL (7 teaspoons) |
450 mg | 40 mL (8 teaspoons) |
500 mg | 45 mL (9 teaspoons) |
550 mg | 45 mL (9 teaspoons) |
600 mg | 50 mL (10 teaspoons) |
In clinical studies of adult patients with Ph+ CML, dose escalation by increments of 100 mg once daily to a maximum of 600 mg once daily was allowed in patients who did not achieve or maintain a hematologic, cytogenetic, or molecular response and who did not have Grade 3 or higher adverse reactions at the recommended starting dosage.
In pediatric patients with BSA <1.1 m2 and an insufficient response after 3 months consider increasing dose by 50 mg increments up to maximum of 100 mg above starting dose. Dose increases for insufficient response in pediatric patients with BSA ≥1.1 m2 can be conducted similarly to adult recommendations in 100 mg increments.
The maximum dose in pediatric and adult patients is 600 mg once daily.
Elevated liver transaminases: If elevations in liver transaminases greater than 5×institutional upper limit of normal (ULN) occur, withhold BOSULIF until recovery to less than or equal to 2.5×ULN and resume at 400 mg once daily thereafter. If recovery takes longer than 4 weeks, discontinue BOSULIF. If transaminase elevations greater than or equal to 3×ULN occur concurrently with bilirubin elevations greater than 2×ULN and alkaline phosphatase less than 2×ULN (Hy's law case definition), discontinue BOSULIF [see Warnings and Precautions (5.3)].
Diarrhea: For National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Grade 3–4 diarrhea (increase of greater than or equal to 7 stools/day over baseline/pretreatment), withhold BOSULIF until recovery to Grade less than or equal to 1. BOSULIF may be resumed at 400 mg once daily [see Warnings and Precautions (5.1)].
For other clinically significant, moderate or severe non-hematological toxicity, withhold BOSULIF until the toxicity has resolved, then consider resuming BOSULIF at a dose reduced by 100 mg taken once daily. If clinically appropriate, consider re-escalating the dose of BOSULIF to the starting dose taken once daily.
In pediatric patients, dose adjustments for non-hematologic toxicities can be conducted similarly to adults, however the dose reduction increments may differ. For pediatric patients with BSA <1.1 m2, reduce dose by 50 mg initially followed by additional 50 mg increment if the adverse reaction (AR) persists. For pediatric patients with BSA ≥1.1 m2 or greater, reduce dose similarly to adults.
Dose reductions for severe or persistent neutropenia and thrombocytopenia are described below (Table 3).
| |
ANC* less than 1000×106/L or Platelets less than 50,000×106/L | Withhold BOSULIF until ANC greater than or equal to1000×106/L and platelets greater than or equal to 50,000×106/L.
|
The recommended starting doses for patients with renal and hepatic impairment are described in Table 4 below.
| Recommended Starting Dosage | |||
|---|---|---|---|
| [see Use in Specific Populations (8.6, 8.7) and Clinical Pharmacology (12.3)]. | |||
| Newly-diagnosed chronic phase Ph+ CML | Chronic, accelerated, or blast phase Ph+ CML with resistance or intolerance to prior therapy | |
Normal renal and hepatic function | 400 mg daily | 500 mg daily | |
Renal impairment | |||
| Creatinine clearance 30 to 50 mL/min | 300 mg daily | 400 mg daily |
| Creatinine clearance less than 30 mL/min | 200 mg daily | 300 mg daily |
Hepatic impairment | |||
| Mild (Child-Pugh A), Moderate (Child-Pugh B) or Severe (Child-Pugh C) | 200 mg daily | 200 mg daily |
| [see Use in Specific Populations (8.6, 8.7) and Clinical Pharmacology (12.3)]. | ||||
| ||||
| Newly-Diagnosed CP Ph+ CML Recommended Starting Dose (Once Daily) By Organ Function | |||
Pediatric Patients by Separated BSA* Band | Normal renal and hepatic function | Renal Impairment: Creatinine clearance 30 to 50 mL/min | Renal Impairment: Creatinine clearance less than 30 mL/min | Hepatic Impairment: Mild (Child-Pugh A), Moderate (Child-Pugh B) or Severe (Child-Pugh C) |
Pediatric < 0.55 m2 | 150 mg | 100 mg | 100 mg | 100 mg |
Pediatric 0.55 to < 0.63 m2 | 200 mg | 150 mg | 100 mg | 100 mg |
Pediatric 0.63 to < 0.75 m2 | 200 mg | 150 mg | 100 mg | 100 mg |
Pediatric 0.75 to < 0.9 m2 | 250 mg | 200 mg | 150 mg | 100 mg |
Pediatric 0.9 to < 1.1 m2 | 300 mg | 200 mg | 200 mg | 150 mg |
Pediatric ≥ 1.1 m2 | 400 mg | 300 mg | 200 mg | 200 mg |
| CP Ph+ CML with Resistance or Intolerance to Prior Therapy Recommended Starting Dose (Once Daily) By Organ Function | |||
Pediatric Patients by Separated BSA* Band | Normal renal and hepatic function | Renal Impairment: Creatinine clearance 30 to 50 mL/min | Renal Impairment: Creatinine clearance less than 30 mL/min | Hepatic Impairment: Mild (Child-Pugh A), Moderate (Child-Pugh B) or Severe (Child-Pugh C) |
Pediatric < 0.55 m2 | 200 mg | 150 mg | 100 mg | 100 mg |
Pediatric 0.55 to < 0.63 m2 | 250 mg | 200 mg | 150 mg | 100 mg |
Pediatric 0.63 to < 0.75 m2 | 300 mg | 200 mg | 200 mg | 150 mg |
Pediatric 0.75 to < 0.9 m2 | 350 mg | 250 mg | 200 mg | 150 mg |
Pediatric 0.9 to < 1.1 m2 | 400 mg | 300 mg | 250 mg | 200 mg |
Pediatric ≥ 1.1 m2 | 500 mg | 400 mg | 300 mg | 200 mg |
The recommended dosage is taken orally once daily with food. Swallow tablets whole. Do not cut, crush, break or chew tablets. Continue treatment with BOSULIF until disease progression or intolerance to therapy.
Capsules may be swallowed whole. For patients who are unable to swallow a whole capsule(s), each capsule can be opened and the contents mixed with applesauce or yogurt. Mixing the capsule contents with applesauce or yogurt cannot be considered a substitute of a proper meal.
If a dose is missed beyond 12 hours, the patient should skip the dose and take the usual prescribed dose on the following day.
Dosage in Adult Patients with Newly-Diagnosed CP Ph+ CML
The recommended dosage of BOSULIF is 400 mg orally once daily with food.
Dosage in Adult Patients with CP, AP, or BP Ph+ CML with Resistance or Intolerance to Prior Therapy
The recommended dosage of BOSULIF is 500 mg orally once daily with food.
Dosage in Pediatric Patients with Newly-Diagnosed CP Ph+ CML or with CP Ph+ CML with Resistance or Intolerance to Prior Therapy
The recommended dose of BOSULIF for pediatric patients with newly-diagnosed CP Ph+ CML is 300 mg/m2 orally once daily with food and the recommended dosage for pediatric patients with CP Ph+ CML that is resistant or intolerant to prior therapy is 400 mg/m2 orally once daily with food and dose recommendations are provided in Table 1. As appropriate, the desired dose can be attained by combining different strengths of BOSULIF tablets or capsules.
BSA* | Newly-Diagnosed Recommended Dose (Once Daily) | Resistant or Intolerant Recommended Dose (Once Daily) |
< 0.55 m2 | 150 mg | 200 mg |
0.55 to < 0.63 m2 | 200 mg | 250 mg |
0.63 to < 0.75 m2 | 200 mg | 300 mg |
0.75 to < 0.9 m2 | 250 mg | 350 mg |
0.9 to < 1.1 m2 | 300 mg | 400 mg |
≥ 1.1 m2 | 400 mg† | 500 mg† |
Preparation Instructions for BOSULIF Capsules Mixed with Applesauce or Yogurt
For patients who are unable to swallow capsules, the contents of the capsules can be mixed with applesauce or yogurt. Remove the required number of capsules from the container to prepare the dose as instructed and the amount of either room temperature applesauce or yogurt in a clean container. Carefully open each capsule, add the entire capsule content of each capsule into the applesauce or yogurt, then mix the entire dose into the applesauce or yogurt. Patients should immediately consume the full mixture in its entirety, without chewing. Do not store the mixture for later use. If the entire preparation is not swallowed do not take an additional dose. Wait until the next day to resume dosing.
Dose | Volume of Applesauce or Yogurt |
100 mg | 10 mL (2 teaspoons) |
150 mg | 15 mL (3 teaspoons) |
200 mg | 20 mL (4 teaspoons) |
250 mg | 25 mL (5 teaspoons) |
300 mg | 30 mL (6 teaspoons) |
350 mg | 30 mL (6 teaspoons) |
400 mg | 35 mL (7 teaspoons) |
450 mg | 40 mL (8 teaspoons) |
500 mg | 45 mL (9 teaspoons) |
550 mg | 45 mL (9 teaspoons) |
600 mg | 50 mL (10 teaspoons) |
In clinical studies of adult patients with Ph+ CML, dose escalation by increments of 100 mg once daily to a maximum of 600 mg once daily was allowed in patients who did not achieve or maintain a hematologic, cytogenetic, or molecular response and who did not have Grade 3 or higher adverse reactions at the recommended starting dosage.
In pediatric patients with BSA <1.1 m2 and an insufficient response after 3 months consider increasing dose by 50 mg increments up to maximum of 100 mg above starting dose. Dose increases for insufficient response in pediatric patients with BSA ≥1.1 m2 can be conducted similarly to adult recommendations in 100 mg increments.
The maximum dose in pediatric and adult patients is 600 mg once daily.
Elevated liver transaminases: If elevations in liver transaminases greater than 5×institutional upper limit of normal (ULN) occur, withhold BOSULIF until recovery to less than or equal to 2.5×ULN and resume at 400 mg once daily thereafter. If recovery takes longer than 4 weeks, discontinue BOSULIF. If transaminase elevations greater than or equal to 3×ULN occur concurrently with bilirubin elevations greater than 2×ULN and alkaline phosphatase less than 2×ULN (Hy's law case definition), discontinue BOSULIF [see Warnings and Precautions (5.3)].
Diarrhea: For National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Grade 3–4 diarrhea (increase of greater than or equal to 7 stools/day over baseline/pretreatment), withhold BOSULIF until recovery to Grade less than or equal to 1. BOSULIF may be resumed at 400 mg once daily [see Warnings and Precautions (5.1)].
For other clinically significant, moderate or severe non-hematological toxicity, withhold BOSULIF until the toxicity has resolved, then consider resuming BOSULIF at a dose reduced by 100 mg taken once daily. If clinically appropriate, consider re-escalating the dose of BOSULIF to the starting dose taken once daily.
In pediatric patients, dose adjustments for non-hematologic toxicities can be conducted similarly to adults, however the dose reduction increments may differ. For pediatric patients with BSA <1.1 m2, reduce dose by 50 mg initially followed by additional 50 mg increment if the adverse reaction (AR) persists. For pediatric patients with BSA ≥1.1 m2 or greater, reduce dose similarly to adults.
Dose reductions for severe or persistent neutropenia and thrombocytopenia are described below (Table 3).
| |
ANC* less than 1000×106/L or Platelets less than 50,000×106/L | Withhold BOSULIF until ANC greater than or equal to1000×106/L and platelets greater than or equal to 50,000×106/L.
|
The recommended starting doses for patients with renal and hepatic impairment are described in Table 4 below.
| Recommended Starting Dosage | |||
|---|---|---|---|
| [see Use in Specific Populations (8.6, 8.7) and Clinical Pharmacology (12.3)]. | |||
| Newly-diagnosed chronic phase Ph+ CML | Chronic, accelerated, or blast phase Ph+ CML with resistance or intolerance to prior therapy | |
Normal renal and hepatic function | 400 mg daily | 500 mg daily | |
Renal impairment | |||
| Creatinine clearance 30 to 50 mL/min | 300 mg daily | 400 mg daily |
| Creatinine clearance less than 30 mL/min | 200 mg daily | 300 mg daily |
Hepatic impairment | |||
| Mild (Child-Pugh A), Moderate (Child-Pugh B) or Severe (Child-Pugh C) | 200 mg daily | 200 mg daily |
| [see Use in Specific Populations (8.6, 8.7) and Clinical Pharmacology (12.3)]. | ||||
| ||||
| Newly-Diagnosed CP Ph+ CML Recommended Starting Dose (Once Daily) By Organ Function | |||
Pediatric Patients by Separated BSA* Band | Normal renal and hepatic function | Renal Impairment: Creatinine clearance 30 to 50 mL/min | Renal Impairment: Creatinine clearance less than 30 mL/min | Hepatic Impairment: Mild (Child-Pugh A), Moderate (Child-Pugh B) or Severe (Child-Pugh C) |
Pediatric < 0.55 m2 | 150 mg | 100 mg | 100 mg | 100 mg |
Pediatric 0.55 to < 0.63 m2 | 200 mg | 150 mg | 100 mg | 100 mg |
Pediatric 0.63 to < 0.75 m2 | 200 mg | 150 mg | 100 mg | 100 mg |
Pediatric 0.75 to < 0.9 m2 | 250 mg | 200 mg | 150 mg | 100 mg |
Pediatric 0.9 to < 1.1 m2 | 300 mg | 200 mg | 200 mg | 150 mg |
Pediatric ≥ 1.1 m2 | 400 mg | 300 mg | 200 mg | 200 mg |
| CP Ph+ CML with Resistance or Intolerance to Prior Therapy Recommended Starting Dose (Once Daily) By Organ Function | |||
Pediatric Patients by Separated BSA* Band | Normal renal and hepatic function | Renal Impairment: Creatinine clearance 30 to 50 mL/min | Renal Impairment: Creatinine clearance less than 30 mL/min | Hepatic Impairment: Mild (Child-Pugh A), Moderate (Child-Pugh B) or Severe (Child-Pugh C) |
Pediatric < 0.55 m2 | 200 mg | 150 mg | 100 mg | 100 mg |
Pediatric 0.55 to < 0.63 m2 | 250 mg | 200 mg | 150 mg | 100 mg |
Pediatric 0.63 to < 0.75 m2 | 300 mg | 200 mg | 200 mg | 150 mg |
Pediatric 0.75 to < 0.9 m2 | 350 mg | 250 mg | 200 mg | 150 mg |
Pediatric 0.9 to < 1.1 m2 | 400 mg | 300 mg | 250 mg | 200 mg |
Pediatric ≥ 1.1 m2 | 500 mg | 400 mg | 300 mg | 200 mg |
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