400 mg given orally per day for chronic phase
600 mg given orally per day for accelerated phase or blast crisis
An increased dose is given to patients if there is no severe adverse drug reaction or severe non-leukemia as in the below areas:
the disease progression fails to reach satisfactory hematologic response after at least three months of treatment, failure to achieve a cytogenetic response after 6-12 months of treatment or loss of a previously completed hematologic or cytogenetic response
600 mg orally once a day for disease progression chronic phase
400 mg orally two times a day for disease progression accelerated phase or blast crisis
continue the treatment until there is no progressive disease or unacceptable toxicity occurs
ponatinib is indicated to treat chronic myeloid leukemia
A dose of 45 mg, four times daily, is administered four times daily
The medication is continued until the disease is reduced to acceptable toxicity
Discontinue treatment if the response doesn’t occur after three months
Induction: 1.25 mg/m2 Subcutaneous twice a day for 2 weeks every 28 days; continue every 28 days till the hematologic response is achieved. maintenance: 1.25 mg/m2 Subcutaneous twice a day for 1 week every 28 days; continue for as long as clinically necessary
Dose Adjustments
Dosing Modifications
Nonhematologic toxicity should be managed symptomatically; therapy may be interrupted and/or delayed until the toxicity is resolved Thrombocytopenia or neutropenia
For hematologic toxicities (e.g., thrombocytopenia, neutropenia), dosage cycles can be delayed or the total number of days throughout the cycle reduced
Grade 3 thrombocytopenia (platelets below 50 x 109/L) or grade 4 neutropenia (AND below 0.5 x 109/L) Delay initiating the next cycle till the ANC and platelet counts are above 1 and 50 x 109/L, respectively
Reduce the number of dosage days by two days for the next cycle (for example 12 or 5 days)
Indicated for Chronic Myeloid Leukemia
Patients with the T3151 mutation:
200 mg orally two times a day
Continue until unacceptable toxicity or the disease progression occurs
Prior treated patients: 80 mg orally every day
Or
40 mg orally two times a day
Continue until unacceptable toxicity or the disease progression occurs
Dose modifications
For adverse reactions, dose reductions:
1st dose diminishment
Prior treated Ph+ CP-CML: 40 mg orally every day
Or
20 mg orally two times a day
Ph+ CP-CML with the T3151 mutation: 160 mg orally two times a day
For patients who are unable to tolerate 1st dose diminishment, permanently discontinue
Thrombocytopenia or neutropenia:
Retain until the ANC is more than 1x 109/L or the platelets are more than 50x 109/L
Resolved within 2 weeks: Restart at the starting dose
Resolved >2 weeks: Restart at a decreased dose
If it reoccurs, restain until the ANC is more than 1x 109/L or the platelets are more than 50x 109/L; then restart at a reduced dose
Asymptomatic amylase or lipase elevation
Retain until the <1.5x ULN occurs
If resolved, restart at a decreased dose
If not resolved, discontinue permanently
If it reoccurs at decreased dose, discontinue permanently
Renal impairment
Mild-severe: Dose adjustment not necessary
Hepatic impairment
Mild-severe: Dose adjustment not necessary
A single oral dose of 20 to 30 mg/kg/day. As an alternative, administer 80 mg/kg as a single dose every three days (for solid tumours). Concomitant irradiation treatment: 80 mg/kg as a single dosage given every three days, starting at least 1 week before radiotherapy, is considered
For > 1year children
230 mg per m2 orally 2x a day
and round to the nearest 50 mg dose
the Maximum dose given is 400 mg per dose
Dosing based on body surface area (BSA):
if BSA 0.32 m2: 50 mg orally 2x a day
if BSA 0.33-0.54 m2: 100 mg orally 2x a day
if BSA 0.55-0.76 m2: 150 mg orally 2x a day
if BSA 0.77-0.97 m2: 200 mg orally 2x a day
if BSA 0.98-1.19 m2: 250 mg orally 2x a day
if BSA 1.2-1.41 m2: 300 mg orally 2x a day
if BSA 1.42-1.63 m2: 350 mg orally 2x a day
if BSA 1.64 m2: 400 mg orally 2x a day
Age:>1 year
340 mg per m2 given orally per day or 170 mg per m2 given orally twice a day
The maximum dose given is 600 mg daily
continue the treatment until there is no progressive disease or unacceptable toxicity occurs
Age: <1year
Safety and efficacy not established
400 mg given orally per day for chronic phase
600 mg given orally per day for accelerated phase or blast crisis
An increased dose is given to patients if there is no severe adverse drug reaction or severe non-leukemia as in the below areas:
the disease progression fails to reach satisfactory hematologic response after at least three months of treatment, failure to achieve a cytogenetic response after 6-12 months of treatment or loss of a previously completed hematologic or cytogenetic response
600 mg orally once a day for disease progression chronic phase
400 mg orally two times a day for disease progression accelerated phase or blast crisis
continue the treatment until there is no progressive disease or unacceptable toxicity occurs
ponatinib is indicated to treat chronic myeloid leukemia
A dose of 45 mg, four times daily, is administered four times daily
The medication is continued until the disease is reduced to acceptable toxicity
Discontinue treatment if the response doesn’t occur after three months
Induction: 1.25 mg/m2 Subcutaneous twice a day for 2 weeks every 28 days; continue every 28 days till the hematologic response is achieved. maintenance: 1.25 mg/m2 Subcutaneous twice a day for 1 week every 28 days; continue for as long as clinically necessary
Dose Adjustments
Dosing Modifications
Nonhematologic toxicity should be managed symptomatically; therapy may be interrupted and/or delayed until the toxicity is resolved Thrombocytopenia or neutropenia
For hematologic toxicities (e.g., thrombocytopenia, neutropenia), dosage cycles can be delayed or the total number of days throughout the cycle reduced
Grade 3 thrombocytopenia (platelets below 50 x 109/L) or grade 4 neutropenia (AND below 0.5 x 109/L) Delay initiating the next cycle till the ANC and platelet counts are above 1 and 50 x 109/L, respectively
Reduce the number of dosage days by two days for the next cycle (for example 12 or 5 days)
Indicated for Chronic Myeloid Leukemia
Patients with the T3151 mutation:
200 mg orally two times a day
Continue until unacceptable toxicity or the disease progression occurs
Prior treated patients: 80 mg orally every day
Or
40 mg orally two times a day
Continue until unacceptable toxicity or the disease progression occurs
Dose modifications
For adverse reactions, dose reductions:
1st dose diminishment
Prior treated Ph+ CP-CML: 40 mg orally every day
Or
20 mg orally two times a day
Ph+ CP-CML with the T3151 mutation: 160 mg orally two times a day
For patients who are unable to tolerate 1st dose diminishment, permanently discontinue
Thrombocytopenia or neutropenia:
Retain until the ANC is more than 1x 109/L or the platelets are more than 50x 109/L
Resolved within 2 weeks: Restart at the starting dose
Resolved >2 weeks: Restart at a decreased dose
If it reoccurs, restain until the ANC is more than 1x 109/L or the platelets are more than 50x 109/L; then restart at a reduced dose
Asymptomatic amylase or lipase elevation
Retain until the <1.5x ULN occurs
If resolved, restart at a decreased dose
If not resolved, discontinue permanently
If it reoccurs at decreased dose, discontinue permanently
Renal impairment
Mild-severe: Dose adjustment not necessary
Hepatic impairment
Mild-severe: Dose adjustment not necessary
A single oral dose of 20 to 30 mg/kg/day. As an alternative, administer 80 mg/kg as a single dose every three days (for solid tumours). Concomitant irradiation treatment: 80 mg/kg as a single dosage given every three days, starting at least 1 week before radiotherapy, is considered
For > 1year children
230 mg per m2 orally 2x a day
and round to the nearest 50 mg dose
the Maximum dose given is 400 mg per dose
Dosing based on body surface area (BSA):
if BSA 0.32 m2: 50 mg orally 2x a day
if BSA 0.33-0.54 m2: 100 mg orally 2x a day
if BSA 0.55-0.76 m2: 150 mg orally 2x a day
if BSA 0.77-0.97 m2: 200 mg orally 2x a day
if BSA 0.98-1.19 m2: 250 mg orally 2x a day
if BSA 1.2-1.41 m2: 300 mg orally 2x a day
if BSA 1.42-1.63 m2: 350 mg orally 2x a day
if BSA 1.64 m2: 400 mg orally 2x a day
Age:>1 year
340 mg per m2 given orally per day or 170 mg per m2 given orally twice a day
The maximum dose given is 600 mg daily
continue the treatment until there is no progressive disease or unacceptable toxicity occurs
Age: <1year
Safety and efficacy not established
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