Promacta Generic Name & Formulations
Legal Class
General Description
Pharmacological Class
See Also
How Supplied
Manufacturer
Generic Availability
Promacta Indications
Indications
Limitations of Use
Promacta Dosage and Administration
Adult
Children
Hepatic Impairment
Patients With Persistent or Chronic ITP and Severe Aplastic Anemia
-
Reduce the initial dose of Promacta in patients with persistent or chronic ITP (patients aged ≥6 years) or refractory severe aplastic anemia who also have hpeatic impairment (see Adults and Children Dosage).
-
Reduce the initial dose of Promacta in patients with hepatic impairment who initiates Promacta for the first-lnie treatment of severe aplastic anemia.
Patients With Chronic Hepatitis C
-
No dosage adjustment is recommended in patients with chronic hepatitis C and hepatic impairment.
Other Modifications
Females and Males of Reproductive Potential
-
Contraception: Advise sexually-active females of reproductive potential to use effective contraception (methods that result in <1% pregnancy rates) during and for at least 7 days after stopping treatment.
Ethnicity
-
For patients of East-/Southeast-Asian ancestry with ITP (adult and pediatric patients 6 years and older only) or severe aplastic anemia: reduce the initial dose.
Promacta Contraindications
Not Applicable
Promacta Boxed Warnings
Boxed Warning
Promacta Warnings/Precautions
Warnings/Precautions
Promacta Pharmacokinetics
Absorption
Eltrombopag is absorbed with a peak concentration occurring 2 to 6 hours after oral administration. Oral absorption of drug-related material following administration of a single 75-mg solution dose was estimated to be at least 52%.
A standard high-fat breakfast (876 calories, 52 g fat, 71 g carbohydrate, 34 g protein, and 427 mg calcium) significantly decreased plasma eltrombopag AUC0-INF by ~59% and Cmax by 65% and delayed Tmax by 1 hour. The decrease in exposure is primarily due to the high calcium content. A meal low in calcium (≤ 50 mg calcium) did not significantly impact plasma eltrombopag exposure, regardless of calorie and fat content.
Distribution
In vitro studies suggest that eltrombopag is highly bound to human plasma proteins (>99%).
Elimination
The plasma elimination half-life of eltrombopag is ~21 to 32 hours in healthy subjects and 26 to 35 hours in patients with ITP.
The predominant route of eltrombopag excretion is via feces (59%), and 31% of the dose is found in the urine. Unchanged eltrombopag in feces accounts for ~20% of the dose; unchanged eltrombopag is not detectable in urine.
Promacta Interactions
Interactions
Promacta Adverse Reactions
Adverse Reactions
Promacta Clinical Trials
Promacta Note
Not Applicable
Promacta Patient Counseling
Promacta Generic Name & Formulations
Legal Class
General Description
Pharmacological Class
See Also
How Supplied
Manufacturer
Generic Availability
Promacta Indications
Indications
Limitations of Use
Promacta Dosage and Administration
Adults and Children
Hepatic Impairment
Patients With Persistent or Chronic ITP and Severe Aplastic Anemia
-
Reduce the initial dose of Promacta in patients with persistent or chronic ITP (patients aged ≥6 years) or refractory severe aplastic anemia who also have hpeatic impairment (see Adults and Children Dosage).
-
Reduce the initial dose of Promacta in patients with hepatic impairment who initiates Promacta for the first-lnie treatment of severe aplastic anemia.
Patients With Chronic Hepatitis C
-
No dosage adjustment is recommended in patients with chronic hepatitis C and hepatic impairment.
Other Modifications
Females and Males of Reproductive Potential
-
Contraception: Advise sexually-active females of reproductive potential to use effective contraception (methods that result in <1% pregnancy rates) during and for at least 7 days after stopping treatment.
Ethnicity
-
For patients of East-/Southeast-Asian ancestry with ITP (adult and pediatric patients 6 years and older only) or severe aplastic anemia: reduce the initial dose.
Promacta Contraindications
Not Applicable
Promacta Boxed Warnings
Boxed Warning
Promacta Warnings/Precautions
Warnings/Precautions
Promacta Pharmacokinetics
Absorption
Eltrombopag is absorbed with a peak concentration occurring 2 to 6 hours after oral administration. Oral absorption of drug-related material following administration of a single 75-mg solution dose was estimated to be at least 52%.
A standard high-fat breakfast (876 calories, 52 g fat, 71 g carbohydrate, 34 g protein, and 427 mg calcium) significantly decreased plasma eltrombopag AUC0-INF by ~59% and Cmax by 65% and delayed Tmax by 1 hour. The decrease in exposure is primarily due to the high calcium content. A meal low in calcium (≤ 50 mg calcium) did not significantly impact plasma eltrombopag exposure, regardless of calorie and fat content.
Distribution
In vitro studies suggest that eltrombopag is highly bound to human plasma proteins (>99%).
Elimination
The plasma elimination half-life of eltrombopag is ~21 to 32 hours in healthy subjects and 26 to 35 hours in patients with ITP.
The predominant route of eltrombopag excretion is via feces (59%), and 31% of the dose is found in the urine. Unchanged eltrombopag in feces accounts for ~20% of the dose; unchanged eltrombopag is not detectable in urine.
Promacta Interactions
Interactions
Promacta Adverse Reactions
Adverse Reactions
Promacta Clinical Trials
Promacta Note
Not Applicable
Promacta Patient Counseling
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