Gavreto Generic Name & Formulations
Legal Class
General Description
Pharmacological Class
How Supplied
Manufacturer
Generic Availability
Mechanism of Action
Gavreto Indications
Indications
Advanced or metastatic RET fusion-positive thyroid cancer in patients who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate).
Gavreto Dosage and Administration
Adult
Confirm presence of a RET gene fusion. Take on an empty stomach. ≥12yrs: 400mg once daily. Continue until disease progression or until unacceptable toxicity. Dose modifications for adverse reactions, use with CYP3A and/or P-gp inhibitors, or with CYP3A inducers: see full labeling.
Children
Gavreto Contraindications
Not Applicable
Gavreto Boxed Warnings
Not Applicable
Gavreto Warnings/Precautions
Warnings/Precautions
Gavreto Pharmacokinetics
Absorption
Median time to peak concentration ranged from 2–4 hours.–
Distribution
Mean apparent volume of distribution: 303 L. Plasma protein bound: 97.1%. Blood-to-plasma ratio: 0.6–0.7.
Elimination
Fecal (73%), renal (6%). Half-life: 15.7 hours.
Gavreto Interactions
Interactions
Potentiated by strong or moderate CYP3A inhibitors and/or P-gp inhibitors. Avoid concomitant strong or moderate CYP3A and/or P-gp inhibitors; if unavoidable, reduce Gavreto dose. Antagonized by strong or moderate CYP3A inducers; avoid concomitant use; if unavoidable, increase Gavreto dose. May antagonist hormonal contraceptives.
Gavreto Adverse Reactions
Adverse Reactions
Gavreto Clinical Trials
See Literature
Gavreto Note
Not Applicable
Gavreto Patient Counseling
See Literature
Gavreto Generic Name & Formulations
Legal Class
General Description
Pharmacological Class
How Supplied
Manufacturer
Generic Availability
Mechanism of Action
Gavreto Indications
Indications
Gavreto Dosage and Administration
Adult
Confirm presence of a RET gene fusion. Take on an empty stomach. 400mg once daily. Continue until disease progression or until unacceptable toxicity. Dose modifications for adverse reactions, use with CYP3A and/or P-gp inhibitors, or with CYP3A inducers: see full labeling.
Children
Gavreto Contraindications
Not Applicable
Gavreto Boxed Warnings
Not Applicable
Gavreto Warnings/Precautions
Warnings/Precautions
Gavreto Pharmacokinetics
Absorption
Median time to peak concentration ranged from 2–4 hours.–
Distribution
Mean apparent volume of distribution: 303 L. Plasma protein bound: 97.1%. Blood-to-plasma ratio: 0.6–0.7.
Elimination
Fecal (73%), renal (6%). Half-life: 15.7 hours.
Gavreto Interactions
Interactions
Potentiated by strong or moderate CYP3A inhibitors and/or P-gp inhibitors. Avoid concomitant strong or moderate CYP3A and/or P-gp inhibitors; if unavoidable, reduce Gavreto dose. Antagonized by strong or moderate CYP3A inducers; avoid concomitant use; if unavoidable, increase Gavreto dose. May antagonist hormonal contraceptives.
Gavreto Adverse Reactions
Adverse Reactions
Gavreto Clinical Trials
See Literature
Gavreto Note
Not Applicable
Gavreto Patient Counseling
See Literature
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