Mitotane Interactions

Brand names: Lysodren

Cytochrome P450 3A4 Inducers

Route: Oral

FDA Black Box Warning

WARNING: ADRENAL CRISIS IN THE SETTING OF SHOCK, SEVERE TRAUMA OR INFECTION Patients treated with LYSODREN are at increased risk for developing adrenal crisis in the setting of shock, severe trauma or infection that may lead to death. If shock, severe trauma or infection occurs or develops, temporarily discontinue LYSODREN and administer exogenous steroids. Monitor patients closely for infections and instruct patients to contact their physician immediately if injury, infection, or any other concomitant illness occurs [see Dosage and Administration (2.3) and Warnings and Precautions (5.1)]. WARNING: ADRENAL CRISIS IN THE SETTING OF SHOCK, SEVERE TRAUMA OR INFECTION See full prescribing information for complete boxed warning. Patients treated with LYSODREN are at increased risk for developing adrenal crisis in the setting of shock, severe trauma or infection that may lead to death. If shock, severe trauma or infection occurs or develops, temporarily discontinue LYSODREN and administer exogenous steroids. Monitor patients closely for infections and instruct patients to contact their physician immediately if injury, infection, or any other concomitant illness occurs ( 2.3 , 5.1 ).

Contraindications

4 CONTRAINDICATIONS None. None. ( 4 )

Pregnancy & Breastfeeding

8.1 Pregnancy Risk Summary LYSODREN can cause fetal harm. Limited postmarketing cases report preterm births and early pregnancy loss in women treated with LYSODREN during pregnancy. Animal reproduction studies have not been conducted with mitotane. Advise pregnant women of the potential risk to a fetus. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

9 interactions on record

Mitotane + DoravirineContraindicated

Co-administration decreases doravirine plasma concentrations. At least a 4-week cessation period is recommended prior to initiation of PIFELTRO.

Source: NLP:doravirine

Mitotane decreases the levels and efficacy of hormonal contraceptives. Avoid concomitant use.

Source: NLP:mitotane

Mitotane + WarfarinContraindicated

Mitotane induces warfarin metabolism, reducing its level and efficacy. Avoid concomitant use; if unavoidable, monitor INR and adjust dose.

Source: NLP:mitotane

Mitotane is a strong CYP3A inducer that may decrease levels of CYP3A substrates, potentially leading to serious therapeutic failures. Avoid concomitant use or modify substrate dosage.

Source: NLP:mitotane

Strong CYP3A4 inducer may reduce plasma macimorelin concentrations and lead to false positive test results. Discontinue prior to use.

Source: NLP:macimorelin acetate

May increase serum thyroxine-binding globulin concentration, resulting in initial transient increase in FT4 followed by decreased serum T4.

Source: NLP:levothyroxine sodium

May increase serum thyroxine-binding globulin concentration, altering T3 serum transport. Closely monitor thyroid hormone parameters.

Source: NLP:liothyronine sodium