What are Enasidenib warning

 Warnings

Differentiation syndrome

• In the clinical trial, 14% of patients treated with enasidenib experienced symptoms of differentiation syndrome, which can be fatal if not treated
• Symptoms may include fever, dyspnea, acute respiratory distress, pulmonary infiltrates, pleural or pericardial effusions, rapid weight gain or peripheral edema, lymphadenopathy, bone pain, and hepatic, renal, or multiorgan dysfunction
• Differentiation syndrome has been observed with and without concomitant hyperleukocytosis, as early as 1 day and at up to 5 months after initiating enasidenib
• If differentiation syndrome is suspected, initiate corticosteroid therapy and hemodynamic monitoring until symptom resolution
• Taper corticosteroids only after resolution of symptoms; differentiation syndrome symptoms may recur with premature discontinuation of corticosteroids
• If severe pulmonary symptoms requiring intubation or ventilator support and/or renal dysfunction persist for >48 hr after initiation of corticosteroids, interrupt enasidenib until signs and symptoms are no longer severe
• Hospitalization for close observation and monitoring of patients with pulmonary and/or renal manifestation is recommended

Contraindications

None

Cautions

Differentiation syndrome reported, which can be fatal if not treated

Based on animal embryofetal toxicity studies, can cause embryofetal harm when administered to pregnant women. drugs available for pregnant women 

Drug interaction overview

• OATP1B1, OATP1B3, and BCRP substrates

1. Enasidenib is an OATP1B1, OATP1B3, and BCRP inhibitor
2. Coadministration with OATP1B1, OATP1B3, and BCRP substrates will increase effects and toxicities of these substrates
3. Decrease dose of OATP1B1, OATP1B3, and BCRP substrate(s) as recommended in respective prescribing information, and as clinically indicated

• P-gp substrates

1. Enasidenib is a P-gp inhibitor
2. Coadministration with P-gp substrates will increase effects and toxicities of these substrates
3. For a sensitive P-gp substrate may lead to serious adverse reactions, decrease dose or modify dosing frequency of such a P-gp substrate and monitor for adverse reactions as recommended in respective prescribing information

       

IDHIFA (ENASIDENIB)