A Milestone Moment: FDA Approves Addyi® for Hypoactive Sexual Desire Disorder in Postmenopausal Women
December 17, 2025
Brand Name :
rezlidhia
Synonyms :
olutasidenib
Class :
Anti-neoplastic, Isocitrate dehydrogenase 1
Dosage Forms & Strengths
Capsule
150mg
150
mg
Capsules
Orally
twice a day
until the disease progresses
Dose Adjustments
Differentiation syndrome
Withhold REZLIDHIA if differentiation syndrome is suspected until signs and symptoms become improved
Systemic corticosteroids should be given; hemodynamic monitoring should start and continue for at least three days after symptom remission
Restart REZLIDHIA at 150 mg twice daily once the differentiation syndrome has subsided.
may diminish the serum concentration of CYP3A4 Inducers
may diminish the serum concentration of CYP3A4 substrates
it may decrease by affecting the hepatic enzyme CYP3A4 metabolism
it decreases by affecting the hepatic enzyme CYP3A4 metabolism
it decreases by affecting the hepatic enzyme CYP3A4 metabolism
it decreases by affecting the hepatic enzyme CYP3A4 metabolism
it decreases by affecting the hepatic enzyme CYP3A4 metabolism
it decreases by affecting the hepatic enzyme CYP3A4 metabolism
it decreases by affecting the hepatic enzyme CYP3A4 metabolism
it decreases by affecting the hepatic enzyme CYP3A4 metabolism
it decreases by affecting the hepatic enzyme CYP3A4 metabolism
it decreases by affecting the hepatic enzyme CYP3A4 metabolism
it decreases by affecting the hepatic enzyme CYP3A4 metabolism
it decreases by affecting the hepatic enzyme CYP3A4 metabolism
it decreases by affecting the hepatic enzyme CYP3A4 metabolism
it decreases by affecting the hepatic enzyme CYP3A4 metabolism
it decreases by affecting the hepatic enzyme CYP3A4 metabolism
olutasidenib: they may diminish the serum concentration of CYP3A4 Inducers
olutasidenib: they may diminish the serum concentration of CYP3A4 Inducers
olutasidenib: they may diminish the serum concentration of CYP3A4 Inducers
olutasidenib: they may diminish the serum concentration of CYP3A4 Inducers
olutasidenib: they may diminish the serum concentration of CYP3A4 Inducers
it may enhance the metabolism when combined with aripiprazole lauroxil
Frequency defined:
>10%
All grades
ALT decreased
Sodium decreased
Creatinine decreased
Arthralgia
Bilirubin increased
Pyrexia
Rash
Diarrhea
Edema
Vomiting
Decreased appetite
Leukocytosis
Abdominal pain
Mucositis
Increased uric acid
Cough
Grades 3 and 4
ALT increased
1-10%
All grades
Grades 3 and 4
Potassium decreased
Lipase increased
Hypertension
Edema
Arthralgia
Creatinine decreased
Differentiation syndrome
Diarrhea
Sodium decreased
Abdominal pain
Cough
Uric acid increased
Pyrexia
rash
Pregnancy consideration: Not recommended as it may cause fetal harm
Lactation: Excretion of the drug in human breast milk is unknown
Pregnancy category:
Category A: well-controlled and Satisfactory studies show no risk to the fetus in the first or later trimester.
Category B: there was no evidence of risk to the fetus in animal studies, and there were not enough studies on pregnant women.
Category C: there was evidence of risk of adverse effects in animal reproduction studies, and no adequate evidence in human studies must take care of potential risks in pregnant women.
Category D: adequate data available with sufficient evidence of human fetal risk from various platforms, but despite the potential risk, and used only in emergency cases for potential benefits.
Category X: Drugs listed in this category outweigh the risks over benefits. Hence these categories of drugs need to be avoided by pregnant women.
Category N: There is no data available for the drug under this category
Patient information leaflet
Generic Name: olutasidenib
Pronounced: olu-ta-si-dee-neeb
Why do we use olutasidenib?
It is an isocitrate dehydrogenase-1 (IDH1) inhibitor prescribed for the treatment of patients with relapsed or resistant acute myeloid leukemia (AML)