ORSERDU (elacestrant hcl)

There are 3 contraindications. Absolute contraindication.

Contraindication List
Child-pugh class C hepatic impairment
Lactation
Severe hepatic disease

There are 2 severe contraindications. Adequate patient monitoring is recommended for safer drug use.

Severe List
Child-pugh class B hepatic impairment
Pregnancy

There are 2 moderate contraindications. Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.

Moderate List
Hypercholesterolemia
Hypertriglyceridemia

There are 2 severe adverse reactions.

More Frequent	Less Frequent
Increased alanine transaminase Increased aspartate transaminase	None.

Rare/Very Rare
None.

There are 21 less severe adverse reactions.

More Frequent	Less Frequent
Acute abdominal pain Anemia Anorexia Constipation Diarrhea Drug-induced hot flash Dyspepsia Fatigue Headache disorder Hypercholesterolemia Hypertriglyceridemia Hyponatremia Musculoskeletal pain Nausea Vomiting	Cough Dizziness Dyspnea Gastroesophageal reflux disease Insomnia Skin rash

Rare/Very Rare
None.

Elacestrant use during pregnancy can cause fetal harm based on findings in an animal study and the mechanism of action of the drug. Human data on elacestrant use during pregnancy are not available to determine the drug-associated risk. Administration of oral elacestrant to pregnant rats during the period of organogenesis resulted in structural abnormalities and embryofetal death at maternal exposures below the recommended dose based on AUC.

Maternal toxicity (reduced weight gain, low food consumption, red vulvar discharge) was also observed in rats. Verify pregnancy status in females of reproductive potential prior to initiating elacestrant. Apprise patients of the potential hazard to the fetus if elacestrant is used during pregnancy.

It is unknown whether elacestrant distributes into human milk, or affects milk production or the breast-fed infant. Because of the potential for serious adverse reactions in breast-fed infants, advise women to not breast-feed during treatment with elacestrant and for 1 week after the last dose.

In the EMERALD trial, 43 and 17% of patients were >=65 and >=75 years of age. There were no overall differences in the safety or efficacy of elacestrant between patients >=65 years and younger adults. There was an insufficient number of patients >=75 years of age to assess age-related differences in safety or efficacy. No clinically important differences in elacestrant pharmacokinetics were observed based on age (range 24-89 years).