In patients with ER+, HER2−, ESR1m MBC who are post AI1
Oral Inluriyo fits into your patients’ lives1a,b
400 mg
Two 200-mg tablets
One oral dose
Instruct patients to take Inluriyo:
- On an empty stomach
- At least 2 hours before food or 1 hour after food
- At approximately the same time daily
- By swallowing tablets whole
One dose, once daily: extend their time on oral ET with Inluriyo.
Image depicting the Inluriyo dosing regimen: one 400 mg oral dose (two 200- mg tablets). Instruct patients to take Inluriyo: on an empty stomach, at least 2 hours before food or 1 hour after food, at approximately the same time daily, and by swallowing tablets whole. One dose, once daily: extend their time on oral ET with Inluriyo
The recommended dosage of Inluriyo is 400 mg orally once daily until disease progression or unacceptable toxicity.
a Pre/perimenopausal women and men treated with Inluriyo should be treated with gonadotropin-releasing hormone agonist (GnRH) according to clinical practice standards.1
b If patient misses a dose by 6 or more hours or vomits, instruct the patient to take the next dose the following day at its scheduled time.1
Recommended Inluriyo dose modifications for adverse reactions (except hepatotoxicity)1
| Grade | Inluriyo Dosage Modifications |
|---|---|
| Persistent or recurrent Grade 2 that does not resolve with maximal supportive measures within 7 days to baseline or Grade 1 | Suspend until toxicity resolves to baseline or ≤Grade 1. Resume Inluriyo at the same dose level. |
| Grade 3 or 4 (except nonhepatic asymptomatic laboratory changes) | Suspend until toxicity resolves to baseline or ≤Grade 1. Resume Inluriyo at next lower dose level. |
Table depicting recommended Inluriyo dose modification guidelines for adverse reactions (except hepatotoxicity) according to grade. In the event of persistent or recurrent Grade 2 adverse reactions that do not resolve with maximal supportive measures within 7 days to baseline or Grade 1: suspend until toxicity resolves to baseline or is less than or equal to Grade 1; then resume Inluriyo at the same dose level. In the event of Grade 3 or 4 adverse reactions (except nonhepatic asymptomatic laboratory changes): suspend until toxicity resolves to baseline or is less than or equal to Grade 1; then resume Inluriyo at the next lower dose level.
If dose reduction is necessary, decrease the dose by 200 mg. Discontinue Inluriyo for patients unable to tolerate 200 mg once daily.1
Recommended Inluriyo dosage modifications for hepatotoxicity1
Monitor alanine aminotransferase (ALT)/aspartate aminotransferase (AST) during Inluriyo therapy as clinically indicated.
| Liver Transaminase | Inluriyo Dose Modifications |
|---|---|
| Persistant or recurrent AST/ALT >3.0-5.0 x ULN | Suspend until toxicity resolves to baseline or to >ULN-3.0 x ULN. Resume Inluriyo at the same dose level. |
| If AST/ALT at baseline is within the normal range: AST/ALT >5.0-20 x ULN or If AST/ALT at baseline is above ULN: AST/ALT ≥3 x baseline (if AST/ALT ≥1.5 x ULN at baseline) or AST/ALT >8 x ULN (whichever is the lower threshold) | Suspend until toxicity resolves to baseline or to >ULN-3.0 x ULN. Resume Inluriyo at next lower dose level or discontinue if receiving 200 mg daily. |
| AST/ALT >20.0 x ULN OR AST/ALT ≥3 x ULN concurrent with TBL ≥2 x ULN (if AST/ALT <1.5 x ULN at baseline), in the absence of cholestasis OR AST/ALT ≥2 x baseline concurrent with TBL ≥2 x ULN (if AST/ALT ≥1.5 x ULN at baseline), in the absence of cholestasis | Discontinue Inluriyo. |
Table depicting recommended Inluriyo dosage modification guidelines for hepatotoxicity according to liver transaminase level. Monitor alanine aminotransferase (ALT)/aspartate aminotransferase (AST) during imlunestrant therapy as clinically indicated. In the event of persistent or recurrent aspartate aminotransferase (AST) or alanine aminotransferase (ALT) greater than 3.0 to 5.0 × the upper limit of normal (ULN): suspend until toxicity resolves to baseline or is greater than ULN to 3.0 × ULN; then resume Inluriyo at the same dose level. If AST or ALT at baseline is within the normal range—AST or ALT is greater than 5.0 to 20 × ULN, or if AST or ALT at baseline is above ULN—AST or ALT is greater than or equal to 3 × baseline (if AST or ALT is greater than or equal to 1.5 × ULN at baseline), or AST or ALT is greater than 8 × ULN (whichever is the lower threshold): suspend until toxicity resolves to baseline or is greater than ULN to 3.0 × ULN. Resume Inluriyo at next lower dose level or discontinue if receiving 200 mg daily. In the event AST or ALT is greater than 20.0 × ULN, or AST or ALT is greater than or equal to 3 × ULN concurrent with the total bilirubin level (TBL) is greater than or equal to 2 × ULN (if AST or ALT is less than 1.5 × ULN at baseline), in the absence of cholestasis, or AST or ALT is gr eater than or equal to 2 × baseline concurrent with TBL is greater than or equal to 2 × ULN (if AST or ALT is greater than or equal to 1.5 × ULN at baseline), in the absence of cholestasis: discontinue Inluriyo."
Considerations for Inluriyo dosage modification
Dosage in Patients with Hepatic Impairment1
- The recommended dosage of Inluriyo for patients with moderate (Child-Pugh B) or severe (Child-Pugh C) hepatic impairment is 200 mg once daily. Monitor for increased adverse reactions. No dosage modification is recommended for patients with mild hepatic impairment (Child-Pugh A)
Dosage Modifications for Drug Interactions1
- Strong CYP3A Inhibitors: Avoid concomitant use with strong CYP3A inhibitors. If concomitant use cannot be avoided, decrease the Inluriyo dosage to 200 mg once daily
- Strong CYP3A Inducers: Avoid concomitant use with strong CYP3A inducers. If concomitant use cannot be avoided, increase the Inluriyo dosage to 600 mg once daily
ALT=alanine aminotransferase; AST=aspartate aminotransferase; CYP3A=cytochrome P450 3A; ER+=estrogen receptor-positive; ESR1m=estrogen receptor-1-mutated; HER2–=human epidermal growth factor receptor 2-negative; TBL=total bilirubin level; ULN=upper limit of normal.
Reference:
- Inluriyo. Prescribing Information. Lilly USA, LLC.