Dosing | Inluriyo® (imlunestrant) + Verzenio® (abemaciclib)

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Dosing and administration instructions^1,2

Inluriyo + Verzenio Dosing Schedule — Image depicting dosing information for Inluriyo and Verzenio: The dosing schedule for Inluriyo is 400 mg once daily: 2 tablets per dose. The dosing schedule for Verzenio is 150 mg twice daily: 1 tablet per dose.
Administration instructions: Inluriyo should be taken on an empty stomach (at least 2 hours before or 1 hour after food), and may be taken at the same time as Verzenio. If taken separately, Verzenio can be taken with or without food. Take the tablets at approximately the same time daily.
If patients miss a dose of Inluriyo by ≥6 hours or vomit when taking Inluriyo: instruct them to take the next dose the next day at its scheduled time. If patients miss a dose of Verzenio or vomit when taking Verzenio: instruct them to take the next dose at its scheduled time. Instruct patients to swallow Inluriyo and Verzenio tablets whole. Patients should not ingest split, crushed, chewed, or otherwise not intact tablets. Instruct patients to avoid grapefruit products when taking Verzenio.

AI=aromatase inhibitor; ER+=estrogen-receptor-positive; ESR1m=estrogen receptor-1-mutated; HER2–=human epidermal growth factor receptor 2-negative; MBC=metastatic breast cancer.

Recommended Inluriyo dosage 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	Withhold until toxicity resolves to baseline or ≤ Grade 1. Resume Inluriyo at the same dose.
Grade 3 or 4 (except nonhepatic asymptomatic laboratory changes)	Withhold until toxicity resolves to baseline or ≤ Grade 1. Resume Inluriyo at next lower dose.

Table depicting recommended Inluriyo dosage 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: withold until toxicity resolves to baseline or is less than or equal to Grade 1; then resume Inluriyo at the same dose. In the event of Grade 3 or 4 adverse reactions (except nonhepatic asymptomatic laboratory changes): withold until toxicity resolves to baseline or is less than or equal to Grade 1; then resume Inluriyo at the next lower dose.

The recommended dosage of Inluriyo is 400 mg orally once daily until disease progression or unacceptable toxicity. If dosage 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 Dosage Modifications
Persistent or recurrent: AST/ALT >3.0 to 5.0 x ULN	Withhold until toxicity resolves to baseline or to >ULN-3.0 x ULN Resume Inluriyo at the same dose.
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)	Withhold until toxicity resolves to baseline or to >ULN-3.0 X ULN Resume Inluriyo at next lower dose 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	Permanently 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 AST or ALT greater than 3.0 to 5.0 x the upper limit of normal (ULN): withold until toxicity resolves to baseline or is greater than ULN to 3.0 x ULN; then resume Inluriyo at the same dose. If AST or ALT at baseline is within the normal range—AST or ALT is greater than 5.0 to 20 x ULN, or if AST or ALT at baseline is above ULN—AST or ALT is greater than or equal to 3 x baseline (if AST or ALT is greater than or equal to 1.5 x ULN at baseline), or AST or ALT is greater than 8 x ULN (whichever is the lower threshold): withhold until toxicity resolves to baseline or is greater than ULN to 3.0 x ULN. Resume Inluriyo at next lower dose or discontinue if receiving 200 mg daily. In the event AST or ALT is greater than 20.0 x ULN, or AST or ALT is greater than or equal to 3 x ULN concurrent with the total bilirubin level (TBL) is greater than or equal to 2 x ULN (if AST or ALT is less than 1.5 x ULN at baseline), in the absence of cholestasis, or AST or ALT is greater than or equal to 2 x baseline concurrent with TBL is greater than or equal to 2 x ULN (if AST or ALT is greater than or equal to 1.5 x ULN at baseline), in the absence of cholestasis: permanently discontinue Inluriyo.

ALT=alanine aminotransferase; AST=aspartate aminotransferase; TBL=total bilirubin level; ULN=upper limit of normal.

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

CYP3A=cytochrome P450 3A.

Verzenio may require dosing modifications for hepatic impairment, diarrhea, hematologic toxicities, hepatotoxicity, ILD/pneumonitis, VTEs, and other toxicities or drug interactions. Dose interruptions or discontinuations are sometimes required.^1,2

See Verzenio dose modifications

ILD=interstitial lung disease; VTE=venous thromboembolism.

Reference:

Inluriyo. Prescribing Information. Lilly USA, LLC.
Verzenio. Prescribing Information. Lilly USA, LLC.

CMAT-31276 09/2026

Indications

Inluriyo^® in combination with Verzenio^® is indicated:

for the treatment of adults with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, estrogen receptor-1 (ESR1)-mutated advanced or metastatic breast cancer, as detected by an FDA-authorized test, with disease progression following at least one line of endocrine therapy^1,2

Inluriyo monotherapy is indicated:

for the treatment of adults with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, estrogen receptor-1 (ESR1)-mutated advanced or metastatic breast cancer, as detected by an FDA-authorized test, with disease progression following at least one line of endocrine therapy¹

IMPORTANT SAFETY INFORMATION FOR INLURIYO® (imlunestrant) AS MONOTHERAPY IN COMBINATION WITH VERZENIO® (abemaciclib)

Diarrhea: Severe diarrhea associated with dehydration and infection occurred in patients treated with Verzenio. Instruct patients at the first sign of loose stools to initiate antidiarrheal therapy, increase oral fluids, and notify their healthcare provider. In EMBER-3, diarrhea occurred in 86% of patients who received Inluriyo in combination with Verzenio; Grade 3 or 4 diarrhea occurred in 9%. Follow specific dose modification and management instructions located in the Prescribing Information for each drug.

Neutropenia: Neutropenia, including febrile neutropenia and fatal neutropenic sepsis, occurred in patients treated with Verzenio. In EMBER-3, neutrophil count decreased in 86% of patients who received Inluriyo in combination with Verzenio; Grade 3 or 4 decreases occurred in 21%. Monitor complete blood counts prior to the start of Verzenio therapy, every 2 weeks for the first 2 months, monthly for the next 2 months, and as clinically indicated. Follow specific dose modification and management instructions located in the Prescribing Information for each drug.

Interstitial Lung Disease (ILD)/Pneumonitis: Severe, life-threatening, or fatal interstitial lung disease (ILD) or pneumonitis can occur in patients treated with Verzenio and other CDK4/6 inhibitors. In EMBER-3, ILD or pneumonitis occurred in 2.9% of patients who received Inluriyo in combination with Verzenio. Monitor for clinical symptoms or radiological changes indicative of ILD/pneumonitis. Permanently discontinue Verzenio in all patients with Grade 3 or 4 ILD or pneumonitis. Follow specific dose modification and management instructions located in the Prescribing Information for each drug.

Hepatotoxicity: Increases in serum transaminase levels have been observed. Perform liver function tests (LFTs) before initiating treatment with Verzenio. Monitor LFTs every 2 weeks for the first 2 months, monthly for the next 2 months, and as clinically indicated with Verzenio. Monitor ALT and AST during treatment with Inluriyo as clinically indicated. In EMBER-3, ALT increase occurred in 33% for all grades (Grade 3 or 4: 5%) and AST increase occurred in 36% for all grades (Grade 3 or 4: 2.5%) of patients who received Inluriyo in combination with Verzenio. Follow specific dose modification and management instructions located in the Prescribing Information for each drug.

Venous Thromboembolism: Deaths due to venous thromboembolism have been reported in patients treated with Verzenio. In EMBER-3, venous thromboembolic events occurred in 4.8% of patients who received Inluriyo in combination with Verzenio. Monitor patients for signs and symptoms of thrombosis and pulmonary embolism and treat as medically appropriate. Follow specific dose modification and management instructions located in the Prescribing Information for each drug.

Embryo-Fetal Toxicity: Inluriyo and Verzenio can cause fetal harm when administered to a pregnant woman. Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Verify pregnancy status in females of reproductive potential prior to initiating treatment. Advise females of reproductive potential to use effective contraception during treatment with Inluriyo in combination with Verzenio and for 3 weeks after the last dose of Verzenio or 1 week after the last dose of Inluriyo, whichever is longer. Advise males with female partners of reproductive potential to use effective contraception during treatment and for 1 week after the last dose of Inluriyo.

For Inluriyo monotherapy, advise females of reproductive potential and males with female partners of reproductive potential to use effective contraception during treatment with Inluriyo and for 1 week after the last dose.

Increased Serum Creatinine Without Affecting Renal Function: Verzenio can increase serum creatinine. These increases were not associated with changes in glomerular function. In EMBER-3, creatinine increase occurred in 36% for all grades (Grade 3 or 4: 1.1%) of patients who received Inluriyo in combination with Verzenio. During Verzenio treatment, use alternative measures that are not based on serum creatinine to assess renal function, such as BUN, cystatin C, or calculated GFR.

Serious and Fatal Adverse Reactions for Inluriyo in Combination with Verzenio: Serious adverse reactions occurred in 21% of patients who received Inluriyo in combination with Verzenio. Serious adverse reactions in >1% of patients who received Inluriyo in combination with Verzenio included pneumonia (2.4%), abdominal pain, and renal failure (each 1.4%). Fatal adverse reactions occurred in 3.8% of patients who received Inluriyo in combination with Verzenio, including pneumonia (1.4%), myocardial infarction, interstitial lung disease, and sepsis (0.5% each).

Most Common Adverse Reactions for Inluriyo in Combination with Verzenio: The most common (≥10%) adverse reactions with Inluriyo in combination with Verzenio, including laboratory abnormalities, were decreased neutrophils, diarrhea, decreased hemoglobin, decreased lymphocytes, nausea, decreased platelets, fatigue, increased triglycerides, infections, increased AST, increased creatinine, increased ALT, vomiting, musculoskeletal pain, abdominal pain, decreased appetite, increased cholesterol, rash, cough, headache, and decreased weight.

Serious and Fatal Adverse Reactions for Inluriyo Monotherapy: Serious adverse reactions occurred in 10% of patients who received Inluriyo. Serious adverse reactions in >1% of patients included pleural effusion (1.2%). Fatal adverse reactions occurred in 1.8% of patients who received Inluriyo, including cardiac arrest, acute myocardial infarction, right ventricular failure, hypovolemic shock, and upper gastrointestinal hemorrhage (each 0.3%).

Most Common Adverse Reactions for Inluriyo Monotherapy: The most common (≥10%) adverse reactions with Inluriyo monotherapy, including laboratory abnormalities were decreased hemoglobin, musculoskeletal pain, decreased calcium, decreased neutrophils, increased AST, fatigue, diarrhea, increased ALT, increased triglycerides, nausea, decreased platelets, constipation, increased cholesterol, and abdominal pain.

Drug Interactions – Inluriyo:

Avoid concomitant use with strong CYP3A inhibitors. If concomitant use cannot be avoided, decrease the Inluriyo dosage. Avoid concomitant use with strong CYP3A inducers. If concomitant use cannot be avoided, increase the Inluriyo dosage. See Prescribing Information for recommended dosage modifications.
Imlunestrant inhibits both P-gp and BCRP. Avoid concomitant use unless otherwise recommended in the Prescribing Information for P-gp or BCRP substrates where minimal concentration changes may lead to serious adverse reactions.

Drug Interactions – Verzenio:

CYP3A Inhibitors: Avoid concomitant use of ketoconazole. Reduce the Verzenio dose with concomitant use of other strong and moderate CYP3A inhibitors. Monitor for adverse reactions and follow the specific dose modification instructions located in the Prescribing Information. Patients should avoid grapefruit products.
CYP3A Inducers: Avoid concomitant use of strong and moderate CYP3A inducers and consider alternative agents.

Lactation: Because of the potential for serious adverse reactions in the breastfed child, advise lactating women to not breastfeed during treatment with Inluriyo in combination with Verzenio and for 3 weeks after the last dose of Verzenio or 1 week after the last dose of Inluriyo, whichever is longer.

For Inluriyo monotherapy, advise lactating women to not breastfeed during treatment with Inluriyo and for 1 week after the last dose.

Hepatic Impairment: With Inluriyo, reduce the dose in patients with moderate or severe hepatic impairment. The recommended dosage for patients with moderate (Child-Pugh B) or severe (Child-Pugh C) hepatic impairment is 200 mg once daily. No dosage modification is recommended for patients with mild hepatic impairment (Child-Pugh A).

With Verzenio, reduce the dosing frequency to once daily in patients with severe hepatic impairment (Child-Pugh C). No dosage adjustments are necessary in patients with mild or moderate hepatic impairment (Child-Pugh A or B).

Infertility: Inluriyo may impair fertility in females and males of reproductive potential.

Verzenio may impair fertility in males of reproductive potential.

Inluriyo (imlunestrant) is available as 200 mg tablets.

Verzenio (abemaciclib) is available as 50 mg, 100 mg, 150 mg, and 200 mg tablets.

Please click to access Prescribing Information Inluriyo and Verzenio.

IN VZ HCP ISI Combo+Mono APPR

Inluriyo^® and Verzenio^® are registered trademarks and Lilly Support Services^™ is a trademark owned or licensed by Eli Lilly and Company, its subsidiaries, or affiliates.

In post-AI ER+, HER2–, ESR1m MBC

Inluriyo + Verzenio helps your patients continue an oral dosing routine^1,2

ADMINISTRATION INSTRUCTIONS

Indications

IMPORTANT SAFETY INFORMATION FOR INLURIYO® (imlunestrant) AS MONOTHERAPY IN COMBINATION WITH VERZENIO® (abemaciclib)

In post-AI ER+, HER2–, ESR1m MBC

Inluriyo + Verzenio helps your patients continue an oral dosing routine1,2

ADMINISTRATION INSTRUCTIONS

Indications

IMPORTANT SAFETY INFORMATION FOR INLURIYO® (imlunestrant) AS MONOTHERAPY IN COMBINATION WITH VERZENIO® (abemaciclib)

Inluriyo + Verzenio helps your patients continue an oral dosing routine^1,2