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

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Adverse reactions (≥10%) in patients who received Inluriyo + Verzenio in EMBER-3^1,2


Adverse Reaction^a,b	Inluriyo + Verzenio (n=208)		Inluriyo (n=327)
Adverse Reaction^a,b	All Grades %	Grades 3 or 4 %	All Grades %	Grades 3 or 4 %
Gastrointestinal Disorders
Diarrhea	86	9	23	0.3
Nausea	51	1.9	18	0.3
Vomiting	32	0.5	10	0.6
Abdominal pain^c	24	1.9	11	0.3
General Disorders and Administration Site Conditions
Fatigue^c	41	5	24	0.3
Infections and Infestations
Infections^c	36	7	25	3.4
Musculoskeletal Disorders
Musculoskeletal pain^c	25	1.4	31	2.8
Metabolism and Nutrition Disorders
Decreased appetite^c	22	1.0	9	0.3
Skin and Subcutaneous Tissue Disorders
Rash^c	14	1.4	4.9	0
Respiratory, Thoracic and Mediastinal Disorders
Cough^c	13	0	9	0
Nervous System Disorders
Headache^c	10	0.5	9	0
Investigations
Weight decreased	10	0	4.6	0

Table depicting adverse reactions (≥10%) with a median duration follow-up of 29 months (graded using NCI CTCAE version 5.0), according to grade, reported in EMBER-3 for Inluriyo plus Verzenio (n=208) and Inluriyo (n=327).

All Grades gastrointestinal disorders: diarrhea was 86% for Inluriyo plus Verzenio vs 23% for Inluriyo; nausea was 51% for Inluriyo plus Verzenio vs 18% for Inluriyo; vomiting was 32% for Inluriyo plus Verzenio vs 10% for Inluriyo; and abdominal pain (includes other related terms) was 24% for Inluriyo plus Verzenio vs 11% for Inluriyo.

Grades 3 or 4 gastrointestinal disorders: diarrhea was 9% for Inluriyo plus Verzenio vs 0.3% for Inluriyo; nausea was 1.9% for Inluriyo plus Verzenio vs 0.3% for Inluriyo; vomiting was 0.5% for Inluriyo plus Verzenio vs 0.6% for Inluriyo; and abdominal pain (includes other related terms) was 1.9% for Inluriyo plus Verzenio vs 0.3% for Inluriyo. All Grades investigations: weight decreased was 10% for Inluriyo plus Verzenio vs 4.6% for Inluriyo. Grades 3 or 4 investigations: weight decreased was 0% for Inluriyo plus Verzenio vs 0% for Inluriyo.

All Grades general disorders and administration site conditions: fatigue (includes other related terms) was 41% for Inluriyo plus Verzenio vs 24% for Inluriyo.

Grades 3 or 4 general disorders and administration site conditions: fatigue (includes other related terms) was 5% for Inluriyo plus Verzenio vs 0.3% for Inluriyo.

All Grades infections and infestations: infections (includes other related terms) were 36% for Inluriyo plus Verzenio vs 25% for Inluriyo. Grades 3 or 4 infections and infestations: infections (includes other related terms) were 7% for Inluriyo plus Verzenio vs 3.4% for Inluriyo.

All Grades musculoskeletal disorders: musculoskeletal pain (includes other related terms) was 25% for Inluriyo plus Verzenio vs 31% for Inluriyo.

Grades 3 or 4 musculoskeletal disorders: musculoskeletal pain (includes other related terms) was 1.4% for Inluriyo plus Verzenio vs 2.8% for Inluriyo.

All Grades skin and subcutaneous tissue disorders: rash (includes other related terms) was 14% for Inluriyo plus Verzenio vs 4.9% for Inluriyo. Grades 3 or 4 skin and subcutaneous tissue disorders: rash (includes other related terms) was 1.4% for Inluriyo plus Verzenio vs 0% for Inluriyo. All Grades metabolism and nutrition disorders: decreased appetite (includes other related terms) was 22% for Inluriyo plus Verzenio vs 9% for Inluriyo.

Grades 3 or 4 metabolism and nutrition disorders: decreased appetite (includes other related terms) was 1% for Inluriyo plus Verzenio vs 0.3% for Inluriyo.

All Grades respiratory, thoracic and mediastinal disorders: cough (includes other related terms) was 13% for Inluriyo plus Verzenio vs 9% for Inluriyo. Grades 3 or 4 respiratory, thoracic and mediastinal disorders: cough (includes other related terms) was 0% for Inluriyo plus Verzenio vs 0% for Inluriyo. All Grades nervous system disorders: headache (includes other related terms) was 10% for Inluriyo plus Verzenio vs 9% for Inluriyo.

Grades 3 or 4 nervous system disorders: headache (includes other related terms) was 0.5% for Inluriyo plus Verzenio vs 0% for Inluriyo.

^aMedian duration follow-up of 29 months.^1-3

^bAdverse reactions were graded using NCI CTCAE version 5.0.^1,2

^cIncludes other related terms.^1,2

AR=adverse reaction; CTCAE=Common Terminology Criteria for Adverse Events; NCI=National Cancer Institute.

Adverse reactions (≥10%) in patients who received Inluriyo in EMBER-3¹


Adverse Reaction^a,b	Inluriyo (n=327)		Fulvestrant (n=292) or Exemestane (n=32)
Adverse Reaction^a,b	All Grades %	Grades 3 or 4 %	All Grades %	Grades 3 or 4 %
Musculoskeletal Disorders
Musculoskeletal pain	30	3.7	29	1.9
General Disorders and Administration Site Conditions
Fatigue^c	23	0.3	14	0.6
Gastrointestinal Disorders
Diarrhea	22	0.6	12	0
Nausea	17	0.3	13	0
Constipation	10	0	6	0.3
Abdominal pain^c	10	0.3	6	0.6

Table depicting adverse reactions (≥10%) with a median duration follow-up of 16 months (graded using NCI CTCAE version 5.0), according to grade, reported in EMBER-3 for Inluriyo (n=327) and fulvestrant (n=292) or exemestane (n=32).

All Grades musculoskeletal disorders: musculoskeletal pain was 30% for Inluriyo vs 29% for fulvestrant or exemestane.

Grades 3 or 4 musculoskeletal disorders: musculoskeletal pain was 3.7% for Inluriyo vs 1.9% for fulvestrant or exemestane.

All Grades general disorders and administration site conditions: fatigue (includes other related terms) was 23% for Inluriyo vs 14% for fulvestrant or exemestane.

Grades 3 or 4 general disorders and administration site conditions: fatigue (includes other related terms) was 0.3% for Inluriyo vs 0.6% for fulvestrant or exemestane.

All Grades gastrointestinal disorders: diarrhea was 22% for Inluriyo vs 12% for fulvestrant or exemestane; nausea was 17% for Inluriyo vs 13% for fulvestrant or exemestane; constipation was 10% for Inluriyo vs 6% for fulvestrant or exemestane; and abdominal pain (includes other related terms) was 10% for Inluriyo vs 6% for fulvestrant or exemestane.

Grades 3 or 4 gastrointestinal disorders: diarrhea was 0.6% for Inluriyo vs 0% for fulvestrant or exemestane; nausea was 0.3% for Inluriyo vs 0% for fulvestrant or exemestane; constipation was 0% for Inluriyo vs 0.3% for fulvestrant or exemestane; and abdominal pain (includes other related terms) was 0.3% for Inluriyo vs 0.6% for fulvestrant or exemestane.

^aMedian duration follow-up of 16 months.^1,4

^bAdverse reactions were graded using NCI CTCAE version 5.0.¹

^cIncludes other related terms.¹

At median follow-up of 29 months, Inluriyo + Verzenio (n=208)^1-3

Serious ARs occurred in 21% of patients who received Inluriyo + Verzenio

Serious ARs in >1% of patients who received Inluriyo + Verzenio included pneumonia (2.4%), abdominal pain, and renal failure (each 1.4%)

Fatal ARs occurred in 3.8% of patients who received Inluriyo + Verzenio vs 1.8% with Inluriyo

Fatal ARs included pneumonia (1.4%), myocardial infarction, ILD, and sepsis (1 patient, 0.5% each)

At median follow-up of 16 months, Inluriyo monotherapy (n=327)^1,4

Serious ARs occurred in 10% of patients who received Inluriyo

Serious ARs in >1% of patients receiving Inluriyo included pleural effusion (1.2%)

Fatal ARs occurred in 1.8% of patients who received Inluriyo vs 1.9% with fulvestrant or exemestane

Fatal ARs with Inluriyo included cardiac arrest, acute myocardial infarction, right ventricular failure, hypovolemic shock, and upper gastrointestinal hemorrhage (each 0.3%)

Inluriyo label contains no Boxed Warning; no warnings for QTc prolongation or bradycardia.

In EMBER-3^1,2

Most patients were able to stay on Inluriyo + Verzenio^1,2,5

Discontinuations due to ARs^1,2,5

1^%

discontinued Inluriyo alone

3.4^%

discontinued Verzenio alone

9.1% discontinued both Inluriyo and Verzenio

ARs for Inluriyo resulted in:¹

Permanent discontinuation in 1% of patients, including increased ALT and anemia (0.5% each)
Dosage interruption in 50% of patients ≥2%, including diarrhea (14%), neutropenia (9%), decreased neutrophil count (6%), nausea (6%), anemia (6%), increased ALT (2.4%), and vomiting (2.4%)
Dose reductions in 18% of patients ≥1%, including diarrhea (6%), neutropenia (1.9%), nausea (1.9%), increased ALT (1.9%), and decreased neutrophil count (1.4%)

ARs for Verzenio resulted in:²

Permanent discontinuation in 3.4% of patients, including increased ALT (1.4%), bile duct stone, diarrhea, drug-induced liver injury, prolonged QT interval, fatigue, maculo-papular rash, renal failure, and vomiting (0.5% each)
Dosage interruption in 59% of patients ≥2%, including diarrhea (20%), neutropenia (10%), decreased neutrophil count (8%), anemia (6%), nausea (6%), increased AST (2.4%), fatigue (2.4%), and vomiting (2.4%)
Dose reductions in 42% of patients ≥1%, including diarrhea (20%), neutropenia (5%), nausea (3.4%), decreased neutrophil count (3.4%), fatigue (2.4%), anemia (1.9%), increased AST (1.9%), and increased ALT (1.4%)

ARs for both Inluriyo and Verzenio resulted in:⁵

Permanent discontinuation in 9.1% of patients, including increased ALT (1.4%), fatigue (1%), renal failure (1%), bile duct stone, clostridial infection, diarrhea, drug-induced liver injury, prolonged QT interval, maculo-papular rash, and vomiting (0.5% each)

ALT=alanine aminotransferase; AR=adverse reaction; AST=aspartate aminotransferase; QT=QT interval.

Select laboratory abnormalities (≥10%) that worsened from baseline in patients who received Inluriyo + Verzenio in EMBER-3^1,2


Lab Abnormality^a	Inluriyo + Verzenio^b		Inluriyo^b
Lab Abnormality^a	All Grades %	Grades 3 or 4 %	All Grades %	Grades 3 or 4 %
Hematology
Neutrophil count decreased	86	21	28	4.3
Hemoglobin decreased	81	9	34	2.2
Lymphocyte count decreased	58	9	29	2.2
Platelet count decreased	48	2.4	18	2.8
Chemistry
Triglycerides increased	40	2.3	22	0
AST increased	36	2.5	27	1.9
Creatinine increased	36	1.1	6	0.3
ALT increased	33	5	22	1.3
Cholesterol increased	18	0	12	0.4

All-Grades hematology: neutrophil count decreased was 86% for Inluriyo plus Verzenio vs 28% for Inluriyo; white blood cell decreased was 86% for Inluriyo plus Verzenio vs 33% for Inluriyo; hemoglobin decreased was 81% for Inluriyo plus Verzenio vs 34% for Inluriyo; lymphocyte count decreased was 58% for Inluriyo plus Verzenio vs 29% for Inluriyo; platelet count decreased was 48% for Inluriyo plus Verzenio vs 18% for Inluriyo.

Grades 3 or 4 hematology: neutrophil count decreased was 21% for Inluriyo plus Verzenio vs 4.3% for Inluriyo; white blood cell decreased was 11% for Inluriyo plus Verzenio vs 2.5% for Inluriyo; hemoglobin decreased was 9% for Inluriyo plus Verzenio vs 2.2% for Inluriyo; lymphocyte count decreased was 9% for Inluriyo plus Verzenio vs 2.2% for Inluriyo; platelet count decreased was 2.4% for Inluriyo plus Verzenio vs 2.8% for Inluriyo.

All-Grades chemistry: triglycerides increased was 40% for Inluriyo plus Verzenio vs 22% for Inluriyo; creatinine increased was 36% for Inluriyo plus Verzenio vs 6% for Inluriyo; AST increased was 36% for Inluriyo plus Verzenio vs 27% for Inluriyo; ALT increased was 33% for Inluriyo plus Verzenio vs 22% for Inluriyo; cholesterol increased was 18% for Inluriyo plus Verzenio vs 12% for Inluriyo.

Grades 3 or 4 chemistry: triglycerides increased was 2.3% for Inluriyo plus Verzenio vs 0% for Inluriyo; creatinine increased was 1.1% for Inluriyo plus Verzenio vs 0.3% for Inluriyo; AST increased was 2.5% for Inluriyo plus Verzenio vs 1.9% for Inluriyo; ALT increased was 5% for Inluriyo plus Verzenio vs 1.3% for Inluriyo; cholesterol increased was 0% for Inluriyo plus Verzenio vs 0.4% for Inluriyo

^aGraded according to NCI CTCAE version 5.0. Median follow-up was 29 months.^1-3

^bThe denominator used to calculate the frequency varied from 178 to 205 based on the number of patients with a baseline value and at least one post-treatment value.^1,2

ALT=alanine aminotransferase; AST=aspartate aminotransferase; CTCAE=Common Terminology Criteria for Adverse Events; NCI=National Cancer Institute.

Select laboratory abnormalities (≥10%) that worsened from baseline in patients who received Inluriyo in EMBER-3¹


Lab Abnormality	Inluriyo^b		Fulvestrant or Exemestane^b
Lab Abnormality	All Grades %	Grades 3 or 4 %	All Grades %	Grades 3 or 4 %
Hematology
Hemoglobin decreased	30	1.2	35	3.4
Neutrophils decreased	26	4	29	4.7
Platelets decreased	16	1.8	14	1.3
Chemistry
Calcium decreased	26	0	19	0.6
AST increased	25	1.9	27	2.3
ALT increased	21	1.3	23	1
Triglycerides increased	21	0	22	1.2
Cholesterol increased	10	0	12	0

Table depicting the lab abnormalities in ≥10% of patients in the Inluriyo arm (graded according to NCI CTCAE version 5.0) reported in EMBER-3 for Inluriyo (imlunestrant) vs fulvestrant or exemestane. The denominator used to calculate the rate varied from 252 to 325 based on the number of patients with a baseline value and at least one post-treatment value.

All-Grades hematology: hemoglobin decreased was 30% for Inluriyo vs 35% for fulvestrant or exemestane; neutrophils decreased was 26% for Inluriyo vs 29% for fulvestrant or exemestane; platelets decreased was 16% for Inluriyo vs 14% for fulvestrant or exemestane.

Grades 3 or 4 hematology: hemoglobin decreased was 1.2% for Inluriyo vs 3.4% for fulvestrant or exemestane; neutrophils decreased was 4% for Inluriyo vs 4.7% for fulvestrant or exemestane; platelets decreased was 1.8% for Inluriyo vs 1.3% for fulvestrant or exemestane.

All-Grades chemistry: calcium decreased was 26% for Inluriyo vs 19% for fulvestrant or exemestane; AST increased was 25% for Inluriyo vs 27% for fulvestrant or exemestane; ALT increased was 21% for Inluriyo vs 23% for fulvestrant or exemestane; triglycerides increased was 21% for Inluriyo vs 22% for fulvestrant or exemestane; cholesterol increased was 10% for Inluriyo vs 12% for fulvestrant or exemestane.

Grades 3 or 4 chemistry: calcium decreased was 0% for Inluriyo vs 0.6% for fulvestrant or exemestane; AST increased was 1.9% for Inluriyo vs 2.3% for fulvestrant or exemestane; ALT increased was 1.3% for Inluriyo vs 1% for fulvestrant or exemestane; triglycerides increased was 0% for Inluriyo vs 1.2% for fulvestrant or exemestane; cholesterol increased was 0% for Inluriyo vs 0% for fulvestrant or exemestane.

^aGraded according to NCI CTCAE version 5.0. Median duration of follow-up was 16 months.^1,4

^bThe denominator used to calculate the rate varied from 252 to 325 based on the number of patients with a baseline value and at least one post-treatment value.¹

Inluriyo + Verzenio: No burden of cardiac monitoring or eye exams^1,2

No requirements for:^1,2,4

ECG monitoring

Ocular monitoring

Blood glucose monitoring

Prophylactic steroid mouthwash

Required monitoring for Inluriyo and Verzenio: CBCs, LFTs, lipid profile monitoring, signs and symptoms of ILD/pneumonitis, and signs and symptoms of thrombosis and pulmonary embolism.

Follow the specific monitoring, dose modification, and management instructions in the full Prescribing Information for Inluriyo and Verzenio.

CBC=complete blood count; ECG=electrocardiogram; ILD=interstitial lung disease; LFT=liver function test.

References:

Inluriyo. Prescribing Information. Lilly USA, LLC.
Verzenio. Prescribing Information. Lilly USA, LLC.
Jhaveri KL, Neven P, Casalnuovo ML, et al. Imlunestrant with or without abemaciclib in advanced breast cancer: updated efficacy results from the phase III EMBER-3 trial. Ann Oncol. 2025;Epub(Incl suppl mat). doi:10.1016/j.annonc.2025.11.018
Jhaveri KL, Neven P, Casalnuovo ML, et al. Imlunestrant with or without abemaciclib in advanced breast cancer. N Engl J Med. 2025;392(12)(Incl suppl mat + protocol):1189-1202. doi:10.1056/NEJMoa2410858
Data on File. CREF-6041. Lilly USA, LLC.

CMAT-31275 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.

Inluriyo®. Verzenio®. Established safety profiles.1,2

Adverse reactions (≥10%) in patients who received Inluriyo + Verzenio in EMBER-31,2

Adverse reactions (≥10%) in patients who received Inluriyo in EMBER-31

In EMBER-31,2

1%

3.4%

Select laboratory abnormalities (≥10%) that worsened from baseline in patients who received Inluriyo + Verzenio in EMBER-31,2

Select laboratory abnormalities (≥10%) that worsened from baseline in patients who received Inluriyo in EMBER-31

No requirements for:1,2,4