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Inluriyo is a brand name for Imlunestrant. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Inluriyo is indicated as monotherapy for the treatment of adult patients with oestrogen receptor (ER)- positive, HER2-negative, locally advanced or metastatic breast cancer with an activating ESR1- mutation, who have disease progression following prior treatment with an endocrine based regimen (for biomarker-based…
Verbatim from this product's EMA label. Tap a section to expand.
Treatment should be initiated and supervised by a physician experienced in the use of anticancer therapies. Patient selection Patients with ER-positive, HER2-negative advanced breast cancer should be selected for treatment based on the presence of an activating ESR1-mutation in tumour or in plasma specimens, using a CE- marked in vitro diagnostic (IVD) with the corresponding intended purpose.
If the CE-marked IVD is not available, the presence of an activating ESR1-mutation should be assessed by an alternative validated test. Posology The recommended dose of imlunestrant is 400 mg orally (two 200 mg film-coated tablets), once daily.
It is recommended that treatment is continued as long as the patient is deriving clinical benefit from therapy or until unacceptable toxicity occurs. 3 Missed dose If a dose is missed, it can be taken up to 6 hours after the time it is usually taken.
After more than 6 hours, the dose should be skipped for that day. An additional dose should not be taken. On the next day, the dose should be taken at the usual time. Vomiting If the patient vomits after taking the dose, the patient should not take an additional dose on that day and should resume the usual dosing schedule the next day at the usual time.
Dose adjustments If dose reduction is necessary, the dose should be decreased by 200 mg. Management of some adverse reactions may require dose interruption and/or dose reduction as shown in Tables 1 and 2. The treatment should be discontinued for patients unable to tolerate 200 mg once daily.
Table 1:
Recommended dose modification for increased ALT and AST Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) should be monitored during treatment, and as clinically indicated. Toxicitya Dose modification Persistent or Recurrent Grade 2 AST or ALT, if baseline was normal Suspend until toxicity resolves to baseline or Grade 1 if baseline was normal.
Dose reduction is not required. Grade 3 AST or ALT if baseline was normal Or Grade 2 or above AST or ALT if baseline was abnormal Or AST or ALT > 8 × ULN (whichever is the lower threshold) Suspend until toxicity resolves to baseline or Grade 1 if baseline was normal.
Resume at 200 mg dose level or discontinue if receiving 200 mg daily. Grade 4 AST or ALT if baseline was normal Discontinue dosing. AST or ALT ≥ 3 × ULN concurrent with total bilirubin (TBL) ≥ 2 × ULN if baseline was normal in the absence of cholestasis Or AST or ALT ≥ 2 × baseline concurrent with TBL ≥ 2 × ULN if baseline was abnormal, in the absence of cholestasis Discontinue dosing.
0 %). 8 %) only. Tabulated list of adverse reactions The frequencies of adverse drug reactions (ADRs) displayed below are based on pooled data in 378 patients, treated with 400 mg imlunestrant once daily from a randomised, open-label, multicenter Phase 3 study (EMBER-3) and an open-label, multicenter, dose escalation and dose expansion phase 1a/1b study (EMBER).
In the following tables, adverse reactions are listed in order of MedDRA body system organ class and frequency. Frequency gradings are: very common (≥ 1 / 10), common (≥ 1 / 100 to < 1 / 10), uncommon (≥ 1 / 1 000 to < 1 / 100), rare (≥ 1 / 10 000 to < 1 / 1 000), very rare (< 1 / 10 000), and 7 not known (cannot be estimated from the available data).
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Table 3:
Adverse drug reactions in patients receiving imlunestrant System organ class Very common Common Metabolism and Nutrition Disorders Decreased appetite a Nervous System Disorders Headache Vascular Disorders Venous thromboembolism a Hot flush a Respiratory, Thoracic and Mediastinal Disorders Cough a Gastrointestinal Disorders Diarrhoea Nausea Vomiting Constipation Abdominal pain a Musculoskeletal Disorders Joint and muscular skeletal pain b Back pain General Disorders and Administration Site Conditions Fatigue a Investigations c ALT increased AST increased Triglycerides increased a Consolidated term consisting of analogous preferred terms.
b Consolidated term consisting of preferred terms: arthralgia, myalgia, musculoskeletal discomfort, musculoskeletal chest pain, musculoskeletal pain, pain in extremity, neck pain. c Based on laboratory assessments. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
Food effect Imlunestrant exposures in the presence of a high-fat meal are unknown. The dose should be taken in the fasted state as higher exposures may occur with food. Excipients This medicinal product contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially “sodium-free”.
6). 1. 5
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0 ULN: upper limit of normal Table 2: Recommended dose modification for adverse reactions (except increased ALT and AST) Toxicitya Dose 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.
Dose reduction is not required. Grade 3 (except non-hepatic asymptomatic laboratory changes) Suspend until toxicity resolves to baseline or ≤ Grade 1. Resume at next lower dose level or discontinue if receiving 200 mg daily. 4 Grade 4 (except non-hepatic asymptomatic laboratory changes) Suspend until toxicity resolves to baseline or ≤ Grade 1.
Resume at next lower dose level or discontinue if receiving 200 mg daily. Closely monitor on resuming treatment. 0 Strong CYP3A inducers Concomitant use of strong CYP3A inducers should be avoided. 5). Strong CYP3A inhibitors Concomitant use of strong CYP3A inhibitors should be avoided.
5). 2). 2). Hepatic impairment No dose adjustment is recommended for patients with mild hepatic impairment (Child-Pugh A). The dose should be reduced to 200 mg once daily in patients with moderate (Child-Pugh B) or severe (Child-Pugh C) hepatic impairment.
Renal impairment No dose adjustment is necessary in patients with mild or moderate renal impairment. 2). Treatment should be administered with caution in patients with severe renal impairment, with close monitoring for signs of toxicity.
Paediatric population There is no relevant use of imlunestrant in the paediatric population in the indication of locally advanced breast cancer. Method of administration Inluriyo is for oral use. Patients should take their dose at approximately the same time each day.
2). The tablets should be swallowed whole (patients should not split, crush, or chew the tablets before swallowing). The effects of splitting, crushing, or chewing the tablets have not been investigated and may impact the safety, efficacy, or stability of the product.
Exposure to the active substance could be harmful for caregivers.
It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.