M-SE-00001202
Adjuvant indikation1
Adjuvant behandling av resekterad icke-småcellig lungcancer (NSCLC)
Alecensa är indicerat som monoterapi för adjuvant behandling efter komplett tumörresektion hos vuxna patienter med ALK‑positiv NSCLC med hög risk för återfall.
Clinical use:
The indication is granted market authorization based on objective response rate (ORR) demonstrated in a single-arm Phase II trial. Overall survival (OS) benefit in a single-arm trial cannot be confirmed.
In the pivotal trial, the majority of the clinical responses occurred within 16 weeks. Benefit of continued treatment should be regularly assessed, with the optimal duration of therapy varying for each individual patient.
Distribution Restrictions: ERIVEDGE is only available through a controlled distribution program called the ERIVEDGE Pregnancy Prevention Program (EPPP). For more information please contact the EPPP at 1-888-748-8926 or log onto rocheproplus.ca/en/products-resources/erivedge.html.
Geriatrics (≥65 years of age): Elderly patients should be treated with caution and monitored for adverse events.
Pediatrics (<18 years of age): The safety and efficacy of ERIVEDGE in pediatric patients has not been established. Irreversible premature fusion of the epiphyses and precocious puberty have been reported in pediatric patients exposed to ERIVEDGE. Premature fusion can progress after discontinuation of treatment. Due to safety concerns ERIVEDGE is contraindicated in children and adolescents aged below 18 years.
Contraindications:
Female patients who are pregnant or at risk of becoming pregnant
Breastfeeding female patients
Female patients of childbearing potential (FCBP) and male patients who do not comply with the ERIVEDGE Pregnancy Prevention Program
Children and adolescents aged less than 18 years of age
Patients who are hypersensitive to vismodegib or to any ingredient in the formulation
Most serious warnings and precautions:
Embryo-fetal death or severe birth defects: Can cause severe malformations, including craniofacial anomalies, midline defects and limb defects when administered to a female who is pregnant. Must not be used during pregnancy.
Effects on post-natal development: Irreversible premature fusion of the epiphyses (EPF) and precocious puberty have been reported in pediatric patients exposed to ERIVEDGE. In some cases of EPF, fusion progressed after drug discontinuation.
Renal impairment: The safety and efficacy of ERIVEDGE in patients with severe renal impairment have not been studied. No dedicated clinical studies have been conducted to evaluate the effect of mild, moderate and severe renal impairment on the pharmacokinetics of vismodegib.
Hepatic impairment: ERIVEDGE is not recommended for use in patients with severe hepatic impairment since limited data are available in these patients. ERIVEDGE should be used with caution in patients with mild and moderate hepatic impairment.
Other relevant warnings and precautions:
Effects on post-natal development
Blood donation: Patients must not donate blood while on treatment and for 24 months after discontinuation
Patients with advanced BCC (aBCC) have an increased risk of developing cutaneous squamous cell carcinoma (cuSCC). Cases of cuSCC have been reported in aBCC patients treated with ERIVEDGE. All patients should be monitored routinely while taking ERIVEDGE
Cardiovascular-related events
Decreased appetite, decreased weight and dehydration
Electrolyte abnormalities
Hepatotoxicity
Patients with a history of pancreatitis or gallbladder disease
Gastrointestinal-related events
Anaemia and lymphopenia
Grade 1 hypersensitivity
Arthralgia, back pain, muscle spasms, fractures, and elevated creatine phospohokinase (CPK) measurements reported
Syncope, dysgeusia and ageusia
Psychiatric disorders
Renal disorders and cases of renal failure have been observed in patients treated with ERIVEDGE
Amenorrhea has been observed in clinical trials in 30% of FCBP (Female of Childbearing Potential). Potential to impair fertility in patients
Blood work monitoring
For more information:
Please consult the Product Monograph for important information relating to warnings and precautions, adverse reactions, drug interactions, and dosing information that has not been discussed in this piece.
The Product Monograph is also available by calling us at 1-888-762-4388.
Verkningsmekanism1
Alektinib är en starkt selektiv och potent ALK- och rearranged under transfektion (Rearranged During Transfection, RET)-tyrosinkinashämmare. I prekliniska studier ledde hämning av ALK-tyrosinkinasaktiviteten till blockering av nedströms signalvägar inklusive signalomvandlare och transkriptionsaktiverare 3 (Signal Transducer and Activator, STAT 3) och fosfoinositid 3-kinas (PI3K)/proteinkinas B (AKT), samt induktion av tumörcelldöd (apoptos).
Alektinib uppvisar aktivitet in vitro och in vivo mot muterade former av ALK-enzymet, inklusive mutationer som är ansvariga för resistens mot krizotinib. Huvudmetaboliten av alektinib (M4) har visat liknande potens och aktivitet in vitro.
Baserat på prekliniska data är alektinib inte ett substrat för P-gp eller BCRP, som båda är utflödestransportörer i blodhjärnbarriären, och kan därför distribueras och stanna kvar i det centrala nervsystemet.
Studiedesign
* Stage IB (tumours ≥4 cm), II or IIIA NSCLC classified according to the 7th edition of the UICC/AJCC.2
† Cisplatin + pemetrexed, cisplatin + vinorelbine or cisplatin + gemcitabine; cisplatin could be switched to carboplatin in case of intolerability.
‡ DFS defined as the time from randomisation to the first documented recurrence of disease or new primary NSCLC as determined by the investigator, or death of any cause.2
§ Defined as the time from randomisation to the first documented recurrence of disease in the CNS, or death by any cause; this endpoint was exploratory.2
Effekt
Alecensa provided consistent DFS benefit across stage IB through stage IIIA2*
OS data were not mature at the time of the primary DFS analysis with 2,3% of deaths reported overall2
*This analysis is exploratory and not powered to demonstrate statistical significance between treatment arms and should therefore be interpreted with caution.
† Stage IB (tumours ≥4 cm), II or IIIA NSCLC classified according to the 7th edition of the UICC/AJCC.2
Säkerhet
Referenser
- www.fass.se
- Wu Y-L, et al. N Engl J Med 2024;390(14):1265–1276;
- Hida T, et al. Lancet 2017;390(10089):29–39;
- Peters S, et al. N Engl J Med 2017;377(9):829–838;
- Zhou C, et al. Lancet Respir Med 2019;7(5):437–446;
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ALECENSA patientinformation
ALECENSA® (alektinib), ALK-hämmare, L01ED03. (M, Rx, F). Hårda kapslar i blisterförpackning, 150 mg.
Indikationer: Adjuvant behandling av resekterad icke-småcellig lungcancer (NSCLC): ALECENSA är indicerat som monoterapi för adjuvant behandling efter komplett tumörresektion hos vuxna patienter med anaplastiskt lymfomkinas (ALK)-positiv NSCLC med hög risk för återfall. Behandling av avancerad NSCLC: ALECENSA är indicerat som monoterapi för första linjens behandling av vuxna patienter med ALK-positiv, avancerad NSCLC. ALECENSA är indicerat som monoterapi för behandling av vuxna patienter med ALK-positiv avancerad NSCLC som tidigare behandlats med krizotinib.
Kontraindikationer: Överkänslighet mot alektinib eller mot något hjälpämne i läkemedlet.
Varningar och försiktighet: Interstitiell lungsjukdom (ILS)/pneumonit, levertoxicitet, grav myalgi och förhöjt kreatinfosfokinas (CK), bradykardi, hemolytisk anemi, gastrointestinal perforation och fotosensitivitet, embryofetal toxicitet.. Laktosintolerans: Detta läkemedel innehåller laktos. Patienter med något av följande sällsynta ärftliga tillstånd bör inte använda detta läkemedel: galaktosintolerans, total laktasbrist eller glukos-galaktosmalabsorption.
Interaktioner: Grapefrukt och pomerans. Lämplig övervakning rekommenderas för patienter som samtidigt intar starka CYP3A-inducerare, starka CYP3A-hämmare, P-gp-substrat eller bröstcancerresistent protein- (BCRP) substrat.
Fertilitet, graviditet och amning: ALECENSA kan orsaka fosterskador när det ges till en gravid kvinna. Kvinnliga patienter i fertil ålder som får ALECENSA måste använda mycket effektiva preventivmetoder under behandlingen och i minst 5 veckor efter den sista dosen av ALECENSA
Manliga patienter med kvinnliga partners i fertil ålder måste använda mycket effektiva preventivmetoder under behandlingen och i minst 3 månader efter den sista dosen av ALECENSA.
Datum för översyn av produktresumén: 2024-10-17
Läs alltid bipacksedeln noggrant innan läkemedlet används. För mer information, se www.fass.se.
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Tel 08-726 12 00
www.roche.se