FrancophonIA/ELRC3.0 huggingface dataset:
English: Alirocumab is a human IgG1 monoclonal antibody produced in Chinese Hamster Ovary cells by recombinant DNA technology.
Croatian: Alirokumab je humano IgG1 monoklonsko protutijelo koje se proizvodi u stanicama jajnika kineskog hrčka tehnologijom rekombinantne DNK.
English: Each pre-filled pen or pre-filled syringe is for single use only.
Croatian: Jedna napunjena brizgalica ili napunjena štrcaljka namijenjena je samo za jednokratnu uporabu.
English: Table 3: Efficacy of Alirocumab in ODYSSEY OUTCOMES (Overall Population)
Croatian: Tablica 3: Djelotvornost alirokumaba u ispitivanju ODYSSEY
English: • Check the liquid is clear, colourless to pale yellow and free from particles - if not, do not use (see picture A).
Croatian: • Provjerite je li tekućina bistra, bezbojna do blijedo žuta i da ne sadrži čestice - u suprotnom je nemojte upotrijebiti (pogledajte sliku A).
English: Limited data are available in patients with severe renal impairment; in these patients the exposure to alirocumab was approximately 2-fold higher compared with subjects with normal renal function.
Croatian: Dostupni su ograničeni podaci o primjeni u bolesnika s teškim oštećenjem bubrežne funkcije; u tih je bolesnika izloženost alirokumabu bila približno dvostruko veća nego u ispitanika s normalnom bubrežnom funkcijom.
English: Anti-drug antibody responses, including NAb, were low titer and did not appear to have a clinically meaningful impact on the efficacy or safety of alirocumab, except for a higher rate of injection site reactions in patients with treatment emergent ADA compared to patients who were ADA negative (7.5% vs 3.6%).
Croatian: Odgovori protutijelima na lijek, uključujući neutralizirajuća protutijela, bili su niskog titra i nije se činilo da imaju klinički značajan utjecaj na djelotvornost ili sigurnost alirokumaba, osim veće stope reakcija na mjestu injiciranja u bolesnika s protutijelima na lijek u usporedbi s bolesnicima koji nemaju protutijela na lijek (7,5% nasuprot 3,6%).
English: Excluding injection site reactions (ISRs) that occurred after these placebo injections, the frequency of ISRs was 11.8%.
Croatian: Isključujući reakcije na mjestu injiciranja koje su se javile nakon ovih injekcija s placebom, učestalost reakcija na mjestu injiciranja bila je 11,8%.
English: Most patients (88.8%) were receiving high intensity statin therapy with or without other LMT at randomization.
Croatian: Većina bolesnika (88,8%) primala je terapiju statinima visokog intenziteta s ili bez drugih terapija za modificiranje lipida pri randomizaciji.
English: If the solution is discoloured or contains visible particulate matter, the solution should not be used.
Croatian: Ako je otopina promijenila boju ili sadrži vidljive čestice, ne smije se upotrijebiti.
English: Immunogenicity data are highly dependent on the sensitivity and specificity of the ADA assay.
Croatian: Podaci o imunogenosti uvelike ovise o osjetljivosti i specifičnosti testa na protutijela na lijek.
English: In the event of an overdose, the patient should be treated symptomatically, and supportive measures instituted as required.
Croatian: U slučaju predoziranja, bolesnika treba liječiti simptomatski te po potrebi uvesti potporne mjere.
English: Alirocumab also results in reductions in lipoprotein (a) [Lp(a)], which is a form of LDL that is bound to apolipoprotein (a).
Croatian: Alirokumab dovodi i do snižavanja vrijednosti lipoproteina (a) [Lp(a)], jednog oblika LDL-a koji se vezuje za apolipoprotein (a).
English: All-cause mortality
Croatian: Smrtnost od svih uzroka
English: If you stop using Praluent
Croatian: Ako prestanete primjenjivati Praluent
English: • if you are allergic to alirocumab or any of the other ingredients of this medicine (listed in section 6).
Croatian: Nemojte primjenjivati Praluent • ako ste alergični na alirokumab ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
English: What Praluent contains
Croatian: Što Praluent sadrži
English: There was no other evidence of alirocumab-related immune dysfunction in the offspring.
Croatian: U mladunčadi nisu pronađeni drugi dokazi disfunkcije imunosnog sustava povezane s alirokumabom.
English: A multicentre, double-blind, placebo-controlled trial included 18,924 adult patients (9462 alirocumab; 9462 placebo) followed for up to 5 years.
Croatian: Multicentrično, dvostruko slijepo, placebom kontrolirano ispitivanje uključivalo je 18 924 odrasla bolesnika (9462 liječena alirokumabom; 9462 koji su primali placebo) koji su praćeni do 5 godina.
English: • Pull the needle out of the skin at the same angle as it was inserted.
Croatian: • Izvucite iglu iz kože pod istim kutom pod kojim ste je uboli.
English: However, maternal toxicity was noted in pregnant rats at systemic exposures estimated to be approximately 5.3 times greater than the human exposure at the 150 mg Q2W dose (based on exposure measured in non-pregnant rats during a 5-week toxicology study).
Croatian: Međutim, toksičnost za majku primijećena je u gravidnih ženki štakora pri sistemskim izloženostima za koje je procijenjeno da su približno 5,3 puta veće od one koja se postiže u ljudi nakon primjene doze od 150 mg jednom svaka 2 tjedna (utvrđeno na temelju izloženosti izmjerene u negravidnih ženki štakora tijekom 5-tjednog toksikološkog ispitivanja).
English: • The other ingredients are histidine, sucrose, polysorbate 20 and water for injection.
Croatian: • Drugi sastojci su histidin, saharoza, polisorbat 20 i voda za injekcije.
English: • redness, itching, swelling, pain/tenderness where the medicine was injected (local injection site reactions)
Croatian: • crvenilo, svrbež, oticanje, bol/osjetljivost na mjestu injiciranja lijeka (lokalne reakcije na mjestu injiciranja)
English: • Do not heat the syringe, let it warm up on its own.
Croatian: • Nemojte zagrijavati štrcaljku, pričekajte da se sama ugrije.
English: Steady state was reached after 2 to 3 doses with an accumulation ratio up to a maximum of about 2-fold.
Croatian: Stanje dinamičke ravnoteže postignuto je nakon 2 do 3 doze, uz najviše dvostruki omjer kumulacije.
English: • Adults with high cholesterol levels in their blood and with cardiovascular disease to reduce cardiovascular risk.
Croatian: • Praluent se koristi u odraslih osoba s visokim vrijednostima kolesterola u krvi i s kardiovaskularnom bolešću kako bi se smanjio kardiovaskularni rizik.
English: It is not known whether alirocumab is excreted in human milk.
Croatian: Nije poznato izlučuje li se alirokumab u majčino mlijeko.
English: • This pen can only be used for one single injection, and must be thrown away after use.
Croatian: • Ova se brizgalica može upotrijebiti samo za jednu injekciju, nakon čega se mora baciti.
English: Most common adverse reactions leading to treatment discontinuation in patients treated with Praluent were local injection site reactions.
Croatian: Najčešće nuspojave koje su dovodile do prekida liječenja u bolesnika liječenih lijekom Praluent bile su lokalne reakcije na mjestu injiciranja.
English: In ten phase 3 controlled trials, involving patients with primary hypercholesterolemia and mixed dyslipidaemia, the most common adverse reactions were local injection site reactions, upper respiratory tract signs and symptoms, and pruritus.
Croatian: U deset kontroliranih ispitivanja faze 3, koja su uključivala bolesnike s primarnom hiperkolesterolemijom i miješanom dislipidemijom, najčešće nuspojave bile su lokalne reakcije na mjestu injiciranja, znakovi i simptomi gornjih dišnih putova te pruritus.
English: Since alirocumab is a biological medicinal product, no pharmacokinetic effects of alirocumab on other medicinal products and no effect on cytochrome P450 enzymes are anticipated.
Croatian: Budući da je alirokumab biološki lijek, ne očekuje se da će imati farmakokinetičkih učinaka na druge lijekove, niti se očekuje da će utjecati na enzime citokroma P450.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Praluent in one or more subsets of the paediatric population in the treatment of elevated cholesterol (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove odgodila je obvezu podnošenja rezultata ispitivanja lijeka Praluent u jednoj ili više podskupina pedijatrijske populacije u liječenju povišenih vrijednosti kolesterola (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: For detailed results see Table 2.
Croatian: Za detaljne rezultate vidjeti Tablicu 2 u nastavku.
English: Local injection site reactions, including erythema/redness, itching, swelling, and pain/tenderness, were reported in 6.1% of patients treated with alirocumab versus 4.1% in the control group (receiving placebo injections).
Croatian: Lokalne reakcije na mjestu injiciranja, uključujući eritem/crvenilo, svrbež, oticanje i bol/osjetljivost, prijavljene su u 6,1% bolesnika liječenih alirokumabom naspram 4,1% bolesnika u kontrolnoj skupini (koji su primali injekcije placeba).
English: 1 ml solution in a siliconised Type 1 clear glass syringe, equipped with a stainless steel staked needle, a styrene-butadiene rubber soft needle shield, and an ethylene tetrafluoroethylene -coated bromobutyl rubber plunger stopper.
Croatian: 1 ml otopine u silikoniziranoj štrcaljki od bezbojnog stakla (tipa 1), opremljenoj pričvršćenom iglom od nehrđajućeg čelika, mekim zaštitnim pokrovom igle od stiren-butadienske gume i čepom klipa od brombutilne gume obloženim etilen-tetrafluoroetilenom.
English: Your doctor will check your cholesterol levels and may adjust the dose (up or down) during treatment.
Croatian: Vaš će liječnik tijekom liječenja provjeravati vrijednosti kolesterola i možda prilagoditi dozu lijeka (povećati ili smanjiti).
English: Always check the label of your pen to make sure you have the right medicine and the right strength.
Croatian: Uvijek provjerite naljepnicu brizgalice kako biste bili sigurni da imate pravi lijek i pravu jačinu.
English: • upper respiratory tract signs or symptoms such as sore throat, running nose, sneezing
Croatian: • znakovi ili simptomi u gornjim dišnim putovima, poput grlobolje, curenja iz nosa i kihanja
English: The discontinuation rate due to local injection site reactions was comparable between the two groups (0.2% in the alirocumab group versus 0.3% in the control group).
Croatian: Stopa prekida liječenja zbog lokalnih reakcija na mjestu injiciranja bila je usporediva između tih dviju skupina (0,2% u skupini koja je primala alirokumab naspram 0,3% u kontrolnoj skupini).
English: LDL-C values <25 mg/dL (<0.65 mmol/L)
Croatian: Vrijednosti LDL-C <25 mg/dl (<0,65 mmol/l)
English: The frequency of adverse reactions reported during post-marketing use cannot be determined as they are derived from spontaneous reports.
Croatian: Učestalost nuspojava prijavljenih nakon stavljanja lijeka u promet ne može se utvrditi budući da su izvedene iz spontanih prijava.
English: In the phase 3 studies, 31% of patients had type 2 diabetes mellitus, and 64% of patients had a history of coronary heart disease.
Croatian: U ispitivanjima faze 3, 31% bolesnika imalo je šećernu bolest tipa 2, dok je njih 64% imalo koronarnu srčanu bolest u anamnezi.
English: If you are not sure when to inject Praluent, call your doctor, pharmacist or nurse.
Croatian: Ako niste sigurni kada trebate injicirati Praluent, nazovite svog liječnika, ljekarnika ili medicinsku sestru.
English: Although adverse consequences of very low LDL-C were not identified in alirocumab trials, the long-term effects of very low levels of LDL-C are unknown.
Croatian: Iako nisu bile zabilježene nuspojave vrlo niske razine LDL-C u ispitivanjima alirokumaba, dugoročni učinci vrlo niskih razina LDL-C nisu poznati.
English: Hypersensitivity, hypersensitivity vasculitis
Croatian: Poremećaji imunološkog sustava preosjetljivost, hipersenzitivni vaskulitis
English: What Praluent is
Croatian: Što je Praluent
English: CHOICE I study
Croatian: Ispitivanje CHOICE I
English: The following adverse reactions were reported in patients treated with alirocumab in pooled controlled studies and/or post-marketing use (see Table 1).
Croatian: Sljedeće su nuspojave prijavljene u bolesnika liječenih alirokumabom u objedinjenim podacima iz kontroliranih ispitivanja i/ili nakon stavljanja lijeka u promet (vidjeti Tablicu 1).
English: • Check the liquid is clear, colourless to pale yellow and free from particles; if not, do not use.
Croatian: • Provjerite je li tekućina bistra, bezbojna do blijedo žuta i da ne sadrži čestice - u suprotnom je nemojte upotrijebiti.
English: Approximately 2615 (27.7%) of 9451 patients treated with alirocumab required dose adjustment to 150 mg Q2W.
Croatian: Približno 2615 (27,7%) od 9451 bolesnika liječenih alirokumabom zahtijevalo je prilagodbu doze na 150 mg jednom svaka dva tjedna.
English: Driving and using machines This medicine is not expected to have any effect on your ability to drive or use machines.
Croatian: Ne očekuje se da bi ovaj lijek mogao utjecati na sposobnost upravljanja vozilima ili rada sa strojevima.
English: (75 milligrams per ml) or 150 milligrams (150 milligrams per ml) of alirocumab.
Croatian: (75 miligrama po ml) ili 150 miligrama (150 miligrama po ml) alirokumaba.
English:  Look at the label on the pen.
Croatian: Pogledajte naljepnicu na brizgalici
English: The usual starting dose for Praluent is 75 mg administered subcutaneously once every 2 weeks.
Croatian: Uobičajena početna doza lijeka Praluent je 75 mg supkutano jednom svaka 2 tjedna.
English: • Clean skin in the injection area with an alcohol wipe.
Croatian: • Očistite kožu na mjestu injiciranja tupferom natopljenim alkoholom.
English: The efficacy of alirocumab was investigated in ten phase 3 trials (five placebo-controlled and five ezetimibe-controlled studies), involving 5296 randomised patients with hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, with 3188 patients randomised to alirocumab.
Croatian: Djelotvornost alirokumaba ocjenjivala se u deset ispitivanja faze 3 (pet placebom kontroliranih i pet ezetimibom kontroliranih ispitivanja), u kojima je sudjelovalo 5296 randomiziranih bolesnika s hiperkolesterolemijom (heterozigotnom obiteljskom ili stečenom) ili miješanom dislipidemijom, od kojih je njih 3188 bilo randomizirano za liječenje alirokumabom.
English: Clinical efficacy and safety in primary hypercholesterolaemia and mixed dyslipidaemia
Croatian: Klinička djelotvornost i sigurnost u primarnoj hiperkolesterolemiji i miješanoj dislipidemiji
English: Other medicines and Praluent Tell your doctor, pharmacist or nurse if you are using, have recently used or might use any other medicines.
Croatian: Obavijestite svog liječnika, ljekarnika ili medicinsku sestru ako primjenjujete, nedavno ste primijenili ili biste mogli primijeniti bilo koje druge lijekove.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Praluent in all subsets of the paediatric population in the treatment of mixed dyslipidaemia (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove izuzela je obvezu podnošenja rezultata ispitivanja lijeka Praluent u svim podskupinama pedijatrijske populacije u liječenju miješane dislipidemije (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: Effects of alirocumab on other medicinal products
Croatian: Učinci alirokumaba na druge lijekove
English: The dose of Praluent can be individualised based on patient characteristics such as baseline LDL-C level, goal of therapy, and response.
Croatian: Doza lijeka Praluent može se prilagoditi svakom bolesniku pojedinačno na temelju značajki poput početne vrijednosti LDL-C, terapijskog cilja i odgovora na liječenje.
English: PCSK9 binds to the low-density lipoprotein receptors (LDLR) on the surface of hepatocytes to promote LDLR degradation within the liver.
Croatian: PCSK9 se vezuje za receptore lipoproteina niske gustoće (engl. low-density lipoprotein receptors, LDLR) na površini hepatocita kako bi potaknuo razgradnju LDLR-a unutar jetre.
English: Do not expose syringe to direct sunlight.
Croatian: Nemojte izlagati štrcaljku izravnoj sunčevoj svjetlosti.
English: If you forget to use Praluent
Croatian: Ako ste zaboravili primijeniti Praluent
English: ODYSSEY OUTCOMES study
Croatian: Ispitivanje ODYSSEY
English: Tell your doctor if you have kidney or liver disease before using this medicine, because Praluent has been studied in few patients with severe kidney disease and not in patients with severe liver disease.
Croatian: Prije nego što primijenite ovaj lijek, recite svom liječniku ako imate bolest bubrega ili jetre, jer se Praluent ispitivao u malobrojnih bolesnika s teškom bubrežnom bolešću, dok se u bolesnika s teškom jetrenom bolešću uopće nije ispitivao.
English: Three of the ten studies were conducted exclusively in patients with heterozygous familial hypercholesterolaemia (heFH).
Croatian: Tri od tih deset ispitivanja bila su provedena isključivo u bolesnika s heterozigotnom obiteljskom hiperkolesterolemijom.
English: Alirocumab is a fully human IgG1 monoclonal antibody that binds with high affinity and specificity to proprotein convertase subtilisin kexin type 9 (PCSK9).
Croatian: Alirokumab je potpuno humano IgG1 monoklonsko protutijelo koje se s visokim afinitetom i specifičnošću vezuje za proproteinsku konvertazu suptilizin keksin tipa 9 (engl. proprotein convertase subtilisin kexin type 9, PCSK9).
English: Of these 2615 patients, 805 (30.8%) were down-titrated to 75 mg Q2W.
Croatian: Od tih 2615 bolesnika, u 805 (30,8%) doza je smanjena na 75 mg jednom svaka dva tjedna.
English: Before you use the syringe for the first time, your doctor, pharmacist or nurse will show you how to inject Praluent.
Croatian: Prije nego što prvi puta upotrijebite štrcaljku, Vaš liječnik, ljekarnik ili medicinska sestra pokazat će Vam kako injicirati Praluent.
English: If you develop a serious allergic reaction, stop using Praluent , talk to your doctor right away.
Croatian: Ako razvijete ozbiljnu alergijsku reakciju, prestanite primjenjivati Praluent i odmah se obratite svome liječniku.
English: Prior to initiating Praluent secondary causes of hyperlipidaemia or mixed dyslipidaemia (e.g., nephrotic syndrome, hypothyroidism) should be excluded.
Croatian: Prije početka liječenja lijekom Praluent potrebno je isključiti sekundarne uzroke hiperlipidemije ili miješane dislipidemije (npr. nefrotski sindrom, hipotireozu).
English: The pharmacodynamic effect of alirocumab in lowering LDL-C is indirect, and mediated through the binding to PCSK9.
Croatian: Farmakodinamički učinak alirokumaba na sniženje vrijednosti LDL-C je neizravan, te se odvija putem vezivanja za PCSK9.
English: What Praluent looks like and contents of the pack Praluent is a clear, colourless to pale yellow solution for injection that comes in a pre-filled syringe.
Croatian: Kako Praluent izgleda i sadržaj pakiranja Praluent je bistra, bezbojna do blijedo žuta otopina za injekciju koja dolazi u napunjenoj štrcaljki.
English: Hazard ratios were calculated posthoc; for all CV events, HR=0.91 (95% CI, 0.62 to 1.34); for MACE-plus, HR=0.52 (95% CI, 0.31 to 0.90).
Croatian: Omjeri hazarda (HR) izračunavali su se post-hoc; za sve KV događaje, HR=0,91 (95% CI, 0,62 - 1,34); za MACE-plus događaje, HR=0,52 (95% CI, 0,31 - 0,90).
English: • PCSK9 is a protein secreted by liver cells.
Croatian: • PCSK9 je protein koji luče jetrene stanice.
English: Patients had experienced an acute coronary syndrome (ACS) event 4 to 52 weeks prior to randomization and were treated with a lipid-modifying-therapy (LMT) regimen that was statin-intensive (defined as atorvastatin 40 or 80 mg, or rosuvastatin 20 or 40 mg) or at maximally tolerated dose of those statins, with or without other LMT.
Croatian: Bolesnici su doživjeli akutni koronarni sindrom 4 do 52 tjedna prije randomizacije i bili su liječeni terapijom za modificiranje lipida koja je uključivala intenzivnu dozu statina (definirana kao atorvastatin 40 ili 80 mg, ili rosuvastatin 20 ili 40 mg) ili maksimalno podnošljivu dozu tih statina, s ili bez druge terapije za modificiranje lipida.
English: Do not use this medicine if it looks discoloured or cloudy, or if it contains visible flakes or particles.
Croatian: Lijek se ne smije primijeniti ako je promijenio boju, ako je mutan ili ako sadrži vidljive pahuljice ili čestice.
English: Monthly exposure with 300 mg every 4 weeks treatment was similar to that of 150 mg every 2 weeks.
Croatian: Mjesečna izloženost kod primjene 300 mg alirokumaba svaka 4 tjedna bila je slična onoj kod primjene 150 mg svaka 2 tjedna.
English: • Do not inject Praluent with other injectable medicines at the same spot.
Croatian: • Nemojte injicirati Praluent na istom mjestu s drugim lijekovima koji se primjenjuju injekcijom.
English: Frequencies for all adverse reactions identified from clinical trials have been calculated based on their incidence in pooled phase 3 clinical trials.
Croatian: Učestalost svih nuspojava zabilježenih u kliničkim ispitivanjima izračunata je na temelju incidencije u objedinjenim podacima kliničkih ispitivanja faze 3.
English: • Hold the syringe in the middle of the syringe body with the needle pointing away from you.
Croatian: • Štrcaljku držite za srednji dio tijela i usmjerite iglu od sebe.
English: A multicenter, double-blind, ezetimibe-controlled, 24 week study included 248 patients with documented statin intolerance due to skeletal muscle-related symptoms.
Croatian: Multicentrično, dvostruko slijepo, ezetimibom kontrolirano, 24-tjedno ispitivanje uključivalo je 248 bolesnika s dokumentiranim nepodnošenjem statina zbog simptoma povezanih sa skeletnim mišićima.
English: • Praluent contains the active substance alirocumab.
Croatian: • Praluent sadrži djelatnu tvar alirokumab.
English: The primary efficacy endpoint in all of the phase 3 studies was the mean percent reduction from baseline in LDL-C at week 24 as compared to placebo or ezetimibe.
Croatian: Primarna mjera ishoda za djelotvornost u svim ispitivanjima faze 3 bila je srednja vrijednost postotka sniženja vrijednosti LDL-C u 24. tjednu u odnosu na početne vrijednosti u usporedbi s placebom ili ezetimibom.
English: There are no data from the use of Praluent in pregnant women.
Croatian: Nema podataka o primjeni lijeka Praluent u trudnica.
English: Green Button
Croatian: Zeleno dugme
English: In the cardiovascular outcomes controlled study, 2505 patients (26.5%) treated with Praluent were ≥65 years of age and 493 patients (5.2%) treated with Praluent were ≥75 years of age.
Croatian: U kontroliranom ispitivanju kardiovaskularnih ishoda, 2505 bolesnika (26,5%) liječenih lijekom Praluent bili su u dobi od >65 godina, a 493 bolesnika (5,2%) liječenih lijekom Praluent u dobi od >75 godina.
English: Table 1 - Adverse Reactions reported in patients treated with alirocumab in controlled studies and post-marketing use
Croatian: Tablica 1 - Nuspojave prijavljene u bolesnika liječenih alirokumabom u kontroliranim ispitivanjima i nakon stavljanja lijeka u promet
English: Praluent can be stored outside the refrigerator (below 25 °C) protected from light for a single period not exceeding 30 days.
Croatian: Praluent se može čuvati izvan hladnjaka (ispod 25°C) zaštićen od svjetlosti u jednokratnom razdoblju koje nije duže od 30 dana.
English: • Do not heat the pen, let it warm up on its own.
Croatian: • Nemojte zagrijavati brizgalicu, pričekajte da se sama ugrije.
English: In in vitro assays, alirocumab did not induce Fc-mediated effector function activity (antibody-dependent cell-mediated toxicity and complement-dependent cytotoxicity) either in the presence or absence of PCSK9 and no soluble immune complexes capable of binding complement proteins were observed for alirocumab when bound to PCSK9.
Croatian: U testovima in vitro alirokumab nije inducirao aktivnost efektorske funkcije posredovanu Fc-ulomkom (stanično posredovanu toksičnost ovisnu o protutijelima i citotoksičnost ovisnu o komplementu) ni u prisustvu ni u odsustvu PCSK9, a nisu primijećeni ni topljivi imunokompleksi sposobni vezivati proteine komplementa kada se alirokumab vezao za PCSK9.