Onco Wiki - Drogas

Ipilimumab

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IDDRUG-IPILIMUMAB
TipoFármaco
Aliaces
El pez de la pielІпілімумаб
Situaciónreviewed 2026-04-27 | pending_clinical_signoff
EnfermedadesDIS-ESOPHAGEAL DIS-MELANOMA DIS-MESOTHELIOMA DIS-NSCLC DIS-RCC
FuentesSRC-ESMO-MELANOMA-2024 SRC-NCCN-MELANOMA-2025

Datos sobre drogas

ClaseAnticuerpo monoclonal anti-CTLA-4 (inhibidor del punto de control inmune)
MecanismoFully human IgG1κ monoclonal antibody targeting cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4 / CD152), an inhibitory checkpoint receptor expressed on activated T cells and constitutively on regulatory T cells (Tregs). By blocking CTLA-4 / B7 (CD80/CD86) engagement at the T-cell priming stage in lymph nodes, ipilimumab releases an early brake on T-cell activation and expands the anti-tumor T-cell repertoire; the IgG1 isotype also depletes intratumoral Tregs via Fc-mediated ADCC. Mechanism is complementary and non-redundant with anti-PD-1 (which acts at the effector phase in the tumor microenvironment), giving clear efficacy gains in combination but also markedly increased irAE burden. Historical first-in-class ICI (FDA 2011 melanoma — Hodi NEJM 2010, first OS-prolonging therapy in metastatic melanoma). Pivotal combination trials: CheckMate-067 (nivo+ipi vs nivo vs ipi melanoma 1L...
Dosificación típicaMelanoma 1L combo: ipilimumab 3 mg/kg IV over 90 minutes every 3 weeks × 4 doses + nivolumab 1 mg/kg IV q3w × 4 doses (induction), then nivolumab monotherapy 240 mg q2w or 480 mg q4w until progression / toxicity / 24 mo. RCC 1L combo: ipilimumab 1 mg/kg + nivolumab 3 mg/kg IV q3w × 4 doses, then nivo mono. Mesothelioma / MSI-H mCRC / HCC / NSCLC 1L combos: per protocol-specific schedules (typically 1 mg/kg q3w or q6w with nivolumab). Adjuvant melanoma monotherapy: 10 mg/kg q3w × 4 then q12w up to 3 yr (largely superseded by nivolumab adjuvant). No formal renal or hepatic dose adjustment (mAb catabolism). Hold for G2-3 irAE; permanently discontinue for G4 irAE, myocarditis, recurrent G3 desp...
Ucrania registradaCierto
NSZU reembolsadoCierto
Ucrania verificada por última vez2026-04-27

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Notas

CTLA-4 irAE pattern differs from PD-1: earlier onset (often within first cycle), more colitis, more hypophysitis, less pneumonitis / thyroiditis (vs PD-1). Cumulative cycle count rather than ongoing exposure drives toxicity (because of long half-life and IgG1 effector functions); after 4-cycle induction the irAE risk trajectory continues for weeks-to-months. Hypophysitis is often permanent — patients require lifelong corticosteroid + thyroid hormone replacement. Baseline workup before any combo with anti- PD-1: TFTs, LFTs, creatinine, cortisol (AM), HbA1c, lipase / amylase, troponin if cardiac risk, HBV/HCV, CT chest, dermatologic exam. Monitor TFTs / LFTs / creatinine / cortisol before each cycle for first 4 cycles then before each nivo dose. Hospitalize early and treat aggressively with high-dose IV methylprednisolone for any G3-4 irAE; escalate to infliximab / mycophenolate / IVIG / ATG for steroid-refractory. Cross-disease entity: ipilimumab is used in melanoma (1L combo nivo, adjuvant mono superseded by nivo), RCC (1L combo nivo intermediate/poor risk), MSI-H/dMMR CRC (combo nivo), HCC (combo nivo post sorafenib), mesothelioma (1L combo nivo), NSCLC (1L combo nivo ± chemo), e...

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