Irinotecan Liposomal Brand Name– ONIVYDE
What is Irinotecan Liposomal
Irinotecan liposomal (Onivyde; IHL-305; CPX-1) is a topoisomerase I inhibitor.
It is indicated, in combination with 5-fluorouracil (5-FU) and leucovorin (LV), for the treatment of metastatic adenocarcinoma of the pancreas that has progressed after gemcitabine-based therapy.
In a randomized, open-label clinical trial, the combination of irinotecan liposome plus 5-FU/LV (n = 117) significantly improved overall survival (OS) over 5-FU/LV alone (n = 119) in patients with gemcitabine-resistant, metastatic pancreatic cancer (6.1 vs. 4.2 months; p = 0.014).
Irinotecan liposomal is not approved for use as a single agent for the treatment of patients with metastatic adenocarcinoma of the pancreas, as it showed no improvements over 5-FU/LV in this clinical trial (HR 1; p = 0.97).
It carries a black box warning for severe neutropenia resulting in fatal neutropenic sepsis and severe diarrhea.
Irinotecan liposomal was approved by the FDA in October 2015.
Indications
- pancreatic cancer
For the treatment of metastatic pancreatic cancer, in combination with 5-fluorouracil (5-FU) and leucovorin, in patients with disease progression after gemcitabine-based therapy
Side Effects
- alopecia
- alopecia
- anaphylactoid reactions
- anemia
- anemia
- anorexia
- anorexia
- asthenia
- asthenia
- bradycardia
- cough
- dehydration
- dehydration
- diaphoresis
- diarrhea
- diarrhea
- dyspnea
- edema
- elevated hepatic enzymes
- elevated hepatic enzymes
- fatigue
- fatigue
- fever
- fever
- flushing
- hypersalivation
- hypoalbuminemia
- hypoalbuminemia
- hypocalcemia
- hypocalcemia
- hypokalemia
- hypokalemia
- hypomagnesemia
- hyponatremia
- hyponatremia
- hypophosphatemia
- hypophosphatemia
- infection
- infection
- infusion-related reactions
- lacrimation
- lymphopenia
- lymphopenia
- miosis
- nausea
- nausea
- neutropenia
- neutropenia
- oral ulceration
- pneumonitis
- pruritus
- rash
- renal failure (unspecified)
- rhinitis
- stomatitis
- stomatitis
- thrombocytopenia
- thrombocytopenia
- urticaria
- vomiting
- vomiting
- weight loss
- weight loss
Monitoring Parameters
- CBC with differential
- LFTs
- pregnancy testing
Contraindications
- Asian patients
- bone marrow suppression
- breast-feeding
- chemotherapy
- contraception requirements
- dehydration
- diarrhea
- ensure correct formulation selection
- fungal infection
- GI obstruction
- herpes infection
- infection
- infertility
- infusion-related reactions
- male-mediated teratogenicity
- neutropenia
- pneumonitis
- pregnancy
- pregnancy testing
- radiation therapy
- reproductive risk
Interactions
- Acalabrutinib
- Amoxicillin; Clarithromycin; Lansoprazole
- Amoxicillin; Clarithromycin; Omeprazole
- Apalutamide
- Atazanavir
- Atazanavir; Cobicistat
- Atracurium
- Atropine; Hyoscyamine; Phenobarbital; Scopolamine
- Belladonna Alkaloids; Ergotamine; Phenobarbital
- Bosentan
- Brigatinib
- Cabozantinib
- Carbamazepine
- Carvedilol
- Ceritinib
- Chloramphenicol
- Cisatracurium
- Clarithromycin
- Cobicistat
- Conivaptan
- Darolutamide
- Darunavir
- Darunavir; Cobicistat
- Darunavir; Cobicistat; Emtricitabine; Tenofovir alafenamide
- Dasabuvir; Ombitasvir; Paritaprevir; Ritonavir
- Delavirdine
- Dextromethorphan; Quinidine
- Elvitegravir; Cobicistat; Emtricitabine; Tenofovir Alafenamide
- Elvitegravir; Cobicistat; Emtricitabine; Tenofovir Disoproxil Fumarate
- Enzalutamide
- Flibanserin
- Fosamprenavir
- Fosphenytoin
- Fostamatinib
- Gemfibrozil
- Glecaprevir; Pibrentasvir
- grapefruit juice
- Idelalisib
- Indinavir
- Isoniazid, INH; Pyrazinamide, PZA; Rifampin
- Isoniazid, INH; Rifampin
- Itraconazole
- Ketoconazole
- Letermovir
- Lomitapide
- Lopinavir; Ritonavir
- Lumacaftor; Ivacaftor
- Mefloquine
- Mephobarbital
- Mifepristone
- Mitotane
- Mivacurium
- Nefazodone
- Nelfinavir
- Neratinib
- Ombitasvir; Paritaprevir; Ritonavir
- Osimertinib
- Palifermin
- Pancuronium
- Penicillamine
- Phenobarbital
- Phenytoin
- Posaconazole
- Primidone
- Prochlorperazine
- Propafenone
- Quinidine
- Regorafenib
- Ribociclib
- Ribociclib; Letrozole
- Rifampin
- Ritonavir
- Rocuronium
- Saquinavir
- Sofosbuvir; Velpatasvir
- Sofosbuvir; Velpatasvir; Voxilaprevir
- Sorafenib
- St. John’s Wort, Hypericum perforatum
- Succinylcholine
- Tafamidis
- Telithromycin
- Temsirolimus
- Tipranavir
- Tuberculin Purified Protein Derivative, PPD
- Tucatinib
- Vecuronium
- Voriconazole
