Peringatan Keamanan

There is no clinical experience with overdose with talimogene laherparepvec FDA Label, L2209. Doses up to 4 mL at a concentration of 10^8 PFU/mL every 2 weeks have been administered in clinical trials with no evidence of dose-limiting toxicity FDA Label, L2209. The maximum dose of talimogene laherparepvec that can be safely administered has not been determined FDA Label, L2209.

Nevertheless, some adverse reactions that are possible from taking talimogene laherparepvec range from fatigue, chills, pyrexia, nausea, influenza-like illness, injection site pain, to even injection site complications (including cellulitis, systemic bacterial infection, and others), herpetic infection, or plasmacytoma at or near the injection site FDA Label, L2209.

As a result, healthcare providers and caregivers must observe the necessary safety precautions when administering talimogene laherparepvec to patients as accidental exposure to the agent can lead to exposure to and transmission of talimogene laherparepvec and herpetic infection in individuals who do not need the medication or in whom the medication is not indicated FDA Label, L2209. Moreover, in the event of a suspected overdose or inadvertent intravenous administration, the patient should be treated symptomatically, ie. with acyclovir or other anti-viral agents and supportive measures instituted as needed FDA Label, L2209.

Talimogene laherparepvec

DB13896

biotech approved experimental investigational

Deskripsi

Talimogene laherparepvec is an oncolytic treatment used in local treatment of unresectable cutaneous, subcutaneous, and nodal lesions in patients with recurrent melanoma. It is a genetically administered herpes simplex virus 1 (HSV-1) that expresses human cytokine granulocyte-macrophage colony stimulating factor (GM-CSF) with antitumor and immune-stimulating activities. It specifically replicates within tumor cells and causes lysis. It was approved by the FDA in 2015 under the market name Imlygic.

In general, talimogene laherparepvec has been modified so that it can infect and multiply inside melanoma cells L2221. The drug subsequently uses the melanoma cells' own machinery to multiply, eventually overwhelming the melanoma cells and killing them L2221. Alternatively, although talimogene laherparepvec also enters healthy cells, it is not designed to multiply inside them L2221.

Struktur Molekul 2D

Struktur tidak tersedia

Peta Jejaring Molekuler
Legenda: Obat • Target • Gen • Enzim • (Panah → menunjukkan arah efek / relasi) • Transporter • Carrier

Profil Farmakokinetik

Waktu Paruh (Half-Life) Readily accessible data regarding the half-life of talimogene laherparepvec is not available, although talimogene laherparepvec DNA has been found in patient subjects' injected tumor through 84 days [FDA Label] and the half-lives of antibody-based therapeutics are often times generally long, on the order of days versus hours with small molecule drugs [T165].
Volume Distribusi Talimogene laherparepvec is a genetically modified and replication-competent HSV-1 virus [L2212]. Therefore, its pharmacokinetics and biodistribution are driven by the specific site of intralesional injection, tumor-selective replication, and release from tumor tissue [L2212]. As a result, the specific pharmacokinetics of the agent, including distribution may vary depending on particular parameters of each unique administration.
Klirens (Clearance) Although readily accessible data regarding the clearance of talimogene laherparepvec is not available, in an ongoing melanoma study, it was determined that the proportion of patients with detectable talimogene laherparepvec DNA in blood and urine was highest during the second cycle of therapy [L2212]. Additionally, even though talimogene laherparepvec DNA was detected in samples from injected lesions in about 90% of patients, only 14% of patients tested positive for infective virus by 50% Tissue Culture Infectious Dose (TCID50) assay, all within 8 days of treatment administration [L2212]. 17% of samples from the exterior occlusive dressing tested positive for talimogene laherparepvec DNA but none tested positive for the presence of infective virus [L2212]. Moreover, only 1 sample had detectable talimogene laherparepvec DNA located on the oral mucosa - but the sample did not test positive for the presence of infective virus [L2212].

Absorpsi

Cellular uptake of talimogene laherparepvec occurs through HSV-1 receptors on both tumor and non-tumor cells following local injection into physical tumors L2212. After injection, the talimogene laherparepvec subsequently replicates intratumorally, where bioavailability and systemic concentration of the agent are not largely predictive of drug substance activity and therefore such data has not been evaluated to any particular degree L2212.

Metabolisme

Talimogene laherparepvec is cleared through general host defense mechanisms like autophagy and adaptive immune responses L2212. The agent is ultimately degraded by common endogenous protein and DNA catabolic pathways L2212. As with other wild-type HSV-1 (herpes simplex virus type-1) infections, a latent pool of talimogene laherparepvec DNA may persist in neuronal cell bodies innervating the injection sites L2212. Consequently, the occurrence of latent infection with talimogene laherparepvec cannot be excluded L2212.

Rute Eliminasi

In an ongoing melanoma study, interim results from 30 patients show that talimogene laherparepvec DNA was detected at transient and low concentrations in blood in 90% of patients and in urine in 20% of patients in the study, which suggests that perhaps at least some portion of the drug is eliminated in the urine FDA Label, L2209, L2212, L2221.

Interaksi Obat

38 Data
Darbepoetin alfa The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Talimogene laherparepvec.
Erythropoietin The risk or severity of Thrombosis can be increased when Erythropoietin is combined with Talimogene laherparepvec.
Peginesatide The risk or severity of Thrombosis can be increased when Peginesatide is combined with Talimogene laherparepvec.
Methoxy polyethylene glycol-epoetin beta The risk or severity of Thrombosis can be increased when Methoxy polyethylene glycol-epoetin beta is combined with Talimogene laherparepvec.
Lidocaine The risk or severity of methemoglobinemia can be increased when Talimogene laherparepvec is combined with Lidocaine.
Ropivacaine The risk or severity of methemoglobinemia can be increased when Talimogene laherparepvec is combined with Ropivacaine.
Bupivacaine The risk or severity of methemoglobinemia can be increased when Talimogene laherparepvec is combined with Bupivacaine.
Cinchocaine The risk or severity of methemoglobinemia can be increased when Talimogene laherparepvec is combined with Cinchocaine.
Dyclonine The risk or severity of methemoglobinemia can be increased when Talimogene laherparepvec is combined with Dyclonine.
Procaine The risk or severity of methemoglobinemia can be increased when Talimogene laherparepvec is combined with Procaine.
Prilocaine The risk or severity of methemoglobinemia can be increased when Talimogene laherparepvec is combined with Prilocaine.
Proparacaine The risk or severity of methemoglobinemia can be increased when Talimogene laherparepvec is combined with Proparacaine.
Meloxicam The risk or severity of methemoglobinemia can be increased when Talimogene laherparepvec is combined with Meloxicam.
Oxybuprocaine The risk or severity of methemoglobinemia can be increased when Talimogene laherparepvec is combined with Oxybuprocaine.
Cocaine The risk or severity of methemoglobinemia can be increased when Talimogene laherparepvec is combined with Cocaine.
Mepivacaine The risk or severity of methemoglobinemia can be increased when Talimogene laherparepvec is combined with Mepivacaine.
Levobupivacaine The risk or severity of methemoglobinemia can be increased when Talimogene laherparepvec is combined with Levobupivacaine.
Diphenhydramine The risk or severity of methemoglobinemia can be increased when Talimogene laherparepvec is combined with Diphenhydramine.
Benzocaine The risk or severity of methemoglobinemia can be increased when Talimogene laherparepvec is combined with Benzocaine.
Chloroprocaine The risk or severity of methemoglobinemia can be increased when Talimogene laherparepvec is combined with Chloroprocaine.
Phenol The risk or severity of methemoglobinemia can be increased when Talimogene laherparepvec is combined with Phenol.
Tetrodotoxin The risk or severity of methemoglobinemia can be increased when Talimogene laherparepvec is combined with Tetrodotoxin.
Benzyl alcohol The risk or severity of methemoglobinemia can be increased when Talimogene laherparepvec is combined with Benzyl alcohol.
Capsaicin The risk or severity of methemoglobinemia can be increased when Talimogene laherparepvec is combined with Capsaicin.
Etidocaine The risk or severity of methemoglobinemia can be increased when Talimogene laherparepvec is combined with Etidocaine.
Articaine The risk or severity of methemoglobinemia can be increased when Talimogene laherparepvec is combined with Articaine.
Tetracaine The risk or severity of methemoglobinemia can be increased when Talimogene laherparepvec is combined with Tetracaine.
Propoxycaine The risk or severity of methemoglobinemia can be increased when Talimogene laherparepvec is combined with Propoxycaine.
Pramocaine The risk or severity of methemoglobinemia can be increased when Talimogene laherparepvec is combined with Pramocaine.
Butamben The risk or severity of methemoglobinemia can be increased when Talimogene laherparepvec is combined with Butamben.
Butacaine The risk or severity of methemoglobinemia can be increased when Talimogene laherparepvec is combined with Butacaine.
Oxetacaine The risk or severity of methemoglobinemia can be increased when Talimogene laherparepvec is combined with Oxetacaine.
Ethyl chloride The risk or severity of methemoglobinemia can be increased when Talimogene laherparepvec is combined with Ethyl chloride.
Butanilicaine The risk or severity of methemoglobinemia can be increased when Talimogene laherparepvec is combined with Butanilicaine.
Metabutethamine The risk or severity of methemoglobinemia can be increased when Talimogene laherparepvec is combined with Metabutethamine.
Quinisocaine The risk or severity of methemoglobinemia can be increased when Talimogene laherparepvec is combined with Quinisocaine.
Ambroxol The risk or severity of methemoglobinemia can be increased when Talimogene laherparepvec is combined with Ambroxol.
Etrasimod The risk or severity of immunosuppression can be increased when Talimogene laherparepvec is combined with Etrasimod.

Target Protein

Granulocyte-macrophage colony-stimulating factor CSF2

Referensi & Sumber

Textbook
  • ISBN: 3319637576
    Sandip Pravin Patel, Razelle Kurzrock (2017). Early Phase Cancer Immunotherapy: Current Cancer Research. Springer.

Contoh Produk & Brand

Produk: 4 • International brands: 0
Produk
  • Imlygic
    Injection, suspension • 1000000 [PFU]/1mL • Intralesional • US • Approved
  • Imlygic
    Injection, suspension • 100000000 [PFU]/1mL • Intralesional • US • Approved
  • Imylgic
    Injection, solution • 1000000 PFU/ml • Intralesional • EU • Approved
  • Imylgic
    Injection, solution • 100000000 PFU/ml • Intralesional • EU • Approved

Sekuens Gen/Protein (FASTA)

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