Brand Name :
Imlygic
Synonyms :
talimogene laherparepvec
Class :
Oncolytic Immunotherapy
Dosage Forms & Strengths
intralesional injectable solution
106 (one million) plaque-formation units (PFU)/mL solution (available for use as a 1-mL single vial)
108 (or 100 million) PFU/mL of the solution (available for use as a 1-mL single vial)
starting dose: about 4 mL concentration of 106 (one million) PFU/mL
Second dose: about 4 mL concentration in 108 (100 million) PFU/mL administered three weeks after the initial therapy
All subsequent therapies (reinitiation included): about 4 mL concentration in 108 (100 million) PFU/mL administered two weeks after the previous therapy
Continue therapy for 6 months or till there are no more injectable lesions.
If unresectable subcutaneous, cutaneous, or nodal lesions develop after a full response, restart therapy.
Determine the dose volume for every lesion
The size of a lesion depends on its longest dimension.
When the lesions are grouped together, they should be injected as a singular lesion based on the following:
Above 5 cm: 4 mL/lesion
Above 2.5 to 5 cm: 2 mL/lesion
Above 1.5 to 2.5 cm: 1 mL/lesion
Above 0.5 to 1.5 cm: 0.5 mL/lesion
Below 0.5 cm: 0.1 mL/lesion
Dose Adjustments
Dosage Modifications
Renal or Hepatic impairment: there are No clinical trials have been conducted on the pharmacokinetics of talimogene laherparepvec with renal or hepatic impairment.
Safety & efficacy not established
Refer to the adult dosing regimen
l-methylfolate-pyridoxal 5′-phosphate-methylcobalamine
may decrease the serum concentration of Quinolones
may decrease the therapeutic effect when combined with lenograstim
may diminish the therapeutic effect when combined with lipegfilgrastim
may increase the adverse effect when combined with antineoplastic agents
may increase the levels of serum concentration
may increase the levels of serum concentration
may increase the levels of serum concentration
may increase the levels of serum concentration
may increase the levels of serum concentration
may increase the levels of serum concentration
may increase the levels of serum concentration
may increase the levels of serum concentration
may increase the levels of serum concentration
may increase the levels of serum concentration
immunosuppressants increase the toxicity of talimogene laherparepvec
immunosuppressants increase the toxicity of talimogene laherparepvec
immunosuppressants increase the toxicity of talimogene laherparepvec
immunosuppressants increase the toxicity of talimogene laherparepvec
immunosuppressants increase the toxicity of talimogene laherparepvec
may have an increasingly adverse effect when combined with talimogene laherparepvec
may have an increasingly adverse effect when combined with talimogene laherparepvec
may have an increasingly adverse effect when combined with talimogene laherparepvec
may have an increasingly adverse effect when combined with talimogene laherparepvec
may have an increasingly adverse effect when combined with talimogene laherparepvec
may have an increasingly adverse effect when combined with talimogene laherparepvec
may have an increasingly adverse effect when combined with talimogene laherparepvec
may have an increasingly adverse effect when combined with talimogene laherparepvec
may have an increasingly adverse effect when combined with talimogene laherparepvec
may have an increasingly adverse effect when combined with talimogene laherparepvec
may have an increasingly adverse effect when combined with talimogene laherparepvec
may have an increasingly adverse effect when combined with talimogene laherparepvec
talimogene laherparepvec: they may increase the toxic effect of immunostimulants
talimogene laherparepvec: they may increase the toxic effect of immunostimulants
talimogene laherparepvec: they may increase the toxic effect of immunostimulants
talimogene laherparepvec: they may increase the toxic effect of immunostimulants
talimogene laherparepvec: they may increase the toxic effect of immunostimulants
may increase the immunosuppressive effect of immunosuppressants
may increase the adverse effect of Immunosuppressants
Antivirals may diminish the therapeutic effect of Talimogene Laherparepvec.
Antivirals may diminish the therapeutic effect of Talimogene Laherparepvec.
Antivirals may diminish the therapeutic effect of Talimogene Laherparepvec.
Antivirals may diminish the therapeutic effect of Talimogene Laherparepvec.
Antivirals may diminish the therapeutic effect of Talimogene Laherparepvec.
antiherpetic antivirals decrease the efficacy of talimogene laherparepvec
it may diminish the excretion rate when combined with corifollitropin alfa resulting in an enhanced serum level
it may diminish the excretion rate when combined with corifollitropin alfa resulting in an enhanced serum level
it may diminish the excretion rate when combined with corifollitropin alfa resulting in an enhanced serum level
it may diminish the excretion rate when combined with corifollitropin alfa resulting in an enhanced serum level
may decrease the therapeutic effects of antiherpetic antivirals
it enhance the risk of pulmonary toxicity
Actions and spectrum:
talimogene laherparepvec is an oncolytic viral therapy used in the treatment of advanced melanoma. It is a modified herpes simplex virus type 1 that selectively replicates in tumor cells, leading to their destruction. T
he virus also encodes granulocyte-macrophage colony-stimulating factor (GM-CSF), which stimulates the immune response against the tumor. The spectrum of talimogene laherparepvec is limited to its treatment of unresectable melanoma lesions in the skin and lymph nodes.
Frequency defined
1-10% (all grades)
Abdominal pain (8.9%)
decreased Weight (5.8%)
Oropharyngeal pain (5.8%)
Dizziness (9.6%)
1-10% (grade 3)
Fatigue (2.1%)
Pain in extremities (1.4%)
Vomiting (1.7%)
>10% (all grades)
Chills (48.6%)
Nausea (35.6%)
Injection site pain (27.7%)
Diarrhea (18.8%)
Myalgia (17.5%)
Pain in extremities (16.4%)
Fatigue (50.3%)
Pyrexia (42.8%)
Influenza like illness (30.5%)
Vomiting (21.2%)
Headache (18.8%)
Arthralgia (17.1%)
Constipation (11.6%)
<1% (grade 3)
Injection site pain
Diarrhea
Myalgia
Headache
decreased Weight
Influenza like illness
Nausea
Abdominal pain
Arthralgia
Black Box Warning:
talimogene laherparepvec carries a black box warning regarding the risk of potential herpetic infections. The use of this medication can result in disseminated herpetic infection, including encephalitis and death. It is important to avoid the contact with herpetic lesions or bodily fluids from treated individuals.
Contraindication/Caution:
Contraindication:
talimogene laherparepvec is contraindicated in individuals with a known history of severe hypersensitivity reactions to the medication or any of its components. Additionally, it should not be administered to patients with hypersensitivity to herpes simplex virus or other components of the product.
The safety and efficacy of talimogene laherparepvec have not been established in immunocompromised patients or individuals with active systemic infections. caution should be given to the potential risks and benefits before initiating treatment in these patient populations.
Caution:
Comorbidities:
The comorbidities associated with talimogene laherparepvec are not well known. However, it should be used under caution in patients with underlying medical conditions, particularly those affecting the immune system or autoimmune disorders.
talimogene laherparepvec is a live virus-based therapy and may potentially cause an exacerbation of autoimmune conditions or increase the risk of infections in patients with compromised immune systems.
Therefore, a thorough evaluation of the patient’s medical history and individual risk-benefit assessment should be performed before initiating treatment with talimogene laherparepvec. Close monitoring and appropriate management of comorbidities are essential during treatment.
Pregnancy consideration: N/A
Lactation: N/A
Pregnancy category:
Pharmacology:
talimogene laherparepvec is an oncolytic viral therapy designed to selectively replicate within tumor cells and induce tumor cell death. It is derived from the herpes simplex virus type 1 (HSV-1) and has been genetically modified to express the granulocyte-macrophage colony-stimulating factor (GM-CSF). The GM-CSF expression enhances the immune response against tumor cells by promoting the activation and proliferation of dendritic cells, T-cells, and macrophages.
Pharmacodynamics:
Pharmacokinetics:
Absorption
talimogene laherparepvec is directly injected into tumor lesions, allowing it to directly access the tumor cells. It is designed to replicate within the tumor cells and spread to adjacent cancerous tissue.
Distribution
talimogene laherparepvec distribution is primarily limited to the injected tumor site and surrounding tissues. It does not have significant systemic distribution.
Metabolism
talimogene laherparepvec is designed to replicate within tumor cells, and its replication and metabolic processes occur within the tumor microenvironment. The exact details of its intracellular metabolism are not typically described in the literature.
Elimination and excretion
talimogene laherparepvec is not excreted in the traditional sense, as it remains localized within the tumor site and surrounding tissues. Over time, the virus-infected tumor cells may undergo lysis and be eliminated by the body’s natural processes.
Administration:
talimogene laherparepvec is administered through direct injection into tumor lesions. The injection is typically performed by a healthcare professional, such as an oncologist or surgeon, who has experience with this type of procedure. The injection is delivered directly into visible tumor lesions using a fine needle.
The exact dosage and frequency of administration may vary depending on factors such as the location and size of tumor and the patient’s overall health and treatment response. The administration procedure aims to deliver the viral therapy directly to the tumor site, allowing it to infect and replicate within the cancer cells.
Patient information leaflet
Generic Name: talimogene laherparepvec
Pronounced: [ tal-IM-oh-jeen-la-HER-pa-REP-vek ]
Why do we use talimogene laherparepvec?
talimogene laherparepvec is a medication used for the treatment of certain types of skin cancer, specifically advanced melanoma that cannot be surgically removed. It is used in patients with unresectable cutaneous, subcutaneous, and nodal lesions. The medication is a genetically modified herpes simplex virus type 1 that selectively replicates within tumor cells and stimulates an immune response against the cancer cells.
By injecting talimogene laherparepvec directly into the tumor lesions, it can help shrink the size of the tumors, reduce their spread, and potentially improve overall survival rates. This therapy is typically used when surgical removal of the cancer is not feasible or as an adjunct to surgery in cases of high-risk melanoma.
ADVERTISEMENT
