Drug reference
Talimogene laherparepvec is an oncolytic immunotherapy derived from herpes simplex virus type-1 Immune system and malignant disease which causes tumour lysis and the release of tumour- derived antigens.
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Unresectable metastatic melanoma with no bone, brain, or visceral disease ▶BY INTRALESIONAL INJECTION ▶Adult: (consult product literature)
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Severely immunocompromised patients CONTRA-INDICATIONS, FURTHER INFORMATION Manufacturer advises avoid in patients who are severely immunocompromised, for example, those with severe congenital or acquired cellular and/or humoral immune deficiency—may be at increased risk of disseminated herpetic infection.
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Administration of antivirals (may interfere with effectiveness of Imlygic ®). autoimmune disease. immunocompromised patients. multiple myeloma (risk of plasmacytoma at injection site) CAUTIONS, FURTHER INFORMATION ▶Immunocompromised patients Manufacturer advises caution in patients who are immunocompromised, for example, those with HIV/AIDS, leukaemia, lymphoma, common variable immunodeficiency, or in those who require chronic high-dose steroids or other immunosuppressive agents—risk of disseminated herpetic infection.
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NICE decisions ▶Talimogene laherparepvec for treating unresectable metastatic melanoma (September 2016) NICE TA410 Talimogene laherparepvec is recommended as an option for treating unresectable, regionally or distantly metastatic (Stage IIIB, IIIC or IVM1a) melanoma that has not spread to bone, brain or other internal organs, only if: . treatment with systemically administered immunotherapies is not suitable and, . the manufacturer provides talimogene laherparepvec with the discount agreed in the patient access scheme. Patients whose treatment was started within the NHS before this guidance was published should have the option to continue treatment, without change to their funding arrangements, until they and their clinician consider it appropriate to stop. www.nice.org.uk/guidance/ta410
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▶Common or very common Anaemia. anxiety. arthralgia. chills. confusion. constipation. cough. deep vein thrombosis. dehydration. depression. diarrhoea. dizziness. dyspnoea exertional. ear pain. fatigue. fever. flushing. gastrointestinal discomfort. headache. hypertension. immune-mediated events. increased risk of infection. influenza like illness. insomnia. malaise. myalgia. nausea. neoplasm complications. oropharyngeal pain. pain. peripheral oedema. procedural pain. secretion discharge. skin reactions. tachycardia. vomiting. weight decreased. wound complications ▶Uncommon Glomerulonephritis. injection site plasmacytoma. post procedural infection. respiratory disorders. vasculitis SIDE-EFFECTS, FURTHER INFORMATION Necrosis or ulceration of tumour tissue may occur, and impaired healing at the injection site has been reported. Manufacturer advises careful wound care and infection precautions; if persistent infection or delayed healing develops, the risks and benefits of continuing treatment should be considered.
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Manufacturer advises use of latex condoms.
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Manufacturer advises avoid—no information available.
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Manufacturer advises avoid—no information available.
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Consult product literature for information on injection technique. l HANDLING AND STORAGE Manufacturer advises caution in handling—risk of accidental exposure; avoid preparation or administration if immunocompromised or pregnant. For further information, see the Physician’s Brochure provided by the manufacturer. Store and transport frozen at -90ºC to -70ºC—consult product literature for further information on thawing and storage after thawing.
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There can be variation in the licensing of different medicines containing the same drug. Solution for injection EXCIPIENTS: May contain Sorbitol ELECTROLYTES: May contain Sodium ▶Imlygic (Amgen Ltd) A Talimogene laherparepvec 1 million plaque forming units per 1 ml Imlygic 1million plaque forming units/1ml solution for injection vials | 1 vial P £1,670.00 Talimogene laherparepvec 100 million plaque forming units per 1 ml Imlygic 100million plaque forming units/1ml solution for injection vials | 1 vial P £1,670.00 IMMUNOSTIMULANTS › INTERFERONS
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Manufacturer advises that patients and carers should be informed about the risks of treatment, advised to avoid touching or scratching injection sites, and to keep these sites covered with occlusive dressings. Close contacts should avoid direct Immune system and malignant disease contact with injected lesions or body fluids of treated patients during treatment and for up to 30 days after last treatment—if exposed, clean the affected area and seek medical attention if symptoms of herpetic infection develop; close contacts who are immunocompromised or pregnant should not be exposed to potentially contaminated materials. For further information, see the Information for Patients and Close Contacts provided by the manufacturer. Provide patient alert card—record batch number for each administration of Imlygic ®. Driving and skilled tasks Manufacturer advises that patients and their carers should be counselled on the effects on driving and performance of skilled tasks—risk of dizziness and confusion.
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(consult product literature)
First-line fragment. Read the complete Indications and Dose section above.
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