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Talimogene laherparepvec injection

Updated 2 Feb 2023 | Talimogene laherparepvec


Injections of talimogene laherparepvec.

Drugs List

  • IMLYGIC 100million units/ml injection
  • IMLYGIC 1million units/ml injection
  • talimogene laherparepvec 100million units/ml solution for injection vial
  • talimogene laherparepvec 1million units/ml solution for injection vial
  • Therapeutic Indications


    Unresectable metastatic melanoma (stage IIIB, IIIC, and IVM1a)

    Treatment of adults with unresectable melanoma that is regionally or distantly metastatic (Stage IIIB, IIIC and IVM1a) with no bone, brain, lung or other visceral disease.


    Whilst the doses stated below are those recommended by the manufacturer, local cancer network protocols for the relevant indication should be consulted.


    Initial dose: Up to 4 ml talimogene laherparepvec 1 million units/ml injected into lesions in order of size starting with the largest.

    Second dose: Up to 4 ml talimogene laherparepvec 100 million units/ml injected into lesions starting with new lesions that have developed since initial treatment, then prioritise the remaining lesions based on size.

    All subsequent treatments (including re-initiation): Up to 4 ml talimogene laherparepvec 100 million units/ml injected into lesions starting with new lesions that have developed since initial treatment, then prioritise the remaining lesions based on size.

    Dose per Lesion
    Lesion greater than 5 cm long: Up to 4 ml
    Lesion between 2.5 and 5 cm long: Up to 2 ml
    Lesion between 1.5 and 2.5 cm long: Up to 1 ml
    Lesion between 0.5 and 1.5 cm long: Up to 0.5 ml
    Lesion less 0.5 cm long: Up to 0.1 ml


    For intralesional injection.

    Inject intralesionally into cutaneous, subcutaneous and/or nodal lesions that are visible, palpable or detectable by ultrasound.
    Using a single insertion point, inject talimogene laherparepvec along multiple tracks as far as the radial reach of the needle allows within the lesion to achieve even and complete dispersion. Multiple insertion points may be used if the lesion is larger than the radial reach of the needle.
    Apply pressure to the injection site for 30 seconds after injection, then swab with alcohol and cover with an absorbent pad and dry occlusive dressing.


    Children under 18 years
    Severe immunosuppression
    Hereditary fructose intolerance

    Precautions and Warnings

    Autoimmune disease
    History of radiotherapy
    Lesions close to airways
    Restricted sodium intake
    Lesions in poorly vasculatised areas

    Sodium content of formulation may be significant
    Advise ability to drive/operate machinery may be affected by side effects
    Treatment to be initiated and supervised by a specialist
    Presentations with sorbitol unsuitable in hereditary fructose intolerance
    Accidental contact of soln with skin/mucous membranes-rinse well with water
    Advise patient and carers to wear gloves when changing dressings
    Advise patient to avoid touching or scratching the injection site
    Avoid applying topical antiviral to injection site
    Avoid contact with body fluids during and for 30 days after treatment
    Avoid contact with treatment site during and for 30 days after treatment
    Consult local policy on the safe use of anti-cancer drugs
    Record name and batch number of administered product
    Staff: Not to be handled by pregnant staff
    Reactivation of herpes simplex may occur
    Treatment may adversely affect wound healing
    Advise patient to seek advice at first indications of pregnancy
    Female: Ensure adequate contraception during treatment
    Male & Female: Use of condoms recommended during treatment

    Patients should be provided with an alert card to inform them of the risks of treatment.

    Caregivers and close contacts should be warned to avoid contact with injected lesions and/or body fluids of treated patients during the treatment period and for 30 days after the last treatment. Caregivers should wear gloves when changing dressings, pregnant or immunocompromised people should not change the patients dressings.

    Pregnancy and Lactation


    Talimogene laherparepvec is contraindicated during pregnancy.

    The manufacturer recommends avoiding the use of talimogene laherparepvec during pregnancy. Talimogene laherparepvec treatment has not been studied in pregnant women. However infections of wild type HSV-1 have the potential to cross the placental barrier and have been associated with serious adverse effects including multi-organ failure and death.
    Transplacental metastases of malignant melanoma can occur. Talimogene laherparepvec is designed to enter and replicate in the tumour tissue so there is a risk of foetal exposure from tumour tissue that has crossed the placenta.


    Talimogene laherparepvec is contraindicated during breastfeeding.

    Due to the potential for serious toxicity in the nursing infant the manufacturer recommends that breastfeeding is discontinued during treatment. It is not known whether this agent or its metabolites are excreted in human breast milk.

    The effect of concurrent therapies must also be considered.

    Side Effects

    Abdominal discomfort
    Abdominal pain
    Airway obstruction
    Axillary pain
    Back pain
    Deep vein thrombosis (DVT)
    Discharge (injection site)
    Ear pain
    Erythema at injection site
    Exacerbation of psoriasis
    Granulomatous dermatitis
    Groin pain
    Haemorrhage (injection site)
    Hypersensitivity reactions
    Infected neoplasm
    Inflammation (injection site)
    Influenza-like symptoms
    Injection site reactions
    Local infection at injection site
    Oral herpes
    Oropharyngeal pain
    Pain on injection
    Painful extremities
    Peripheral oedema
    Procedural pain
    Swelling (injection site)
    Tumour pain
    Upper respiratory tract infection
    Weight loss
    Wound healing retarded
    Wound secretion


    It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

    The following number will direct the caller to the relevant local centre (0844) 892 0111

    Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( ) or if this is unavailable at the backup site ( ).

    Further Information

    Last Full Review Date: September 2019

    Reference Sources

    Summary of Product Characteristics: Imlygic solution for injection. Amgen Ltd. Revised March 2019.

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