Talimogene laherparepvec injection
- Drugs List
- Therapeutic Indications
- Dosage
- Administration
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Injections of talimogene laherparepvec.
Drugs List
Therapeutic Indications
Uses
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.
Dosage
Whilst the doses stated below are those recommended by the manufacturer, local cancer network protocols for the relevant indication should be consulted.
Adults
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
Administration
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.
Contraindications
Children under 18 years
Severe immunosuppression
Breastfeeding
Hereditary fructose intolerance
Pregnancy
Precautions and Warnings
Autoimmune disease
History of radiotherapy
Immunosuppression
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
Pregnancy
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.
Lactation
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
Anaemia
Anxiety
Arthralgia
Axillary pain
Back pain
Cellulitis
Chills
Confusion
Constipation
Contusion
Cough
Deep vein thrombosis (DVT)
Dehydration
Depression
Dermatitis
Diarrhoea
Discharge (injection site)
Dizziness
Dyspnoea
Ear pain
Erythema at injection site
Exacerbation of psoriasis
Fatigue
Flushing
Glomerulonephritis
Granulomatous dermatitis
Groin pain
Haemorrhage (injection site)
Headache
Hypersensitivity reactions
Hypertension
Infected neoplasm
Inflammation (injection site)
Influenza-like symptoms
Injection site reactions
Insomnia
Keratitis
Local infection at injection site
Malaise
Myalgia
Nausea
Oral herpes
Oropharyngeal pain
Pain
Pain on injection
Painful extremities
Peripheral oedema
Plasmacytoma
Pneumonitis
Procedural pain
Pyrexia
Rash
Swelling (injection site)
Tachycardia
Tumour pain
Upper respiratory tract infection
Vasculitis
Vitiligo
Vomiting
Weight loss
Wound healing retarded
Wound secretion
Overdosage
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 ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
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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