Active Ingredient: Talimogene laherparepvec
Talimogene laherparepvec is indicated for the 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.
For this indication, competent medicine agencies globally authorize below treatments:
Intratumor
4,000,000 - 400,000,000 [PFU]
From 4,000,000 To 400,000,000 [PFU] once every 14 day(s)
4,000,000 [PFU]
400,000,000 [PFU]
Talimogene laherparepvec is provided in single use vials of 1 mL each in two different concentrations:
The total injection volume for each treatment visit should be up to a maximum of 4 mL. The initial recommended dose is up to a maximum of 4 mL of talimogene laherparepvec at a concentration of 106 (1 million) PFU/mL. Subsequent doses should be administered up to 4 mL of talimogene laherparepvec at a concentration of 108 (100 million) PFU/mL.
The recommended dosing schedule for talimogene laherparepvec is shown in table 1.
Table 1. Recommended dosing schedule for Talimogene laherparepvec:
| Treatment visit | Treatment interval | Maximum total injection volume | Dose concentrations | Prioritisation of lesions to be injected |
|---|---|---|---|---|
| Initial | - | Up to 4 ml | 106 (1 million) PFU/ml | Inject largest lesion(s) first. |
| Prioritise injection of remaining lesions based on lesion size until maximum injection volume is reached. | ||||
| Second | 3 weeks after initial treatment | Up to 4 ml | 108 (100 million) PFU/ml | First inject any new lesions (lesions that may have developed since initial treatment). |
| Prioritise injection of remaining lesions based on lesion size until maximum injection volume is reached. | ||||
| All subsequent treatment visits (including re-initiation) | 2 weeks after previous treatment | Up to 4 ml | 108 (100 million) PFU/ml | First inject any new lesions (lesions that may have developed since previous treatment). |
| Prioritise injection of remaining lesions based on lesion size until maximum injection volume is reached. |
The volume of talimogene laherparepvec to be injected into each lesion is dependent on the size of the lesion and should be determined according to table 2. The total injection volume for each treatment session should be up to a maximum of 4 mL.
Table 2. Selection of talimogene laherparepvec injection volume based on lesion size:
| Lesion size (longest dimension) | Talimogene laherparepvec injection volume |
|---|---|
| >5 cm | up to 4 ml |
| >2.5 cm to 5 cm | up to 2 ml |
| >1.5 cm to 2.5 cm | up to 1 ml |
| >0.5 cm to 1.5 cm | up to 0.5 ml |
| ≤0.5 cm | up to 0.1 ml |
Patients may experience increase in size of existing lesion(s) or the appearance of a new lesion prior to achieving a response. As long as there are injectable lesion(s) remaining, talimogene laherparepvec should be continued for at least 6 months unless the physician considers that the patient is not benefitting from talimogene laherparepvec treatment or that other treatment is required.
Talimogene laherparepvec treatment may be reinitiated if new lesions appear following a complete response and the physician considers that the patient will benefit from treatment.
Talimogene laherparepvec is to be administered by intralesional injection into cutaneous, subcutaneous, and/or nodal lesions that are visible, palpable or detectable by ultrasound guidance.
Liability Disclaimer : RxReasoner has utilized reasonable care in providing content and services that are accurate, complete and up to date. However, RxReasoner does not accept any responsibility or liability about it. The content and services of RxReasoner are for informational purposes only and they are not intended to be a substitute for the knowledge, expertise, skill, and judgment of physicians, pharmacists, nurses, or other healthcare professionals involved in patient care. RxReasoner offers no medical advice. Users are responsible for the use of the provided content. A shown indication or treatment should not be construed to indicate that the medication is safe, appropriate, or effective in any given patient or under any particular circumstances. The absence of an indication or treatment should not roule out the existence of other appropriate medications. Always seek the advice of a physician or other qualified health provider with any questions you may have regarding a medical condition or medicament. RxReasoner is not liable for any damages allegedly sustained arising out of the use of its content and services.
