Imlygic

Life-threatening herpes infection

Life-threatening herpes infection including spreading to any part of the body far from the injection site (disseminated herpetic infection) may occur. may occur in patients. If you have any new or worsening symptoms, tell your healthcare professional immediately with weakened immune systems. Tell your healthcare professional if you have or have ever had a weakened immune system, if you have HIV/AIDS, blood or bone marrow cancer, or if you are taking steroids or other medicines that suppress your immune system because you may be at increased risk of life-threatening herpes infection.

Herpes infection

Cold sores or a more serious herpes infection may occur during or after treatment with Imlygic. Signs and symptoms related to treatment with Imlygic may be the same as for herpes infections, and include but are not limited to pain, burning or tingling in a blister around the mouth, genitals, on the fingers or ears, eye pain, light sensitivity, discharge from the eyes, or blurry vision, weakness in arms or legs, extreme drowsiness (feeling sleepy), and mental confusion. If you have these signs or any new symptoms, you should follow standard hygiene practices to prevent viral transmission to others.

Section 4.4 Special warnings and precautions for use

Disseminated Herpetic Infection Immunocompromised patients

Disseminated herpetic infection, including serious cases of disseminated herpetic infection, have been reported in patients treated with Imlygic (see section 4.8).

Imlygic has not been studied in immunocompromised patients.

Based on epidemiological data, immunocompromised patients (such as those with HIV/AIDS, leukaemia, lymphoma, common variable immunodeficiency, or who require chronic high-dose steroids or other immunosuppressive agents) may be at increased risk of disseminated herpetic infection. Consider the risks and benefits of treatment before administering Imlygic to immunocompromised patients.

Based on animal data, patients who are severely immunocompromised may be at an increased risk of disseminated herpetic infection and should not be treated with Imlygic (see sections 4.3 and 5.3).

Disseminated herpetic infection may also occur in immunocompromised patients (such as those with HIV/AIDS, leukaemia, lymphoma, common variable immunodeficiency, or who require chronic high-dose steroids or other immunosuppressive agents). The risks and benefits of treatment should be considered before administering Imlygic to these patients.

Herpetic infection in Imlygic-treated patients

In clinical studies, herpetic Herpetic infections (including but not limited to cold sores and herpes keratitis) and serious cases of disseminated herpetic infections have been reported in patients treated with Imlygic (see section 4.8).

Section 4.8 Undesirable Effects

Common

Cellulitis*, Oral herpes, Herpes infections**

** Herpetic infections (including, but not limited to Oral herpes).

Update to include new information on the Vial Thaw Time:

Before use, thaw frozen Imlygic vials at room temperature (20°C to 25°C) until Imlygic is liquid (approximately 30 minutes). The time to achieve complete vial thaw is expected to be 30 to 70 minutes, depending on the ambient temperature. Gently swirl.

Update to Section 6.6 to include new information on the Vial Thaw Time:

Before use, thaw frozen Imlygic vials at room temperature (20°C to 25°C) until Imlygic is liquid (approximately 30 minutes). The time to achieve complete vial thaw is expected to be 30 to 70 minutes, depending on the ambient temperature. Gently swirl.

Update to RMM following renewal of marketing authorisation

Update to RMM following renewal of marketing authorisation

Update to RMM following renewal of marketing authorisation

Editorial updates to align with latest QRD template

Removal of black triangle

Addition of final results from study to investigate talimogene laherparepvec DNA in blood, urine, injection site, exterior of the occlusive dressings, oral mucosa, anogenital area, and suspected herpetic lesions.

This brochure contains important safety information you should know before and during IMLYGIC treatment. Please read this information carefully before and after each treatment. Please also read the IMLYGIC Package Leaflet. To request a copy of this guide, please contact Amgen Medical Information on +44 (0) 1223 436441

This IMLYGIC patient alert card includes contact details of the IMLYGIC prescriber, treatment start date, IMLYGIC batch number and information on the potential development of herpetic lesions and the importance of reporting ADRs. To request a copy of the patient card, please contact Amgen Medical Information on +44 (0) 1223 436441

This educational brochure contains important information regarding the risks of transmission and herpetic complications, and safe use and handling of IMLYGIC.This brochure does not contain a comprehensive description of the risks associated with IMLYGIC. Please read the current Summary of Product Characteristics (SmPC) for IMLYGIC. To request a copy of the brochure, please contact Amgen Medical Information on +44 (0) 1223 436441

• In section 4.4 (special warnings and precautions for use), addition of statement to help improve the overall monitoring of potential herpetic infections
• In section 10, the date of revision has been updated to July 2018

Shelf life updated to 5 years

Reduction to stability period for thawed product

Addition of ATC code (L01XX51) 
New storage condition for finished product in vials after thawing at 25°C: 17 hours for 10⁶ PFU/mL and 85 hours for 10⁸ PFU/mL.

Shelf-life of 8 hours for 10⁶ PFU/mL and 16 hours at 10⁸ PFU/mL at 2°C to 8°C for finished product packed in administration syringes

Shelf-life of: 2.5 hours for 10⁶ PFU/mL and 4 hours for 10⁸ PFU/mL at 25°C for finished product in administration syringe

Extend storage time of finished product in vials after thawing from 12 hours to 31 hours for 10⁶ PFU/mL and from 48 hours to 6 weeks (42 days) for 10⁸ PFU/mL at 2°C to 8°C.

Add needle gauge information to section 4.2