Patient Leaflet Updated 24-Feb-2023 | Amgen Ltd
Imlygic
Imlygic 106 plaque forming units (PFU)/mL solution for injection
Imlygic 108 plaque forming units (PFU)/mL solution for injection
talimogene laherparepvec
1. What Imlygic is and what it is used for
2. What you need to know before and during Imlygic treatment
3. How Imlygic is given
4. Possible side effects
5. How Imlygic is stored
6. Contents of the pack and other information
Imlygic is used to treat adult patients with a type of skin cancer called melanoma that has spread in the skin or to the lymph nodes, when surgery is not an option.
The active ingredient of Imlygic is talimogene laherparepvec. This is a weakened form of herpes simplex virus type-1 (HSV-1), which is commonly called the cold sore virus. To get Imlygic from HSV-1, the virus has been changed so that it multiplies more effectively in tumours than in normal cells. This leads to destruction of infected tumour cells. This medicine also works by helping your immune system to recognise and destroy tumours throughout your body.
Talk to your healthcare professional before being given this medicine.
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. If you have any new or worsening symptoms, tell your healthcare professional immediately. 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.
Accidental spread of Imlygic to yourself and others
Imlygic can be spread to other parts of your body or to other people through direct contact with your body fluids or injection sites.
You should do the following to avoid spreading Imlygic to other areas of your body or to your close contacts (close contacts include household members, caregivers, sex partners, or someone you share a bed with):
You should tell your close contacts to:
If your close contacts are accidentally exposed to Imlygic, they should clean the affected area on their body with soap and water and/or a disinfectant. If they develop signs or symptoms of herpes infection, you should ask them to contact their healthcare professional. If herpetic lesions (blisters or sores) are suspected, patients or close contacts have the option of follow-up testing by the Marketing Authorisation Holder for further characterisation of the infection. Please discuss with your healthcare professional.
Close contacts who are pregnant or who have a weakened immune system, and newborns
Ensure that your close contacts who are pregnant or who have a weakened immune system do not touch injection sites, used dressings and cleaning materials. Keep used dressings and cleaning materials away from newborns.
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. If herpetic lesions (blisters or sores) are suspected, patients or close contacts have the option of follow- up testing by the Marketing Authorisation Holder for further characterisation of the infection. Please discuss with your healthcare professional.
Infection and delayed healing at injection site
Imlygic may cause infection at the injection site. Signs and symptoms of infection include pain, redness, warmth, swelling, discharge or a sore (ulcer), fever, and chills. The injection site may take longer to heal than normal. You should tell your healthcare professional if you notice any of these symptoms.
Autoimmune reactions
Imlygic may cause autoimmune reactions (an over-reaction of the body’s immune system). Some people taking this medicine have developed inflammation in the kidneys (glomerulonephritis), narrowing or blockage of blood vessels (vasculitis), swelling of the lungs (pneumonitis), worsening skin scaling (psoriasis), and areas of skin without any colour (vitiligo). Inform your healthcare professional if you have a history of autoimmune disease.
Plasmacytoma
Imlygic may cause cancerous white blood cells to gather at or near the injection site (plasmacytoma). Inform your healthcare professional if you have a history of blood cancer including multiple myeloma.
Difficulty breathing
If you have a tumour in your neck, your healthcare professional may warn you that you might experience compression of your airways during treatment.
Patients with no prior herpes infection
If you have never had herpes infection in the past, you may be more likely to get fever, chills, and flu-like illness within the period of the first 6 treatments.
Imlygic is not recommended for children and adolescents since the effects of this medicine in people younger than 18 years old are not known.
Tell your healthcare professional if you are taking, have recently taken or might take any other medicines, including medicines, such as acyclovir, to treat or prevent herpes infections. Acyclovir and other anti-viral treatments may decrease the effects of Imlygic.
Ask your healthcare professional for advice if you:
Your healthcare professional will determine if Imlygic is right for you.
If you are pregnant or breast-feeding, ask your healthcare professional for advice before being given this medicine. Imlygic may harm your unborn baby.
Women who are able to become pregnant should use effective contraception to avoid pregnancy during treatment with Imlygic. Talk to your healthcare professional about suitable methods of contraception.
It is not known whether Imlygic passes into breast milk. It is important to tell your healthcare professional if you are breast-feeding or plan to do so. They will then help you decide whether to stop breast-feeding, or whether to stop taking Imlygic, taking into account the benefit of breast-feeding to the baby and the benefit of Imlygic to you.
When you are being treated with Imlygic you may experience symptoms such as dizziness or confusion. This may impair your ability to drive or operate machinery. Use caution when driving or operating machinery until you are certain that this medicine does not adversely affect you.
This medicine contains 7.7 mg sodium (main component of cooking/table salt) in each 1 mL vial. This is equivalent to 0.4% of the recommended maximum daily dietary intake of sodium for an adult.
This medicine contains 20 mg sorbitol in each 1 mL vial.
This medicine is given in a healthcare facility under the supervision of a healthcare professional. The initial recommended dose is up to 4 mL of Imlygic at a concentration of 106 (1 million) PFU/mL.
Subsequent doses will be up to 4 mL of Imlygic at a concentration of 108 (100 million) PFU/mL.
Your healthcare professional will inject this medicine directly into your tumour(s) with a needle and a syringe. Your second injection will be given 3 weeks after the first injection. After that, you will receive injections every 2 weeks for as long as you have the tumour(s).
Your healthcare professional will decide which tumour(s) to inject and may not inject every tumour. Your existing tumour(s) may increase in size and new tumour(s) could appear while you are being treated with Imlygic.
You can expect to be treated with Imlygic for at least 6 months or longer.
It is important for you to keep all your appointments to receive this medicine. If you miss an appointment, ask your healthcare professional when to schedule your next dose.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Keeping wounds clean and dressed can help prevent infections caused by bacteria (cellulitis) at the injection site.
Flu-like illness, fevers and chills have been seen in patients treated with Imlygic. These symptoms generally resolve within the first 72 hours after treatment.
The following side effects have been reported in patients receiving Imlygic:
Very common (may affect more than 1 in 10 people):
Common (may affect up to 1 in 10 people):
Uncommon (may affect up to 1 in 100 people):
If you get any side effects, talk to your healthcare professional. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below). By reporting side effects you can help provide more information on the safety of this medicine.
or search for MHRA Yellow Card in the Google Play or Apple App Store
Imlygic will be stored by the healthcare professionals at your healthcare facility.
Do not use this medicine after the expiry date which is stated on the label and carton after EXP. The expiry date refers to the last day of that month.
Store and transport frozen at -90°C to -70°C.
Store in the original carton in order to protect from light.
This medicinal product contains genetically modified cells. Local guidelines should be followed.
Imlygic is a clear to semi-translucent (106 PFU/mL) or semi-translucent to opaque (108 PFU/mL) liquid. It is supplied as a 1 mL preservative free solution in a single–use vial (cyclic olefin polymer plastic resin) with stopper (chlorobutyl elastomer) and seal (aluminium) with flip-off cap (polypropylene).
The vial cap is colour coded: 106 PFU/mL is light green and 108 PFU/mL is royal blue.
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
This leaflet was last revised in February 2023.
216 Cambridge Science Park, Milton Road, Cambridge, CB4 0WA, UK
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