Imlygic
Educational Risk Minimisation Materials to help reduce the risk associated with using this medicine.
IMLYGIC Information for Patients and Close Contacts
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
IMLYGIC Patient Alert Card
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
Send us feedback
If you would like to make a comment or send us feedback on this material, click here.
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information.
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine.
This PIL is in PDF format and so you must have a PDF reader installed on your device to read it.
Text only version for the visually impaired
Below is a text only representation of the Patient Information leaflet. The original may contain images or tables and can be viewed in PDF format using the link above. This PIL may be available from the RNIB in large print, Braille or audio CD. For further information please call the RNIB Medicine Leaflet line on 0800 198 5000. The product code(s) for this leaflet is/are: EU/1/15/1064/002, EU/1/15/1064/001.
Imlygic
Package leaflet: Information for the patient
Imlygic 106 plaque forming units (PFU)/mL solution for injection
Imlygic 108 plaque forming units (PFU)/mL solution for injection
talimogene laherparepvec
▼This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your healthcare professional (doctor or nurse).
- If you get any side effects, talk to your healthcare professional. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet
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
1. What Imlygic is and what it is used for
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. Imlygic also works by helping your immune system to recognise and destroy tumours throughout your body.
2. What you need to know before and during Imlygic treatment
You will not be given Imlygic:
- if you are allergic to talimogene laherparepvec or any of the other ingredients of this medicine (listed in section 6).
- if your healthcare professional has told you that you have a severely weakened immune system.
Warnings and precautions
Talk to your healthcare professional before being given Imlygic.
Patients with weakened immune systems
Life-threatening herpes infection may occur in patients 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.
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):
- Avoid direct contact between your injection sites or body fluids (e.g. blood and urine) and close contacts (e.g. use latex condoms when engaging in sexual activity, avoid kissing close contacts if either of you has an open mouth sore) while you are being treated with Imlygic and up to 30 days after your last dose.
- Avoid touching or scratching the injection sites.
- Keep injection sites covered with airtight and watertight dressings at all times. Apply the dressing as instructed by your healthcare professional. If the dressing comes loose or falls off, replace it immediately with a clean dressing.
- Place all used dressings and cleaning materials in a sealed plastic bag and throw them away in your household waste.
You should tell your close contacts to:
- Avoid direct contact with your body fluids or injection sites.
- Wear gloves while changing your dressing.
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.
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 pain, burning or tingling in a blister around the mouth or genitals, or 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, you should follow standard hygiene practices to prevent viral transmission to others.
Infection and delayed healing at Imlygic 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 Imlygic 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 collect 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 with Imlygic.
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 illnesses within the period of the first 6 treatments with Imlygic.
Children and adolescents
Imlygic is not recommended for children and adolescents since the effects of Imlygic in people younger than 18 years old are not known.
Other medicines and Imlygic
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.
Pregnancy and breast-feeding
Ask your healthcare professional for advice if you:
- think you may be pregnant
- or are planning to have a baby.
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 is excreted in 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.
Driving and using machines
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 Imlygic does not adversely affect you.
Imlygic contains sodium and sorbitol
Imlygic contains approximately 30 mg (1.3 mmol) sodium in each 4 mL dose. This should be taken into consideration by patients on a controlled sodium diet.
Imlygic contains sorbitol (E420), if you have been told by your healthcare professional that you have a reaction to some sugars, contact your healthcare professional before taking this medicinal product.
3. How Imlygic is given
Imlygic 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 Imlygic directly into your tumour(s) with a needle and 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.
If you miss a dose of Imlygic
It is important for you to keep all your appointments to receive Imlygic. If you miss an appointment, ask your healthcare professional when to schedule your next dose.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Infection caused by bacteria (cellulitis) at the injection site has been commonly seen in patients receiving Imlygic. Keeping wounds clean and dressed can help prevent these types of infections.
Very commonly, flu-like illnesses, 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):
- Tissue swelling (peripheral oedema)
- Headache
- Cough
- Vomiting, diarrhoea, constipation, nausea
- Muscle pain (myalgia), painful/swollen joints (arthralgia), limb pain
- Flu-like illness, fever (pyrexia), chills, fatigue, pain
- Pain, redness, bleeding, swelling, inflammation, secretion, discharge, and warmth at the injection site
Common (may affect up to 1 in 10 people):
- Infection caused by bacteria (cellulitis), cold sores (oral herpes)
- Tumour pain, infected tumour
- Low red blood cell numbers (anaemia)
- Side effects related to the immune system such as narrowing or blockage of blood vessels (vasculitis), inflammation of the lungs (pneumonitis), worsening scaling of the skin (worsening psoriasis), and inflammation of kidneys (glomerulonephritis)
- Dehydration
- Confusion, anxiety, depression, dizziness, difficulty sleeping (insomnia)
- Pain in ear, throat, abdomen, groin, back and underarm
- Faster heart rate at rest (tachycardia)
- Blood clot within a deep vein (deep vein thrombosis), high blood pressure (hypertension), redness in the face (flushing)
- Shortness of breath (dyspnoea exertional), upper respiratory infection
- Abdominal discomfort
- Areas of skin without any colour (vitiligo), rash, inflamed skin (dermatitis)
- Generally feeling unwell
- Weight loss
- Wound complication, secretion, bruising (contusion), pain after procedure
Uncommon (may affect up to 1 in 100 people):
- Incision site infection
- Cancerous white blood cells at or near the injection site (plasmacytoma).
- Eye infection caused by herpes (keratitis herpetic)
- Compressed airways (obstructive airways disorder)
Reporting of side effects
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.
United Kingdom
Ireland
Earlsfort Terrace
IRL - Dublin 2
Malta
The Medicines Authority
Post-Licensing Directorate
203 Level 3
Rue D'Argens
GŻR-1368 Gżira
5. How Imlygic is stored
Imlygic will be stored by the healthcare professionals at your healthcare facility.
Keep this medicine out of the sight and reach of children.
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.
6. Contents of the pack and other information
What Imlygic contains
- The active substance is talimogene laherparepvec.
Each vial contains 1 extractable mL of solution at a nominal concentration of 1 x 106 (1 million) plaque forming units (PFU)/mL or 1 x 108 (100 million) PFU/mL. - The other ingredients are di-sodium phosphate dihydrate, sodium dihydrogen phosphate dihydrate, sodium chloride, myo-inositol, sorbitol (E420), water for injections (see section 2).
What Imlygic looks like and contents of the pack
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.
Marketing Authorisation Holder and Manufacturer
Minervum 7061
NL-4817 ZK Breda
The Netherlands
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
This leaflet was last revised in July 2016.
Other sources of information
Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Amgen Ltd
Address : 240 Cambridge Science Park, Milton Road, Cambridge, CB4 0WD
Telephone : +44 (0)1223 420 305
Fax : +44 (0)1223 426 314
Medical Information Direct Line : +44 (0)1223 436 441
Medical Information e-mail : gbinfoline@amgen.com
Customer Care direct line : +44 (0)808 0100 321
Medical Information Fax : +44 (0)1223 426 314
Legal categories
- POM
Active ingredients/generics
- talimogene laherparepvec
Summaries of Product Characteristics (SPCs):