10 6 plaque-forming units (PFU) / ml, 10 8 plaque-forming units (PFU) / ml injection solution
talimogen laherparepvek
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, which has spread to the skin or to the lymph nodes and cannot be removed by surgery.
The active substance in Imlygic is talimogen laherparepvek. It is an attenuated form of the herpes simplex virus type-1 ( HSV -1 ), commonly known as the cold sore virus. To create Imlygic from HSV -1, the virus has been altered so that it multiplies more efficiently in tumor cells than in normal cells. This destroys infected tumor cells. This drug also works by helping the immune system recognize and destroy tumors in your body.
2. What you need to know before and during treatment with Imlygic
You will not receive Imlygic:
- if you are allergic to talimogen laherparepvek or any of the other ingredients of this medicine (listed in section 6).
- if your doctor has told you that you have a severely weakened immune system.
Warnings and cautions
Talk to your doctor before receiving this medicine.
Patients with weakened immune systems
Life-threatening herpes infection can occur in patients with compromised immune systems. Tell your doctor if you have or have had a weakened immune system if you have HIV / AIDS, blood cancer, bone marrow cancer, or if you are taking cortisone or any other medicine that weakens the immune system.
Accidental spreading of Imlygic to yourself and others
Imlygic can spread to other parts of the body and to other people you have direct contact with via body fluids or injection sites.
Follow the instructions below to avoid spreading Imlygic to other parts of the body or to relatives (eg family members, caregivers, sex partners, or someone you share a bed with):
- Make sure that the injection sites and body fluids (eg blood and urine) do not come into direct contact with your relatives (eg use condoms during sexual intercourse, avoid kissing relatives if any of you have an open cold sore) while you be treated with this medicine and for up to 30 days after your last dose .
- Avoid touching or scratching the injection sites.
- The injection sites should always be kept covered with airtight and waterproof dressings. Put on the bandage according to the instructions you have received from the healthcare staff. If the dressing comes loose or falls off, apply a new dressing immediately.
- Put all used dressings and detergent in a plastic bag, seal it and throw it in the household waste.
Tell your loved ones to:
- Avoid direct contact with your body fluids and injection sites.
- Wear gloves when changing your bandages.
If relatives come into contact with Imlygic by mistake, they should wash the affected area with soap and water and/or a disinfectant. If they experience signs or symptoms of a herpes infection, ask them to consult a doctor. In case of suspected herpes lesions (blisters or wounds), patients or relatives have the opportunity to have follow-up tests performed by the holder of the marketing authorization for further determination of infection. Discuss this with your doctor.
Relatives who are pregnant or who have a weakened immune system and newborn children
Make sure that relatives who are pregnant or have a weakened immune system do not touch your injection sites, use bandages or detergent. Do not allow newborn babies to come in contact with used dressings and detergents.
Herpes infection
Cold sores or a more serious herpes infection can occur during or after treatment with Imlygic. Signs and symptoms associated with Imlygic treatment can be the same as in a herpes infection and include pain, a burning sensation or tingling in blisters around the mouth, genitals, fingers or ears, eye pain, photosensitivity, watery eyes, blurred vision, weakness in arms or legs, very severe drowsiness (feeling sleepy), and confusion. If you experience such symptoms, follow normal hygiene procedures to prevent the spread of the virus to others. In case of suspected herpes lesions (blisters or wounds), patients or relatives have the opportunity to have follow-up tests done by the holder of the marketing authorization for further determination of infection. Discuss this with your doctor.
Infection and delayed healing at the injection site
Imlygic may cause infection at the injection site. Signs and symptoms of infection are pain, redness, feeling hot, swelling, discharge or sores, fever, and chills. It may take longer than usual for the injection site to heal. Tell your doctor if you get any of these symptoms.
Autoimmune reactions
Imlygic can cause autoimmune reactions (an overreaction in the body’s immune system). Some people who use this medicine have suffered from inflammation of the kidneys ( glomerulonephritis ), constricted or blocked blood vessels ( vasculitis ), swelling of the lungs ( pneumonitis ), worsening of the skin ( psoriasis ), and areas of colorless skin (vitiligo). Tell your healthcare provider if you have or have had an autoimmune disease.
Plasmocytoma
Imlygic may cause white blood cell cells to accumulate at or near the injection site (plasmocytoma). Tell your doctor if you have or have had blood cancer, including multiple myeloma.
Breathing difficulties
If you have a tumor on your neck, your doctor may warn you that your airways may feel narrow during treatment.
Patients without any previous herpes infection
If you have never had a herpes infection before, you are more likely to get a fever, chills, and flu-like symptoms during the period of the first 6 treatments.
Children and young people
Imlygic is not recommended for use in children and adolescents as the effects of this medicine in people under 18 years of age are not known.
Other medicines and Imlygic
Tell your doctor if you are taking, have recently taken, or might take any other medicines. This also applies to medicines, such as aciclovir, which are used to treat or prevent herpes infections. Acyclovir and other treatments for the virus can reduce the effects of Imlygic.
Pregnancy, breastfeeding and fertility
Ask a doctor for advice:
- if you think you are pregnant
- if you are planning to have children.
Your doctor will decide if Imlygic is right for you.
If you are pregnant or breastfeeding, talk to your doctor before taking this medicine. Imlygic can harm the unborn baby.
Women who have the ability to become pregnant should use an effective contraceptive during treatment with Imlygic. Talk to your doctor about appropriate contraceptive methods.
It is not known if Imlygic passes into breast milk. It is important that you tell your doctor if you are breastfeeding or planning to do so. Your doctor will help you decide whether to stop breastfeeding or to stop taking Imlygic, taking into account your baby’s benefit from breastfeeding and your benefit from Imlygic.
Driving and using machines
When you are treated with Imlygic, you may experience symptoms such as dizziness or confusion. This may impair your ability to drive or use machines. Be careful when driving or using machines until you are sure that this medicine does not adversely affect you.
Imlygic contains sodium and sorbitol
This product contains 7.7 mg sodium (the main ingredient in saline/table salt) per vial of 1 ml. . This corresponds to 0.4% of the highest recommended daily intake of sodium for adults.
This drug contains 20 mg of sorbitol per vial of 1 ml.
3. How Imlygic is given
This medicine is given in a healthcare facility under the supervision of a doctor. The recommended starting dose is a maximum of 4 ml Imlygic with a concentration of 10 6 (1 million) PFU/ml. Subsequent doses are a maximum of 4 ml Imlygic with a concentration of 10 8 (100 million) PFU/ml.
Healthcare professionals will inject the drug directly into the tumor one with a syringe and a needle. You will be given the second injection 3 weeks after the first. You will then be given an injection every two weeks as long as you have the tumors left.
Your doctor will decide which tumors to inject and it is not certain that all of your tumors will be injected. Existing tumors can become larger and new tumors can appear during the time you are being treated with Imlygic.
You can expect the treatment with Imlygic to last for at least 6 months or longer.
If you forget to take Imlygic
It is important that you come to all visits to get the medicine. If you miss a visit, ask your doctor when you should receive the next dose.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Keep wounds clean and covered with bandages to minimize the risk of bacterial infections at the injection site ( cellulite ).
Influenza-like symptoms, fever, and chills have been observed in patients treated with Imlygic. These symptoms generally subside 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 user in 10):
- Swelling of tissue (peripheral edema )
- Headache
- Cough
- Vomiting, diarrhea, constipation, nausea
- Muscle pain ( myalgia ), aching / swollen joints ( arthralgia ), pain in arms and / or legs
- Flu-like symptoms , fever, chills, fatigue, pain
- Pain, redness , bleeding, swelling, inflammation , secretions and feeling of heat at the injection site
Common (may affect up to 1 in 10 people):
- Bacterial infection ( cellulite ), cold sores ( oral herpes )
- Tumor pain, infected tumor
- Fatigue, headache, dizziness and paleness (low red blood cell count – anemia )
- Side effects associated with the immune system:
- fever, fatigue, weight loss, muscle and joint pain (narrowing or blockage of blood vessels – vasculitis )
- shortness of breath, cough, fatigue, loss of appetite, unintentional weight loss ( pneumonia – pneumonitis )
- increased number of skin spots that are dry, red and covered by a silvery scaly surface (aggravated skin peeling – aggravated psoriasis )
- pink or charcoal-colored urine, frothy urine, high blood pressure , fluid retention (nephritis – glomerulonephritis ).
- Dehydration
- Confusion, anxiety, depression, dizziness, difficulty sleeping ( insomnia )
- Pain in the ear, neck, abdomen (stomach), groin, back and armpits
- Faster heart rhythm at rest ( tachycardia )
- Pain, swelling, feeling hot and sore in one leg or arm due to a blood clot in a vein (deep vein thrombosis ), high blood pressure ( hypertension ), flushing
- Shortness of breath ( dyspnoea ), upper respiratory tract infection
- Abdominal discomfort (stomach)
- Colorless skin areas (vitiligo), rash, dermatitis ( dermatitis )
- General malaise
- Weight loss
- Wound complications, secretions, bruising (swelling), pain after treatment
Uncommon (may affect up to 1 in 100 people):
- Infection at the injection site
- A tumor of white blood cancer cells that grows at or near the injection site (plasmocytoma)
- Eye infection caused by herpes ( herpes keratitis)
- Narrow airways ( airway obstruction )
- Allergic reaction (hypersensitivity)
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. You can also report side effects directly to the Medical Products Agency. By reporting side effects, you can help increase drug safety information.
5. How to store Imlygic
Imlygic will be stored by the healthcare staff at your reception.
Do not use this medicine after the expiry date which is stated on the label and carton after EXP. The expiration date is the last day of the specified month.
Store and transport in a frozen state at -90 ° C to -70 ° C.
Store in the original package. Sensitive to light.
This medicine contains genetically modified cells. Local routines must be followed.
6. Contents of the packaging and other information
Content declaration
- The active substance is talimogen laherparepvek.
One vial contains 1 ml solution at a nominal concentration of 1 × 10 6 (1 million) plaque forming units (PFU) / ml or 1 × 10 8 (100 million) PFU / ml. - The other ingredients are disodium phosphate dihydrate, sodium dihydrogen phosphate dihydrate, sodium chloride, myo-inositol, sorbitol (E420), water for injections (see section 2).
What the medicine looks like and contents of the pack
Imlygic is a clear to semi-transparent (10 6 PFU / ml) or semi-transparent to opaque (10 8 PFU / ml) liquid. It is supplied as a 1 ml solution without preservative in a single-use vial (cyclic olefin polymer plastic) with stopper (chlorobutyl elastomer) and seals (aluminum) with snap cap (polypropylene).
The cap of the vial is color-coded: 10 6 PFU / ml is light green and 10 8 PFU / ml is royal blue.
Marketing Authorization Holder and Manufacturer
Amgen Europe BV
Minervum 7061
4817 ZK Breda
Netherlands
Contact the representative of the marketing authorization holder to find out more about this medicine:
Amgen AB
Tel: +46 (0) 8 6951100