ELAHERE 5 mg/mL concentrate for solution for infusion

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or nurse.
• If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

1. What ELAHERE is and what it is used for
2. What you need to know before you are given ELAHERE
3. How you will be given ELAHERE
4. Possible side effects
5. How to store ELAHERE
6. Contents of the pack and other information

ELAHERE is a cancer medicine that contains the active substance mirvetuximab soravtansine.

ELAHERE is used to treat adults with the following cancers:

• ovarian cancer
• fallopian tube (one of two long, slender tubes that connect the ovaries to the womb) cancer
• primary peritoneal cancer (cancer that forms in the tissue that lines the abdominal wall and covers organs in the abdomen, and has not spread there from another part of the body)

It is used in patients whose cancer cells have a protein on the surface known as folate receptor-alpha (FRα), and who have previously not responded to or are no longer responding to treatment with ‘platinum-based’ chemotherapy, and who have already received one to three prior treatments.

ELAHERE works by finding and attaching to cancer cells that have the FRα protein. This may stop the cancer cells from growing and can help to stop the disease from spreading.

Your doctor will ensure that you have had a test confirming that you are eligible to receive ELAHERE. This test is done on tissue from a biopsy of your tumour. If you have tissue available from a previous surgery or biopsy, that tissue can be tested.

Talk to your doctor or nurse if you have any questions about how ELAHERE works or why this medicine has been prescribed for you.

• if you are allergic to mirvetuximab soravtansine or any of the other ingredients of this medicine (listed in section 6).

Before you are given ELAHERE, talk to your doctor or nurse if you:

• have vision or eye problems that you take medicine for or that need monitoring
• have nerve damage in the arms and legs; symptoms may include numbness, tingling, or weakness
• are pregnant, think you might be pregnant or are planning to become pregnant. This is because ELAHERE could harm your unborn baby.

Seek urgent medical attention if you have any of the following serious side effects (see section 4) during or after treatment:

• Eye problems: ELAHERE can cause serious eye problems, like loss of vision, damage to the cornea (the transparent layer in the front of the eye; keratopathy), dry eyes, abnormal sensitivity of the eyes to light (photophobia) or eye pain. It is important that you immediately report any new or worsening eye problems before the start of each treatment cycle. To help with some of these problems, you are recommended to use lubricating eye drops during treatment. If your eyes have other side effects, your doctor may recommend additional eye drops containing corticosteroids. You will see an eye specialist before starting treatment. You should not use contact lenses during treatment with ELAHERE unless your doctor or eye specialist tells you to. See ‘Eye care’ in section 3 for more information.
• Inflammation in the lungs: Serious, life-threatening lung scaring (interstitial lung disease), including inflammation of the lungs can occur in patients treated with ELAHERE. Your doctor will monitor you for signs of lung inflammation. Tell your doctor immediately if you develop coughing, wheezing, chest pain or difficulty breathing.
• Nerve damage in arms and legs: Nerve damage in your arms and legs can be serious in some patients treated with ELAHERE. Your doctor will monitor you for signs of nerve damage. Tell your doctor immediately if you develop symptoms of nerve damage such as sensations like numbness, tingling, pins and needles (paraesthesia), burning, pain, muscle weakness or an unpleasant, abnormal sense of touch (dysesthesia) in your arms or legs.
• Infusion-related reactions: These can happen during or shortly after receiving an infusion of ELAHERE. To minimise the risk of these reactions, your doctor will give you some medicines, see ‘Medicines given before infusion’ in section 3. In case of serious reactions, your doctor will stop the infusion immediately and give you medicine to treat the reaction.

If you experience any of the above-listed serious side effects, your doctor may withhold or reduce treatment until symptoms resolve. In more serious cases, treatment will be permanently stopped.

This medicine must not be given to children or adolescents under 18 years because it has not been studied in this group.

Tell your doctor if you are taking, have recently taken or might take any other medicines. This includes:

• medicines obtained with or without a prescription
• vitamins and herbal supplements

This is because some medicines may affect the way ELAHERE works. Also, ELAHERE may affect the way other medicines work.

The following medicines may increase the risk of side effects of ELAHERE by increasing the amount of ELAHERE in the blood. These medicines include:

• ceritinib (to treat non-small cell lung cancer)
• clarithromycin (to treat bacterial infections)cobicistat, ritonavir (to treat HIV/AIDS)
• idelalisib (to treat certain blood cancers)
• itraconazole, ketoconazole, posaconazole, voriconazole (to treat fungal infections)
• nefazodone (to treat depression)
• telithromycin (to treat an infection called community-acquired pneumonia)

Do not use ELAHERE if you are pregnant as it may harm your unborn baby.

If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before receiving this medicine.

If you are a woman who can get pregnant:

• You will be asked to take a pregnancy test before you start treatment with ELAHERE.
• You must use an effective contraception during treatment and for 7 months after the last dose of ELAHERE.
• Tell your doctor straight away if you become pregnant during treatment or within 7 months after the last dose of ELAHERE.
• Do not breast-feed during treatment and for 1 month after the last dose. ELAHERE may pass into breast milk.
• It is unknown if this medicine may affect your ability to get pregnant (fertility). However, due to how the medicine works, fertility problems are possible when taking this medicine.

ELAHERE may affect your ability to drive and use machines.

Do not drive, use tools or operate machines when you have any of the following symptoms and until they are completely better:

• blurred vision
• nerve damage causing pain, numbness or weakness in your hands, arms or feet
• feeling tired (fatigue)
• or dizziness

This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say it is essentially ‘sodium-free’.

This medicine contains 2.11 mg of polysorbate 20 in each vial. Polysorbates may cause allergic reactions.

Tell your doctor if you have any known allergies.

Your doctor will give you the following medicines about 30 minutes before each infusion:

• Corticosteroids (such as dexamethasone) to help prevent inflammation
• Antihistamines (such as chlorphenamine) to help prevent allergic reactions
• Antipyretics (such as paracetamol) to reduce fever

You doctor may also give you corticosteroids the day before your infusion if you have previously had infusion-related reactions.

Your doctor will also give you a medicine to reduce nausea and vomiting before each dose and thereafter as needed.

An eye specialist will examine your eyes before you start treatment with ELAHERE.

• Before each 21-day treatment cycle, it is important that you tell your doctor or eye specialist if you have any new or worsening eye problems.
• If you develop moderate or severe eye problems during treatment, your doctor may reduce your dose of ELAHERE until your eye problems improve.
• Your doctor may adjust, withhold or permanently stop ELAHERE treatment if your eye problems get worse.

Contact lenses

• Do not wear contact lenses during treatment with ELAHERE, unless your doctor or eye specialist tells you to.

Eye drops

• You are recommended to use lubricating eye drops when needed throughout ELAHERE treatment. If you experience moderate or severe eye side effects, your doctor may recommend that you take steroid eye drops.
  • Take your steroid eye drops as instructed by your doctor
  • Wait at least 15 minutes after using the steroid eye drops before using the lubricating eye drops.

Your doctor will adjust your dose of ELAHERE if you suffer from any side effects (see section 4, Possible side effects).

Since the infusion is given to you by your doctor or specialist nurse, an overdose is unlikely. If you do receive too much medicine, your doctor will monitor you closely.

If you forget or miss your infusion appointment, call your doctor or your treatment centre to make another appointment as soon as possible. Do not wait until your next planned visit. For the treatment to be fully effective, it is very important not to miss a dose unless recommended by your doctor.

You should not stop treatment without talking with your doctor first.

The treatment with ELAHERE usually requires a number of treatment cycles. The number of infusions that you receive will depend on how your cancer is responding to treatment. Therefore, you should continue receiving ELAHERE even if you see your symptoms improve and until your doctor decides that ELAHERE should be stopped.

Tell your doctor straight away if you notice any of the symptoms of the following serious side effects. You may only get one or some of these symptoms. Signs or symptoms may include:

Very common (may affect more than 1 in 10 people)

• Eye problems: damage to the cornea (the clear front layer of the eye) (keratopathy), clouding of the eye lens (cataract), blurred vision, sensitivity to light (photophobia), eye pain, and dry eyes.
• Inflammation in the lungs: trouble breathing, coughing and scaring of the lungs (seen in X-rays). Other symptoms caused by low levels of oxygen may include confusion, feeling restless, rapid heart rate or blue-ish skin.
• Nerve damage in the arms and legs: pins and needles, tingling, burning sensation, pain, muscle weakness, or an unpleasant, abnormal sense of touch in your arms or legs.

Common (may affect up to 1 in 10 people)

• Infusion-related reactions or hypersensitivity: low blood pressure, fever, chills, nausea, vomiting, headache, feeling lightheaded, trouble breathing, wheezing, rash, flushing (redness), swelling of the face or around the eye, sneezing, itching, and muscle or joint pain.

If you experience any of the above-listed serious side effects, your doctor may withhold or reduce treatment until symptoms resolve. In more serious cases, treatment will be permanently stopped.

Tell your doctor or nurse if you notice any of the following side effects

Very common (may affect more than 1 in 10 people)

• urinary tract infection (UTI)
• loss of appetite
• headache
• swollen belly (abdominal distension)
• belly (abdominal) pain
• diarrhoea
• constipation
• feeling sick (nausea) or vomiting
• joint pain (arthalgia)
• feeling tired

Shown in blood tests

• low red blood cell counts which lead to feeling tired and pale skin (anaemia)
• low blood platelet counts which can lead to bleeding and bruising (thrombocytopenia)
• low blood magnesium levels, which can lead to nausea, weakness, twitching, cramping or irregular heart beat (hypomagnesaemia)
• high levels of aspartate aminotransferase (AST) and alanine aminotransferase (ALT) showing liver problems

Common (may affect up to 1 in 10 people):

• dehydration
• trouble falling and staying asleep, and poor quality of sleep (insomnia)
• taste disturbance (dysgeusia)
• feeling dizzy
• high blood pressure (hypertension)
• build-up of fluid in the belly (abdomen) (ascites)
• stomach acid rising up into the food pipe (gastro-oesophageal reflux disease)
• inflammation of the lining of the mouth (stomatitis)
• indigestion (dyspepsia)
• itchy skin (pruritis)
• muscle pain (myalgia)
• back pain
• pain in arms, hands, legs and feet
• muscle spasms
• weight loss

Shown in blood tests

• low neutrophils counts which can affect your body’s ability to fight infection (neutropenia)
• low blood potassium levels which can lead to weakness, muscle cramps, tingling, and heart rhythm problems (hypokalaemia)
• high blood bilirubin levels which can lead to yellowing of skin or eyes (hyperbilirubinemia)
• high levels of alkaline phosphatase (ALP) and gamma-glutamyl transferase (GGT) showing liver problems

If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme (website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store). By reporting side effects, you can help provide more information on the safety of this medicine.

• The active substance is mirvetuximab soravtansine. Each 20 ml vial contains 100 mg of mirvetuximab soravtansine at a concentration of 5 mg/ml.
• The other ingredients are glacial acetic acid (E260), sodium acetate (E262), sucrose, polysorbate 20 (E432), and water for injections (see section 2, ‘ELAHERE contains sodium’ and ‘ELAHERE contains polysorbate’).

The medicine is a clear to slightly opalescent, colourless solution. It comes in a glass vial with a rubber stopper, an aluminium seal and royal blue flip cap.

Each pack contains 1 vial.