Elahere 5 mg/ml concentrate for solution for infusion – patient leaflet, side effects, dosage

1. What ELAHERE is and what it is used for

What ELAHERE is

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

What ELAHERE is used for

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.

How ELAHERE works

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.

5 mg/mL

concentrate for solution for infusion

mirvetuximab soravtansine

2. What you need to know before you are given ELAHERE

You must not receive ELAHERE

• if you are allergic to mirvetuximab soravtansine or any of

  the other ingredients of this medicine (listed in section 6).

Warnings and precautions

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.

Children and adolescents

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

Other medicines and ELAHERE

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)

Pregnancy, breast-feeding and fertility

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.

  Driving and using machines

  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

ELAHERE contains sodium

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

ELAHERE contains polysorbate

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.

3. How you will be given ELAHERE

ELAHERE will be given to you by a doctor or a nurse experienced in using cancer medicines.

You will receive ELAHERE by an infusion (drip) into your vein.

• Your doctor will calculate your dose based on your body

  weight

• You will be given an infusion once every 3 weeks, in 21-day

  treatment cycles

• Each infusion lasts between 2 to 4 hours

You will be given ELAHERE for as long as your doctor thinks you are benefitting from the treatment.

Medicines given before infusion

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.

Eye care

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.

  ELAHERE® 5 mg/mL concentrate for solution for infusion mirvetuximab soravtansine

  The following information is intended for healthcare professionals only:

  ELAHERE is a cytotoxic medicinal product. Follow applicable special handling and disposal procedures.

  Preparation

  • Calculate the dose (mg) (based on the patient’s adjusted ideal body weight (AIBW)), total volume (mL) of solution required, and the number of vials of ELAHERE needed. More than one vial will be needed for a full dose.
  • Remove the vials of ELAHERE from the refrigerator and allow to warm to room temperature.
  • Parenteral medicinal products should be inspected visually for particulate matter and discolouration prior to administration, whenever solution and container permit. ELAHERE is a clear to slightly opalescent, colourless solution.
  • The medicinal product should not be used if the solution is discoloured or cloudy, or if foreign particulate matter is present.
  • Gently swirl and inspect each vial prior to withdrawing the calculated dose volume of ELAHERE for subsequent further dilution. Do not shake the vial.
  • Using aseptic technique, withdraw the calculated dose volume of ELAHERE for subsequent further dilution. Each vial contains an overfill that allows withdrawal of the labelled amount.
  • ELAHERE contains no preservatives and is intended for single-dose only. Discard any unused solution remaining in the vial.

Dilution

• ELAHERE must be diluted prior to administration with

  5% glucose to a final concentration of 1 mg/mL to 2 mg/mL.

• ELAHERE is not compatible with sodium chloride

  9 mg/mL (0.9%) solution for infusion. ELAHERE must not be mixed with any other medicinal products or intravenous fluids.

• Determine the volume of 5% glucose required to achieve the final diluted active substance concentration. Either remove the excess 5% glucose from a prefilled intravenous bag or add the calculated volume of 5% glucose to a sterile empty intravenous bag. Then add the calculated dose volume of ELAHERE to the intravenous bag.
• Gently mix the diluted solution by slowly inverting the bag several times to assure uniform mixing. Do not shake or agitate.
• After dilution the chemical and physical stability has been demonstrated between 1 mg/mL and 2 mg/mL for 8 hours at 15 ˚C – 25 ˚C or for 24 hours at 2 ˚C – 8 ˚C followed by 8 hours at 15 ˚C – 25 ˚C.

Brief ID: PROD-2025-002435

• From a microbiological point of view, unless the

  method of dilution precludes the risk of microbial contamination, the product should be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of user.

• If the diluted infusion solution is not used

  immediately, store the solution in accordance with section 6.3 of the Summary of the Product Characteristics. If refrigerated, allow the infusion bag to reach room temperature prior to administration. After refrigeration, administer diluted infusion solutions within 8 hours (including infusion time).

• Do not freeze the prepared infusion solution.

Administration

• Inspect the ELAHERE intravenous infusion bag visually

  for particulate matter and discolouration prior to administration.

• Administer pre-medications prior to ELAHERE

  administration (see section 4.2).

• Administer ELAHERE as an intravenous infusion only,

  using a 0.2 or 0.22 µm polyethersulfone (PES) in-line filter. Do not substitute other membrane materials.

• Use of administration delivery devices containing

  di-2-ethylhexyl phthalate (DEHP) should be avoided.

• Administer the initial dose as an intravenous infusion

  at the rate of 1 mg/min. If well tolerated after 30 minutes at 1 mg/min, the infusion rate can be increased to 3 mg/min. If well tolerated after 30 minutes at 3 mg/min, the infusion rate can be increased to 5 mg/min.

• If no infusion-related reactions occur with the previous

  dose, subsequent infusions should be started at the maximally tolerated rate and may be increased up to a maximum infusion rate of 5 mg/min, as tolerated.

• Following the infusion, flush the intravenous line with

  5% glucose to ensure delivery of the full dose. Do not use any other intravenous fluids for flushing.

Disposal

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

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.

Changes to your dose if you suffer from side effects

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

If you are given more ELAHERE than you should have been given

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 a dose of ELAHERE is missed

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.

If you stop treatment with ELAHERE

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.

If you have any further questions about the use of this medicine, ask your doctor or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious side effects

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.

Other side effects

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

Reporting of side effects

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.

5. How to store ELAHERE

ELAHERE will be stored by the doctor and pharmacist at the hospital or clinic.

To correctly store ELAHERE:

• 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 carton and the vial label after EXP. The expiry date refers to the last day of that month.

• Store the vials upright in a refrigerator (2°C - 8°C). Do not

  freeze.

• Keep the vial in the outer carton in order to protect it from

  light.

• If not used immediately, the prepared solution may be

  stored either at room temperature (15°C - 25°C) for no more than 8 hours (including infusion time), or in a fridge (2°C - 8°C) for no more than 24 hours followed by room temperature (15°C - 25°C) for no more than 8 hours (including infusion time).

• Do not use this medicine if you notice the solution is

  cloudy or discoloured.

• Do not throw away any medicines via wastewater. The

  hospital pharmacist will throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What ELAHERE contains

• 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’).

What ELAHERE looks like and contents of the pack

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.

Marketing Authorisation Holder

AbbVie Ltd

Maidenhead

SL6 4UB

United Kingdom

Tel: +44 (0) 1628 561090

Manufacturer

AbbVie Deutschland GmbH & Co. KG

Knollstrasse

67061 Ludwigshafen

Germany

For any information about this medicine, please contact the Marketing Authorisation Holder.

This leaflet was last revised in 12/2025

Other sources of information

Detailed information on this medicine is available on the Medicines and Healthcare products Regulatory Agency (MHRA) website: http://www.mhra.gov.uk.

To listen to or request a copy of this leaflet in Braille, large print or audio, please contact the Marketing Authorisation Holder.

Brief ID: PROD-2025-002435