ELAHERE 5 mg/ml CONCENTRATE FOR INFUSION SOLUTION

Introduction

Package Leaflet: Information for the Patient

ELAHERE 5mg/ml concentrate for solution for infusion

mirvetuximab soravtansine

This medicinal product is subject to additional monitoring, which will allow for quick identification of new safety information. You can help by reporting any side effects you may get. The last section of section 4 will tell you how to report side effects.

Read all of this leaflet carefully before you are given 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 doctor or nurse.
• If you get any side effects, talk to your doctor or nurse, even if they are not listed in this leaflet. See section 4.

Contents of the pack

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

1. What is ELAHERE and what is it used for

What is ELAHERE

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

ELAHERE is used to treat adult women with ovarian cancer, fallopian tube cancer (one of the two long, thin tubes that connect the ovaries to the uterus) or primary peritoneal cancer (cancer that forms in the tissue that lines the abdominal wall and covers the organs in the abdomen, and that has not spread there from another part of the body). It is used in patients whose cancer cells have a protein on their surface known as folate receptor alpha (FRα), and who have previously not responded to or no longer respond to platinum-based chemotherapy, and who have received one to three prior treatments.

How ELAHERE works

The active substance in ELAHERE, mirvetuximab soravtansine, is made up of a monoclonal antibody that binds to a cancer medicine. The monoclonal antibody is a protein that recognizes and binds to the FRα protein on cancer cells. When this happens, mirvetuximab soravtansine enters the cancer cell and releases the cancer medicine DM4. DM4 then stops the normal process of growth of cancer cells. This can help destroy cancer cells and stop the disease from spreading.

Your doctor will make sure that you have had a test that confirms you meet the requirements to receive ELAHERE. This test is done on tissue from your tumor. If you have tissue from a previous surgery or biopsy, this tissue can be analyzed. If you do not have preserved tissue, this test will require a biopsy of the tumor.

Ask your doctor or nurse if you have any questions about how ELAHERE works or why you have been prescribed this medicine.

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

You must not be given 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, tell your doctor or nurse if:

• you have vision or eye problems that require active treatment or monitoring;
• you have nerve damage in your arms and legs; symptoms may include numbness, tingling, or weakness;
• you are pregnant or plan to become pregnant. ELAHERE may harm your unborn baby if taken during pregnancy.

Go to the emergency room immediatelyif you experience any of the following serious side effects during treatment:

• Eye problems.ELAHERE may cause serious eye problems, such as vision loss, damage to the cornea (the clear layer on the front of the eye; keratopathy), dry eyes, abnormal sensitivity of the eyes to light (photophobia), or eye pain. You will see an eye doctor before starting treatment. It is important that you report any new or worsening eye problems before the start of each treatment cycle. You are advised to use eye drops to hydrate your eyes during treatment. If you experience certain side effects that affect your eyes, your doctor may recommend additional eye drops that contain corticosteroids. You should not wear contact lenses during treatment with ELAHERE unless told to do so by a healthcare professional. For more information, see Eye care in section 3.
• Lung inflammation.Serious and potentially life-threatening lung scarring (interstitial lung disease) can occur in patients treated with ELAHERE, including lung inflammation. Your doctor will monitor you for signs of lung inflammation. Tell your doctor if you experience cough, wheezing, chest pain, or difficulty breathing.
• Nerve damage in arms and legs.Nerve damage in arms and legs can be severe and intense, and can occur when receiving treatment with ELAHERE. Your doctor will monitor you for signs of nerve damage. Tell your doctor if you experience symptoms of nerve damage such as numbness, tingling, pinching (paresthesia), burning, pain, muscle weakness, and distorted sense of touch (dysesthesia) in arms or legs.
• Infusion-related reactions.Infusion-related reactions have occurred with ELAHERE. To minimize the risk of these reactions, your doctor will give you certain medicines, see Medicines given before infusion in section 3. In case of severe reactions, your doctor will immediately stop the infusion and give you supportive treatment.

If you experience any of the above serious side effects, your doctor may stop/reduce the dose until symptoms resolve or, in severe cases, may permanently stop treatment.

Children and adolescents

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

Other medicines and ELAHERE

Tell your doctor if you are taking, have recently taken, or might take any other medicines, including those that are not prescribed, vitamins, and herbal supplements. This is because some medicines may affect how ELAHERE works. Also, ELAHERE may affect how 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 (cancer medicine for the treatment of non-small cell lung cancer)
• clarithromycin (antibiotic for the treatment of bacterial infections)
• cobicistat, ritonavir (antiviral medicines for the treatment of HIV/AIDS)
• idelalisib (cancer medicine for the treatment of certain blood cancers)
• itraconazole, ketoconazole, posaconazole, voriconazole (antifungal medicines for the treatment of fungal infections)
• nefazodone (antidepressant)
• telithromycin (antibiotic for the treatment of community-acquired pneumonia)

Contraceptives

Women who can become pregnant must use effective contraceptive methods during treatment and for up to 7 months after the last dose of ELAHERE.

Pregnancy

ELAHERE may harm your unborn baby if taken during pregnancy because it contains a component that can harm genes and rapidly growing cells. Therefore, ELAHERE is not recommended during pregnancy. If you are pregnant, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine.

If you become pregnant during treatment with ELAHERE or in the 7 months following treatment discontinuation, tell your doctor immediately.

If you can become pregnant, you will be asked to have a pregnancy test before starting treatment with ELAHERE.

Breast-feeding

Do not breast-feed during treatment or for 1 month after the last dose. ELAHERE may pass into breast milk.

Fertility

No fertility studies have been conducted with ELAHERE, and there are no data on the effect of the medicine on fertility. However, due to the way the medicine works, it is possible that fertility problems may occur when taking this medicine.

Driving and using machines

ELAHERE may affect your ability to drive or use machines. If you experience blurred vision, nerve damage that causes pain, numbness, or weakness in your hands, arms, or feet, fatigue, or dizziness, do not drive or use tools or machines until your symptoms have completely resolved.

ELAHERE contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per dose; this is essentially “sodium-free”.

ELAHERE contains polysorbate

This medicine contains 2.11 mg of polysorbate 20 per vial. Polysorbates may cause allergic reactions. Tell your doctor if you have any known allergies.

3. How ELAHERE will be given to you

ELAHERE will be given to you by a doctor or nurse with experience in the use of cancer medicines.

Your doctor will calculate your dose based on your body weight. You will receive ELAHERE through a drip (intravenous infusion) into a vein over a period of 2 to 4 hours, once every 3 weeks (this is known as a 21-day treatment cycle).

Your doctor will decide how many cycles you need.

Medicines given before infusion

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

• corticosteroids (such as dexamethasone) to prevent inflammation
• antihistamines (such as diphenhydramine) to prevent allergic reactions
• antipyretics (such as paracetamol) to reduce fever

You may also be given corticosteroids the day before infusion if you have had infusion-related reactions before.

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

Eye care

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

• Before each treatment cycle, it is important that you tell your doctor or eye doctor if you have any new or worsening eye problems. If you experience moderate or severe eye problems during treatment, your doctor may reduce your dose until the problems improve.
• Your doctor may adjust, stop, or permanently discontinue treatment with ELAHERE if signs and symptoms reveal any worsening of eye problems.

Contact lenses

• Do not wear contact lenses during treatment with ELAHERE unless told to do so by your doctor or eye doctor.

Eye drops

• You are advised to use lubricating eye drops as needed throughout treatment with ELAHERE.
• If you experience moderate or severe eye side effects, your doctor may recommend that you use corticosteroid eye drops.
• It is important that you follow your doctor's instructions on when to use corticosteroid eye drops and wait at least 15 minutes after using corticosteroid eye drops before using lubricating eye drops.

Changes in your dose if you experience side effects

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

If you are given too much ELAHERE

Since the infusion is given to you by a doctor or nurse specialist, it is unlikely that you will be given too much medicine. If you are given too much medicine by mistake, your doctor will take the necessary steps to monitor you and assist you.

If you miss a dose of ELAHERE

If you miss or do not attend your appointment, call your doctor or treatment center to schedule another appointment as soon as possible. Do not wait until your next scheduled visit. To ensure the treatment is fully effective, it is very important not to miss any doses unless advised by your doctor.

If you stop treatment with ELAHERE

Do not stop treatment without consulting your doctor first.

Treatment with ELAHERE usually requires several cycles of treatment. The number of infusions you receive will depend on how your cancer responds to treatment. Therefore, you should continue to receive ELAHERE even if you see that your symptoms improve and until your doctor decides that you should stop receiving ELAHERE.

If you have any other 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. The following side effects have been reported with this medicine.

Tell your doctor or nurse immediately or go to the emergency room if you experience any of the following side effects during or after treatment:

• Eye problems(very common, may affect more than 1 in 10 people): signs or symptoms may include damage to the cornea, the clear layer on the front of the eye (keratopathy), cataracts, blurred vision, sensitivity to light (photophobia), eye pain, and dry eyes.
• Lung inflammation(very common, may affect more than 1 in 10 people): signs or symptoms may include difficulty breathing, cough, low oxygen levels that cause confusion, restlessness, rapid heartbeat, blue-tinged skin, or scarring in the lungs that would be seen on an X-ray.
• Nerve damage in arms and legs(very common, may affect more than 1 in 10 people): signs and symptoms of nerve damage may include pinching, tingling, or burning sensations, pain due to nerve damage, muscle weakness, and unpleasant or abnormal sense of touch, especially in arms or legs.
• Infusion-related reactions/hypersensitivity(common, may affect up to 1 in 10 people):signs and symptoms of infusion-related reactions may include low blood pressure, fever, chills, nausea, vomiting, headache, dizziness, difficulty breathing, wheezing, skin rash, flushing, swelling of the face or around the eye, sneezing, itching, and muscle or joint pain.

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 (infection of the parts of the body that collect and get rid of urine)
• low red blood cell count, which can cause tiredness and pale skin (anemia)
• low platelet count, which can cause bleeding and bruising (thrombocytopenia)
• loss of appetite
• low magnesium levels in the blood; symptoms include nausea, weakness, spasms, cramps, or irregular heartbeat (hypomagnesemia)
• headache
• stomach swelling (abdominal distension)
• stomach pain (abdominal pain)
• diarrhea
• constipation
• feeling sick (nausea)
• vomiting
• joint pain (arthralgia)
• fatigue
• blood tests showing increased levels of aspartate aminotransferase (AST) and alanine aminotransferase (ALT) in the blood, indicating liver problems

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

• low levels of neutrophils, a type of white blood cell that fights infections (neutropenia)
• low levels of potassium in the blood, which can cause weakness, muscle cramps, tingling, and changes in heart rhythm (hypokalemia)
• dehydration
• difficulty sleeping or poor quality sleep (insomnia)
• altered taste (dysgeusia)
• feeling dizzy
• high blood pressure (hypertension)
• fluid buildup in the abdomen (ascites)
• gastroesophageal reflux disease (GERD), a condition in which stomach acid flows back into the tube that carries food from the mouth to the stomach
• inflammation of the lining of the mouth (stomatitis)
• indigestion (dyspepsia)
• high levels of bilirubin in the blood (hyperbilirubinemia), which can cause yellowing of the skin or eyes
• itching (pruritus)
• muscle pain (myalgia)
• back pain
• pain in arms, hands, legs, and feet
• muscle spasms
• blood tests showing increased levels of alkaline phosphatase (FA) and gamma-glutamyltransferase (GGT) in the blood, indicating liver problems
• weight loss

Reporting of side effects

If you experience any side effects, talk to your doctor or nurse, even if they are not listed in this leaflet. You can also report side effects directly through the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of ELAHERE

ELAHERE will be stored by the doctor and the pharmacist in the hospital or center.

This information is intended only for healthcare professionals.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiration date shown on the carton and on the vial label after CAD/EXP. The expiration date is the last day of the month indicated.

Store the vials in an upright position in the refrigerator (between 2°C - 8°C). Do not freeze.

Store the vial in the outer packaging to protect it from light.

If the diluted infusion solution is not used immediately, store it at room temperature (between 15°C - 25°C) for a maximum of 8 hours (including infusion time), or in the refrigerator (between 2°C - 8°C) for a maximum of 24 hours followed by room temperature (15°C - 25°C) for a maximum of 8 hours (including infusion time).

Do not use this medicine if you notice that the solution is cloudy or has changed color.

Medicines should not be disposed of via wastewater. The hospital pharmacist will dispose of unused medicines. This will help protect the environment.

6. Package Contents and Additional Information

Composition of ELAHERE

• The active ingredient is mirvetuximab soravtansine.
• The other ingredients are glacial acetic acid (E 260), sodium acetate (E 262), sucrose, polysorbate 20 (E 432), and water for injectable preparations (see section 2).

Appearance of the Product and Package Contents

This medicine is a colorless solution, transparent to slightly opalescent. It is presented in a glass vial with a rubber stopper, aluminum seal, and a dark blue flip-off cap.

Each package contains 1 vial.

Marketing Authorization Holder

AbbVie Deutschland GmbH & Co. KG

Knollstrasse

67061 Ludwigshafen

Germany

Manufacturer

Almac Pharma Services (Ireland) Limited

Finnabair Industrial Estate,

Dundalk, A91 P9KD, Ireland

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Date of Last Revision of this Prospectus:

Other Sources of Information

Detailed information about this medicine is available on the European Medicines Agency website: https://www.ema.europa.eu, and on the website of the Spanish Agency for Medicines and Health Products (AEMPS): http://www.aemps.gob.es/

To request a copy of this prospectus in Braille, large print, or to listen to it in audio, please contact the local representative of the marketing authorization holder.

--------------------------------------------------------------------------------------------------------------------

This information is intended only for healthcare professionals:

ELAHERE is a cytotoxic medicine. Special handling and disposal procedures should be followed.

Preparation

• Calculate the dose (mg) (based on the patient's ideal body weight [IBW]), the total volume (ml) of solution required, and the number of ELAHERE vials needed. More than one vial will be required for a full dose.
• Remove the ELAHERE vials from the refrigerator and let them reach room temperature.
• Parenteral medicines should be inspected visually for particles and color change before administration, whenever the solution and container permit. ELAHERE is a colorless solution, transparent to slightly opalescent.
• Do not use the medicine if the solution has changed color or is cloudy, or if there are foreign particles.
• Gently move and inspect each vial before withdrawing the calculated dose volume of ELAHERE for subsequent dilution. Do not shake the vial.
• Using aseptic technique, withdraw the calculated dose volume of ELAHERE for subsequent dilution.
• ELAHERE does not contain preservatives and is for single use only. Discard any unused solution remaining in the vial.

Dilution

• ELAHERE should be diluted before 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 should not be mixed with any other medicine or intravenous fluid.
• Determine the volume of 5% glucose needed to achieve the final concentration of the diluted active ingredient. Remove excess 5% glucose from a preloaded intravenous bag or add the calculated volume of 5% glucose to an empty sterile 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 ensure a uniform mixture. Do not shake.
• After dilution, chemical and physical stability has been demonstrated between 1 mg/ml and 2 mg/ml for 8 hours at 15°C – 25°C or 24 hours at 2°C – 8°C and subsequently 8 hours at 15°C – 25°C.
• From a microbiological point of view, unless the dilution method excludes the risk of microbial contamination, the medicine should be used immediately. If not used immediately, the in-use storage times and conditions are the responsibility of the user.
• If the diluted infusion solution is not used immediately, store the solution according to section 6.3 of the Summary of Product Characteristics or Package Leaflet. If refrigerated, let the infusion bag reach room temperature before administration. After refrigeration, administer the diluted infusion solutions within 8 hours (including infusion time).
• Do not freeze the prepared infusion solution.

Administration

• Visually inspect the ELAHERE intravenous infusion bag for particles and color change before administration.
• Administer premedication before administration of ELAHERE (see section 4.2).
• Administer ELAHERE only by intravenous infusion, using a 0.2 or 0.22 μm polyethersulfone (PES) in-line filter. Do not substitute with other membrane materials.
• Avoid using administration devices that contain di-2-ethylhexyl phthalate (DEHP).
• Administer the initial dose by intravenous infusion at a rate of 1 mg/min. If well tolerated after 30 minutes at 1 mg/min, the infusion rate may be increased to 3 mg/min. If well tolerated after 30 minutes at 3 mg/min, the infusion rate may be increased to 5 mg/min.
• If no infusion-related reactions occur with the previous dose, subsequent infusions should be started at the maximum tolerated rate and may be increased up to a maximum infusion rate of 5 mg/min, as tolerated.
• After infusion, flush the intravenous line with 5% glucose to ensure administration of the full dose. Do not use any other intravenous fluid for flushing.

Disposal

Disposal of unused medicine and all materials that have come into contact with it should be carried out in accordance with local regulations.