2. What should I know before I am given Elahere?
Do not use if you have ever had an allergic reaction to Elahere or any of the ingredients
listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines,
or are pregnant or plan to become pregnant or are breastfeeding.
3. What if I am taking other medicines?
Some medicines may interfere with Elahere and affect how it works.
4. How is Elahere given?
You will receive Elahere by an infusion (drip) into your vein (intravenously) over
2 to 4 hours, once every 3 weeks (this is known as a 21-day treatment cycle).
5. What should I know while I am treated with Elahere?
|
Things you should do
|
Remind any doctor, dentist, pharmacist or eye care professional you visit that you
are being treated with Elahere.
Before each treatment cycle, it is important that you tell your doctor or eye care
professional if you have any new or worsening eye problems.
Call your doctor straight away if you experience any signs and symptoms of problems
with your eyes (i.e. blurred vision, dry eyes, sensitivity to light, eye pain, or
new or worsening vision changes), inflammation in the lungs, nerve damage in your
arms and legs and infusion-related reactions / hypersensitivity. For more information,
see Section 2 What should I know before I am given Elahere? In the full CMI. |
|
Things you should not do
|
Do not miss any of your scheduled appointments relating to your treatment with Elahere.
|
|
Driving or using machines
|
Elahere may affect your ability to drive and use machines. If you feel any symptoms
that may affect your ability to drive, do not drive, or use machines until the symptoms
stops.
|
6. Are there any side effects?
The more serious side effects can include signs and symptoms of problems with your
eyes, inflammation in the lungs, nerve damage in your arms and legs and infusion-related
reactions / hypersensitivity.
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.
You can report side effects to your doctor, or directly at www.tga.gov.au/reporting-problems .
Active ingredient(s):
mirvetuximab soravtansine (mer-veh-tuk-sih-mab soh-rav-tan-seen)
Full Consumer Medicine Information (CMI)
This leaflet provides important information about being treated with Elahere. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about being treated with Elahere.
Where to find information in this leaflet:
1. Why am I being treated with Elahere?
Elahere contains the active ingredient mirvetuximab soravtansine.
Elahere is a type of medicine called an antibody drug conjugate. It is made up of
an antibody attached to a cancer medicine called DM4. The antibody is a protein that
attaches to another protein on cancer cells known as folate receptor-alpha (FRα).
When this happens, Elahere enters the cancer cells and releases the DM4, which kills
cancer cells by stopping their normal growth process.
Elahere is used to treat adults with cancer of the ovary, the fallopian tubes (part
of the female reproductive system that connects the ovaries to the uterus), or the
peritoneum (the membrane lining the abdomen).
Elahere is used in patients whose cancer cells test positive to FRα, and are no longer
responding to treatment with platinum-based chemotherapy and who have received 1 to
3 prior lines of chemotherapy. This test is done on tissue from your tumour. If you
have tissue available from a previous surgery or biopsy, this archived material may
be used. If you do not have prior tissue, this test will require a tumour biopsy.
Your doctor will ensure that you had a test to make sure Elahere is right for you.
Talk to your doctor or nurse if you have any questions about how Elahere works or
why this medicine has been prescribed for you.
2. What should I know before I am given Elahere?
Warnings
Do not use Elahere if:
you are allergic to mirvetuximab soravtansine, or any of the ingredients listed at
the end of this leaflet.
Always check the ingredients to make sure you can use this medicine.
Check with your doctor if you:
have vision or eye problems requiring active treatment or monitoring
have nerve damage in the arms and legs (symptoms may include numbness, tingling or
weakness)
are pregnant or plan to become pregnant.
During treatment, you may be at risk of developing certain side effects. It is important
you understand these risks and how to monitor for them. See additional information
under Section
6. Are there any side effects? and tell your doctor if you have any symptoms of serious side effects described.
Eye problems
Eye problems are common with Elahere and can cause severe eye problems such as loss
of vision, damage to the cornea (the transparent layer in the front of the eye), dry
eyes, abnormal sensitivity of the eyes to light or eye pain.
Tell your doctor right away if you develop any eye problems during treatment with
Elahere, including blurred vision, dry eyes, sensitivity to light, eye pain, or new
or worsening vision changes.
You will see an eye care professional before starting treatment. It is important that
you report any new or worsening eye problems before the start of each treatment cycle.
You should use eye drops to moisturise the eyes during treatment. If you develop certain
side effects affecting the eyes, your doctor may prescribe additional eye drops containing
corticosteroids. Do not wear contact lenses throughout your treatment with Elahere
unless you are told to use them by a doctor.
Inflammation in the lungs
Severe, life-threatening scarring of the lungs 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 if you develop coughing, wheezing, chest pain or difficulty breathing.
Nerve damage in arms and legs
Nerve damage in arms and legs can be serious and severe and can occur when treated
with Elahere. Your doctor will monitor you for signs of nerve damage.
Tell your doctor if you develop symptoms of nerve damage such as sensations like numbness,
tingling, pins and needles, burning, pain, muscle weakness and distorted sense of
touch in your arms or legs.
Infusion-related reactions
Infusion-related reactions have occurred with Elahere. Your doctor will give you some
medicines before you are given Elahere to help prevent infusion-related reactions.
In case of severe reactions, your doctor will stop the infusion immediately and you
will be given supportive treatment.
Pregnancy, Breastfeeding and Fertility
Pregnancy must be ruled out before treatment.
If you are able to become pregnant, you will be asked to take a pregnancy test before
you start treatment with Elahere.
Elahere could harm an unborn baby if taken during pregnancy because it contains a
compound that can damage genes and cells that are growing rapidly. Therefore, using
Elahere during pregnancy is not recommended.
Tell your doctor immediately if you become pregnant during treatment with Elahere
or within seven months after stopping treatment.
If you are able to become pregnant, you must use an effective contraception during
treatment and for 7 months after the last dose of Elahere.
You must not breast-feed during treatment with Elahere and for 1 month after the last
dose. It is not known if Elahere passes into breast milk.
The effect of Elahere on female fertility is unknown. Due to how the medicine works,
fertility problems are possible when taking this medicine.
It is not known if Elahere is safe and effective in children under the age of 18 years.
3. What if I am taking other medicines?
Tell your doctor or pharmacist if you are taking any other medicines, including any
medicines, vitamins or supplements that you buy without a prescription from your pharmacy,
supermarket or health food shop. Taking certain other medicines during treatment with
Elahere may cause side effects.
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 to treat non-small cell lung cancer)
clarithromycin (antibiotic for treating bacterial infections)
cobicistat, ritonavir (antiviral medicines to treat HIV/AIDS)
idelalisib (cancer medicine to treat certain blood cancers)
itraconazole, ketoconazole, posaconazole, voriconazole (antifungal medicines to treat
fungal infections)
The following medicines may decrease the amount of Elahere in the blood. These medicines
include:
phenytoin (medicine used to treat epilepsy or certain heart conditions)
rifampicin (medicine used to treat tuberculosis and other serious infections)
carbamazepine (medicine used to treat epilepsy to prevent convulsions, fits)
4. How is Elahere given?
How is Elahere administered?
Elahere will be given to you by a doctor or a nurse experienced in using cancer medicines.
Your doctor will calculate your dose based on your body weight. You will receive Elahere
by an infusion (drip) into your vein (intravenously) over 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.
You may be given other medicines before you are given Elahere. This is to help prevent
side effects of the treatment.
If you miss a dose of Elahere
If you forget or miss your 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 are given more Elahere than you should have been given
Since the infusion is given to you by your doctor or nurse, it is unlikely that you
will be given too much. If you experience any side effects after being given Elahere,
tell your doctor or nurse immediately.
5. What should I know while I am treated with Elahere?
Things you should do
Call your doctor straight away if you:
Experience any signs and symptoms of problems with your eyes, inflammation in the
lungs, nerve damage in your arms and legs and infusion-related reactions / hypersensitivity
listed in
Section 6. Are there any side effects?
Remind any doctor, dentist, pharmacist or eye care professional you visit that you
are being treated with Elahere.
Things you should not do
Do not miss any of your scheduled appointments.
Do not wear contact lenses during treatment with Elahere, unless you are told to do
so by your doctor or eye care professional.
Eye care
An eye care professional will examine your eyes prior to starting treatment with Elahere.
Before each treatment cycle, it is important that you tell your doctor or eye care
professional if you have any new or worsening eye problems. If you develop moderate
or severe eye problems during treatment, your doctor may reduce the dose of your treatment
until your problems improve.
Your doctor may adjust, withdraw or permanently stop Elahere treatment if signs and
symptoms reveal any worsening problems in your eyes.
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 topical steroid eye drops.
It is important to follow your doctor’s instruction for when to take steroid eye drops,
and to wait at least 15 minutes after using the topical steroid eye drops before using
the lubricating eye drops.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how Elahere
affects you.
Elahere may affect your ability to drive and use machines. If you experience blurred
vision or nerve damage causing pain, numbness or weakness in your hands, arms or feet,
do not drive, use tools, or operate machines until your symptoms are completely better.
Looking after your medicine
Elahere will be stored by the doctor, nurse, or pharmacist at the hospital or clinic
in a refrigerator at a temperature between 2°C to 8°C.
6. Are there any side effects?
All medicines can have side effects. If you do experience any side effects, most of
them are minor and temporary. However, some side effects may need medical attention.
See the information below and, if you need to, ask your doctor, nurse or pharmacist
if you have any further questions about side effects.
Less serious side effects
Serious side effects
For serious side effects, your doctor may change your dose of Elahere, delay treatment
or completely stop treatment if you have certain side effects.
Tell your doctor, nurse or pharmacist if you notice anything else that may be making
you feel unwell.
Other side effects not listed here may occur in some people.
Reporting side effects
After you have received medical advice for any side effects you experience, you can
report side effects to the Therapeutic Goods Administration online at
www.tga.gov.au/reporting-problems . By reporting side effects, you can help provide more information on the safety of
this medicine.
Always make sure you speak to your doctor or pharmacist before you decide to stop
taking any of your medicines.
7. Product details
This medicine is only available with a doctor's prescription.
What Elahere contains
|
Active ingredient
(main ingredient)
|
mirvetuximab soravtansine
|
|
Other ingredients
(inactive ingredients)
|
glacial acetic acid
sodium acetate
sucrose
polysorbate 20
water for injections
|
The vial stopper is NOT made with natural rubber latex.
Do not take this medicine if you are allergic to any of these ingredients.
What Elahere looks like
Elahere is a sterile, preservative-free, clear to slightly opalescent, colourless
solution. Elahere is supplied in a pack size of 1 single-dose vial containing 100
mg/20 mL concentrate solution for infusion (AUST R 472925).
Who distributes Elahere
Elahere is distributed in Australia by:
AbbVie Pty Ltd
241 O'Riordan Street
Mascot NSW 2020
Australia
This leaflet was prepared in February 2026.
© 2026 AbbVie. All rights reserved. ELAHERE and its design are trademarks of ImmunoGen,
Inc., an AbbVie company.