ELAHERE 5 mg /Ml Концентрат Для Инфузионного Раствора

Содержание инструкции

1. ELAHERE 5 mg/mL concentrate for solution for infusion
   1. What is ELAHERE and what it is used for
   2. What you need to know before you receive ELAHERE
   3. How ELAHERE is administered
   4. Possible side effects
   5. How to store ELAHERE
   6. Package Contents and Other Information

ELAHERE 5 mg/mL concentrate for solution for infusion

mirvetuximab soravtansine
V

Medicinal product subject to additional monitoring. This will allow the rapid identification of
new safety information. You can contribute by reporting any adverse effects
experienced during the use of this medicine. See the end of section 4 for
information on how to report adverse effects.

Read this leaflet carefully before you receive this medicine as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or nurse.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or nurse. See section 4.

Contents of this leaflet

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

1. What is ELAHERE and what it is used for

What is ELAHERE
ELAHERE is an anti-cancer medicine that contains the active substance mirvetuximab soravtansine.
ELAHERE is used for the treatment of adults with ovarian cancer, fallopian tube cancer (one
of the two long, thin tubes that connect the ovaries to the uterus) or primary peritoneal cancer (a
cancer that forms in the tissue lining the abdominal wall and covering the organs in the abdomen and that
has not spread to this site from another part of the body). It is used in patients whose cancer cells
have a protein known as folate receptor alpha (FRα) on their surface and who have not
responded previously or no longer respond to treatment with “platinum-based” chemotherapy and
who have already received one to three previous treatments.

How ELAHERE works
The active substance contained in ELAHERE, mirvetuximab soravtansine, consists of a monoclonal
antibody that is linked to an anti-cancer medicine. The monoclonal antibody is a protein that
recognizes the FRα protein on cancer cells and binds to it. When this happens, mirvetuximab
soravtansine enters the cancer cell and releases the anti-cancer medicine DM4. DM4 then stops
the normal growth process of cancer cells. This can help kill cancer cells and stop the spread of the disease.
The doctor will make sure that you undergo a test to confirm your suitability to receive ELAHERE.
This test is performed on tissue taken from the tumor. If this tissue is available from a
previous surgery or biopsy, the test can be performed on this preserved material. If previous tissue is not available, the test will require a tumor biopsy.
Ask your doctor or nurse if you have any questions about how ELAHERE works or
why this medicine has been prescribed for you.

2. What you need to know before you receive 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 receive ELAHEREtalk to 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 the fetus if taken during pregnancy.

Seek urgent medical attentionif you experience any of the serious side effects listed below during treatment (see section 4):

• Eye problems.ELAHERE can cause serious eye problems, such as vision loss, damage to the cornea (the clear layer at the front of the eye; keratopathy), dry eyes, abnormal sensitivity of the eyes to light (photophobia), or eye pain. You will be examined by an ophthalmologist before starting treatment. It is important that you report any new eye problems, or worsening of an existing eye problem, before starting each treatment cycle. The use of eye drops to moisturize the eyes is recommended during treatment. If specific eye side effects occur, your doctor may recommend the use of an additional eye drop containing corticosteroids. You should not wear contact lenses during treatment with ELAHERE, unless advised by a healthcare professional. See “Eye care” in section 3 for more information.
• Lung inflammation.Patients treated with ELAHERE may develop scarring in the lungs (interstitial lung disease), including lung inflammation, which is severe and potentially life-threatening. 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 the arms and legs.Nerve damage in the arms and legs can be severe and intense and may occur during 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 sensations of numbness, tingling, pins and needles (paresthesia), burning, pain, muscle weakness, and altered sense of touch (dysesthesia) in your 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 some medicines, see “Medicines given before the infusion” in section 3. If severe reactions occur, your doctor will immediately stop the infusion and give you supportive treatment.

If you experience any of the serious side effects listed above, your doctor may
suspend/reduce treatment until the symptoms resolve, or, in the most severe cases, treatment
will be stopped permanently.

Children and adolescents
This medicine must not be given to children or adolescents under 18 years of age, because
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 prescription and over-the-counter medicines, vitamins, and herbal supplements, because
some medicines can affect the action of ELAHERE. Also, ELAHERE can affect
the action of other medicines.
The following medicines may increase the risk of side effects of ELAHERE, by increasing
the levels of ELAHERE in the blood. These medicines include:

• ceritinib (anticancer 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 (anticancer medicine for the treatment of some 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)

Contraception
Women of childbearing potential must use effective contraceptive measures
during treatment and for 7 months after the last dose of ELAHERE.

Pregnancy
ELAHERE may harm the fetus if taken during pregnancy, because it contains a compound that
can damage genes and rapidly growing cells. Therefore, the use of ELAHERE is not
recommended during pregnancy. If you are pregnant, suspect you may be pregnant, or are planning a
pregnancy, ask your doctor for advice before taking this medicine.
If you become pregnant during treatment with ELAHERE, or within 7 months
after stopping treatment, tell your doctor immediately.
If you are a woman of childbearing potential, you will be asked to take a pregnancy test before starting
treatment with ELAHERE.

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

Fertility
Fertility studies have not been conducted with ELAHERE and there are no data on the effect of the medicine
on fertility. However, due to the mechanism of action of the medicine, fertility problems are
possible when taking this medicine.

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

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

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

3. How ELAHERE is administered

ELAHERE will be administered by a doctor or nurse experienced in the use of anticancer medications.
The doctor will calculate the dose based on body weight. You will receive ELAHERE via an infusion
(drip) into a vein (intravenously) over 2-4 hours once every 3 weeks (this is known as a “21-day
treatment cycle”). The doctor will decide the number of cycles you need.

Medicines given before the infusion
The doctor will give you the following medicines approximately 30 minutes before each infusion:

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

In addition, you may receive corticosteroids the day before the infusion if you have previously
experienced infusion-related reactions.
The doctor will also give you a medicine to reduce nausea and vomiting before each dose and
afterwards, if needed.

Eye care
An ophthalmologist will perform an eye examination before you start treatment with ELAHERE.

• Before each treatment cycle, it is important that you tell your doctor or ophthalmologist about any new eye problems, or worsening of an existing eye problem. If you develop moderate or severe eye problems during treatment, your doctor may reduce the treatment dose until the problems improve.
• The doctor may adjust, suspend, or permanently discontinue treatment with ELAHERE if signs and symptoms reveal worsening of eye problems.

Contact lenses

• Do not wear contact lenses during treatment with ELAHERE, unless instructed by your doctor or ophthalmologist.

Eye drops

• The use of lubricating eye drops is recommended, as needed, throughout the duration of treatment with ELAHERE.
• If you experience moderate or severe ocular side effects, your doctor may prescribe you a topical steroid eye drop.
• It is important to follow your doctor’s instructions on when to use the topical steroid eye drop and wait at least 15 minutes after instilling the topical steroid eye drop before using lubricating eye drops.

Dose adjustments if side effects occur
The doctor will adjust the dose of ELAHERE if side effects occur (see section 4,
Possible side effects).

If you receive more ELAHERE than you should
Since the infusion is given by a doctor or specialized nurse, an
overdose is unlikely. If you inadvertently receive an excessive amount of medicine, the
doctor will take appropriate measures to monitor you and provide you with care.

If you miss a dose of ELAHERE
If you forget or miss an appointment, contact your doctor or treatment center to schedule another
appointment as soon as possible. Do not wait until your next scheduled visit.
It is very important not to miss a dose, unless advised by your doctor, for the treatment to be fully effective.

If you stop treatment with ELAHERE
You should not stop treatment without first talking to your doctor.
Treatment with ELAHERE usually requires a number of treatment cycles. The number of
infusions you will receive will depend on how the tumor responds to treatment. Therefore, you should continue to
receive ELAHERE even if you see an improvement in your symptoms and until your doctor decides
to stop ELAHERE.
If you have any questions about using 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.
Seek immediate medical attention from your doctor or nurse, or urgent medical care, 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 corneal damage, the clear layer of the eye (keratopathy), clouding of the lens of the eye (cataract), blurred vision, sensitivity to light (photophobia), eye pain and dry eye.
• Lung inflammation(very common, may affect more than 1 in 10 people): signs or symptoms may include difficulty breathing, cough, low levels of oxygen causing confusion, restlessness, rapid heartbeat, bluish skin or scarring of the lungs detectable by an X-ray.
• Nerve damage in the arms and legs(very common, may affect more than 1 in 10 people): signs and symptoms of nerve damage may include a pins and needles sensation, tingling or burning sensation, pain due to nerve damage, muscle weakness and an abnormal unpleasant sense of touch, particularly in the 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, rash, flushing, swelling of the face or around the eyes, sneezing, itching, 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 (infection of the parts of the body where urine is collected and passes out)
• low number of red blood cells, which can cause fatigue and paleness (anemia)
• low number of platelets in the blood, which can cause bleeding and bruising (thrombocytopenia)
• loss of appetite
• low levels of magnesium in the blood, the symptoms of which include nausea, weakness, spasm, cramps or irregular heartbeat (hypomagnesemia)
• headache
• swollen abdomen (abdominal distension)
• stomach pain (abdominal pain)
• diarrhea
• constipation
• feeling unwell (nausea)
• vomiting
• joint pain (arthralgia)
• fatigue
• blood tests showing increased levels of aspartate aminotransferase (AST) and alanine aminotransferase (ALT), 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 heart rhythm disturbances (hypokalaemia)
• dehydration
• difficulty falling asleep and staying asleep and poor quality sleep (insomnia)
• altered taste (dysgeusia)
• feeling dizzy
• high blood pressure (hypertension)
• fluid accumulation in the abdomen (ascites)
• condition in which stomach acid flows back up into the esophagus (gastro-oesophageal reflux disease)
• 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
• muscle pain (myalgia)
• back pain
• pain in the arms, hands, legs and feet
• muscle spasms
• blood tests showing increased levels of alkaline phosphatase (ALP) and gamma-glutamyltransferase (GGT), indicating liver problems
• weight loss

Reporting of side effects
If you get any side effects, talk to your doctor or nurse. This includes any side effects not listed in this leaflet. You can also report side effects directly through the national reporting system indicated in Annex V. 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.
The following information is intended for healthcare professionals
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 pack and on the
vial label after “Exp.”. The expiry date refers to the last day of that month.
Store the vials in an upright position in a refrigerator (2°C – 8°C). Do not freeze.
Keep the vial in the outer packaging to protect the medicine from light.
If the diluted infusion solution is not used immediately, store it at room temperature
(15°C - 25°C) for no more than 8 hours (including the infusion time) or in a refrigerator (2°C - 8°C) for no
more than 24 hours followed by a maximum of 8 hours (including the infusion time) at room temperature
(15°C - 25°C).
Do not use this medicine if you notice that the solution is cloudy or shows changes in colour.
Do not dispose of any medicine in wastewater. The hospital pharmacist will dispose of the medicines that
are no longer needed. This will help protect the environment.

6. Package Contents and Other Information

What ELAHERE contains

• The active ingredient is mirvetuximab soravtansine.
• The other ingredients are glacial acetic acid (E260), sodium acetate (E262), sucrose, polysorbate 20 (E432) and water for injections (see section 2).

Description of ELAHERE and package contents
This medicine is a colorless solution, from clear to slightly opalescent. It is supplied in a
glass vial, with a rubber stopper, aluminum seal and royal blue tear-off cap.
Each pack contains 1 vial.

Marketing Authorisation Holder
AbbVie Deutschland GmbH & Co. KG
Knollstrasse
67061 Ludwigshafen
Germany

Manufacturer
Almac Pharma Services (Ireland) Limited
Finnabair Industrial Estate,
Dundalk, A91 P9KD, Ireland
For further information on this medicine, contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien
AbbVie SA
Tél/Tel: +32 10 477811

Lietuva
AbbVie UAB
Tel: +370 5 205 3023

България
АбВи ЕООД
Тел: +359 2 90 30 430

Luxembourg/Luxemburg
AbbVie SA
Belgique/Belgien
Tél/Tel: +32 10 477811

Česká republika
AbbVie s.r.o.
Tel: +420 233 098 111

Magyarország
AbbVie Kft.
Tel: +36 1 455 8600

Danmark
AbbVie A/S
Tlf: +45 72 30-20-28

Malta
V.J.Salomone Pharma Limited
Tel: +356 21220174

Deutschland
AbbVie Deutschland GmbH & Co. KG
Tel: 00800 222843 33 (gebührenfrei)
Tel: +49 (0) 611 / 1720-0

Nederland
AbbVie B.V.
Tel: +31 (0)88 322 2843

Eesti
AbbVie OÜ
Tel: +372 623 1011

Norge
AbbVie AS
Tlf: +47 67 81 80 00

Ελλάδα
AbbVie ΦΑΡΜΑΚΕΥΤΙΚΗ Α.Ε.
Τηλ: +30 214 4165 555

Österreich
AbbVie GmbH
Tel: +43 1 20589-0

España
AbbVie Spain, S.L.U.
Tel: +34 91 384 09 10

Polska
Abbvie Sp. z o.o.
Tel: +48 22 372 78 00

France
AbbVie
Tél: +33 (0) 1 45 60 13 00

Portugal
AbbVie, Lda.
Tel: +351 (0)21 1908400

Hrvatska
AbbVie d.o.o.
Tel: +385 (0)1 5625 501

România
AbbVie S.R.L.
Tel: +40 21 529 30 35

Ireland
AbbVie Limited
Tel: +353 (0)1 4287900

Slovenija
AbbVie Biofarmacevtska družba d.o.o.
Tel: +386 (1)32 08 060

Ísland
Vistor hf.
Tel: +354 535 7000

Slovenská republika
AbbVie s.r.o.
Tel: +421 2 5050 0777

Italia
AbbVie S.r.l.
Tel: +39 06 928921

Suomi/Finland
AbbVie Oy
Puh/Tel: +358 (0)10 2411 200

Κύπρος
Lifepharma (Z.A.M.) Ltd
Τηλ: +357 22 34 74 40

Sverige
AbbVie AB
Tel: +46 (0)8 684 44 600

Latvija
AbbVie SIA
Tel: +371 67605000

Other sources of information
More detailed information on this medicine is available on the website of the European Medicines Agency, https://www.ema.europa.eu/ .
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in commerce.
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The following information is intended for healthcare professionals only:
ELAHERE is a cytotoxic medicine. Follow the specific procedures for handling and
disposal that apply.
Preparation

• Calculate the dose (mg) (based on the patient's adjusted ideal body weight (AIBW)), 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 allow them to warm to room temperature.
• If the solution and container allow, parenteral medicines should be visually inspected for particulate matter and colour changes before administration. ELAHERE is a colorless solution, from clear to slightly opalescent.
• The medicine should not be used if the solution has a colour change or is cloudy, or if there is foreign particulate matter present.
• Gently swirl and inspect each vial before 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.
• ELAHERE does not contain preservatives and is for single use only. Discard any remaining solution in the vial.

Dilution

• ELAHERE must be diluted before administration with 5% glucose, to a final concentration between 1 mg/mL and 2 mg/mL.
• ELAHERE is not compatible with sodium chloride 9 mg/mL (0.9%) infusion solution. ELAHERE should not be mixed with other medicines or intravenous fluids.
• Determine the volume of 5% glucose needed to achieve the final active ingredient diluted concentration. Remove excess 5% glucose from a pre-filled intravenous infusion bag or add the calculated volume of 5% glucose to a sterile empty intravenous infusion bag. Then add the calculated dose volume of ELAHERE to the intravenous infusion bag.
• Gently mix the diluted solution by slowly inverting the bag several times to ensure uniform mixing. Do not shake or agitate.
• 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 for 24 hours at a temperature of 2°C - 8°C followed by 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 must be used immediately. If the medicine is not used immediately, the storage times and conditions during use are the responsibility of the user.
• If the diluted solution is not used immediately, store the solution in accordance with section 6.3 of the Summary of Product Characteristics. If the infusion bag was refrigerated, allow it to reach room temperature before administration. After refrigeration, diluted infusion solutions must be administered within 8 hours (including infusion time).
• Do not freeze the prepared infusion solution.

Administration

• Visually inspect the ELAHERE intravenous infusion bag for particulate matter or colour change before administration.
• Administer premedication before ELAHERE (see section 4.2).
• Administer ELAHERE exclusively as an intravenous infusion, using a 0.2 or 0.22 µm polyethersulfone (PES) in-line filter. Do not substitute other membrane materials.
• The use of administration devices containing di-2-ethylhexyl phthalate (DEHP) should be avoided.
• Administer the initial dose as an 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, with the possibility of increasing to a maximum infusion rate of 5 mg/min, if tolerated.
• After the infusion, flush the intravenous line with 5% glucose to ensure delivery of the full dose. Do not use other intravenous fluids for flushing.

Disposal
Unused medicine and waste materials derived from such medicine should be disposed of in accordance
with local regulations.