InfoCons Consumer Protection informs you – TEPEZZA – Package Leaflet

Before anything else

Read all of this leaflet carefully before you start using 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. This includes any possible side effects not listed in this leaflet . See section 4.

ℹ️ 1. What TEPEZZA is and what it is used for

TEPEZZA contains teprotumumab, a type of protein ( monoclonal antibody ).

This medicine is used in adults to treat moderate to severe thyroid eye disease (TED).

TED is an autoimmune condition where the immune system (the body’s natural defences) attacks the muscles and fat around the eyes. A protein called IGF -1R is found in the muscles and fat around the eyes. In people with TED, the immune system activates IGF -1R, causing inflammation and swelling which can push the eyes forward, causing them to bulge. It can also result in double vision, and in severe cases, may cause permanent vision damage.

The active substance in TEPEZZA, teprotumumab, blocks the IGF -1R protein, this keeps the immune system from attacking the muscle and fat tissues around the eyes , which helps reduce swelling, relieve pressure around the eyes and improve disease symptoms.

⚠️ 2. What you need to know before you are given TEPEZZA

Do not use TEPEZZA

• if you are allergic to teprotumumab or any of the other ingredients of this medicine (listed in sectio n 6).
• if you are pregnant (see section ‘Pregnancy, breast -feeding and contraception ’).

If you are not sure, talk to your doctor or nurse before being given TEPEZZA .

29 Warnings and precautions Talk to your doctor or nurse before taking TEPEZZA if you :

• have history of hearing problems or if you use hearing aids
• are sensitive to loud noises
• have diabetes or pre -diabetes
• have inflammatory bowel disease
• are pregnant or planning to have a baby
• smoke
• ever had high blood pressure You should stop smoking before starting treatment, and your doctor may need to monitor your blood pressure before and during treatment.

Your doctor will explain the benefits and risks of TEPEZZA and provide you with a ‘Patient Guide ’ to help you understand the risk of developing hearing problems and the need for effective contraception during treatment.

Infusion -related reactions You will be monitored during the infusion and for 90 minutes afterwards to check if you develop a reaction to the infusion. T ell your doctor or nurse if you develop symptoms of an infusion -related reaction, particularly if this occurs following the monitoring period . Symptoms of infusion -related reactions are listed under “Possible side effects” in section 4.

High blood sugar ( hyperglyc aemia) TEPEZZA may cause blood sugar levels to increase , especially if you already have diabetes or pre-diabetes (see section 4 “Possible side effects”).

Your doctor or nurse will check your blood sugar levels before you start treatment, during treatment, and for up to 6 months after you finish. If your blood sugar is not well controlled with your current diabetes medication, please speak to your doctor. It’s important to make sure your blood sugar is properly managed before starting TEPEZZA treatment.

Hearing problems TEPEZZA may cause problems with your hearing including severe hearing loss , which may be permanent. Symptoms of hearing problems are listed under “Possible side effects” in section 4. If you already have hearing problems, your symptoms may get worse during or after treatment. Contact your doctor as soon as possible if you notice any changes in your hearing at any time.

You should avoid loud noises during treatment . Your hearing will be monitored with a hearing test before starting treatment , during and after completing treatment.

Your doctor will decide if any additional hearing tests are needed and will monitor your hearing for 6 months after you complete treatment. If you experience hearing loss that requires medical treatment, affects your ability to perform everyday tasks, or is getting worse, your doctor may stop your treatment with TEPEZZA.

Inflammatory bowel disease TEPEZZA may worsen existing inflammatory bowel disease (IBD) ; inflammation of the colon and rectum , including ulcerative colitis and Crohn ’s disease . During the treatment if you notice any signs of an IBD flare -up (see section 4), tell your doctor or seek medical help as soon as possible .

30 Children and adolescents TEPEZZA is not recommended for children and adolescents under 18 years of age. The s afety and benefit of this medicine have not been established in these patient populations.

Other medicines and TEPEZZA

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

This includes medicines obtained without a prescription and herbal medicines.

It is important to tell your doctor if you are taking medicines that can affect your hearing, such as:

• certain antibiotics (e.g. aminoglycosides or vancomycin),
• Platinum -containing medicines used to treat cancer,
• water tablets (loop diuretics) used to remove excess fluid.

Using these together with TEPEZZA may increase the risk of hearing problems.

Pregnancy , breast -feeding and contraception

Pregnancy

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

Do not use this medicine if you are pregnant. TEPEZZA may harm your unborn baby.

Contraception If you are able to get pregnant you should use adequate birth control while you are being treated with TEPEZZA and for at least 6 months after your last treatment.

Breast -feeding Do not use this medicine if you are breast -feeding. It is not known if this medicine passes into breast milk, and the risk to the breast -fed infant is unknown. If you plan to breast -feed, ask your doctor or nurse for advice before using this medicine.

Driving and using machines

While you are being treated with TEPEZZA you may experience fatigue or headaches . This may impair your ability to drive or use machines. Do not drive a car or operate machines if you have th ese symptom s.

TEPEZZA contains polysorbate

This medicine contains 1.05 mg of polysorbate 20 in each 10.5 mL volume. Polysorbates may cause allergic reactions. Tell your doctor if you have any known allergies.

💊 3. How TEPEZZA is given

This medicine is given in a hea lthcare facility under the s upervision of a healthcare profe ssional.

You will receive eight infusions given once every three weeks . The dose of T EPEZZA depends on your body weight.

A doctor or nurse will give you this medicine as an intravenous infusion (drip into your vein). Your doctor will decide the duration of the infusion.

31 If too much TEPEZZA is given TEPEZZA is given to you by healthcare professionals and it is unlikely that you will be given too much . If this happens, your doctor will monitor you for any signs or symptoms of side effects and treat these symptoms if necessary.

If a dose of TEPEZZA is missed If you miss a dose, please contact your doctor immediately for advice and to s chedule another appointment to receive T EPEZZA . Your doctor will decide when you should be given your next dose .

If you stop treatment with TEPEZZA Do not stop treatment with TEPEZZA unless you have discussed this with your doctor.

If you have any further questions on 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.

Tell your doctor or nurse immediately if you experience any of the following symptoms during or after the infusion :

Infusion -related reactions (Common, may affect up to 1 in 10 people ) You may experience symptoms such as:

• difficulty in breathing or chest pain
• redness or flushing of the skin or a rash
• chills or shivering
• feeling of being sick
• light headedness
• fast heartbeat
• loss of consciousness Contact a doctor or go to your nearest emergency department immediately if you experience any of the following symptoms:

Very high blood sugar ( hyperglycaemia) TEPEZZA may cause uncontrolled high blood sugar, especially if you already have diabetes or pre-diabetes. Tell your doctor, nurse or go to your nearest emergency department immediately if you experience signs of very high blood sugar, including:

• diabetic ketoacidosis (uncommon, may affect up to 1 in 100 people) – a potentially life-threatening condition in people with diabetes where a lack of insulin causes an increase in blood sugar levels and ketones . Early symptoms include feeling very thirsty and urinating more often than usual. You may experience other symptoms such as nausea, vomiting, feeling tired or confused, stomach pain, faster or deeper breathing, and fruity -smelling breath .
• hyperosmolar hyperglycaemic state (not known, frequency cannot be estimated from the available data) – a serious condition that occurs when blood sugar becomes extremely high over several days or weeks, leading to severe dehydration and confusion.

32 Contact a doctor as soon as possible if you experience any of the following symptoms:

Hearing problems You may experience symptoms such as :

Common (may affect up to 1 in 10 people)

• feeling of blocked ears, or pressure in the ear (ear discomfort)
• partial or total loss of hearing
• ringing or buzzing in the ears (tinnitus)
• hearing your own voice louder than normal
• muffled hearing

Uncommon (may affect up to 1 in 100 people)

• damage to the ear drum
• increased sensitivity to particular sounds Worsening of inflammatory bowel disease (Uncommon , may affect up to 1 in 100 people) The symptoms may include an increased number of loose stools with stomach pain or cramps, or blood in your stools.

See also section 2 “Warnings and precautions” for more information.

Other side effects

Most of the following side effects are mild to moderate.

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

• muscle cramps
• diarrhoea
• hair loss
• feeling extremely tired or lacking energy
• feeling sick ( nausea )
• headache

Common (may affect up to 1 in 10 people)

• dry skin
• change in the sense of taste
• COVID -19
• high blood sugar
• weight loss
• diabetes mellitus
• nail splitting, breaking, or coming away from the nail bed
• loss of eyebrows or eyelashes
• pre-diabetes
• nail discolouration
• missing one or more periods
• irregular periods
• heavy periods
• lighter periods
• pain or cramping during your period

Uncommon (may affect up to 1 in 100 people)

• ingrow n nail

Reporting of side effects

If you get any side effects , talk to your doctor , pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via 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. How to store TEPEZZA

TEPEZZA will be stored by the healthcare professionals at the hospital or clinic.

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

Unopened vials:

Store in a refrigerator (2°C – 8°C) .

Do not freeze.

Keep the vial in the outer carton in order to protect from light.

📦 6. Contents of the pack and other information

What TEPEZZA contains

• The active substance is teprotumumab .
• Each vial contains 500 mg teprotumumab.

The other ingredients are histidine, histidine hydrochloride monohydrate, polysorbate 20 (E432) and trehalose dihydrate. See section 2 “TEPEZZA contains polysorbate ”.

What TEPEZZA looks like and contents of the pack

TEPEZZA is a powder for concentrate for solution for infusion , which is supplied in a glass vial with a rubber stopper containing 500 mg of teprotumumab. The powder is a white to off white powder supplied in a single -dose vial. Each pack contain s one vial.

Marketing Authorisation Holder

Amgen Europe B.V.

Minervum 7061 4817 ZK Breda The Netherlands

Manufacturer

Horizon Therapeutics Ireland DAC Pottery Road, Dun Laoghaire Dublin A96 F2A8 Ireland 34 Manufacturer Amgen NV Telecomlaan 5 -7 1831 Diegem Belgium For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien s.a. Amgen n.v.

Tél/Tel: +32 (0)2 7752711 Lietuva Amgen Switzerland AG Vilniaus filialas Tel: + 370 5 219 7474 България Амджен България ЕООД Тел.: +359 (0)2 424 7440 Luxembourg/Luxemburg s.a. Amgen Belgique/Belgien Tél/Tel: +32 (0)2 7752711 Česká republika Amgen s.r.o.

Tel: +420 221 773 500 Magyarország Amgen Kft.

Tel.: +36 1 35 44 700 Danmark Amgen, filial af Amgen AB, Sverige Tlf.: +45 39617500 Malta Amgen S.r.l.

Italy Tel: +39 02 6241121 Deutschland Amgen GmbH Tel.: +49 89 1490960 Nederland Amgen B.V.

Tel: +31 (0)76 5732500 Eesti Amgen Switzerland AG Vilniaus filialas Tel: + 372 586 09553 Norge Amgen AB Tlf: +47 23308000 Ελλάδα Amgen Ελλάς Φαρμακευτικά Ε.Π.Ε.

Τηλ: +30 210 3447000 Österreich Amgen GmbH Tel: +43 (0)1 50 217 España Amgen S.A.

Tel: +34 93 600 18 60 Polska Amgen Biotechnologia Sp. z o.o.

Tel.: +48 22 581 3000 France Amgen S.A.S.

Tél: +33 (0)9 69 363 363 Portugal Amgen Biofarmacêutica, Lda.

Tel: +351 21 4220606 Hrvatska Amgen d.o.o.

Tel: +385 (0)1 562 57 20 România Amgen România SRL Tel: +4021 527 3000 Ireland Amgen Ireland Limited Tel: +353 1 8527400 Slovenija AMGEN zdravila d.o.o.

Tel: +386 (0)1 585 1767 35 Ísland Vistor Sími: +354 535 7000 Slovenská republika Amgen Slovakia s.r.o.

Tel: +421 2 321 114 49 Italia Amgen S.r.l.

Tel: +39 02 6241121 Suomi/Finland Amgen AB, sivuliike Suomessa/Amgen AB, filial i Finland Puh/Tel: +358 (0)9 54900500 Kύπρος C.A. Papaellinas Ltd Τηλ: +357 22741 741 Sverige Amgen AB Tel: +46 (0)8 6951100 Latvija Amgen Switzerland AG Rīgas filiāle Tel: +371 257 25888

This leaflet was last revised in

Other sources of information Detailed information on this medicine is available on the European Medicines Agency website: https://www.ema.europa.eu . ——————————————————————————————— —————————

🩺 Information intended for healthcare professionals only

Posology and method of administration TEPEZZA should be prepared by a healthcare professional using aseptic technique to ensure the sterility of the prepared solution.

Preparation of the medicinal product before administration Step 1: Calculate the dose (mg) and determine the number of vials needed for the 10 or 20 mg/kg dose based on patient weight. Each TEPEZZA vial contains 500 mg of teprotumumab.

Step 2: Using appropriate aseptic technique, reconstitute each vial with 10 mL of water for injection s.

Ensure that the stream of diluent is not directed onto the lyophili sed powder, which has a cake -like appearance. Do not shake, but gently swirl the solution by rotating the vial until the lyophili sed powder is dissolved. The reconstituted solution has a total volume of 10.5 mL. Withdraw 10.5 mL of reconstituted solution to obtain 500 mg. After reconstitution, the final concentration is 47.6 mg/m L.

Step 3: The reconstituted solution must be further diluted in sodium chloride 9 mg/m L (0.9%) solution for infusion, prior to infusion. To prepare the diluted solution, use 100 mL infusion bags for a dose less than 1 800 mg, and 250 mL infusion bags for a dose equal of greater than 1 800 mg. To maintain a constant volume in the infusion bag, a sterile syringe and needle should be used to remove the volume equivalent to the amount of the reconstituted solution to be placed into the infusion bag. The volume of sodium chloride 9 mg/m L (0.9%) solution withdrawn must be discarded .

Step 4: Withdraw the required volume from the reconstituted vial(s) based on the patient’s weight (in kg) and transfer into an intravenous bag containing sodium chloride 9 mg/m L (0.9%) solution for infusion . Mix the diluted solution by gentle inversion. Do not shake. If refrigerated prior to administration, allow the diluted solution to reach room temperature prior to infusion . Care should be taken to ensure the sterility of the prepared solution.

No incompatibilities between teprotumumab and polyethylene (PE), polyvinyl chloride (PVC), polyurethane (PUR) or polyolefin (PO) bags and intravenous administration sets have been observed.

Appearance on reconstitution After reconstitution, TEPEZZA is a nearly colourless or slightly brown, clear to opalescent solution which is free of foreign particulate matter. The reconstituted solution should be inspected for particular matter and discolo uration prior to administration. Discard the solution if particulate matter is present or discolo uration is observed.

Storage of reconstituted and diluted infusion solution Chemical and physical in -use stability of the reconstituted solution in the vial has been demonstrated for up to 4 hours at room temperature (20°C – 25°C) or up to 48 hours at 2°C to 8°C storage condition.

Chemical and physical in -use stability of the diluted solution in the infusion bag has been demonstrated for 24 hours at 2°C to 8ºC followed by 24 hours at room temperature (20°C – 25°C) storage condition.

From a microbiological point of view, the product should be used immediately. If not used immediately, in -use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2°C to 8°C, unless reconstitution and dilution has taken place in controlled and validated aseptic conditions. If refrigerated prior to administration, the diluted solution should be at room temperature prior to infusion.

Method of a dministration

• This medicinal product must be administered as an intravenous infusion. It must not be administered as an intravenous push or bolus.
• Prior to infusion:
• the powder must be reconstituted with water for injections.
• The reconstituted solution must be further diluted in sodium chloride 9 mg/mL (0.9%) solution for infusion.
• TEPEZZA must not be co -administered with other medicinal products through the same infusion line.
• For the first 2 infusions, the diluted solution must be administered intravenously over at least 90 minutes. If well tolerated, the minimum time for subsequent infusions can be reduced to 60 minutes.
• If the 60 -minute infusion is not well tolerated, the minimum time for subsequent infusions should remain at 90 minutes, the rate of infusion should be reduced and pre -medication is recommended for subsequent infusions.

Special precautions for disposal and other handling Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

📄 Package Leaflet – official source

This article reproduces the information in the official package leaflet, as authorised in the European Union. You can consult the original document here: Product information TEPEZZA (PDF, ec.europa.eu).

You can check this medicine at any time in the Union Register of medicinal products (EU number EU/1/25/1941).

⚠️ Important: This article is for information purposes only and does not replace medical advice or the package leaflet inside the medicine box. Read the leaflet carefully before use. For any questions about your treatment, talk to your doctor or pharmacist. If you experience side effects, tell your doctor or pharmacist and report them through your national reporting system.