Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - orserdu

Document Subject

Generated Narrative: MedicinalProductDefinition mp8fdef97116c9e46e3458e3dc3216f0d9

identifier: http://ema.europa.eu/identifier/EU/1/23/1756/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: ORSERDU 86 mg film-coated tablets

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

part: nan

type: Strength part

part

part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-8fdef97116c9e46e3458e3dc3216f0d9

identifier: http://ema.europa.eu/identifier/EU/1/23/1756/001

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - orserdu

Attesters

What is in this leaflet

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

What ORSERDU is

ORSERDU contains the active substance elacestrant which belongs to a group of medicines called selective estrogen receptor degraders.

What ORSERDU is used for

This medicine is used to treat postmenopausal women and adult men who have a specific type of breast cancer that is advanced or has spread to other parts of the body (metastatic). It can be used to treat breast cancer that is estrogen receptor (ER)-positive, meaning that the cancer cells have receptors for the hormone oestrogen on their surface, and that is human epidermal growth factor receptor 2 (HER2)-negative, meaning that cancer cells have no or only a small amount of this receptor on their surface. ORSERDU is used as monotherapy (used on its own) in patients whose cancer has not responded to or progressed further following at least one line of hormonal treatment including a CDK 4/6 inhibitor and who have certain changes (mutations) in a gene called ESR1. Your doctor will take a sample of your blood, which will be tested for these ESR1 mutations. A positive result is required for initiation of treatment with ORSERDU.

How ORSERDU works

Oestrogen receptors are a group of proteins found inside the cells. They are activated when the hormone oestrogen binds to them. By binding to these receptors, oestrogen can in some cases stimulate cancer cells to grow and multiply. ORSERDU contains the active substance elacestrant that binds to the oestrogen receptors in the cancer cells and stops them from working. By blocking and destroying oestrogen receptors, ORSERDU can reduce the growth and spread of breast cancer and help to kill cancer cells.

If you have any questions about how ORSERDU works or why this medicine has been prescribed for you, ask your doctor, pharmacist, or nurse.

Do not use ORSERDU if:

• you are allergic to elacestrant or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions Talk to your doctor or pharmacist before taking ORSERDU

• if you have any liver disease (examples of liver disease include cirrhosis (scarring of the liver), liver impairment or cholestatic jaundice (yellowing of the skin and eyes due to a reduced flow of bile from the liver)). Your doctor will monitor you regularly and closely for adverse reactions.

By having advanced breast cancer you may have an increased risk of developing blood clots in your veins (a type of blood vessel). It is unknown if ORSERDU also increases this risk.

Children and adolescents ORSERDU should not be given to children and adolescents under 18 years of age.

Other medicines and ORSERDU Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This is because ORSERDU can affect the way some other medicines work. Also, some other medicines can affect the way ORSERDU works.

Tell your doctor if you take any of the following medicines:

• antibiotics to treat bacterial infections (such as ciprofloxacin, clarithromycin, erythromycin, rifampicin, telithromycin)
• medicine for low blood sodium (such as conivaptan)
• medicines to treat depression (such as nefazodone or fluvoxamine)
• medicine to treat anxiety and alcohol withdrawal (such as tofisopam).
• medicines for the treatment of other cancers (such as crizotinib, dabrafenib, imatinib, lorlatinib, or sotorasib)
• medicines for high blood pressure or chest pain (such as bosentan, diltiazem or verapamil)
• medicines for fungal infections (such as fluconazole, isavuconazole, itraconazole, ketoconazole, posaconazole, or voriconazole)
• medicines for HIV infection (such as efavirenz, etravirine, indinavir, lopinavir, ritonavir, nelfinavir, saquinavir, or telaprevir)
• medicines to treat irregular heartbeats (such as digoxin, dronedarone, or quinidine)
• medicines used in organ transplantation to prevent rejection (such as cyclosporine)
• medicines to prevent cardiovascular events and to treat high levels of cholesterol (such as rosuvastatin)
• medicines used to prevent seizures (such as carbamazepine, cenobamate, phenobarbital, phenytoin, or primidone)
• medicines to treat vomiting (such as aprepitant)
• herbal medicines used to treat depression containing St. John s wort

ORSERDU with food and drink Do not drink grapefruit juice or eat grapefruit while on treatment with ORSERDU as it may change the amount of ORSERDU in your body and increase the side effects of ORSERDU (see Section 3 How to take ORSERDU .

Pregnancy, breast-feeding and fertility This medicine should only be used in postmenopausal women and in men.

Pregnancy ORSERDU may harm an unborn baby. You must not take ORSERDU if you are pregnant, think you may be pregnant or are planning to have a baby. If you think you may be pregnant or planning to have a baby, ask your doctor, or pharmacist for advice before using this medicine.

If you are a woman who could become pregnant, you should use effective contraception while you are being treated with ORSERDU and for one week after stopping treatment with ORSERDU. Ask your doctor for suitable methods. If you are a woman who could become pregnant, your doctor will rule out an existing pregnancy before starting you on treatment with ORSERDU. This may include having a pregnancy test.

Breast-feeding You must not breast-feed while on treatment with ORSERDU and for one week after the last dose of ORSERDU. During treatment, your doctor will discuss the potential risks of taking ORSERDU during pregnancy or breast-feeding.

Fertility ORSERDU may impair fertility in women and men.

Driving and using machines ORSERDU has no or negligible influence on the ability to drive and use machines. However, since fatigue, weakness, and difficulty sleeping have been reported in some patients taking elacestrant, caution should be observed by patients who experience those adverse reactions when driving or operating machinery.

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

ORSERDU should be taken with food, just avoid grapefruit and grapefruit juice during treatment with ORSERDU (see section 2 ORSERDU with food and drink ). Taking ORSERDU with food may reduce nausea and vomiting.

Take your dose of this medicine at approximately the same time each day. This will help you to remember to take your medicine.

ORSERDU tablets should be swallowed whole. They should not be chewed, crushed or split prior to swallowing. Do not take a tablet that is broken, cracked or otherwise damaged.

The recommended dose of ORSERDU is 345 mg (one 345 mg film-coated tablet) once daily. Your doctor will tell you exactly how many tablets to take. In certain situations (i.e. in case of liver problems, side effects, or if you are also using certain other medicines your doctor may instruct you to take a lower dose of ORSERDU, e.g. 258 mg (3 tablets of 86 mg) once daily, 172 mg (2 tablets of 86 mg) once daily, or 86 mg (1 tablet of 86 mg) once daily.

If you take more ORSERDU than you should Tell your doctor or pharmacist if you think you have accidentally taken more ORSERDU than you should. He or she will decide what to do.

If you forget to take ORSERDU If you forget to take a dose of ORSERDU, take it as soon as you remember. You may still take a forgotten dose up to 6 hours after the time you should have taken it. If more than 6 hours have passed or if you vomit after taking the dose, skip the dose for that day and take the next dose at your usual time the next day. Do not take a double dose to make up for the one that you missed.

If you stop taking ORSERDU Do not stop using this medicine without talking to your doctor or pharmacist. If treatment with ORSERDU is stopped, your condition may worsen.

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

Like all medicines, this medicine can cause side effects, although not everybody gets them. Tell your doctor or nurse if you notice any of the following side effects:

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

• Decreased appetite
• Feeling sick (nausea)
• Increased triglycerides and cholesterol levels in your blood
• Vomiting
• Tiredness (fatigue)
• Indigestion (dyspepsia)
• Diarrhoea
• Decreased calcium levels in your blood
• Back pain
• Increased creatinine levels in your blood
• Joint pain (arthralgia)
• Decreased sodium levels in your blood
• Constipation
• Headache
• Hot flushes
• Abdominal pain
• Low levels of red blood cells, as measured in blood tests (anaemia)
• Decreased potassium levels in your blood
• Elevated liver function, as measured in blood tests (alanine aminotransferase increased, aspartate aminotransferase increased)

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

• Pain in hands or legs (pain in extremity)
• Weakness (asthenia)
• Infection of the parts of the body that collect and pass out urine (urinary tract infection)
• Cough
• Shortness of breath (dyspnoea)
• Difficulty falling and staying asleep (insomnia)
• Elevated liver function, as measured in blood tests (Blood alkaline phosphatase increased)
• Rash
• Low levels of lymphocytes (a type of white blood cell), as measured in blood tests (Lymphocyte count decreased)
• Bone pain
• Dizziness
• Chest pain relating to the muscles and bones in the chest (Musculoskeletal chest pain)
• Inflammation of the mouth and lips (stomatitis)
• Fainting (syncope)

Uncommon (may affect up to 1 in every 100 people)

• Increased risk of blood clots (thromboembolism)
• Liver failure (acute hepatic failure)

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.

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 blister pack after EXP. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

Do not use this medicine if you notice any damage to the packaging or if there are any signs of tampering.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What ORSERDU contains

• The active substance is elacestrant.

Each 86 mg ORSERDU film-coated tablet contains 86.3 mg of elacestrant. * Each 345 mg ORSERDU film-coated tablet contains 345 mg of elacestrant

The other ingredients are:

Tablet core Microcrystalline cellulose [E460] Silicified microcrystalline cellulose Crospovidone [E1202] Magnesium stearate [E470b] Colloidal silicon dioxide [E551]

Film-coating Opadry II 85F105080 Blue containing polyvinyl alcohol [E1203], titanium dioxide [E171], macrogol [E1521], talc [E553b] and brilliant blue FCF aluminium lake [E133]

What ORSERDU looks like and contents of the pack

ORSERDU is supplied as film-coated tablets in aluminium blisters.

ORSERDU 86 mg film-coated tablets Blue to light blue, biconvex round shaped film-coated tablet with ME debossed on one side and plain face on the opposite side. Approximate diameter: 8.8 mm.

ORSERDU 345 mg film-coated tablets Blue to light blue, biconvex, oval shaped film-coated tablet with MH debossed on one side and plain face on the opposite side. Approximate size: 19.2 mm (length), 10.8 mm (width).

Each pack contains 28 film-coated tablets (4 blisters with 7 tablets each).

Marketing Authorisation Holder Stemline Therapeutics B.V.
Basisweg 1043 AP Amsterdam
The Netherlands

Manufacturer Stemline Therapeutics B.V. Basisweg 1043 AP Amsterdam
The Netherlands

or

Berlin Chemie AG Glienicker Weg 12489 Berlin Germany

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Belgi /Belgique/Belgien; ; esk republika; Danmark; Eesti; ; Hrvatska; Ireland; sland; ; Latvija; Lietuva; Luxembourg/Luxemburg; Magyarorsz g; Malta; Nederland; Norge; Polska; Portugal; Rom nia; Slovenija; Slovensk republika; Suomi/Finland; Sverige Stemline Therapeutics B.V. Tel: +44 (0)800 047 8EUmedinfo@menarinistemline.com

Italia Menarini Stemline Italia S.r.l. Tel: +39 800776EUmedinfo@menarinistemline.com

Deutschland Menarini Stemline Deutschland GmbH Tel: +49 (0)800 0008EUmedinfo@menarinistemline.com

sterreich Stemline Therapeutics B.V. Tel: +43 (0)800 297 EUmedinfo@menarinistemline.com Espa a Menarini Stemline Espa a, S.L.U. Tel: +34919490EUmedinfo@menarinistemline.com

United Kingdom (Northern Ireland) Stemline Therapeutics B.V. Tel: +44 (0)800 047 8EUmedinfo@menarinistemline.com

France Stemline Therapeutics B.V. T l: +33 (0)800 991EUmedinfo@menarinistemline.com

This leaflet was last revised in

Detailed information on this medicine is available on the European Medicines Agency web site: