Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - epysqli

Document Subject

Generated Narrative: MedicinalProductDefinition mpeb1bff8909fbce324e442418d542373f

identifier: http://ema.europa.eu/identifier/EU/1/23/1735/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Epysqli 300 mg concentrate for solution for infusion

type: Full name

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part: nan

type: Invented name part

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part: nan

type: Scientific name part

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type: Strength part

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type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-eb1bff8909fbce324e442418d542373f

identifier: http://ema.europa.eu/identifier/EU/1/23/1735/001

status: Final

type: Package Leaflet

category: Raw

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

author: Organization ACME industry

title: TEST PURPOSES ONLY - epysqli

Attesters

What is in this leaflet

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

What is Epysqli Epysqli contains the active substance eculizumab and it belongs to a class of medicines called monoclonal antibodies. Eculizumab binds to and inhibits a specific protein in the body that causes inflammation and so prevents your body s systems from attacking and destroying vulnerable blood cells, kidneys, muscles or eye nerves and spinal cord.

What is Epysqli used for Epysqli is used to treat adults and children patients with a certain type of disease affecting the blood system called Paroxysmal Nocturnal Haemoglobinuria (PNH). In patients with PNH, their red blood cells can be destroyed which can lead to low blood counts (anaemia), tiredness, difficulty in functioning, pain, dark urine, shortness of breath, and blood clots. Eculizumab can block the body s inflammatory response, and its ability to attack and destroy its own vulnerable PNH blood cells.

Do not use Epysqli

• If you are allergic to eculizumab, proteins derived from mouse products, other monoclonal antibodies, or any of the other ingredients of this medicine (listed in section 6).
• If you have not been vaccinated against meningococcal infection unless you take antibiotics to reduce the risk of infection until 2 weeks after you have been vaccinated .
• If you have a meningococcal infection.

Warnings and precautions

Meningococcal and other Neisseria infections alert Epysqli treatment may reduce your natural resistance to infections, especially against certain organisms that cause meningococcal infection (severe infection of the linings of the brain and sepsis) and other Neisseria infections including disseminated gonorrhea.

Consult your doctor before you take Epysqli to be sure that you receive vaccination against Neisseria meningitidis, an organism that causes meningococcal infection, at least 2 weeks before beginning therapy, or that you take antibiotics to reduce the risk of infection until 2 weeks after you have been vaccinated. Ensure that your current meningococcal vaccination is up to date. You should also be aware that vaccination may not prevent this type of infection. In accordance with national recommendations, your doctor might consider that you need supplementary measures to prevent infection.

If you are at risk of gonorrhoea, ask your doctor or pharmacist for advice before using this medicine.

Meningococcal infection symptoms

Because of the importance of rapidly identifying and treating certain types of infection in patients who receive Epysqli, you will be provided a card to carry with you, listing specific trigger symptoms. This card is named: Patient Safety Card .

If you experience any of the following symptoms, you should immediately inform your doctor:

• headache with nausea or vomiting
• headache with a stiff neck or back
• fever
• rash
• confusion
• severe muscle aches combined with flu-like symptoms
• sensitivity to light

Treatment for meningococcal infection while travelling

If you are travelling in a remote region where you are unable to contact your doctor or in which you find yourself temporarily unable to receive medical treatment, your doctor can make arrangements to issue, as a preventive measure, a prescription for an antibiotic to counter Neisseria meningitidis that you keep with you. If you experience any of the symptoms amongst those cited above, you should take the antibiotics as prescribed. You should bear in mind that you should see a doctor as soon as possible, even if you feel better after having taken the antibiotics.

Infections Before starting Epysqli, inform your doctor if you have any infections.

Allergic reactions Epysqli contains a protein and proteins can cause allergic reactions in some people.

Children and adolescents Patients less than 18 years of age must be vaccinated against Haemophilus influenzae and pneumococcal infections

Elderly There are no special precautions needed for the treatment of patients aged from 65 years and over.

Other medicines and Epysqli Tell your doctor or pharmacist if you are using or have recently used or might use any other medicines.

Pregnancy, breast-feeding, and fertility If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

Women of childbearing potential The use of effective contraception during treatment and up to 5 months after treatment should be considered in women who are able to get pregnant.

Pregnancy/ Breast-feeding If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

Driving and using machines Epysqli has no or negligible influence on the ability to drive and use machines.

Epysqli contains sodium Once diluted with sodium chloride 9 mg/mL (0.9 %) solution for injection, this medicine contains 0.35 g sodium (main component of cooking/table salt) in 180 mL at the maximal dose. This is equivalent to 17.5 % of the recommended maximum daily dietary intake of sodium for an adult. You should take this into consideration if you are on a controlled sodium diet.

Once diluted with sodium chloride 4.5 mg/mL (0.45 %) solution for injection, this medicine contains 0.19 g sodium (main component of cooking/table salt) in 180 mL at the maximal dose. This is equivalent to 9.5 % of the recommended maximum daily dietary intake of sodium for an adult. You should take this into consideration if you are on a controlled sodium diet.

At least 2 weeks before you start treatment with Epysqli, your doctor will administer a vaccine against meningococcal infection if it was not previously administered or if your vaccination is outdated. If your child is below the age of vaccination or if you are not vaccinated at least 2 weeks before you start treatment with Epysqli, your doctor will prescribe antibiotics to reduce the risk of infection until 2 weeks after you have been vaccinated. Your doctor will administer a vaccine to your child aged less than 18 years against Haemophilus influenzae and pneumococcal infections according to the national vaccination recommendations for each age group.

Instructions for proper use The treatment will be given by your doctor or other health care provider by infusing a dilution of the Epysqli vial from a drip bag through a tube directly into one of your veins. It is recommended that the beginning of your treatments, called the initial phase, will extend over 4 weeks, followed by a maintenance phase.

For adults

Initial Phase: Every week for the first four weeks, your doctor will administer an intravenous infusion of diluted Epysqli. Each infusion will consist of a dose of 600 mg (2 vials of 30 ml) and will take 25 minutes (35 minutes 10 minutes).

Maintenance Phase: In the fifth week, your doctor will administer an intravenous infusion of diluted Epysqli at a dose of 900 mg (3 vials of 30 ml) over a 25 45 minute (35 minutes 10 minutes) period. After the fifth week, your doctor will administer 900 mg of diluted Epysqli every two weeks as a long-term treatment.

For children and adolescents

Children and adolescents who are 40 kg weight and over are treated with the adult dosing.

Children and adolescents who are under 40 kg weight require a lower dose based on how much they weigh. Your doctor will calculate this.

For children and adolescents aged less than 18 years: Body Weight Initial Phase Maintenance Phase 30 to < 40 kg 600 mg weekly for the first 2 weeks 900 mg at week 3; then 900 mg every 2 weeks 20 to < 30 kg 600 mg weekly for the first 2 weeks 600 mg at week 3; then 600 mg every 2 weeks 10 to < 20 kg 600 mg weekly 1 300 mg at week 2; then 300 mg every 2 weeks 5 to < 10 kg 300 mg weekly 1 300 mg at week 2; then 300 mg every 3 weeks

Following each infusion, you will be monitored for about one hour. Your doctor s instructions should be carefully observed.

If you receive more Epysqli than you should If you suspect that you have been accidentally administered a higher dose of Epysqli than prescribed, please contact your doctor for advice.

If you forget an appointment to receive Epysqli If you forget an appointment, please contact your doctor immediately for advice and see section below If you stop using Epysqli .

If you stop using Epysqli for PNH Interrupting or ending treatment with Epysqli may cause your PNH symptoms to come back more severely soon. Your doctor will discuss the possible side effects with you and explain the risks. Your doctor will want to monitor you closely for at least 8 weeks.

The risks of stopping Epysqli include an increase in the destruction of your red blood cells, which may cause:

• A significant fall in your red blood cell counts (anaemia),
• Confusion or change in how alert you are,
• Chest pain, or angina,
• An increase in your serum creatinine level (problems with your kidneys), or
• Thrombosis (blood clotting). If you have any of these symptoms, contact your doctor.

Like all medicines, this medicine can cause side effects, although not everybody gets them. Your doctor will discuss the possible side effects with you and explain the risks and benefits of Epysqli with you prior to treatment. The most serious side effect was meningococcal sepsis (frequency not known (cannot be estimated from the available data)). If you experience any of the meningococcal infection symptoms (see section 2 Meningococcal and other Neisseria infections alert ), you should immediately inform your doctor.

If you are not sure what the side effects below are, ask your doctor to explain them to you.

Very common: may affect more than 1 in 10 people:

• headache.

Common: may affect up to 1 in 10 people: infection of the lung (pneumonia), common cold (nasopharyngitis), infection of the urinary system (urinary tract infection), low white blood cell count (leukopenia), reduction in red blood cells which can make the skin pale and cause weakness or breathlessness inability to sleep dizziness, taste disorders (dysgeusia), high blood pressure upper respiratory tract infection, cough, throat pain (oropharyngeal pain), bronchitis, cold sores (herpes simplex) diarrhoea, vomiting, nausea, abdominal pain, rash, hair loss (alopecia), itchy skin (pruritus) pain in thejoints (arms and legs) fever (pyrexia), feeling tired (fatigue), influenza like illness

Uncommon: may affect up to 1 in 100 people: severe infection (meningococcal infection), sepsis, septic shock, viral infection, , lower respiratory tract infection, stomach flu (gastrointestinal infection), cystitis infection, fungal infection, collection of pus (abscess), type of infection of the skin (cellulitis), influenza, sinusitis, tooth infection (abscess) relatively few platelets in blood (thrombocytopenia), low level of lymphocytes a specific type of white blood cells (lymphopenia), feeling your heartbeat serious allergic reaction which causes difficulty in breathing or dizziness (anaphylactic reaction), hypersensitivity loss of appetite depression, anxiety, mood swings tingling in part of the body (paresthesia), shaking vision blurred ringing in the ears, vertigo sudden and rapid development of extremely high blood pressure, low blood pressure, hot flush, vein disorder dyspnoea (difficulty breathing), nose bleed, stuffy nose (nasal congestion), throat irritation, runny nose (rhinorrhoea) inflammation of the peritoneum (the tissue that lines most of the organs of the abdomen), constipation, stomach discomfort after meals (dyspepsia), abdominal distension hives, redness of the skin, dry skin, red or purple spots under the skin, increased sweating muscle cramp, muscle aches, back and neck pain, bone pain, joint swelling, pain in the limbs (arms and legs) kidney disorder, difficulties or pain when urinating (dysuria), blood in urine spontaneous penile erection swelling (edema), chest discomfort, feeling of weakness (asthenia), chest pain, infusion site pain, chills increase of liver enzymes, decrease of the proportion of blood volume that is occupied by red blood cells, decrease in the protein in red blood cells that carries oxygen infusion related reaction

Rare: may affect up to 1 in 1 000 people: infection by fungi (Aspergillus infection), infection of the joint (arthritis bacterial), Haemophilus influenzae infection, gum infection, impetigo, bacterial sexual transmitted disease (gonorrhea) skin tumor (melanoma), bone marrow disorder destruction of red blood cells (haemolysis), clumping of cells, abnormal clotting factor, abnormal blood clotting, disease with thyroid overactivity (Basedow s disease) sleep disorder, abnormal dreams fainting irritation of eye bruise unusual backflow of food from stomach, gum pain yellowing of the skin and/or eyes (jaundice) inflammation of the skin, skin colour disorder spasm of mouth muscle menstrual disorder abnormal leakage of the infused medicine out of the vein, infusion site abnormal sensation, feeling hot

Reporting of side effects If you get any side effects, talk to your doctor or 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 the vial label after EXP . The expiry date refers to the last day of that month.

Store in a refrigerator (2 C 8 C).

Do not freeze.

Epysqli vials in the original package may be removed from refrigerated storage for only one single period of up to 2 months at room temperature (up to 30 C), but not beyond the original expiry date. At the end of this period the product can be put back in the refrigerator.

Store in the original package in order to protect from light.

After dilution, the product should be used within 24 hours at 2 C 8 C or at room temperature (up to 30 C). However, if the solution is prepared in aseptic (germ-free) conditions, it can be stored in the refrigerator at 2 C to 8 C up to 3 months and for an additional 72 hours at room temperature (up to 30 C) when diluted with sodium chloride 9 mg/ml (0.9 %) solution for injection, sodium chloride 4.5 mg/ml (0.45 %) solution for injection.

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

What Epysqli contains

• The active substance is eculizumab (300 mg/ 30 ml in a vial corresponding to 10 mg/ml).

• The other ingredients are:

• sodium dihydrogen phosphate monohydrate (see section 2 Epysqli contains sodium )

• disodium hydrogen phosphate heptahydrate (see section 2 Epysqli contains sodium )

• trehalose dihydrate

• polysorbate Solvent: Water for injections

What Epysqli looks like and contents of the pack Epysqli is presented as a concentrate for solution for infusion (30 ml in a vial pack size of 1 vial). Epysqli is a clear and colourless solution.

Marketing Authorisation Holder and Manufacturer Samsung Bioepis NL. B.V. Olof Palmestraat 2616 LR Delft The Netherlands

This leaflet was last revised in.

Other sources of information

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