InfoCons Consumer Protection informs you – Parsabiv – Package Leaflet

Before anything else

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

Parsabiv contains the active substance etelcalcetide, which red uces parathyroid hormone known as PTH.

Parsabiv is used to treat secondary hyperparathyroidism in pati ents with serious kidney disease who need haemodialysis to clear their blood of waste products.

In secondary hyperparathyroidism too much PTH is produced by th e parathyroid glands (four small glands in the neck). “Secondary” means that the hyperparathyroi dism is caused by another condition, e.g. kidney disease. Secondary hyperparathyroidism can cause th e loss of calcium from the bones, which can lead to bone pain and fractures and problems with blo od and heart vessels. By controlling the levels of PTH, Par sabiv helps to control calcium and phosph ate in your body.

⚠️ 2. What you need to know before you use Parsabiv

Do not use Parsabiv

• if you are allergic to etelcal cetide or any of the other ingr edients of this medicine (listed in section 6).
• if you have very low levels of calcium in your blood. Your do ctor will monitor your blood calcium levels.

Warnings and precautions

Before you are given Parsabiv, tell your doctor if you have or have ever had:  heart problems, such as heart fa ilure or arrhythmias (abnormal heart rhythm);  seizures (fits or convulsions).

Parsabiv reduces calcium levels. Please tell your doctor if you have spasms, twitches, or cramps in your muscles, or numbness or tingling in your fingers, toes or around your mouth or seizures, confusion or loss of consciousne ss while being treated with Par sabiv. For additional information see section 4.

Low calcium levels can cause abnormal heart rhythm. Tell your d octor if you exper ience an unusually fast or pounding heartbeat, if yo u have heart rhythm problems o r heart failure or if you take medicines that can cause heart rhythm prob lems, while receiving Parsabiv. For additional information see section 4.

Very low levels of PTH over long periods can result in a type o f abnormal bone structure known as adynamic bone which can only be diagnosed by biopsy. Your PTH l evels will be monitored during treatment with Parsabiv and your dose of Parsabiv may be reduce d if your PTH levels become very low.

Children and adolescents

It is not known whether Parsabiv is safe and effective in child ren less than 18 years of age as it has not been studied in these patients.

Other medicines and Parsabiv

Tell your doctor if you are taking, have recently taken or migh t take any other med icines, including those medicines obtained without a prescription, or any other m edicines that lower serum calcium (e.g. cinacalcet and denosumab).

You should not receive Parsabiv together with cinacalcet. Tell your doctor if you are taking cinacalcet or have recently taken cinacalcet.

Pregnancy Parsabiv has not been tested in pregnant women. It is not known whether Parsabiv can harm your unborn baby. Tell your doctor if you are pregnant, think you ma y be pregnant, or plan to get pregnant when taking Parsabiv. As a precautionary measure, it is prefera ble to avoid the use of Parsabiv during pregnancy.

Breast-feeding

It is not known whether Parsabiv can pass into bre ast milk. Tel l your doctor if you are breast-feeding or plan to do so. You r doctor will then hel p you decide whether to stop breast-feeding, or whether to stop taking Parsabiv, considering the benef it of breast-feeding to the baby and the benefit of Parsabiv to the mother.

Driving and using machines

Parsabiv has no or negligible i nfluence on the ability to drive and use machines. However certain symptoms of low calcium levels (such as fits or convulsions) ca n affect your ability to drive or operate machinery.

Parsabiv contains sodium

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

💊 3. How to use Parsabiv

The recommended starting dose for Parsabiv is 5 mg. It will be given by a doctor or nurse at the end of your haemodialysis treatment thr ough the tube (bloodline) that connects you to th e haemodialysis machine. Parsabiv will be given 3 times per week . The dose may be increased up to 15 mg or lowered down to 2.5 mg depending on your response. You may need to take calcium and vitamin D supplements while be ing treated with Parsabiv. Your doctor will discuss this with you.

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, altho ugh not everybody gets them.

Low calcium levels in blood (h ypocalcaemia) have been reported commonly (may affect up to 1 in 10 people). If you feel numbness or tingling around your mouth or in your extremities, muscle aches or cramps and seizures (fits), you should tell your doctor immedia tely. These may be signs that your calcium levels are too low.

Very common: may affect more than 1 in 10 people

 Nausea  Vomiting  Diarrhoea  Muscle spasms  Low calcium levels in blood with no symptoms

Common: may affect up to 1 in 10 people

 High potassium levels in blood  Low phosphate levels in blood  Headache  Numbness or tingling sensation  Worsening heart failure  Disturbances in the heart’s electrical activity seen as QT prol ongation on electrocardiogram  Low blood pressure  Muscle pain

Uncommon: may affect up to 1 in 100 people

 Seizures (fits or co nvulsions); for additio nal information see section 2

Not known: frequency ca nnot be estimated fro m the available dat a

 Allergic reactions (includ ing anaphylactic reactions)

Reporting of side effects

If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects direct ly via the national repo rting system listed in Appendix V . By reporting side effects you can help provide more informati on on the safe ty of this medicine.

🌡️ 5. How to store Parsabiv

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 after EXP. The expiry date refers to the last d ay of that month.

Store in a refrigerator (2°C – 8°C). Keep the vial in the o uter carton in order to protect from ligh t.

Once removed from the refrigerator:  Parsabiv is stable for a maximum of 7 cumu lative days if stored in the original carton. No special temperature storage requirements are needed.  If removed from the original carton Parsabiv is stable for a ma ximum of 4 hours if protected from direct sunlight.

31 Do not use this medicine if you notice it has par ticles or it h as changed colour.

For single use only.

Do not throw away any medicines via wastewater or household was te. Ask your pharmacist how to throw away medicines y ou no longer use. The se measures will hel p protect the environment.

📦 6. Contents of the pack and other information

What Parsabiv contains

• The active substance is etelcalcetide.

Parsabiv 2.5 mg solution for inj ection: Each vial contains 2.5 mg of etelcalcetide in 0.5 mL solution (5 mg/mL). Parsabiv 5 mg solution for injection: Each vial contains 5 mg o f etelcalcetide in 1 mL solution (5 mg/mL).

Parsabiv 10 mg solution for inje ction: Each vial contains 10 mg of etelcalcetide in 2 mL solution (5 mg/mL).

• The other ingredients are sodium chloride, succinic acid, water for injections, hydrochloric acid,

and sodium hydroxide (refer to section 2: Parsabiv contains sod ium).

What Parsabiv looks like a nd contents of the pack Parsabiv is a clear and colourless liquid.

Parsabiv is a solution fo r injection in a vial.

Pack sizes of 1, 6, 12 and 42 vials.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Amgen Europe B.V.

Minervum 7061 4817 ZK Breda The Netherlands

Marketing Authorisation Holder

Amgen Europe B.V.

Minervum 7061 4817 ZK Breda The Netherlands

Manufacturer

Amgen NV Telecomlaan 5-7 1831 Diegem Belgium For any information about this m edicine, please contact the loc al representative of the Marketing Authorisation Holder:

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

Tel/Tél: +32 (0)2 7752711 Lietuva Amgen Switzerland A G Vilniaus filialas Tel: +370 5 219 7474 32 България Амджен България ЕООД Тел.: +359 (0)2 424 7440 Luxembourg/Luxemburg s.a. Amgen Belgique/Belgien Tel/Tél: +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 B.V.

The Netherlands Tel: +31 (0)76 5732500 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 Tel: +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 Ísland Vistor hf.

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 Suom essa/Amgen AB, filial i Finland Puh/Tel: +358 (0)9 54900500 33 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 United Kingdom (Northern Ireland) Amgen Limited Tel: +44 (0)1223 420305

This leaflet was last revised in

Other sources of information Detailed information on this medicine is available on the Europ ean Medicines Agency web site: http://www.ema.europa.eu

📄 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 Parsabiv (PDF, ec.europa.eu).

You can check this medicine at any time in the Union Register of medicinal products (EU number EU/1/16/1142).

⚠️ 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.