Parsabiv

Package leaflet: Information for the patient

Parsabiv 2.5 mg injectable solution, 5 mg injectable solution, 10 mg injectable solution

etelcalcetide
Please read all of this leaflet carefully before you start using 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 you experience any side effects, including those not listed in this leaflet, inform your doctor or nurse. See section 4. Contents of this leaflet
  1. What Parsabiv is and what it is used for
  2. What you need to know before using Parsabiv
  3. How to use Parsabiv
  4. Possible side effects
  5. How to store Parsabiv
  6. Contents of the pack and other information

1. What Parsabiv is and what it is used for

Parsabiv contains the active substance etelcalcetide, which reduces parathyroid hormone, known as PTH.
Parsabiv is used to treat secondary hyperparathyroidism in patients with severe kidney disease who require haemodialysis to remove waste products from their blood.
In secondary hyperparathyroidism, the parathyroid glands (four small glands in the neck) produce too much PTH. "Secondary" means that the hyperparathyroidism is caused by another condition, e.g. kidney disease. Secondary hyperparathyroidism can cause loss of calcium from the bones, which may lead to bone pain and fractures, as well as problems with blood and blood vessels of the heart. By controlling PTH levels, Parsabiv helps manage calcium and phosphate levels in your body.

2. What you need to know before using Parsabiv

Do not use Parsabiv

• if you are allergic to etelcalcetide or to any of the other ingredients of this medicine (listed in section 6);
• if you have very low levels of calcium in your blood. Your doctor will monitor your blood calcium levels.

Warnings and precautions
Before you are given Parsabiv, inform your doctor if you have or have previously had:

• heart problems, such as heart failure or arrhythmias (abnormal heart rhythm);
• seizures (fits or convulsions).
  Parsabiv reduces calcium levels. Inform your doctor if during treatment with Parsabiv you experience muscle spasms, twitching, or cramps, or numbness or tingling in the fingers of the hands and feet or around the mouth, or seizures, confusion, or loss of consciousness. For further information, see section 4.
  Low calcium levels can cause heart rhythm abnormalities. Inform your doctor if during treatment with Parsabiv you experience an unusually fast heartbeat or palpitations, if you have heart rhythm disorders or heart failure, or if you are taking medicines that may cause heart rhythm problems. For further information, see section 4.
  Very low levels of PTH over long periods may lead to a type of bone structural abnormality known as adynamic bone disease, which can only be diagnosed by biopsy. Your PTH levels will be monitored during treatment with Parsabiv, and your dose of Parsabiv may be reduced if your PTH levels become very low.

Children and adolescents
It is not known whether Parsabiv is safe and effective in individuals under 18 years of age, as it has not been studied in these patients.

Other medicines and Parsabiv
Inform your doctor if you are taking, have recently taken, or might take any other medicines, including those without a prescription, or other medicines that lower serum calcium levels (e.g. cinacalcet and denosumab).
Parsabiv must not be administered together with cinacalcet. Inform your doctor if you are taking cinacalcet or have recently taken cinacalcet.

Pregnancy
Parsabiv has not been studied in pregnant women. It is not known whether Parsabiv could be harmful to the unborn baby. Tell your doctor if you are pregnant, suspect you may be pregnant, or are planning a pregnancy during treatment with Parsabiv. As a precaution, it is preferable to avoid using Parsabiv during pregnancy.

Breast-feeding
It is not known whether Parsabiv passes into breast milk. Inform your doctor if you are breast-feeding or planning to breast-feed. Your doctor will help you decide whether to discontinue breast-feeding or treatment with Parsabiv, taking into account the benefits of breast-feeding for the child and the benefits of Parsabiv for the mother.

Driving and using machines
Parsabiv does not alter or alters negligibly the ability to drive and use machines. However, some symptoms of low calcium levels (such as seizures or convulsions) may impair the ability to drive and use machines.

Parsabiv contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per vial, i.e. it is practically “sodium-free”.

3. How to use Parsabiv

The recommended starting dose of Parsabiv is 5 mg. It will be administered by a doctor or nurse at the end of your haemodialysis treatment through the tube (blood line) connecting you to the haemodialysis machine. Parsabiv will be given three times a week. The dose may be increased up to 15 mg or reduced down to 2.5 mg, depending on your response.
During treatment with Parsabiv, you may need to take calcium and vitamin D supplements. Your doctor will discuss this with you.
If you have any doubts about how to use this medicine, consult your doctor or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Low levels of calcium in the blood (hypocalcaemia) have been commonly reported (may affect up to 1 in 10 people). If you experience numbness or tingling around the mouth or extremities, muscle pains or cramps, or seizures (fits), you must immediately inform your doctor.
These symptoms may indicate that your calcium levels are too low.

Very common: may affect more than 1 in 10 people

• Nausea
• Vomiting
• Diarrhoea
• Muscle spasms
• Low levels of calcium in the blood without symptoms

Common: may affect up to 1 in 10 people

• High levels of potassium in the blood
• Low levels of phosphate in the blood
• Headache
• Sensation of numbness or tingling
• Worsening of heart failure
• Disturbances in the heart's electrical activity observed as QT prolongation on electrocardiogram
• Low blood pressure
• Muscle pain

Uncommon: may affect up to 1 in 100 people

• Seizures (fits or convulsions); for further information see section 2

Not known: frequency cannot be estimated from the available data

• Allergic reactions (including anaphylactic reactions)

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, tell your doctor or nurse. You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety 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 stated on the carton after "Exp". The expiry date refers to the last day of that month.
Store in the refrigerator (2°C - 8°C).
Keep the vial in the outer packaging to protect the medicine from light.

After removal from the refrigerator:

• Parsabiv is stable for a maximum of 7 cumulative days if stored in the original carton. This medicine does not require any specific storage temperature conditions.
• Once removed from the original carton, Parsabiv is stable for a maximum of 4 hours, provided it is protected from direct sunlight. Do not use this medicine if you notice the presence of particles or any change in colour.
  Single-use. Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Parsabiv contains

• The active substance is etelcalcetide.
  Parsabiv 2.5 mg solution for injection: Each vial contains 2.5 mg of etelcalcetide in 0.5 mL of solution (5 mg/mL).
  Parsabiv 5 mg solution for injection: Each vial contains 5 mg of etelcalcetide in 1 mL of solution (5 mg/mL).
  Parsabiv 10 mg solution for injection: Each vial contains 10 mg of etelcalcetide in 2 mL of solution (5 mg/mL).
• The other components are sodium chloride, succinic acid, water for injections, hydrochloric acid and sodium hydroxide (see section 2: Parsabiv contains sodium).

Description of the appearance of Parsabiv and contents of the pack
Parsabiv is a clear, colourless liquid. Parsabiv is an injectable solution in a vial. Packs contain 1, 6, 12 or 42 vials. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Amgen Europe B.V.
Minervum 7061
4817 ZK Breda
The Netherlands

Manufacturer
Amgen NV
Telecomlaan 5-7
1831 Diegem
Belgium

For further information on this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien
s.a. Amgen n.v.
Tel/Tél: +32 (0)2 7752711

България
Амджен България ЕООД
Тел.: +359 (0)2 424 7440

Česká republika
Amgen s.r.o.
Tel: +420 221 773 500

Danmark
Amgen, filial af Amgen AB, Sverige
Tlf: +45 39617500

Deutschland
AMGEN GmbH
Tel.: +49 89 1490960

Eesti
Amgen Switzerland AG Vilniaus filialas
Tel: +372 586 09553

Ελλάδα
Amgen Ελλάς Φαρμακευτικά Ε.Π.Ε.
Τηλ.: +30 210 3447000

España
Amgen S.A.
Tel: +34 93 600 18 60

France
Amgen S.A.S.
Tél: +33 (0)9 69 363 363

Hrvatska
Amgen d.o.o.
Tel: +385 (0)1 562 57 20

Ireland
Amgen Ireland Limited
Tel: +353 1 8527400

Ísland
Vistor hf.
Sími: +354 535 7000

Italia
Amgen S.r.l.
Tel: +39 02 6241121

Kύπρος
C.A. Papaellinas Ltd
Τηλ.: +357 22741 741

Latvija
Amgen Switzerland AG Rīgas filiāle
Tel: +371 257 25888

Lietuva
Amgen Switzerland AG Vilniaus filialas
Tel: +370 5 219 7474

Luxembourg/Luxemburg
s.a. Amgen
Belgique/Belgien
Tel/Tél: +32 (0)2 7752711

Magyarország
Amgen Kft.
Tel.: +36 1 35 44 700

Malta
Amgen B.V.
The Netherlands
Tel: +31 (0)76 5732500

Nederland
Amgen B.V.
Tel: +31 (0)76 5732500

Norge
Amgen AB
Tel: +47 23308000

Österreich
Amgen GmbH
Tel: +43 (0)1 50 217

Polska
Amgen Biotechnologia Sp. z o.o.
Tel.: +48 22 581 3000

Portugal
Amgen Biofarmacêutica, Lda.
Tel: +351 21 4220606

România
Amgen România SRL
Tel: +4021 527 3000

Slovenija
AMGEN zdravila d.o.o.
Tel: +386 (0)1 585 1767

Slovenská republika
Amgen Slovakia s.r.o.
Tel: +421 2 321 114 49

Suomi/Finland
Amgen AB, sivuliike Suomessa / Amgen AB, filial i Finland
Puh/Tel: +358 (0)9 54900500

Sverige
Amgen AB
Tel: +46 (0)8 6951100

United Kingdom (Northern Ireland)
Amgen Limited
Tel: +44 (0)1223 420305

Other sources of information
More detailed information on this medicine is available on the website of the European Medicines Agency: http://www.ema.europa.eu/