PARSABIV 5 mg INJECTABLE SOLUTION

Introduction

Package Leaflet: Information for thepatient

Parsabiv 2.5 mg solution for injection

Parsabiv 5 mg solution for injection

Parsabiv 10 mg solution for injection

etelcalcetide

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 experience any side effects, talk to your doctor or nurse, even if they are not listed in this leaflet. See section 4.

Contents of the pack

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

1. What is Parsabiv and what is it used for

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

Parsabiv is used to treat secondary hyperparathyroidism in patients with severe kidney disease who need 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 disease, such as kidney disease. Secondary hyperparathyroidism can cause calcium to be lost from the bones, which can cause pain and bone fractures and problems in the blood vessels and heart. By controlling PTH levels, Parsabiv helps to control calcium and phosphorus in your body.

2. What you need to know before you use Parsabiv

Do not use Parsabiv

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

Warnings and precautions

Before you start receiving Parsabiv, tell your doctor if you have or have ever had:

• heart problems, such as heart failure or arrhythmias (abnormal heart rhythm);
• seizures (fits or convulsions).

Parsabiv reduces calcium levels. Tell your doctor if you have muscle spasms, twitching, or cramps, or numbness or tingling in your fingers, toes, or around your mouth, or seizures, confusion, or loss of consciousness during treatment with Parsabiv. For more information, see section 4.

Low calcium levels can cause an abnormal heart rhythm. Tell your doctor if you experience an unusually fast or strong heartbeat, if you have heart rhythm problems or heart failure, or if you are taking medicines that can cause heart rhythm problems, while you are receiving Parsabiv. For more information, see section 4.

Very low PTH levels for long periods can cause a type of abnormal bone structure known as adynamic bone disease, which can only be diagnosed by biopsy. Your PTH levels will be checked during treatment with Parsabiv and your dose of Parsabiv may be reduced if your PTH levels become too low.

Children and adolescents

It is not known if Parsabiv is safe and effective in children under 18 years of age, as it has not been studied in these patients.

Other medicines and Parsabiv

Tell your doctor if you are using, have recently used, or might use any other medicines, including those obtained without a prescription, or any other medicine that lowers serum calcium (e.g. cinacalcet and denosumab).

You must not receive Parsabiv with cinacalcet. Tell your doctor if you are receiving or have recently received cinacalcet.

Pregnancy

Parsabiv has not been studied in pregnant women. It is not known if Parsabiv can harm the unborn child. Tell your doctor if you are pregnant, think you may be pregnant, or plan to become pregnant while using Parsabiv. As a precaution, it is recommended to avoid using Parsabiv during pregnancy.

Breast-feeding

It is not known if Parsabiv passes into breast milk. Tell your doctor if you are breast-feeding or plan to breast-feed. Your doctor will help you decide whether to stop breast-feeding or stop Parsabiv treatment, taking into account the benefits of breast-feeding for the baby and the benefits of Parsabiv for the mother.

Driving and using machines

Parsabiv has no or negligible influence on the ability to drive and use machines. However, certain symptoms of low calcium levels (such as fits or convulsions) may affect your ability to drive or use machines.

Parsabiv contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per vial; this is essentially "sodium-free".

3. How to use Parsabiv

The recommended initial dose of Parsabiv is 5 mg. It will be given to you by a doctor or nurse at the end of haemodialysis through the tube (the line) that connects you to the haemodialysis machine. Parsabiv will be given 3 times a week. The dose can be increased to 15 mg or decreased to 2.5 mg based on your response.

You may need to take calcium and vitamin D supplements while you are receiving 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, although not everybody gets them.

Low calcium levels in the blood (hypocalcaemia) have been reported frequently (may affect up to 1 in 10 people). If you feel numbness or tingling around your mouth or in your limbs, muscle pains or cramps and convulsions (fits), you should tell your doctor immediately. These may be symptoms 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 the blood without symptoms

Common: may affect up to 1 in 10 people

• High potassium levels in the blood
• Low phosphorus levels in the blood
• Headache
• Numbness or tingling
• Worsening of heart failure
• Changes in heart activity observed as prolongation of the QT interval on the electrocardiogram
• Low blood pressure
• Muscle pain

Uncommon: may affect up to 1 in 100 people

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

Frequency 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, talk to your doctor or nurse, even if they are 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. Storage of 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 is the last day of the month shown.

Store in a refrigerator (2°C - 8°C).

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

Once removed from the refrigerator:

• Parsabiv is stable for a maximum of 7 accumulated days if stored in the original packaging. It does not require any special storage conditions.
• Once removed from the original packaging, Parsabiv is stable for a maximum of 4 hours if protected from direct sunlight.

Do not use this medicine if you notice particles or a change in colour.

For single use only.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help to 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 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 ingredients are sodium chloride, succinic acid, water for injections, hydrochloric acid, and sodium hydroxide (see section 2: Parsabiv contains sodium).

Appearance and packaging

Parsabiv is a clear and colourless liquid.

Parsabiv is a solution for 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

Netherlands

Marketing authorisation holder

Amgen Europe B.V.

Minervum 7061

4817 ZK Breda

Netherlands

Manufacturer

Amgen NV

Telecomlaan 5-7

1831 Diegem

Belgium

You can request more information about this medicine from the local representative of the marketing authorisation holder:

Date of last revision of this leaflet:

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu