Parsabiv 2.5 mg solution for injection

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Parsabiv 2.5 mg solution for injection

Parsabiv 5 mg solution for injection

Parsabiv 10 mg solution for injection

etelcalcetide

Read the entire 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 questions, ask your doctor or nurse.
• If you experience any side effects, talk to your doctor or nurse, even if it is not one of the side effects listed in this leaflet. See section 4.

Contents of the 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 hemodialysis 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 may lead to loss of calcium from the bones, which can cause bone pain and fractures, as well as problems in the blood vessels and heart. By controlling PTH levels, Parsabiv helps regulate calcium and phosphorus 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 starting treatment with Parsabiv, inform 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. Inform your doctor if you experience muscle spasms, twitches 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 additional information, see section 4.

Low calcium levels may cause an abnormal heart rhythm. Inform your doctor if you experience an unusually fast or strong heartbeat, have heart rhythm problems or heart failure, or are taking medications that may cause heart rhythm disturbances while receiving Parsabiv. For additional information, see section 4.

Very low PTH levels over prolonged periods may lead to an abnormal bone structure known as adynamic bone, 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 too low.

Children and adolescents

It is unknown whether 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

Inform your doctor if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription, or any other medicine that may lower serum calcium (for example, cinacalcet and denosumab).

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

Pregnancy

Parsabiv has not been studied in pregnant women. It is unknown whether Parsabiv can harm the fetus. Inform your doctor if you are pregnant, think you may be pregnant, or plan to become pregnant while using Parsabiv. As a precautionary measure, it is advisable to avoid using Parsabiv during pregnancy.

Breast-feeding

It is unknown whether Parsabiv passes into breast milk. Inform your doctor if you are breast-feeding or plan 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 baby and the benefits of Parsabiv for the mother.

Driving and use of machines

The effect of Parsabiv on the ability to drive and use machines is negligible or none. However, certain symptoms of low calcium levels (such as seizures or convulsions) may affect your ability to drive or operate machinery.

Parsabiv contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per vial; essentially, "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 hemodialysis through the tube (the line) that connects you to the dialysis machine. Parsabiv will be given 3 times a week. The dose may be increased up to 15 mg or decreased down to 2.5 mg depending on your response.

You may need to take calcium and vitamin D supplements while receiving treatment with Parsabiv. Your doctor will discuss this with you.

If you have any further questions about 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 everyone gets them.

Low blood calcium levels (hypocalcemia) have been reported frequently (may affect up to 1 in 10 people). If you experience numbness or tingling around the mouth or in the extremities, muscle pains or cramps, or seizures (fits), you must inform your doctor immediately. These may be symptoms of low calcium levels.

Very common: may affect more than 1 in 10 people

• Nausea
• Vomiting
• Diarrhea
• Muscle spasms
• Low blood calcium levels without symptoms

Common: may affect up to 1 in 10 people

• High blood potassium levels
• Low blood phosphate levels
• Headache
• Sensation of numbness or tingling
• Worsening of heart failure
• Changes in the heart's electrical activity seen as prolongation of the QT interval 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

Frequency not known: frequency cannot be estimated from the available data

• Allergic reactions (including anaphylactic reactions)

Reporting of side effects

If you experience any type of side effect, talk to your doctor or nurse, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the national reporting system included 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 stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Store in a refrigerator (between 2 °C and 8 °C).

Keep the vial in the outer packaging to protect it from light.

Once removed from the refrigerator:

• Parsabiv is stable for up to a total of 7 days if kept in its original packaging. No special temperature requirements apply during this period.
• After removal from the original packaging, Parsabiv is stable for up to 4 hours if protected from direct sunlight.

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

For single use only.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.

6. Contents of the container and other information

Composition of Parsabiv

• The active substance is etelcalcetide.

Parsabiv 2.5 mg injectable solution: Each vial contains 2.5 mg of etelcalcetide in 0.5 ml of solution (5 mg/ml).

Parsabiv 5 mg injectable solution: Each vial contains 5 mg of etelcalcetide in 1 ml of solution (5 mg/ml).

Parsabiv 10 mg injectable solution: 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).

Nature of the product and contents of the container

Parsabiv is a clear, colourless liquid.

Parsabiv is an injectable solution in a vial.

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

Some pack sizes may not be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder and Manufacturer:

Amgen Europe B.V.

Minervum 7061

4817 ZK Breda

The Netherlands

Marketing Authorization Holder

Amgen Europe B.V.

Minervum 7061

4817 ZK Breda

The Netherlands

Manufacturer

Amgen NV

Telecomlaan 5-7

1831 Diegem

Belgium

For more information about this medicine, please contact the local representative of the Marketing Authorization Holder:

Date of the most recent review of this leaflet:

Other sources of information

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