Parsabiv

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 get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

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

Warnings and precautions

Before you are given 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. 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 consciousness while being treated with Parsabiv. For additional information see section 4.

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

Very low levels of PTH over long periods can result in a type of 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 very low.

Children and adolescents

It is not known whether Parsabiv is safe and effective in children 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 might take any other medicines, including those medicines obtained without a prescription, or any other medicines that lower serum calcium.

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

Pregnancy and breast-feeding

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 may be pregnant, or plan to get pregnant when taking Parsabiv. You and your doctor should decide if you should use Parsabiv.

It is not known whether Parsabiv can pass into breast milk. Tell your doctor if you are breast-feeding or plan to do so. Your doctor will then help you decide whether to stop breast-feeding, or whether to stop taking Parsabiv, considering the benefit of breast-feeding to the baby and the benefit of Parsabiv to 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) can affect your ability to drive or operate machinery.

Important information about some of the ingredients of Parsabiv

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

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 directly (see details below). By reporting side effects you can help provide more information on the safety of this medicine.

United Kingdom

or search for MHRA Yellow Card in the Google Play or Apple App Store

Ireland

Malta

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 solution (5 mg/mL).
  Parsabiv 5 mg solution for injection: Each vial contains 5 mg of etelcalcetide in 1 mL solution (5 mg/mL).
  Parsabiv 10 mg solution for injection: 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.

What Parsabiv looks like and contents of the pack

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

Marketing Authorisation Holder

Manufacturer