Parsabiv 2,5 mg solucion inyectable

Label: information for thepatient

Parsabiv 2.5 mg injectable solution

Parsabiv 5 mg injectable solution

Parsabiv 10 mg injectable solution

etelcalcetide

Read this label carefully before starting to use this medication, because it contains important information for you.

- Keep this label, as you may need to read it again.

- If you have any questions, consult your doctor or nurse.

-If you experience any adverse effects, consult your doctor or nurse, even if they are not listed in this label. See section 4.

1. What Parsabiv is and how it is used

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

3. How to use Parsabiv

4. Possible adverse effects

5. Storage of Parsabiv

6. Contents of the package and additional information

Parsabiv contains the active ingredient etelcalcetide, which reduces the 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, for example, kidney disease. Secondary hyperparathyroidism can cause bone calcium loss, which can lead to bone pain and fractures and problems in blood vessels and the heart. By controlling PTH levels, Parsabiv helps control calcium and phosphorus in your body.

Do not use Parsabiv

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

Warnings and precautions

Before starting to receive Parsabiv, inform your doctor if you have ever suffered from:

• Heart problems, such as heart failure or arrhythmias (abnormal heart rhythm);
• Seizures (attacks or crises).

Parsabiv reduces calcium levels. Inform your doctor if you have muscle spasms, cramps, or numbness or tingling in the fingers of the hands, feet, or around the mouth or seizures, confusion, or loss of consciousness during treatment with Parsabiv. For additional information, see section 4.

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

Prolonged very low levels of PTH may cause 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 Parsabiv dose may be reduced if your PTH levels become very low.

Children and adolescents

The safety and efficacy of Parsabiv in children under 18 years of age is unknown, as it has not been studied in these patients.

Other medications and Parsabiv

Inform your doctor if you are using, have used recently, or may need to use any other medication, including those purchased without a prescription, or any other medication that lowers serum calcium (for example, cinacalcet and denosumab).

You should not receive Parsabiv 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 if 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 precaution, it is recommended to avoid the use of Parsabiv during pregnancy.

Lactation

It is unknown if Parsabiv can pass into breast milk. Inform your doctor if you are breastfeeding or plan to breastfeed. Your doctor will help you decide whether to stop breastfeeding or the Parsabiv treatment, taking into account the benefits of breastfeeding for the baby and the benefits of Parsabiv for the mother.

Driving and operating machinery

The influence of Parsabiv on the ability to drive and operate machinery is negligible. However, certain symptoms of low calcium levels (such as seizures) may affect your ability to drive or operate machinery.

Parsabiv contains sodium

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

The recommended initial 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 hemodialysis machine. Parsabiv will be administered 3 times a week. The dose may 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 receiving treatment with Parsabiv. Your doctor will discuss this with you.

If you have any other questions about the use of this medication, ask your doctor or nurse.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

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

Very frequent: may affect more than 1 in 10 people

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

Frequent: may affect up to 1 in 10 people

• High levels of potassium in the blood
• Low levels of phosphorus in the blood
• Headache
• Sensation of numbness or tingling
• Worsening of heart failure
• Alterations in heart electrical activity observed in the form of QT interval prolongation on the electrocardiogram
• Low blood pressure
• Muscle pain

Rare: may affect up to 1 in 100 people

• Seizures (attacks or crises); for additional information, see section 2

Unknown frequency: the frequency cannot be estimated from available data

• Allergic reactions (including anaphylactic reactions)

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or nurse, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the national notification system included in theAppendix V. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

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

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

Once out of the refrigerator:

• Parsabiv is stable for a maximum of 7 days accumulated if stored in the original packaging. No special storage temperature is required.
• Once removed from the original packaging, Parsabiv is stable for a maximum of 4 hours if protected from direct sunlight.

Do not use this medication if you observe particles or a change in color.

For single use only.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

Composition of Parsabiv

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).

Appearance of the product and contents of the package

Parsabiv is a transparent and colorless liquid.

Parsabiv is an injectable solution in a vial.

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

Only some package sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Amgen Europe B.V.

Minervum 7061

4817 ZK Breda

Netherlands

Marketing authorization holder

Amgen Europe B.V.

Minervum 7061

4817 ZK Breda

Netherlands

Manufacturer

Amgen NV

Telecomlaan 5-7

1831 Diegem

Belgium

For more information about this medication, please contact the local representative of the marketing authorization holder:

Last review date of this leaflet:

Other sources of information

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