Zemplar 5 micrograms/ml solution for injection

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Zemplar 5 micrograms/ml injection solution

paricalcitol

Read this entire leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• If you experience any side effects, talk to your doctor, pharmacist or nurse, even if they are side effects not listed in this leaflet. See section 4.

Leaflet contents

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

1. What Zemplar is and what it is used for

Zemplar contains the active substance paricalcitol, which is a synthetic form of active vitamin D.

Active vitamin D is required for the normal function of many tissues in the body, including the parathyroid gland and bones. In people with normal kidney function, this active form of vitamin D is naturally produced by the kidneys. However, in renal failure, the production of active vitamin D is markedly reduced. Therefore, Zemplar provides a source of active vitamin D when the body cannot produce enough, and helps prevent the consequences of low levels of active vitamin D in patients with chronic kidney disease, specifically high levels of parathyroid hormone that may cause bone problems. Zemplar is indicated in adult patients with chronic kidney disease Stage 5.

2. What you need to know before starting Zemplar

Do not use Zemplar

• if you are allergic to paricalcitol or to any of the other ingredients of this medicine (listed in section 6).
• if you have very high levels of calcium or vitamin D in your blood.

Your doctor can tell you whether these conditions apply to you.

Warnings and precautions

Talk to your doctor or nurse before starting Zemplar.

• before starting treatment, it is important that you limit the amount of phosphorus in your diet. Examples of foods high in phosphorus include: tea, soda, beer, cheese, milk, cream, fish, chicken or beef liver, beans, peas, cereals, nuts, and whole grain foods.
• to control phosphorus levels, you may need to use phosphate-binding agents that prevent the absorption of dietary phosphorus.
• if you are taking phosphate-binding agents containing calcium, your doctor may need to adjust your dose.
• your doctor will need to perform blood tests to monitor your treatment.

Use of Zemplar with other medicines

Tell your doctor, nurse, or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Some medicines may affect the action of this medicine or increase the likelihood of side effects. It is particularly important that you inform your doctor if you are taking any of the following medicines:

• for treating fungal infections such as candida or thrush (e.g., ketoconazole)
• for treating heart problems or high blood pressure (e.g., digoxin and diuretics)
• containing a source of phosphate (e.g., medicines that reduce calcium levels in the blood)
• containing calcium or vitamin D, including supplements and multivitamins available without a prescription
• containing magnesium or aluminium (e.g., certain types of medicines for indigestion (antacids) and phosphate binders).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you might be pregnant, or plan to become pregnant, consult your doctor before using this medicine.

It is unknown whether this medicine is safe for pregnant women; therefore, its use is not recommended during pregnancy or if you may become pregnant.

It is not known whether paricalcitol passes into human breast milk. Inform your doctor before breastfeeding while using Zemplar.

Driving and using machines

Zemplar may make you feel dizzy, which could affect your ability to drive safely or operate heavy machinery.

Do not drive or operate machinery if you feel dizzy.

Zemplar contains ethanol

This medicine contains up to 1.3 mg of alcohol (ethanol) per dose, equivalent to approximately 18 mg/kg. The amount in each dose of this medicine is equivalent to approximately 32 ml of beer or 13 ml of wine.

It is unlikely that the amount of alcohol in this medicine will have any noticeable effect in adults or adolescents. However, it may have some effects in young children, such as drowsiness.

The amount of alcohol contained in this medicine may alter the effect of other medicines. Consult your doctor or pharmacist if you are taking other medicines.

If you are pregnant or breastfeeding, consult your doctor or pharmacist before this medicine is administered.

If you have alcohol addiction, consult your doctor or pharmacist before this medicine is administered.

3. How to use Zemplar

Your doctor will use laboratory test results to determine the appropriate initial dose for you. Once you have started treatment with Zemplar, the dose should be adjusted based on the results of routine laboratory tests. Using your test results, your doctor will help you determine the appropriate Zemplar dose for your condition.

Zemplar will be administered by a doctor or nurse while you are being treated with the kidney machine. It will be given through the tube that connects you to the machine. You will not need to receive an injection, as Zemplar can be introduced directly into the tube being used for your treatment. You will not receive Zemplar more frequently than on alternate days and no more than 3 times per week.

If you use more Zemplar than you should

An overdose of Zemplar may cause abnormally high levels of calcium in the blood, which can be harmful. Symptoms that may occur shortly after taking too much Zemplar include a feeling of weakness and/or drowsiness, headache, nausea (feeling sick), vomiting (being sick), dry mouth, constipation, muscle or bone pain, and a metallic taste in the mouth.

If you experience high calcium levels in the blood after using Zemplar, your doctor will prescribe appropriate treatment to return calcium levels to normal. Once your calcium levels return to normal, you will likely be given lower doses of Zemplar.

Your doctor will monitor your blood levels. If you experience any of the symptoms listed above, seek medical advice immediately.

Symptoms that may occur in the long term after excessive intake of Zemplar include loss of appetite, drowsiness, weight loss, dry eyes, runny nose, skin itching, feeling hot and fever, loss of sexual appetite, severe abdominal pain (due to inflammation of the pancreas), and kidney stones. Your blood pressure may be affected and irregular heartbeats (palpitations) may occur. Blood and urine tests may show high cholesterol, urea, nitrogen, and elevated liver enzyme levels. Rarely, Zemplar may cause mental changes such as confusion, drowsiness, insomnia, or nervousness.

Zemplar contains 30% v/v propylene glycol as an excipient. Isolated cases of toxic effects related to high-dose propylene glycol administration have been reported; however, these are not expected when administered to patients undergoing treatment with a kidney machine, as propylene glycol is removed from the blood during dialysis.

If you receive an excessive dose of Zemplar, or experience any of the symptoms listed above, seek medical advice immediately.

In case of overdose or accidental ingestion, go immediately to a medical center or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medication and the amount ingested.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.

Several allergic reactions have been reported with Zemplar. Important: if you notice any of the following adverse effects, inform your doctor or nurse immediately:

• shortness of breath,
• difficulty breathing or swallowing,
• wheezing,
• rash, skin itching or hives,
• swelling of the face, lips, mouth, tongue or throat.

Inform your doctor or nurse if you notice any of the following adverse effects:

Common (may affect up to 1 in 10 people):

• low levels of parathyroid hormone
• high levels of calcium (feeling unwell or being unwell, constipation or confusion); phosphorus in the blood (likely asymptomatic but may make bones susceptible to fracture)
• headache
• unusual taste in the mouth
• skin itching

Uncommon (may affect up to 1 in 100 people):

• blood infection, pneumonia (lung infection), sore throat, vaginal infections, flu
• breast cancer
• decreased number of red blood cells (anemia – feeling weak, shortness of breath, paleness); decreased number of white blood cells (increased susceptibility to infections), swelling of neck, armpit and/or groin lymph nodes
• high levels of parathyroid hormone
• high levels of potassium in the blood, low levels of calcium in the blood, loss of appetite
• confusion, sometimes severe (delirium), personality disorders (not feeling like oneself), agitation (feeling nervous, anxious), trouble sleeping, restlessness
• coma (deep state of unconsciousness during which a person cannot interact with the environment), stroke, fainting, muscle spasms in arms and legs, even during sleep, decreased sense of touch, tingling or numbness, dizziness
• increased pressure in the eye, red conjunctiva (itching/sticky eyelids)
• ear pain
• myocardial infarction, irregular or rapid heartbeat
• low blood pressure, high blood pressure
• fluid in the lungs, asthma, wheezing, difficulty breathing, nosebleeds, cough
• rectal bleeding, inflammation of the colon, diarrhea, stomach pain, difficulty swallowing, constipation, nausea, vomiting, dry mouth
• skin rash with itchy blisters, hair loss, excessive hair growth, excessive and unpredictable sweating
• joint pain, joint stiffness, back pain, muscle spasms, muscle pain
• breast pain, difficulty achieving an erection
• abnormal walking pattern, general swelling or localized swelling of ankles, feet and legs, injection site pain, fever, chest pain, unusual tiredness or weakness, general feeling of discomfort, thirst
• prolonged bleeding time (blood does not clot as quickly), increased liver enzyme, changes in laboratory test results, weight loss

Frequency not known (cannot be estimated from available data):

• swelling of the face, lips, mouth, tongue or throat which may cause difficulty swallowing or breathing; skin itching (urticaria); stomach bleeding.

You may not recognize these adverse effects unless your doctor has previously informed you about them.

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effect not mentioned in this leaflet, inform your doctor, nurse or pharmacist immediately.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Zemplar

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

No special storage conditions are required.

Zemplar must be used immediately after opening.

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.

Do not use this medicine if you notice particles or discoloration.

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

6. Contents of the container and other information

Composition of Zemplar

• The active substance is paricalcitol. Each ml of solution contains 5 micrograms of paricalcitol.

The other components are: ethanol (alcohol), propylene glycol and water for injections.

Appearance of the product and contents of the container

Zemplar is an aqueous, clear, colourless solution free from visible particles. It is supplied in packs containing 5 ampoules of 1 ml or 2 ml, or 5 glass vials of 1 ml or 2 ml.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

ABBVIE SPAIN S.L.U.

Avenida de Burgos, 91 - 28050 Madrid, SPAIN.

Manufacturer:

Ampoules:

AbbVie S.r.l., S.R.148 Pontina km 52 snc, 04011 Campoverde di Aprilia (LT), Italy.

Vials:

AbbVie S.r.l., S.R.148 Pontina km 52 snc, 04011 Campoverde di Aprilia (LT), Italy.

This medicinal product is authorised in the Member States of the European Economic Area under the following names:

Austria: Zemplar 5 Mikrogramm/ml - Injektionslösung

Czech Republic: Zemplar

Germany: Zemplar 5 Mikrogramm/ml Injektionslösung

Ireland: Zemplar 5 micrograms/ml solution for injection

Italy: Zemplar 5 microgrammi/ml soluzione iniettabile

Slovakia: Zemplar 5 mikrogramov/ml injekcný roztok

Spain: Zemplar 5 microgramos/ml solución inyectable

United Kingdom: Zemplar 5 micrograms/ml solution for injection

This leaflet has been reviewed in October 2024

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

To listen to or request a copy of this leaflet in , or

This information is intended for healthcare professionals:

Zemplar 5 micrograms/ml solution for injection

Preparation for injection solution

Zemplar 5 micrograms/ml solution for injection is for single use only. As with other parenteral medicines, the solution should be inspected visually for particulate matter and discoloration prior to administration.

Compatibility

Propylene glycol interacts with heparin and neutralizes its effects. Zemplar injectable solution contains propylene glycol as an excipient and must be administered through a different administration site from heparin.

This medicinal product must not be mixed with other medicinal products.

Storage and expiry

Parenteral products should be inspected before administration for the presence of visible particles and discoloration. The solution is clear and colourless.

This medicinal product does not require special storage conditions.

The shelf life of this medicine is 3 years (vial) or 2 years (ampoule).

Dosage and method of administration

Zemplar injectable solution is administered through the haemodialysis access.

Adults

1. The initial dose should be calculated based on baseline parathyroid hormone (PTH) levels.

The initial dose of paricalcitol is based on the following formula:

Initial dose (micrograms) = baseline intact PTH level in pmol/l