Package Insert: Information for the Patient

Zemplar5 micrograms/mL Injectable Solution

paricalcitol

Read this entire package insert carefully before starting to use this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package insert. See section 4.

1. What is Zemplar and what is it used for

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

3. How to use Zemplar

4. Possible adverse effects

5. Storage of Zemplar

6. Contents of the package and additional information

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

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

Do not use Zemplar

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

Your doctor may tell you if these conditions apply to you.

Warnings and precautions

Consult your doctor or nurse before starting to use Zemplar.

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

Use of Zemplar with other medications

Inform your doctor, nurse, or pharmacist if you are using, have used recently, or may need to use any other medication.

Some medications may affect the action of this medication or increase the likelihood of adverse effects. It is particularly important to inform your doctor if you are using any of the following medications:

• to treat fungal infections such as candida or aphthae (for example, ketoconazole)
• to treat heart problems or high blood pressure (for example, digoxin and diuretics)
• that contain a source of phosphate (for example, medications that lower calcium levels in the blood)
• that contain calcium or vitamin D, including supplements and multivitamins that can be purchased without a prescription
• that contain magnesium or aluminum (for example, some types of antacids and phosphorus-binding agents)

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor before using this medication.

The safety of this medication for pregnant women is unknown, so its use is not recommended during pregnancy or if you may become pregnant.

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

Driving and operating machinery

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

Do not drive or operate machinery if you feel dizzy.

Zemplar contains ethanol

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

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

The amount of alcohol in this medication may affect the effect of other medications. Consult your doctor or pharmacist if you are taking other medications.

If you are pregnant or breastfeeding, consult your doctor or pharmacist before being administered this medication.

If you have a history of alcohol addiction, consult your doctor or pharmacist before being administered this medication.

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

Zemplar will be administered by the doctor or nurse while you are being treated with the kidney machine. It will be administered 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 that is being used for your treatment. You will not be receiving Zemplar more frequently than every other day and no more than 3 times a week.

If you use more Zemplar than you should

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

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

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

Long-term symptoms that may occur after excessive intake of Zemplar include loss of appetite, drowsiness, weight loss, dry eyes, nasal discharge, skin itching, feeling of heat and fever, loss of sexual appetite, severe abdominal pain (due to pancreatitis inflammation) and kidney stones. Your blood pressure may be affected and irregular heartbeats (palpitations) may occur. Blood and urine analysis results 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% by volume of propylene glycol as an excipient. Isolated cases of toxic effects related to the administration of high doses of propylene glycol have been described, although they are not expected when administered to patients undergoing kidney machine treatment, as propylene glycol is eliminated from the blood during dialysis.

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

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

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

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

• shortness of breath,
• difficulty breathing or swallowing,
• whistling,
• hives, itching, or urticaria,
• inflammation of the face, lips, mouth, tongue, or throat.

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

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

• low levels of parathyroid hormone
• high levels of calcium (feeling sick or being sick, constipated or confused); phosphate in the blood (probably asymptomatic but may make bones susceptible to fracture)
• headache
• strange taste in the mouth
• itching skin

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

• blood infection, pneumonia (lung infection), sore throat, vaginal infections, flu
• breast cancer
• decrease in red blood cell count (anemia – feeling weak, difficulty breathing, paleness); decrease in white blood cell count (increased susceptibility to infections), inflammation of lymph nodes in the neck, armpits, and/or groin
• high levels of parathyroid hormone
• high levels of potassium in the blood, low levels of calcium in the blood, loss of appetite
• confusion, which in some cases is severe (delirium), personality disorders (not feeling like oneself), agitation (feeling nervous or anxious), sleep problems, nervousness
• coma (deep state of unconsciousness during which a person cannot interact with their environment), stroke, fainting, muscle spasms in arms and legs, even during sleep, decreased tactile sensation, tingling or numbness, dizziness
• increased eye pressure, red conjunctiva (itchy/red eyelids)
• ear pain
• heart attack, irregular or rapid heart rhythm
• low blood pressure, high blood pressure
• fluid in the lungs, asthma, wheezing, difficulty breathing, nasal bleeding, cough
• rectal bleeding, colon inflammation, diarrhea, stomach pain, difficulty swallowing, constipation, nausea, vomiting, dry mouth
• skin rash with blisters and itching, 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 gait, general swelling or localized swelling of the ankles, feet, and legs, pain at the injection site, fever, chest pain, unusual fatigue or weakness, general feeling of discomfort, thirst
• prolonged bleeding time (blood does not clot as quickly), increased liver enzyme, change in laboratory test results, weight loss

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

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

You may not identify these side effects unless your doctor has previously informed you.

If you consider any of the side effects you are experiencing to be severe or if you notice any side effect not mentioned in this prospectus, inform your doctor, nurse, or pharmacist immediately.

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect not listed in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

No special storage conditions are required.

Zemplar should be used immediately after opening.

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.

Do not use this medication if you observe particles or discoloration.

Medications should not be disposed of through drains or trash. Ask your pharmacist how to dispose of the packaging and unused medications. This will help protect the environment..

Composition of Zemplar

- The active ingredient is paricalcitol. Each ml of solution contains 5 micrograms of paricalcitol.

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

Appearance of the product and contents of the package

Zemplar is a clear, colorless, and particle-free aqueous solution. It is presented in containers with 5 ampoules of 1 ml or 2 ml or 5 glass vials of 1 ml or 2 ml.

Holder of the marketing authorization and responsible for manufacturing

Holder:

ABBVIE SPAIN. S.L.U.

Avenida de Burgos, 91- 28050 Madrid. ESPAÑA.

Responsible for manufacturing:

Ampoules:

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

Vials:

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

AbbVie Deutschland GmbH &Co. KG, Knollstrasse, 67061 Ludwigshafen, Germany

This medicine is authorized in the member states of the European Economic Area with 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 injekcnýroztok

Spain:Zemplar 5 microgramos/ml solución inyectable

United Kingdom:Zemplar 5 micrograms/ml solution for injection

This leaflet has been reviewed in October 2024

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/

To listen to or request a copy of this leaflet in , or , please contact the Holder of the Marketing Authorization.

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This information is intended for healthcare professionals:

Zemplar 5 microgramos/ml solución inyectable

Preparation for injectable solution

Zemplar 5 microgramos/ml solución inyectable is for single use. As with other parenteral medications, observe the solution for particles and color before administration.

Compatibility

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

This medication should not be mixed with other medications.

Storage and expiration

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

This medication does not require special storage conditions.

This medication has an expiration date of 3 years (vial) or 2 years (ampoule).

Dosage and administration

Zemplar injectable solution is administered through the dialysis access.

Adults

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

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

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

8

O

=baseline level of intact PTH in pg/ml

80

and administered as an intravenous bolus, with a maximum frequency of alternate days and at any time during dialysis.

The maximum safe dose administered in clinical studies was 40 micrograms.

2) Dose titration:

The currently accepted levels for the PTH range in patients with terminal renal failure undergoing dialysis are not more than1.5 to3 times the upper limit of the non-uremic normal,15.9 to31.8 pmol/l (150-300 pg/ml) for intact PTH. To achieve the desired levels of physiological variables, individualized dose titration is necessary. If hypercalcemia or a corrected Ca x P product, persistently elevated, greater than 5.2 mmol2/l2(65 mg2/dl2), is observed, the dose should be reduced or discontinued until these parameters normalize. Then, the administration of paricalcitol should be restarted at lower doses. It may be necessary to reduce the dose when PTH levels decrease in response to therapy.

A suggested table is provided as an approximation of dose titration: