Paricalcitol Sun 2 micrograms/ml solution for injection EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Paricalcitol SUN 2 micrograms/ml solution for injection EFG

Paricalcitol SUN 5 micrograms/ml solution for injection EFG

Read all of this 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 or nurse.
• If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. See section 4.

Contents of this leaflet

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

1. What Paricalcitol SUN is and what it is used for

Paricalcitol SUN contains the active substance 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 glands 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, Paricalcitol SUN 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, namely high levels of parathyroid hormone which can cause bone problems. Paricalcitol SUN is used in adult patients with stage 5 chronic kidney disease.

2. What you need to know before Paricalcitol SUN is administered to you

Do not use Paricalcitol SUN

• 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 will monitor your blood levels and can tell you whether these conditions apply to you.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before Paricalcitol SUN is administered to you:

• Before starting treatment, it is important that you limit the amount of phosphorus you consume in your diet. Some examples of foods high in phosphorus include tea, soft drinks, beer, cheese, milk, cream, fish, chicken or beef liver, beans, peas, cereals, nuts, and whole grain foods.
• Phosphate binder medications, which prevent the absorption of dietary phosphorus, may be needed to control phosphorus levels.
• If you are taking phosphate binders containing calcium, your doctor may need to adjust your dose.
• Your doctor will need to perform blood tests to monitor your treatment.

Children and adolescents

Paricalcitol SUN is not recommended for use in children and adolescents under 18 years of age.

Use of Paricalcitol SUN with other medicines

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

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

• medicines to treat fungal infections such as candida or thrush (e.g., ketoconazole)
• medicines to treat heart conditions or high blood pressure (e.g., digoxin and diuretics)
• medicines containing a source of phosphate (e.g., medicines used to reduce blood calcium levels)
• medicines containing calcium or vitamin D, including supplements and multivitamins available without a prescription
• medicines containing magnesium or aluminum (e.g., certain types of indigestion medicines called antacids) and phosphate binders
• medicines to treat high cholesterol (e.g., cholestyramine)

Use of Paricalcitol SUN with food and drink

Paricalcitol SUN may be administered with or without food.

Pregnancy and breastfeeding

If you are pregnant, breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor, pharmacist, or nurse 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 Paricalcitol SUN.

Driving and using machines

Paricalcitol SUN may make you feel dizzy. Do not drive or operate machinery if you feel dizzy.

Paricalcitol SUN contains ethanol

This medicine contains 20% v/v ethanol (alcohol). Each dose may contain up to 1.3 g of ethanol. This medicine may be harmful to people with alcoholism.

The alcohol content should be taken into account in pregnant or breastfeeding women, children, and high-risk groups such as patients with liver disease or epilepsy.

3. How to use Paricalcitol SUN

Dosage

Your doctor will use laboratory test results to determine the appropriate starting dose for you. Once you have started treatment with Paricalcitol SUN, the dose may be adjusted based on the results of routine laboratory tests. Using these test results, your doctor will determine the appropriate dose of Paricalcitol SUN for you.

Paricalcitol SUN will be administered by a doctor or nurse while you are receiving your kidney machine treatment. It will be given through the tube (line) used to connect you to the machine. You will not need to receive an injection, as Paricalcitol SUN can be administered directly into the tube used for the treatment. Paricalcitol SUN will be administered no more frequently than on alternate days and no more than three times per week.

If you are given more Paricalcitol SUN than you should

Too much Paricalcitol SUN may cause high levels of calcium (in blood and urine) and phosphate in the blood, which may require treatment. In addition, excessive Paricalcitol SUN may reduce levels of parathyroid hormone.

Symptoms that may occur after receiving an overdose of Paricalcitol SUN include:

• feeling weak or drowsy
• headache
• discomfort or feeling unwell
• dry mouth, constipation
• muscle and bone pain
• unusual taste in the mouth.

Symptoms that may develop after a prolonged period of receiving too much Paricalcitol SUN include:

• loss of appetite
• drowsiness
• weight loss
• eye irritation
• runny nose
• skin itching
• feeling hot and feverish
• loss of sexual appetite
• severe abdominal pain
• kidney stones
• your blood pressure may be affected and you may become aware of your own heartbeat (palpitations).

If you experience any of the above symptoms, seek medical attention immediately.

However, your doctor will monitor your blood levels, and if you have high blood calcium levels after administration of Paricalcitol SUN, your doctor will ensure that you receive appropriate treatment to return calcium levels to normal. Once your calcium levels return to normal, Paricalcitol SUN may be restarted at a lower dose.

Paricalcitol SUN contains 15% by volume of propylene glycol as an excipient. Cases of toxic effects related to the administration of high doses of propylene glycol have been rarely reported, and such effects are not expected when administered to patients with renal failure undergoing treatment with a kidney machine, because propylene glycol is removed from the blood during dialysis.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Important:

Various allergic reactions have been observed with Paricalcitol SUN. Inform your doctor or nurse immediately if you notice any of the following adverse effects

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

These adverse effects are uncommon or their frequency is unknown.

Inform your doctor or nurse immediately if you have gastrointestinal bleeding. This may present as black stools.

The frequency of this adverse effect is unknown.

Inform your doctor as soon as possible if you experience any of the following adverse effects:

Frequent: may affect up to 1 in 10 people

• headache
• unusual taste in the mouth
• skin itching
• low parathyroid hormone levels
• high calcium levels (feeling unwell, constipation, or confusion); high phosphate levels in blood (may not cause symptoms but can make bones more prone to fractures).

Uncommon (may affect up to 1 in 100 people)

• blood infection; 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 lymph nodes in the neck, armpits, and/or groin; prolonged bleeding time (blood does not clot as quickly)
• myocardial infarction; stroke; chest pain; irregular or rapid heartbeat; low blood pressure; increased blood pressure
• coma (a deep state of unconsciousness during which a person cannot interact with their surroundings)
• unusual tiredness, weakness; dizziness; fainting
• pain at the injection site
• pneumonia (lung infection); fluid in the lungs; asthma (wheezing, cough, difficulty breathing)
• sore throat; cold; fever; flu-like symptoms; conjunctivitis (itching/eye discharge in the eyelids); increased eye pressure; ear pain; nosebleeds
• nervous spasms; confusion, sometimes severe (delirium); agitation (feeling restless, anxious); nervousness; personality disorders (feeling unlike oneself)
• tingling or numbness; reduced sense of touch; sleep problems; night sweats; muscle cramps in arms and legs, even during sleep
• dry mouth; thirst; nausea; difficulty swallowing; vomiting; loss of appetite; weight loss; heartburn; diarrhea and stomach pain; constipation; rectal bleeding
• difficulty achieving an erection; breast cancer; vaginal infections
• breast pain; back pain; muscle/joint pain; sensation of heaviness due to generalized swelling or localized swelling in ankles, feet, and legs (edema); abnormal walking pattern
• hair loss; excessive hair growth
• increased liver enzymes; increased parathyroid hormone levels; increased blood potassium levels; decreased blood calcium levels.

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

Reporting of adverse effects

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

5. Storage of Paricalcitol SUN

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

Store vials in the outer packaging to protect from light. This medicine does not require any special storage conditions.

Paricalcitol SUN must be used immediately after opening.

Do not use Paricalcitol SUN after the expiry date stated on the vial and on the packaging after EXP:. The expiry date refers to the last day of the month indicated.

Do not use Paricalcitol SUN 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 containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Paricalcitol SUN

• The active substance is paricalcitol.

Paricalcitol SUN 2 micrograms/ml: 1 ml of solution contains 2 micrograms of paricalcitol.

Paricalcitol SUN 5 micrograms/ml: 1 ml of solution contains 5 micrograms of paricalcitol.

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

Appearance of Paricalcitol SUN and contents of the pack

Paricalcitol SUN solution for injection is an aqueous, clear, colourless solution free from visible particles.

Paricalcitol SUN 2 micrograms/ml is packed in boxes containing 5 glass vials of 1 ml of injectable solution.

Paricalcitol SUN 5 micrograms/ml is packed in boxes containing 5 glass vials of 1 ml or 2 ml of injectable solution.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132 JH Hoofddorp

The Netherlands

For more information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder

Sun Pharma Laboratorios, S.L.

Rambla de Catalunya, 53-55

08007 Barcelona

Spain

Tel: +34 93 342 78 90

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

Germany: Paricalcitol SUN 2 Mikrogramm/ml Injektionslösung
Paricalcitol SUN 5 Mikrogramm/ml Injektionslösung

Italy: Paracalcitolo SUN 2 microgrammi/ml soluzione iniettabile
Paracalcitolo SUN 5 microgrammi/ml soluzione iniettabile

Spain: Paricalcitol SUN 2 microgramos/ml solución inyectable EFG
Paricalcitol SUN 5 microgramos/ml solución inyectable EFG

Date of most recent review of this summary: February 2019

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

This information is intended for healthcare professionals only:

INFORMATION FOR HEALTHCARE PROFESSIONALS

Refer to the Summary of Product Characteristics for further information

How to prepare and administer Paricalcitol SUN

Preparation of the injectable solution

Paricalcitol SUN is for single use only. As with other parenteral medicinal products, the diluted solution should be inspected visually for particles and discolouration prior to administration.

Incompatibilities

Propylene glycol interacts with heparin and neutralises its effects. Paricalcitol SUN contains propylene glycol as an excipient and must be administered through a different injection port than heparin.

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

Storage

Parenteral medicinal products should be inspected visually for particles and discolouration prior to administration. The solution is clear and colourless.

Keep in the original packaging. This medicinal product does not require special storage conditions.

Dosage and method of administration

Paricalcitol SUN is administered via 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
8

Or

= baseline intact PTH level in pg/ml
80

and administered intravenously (IV) as a bolus, with a maximum frequency of every other day, at any time during dialysis.

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

2. Dose adjustment:

The currently accepted target range for PTH levels in patients with end-stage renal disease on dialysis is no more than 1.5 to 3 times the upper normal non-uraemic limit, i.e., 15.9 to 31.8 pmol/l (150–300 pg/ml) for intact PTH. To achieve appropriate physiological levels, individualised monitoring and dose adjustment are required. If hypercalcaemia or a persistently elevated corrected Ca x P product greater than 5.2 mmol²/l² (65 mg²/dl²) is observed, the dose should be reduced or interrupted until these parameters normalise. Therapy should then be restarted at a lower dose. Dose reduction may also be necessary when PTH levels decrease in response to treatment.

The following table is suggested as a guide for dose adjustment: