Paricalcitol Fresenius

Package Leaflet: Information for the User

Paricalcitol Fresenius 2 micrograms/ml, Solution for Injection

Paricalcitol Fresenius 5 micrograms/ml, Solution for Injection

Paricalcitol

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

• You should 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.

Contents of the pack:

• 1. What is Paricalcitol Fresenius and what is it used for
• 2. Before you use Paricalcitol Fresenius
• 3. How to use Paricalcitol Fresenius
• 4. Possible side effects
• 5. How to store Paricalcitol Fresenius
• 6. Contents of the pack and other information

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

The active substance of Paricalcitol Fresenius is paricalcitol, a synthetic form of active vitamin D.
Active vitamin D is necessary for the proper functioning of many tissues in the body, including the kidneys and bones.
In people with normal kidney function, this active form of vitamin D is naturally produced by the kidneys, but in kidney failure, its production is significantly reduced. Paricalcitol Fresenius provides a source of active vitamin D when the body is unable to produce it in sufficient quantities. This helps prevent the consequences of low levels of active vitamin D in patients with kidney failure, i.e., high levels of parathyroid hormone, which can cause bone disorders. Paricalcitol Fresenius is used in adult patients with stage 5 kidney disease.

2. Before you use Paricalcitol Fresenius

When not to use Paricalcitol Fresenius

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

Your doctor will inform you if these situations apply to you.

Warnings and precautions

Before starting treatment with Paricalcitol Fresenius, you should discuss it with your doctor or nurse.

• Before starting treatment, you should limit the amount of phosphorus in your diet. Examples of foods high in phosphorus include: tea, sparkling water, beer, cheese, milk, cream, fish, chicken or beef liver, beans, peas, breakfast cereals, nuts, and grains.
• In order to ensure adequate phosphorus levels in the body, it may be necessary to take phosphate-binding medicines, which prevent the absorption of phosphates from food.
• If you are taking phosphate-binding medicines that contain calcium, your doctor may recommend changing their dose.
• Your doctor will order blood tests to monitor the course of treatment.

Children and adolescents

The safety and efficacy of paricalcitol in children have not been established. There are no data available for children under 5 years of age. Paricalcitol Fresenius should not be used in this patient group.

Paricalcitol Fresenius and other medicines

Tell your doctor about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
Some medicines may affect the action of this medicine or increase the risk of side effects. It is particularly important that you inform your doctor if you are taking any of the following medicines:

• used to treat fungal infections, such as candidiasis or aspergillosis (e.g., ketoconazole),
• used to treat heart disease or high blood pressure (e.g., digoxin and diuretics),
• containing phosphates (e.g., medicines that lower calcium levels in the blood),
• containing calcium or vitamin D, including supplements and multivitamins that can be purchased without a prescription,
• containing magnesium or aluminum, e.g., certain types of antacids (neutralizing stomach acid) and phosphate binders,
• used to treat high cholesterol (e.g., cholestyramine).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine.
The use of this medicinal product during pregnancy is not recommended, as it is not known whether it is safe for pregnant women.
It is not known whether Paricalcitol Fresenius passes into breast milk. You should inform your doctor if you are taking Paricalcitol Fresenius before starting breastfeeding.

Driving and using machines

Paricalcitol Fresenius may cause dizziness, which may affect your ability to drive or operate heavy machinery.
You should not drive or operate machinery if you feel dizzy.

Paricalcitol Fresenius contains ethanol and propylene glycol

Paricalcitol Fresenius 2 micrograms/ml
This medicine contains 1.8 g of alcohol (ethanol) in the maximum dose of 20 ml, which is equivalent to 88 mg/ml (11 vol%).
The amount of alcohol in 20 ml of this medicine is equivalent to 45 ml of beer or 18 ml of wine.
The amount of alcohol in this medicine is unlikely to have an effect on adults and adolescents, and its effect on children is likely to be negligible. It may cause some effect in younger children, e.g., drowsiness.
Alcohol in this medicine may alter the effects of other medicines. If you are taking other medicines, you should consult your doctor or pharmacist.
If you are pregnant or breastfeeding, you should consult your doctor or pharmacist before taking this medicine.
If you are addicted to alcohol, you should consult your doctor or pharmacist before taking this medicine.
Paricalcitol Fresenius 5 micrograms/ml
This medicine contains 0.7 g of alcohol (ethanol) in the maximum dose of 8 ml, which is equivalent to 88 mg/ml (11 vol%).
The amount of alcohol in 8 ml of this medicine is equivalent to less than 18 ml of beer or 7 ml of wine.
The small amount of alcohol in this medicine is unlikely to have a noticeable effect.
Paricalcitol Fresenius 2 micrograms/ml
This medicine contains 8.1 g of propylene glycol in the maximum dose of 20 ml, which corresponds to 404 mg/ml.
Pregnant or breastfeeding women should not use this medicine without consulting a doctor. Patients with liver or kidney disorders should not use this medicine without consulting a doctor.
The doctor may decide to perform additional tests on such patients.
Paricalcitol Fresenius 5 micrograms/ml
This medicine contains 3.2 g of propylene glycol in the maximum dose of 8 ml, which corresponds to 404 mg/ml.

3. How to use Paricalcitol Fresenius

Your doctor will use laboratory test results to determine the correct initial dose for your specific condition. At the start of paricalcitol treatment, dose adjustments may be necessary based on routine laboratory test results. Using laboratory test results, your doctor will help determine the correct dose of paricalcitol.
Paricalcitol Fresenius will be administered by your doctor or nurse during a hemodialysis procedure. No venipuncture is required, as Paricalcitol Fresenius can be administered directly into the dialysate used during the procedure.
Paricalcitol Fresenius should not be administered more frequently than every other day and no more than three times a week.

Use in children

There is no information on the use of paricalcitol in children under 5 years of age,
and experience with its use in children over 5 years of age is limited.
Your doctor will decide whether treatment is necessary.

Overdose of Paricalcitol Fresenius

Taking more Paricalcitol Fresenius than prescribed may cause abnormally high levels of calcium in the blood, which can be harmful.
Symptoms that may occur soon after taking too much Paricalcitol Fresenius may include feelings of weakness and/or drowsiness, headache, nausea or vomiting, dry mouth, constipation, muscle or bone pain, and a metallic taste in the mouth.
If high levels of calcium in the blood occur after taking Paricalcitol Fresenius, your doctor will use appropriate treatment to return calcium levels to normal. After calcium levels return to normal, your doctor may recommend taking Paricalcitol Fresenius at a lower dose.
Your doctor will monitor your blood levels. If you experience any of the above symptoms, you should seek medical attention immediately.
Symptoms that may occur if too much Paricalcitol Fresenius is taken for a long time include loss of appetite, drowsiness, weight loss, eye irritation, runny nose, itching of the skin, feeling hot and feverish, loss of sex drive, severe stomach pain (caused by pancreatitis), and kidney stones.
There may be changes in blood pressure and irregular heartbeat (palpitations).
Blood and urine tests may show high levels of cholesterol, urea, nitrogen, and elevated liver enzyme levels. Paricalcitol Fresenius may rarely cause mental changes including disorientation, drowsiness, insomnia, or nervousness.
Paricalcitol Fresenius contains propylene glycol. Cases of toxic effects associated with high doses of propylene glycol are rarely reported and are not expected if propylene glycol is administered to patients with kidney failure during hemodialysis, as it is removed from the blood during this procedure.
If you take too much Paricalcitol Fresenius or experience any of the above symptoms, you should seek medical attention immediately.

4. Possible side effects

Like all medicines, Paricalcitol Fresenius can cause side effects, although not everybody gets them.
Various allergic reactions have been observed with the use of paricalcitol.

Note: If you notice any of the following side effects, you should immediately inform your doctor or nurse:

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

If you experience any of the following side effects, you should inform your doctor or nurse:

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

• low levels of parathyroid hormone in the blood,
• high levels of calcium in the blood (nausea or vomiting, constipation, or confusion), high levels of phosphorus in the blood (probably without symptoms, but may increase the risk of bone fractures),
• headache,
• unusual taste in the mouth,
• itching of the skin.

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

• blood infection, pneumonia (lung infection), sore throat, vaginal infections, flu,
• breast cancer,
• decreased red blood cell count (anemia - weakness, shortness of breath, pale skin),
• decreased white blood cell count (increased risk of infections), enlarged lymph nodes in the neck, armpits, and/or groin,
• high levels of parathyroid hormone in the blood,
• high levels of potassium in the blood, low levels of calcium in the blood, loss of appetite,
• disorientation, which can be severe (confusion), personality disorders (feeling not oneself), agitation (feeling shaken or restless), sleep disturbances, nervousness,
• coma (a state of deep unconsciousness, in which a person does not respond to their environment), stroke, fainting, muscle spasms in the arms and legs, even during sleep, decreased sensation, tingling, or numbness, dizziness,
• increased pressure in the eyes, conjunctivitis (itching/dry discharge on the eyelids),
• ear pain
• heart attack, irregular/fast heartbeat,
• low blood pressure, high blood pressure,
• fluid in the lungs, asthma (wheezing), breathing difficulties, nosebleeds, cough,
• bleeding from the rectum, colitis, diarrhea, stomach pain, difficulty swallowing, constipation, nausea, vomiting, dry mouth,
• rash with itchy blisters on the skin, hair loss, excessive hair growth, excessive and unpredictable sweating,
• joint pain, joint stiffness, back pain, muscle tremors, muscle pain,
• chest pain, difficulty achieving or maintaining an erection
• abnormal gait, generalized or localized swelling of the ankles, feet, and legs, pain at the injection site, fever, chest pain, inadequate feeling of tiredness or weakness, general feeling of discomfort, thirst,
• prolonged bleeding time (blood takes longer to clot), increased liver enzyme activity, abnormal laboratory test results, weight loss.

Side effects with unknown frequency(frequency cannot be estimated from the available data):

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

Some of the above symptoms you will not be able to identify yourself, unless you are informed about them by your doctor.

Reporting of side effects

If you experience any side effects, including those not listed in this leaflet, you should inform your doctor or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Aleje Jerozolimskie 181 C, PL-02-222 Warsaw, Tel.: + 48 22 49 21 301, Fax: + 48 22 49 21 309,
Website: https://smz.ezdrowie.gov.pl.
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Paricalcitol Fresenius

Keep this medicine out of the sight and reach of children.
There are no special storage instructions for this medicine.
Paricalcitol Fresenius should be used immediately after opening.
Do not use this medicine after the expiry date stated on the carton after the words “Expiry date (EXP)”. The expiry date refers to the last day of the month stated.
Do not use this medicine if the solution has changed color or is cloudy.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Paricalcitol Fresenius contains

• The active substanceis paricalcitol.
• The other ingredients are: ethanol, propylene glycol, and water for injections.

What Paricalcitol Fresenius looks like and contents of the pack

Paricalcitol Fresenius is a clear, colorless solution without visible particles.
Paricalcitol Fresenius 2 micrograms/ml is supplied in packs containing 1 or 5 glass ampoules of 1 ml and in packs containing 1 or 5 glass vials of 1 ml.
Paricalcitol Fresenius 5 micrograms/ml is supplied in packs containing 1 or 5 glass ampoules of 1 ml or 2 ml and in packs containing 1 or 5 glass vials of 1 ml or 2 ml.
Not all pack sizes may be marketed.

Marketing Authorization Holder

Fresenius Medical Care Nephrologica Deutschland GmbH
Else-Kröner-Straße 1
61352 Bad Homburg v.d.H.
Germany

Manufacturer

Fresenius Medical Care Deutschland GmbH
Else-Kröner-Straße 1
61352 Bad Homburg v.d.H.
Germany

Distributor:

Fresenius Medical Care Polska S.A.,
60-118 Poznań,
ul. Krzywa 13
tel.: 0-61 83-92-600
fax: 0-61 83-92-601
Date of last revision of the leaflet:06/2021
Information intended for healthcare professionals only

Paricalcitol Fresenius, 2 and 5 micrograms/ml, Solution for Injection

Paricalcitol Fresenius is intended for single use only. As with all injectable medicines, the solution should be inspected before administration to exclude the presence of particles or a change in the color of the solution.

Incompatibilities

Propylene glycol interacts with heparin and neutralizes its effect. Paricalcitol Fresenius contains propylene glycol as an excipient and should therefore be administered through a different access line than heparin.
This medicinal product must not be mixed with other medicinal products.

Shelf life

Shelf life: 2 years.

Posology and method of administration

Paricalcitol Fresenius is administered through a vascular access used for hemodialysis.
Adults

• 1) The initial dose should be calculated based on the initial parathyroid hormone (PTH) level.

The initial dose of paricalcitol is calculated using the following formula:
initial dose (in micrograms) =
initial intact PTH level in pmol/l
8

Or

=
and is administered as a rapid intravenous injection no more frequently than every other day, at any time during dialysis.
The maximum dose administered safely in clinical trials was 40 micrograms.
initial intact PTH level in pg/ml
80

• 2) Dose adjustment

It is currently believed that the target range for PTH levels in dialysis patients with end-stage kidney disease should not exceed 1.5 to 3 times the upper limit of normal for intact PTH (iPTH) in non-uremic subjects, 15.9 to 31.8 pmol/l (150-300 pg/ml). Achieving appropriate physiological target values requires careful monitoring and individual dose adjustment. In the event of hypercalcemia or persistently elevated corrected calcium-phosphorus product above 5.2 mmol/l (65 mg/dl), the dose should be reduced or administration of the medicine should be discontinued until these parameters return to normal. Paricalcitol Fresenius administration can then be restarted at a lower dose. Dose reductions may be necessary as PTH levels decrease in response to treatment.
The following table provides guidelines for dose adjustment: