Paricalcitol Fresenius

Leaflet attached to the packaging: information for the user

Paricalcitol Fresenius 2 micrograms/ml, solution for injection

Paricalcitol Fresenius 5 micrograms/ml, solution for injection

Paricalcitol

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or nurse.
• -If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or nurse. See section 4.

Table of contents of the leaflet:

• 1. What is Paricalcitol Fresenius and what is it used for
• 2. Important information before using Paricalcitol Fresenius
• 3. How to use Paricalcitol Fresenius
• 4. Possible side effects
• 5. How to store Paricalcitol Fresenius
• 6. Contents of the packaging 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 body tissues, 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 is a source of active vitamin D when the body is unable to produce it in sufficient quantities. It 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. Important information before using Paricalcitol Fresenius

When not to use Paricalcitol Fresenius

The doctor will inform the patient if these situations apply to them.

Warnings and precautions

Before starting treatment with Paricalcitol Fresenius, the patient should discuss it with their doctor or nurse.

• Before starting treatment, the patient should limit their phosphorus intake. Examples of phosphorus-rich foods include: tea, sparkling water, beer, cheese, milk, cream, fish, chicken or beef liver, beans, peas, cereal, nuts, and grains.
• In order to ensure proper phosphorus levels in the body, it may be necessary to take phosphate-binding medications, which prevent phosphate absorption from food.
• If the patient is taking phosphate-binding medications that contain calcium, the doctor may recommend changing their dose.
• The doctor will order blood tests to monitor the 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

The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Some medicines may affect the action of Paricalcitol Fresenius or increase the risk of side effects. It is particularly important for the patient to inform their doctor if they 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 phosphorus (e.g., medications 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 (acid-neutralizing medications) and phosphate binders,
• used to treat high cholesterol (e.g., cholestyramine).

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor before using this medicine.
It is not known whether the use of this medicinal product is safe in pregnant women, so its use is not recommended during pregnancy or if there is a possibility of becoming pregnant.
It is not known whether Paricalcitol Fresenius passes into breast milk. The patient should inform their doctor about taking Paricalcitol Fresenius before starting breastfeeding.

Driving and using machines

Paricalcitol Fresenius may cause dizziness, which can affect the patient's ability to drive or operate heavy machinery.
The patient should not drive or operate machinery if they experience dizziness.

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, such as drowsiness.
Alcohol in this medicine may alter the effect of other medicines. If the patient is taking other medicines, they should consult their doctor or pharmacist.
If the patient is pregnant or breastfeeding, they should consult their doctor or pharmacist before using this medicine.
If the patient is addicted to alcohol, they should consult their doctor or pharmacist before using 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 is equivalent to 404 mg/ml.
Pregnant or breastfeeding women should not use this medicine without consulting their doctor. Patients with liver or kidney disorders should not use this medicine without consulting their 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 is equivalent to 404 mg/ml.

3. How to use Paricalcitol Fresenius

The doctor will use laboratory test results to determine the correct initial dose for the individual patient. At the start of paricalcitol treatment, dose adjustment may be necessary based on routine laboratory test results. Using laboratory test results, the doctor will help determine the correct dose of paricalcitol.
Paricalcitol Fresenius will be administered by a 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 will 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.
The doctor will decide whether treatment is necessary.

Using a higher dose of Paricalcitol Fresenius than recommended

Using a higher dose of Paricalcitol Fresenius than recommended 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 using Paricalcitol Fresenius, the doctor will use appropriate treatment to bring the calcium level back to normal. After the calcium level returns to normal, the doctor may recommend taking Paricalcitol Fresenius in a lower dose.
The doctor will monitor blood levels. If the patient experiences any of the above symptoms, they should seek medical attention immediately.
Symptoms that may occur if too much Paricalcitol Fresenius is taken for a longer period include loss of appetite, drowsiness, weight loss, eye irritation, runny nose, itching of the skin, feeling of heat, and fever, loss of sex drive, severe abdominal pain (caused by pancreatitis), and kidney stones.
There may be changes in blood pressure and irregular heartbeat (palpitations).
Blood and urine test results 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.
Propylene glycol is a component of Paricalcitol Fresenius. Cases of toxic symptoms 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 the patient receives too much Paricalcitol Fresenius or experiences any of the above symptoms, they 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 any of the following side effects are observed, the patient should immediately inform their 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 any of the following side effects occur, the patient should inform their 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 (the patient does not feel like themselves), agitation (feeling of shaking, restlessness), sleep disturbances, nervousness,
• coma (a state of deep loss of consciousness, 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/rapid heartbeat,
• low blood pressure, high blood pressure,
• fluid in the lungs, asthma (wheezing), difficulty breathing, nosebleeds, cough,
• rectal bleeding, 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 can cause difficulty swallowing or breathing; itching of the skin (hives). Stomach bleeding.

Some of the above symptoms the patient will not be able to determine on their own unless they are informed by their doctor.

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the patient should tell their 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.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Paricalcitol Fresenius

The medicine should be stored out of sight and reach of children.
There are no special recommendations for storing 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. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Contents of the packaging and other information

What Paricalcitol Fresenius contains

• The active substanceof Paricalcitol Fresenius is paricalcitol.
• Other ingredients of the medicine 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 available 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 available 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 carefully examined 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 than heparin.
This medicinal product must not be mixed with other medicinal products.

Shelf life

Shelf life: 2 years.

Dosage and administration

Paricalcitol Fresenius is administered via a vascular access used for hemodialysis procedures.
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 renal 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 Ca x P 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. Then, paricalcitol administration can be resumed 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: