PARICALCITOL ACCORD 5 micrograms/ml injectable solution

Introduction

Package Leaflet: Information for the User

Paricalcitol Accord 2 micrograms/ml solution for injection EFG

Paricalcitol Accord 5 micrograms/ml solution for injection EFG

Paricalcitol

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

1. What is Paricalcitol Accord and what is it used for.
2. What you need to know before you use Paricalcitol Accord.
3. How to use Paricalcitol Accord
4. Possible side effects.
5. Storing Paricalcitol Accord.
6. Contents of the pack and further information.

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

Paricalcitol Accord 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 gland and bones. In people with normal kidney function, this active form of vitamin D is naturally produced by the kidneys, but in renal failure, the production of active vitamin D is significantly reduced. Therefore, Paricalcitol 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 with high levels of parathyroid hormone that can cause bone problems. Paricalcitol is indicated in adult patients with chronic kidney disease stage 5.

2. What you need to know before you use Paricalcitol Accord

Do not use Paricalcitol Accord:

• 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 be able to tell you if these conditions apply to you.

Warnings and precautions

Talk to your doctor or nurse before you start using Paricalcitol Accord

• Before starting treatment, it is important that you limit the amount of phosphorus ingested in your diet. Examples of foods that contain high levels of phosphorus are: tea, soda, beer, cheese, milk, cream, fish, chicken or beef liver, 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.

Using Paricalcitol Accord with other medicines

Tell your doctor or pharmacist if you are using or have recently used or might use any other medicines.

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

• For treating fungal infections such as thrush (e.g., ketoconazole)
• For treating heart problems or high blood pressure (e.g., digoxin and diuretics)
• That contain a phosphate source (e.g., medicines that decrease 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 (e.g., some types of medicines for indigestion (antacids) and phosphorus binders

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 using this medicine.

It is not known if 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 if Paricalcitol Accord passes into breast milk. Contact your doctor before breastfeeding while using Paricalcitol Accord.

Driving and using machines

Paricalcitol Accord may make you feel dizzy; this may affect your ability to drive safely or use heavy machinery.

Do not drive or use machines if you feel dizzy.

Paricalcitol Accord contains anhydrous ethanol

5 mcg/mL:

This medicine contains up to 2.21 g of ethanol (alcohol) in each dose, which is equivalent to approximately 32 mg/kg. The amount in each dose of this medicine is equivalent to approximately 55 ml of beer or 22 ml of wine.

It is unlikely that the amount of alcohol in this medicine will have an effect on adults and adolescents, and it is likely that its effects in children will not be noticeable. It may have some effects in smaller children, such as a feeling of sleepiness.

The alcohol in this medicine may alter the effects of other medicines. Talk to your doctor or pharmacist if you are taking other medicines.

2 mcg/mL:

This medicine contains up to 5.52 g of ethanol (alcohol) in each dose, which is equivalent to approximately 79 mg/kg. The amount in each dose of this medicine is equivalent to approximately 138 ml of beer or 55 ml of wine.

It is likely that the alcohol in this preparation will affect children. These effects may include sleepiness and changes in behavior. It may also affect their ability to concentrate and participate in physical activities.

The amount of alcohol in this medicine may affect your ability to drive or use machines. This is because it may affect your judgment and reaction time.

The amount of alcohol in this medicine may alter the effects of other medicines. Talk to your doctor or pharmacist if you are taking other medicines.

This medicine is harmful to people with alcoholism.

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

3. How to use Paricalcitol Accord

Your doctor will use the results of laboratory tests to decide the initial dose suitable for you.

Once you have started treatment with Paricalcitol Accord, the dose must be adjusted based on the results of routine laboratory tests. Using the results of your tests, your doctor will help you determine the suitable dose of Paricalcitol Accord for you.

Paricalcitol Accord will be administered by your 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 since Paricalcitol Accord can be introduced directly into the tube being used for your treatment.

You will not receive Paricalcitol Accord more frequently than every other day and no more than 3 times a week.

If you take more Paricalcitol Accord than you should

Too much Paricalcitol Accord can cause high levels of calcium in the blood. The symptoms that may appear after receiving an overdose of Paricalcitol Accord are:

• Feeling of weakness and/or sleepiness
• Headache
• Nausea or vomiting (feeling sick)
• Dry mouth, constipation
• Muscle or bone pain
• Metallic taste in the mouth

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

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

The symptoms that may appear after a long period of receiving too much Paricalcitol Accord are:

• Lack of appetite
• Sleepiness
• Weight loss
• Irritation in the eyes
• Runny nose
• Itching of the skin
• Feeling of fever
• Lack of sexual appetite
• Severe abdominal pain (due to pancreas inflammation)
• Kidney stones
• Your blood pressure may be affected, and you may be aware of your own heartbeat (palpitations).

Your blood pressure may be affected, and irregular heartbeats (palpitations) may occur. The results of blood and urine tests may show high cholesterol, urea, nitrogen, and elevated liver enzyme levels. Rarely, Zemplar may cause mental changes such as confusion, sleepiness, insomnia, or nervousness.

Paricalcitol Accord contains 30% v/v 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 because propylene glycol is eliminated from the blood during dialysis.

If you use too much Paricalcitol Accord or experience any of the above, seek medical advice immediately.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Several allergic reactions have been reported with Paricalcitol Accord. Important: if you notice any of the following side effects, tell your doctor or nurse immediately:

• Shortness of breath
• Difficulty breathing and swallowing
• Wheezing
• Rash, itching of the skin, or hives
• Swelling of the face, lips, mouth, tongue, or throat.

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

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

• Headache;
• Unusual taste in the mouth;
• Itching of the skin;
• Decreased levels of parathyroid hormone;
• Increased levels of calcium (feeling sick, constipated, or confused) and phosphorus in the blood (probably asymptomatic but may make bones susceptible to fracture).

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, difficulty breathing, paleness); decreased number of white blood cells (increased susceptibility to infections), inflammation 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, which can be severe (delirium), personality disorders (not feeling like oneself), agitation (feeling nervous, anxious), sleep disorders, nervousness
• 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 (itchy/ sticky eyelids)
• ear pain
• heart attack, irregular/fast heartbeat
• low blood pressure, high blood pressure
• fluid in the lungs, asthma, wheezing, difficulty breathing, nosebleeds, 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 having an erection
• abnormal gait, general or localized swelling of the ankles, feet, and legs, pain at the injection site, fever, chest pain, unusual tiredness 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 the available data):

• Swelling of the face, lips, mouth, tongue, and throat that can cause difficulty swallowing or breathing; itching of the skin (hives), stomach bleeding.

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

If you think any of the side effects you are experiencing are serious or if you notice any side effects not listed in this leaflet, tell your doctor, nurse, or pharmacist immediately.

Reporting of side effects

If you experience side effects, talk to your doctor, hospital pharmacist, or nurse, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Monitoring System: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Paricalcitol Accord

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

No special temperature storage conditions are required. Keep the ampoule/vial in the outer packaging to protect it from light.

Paricalcitol Accord should be used immediately after opening.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date is the last day of the month shown.

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

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. Container Content and Additional Information

Composition of Paricalcitol Accord

• The active ingredient is paricalcitol. Each ml of solution contains 2 micrograms or 5 micrograms of paricalcitol.
• The other components (excipients) are: anhydrous ethanol (alcohol), propylene glycol, and water for injectable preparations.

Appearance of the Product and Container Content

Paricalcitol Accord is a clear and colorless aqueous solution, free from visible particles.

It is presented in packs with 1 vial or 5 vials of 1 ml or 2 ml.

It is presented in packs with 5 ampoules of 1 ml or 2 ml.

Only some pack sizes may be marketed.

Marketing Authorization Holder

Accord Healthcare S.L.U.

World Trade Center

Moll de Barcelona, s/n

Edifici Est, 6ª planta

08039 Barcelona

Manufacturer

Accord Healthcare Polska Sp.z o.o.,

ul. Lutomierska 50,95-200 Pabianice, Poland

or

Accord Healthcare Single Member S.A.

64th Km National Road Athens, Lamia, Schimatari, 32009

Greece

This pharmaceutical product is authorized in the EEA Member States under the following names:

Date of Last Revision of this Leaflet: June 2021

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

---------------------------------------------------------------------------------------------------------

Instructions for the Healthcare Professional

Paricalcitol Accord 2 micrograms/ml solution for injection

Paricalcitol Accord 5 micrograms/ml solution for injection

Preparation for solution for injection

Paricalcitol Accord 2 micrograms/ml or 5 micrograms/ml solution for injection is for single use. As with other parenteral medicines, the solution should be inspected for particles and discoloration before administration.

Compatibility

Propylene glycol interacts with heparin and neutralizes its effects. Paricalcitol Accord solution for injection contains propylene glycol as an excipient and should be administered through a different administration site than heparin.

This medicinal product must not be mixed with other medicinal products, as compatibility studies have not been performed.

Storage and Validity Period

The solution should be inspected visually before administration for the presence of particles and discoloration.

This medicinal product does not require special temperature storage conditions.

Keep the ampoule/vial in the outer packaging to protect it from light.

This medicinal product has a validity period of 2 years.

Use immediately after opening

Posology and Method of Administration

Paricalcitol Accord is administered by hemodialysis.

Posology

Adults

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

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 as an intravenous bolus dose, with a maximum frequency of every other day and at any time during dialysis.

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

1. Dose titration:

The currently accepted levels for the range of PTH in subjects with end-stage renal disease undergoing dialysis are not more than 1.5 to 3 times the upper limit of normal non-uremic, 15.9 to 31.8 pmol/l (150-300 pg/ml) for intact PTH. To achieve adequate levels of physiological variables, individualized monitoring and dose titration are necessary. If hypercalcemia or an elevated corrected Ca x P product is observed, persistent and higher than 5.2 mmol2/l2 (65 mg2/dl2), the dose should be reduced or interrupted until these parameters normalize.

Then, the administration of paricalcitol should be restarted at a lower dose. It may be necessary to reduce the dose when PTH levels decrease in response to therapy.

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