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ZEMPLAR 5 MICROGRAM/ML SOLUTION FOR INJECTION

Active substance(s): PARICALCITOL

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Label Center Ludwigshafen
CR No.:
CR-0001188-2015
Commodity No.: 10000000136686
Draft No.:
4
Revision date: 16. Feb. 2016
Graphic Artist: H. Haag

Customer: GSK
Product name/Country: Zemplar Inj 5 mcg/ml 1ml / UK/IE
Size:
JMF324 (456 x 272 mm)
Pharma code:
60
Collating mark:
-

Min. text size: 8 pt
Colors: Black

Cutter guide

Package leaflet: Information for the user
Zemplar 5 micrograms/ml solution for injection
Paricalcitol
Read all of this leaflet carefully before you are given 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 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.
What is in this leaflet:
1. What Zemplar is and what it is used for
2. What you need to know before you are given Zemplar
3. How Zemplar is used
4. Possible side effects
5. How to store Zemplar
6. Contents of the pack and other information
1. What Zemplar is and what is it used for
Zemplar is a synthetic analogue of activated vitamin D that is used to prevent and
treat high levels of parathyroid hormone in the blood in people who have kidney failure
and are being treated on a kidney machine (haemodialysis). High levels of parathyroid
hormone can be caused by low levels of “activated” vitamin D in patients with kidney
failure.
Activated vitamin D is required for normal functioning of many tissues of the body,
including the kidneys and bones.
2. What you need to know before you are given Zemplar
You should not be given Zemplar:
- if you are allergic to paricalcitol 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 your blood. Your doctor will
monitor your blood levels and be able to tell you if these conditions apply to you
Warnings and precautions
- Before the treatment begins, it is important to limit the amount of phosphorus in your
diet. Examples of foods high in phosphorous include tea, soda, beer, cheese, milk,
cream, fish, chicken or beef liver, beans, peas, cereals, nuts, and grains.
- Phosphate-binding medicines, which keep phosphate from being absorbed from
your food, may be needed to control phosphorus levels.

- If you are taking calcium-based phosphate binders, the doctor may need to adjust
your dose.
- Your doctor will need to do blood tests to monitor your treatment.
Other medicines and Zemplar
Please tell your doctor, nurse or pharmacist if you are taking, have recently taken or
might take any other medicines.
Some medicines can affect the action of Zemplar or make side effects more likely. It is
particularly important to tell your doctor if you are taking any of the following medicines:
• to treat fungal infections such as candida or thrush, (i.e., ketoconazole)
• to treat heart or blood pressure (e.g. digoxin and diuretics or water pills).
• that contain magnesium (e.g. some types of indigestion medicines called antacids,
such as magnesium trislilicate).
• that contain aluminium (e.g. phosphate-binders, such as aluminium hydroxide).
Ask your doctor, nurse, or pharmacist for advice before taking any medicine.
Zemplar with food and drink
Zemplar may be given with or without food.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or planning to have a
baby, ask your doctor for advice before taking this medicine
It is not known if it is safe for pregnant or breast-feeding women to use this medicine.
Therefore it should only be used after discussion with your doctor, who will help you
make the best decision for you.
Driving and using machines
Whilst you are being treated with Zemplar, your ability to drive safely or use heavy
machines may be affected. Zemplar may make you feel dizzy, weak, and/or drowsy.
Do not drive or use machines if you feel these symptoms

Zemplar contains ethanol
This medicinal product contains 20% v/v of ethanol (alcohol). Each dose may contain
up to 1.3g ethanol. Harmful for those suffering from alcoholism. To be taken into
account in pregnant or breast-feeding women, children and high risk groups such as
patients with liver disease or epilepsy.

3. How Zemplar is used
Your doctor will use the results of your laboratory tests to decide the correct starting
dose for you. Once treatment with Zemplar has started, the dose may be adjusted,
based upon the results of routine laboratory tests. Using your lab results, your doctor
will help determine the correct dose of Zemplar for you.
Zemplar will be given by a doctor or nurse while you are having your treatment on the
kidney machine. It will be given through the tube (bloodline) that is used to connect you
to the machine. You will not need to have an injection because Zemplar can be put
directly into the tube that is being used for your treatment. You will not be given Zemplar
more frequently than every other day and not more than three times a week.
If you are given too much Zemplar
Too much Zemplar may lead to high levels of calcium (in the blood and urine) and
phosphate in the blood that may require treatment. Additionally too much Zemplar may
reduce parathyroid hormone levels. Symptoms which can appear soon after receiving
too much Zemplar include:
• feeling weak and/or drowsy
• headache
• feeling sick or being sick
• dry mouth, constipation
• pain in muscles or bones
• unusual taste in the mouth
Symptoms which can develop over a longer period of receiving too much Zemplar
include:
• loss of appetite
• drowsiness
• weight loss
• sore eyes
• runny nose
• itchy skin
• feeling hot and feverish
• loss of sex drive
• severe abdominal pain
• kidney stones
• Your blood pressure may be affected and awareness of your own heartbeat
(palpitations) can occur.
Zemplar contains 30% by volume of Propylene glycol as an ingredient. Cases of
poisonous effects related to the high doses of Propylene glycol have only rarely been
reported and would not be expected when being given to kidney patients on a kidney
machine because Propylene glycol is removed from the blood during dialysis .
If you experience high level of calcium in your blood after taking Zemplar, your doctor
will ensure you receive the appropriate treatment to return your calcium to normal limits.
Once your calcium levels return to normal limits, you maybe given Zemplar at a lower
dose.

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The following information is intended for healthcare professionals only:

Posology and Method of Administration

Zemplar 5 microgram/ml solution for injection

Zemplar solution for injection is administered via haemodialysis access.

Preparation of solution for injection
Zemplar 5 microgram/ml solution for injection is intended for single use only. As with
all drugs administered through injection, the diluted solution should be inspected for
particles and discoloration, prior to administration.

Adults
1) Initial Dose should be calculated based on baseline parathyroid hormone (PTH)
levels:

Compatibility
Propylene glycol interacts with heparin and neutralises its effect. Zemplar solution for
injection contains propylene glycol as an excipient and should be administered through
a different injection port than heparin.

The initial dose of paricalcitol is based on the following formula:
baseline intact PTH level in pmol/l
Initial dose (micrograms)
= _____________________________

8
OR

This medicinal product must not be mixed with other medicinal products.
Storage and shelf life
Parenteral medicinal products should be inspected visually for particulate matter and
discoloration prior to administration. The solution is clear and colourless.

baseline intact PTH level in pg/mL
= ______________________________

80
and administered as an intravenous (IV) bolus dose no more frequently then every
other day at any time during dialysis.

This medicinal product does not require any special storage conditions.
This medicinal product has a shelf life of 2 years.

10000000136686.indd 1

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

16.02.16 10:21

However, your doctor will be checking your blood levels and if you experience any of
the above seek medical advice immediately.

- injection site pain

4. Possible side effects

- pneumonia (lung infection); fluid on the lungs; asthma (wheezing, cough, difficulty
breathing);

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

- sore throat; cold; fever; flu-like symptoms; pink eye (itchy/crusty eyelids); increased
pressure in the eye; earache; nose bleeds

Various allergic reactions have been seen with Zemplar. Important: Tell your doctor
or nurse immediately if you notice any of the following side effects:
• Shortness of breath
• Difficulty breathing or swallowing
• Wheezing
• A rash, itchy skin, or hives
• Swelling of the face, lips, mouth, tongue or throat.

- nervous twitches; confusion, which is sometimes severe (delirium); agitation (feeling
jittery, anxious); nervousness; personality disorders (not feeling like yourself);
- tingling or numbness; decreased touch sensation; problems sleeping; sweating at
night; muscular spasms in arms and legs, even during sleep;

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

- dry mouth; thirsty; nausea; difficulty swallowing; vomiting; loss of appetite; weight
loss; heart burn; diarrhoea and stomach ache; constipation: bleeding from the
rectum;

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

- difficulty having an erection; breast cancer; infections in the vagina

- headache
- unusual taste in the mouth
- itchy skin
- low levels of parathyroid hormone
- high levels of calcium (feeling sick or being sick, constipated or confused);
phosphorous in the blood (probably no symptoms but it can make bones more likely
to break)

- breast pain; back pain; joint/muscular pain; feeling of heaviness caused by general
swelling or localised swelling of the ankles, feet and legs (oedema); abnormal way of
walking;

Uncommon (may affect up to 1 in 100 people) are:
- allergic reactions (such as shortness of breath, wheezing, rash, itching or swelling of
the face and lips); itchy blisters
- blood infection; decreased number of red cells (anaemia – feeling weak, shortness of
breath, looking pale); decreased number of white cells (more likely to get infections);
swollen glands in the neck, armpit and/or groin; increased bleeding time (blood will
not clot so quickly)
- heart attack; stroke; chest pain; irregular/fast heartbeat; low blood pressure; high
blood pressure;

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any
possible side effects not listed in this leaflet. You can also report side effects directly
(see details below)
Ireland:
Healthcare professionals are asked to report any suspected adverse reactions via
HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax:
+353 1 6762517. Website: www.hpra.ie; E-mail: medsafety@hpra.ie.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
In Ireland; AbbVie Limited, Citywest Business Campus, Dublin 24, Ireland
In the UK; AbbVie Ltd., Maidenhead, SL6 4UB, UK
Vial manufacturer:
AbbVie Deutschland GmbH &Co. KG, Knollstrasse, 67061 Ludwigshafen, Germany
This leaflet was last approved in February 2016

United Kingdom:
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the safety of this
medicine.
5. How to store Zemplar
Keep this medicine out of the sight and reach of children
This medicinal product does not require any special storage conditions.
Zemplar 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 refers to the last date of that month.
Do not use this medicine if you notice particles or discolouration.

- hair loss; excessive hair growth,
- increase of a liver enzyme; high levels of parathyroid hormones; high levels of
potassium in the blood; low levels of calcium in the blood
Not known Frequency (frequency cannot be estimated from the available data):

Do not throw away any medicines via wastewater or household waste. Ask your
pharmacist how to throw away medicines you no longer use. These measures will help
to protect the environment.

- swelling of the face, lips, mouth, tongue or throat which may cause difficulty in
swallowing or breathing; itchy skin (hives) , Stomach bleeding . Get medical help
immediately

6. Contents of the pack and further information

You may not be able to tell if you have some of the side effects listed above unless you
are told so by your doctor.

- The active substance is paricalcitol. Each ml of solution contains 5 micrograms of
paricalcitol.
- The other ingredients are: ethanol (alcohol), propylene glycol, and Water for injections.

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

- coma (a deep state of unconsciousness during which the person cannot respond to
the environment)

What Zemplar contains

What Zemplar looks like and contents of the pack
Zemplar solution for injection is a watery, clear and colourless solution, free from visible
particles.
It is supplied in containers with 5 glass ampoules of 1 ml or 2 ml or 5 glass vials of 1 ml
or 2 ml.

- unusual tiredness, weakness; dizziness; fainting

Y011

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2) Titration Dose:
The currently accepted target range for PTH levels in end-stage renal failure subjects
undergoing dialysis is no more than 1.5 to 3 times the non-uremic upper limit of
normal, 15.9 to 31.8 pmol/l (150-300 pg/ml), for intact PTH. Close monitoring and
individual dose titration are necessary to reach appropriate physiological endpoints.
If hypercalcaemia or a persistently elevated corrected Ca x P product greater than
5.2 mmol2/l2 (65 mg2/dl2) is noted, the dosage should be reduced or interrupted
until these parameters are normalised. Then, paricalcitol administration should be
reinitiated at a lower dose. Doses may need to be decreased as the PTH levels
decrease in response to therapy.

The following table is a suggested approach for dose titration:
Suggested Dosing Guidelines
(Dose adjustments at 2 to 4 week intervals)
iPTH Level Relative to Baseline
Same or increased
Decreased by < 30%
Decreased by ≥ 30%, ≤ 60%
Decreased > 60%
IPTH < 15.9 pmol/l (150 pg/mL)

Paricalcitol Dose Adjustment
Increase by 2 to 4 micrograms
Maintain
Decrease by 2 to 4 micrograms

Y011

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16.02.16 10:21

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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