Zomikos

PATIENT REMINDER CARD

The patient reminder card contains important safety information that you should be aware of before and during treatment with zoledronic acid (Zomikos) infusion for oncologic indications

You should be aware of the following before and during treatment with zoledronic acid (Zomikos) infusion

Zomikos

Your doctor has prescribed zoledronic acid (Zomikos) infusion to prevent bone complications (such as fractures) caused by the presence of bone metastases or malignant bone tumors, and to reduce calcium levels in the blood of adult patients when levels are high due to the presence of a tumor. Tumors can accelerate bone turnover, leading to increased calcium release from bones. This condition is called tumor-induced hypercalcemia (TIH).
In patients receiving zoledronic acid (Zomikos) infusions for oncologic indications, a rare adverse reaction called jawbone necrosis (ONJ) (jawbone damage) has been reported. ONJ can also occur after treatment is stopped.
To reduce the risk of developing jawbone necrosis, certain precautions should be taken:

Before starting treatment:

• Before starting treatment, ask your doctor to tell you about ONJ.
• Ask your doctor if a dental examination is recommended before starting treatment with zoledronic acid (Zomikos).
• Tell your doctor or nurse about any oral or dental problems.

Patient undergoing dental surgery (e.g., tooth extraction), those not receiving routine dental care, or patients with gum disease, smokers, patients receiving various cancer treatments, or patients previously treated with bisphosphonates (used to treat or prevent bone disorders) may be at higher risk of developing ONJ.

During treatment:

• Maintain good oral hygiene, ensure proper fitting of dental prostheses, and attend regular dental check-ups.
• Patient undergoing dental treatment or patients before dental surgery (e.g., tooth extraction) should inform their doctor and dentist that they are taking zoledronic acid (Zomikos).
• Immediately contact your doctor and dentist if you experience any oral or dental problems, such as tooth loosening, pain, or swelling, non-healing ulcers, or discharge, as these may be symptoms of jawbone necrosis.

For further information, see the Patient Information Leaflet.

Patient Information Leaflet included in the packaging: information for the patient

Zomikos, 4 mg/5 ml, concentrate for solution for infusion

Zoledronic acid

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.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Zomikos and what is it used for
• 2. Important information before using Zomikos
• 3. How to use Zomikos
• 4. Possible side effects
• 5. How to store Zomikos
• 6. Contents of the pack and other information

1. What is Zomikos and what is it used for

The active substance in Zomikos is zoledronic acid, which belongs to a group of medicines called bisphosphonates. Zoledronic acid works by binding to bone tissue and slowing down bone turnover. It is used:
to prevent bone complications, such as fractures, in adult patients with bone metastases (cancer spread from the original site to the bone);
to reduce calcium levels in the blood of adult patients when levels are high due to the presence of a tumor. Tumors can accelerate bone turnover, leading to increased calcium release from bones. This condition is called tumor-induced hypercalcemia (TIH).

2. Important information before using Zomikos

Follow all your doctor's instructions.
Your doctor will perform blood tests before starting Zomikos and will check your response to treatment at regular intervals.

When not to use Zomikos:

• if you are breastfeeding;
• if you are allergic to zoledronic acid or any other bisphosphonate (a group of medicines to which Zomikos belongs) or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before using Zomikos, discuss with your doctor:

• if you have or have had kidney problems;
• if you have or have had pain, swelling, or numbness in the jaw, a feeling of heaviness in the jaw, or loosening of teeth. Your doctor may recommend a dental examination before starting Zomikos;
• if you are undergoing dental treatmentor plan to undergo dental surgery (e.g., tooth extraction); you should inform your dentist that you are taking Zomikos and tell your doctor about any dental treatment.

During treatment with Zomikos, maintain good oral hygiene (including regular toothbrushing) and attend regular dental check-ups.
Immediately contact your doctor and dentist if you experience any oral or dental problems, such as tooth loosening, pain, or swelling, non-healing ulcers, or discharge, as these may be symptoms of jawbone necrosis.
Patient undergoing chemotherapy and/or radiotherapy, those taking corticosteroids, those undergoing dental surgery, those not receiving routine dental care, those with gum disease, smokers, or those who have taken bisphosphonates (for the treatment or prevention of bone disorders) may be at higher risk of developing jawbone necrosis.
Patient receiving zoledronic acid have reported low calcium levels in the blood (hypocalcemia), which can sometimes cause muscle cramps, dry skin, and a tingling sensation.
There have been reports of irregular heartbeats (arrhythmias), seizures, muscle cramps, and spasms (tetany) due to severe hypocalcemia. In some cases, hypocalcemia can be life-threatening. If any of these situations apply to you, tell your doctor immediately. If you have hypocalcemia, it should be corrected before taking the first dose of Zomikos. You will be given appropriate calcium and vitamin D supplements.

Patient over 65 years of age

Zomikos can be used in patients over 65 years of age. There is no need for special precautions in this age group.

Children and adolescents

Zomikos should not be used in children and adolescents under 18 years of age.

Zomikos and other medicines

Tell your doctor about all the medicines you are taking or have recently taken, and about any medicines you plan to take. It is particularly important to tell your doctor if you are taking:

• antibiotics from the aminoglycoside group (used to treat severe infections), calcitonin (used to treat postmenopausal osteoporosis and hypercalcemia), loop diuretics (used to treat high blood pressure and edema), and other medicines that lower calcium levels, as taking them together with bisphosphonates can cause excessively low calcium levels in the blood;
• thalidomide (used to treat certain blood cancers with bone involvement) or other medicines that can harm the kidneys;
• Aclasta (a medicine that also contains zoledronic acid, used to treat osteoporosis and other non-cancerous bone diseases) or other bisphosphonates, as the combined effects of these medicines taken with Zomikos are not known;
• anti-angiogenic medicines (used to treat cancer), as taking them together with zoledronic acid has been associated with an increased risk of jawbone necrosis (ONJ).

Pregnancy and breastfeeding

Zomikos should not be used during pregnancy. Tell your doctor if you are pregnant or think you may be pregnant.
Zomikos should not be used during breastfeeding.
Before taking any medicine, consult your doctor if you are pregnant or breastfeeding.

Driving and using machines

Very rare cases of drowsiness have been reported with zoledronic acid. Therefore, be cautious when driving, operating machinery, and performing other activities that require focused attention.

Zomikos contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per 5 ml of concentrate, which means it is essentially 'sodium-free'. If your doctor uses 0.9% w/v sodium chloride solution to dilute Zomikos, the resulting sodium dose will be higher.

3. How to use Zomikos

• Zomikos should only be administered by healthcare professionals with experience in the intravenous administration of bisphosphonates.
• Your doctor will advise you to drink plenty of water before each administration of Zomikos to prevent dehydration.
• Follow all other instructions from your doctor, pharmacist, or nurse.

What dose of Zomikos is used

The single dose of Zomikos is 4 mg. If you have kidney problems, your doctor will give you a lower dose of Zomikos, depending on the severity of your kidney disease.

How often is Zomikos used

In the prevention of bone complications caused by bone metastases, one infusion of Zomikos is given every 3 to 4 weeks.
In the treatment of hypercalcemia of malignancy, Zomikos is usually given as a single infusion.

How Zomikos is used

Zomikos is given as an intravenous infusion. The infusion should last at least 15 minutes and should be given as a separate intravenous infusion through a separate infusion line.
Patient with calcium levels in the blood that are not too high will be prescribed calcium and vitamin D to take every day.

Using a higher dose of Zomikos than recommended

Patient who have received higher doses of Zomikos than recommended should be closely monitored. This is necessary due to the risk of abnormal electrolyte levels in the blood (e.g., calcium, phosphorus, and magnesium) and/or changes in kidney function, including severe kidney problems. Patients with low calcium levels may require a calcium infusion.

4. Possible side effects

Like all medicines, Zomikos can cause side effects, although not everybody gets them.
The most common ones are usually mild and will probably disappear within a short time.

Tell your doctor immediately if you experience any of the following side effects:

Common (may affect up to 1 in 10 people):
severe kidney problems (usually detected by your doctor through specific blood tests);
low calcium levels in the blood.
Uncommon (may affect up to 1 in 100 people):
mouth pain, toothache, and/or jaw pain, swelling or non-healing ulcers in the mouth or jaw, discharge, numbness or a feeling of heaviness in the jaw, or loosening of teeth. These may be symptoms of jawbone damage (necrosis).
If you experience any of these symptoms, tell your doctor or dentist immediately during or after treatment with Zomikos;
in patients with postmenopausal osteoporosis treated with zoledronic acid, irregular heartbeats (atrial fibrillation) have been observed. It is not known whether zoledronic acid causes irregular heartbeats, but you should tell your doctor if you experience any such symptoms after taking zoledronic acid;
severe allergic reactions: shortness of breath, swelling mainly of the face and throat.
Rare (may affect up to 1 in 1,000 people):
as a result of low calcium levels: irregular heartbeats (arrhythmias; secondary to hypocalcemia);
kidney problems called Fanconi syndrome (confirmed by your doctor after performing specific urine tests).
Very rare (may affect up to 1 in 10,000 people):
as a result of low calcium levels: seizures, numbness, and muscle spasms (tetany; secondary to hypocalcemia);
if you experience ear pain, ear discharge, and/or ear infection, tell your doctor. These may be symptoms of bone damage in the ear;
very rarely, necrosis of bones other than the jaw, especially the hip and thigh, has been observed. Tell your doctor immediately if you experience symptoms such as pain, pain, or stiffness during or after treatment with Zomikos.
Unknown (frequency cannot be estimated from the available data):
kidney inflammation (interstitial nephritis): symptoms may include decreased urine output, blood in the urine, nausea, general feeling of being unwell.
Tell your doctor immediately if you experience any of the following side effects:
Very common (may affect more than 1 in 10 people):
low phosphate levels in the blood.
Common (may affect up to 1 in 10 people):
headache and flu-like symptoms including fever, fatigue, weakness, sleepiness, chills, and pain in the bones, joints, and/or muscles. In most cases, no special treatment is needed, and the symptoms will disappear within a short time (a few hours or days);
gastrointestinal symptoms such as nausea and vomiting and loss of appetite;
conjunctivitis;
low red blood cell count (anemia).
Uncommon (may affect up to 1 in 100 people):
allergic reactions;
low blood pressure;
chest pain;
skin reactions (redness and swelling) at the injection site, rash, itching;
high blood pressure, shortness of breath, dizziness, anxiety, sleep disturbances, taste disturbances, tremors, numbness, and tingling of hands or feet, diarrhea, constipation, abdominal pain, dry mouth;
low white blood cell and platelet count;
low magnesium and potassium levels in the blood. Your doctor will monitor this and perform any necessary tests;
weight gain;
increased sweating;
drowsiness;
blurred vision, tearing, sensitivity to light;
sudden feeling of cold with fainting, weakness, or collapse;
breathing difficulties, with wheezing and coughing;
hives.
Rare (may affect up to 1 in 1,000 people):
slow heart rate;
confusion;
in rare cases, atypical fractures of the thigh bone, especially in patients treated long-term for osteoporosis. Tell your doctor if you experience pain, weakness, or discomfort in the thigh, hip, or groin, as this may indicate a higher risk of a thigh bone fracture;
interstitial lung disease (inflammation of the tissue surrounding the air sacs in the lungs);
flu-like symptoms, including joint and muscle pain;
painful redness and/or swelling of the eye.
Very rare (may affect up to 1 in 10,000 people):
fainting due to low blood pressure;
severe pain in the bones, joints, and/or muscles, sometimes causing immobilization.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 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.

5. How to store Zomikos

Your doctor, nurse, or pharmacist is informed about how to store Zomikos.
Store in a place out of sight and reach of children.
Do not freeze.
Do not use this medicine after the expiry date stated on the carton after EXP. The expiry date refers to the last day of that month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Zomikos contains

The active substance in Zomikos is zoledronic acid. One vial of 5 ml concentrate contains 4 mg of zoledronic acid, equivalent to 4.264 mg of zoledronic acid monohydrate.
The other ingredients are mannitol, sodium citrate, water for injections.

What Zomikos looks like and contents of the pack

Zomikos is a liquid concentrate in a vial. One vial contains 4 mg of zoledronic acid.
Each pack contains one vial of concentrate. Zomikos is available in packs containing 1, 4, or 10 vials in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Vipharm S.A., ul. A. i F. Radziwiłłów 9, 05-850 Ożarów Mazowiecki, Poland, e-mail: vipharm@vipharm.com.pl, tel.: (+48 22) 679 51 35

This medicinal product has been authorized in the EEA Member States under the following names:

Czech Republic:
Zomikos 4mg/5ml
Germany:
Zoledronsäure Vipharm 4mg/5ml Konzentrat zur Herstellung einer Infusionslösung
Poland:
Zomikos
Slovakia:
Zomikos 4mg/5ml
Hungary:
Zoledronsav Vipharm 4mg/5ml koncentrátum oldatos infúzióhoz
Date of last revision of the leaflet:21.11.2024

INFORMATION FOR MEDICAL STAFF

Preparation and administration of Zomikos

To prepare a solution for infusion containing 4 mg of zoledronic acid, the Zomikos concentrate (5.0 ml) should be diluted in 100 ml of infusion solution without calcium or other solutions without divalent cations.
If a lower dose is required, the appropriate volume of Zomikos should be withdrawn as described below and then diluted in 100 ml of infusion solution. To avoid potential incompatibilities, only 0.9% w/v sodium chloride solution or 5% w/v glucose solution should be used for dilution.

Zomikos solution should not be mixed with solutions containing calcium or other divalent cations, such as Ringer's solution with lactate.

Instructions for preparing reduced doses of Zomikos:
Withdraw the appropriate volume of concentrate, according to the prescribed dose:
4.4 ml for a dose of 3.5 mg
4.1 ml for a dose of 3.3 mg
3.8 ml for a dose of 3.0 mg.
For single use only. Any unused solution should be discarded.
Only clear solutions without particles or discoloration should be used.
During preparation of the infusion, aseptic techniques should be followed. From a microbiological point of view, the diluted infusion solution should be used immediately. If the product is not used immediately, the responsibility for the storage time and conditions before use lies with the user, and the solution is stable for no longer than 24 hours at 2°C – 8°C. Before administration, the refrigerated solution should be allowed to reach room temperature.
Zoledronic acid solution is administered by intravenous infusion over 15 minutes through a separate infusion line.
The patient's hydration status should be assessed before each administration of Zomikos to ensure adequate hydration.
No incompatibilities have been observed between Zomikos and various infusion sets used in the study, made of polyvinyl chloride, polyethylene, and polypropylene.
As there are no data on the compatibility of Zomikos with other intravenously administered drugs, Zomikos should not be mixed with other drugs. The Zomikos solution should always be administered through a separate infusion line.

Storage of Zomikos

• Store in a place inaccessible to children.
• Do not use Zomikos after the expiry date stated on the packaging.
• No special precautions for storage of unopened vials.
• The diluted Zomikos solution should be used immediately to avoid microbial contamination.