Zoledronic Acid Teva – Zoledronic acid uses, dose and side effects


4 mg/5 ml concentrate for infusion solution,
zoledronic acid solution

What Zoledronic Acid Teva is and what it is used for

The active substance in Zoledronic Acid Teva is zoledronic acid which belongs to a group of substances called bisphosphonates. Zoledronic acid works by binding to bone tissue and reducing the rate of bone turnover. It is used for:

  • To prevent bone complications, e.g. fractures, in adult patients with bone metastases (cancer that has spread from the primary cancer site to bone tissue).
  • To reduce the amount of calcium in the blood of adult patients in cases when this is too high due to a tumor. Tumors can accelerate the normal rate of bone turnover in such a way that the release of calcium from the bone tissue increases. This condition is called tumor-induced hypercalcemia (TIH).

What you need to know before you receive Zoledronic Acid Teva

Carefully follow the instructions given to you by your doctor.

Your doctor will take blood tests before you start treatment with Zoledronic Acid Teva and will regularly monitor your response to treatment.

You should not receive Zoledronic Acid Teva:

  • if you are breastfeeding.
  • if you are allergic to zoledronic acid, other bisphosphonates (the group of substances to which zoledronic acid belongs), or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor before receiving Zoledronic Acid Teva:

  • if you have or have had any kidney disease.
  • if you or have had pain, swelling, or numbness in the jaw, a feeling of “heavy jaw” or that a tooth has become loose. Your doctor may recommend that you undergo a dental examination before starting treatment with Zoledronic Acid Teva.
  • if you are undergoing dental treatment or are going to undergo dental surgery, inform your dentist that you are being treated with Zoledronic Acid Teva and inform your doctor about your dental treatment.

While you are being treated with Zoledronic Acid Teva, you should maintain good oral hygiene (including regular tooth brushing) and have regular dental check-ups.

Contact your doctor and dentist immediately if you experience any problems with your mouth or teeth such as loose teeth, pain or swelling, or sores that do not heal or drain, as these may be signs of a condition called osteonecrosis of the jaw.

Patients who are undergoing chemotherapy and/or radiation therapy, who are taking steroids, who are undergoing dental surgery, who do not receive regular dental care, who have gum problems, who are smokers, or who have previously been treated with a bisphosphonate (used to treat or prevent bone disease) may have a higher risk of developing osteonecrosis of the jaw.

Decreased calcium levels in the blood (hypocalcemia) which can sometimes lead to muscle cramps, dry skin, and a burning sensation have been reported in patients treated with Zoledronic Acid Teva. Irregular heart rhythm ( cardiac arrhythmia ), convulsions, spasms, and twitching ( tetany ) have been reported as a result of severe hypocalcemia. In some cases, hypocalcemia can be life-threatening. If any of these occur, talk to your doctor immediately. If you have existing hypocalcemia, it must be corrected before starting the first dose of Zoledronic Acid Teva. You will be given adequate calcium and vitamin supplements.

Patients who are 65 years of age and older

Zoledronic Acid Teva can be given to people aged 65 and over. There is nothing to suggest that any extra precautions would be necessary.

Children and young people

Zoledronic Acid Teva is not recommended for use in adolescents and children under 18 years of age.

Other medicines and Zoledronic Acid Teva

Tell your doctor if you are taking, have recently taken, or might be taking any other medicines, even those without a prescription. You must tell your doctor if you are also taking:

  • Aminoglycosides (medicines used to treat serious infections ), calcitonin (a type of medicine used to treat osteoporosis in postmenopausal women and hypercalcemia), loop diuretics (a type of medicine used to treat high blood pressure or swelling caused by fluid retention (edema) or other medicines that lower calcium levels, as these in combination with bisphosphonates can have the effect of lowering the calcium level in the blood to an excessively low level.
  • Thalidomide (a medicine used to treat a certain type of blood cancer that involves bone tissue) or any other medicine that can damage the kidneys.
  • Other medicines also contain zoledronic acid and are used to treat osteoporosis and other non-cancerous diseases of bone tissue, or any other bisphosphonate, as the effects of combining these medicines with Zoledronic Acid Teva are unknown.
  • Anti-angiogenic medicines (used to treat cancer), as combining these with zoledronic acid have been associated with an increased risk of bone damage ( osteonecrosis ) of the jaw (ONJ).

Pregnancy and breastfeeding

You should not be treated with Zoledronic Acid Teva if you are pregnant. Inform your doctor if you think you may be pregnant.

You must not be treated with Zoledronic Acid Teva if you are breastfeeding.

Consult a doctor before taking any medicine if you are pregnant or breastfeeding.

Driving ability and use of machinery

There have been very rare cases of lethargy and sleepiness associated with the use of zoledronic acid. You should therefore be careful when driving a car, using machines, or performing other activities that require your full concentration.

Zoledronic Acid Teva contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per vial, i.e. it is almost “sodium-free”.

How Zoledronic Acid Teva is used

  • Zoledronic acid should only be given by healthcare professionals who have experience in administering bisphosphonates intravenously, i.e. through a vein.
  • Your doctor will recommend that you drink enough water before each treatment to help prevent dehydration.
  • Follow all other instructions from your doctor, pharmacist, or nurse carefully.

What dose of Zoledronic Acid Teva is given?

  • The single dose that is usually given is 4 mg.
  • If you have impaired kidney function, your doctor will give you a lower dose, which depends on the severity of your kidney problems.

How often will you be treated with Zoledronic Acid Teva?

  • If you are being treated for the prevention of bone tissue complications due to metastases in the bone tissue, you will receive an infusion of Zoledronic Acid Teva every three to four weeks.
  • If you are being treated to reduce the amount of calcium in your blood, you will normally only receive a single infusion of Zoledronic Acid Teva.

How is Zoledronic Acid Teva given?

  • Zoledronic Acid Teva is given as a drip ( infusion ) into a vein over at least 15 minutes and must be given intravenously as a separate infusion in a special infusion tube.

Patients who do not have too much calcium in their blood will also receive a prescription for calcium and vitamin D supplements, which must be taken daily.

If you have been given too much Zoledronic Acid Teva

If you have received doses higher than those recommended, you must be carefully examined by your doctor. This is because you may have abnormal amounts of electrolytes in your blood (eg abnormal amounts of calcium, phosphorus, and magnesium ) and/or changes in kidney function, including severely impaired kidney function. If your calcium level becomes too low, you may need to receive additional calcium by infusion.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The most common of these are usually mild and will most likely disappear after a short time.

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

Common (affects up to 1 in 10 patients):

  • Severe kidney impairment (normally determined by your doctor using some specific blood tests).
  • Low levels of calcium in the blood.

Uncommon (affects up to 1 in 100 patients):

  • Pain in the mouth, teeth, and/or jaw, swelling or sores that do not heal on the inside of the mouth or jaw, warts, numbness, or a feeling of the heavy jaw or tooth loss. These may be signs of bone damage in the jaw ( osteonecrosis ). Tell your doctor and dentist immediately if you experience such symptoms while being treated with Zoledronic Acid Teva or after stopping treatment.
  • Irregular heart rhythm ( atrial fibrillation ) has been observed in patients receiving zoledronic acid for postmenopausal osteoporosis. It is currently unclear whether zoledronic acid causes this irregular heart rhythm but you should report it to your doctor if you experience such symptoms after receiving zoledronic acid.
  • Severe allergic reaction: shortness of breath, swelling mainly of the face and throat.

Rare (affects up to 1 in 1,000 patients):

  • As a result of low calcium levels: irregular heart rhythm (cardiac arrhythmia; as a result of hypocalcemia ).
  • A kidney function disorder called Fanconi syndrome (normally diagnosed by your doctor with urine samples).

Very rare (affects up to 1 in 10,000 patients):

  • As a result of low calcium levels: convulsions, numbness, and twitching (as a result of hypocalcemia).
  • Talk to your doctor if you have ear pain, discharge from the ear, and/or an ear infection. This could be a sign of a bone injury in the ear.
  • Osteonecrosis has, in very rare cases, also been observed in bones other than the jaw, especially in the hip or thigh. Tell your doctor immediately if you experience symptoms such as new or worsening aches, pains, or stiffness during or after treatment with Zoledronic Acid Teva.

Tell your doctor as soon as possible if you experience any of the following side effects:

Very common (affects more than 1 in 10 patients):

  • Low level of phosphate in the blood.

Common (affects up to 1 in 10 patients):

  • Headache and a flu-like condition consisting of fever, fatigue, weakness, drowsiness, chills, and bone, joint, and/or muscle aches. In most cases, no treatment is required and the symptoms disappear after a short time (a few hours or days).
  • Reactions from the gastrointestinal tract, e.g. nausea and vomiting, as well as loss of appetite.
  • Low level of red blood cells ( anemia ).
  • Inflammation in the conjunctiva of the eye.

Uncommon (affects up to 1 in 100 patients):

  • Hypersensitivity reaction.
  • Low blood pressure.
  • Chest pain.
  • Skin reactions ( redness and swelling) at the infusion site, rash, itching.
  • High blood pressure, shortness of breath, dizziness, anxiety, sleep disturbances, changes in taste, tremors, tingling or numbness in the hands and feet, diarrhea, constipation, stomach pain, and dry mouth.
  • A low number of white blood cells and platelets.
  • The low blood level of magnesium and potassium. Your doctor will check this and take the necessary measures.
  •     Weight gain.
  •     Increased sweating.
  • Somnolence.
  • Blurred vision, watery eyes, eye sensitivity to light.
  • A sudden feeling of coldness with fainting, weakness, or collapse.
  • Difficulty breathing with wheezing or coughing.
  • Hives.

Rare (affects up to 1 in 1,000 patients):

  • Slow pulse.
  • Confusion.
  • Unusual femur fractures, especially in patients receiving long-term treatment for osteoporosis, may occur in rare cases. Contact your doctor if you experience pain, weakness, or discomfort in the thigh, hip, or groin as this may be an early sign of a possible femur fracture.
  • Interstitial lung disease ( inflammation of the tissue around the alveoli).
  •    Flu-like symptoms include arthritis and joint swelling.
  •    Painful red and/or swollen eyes.

Very rare (affects up to 1 in 10,000 patients):

  • Fainting due to low blood pressure.
  • Severe pain in bones, joints, and/or muscles, which in some cases can be disabling.

How to store Zoledronic Acid Teva

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

Use before the expiry date which is stated on the carton and vial label after EXP. The expiration date is the last day of the specified month.

This medicine does not require any special storage instructions.

After dilution, the diluted infusion solution should be used immediately. If use is not immediate, storage times and storage conditions before administration are the responsibility of the user. The total time between dilution, storage in a refrigerator at 2°C-8°C, and completion of administration should not exceed 24 hours.

Do not use this medicine if you see any particles or discoloration in the solution.

Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.

Contents of the packaging and other information

Contents declaration

  • The active substance is zoledronic acid. One vial contains 4 mg zoledronic acid, (as monohydrate)
  • Other ingredients are mannitol, sodium citrate, and water for injections.

Appearance and package sizes of the medicine

Zoledronic Acid Teva is supplied as a concentrate (solution) for infusion. Each plastic or clear glass vial contains 5 ml of a clear, colorless concentrate.

Zoledronic Acid Teva is supplied in packs of 1, 4, or 10 vials.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing Authorisation Holder

Teva BV

Swensweg 5

2031 GA Haarlem



Pharmachemie BV

Swensweg 5

2031 GA Haarlem


PLIVA Croatia Ltd

Prilaz baruna Filipovića 25

10,000 Zagreb


Contact the representative of the Marketing Authorization Holder if you would like to know more about this medicine:

België/Belgique/BelgienTeva Pharma Belgium NV/SA/AGTel/Tel: +32 38207373LithuaniaUAB Teva BalticsPhone: +370 52660203
BulgariaTeva Pharma EADPhone: +359 24899585Luxembourg/LuxembourgTeva Pharma Belgium NV/SA/AGBelgique/BelgiumTel/Tel: +32 38207373
Czech RepublicTeva Pharmaceuticals CR, Serophene: +420 251007111MagyarországTeva Gyógyszergyár Zrt.Phone: +36 12886400
DenmarkTeva Denmark A/SPhone: +45 44985511MaltaTeva Pharmaceuticals Ireland- IrelandPhone: +44 2075407117
DeutschlandTEVA GmbHPhone: +49 73140208The NetherlandsTeva Netherlands BVPhone: +31 8000228400
EstoniaUAB Teva Baltic’s Estonian branch phone: +372 6610801NorwayTeva Norway iPhone: +47 66775590
GreeceSpecify ABEEPhone: +30 2118805000Austriaratiopharm Arzneimittel Vertriebs-GmbHPhone: +43 1970070
SpainTeva Pharma, SLUPhone: +34 913873280PolishTeva Pharmaceuticals Polska Sp. z o. iPhone: +48 223459300
FranceTeva HealthPhone: +33 155917800PortugalTeva Pharma – Produtos Farmacêuticos, Lda.Phone: +351 214767550
HrvatskaPliva Hrvatska dooPhone: +385 13720000RomaniaTeva Pharmaceuticals SRLPhone: +40 212306524
IrelandTeva Pharmaceuticals IrelandPhone: +44 2075407117SlovenijaPliva Ljubljana dooPhone: +386 15890390
IcelandTeva Pharma Iceland Ehf.Phone: +354 5503300Slovenian RepublicTEVA Pharmaceuticals Slovakia s.r.oPhone: +421 257267911
ItalyTeva Italia SrlPhone: +39 028917981Finland/FinlandTeva Finland OyPhone/Tel: +358 201805900
CyprusSpecify ABEEGreecePhone: +30 2118805000SwedenTeva Sweden ABPhone: +46 42121100
LatviaUAB Teva Baltic branch in LatviaPhone: +371 67323666United Kingdom (Northern Ireland)Teva Pharmaceuticals IrelandIrelandPhone: +44 2075407117

Leave a Reply