4 mg/5 ml concentrate for infusion solution, solution
zoledronic acid
What Zoledronic acid Actavis is and what it is used for
The active substance in Zoledronic acid Actavis 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 in adult patients 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 use Zoledronic acid Actavis
Carefully follow the instructions given to you by your doctor.
Your doctor will take blood tests before you start treatment with Zoledronic acid Actavis and will regularly monitor how you respond to treatment.
You should not receive Zoledronic acid Actavis:
- if you are allergic (hypersensitive) to zoledronic acid, other bisphosphonates (the group of substances to which Zoledronic acid Actavis belongs), or any other ingredient in this medicine (listed in section 6).
- if you are breastfeeding.
Warnings and precautions
Talk to your doctor before receiving Zoledronic acid Actavis:
- if you or have had any kidney problems.
- 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 Actavis.
- if you are undergoing dental treatment or are going to undergo dental surgery, tell your dentist that you are being treated with Zoledronic acid Actavis and inform your doctor about your dental treatment.
While you are being treated with Zoledronic acid Actavis, 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 levels of calcium 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 Actavis. 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 Actavis. You will be given adequate supplements of calcium and vitamin D.
Patients who are 65 years of age and older
Zoledronic acid Actavis 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 Actavis is not recommended for use in adolescents and children under 18 years of age.
Other medicines and Zoledronic acid Actavis
Tell your doctor if you are taking, have recently taken, or might take any other medicines. 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 involving bone tissue) or any other medicine that can damage the kidneys.
- Other medicines containing zoledronic acid 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 Actavis 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 Actavis if you are pregnant. Inform your doctor if you think you are pregnant.
You must not be treated with Zoledronic acid Actavis if you are breastfeeding.
Consult a doctor before taking any medicine during the period that 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 Actavis 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 Actavis is used
- Zoledronic acid Actavis 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 Actavis 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 Actavis?
- 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 Actavis every three to four weeks.
- If you are being treated to reduce the amount of calcium in your blood, you will normally only receive one infusion of Zoledronic acid Actavis.
How is Zoledronic acid Actavis given?
- Zoledronic acid Actavis 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 Actavis
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 level of calcium is 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 (may affect up to 1 in 10 users):
- Severe kidney impairment (normally determined by your doctor using some specific blood tests).
- Low levels of calcium in the blood.
Uncommon (may affect up to 1 in 100 users):
- 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 you are being treated with Zoledronic acid Actavis 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 (may affect up to 1 in 1,000 users):
- 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 (may affect up to 1 in 10,000 users):
- 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 treatment with Zoledronic acid Actavis or after stopping treatment.
Tell your doctor as soon as possible if you experience any of the following side effects:
Very common (may affect more than 1 in 10 users):
- Low level of phosphate in the blood.
Common (may affect up to 1 in 10 users):
- Headache and a flu-like condition consisting of fever, fatigue, weakness, drowsiness, chills, and aches in bones, joints, and/or muscles. 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.
- Inflammation in the conjunctiva of the eye.
- Low level of red blood cells ( anemia ).
Uncommon (may affect up to 1 in 100 users):
- 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 (may affect up to 1 in 1,000 users):
- 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 including arthritis and joint swelling
- Painful red and/or swollen eyes.
Very rare (may affect up to 1 in 10,000 users):
- 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 Actavis
Your doctor, pharmacist, or nurse knows how to store Zoledronic acid Actavis correctly.
Contents of the packaging and other information
Contents declaration
- The active substance is zoledronic acid. One vial contains 4 mg of zoledronic acid (as a monohydrate).
- Other ingredients are mannitol, sodium citrate, and water for injection.
Appearance and package sizes of the medicine
Zoledronic acid Actavis is supplied as a clear, colorless concentrate for infusion, solution (sterile concentrate) in a plastic vial. One vial contains 5 ml of solution.
Zoledronic acid Actavis is supplied in packs containing 1, 4, or 10 vials.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Actavis Group PTC EHF.
Reykjavíkkurvegur 76 78
220 Hafnarfjordur
Iceland
Manufacturer
Actavis Italy SpA
Via Pasteur, 10
20014 Nerviano (MI)
Italy
Contact the representative of the Marketing Authorization Holder if you would like to know more about this medicine:
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