4 mg/5 ml concentrate for infusion liquid, solution
Zoledronic acid
What Zoledronic acid Mylan is and what it is used for
The active substance in Zoledronic acid Mylan 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 receive Zoledronic acid Mylan
Carefully follow the instructions given to you by your doctor.
Your doctor will take blood tests before you start treatment with Zoledronic acid Mylan and will regularly monitor how you respond to treatment.
You should not receive Zoledronic acid Mylan:
- 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 Mylan:
- 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 Mylan.
- if you are undergoing dental treatment or are going to undergo dental surgery, tell your dentist that you are being treated with Zoledronic acid Mylan and inform your doctor about your dental treatment.
While you are being treated with Zoledronic acid Mylan, 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. 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 pre-existing hypocalcemia, it must be corrected before starting the first dose of zoledronic acid. You will be given adequate supplements of calcium and vitamin D.
Patients who are 65 years of age and older
Zoledronic acid Mylan 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 Mylan is not recommended for use in adolescents and children under 18 years of age.
Other medicines and Zoledronic acid Mylan
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 infertility 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 Mylan 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 Mylan if you are pregnant. Inform your doctor if you are or think you may become pregnant.
You must not be treated with Zoledronic acid Mylan if you are breastfeeding.
Consult a doctor or pharmacist 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 Mylan contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per vial, i.e. it is almost ‘sodium-free’.
How Zoledronic acid Mylan is used
- Zoledronic acid Mylan 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.
The recommended dose of Zoledronic acid Mylan?
- The recommended single dose is 4 mg of zoledronic acid.
- 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 Mylan?
- 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 Mylan 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 Mylan.
How is Zoledronic acid Mylan given?
- Zoledronic acid Mylan 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 Mylan
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 (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 you are being treated with Zoledronic acid Mylan 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 ( occurs in 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 treatment with Zoledronic acid Mylan or after stopping treatment.
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 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 (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 Mylan
Your doctor, pharmacist, or nurse knows how to store Zoledronic acid Mylan correctly (see section 6).
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 sodium citrate, sodium hydroxide, hydrochloric acid, and water for injection.
Appearance and package sizes of the medicine
Zoledronic acid Mylan is supplied as a clear, colored concentrate for infusion, solution.
The concentrate is supplied in a colored glass vial closed with a bromobutyl stopper and an aluminum cap with a plastic component for opening.
One vial contains 5 ml of concentrate.
Zoledronic acid Mylan is supplied in packs containing 1, 4, or 10 vials or as a multipack containing 4 packs containing 1 vial each.
Not all pack sizes may be marketed
Marketing Authorisation Holder
Mylan Pharmaceuticals Limited
Damastown Industrial Park,
Mulhuddart, Dublin 15,
DUBLIN
Ireland
Manufacturer
Hikma Farmacêutica SA
Estrada do Rio da Mó, nº 8, 8-A e 8-B
Fervença, Terrugem SNT, 2705-906
Portugal
VIATRIS SANTE
1 Rue de Turin,
69007 Lyon
France
STERISCIENCE Sp. z o. o
ul. Daniszewska 10
03-230 Warsaw
Poland