Zoledronic acid 5 mg solution for infusion

zoledronic acid

Zoledronic acid 5 mg contains the active substance zoledronic acid. It belongs to a group of medicines called bisphosphonates and is used to treat:

• post-menopausal women and adult men with osteoporosis or osteoporosis caused by treatment with corticosteroids used to treat inflammation
• Paget’s disease of the bone in adults.

Osteoporosis

Osteoporosis is a disease that involves the thinning and weakening of the bones and is common in women after the menopause, but can also occur in men. At the menopause, a woman’s ovaries stop producing the female hormone oestrogen, which helps keep bones healthy. Following the menopause bone loss occurs; bones become weaker and break more easily. Osteoporosis could also occur in men and women because of the long term use of steroids, which can affect the strength of bones. Many patients with osteoporosis have no symptoms but they are still at risk of breaking bones because osteoporosis has made their bones weaker. Decreased circulating levels of sex hormones, mainly oestrogens converted from androgens, also play a role in the more gradual bone loss observed in men. In both women and men, Zoledronic acid 5 mg strengthens the bone and therefore makes it less likely to break. Zoledronic acid 5 mg is also used in patients who have recently broken their hip in a minor trauma such as a fall and therefore are at risk of subsequent bone breaks.

Paget’s disease of the bone

It is normal that old bone is removed and is replaced with new bone material. This process is called remodelling. In Paget’s disease, bone remodelling is too rapid and new bone is formed in a disordered fashion, which makes it weaker than normal. If the disease is not treated, bones may become deformed and painful, and may break. Zoledronic acid 5 mg works by returning the bone remodelling process to normal, securing formation of normal bone, thus restoring strength to the bone.

Follow all instructions given to you by your doctor, pharmacist or nurse carefully before you are given Zoledronic acid 5 mg.

You must not be given Zoledronic acid 5 mg

• if you are allergic to zoledronic acid or any of the other ingredients of this medicine (listed in section 6), or to other bisphosphonates
• if you have hypocalcaemia (this means that the levels of calcium in your blood are too low)
• if you have severe kidney problems
• if you are pregnant
• if you are breast-feeding.

Follow carefully all instructions given to you by your doctor or nurse. Check with your doctor or nurse if you are not sure.

Osteoporosis

The usual dose is 5 mg given as one infusion per year into a vein by your doctor or nurse. The infusion will take at least 15 minutes.

In case you recently broke your hip, it is recommended that Zoledronic acid 5 mg is administered two or more weeks after your hip repair surgery.

It is important to take calcium and vitamin D supplements (for example tablets) as directed by your doctor.

For osteoporosis, Zoledronic acid 5 mg works for one year. Your doctor will let you know when to return for your next dose.

Paget’s disease

For the treatment of Paget’s disease, Zoledronic acid 5 mg should be prescribed only by physicians with experience in the treatment of Paget’s disease of the bone.

The usual dose is 5 mg, given to you as one initial infusion into a vein by your doctor or nurse. The infusion will take at least 15 minutes. Zoledronic acid 5 mg may work for longer than one year, and your doctor will let you know if you need to be treated again.

Your doctor may advise you to take calcium and vitamin D supplements (e.g. tablets) for at least the first ten days after being given Zoledronic acid 5 mg. It is important that you follow this advice carefully so that the level of calcium in your blood does not become too low in the period after the infusion. Your doctor will inform you regarding the symptoms associated with hypocalcaemia.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

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

Side effects related to the first infusion are very common (occurring in more than 30% of patients) but are less common following subsequent infusions. The majority of the side effects, such as fever and chills, pain in the muscles or joints, and headache, occur within the first three days following the dose of Zoledronic acid 5 mg. The symptoms are usually mild to moderate and go away within three days. Your doctor can recommend a mild pain reliever such as ibuprofen or paracetamol to reduce these side effects. The chance of experiencing these side effects decreases with subsequent doses of Zoledronic acid 5 mg.

Some side effects could be serious

Common (may affect up to 1 in 10 people)

Irregular heart rhythm (atrial fibrillation) has been seen in patients receiving Zoledronic acid 5 mg for post-menopausal osteoporosis. It is currently unclear whether Zoledronic acid 5 mg causes this irregular heart rhythm but you should report it to your doctor if you experience such symptoms after you have received Zoledronic acid 5 mg.

Uncommon (may affect up to 1 in 100 people)

• swelling, redness, pain and itching to the eyes or eye sensitivity to light.

Very rare (may affect up to 1 in 10,000 people)

• talk to your doctor if you have ear pain, discharge from the ear, and/or an ear infection. These could be signs of bone damage in the ear.

Not known (frequency cannot be estimated from the available data)

• pain in the mouth and/or jaw
• swelling or non-healing sores in the mouth or jaw
• discharge
• numbness or a feeling of heaviness in the jaw, or loosening of a tooth.

These could 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 5 mg or after stopping treatment.

Kidney disorders (e.g. decreased urine output) may occur. Your doctor should do a blood test to check your kidney function before each dose of Zoledronic acid 5 mg. It is important for you to drink at least 2 glasses of fluid (such as water), within a few hours before receiving Zoledronic acid 5 mg, as directed by your healthcare provider.

If you experience any of the above side effects, you should contact your doctor immediately.

Zoledronic acid 5 mg may also cause other side effects

Very common (may affect more than 1 in 10 people)

• fever

Common (may affect up to 1 in 10 people)

• headache
• dizziness
• sickness
• vomiting
• diarrhoea
• pain in the muscles
• pain in the bones and/or joints
• pain in the back, arms or legs
• flu-like symptoms (e.g. tiredness, chills, joint and muscle pain)
• chills
• feeling of tiredness and lack of interest
• weakness
• pain
• feeling unwell
• swelling and/or pain at the infusion site.

In patients with Paget’s disease, symptoms due to low blood calcium, such as muscle spasms, or numbness, or a tingling sensation especially in the area around the mouth have been reported.

Uncommon (may affect up to 1 in 100 people)

• flu
• upper respiratory tract infections
• decreased red cell count
• loss of appetite
• sleeplessness
• sleepiness which may include reduced alertness and awareness
• tingling sensation or numbness
• extreme tiredness
• trembling
• temporary loss of consciousness
• eye infection or irritation or inflammation with pain and redness
• spinning sensation
• increased blood pressure
• flushing
• cough
• shortness of breath
• upset stomach
• abdominal pain
• constipation
• dry mouth
• heartburn
• skin rash
• excessive sweating
• itching
• skin reddening
• neck pain
• stiffness in muscles, bones and/or joints
• joint swelling
• muscle spasms
• shoulder pain
• pain in your chest muscles and rib cage
• joint inflammation
• muscular weakness
• abnormal kidney test results
• abnormal frequent urination
• swelling of hands, ankles or feet
• thirst
• toothache
• taste disturbances.

Rare (may affect up to 1 in 1,000 people)

• low levels of phosphate in the blood
• unusual fracture of the thigh bone particularly in patients on long-term treatment for osteoporosis may occur rarely.

Contact your doctor if you experience pain, weakness or discomfort in your thigh, hip or groin as this may be an early indication of a possible fracture of the thigh bone.

Not known (frequency cannot be estimated from the available data)

• severe allergic reactions including dizziness and difficulty breathing, swelling mainly of the face and throat
• decreased blood pressure
• dehydration secondary to acute phase reactions (post-dose symptoms such as fever, vomiting and diarrhoea).

Your doctor, pharmacist or nurse knows how to store Zoledronic acid 5 mg properly.

This medicine must be kept out of the sight and reach of children.

This medicine must not be used after the expiry date which is stated on the carton and vial after EXP. The expiry date refers to the last day of that month.

The unopened vial does not require any special storage conditions.

Chemical and physical in-use stability has been demonstrated for 24 hours at 2 to 8°C.

After opening the vial, the product should be used immediately in order to avoid microbial contamination. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2°C – 8°C. Allow the refrigerated solution to reach room temperature before administration.