1. WHAT ACLASTA IS AND WHAT IT IS USED FOR
Aclasta is given as a single infusion (slow injection into a vein) into a vein by a doctor or nurse. It belongs to a group of medicines called bisphosphonates and is used to treat post-menopausal women and men with osteoporosis or osteoporosis caused by treatment with steroids, and Paget's disease of the bone.
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, Aclasta strengthens the bone and therefore makes it less likely to break. Because Aclasta works for a long time, you will not need another dose of Aclasta for a year.
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. Aclasta works by returning the bone remodelling process to normal, securing formation of normal bone, thus restoring strength to the bone.
2. BEFORE YOU ARE GIVEN ACLASTA
Follow all instructions given to you by your doctor carefully before you are given Aclasta.
You should not be given Aclasta
- if you are allergic (hypersensitive) to zoledronic acid, other bisphosphonates or any of the other ingredients of Aclasta.
- if you have hypocalcaemia (this means that the levels of calcium in your blood are too low).
- if you are pregnant or plan to become pregnant.
- if you are breast-feeding.
Take special care with Aclasta
Tell your doctor before you are given Aclasta:
- if you are being treated with Zometa, which contains the same active substance as Aclasta
- if you have a kidney problem, or used to have one.
- if you are unable to take daily calcium supplements.
- if you have had some or all of the parathyroid glands in your neck surgically removed.
- if you have had sections of your intestine removed.
Before you receive treatment with Aclasta, tell your doctor if you have (or have had) pain, swelling or numbness in your gums, jaw or both, if your jaw feels heavy, or if you have lost a tooth. Before you receive dental treatment or undergo dental surgery, tell your dentist you are receiving treatment with Aclasta.
Aclasta is not recommended for anyone under 18 years of age. The use of Aclasta in children and adolescents has not been studied.
Taking other medicines
Please tell your doctor, pharmacist or nurse if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. It is especially important for your doctor to know if you are taking any medicines known to be harmful to your kidneys.
Using Aclasta with food and drink
Make sure you drink enough fluids (at least one or two glasses) before and after the treatment with Aclasta, as directed by your doctor. This will help to prevent dehydration. You may eat normally on the day you are treated with Aclasta.
Elderly patients (age 65 years and over)
Aclasta can be given to older patients.
Pregnancy and breast-feeding
You should not be given Aclasta if you are pregnant or plan to become pregnant.
You should not be given Aclasta if you are breast-feeding.
Ask your doctor, pharmacist or nurse for advice before taking any medicine.
Driving and using machines
If you feel dizzy while taking Aclasta, do not drive or use machines until you feel better.
3. HOW ACLASTA IS GIVEN
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 Aclasta is administered two or more weeks after your hip repair surgery.
Follow carefully all instructions given to you by your doctor or nurse.
It is important to take calcium and vitamin D supplements (for example tablets) as directed by your doctor.
For osteoporosis, Aclasta works for one year and you will need the next dose after one year.
Paget's disease
The usual dose is 5 mg, given to you as one single infusion into a vein by your doctor or nurse. The infusion will take at least 15 minutes. As Aclasta works for a long time, you may not need another dose of Aclasta for a year or longer.
Follow carefully all instructions given to you by your doctor or nurse.
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 Aclasta. 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.
For Paget's disease Aclasta may work for longer than one year, and your doctor will let you know if you need to be treated again.
If a dose of Aclasta is missed
Contact your doctor or hospital as soon as possible to re-schedule your appointment.
Before stopping Aclasta therapy
If you are considering stopping Aclasta treatment, please go to your next appointment and discuss this with your doctor. Your doctor will advise you and decide how long you should be treated with Aclasta.
If you have any questions on the use of this product, ask your doctor, pharmacist or nurse.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Aclasta can cause side effects, although not everybody gets them. In most cases, no specific treatment is required.
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 Aclasta. 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 Aclasta.
Very common side effects (affecting 10 or more in every 100 patients):
Fever
Common side effects (affecting less than 10 in every 100 patients):
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.
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.
Irregular heart rhythm (atrial fibrillation) has been seen in patients receiving Aclasta for postmenopausal osteoporosis. It is currently unclear whether Aclasta causes this irregular heart rhythm but you should report it to your doctor if you experience such symptoms after you have received Aclasta.
Uncommon side effects (affecting less than 1 in every 100 patients):
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.
Skin reactions such as redness, swelling and/or pain at the infusion site may occur. Toothache and taste disturbances may also occur.
Bisphosphonates (the group of substances Aclasta belongs to) may cause swelling, redness, pain and itching of the eyes or eye sensitivity to light.
Persistent pain and/or non-healing sores of the mouth or jaw have been reported primarily in patients treated with bisphosphonates for other illnesses. If you experience these symptoms, tell your doctor or dentist.
Allergic reactions have been reported including rare cases of difficulty breathing, hives and angioedema (such as swollen face, tongue or throat). There have been isolated reports of very serious allergic reactions.
If you notice any of these side effects, tell your doctor.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, pharmacist or nurse.
