|The name of the preparation
||Character; dose; package
||Price after refund
||In which pharmacy?
||solution for infusion;
0.05 mg / ml (5 mg / 100 ml);
Note: reimbursed drug prices are in line with the regulations in force from July 1, 2018.
The preparation contains the substance:zoledronic acid
Prescription drug for proprietary use
What is Aclasta?
A drug from the group of bisphosphonates that inhibits bone resorption, used to treat osteoporosis and other bone tissue diseases.
What does Aclasta contain and how does it work?
The active substance is zoledronic acid, nitrogen-containing organic compound from the group of bisphosphonates. Bisphosphonates are a group of medicines that prevent the loss of bone mass used in the treatment and prevention of bone diseases. Bisphosphonates include alendronate, etidronate, clodronate, ibandronic acid, zoledronic acid, pamidronate and risedronate.
Bone tissue is composed of cells and protein fibers and minerals of Calcium
and phosphorus, forming compounds called hydroxyapatites. Bones are subject to constant remodeling thanks to the action of osteoclasts and osteoblasts. Osteoclasts (osteoclastic cells) located in the bone marrow cause dissolution and resorption of bone tissue. In turn, osteoblasts (osteogenic cells) produce an organic part of the bone and are responsible for bone growth and remodeling. In healthy people, the activity of both these cell types is in equilibrium. In the case of some diseases, bone resorption processes may, however, prevail over the process of their construction, which results reduction of bone mass and an increased risk of fractures. Bisphosphonates, by joining with bone hydroxyapatites, build into the bone tissue, stabilize inorganic compounds contained in the bones and inhibit the activity of osteoclasts and accelerate the process of their cell death (apoptosis). This leads to a slower process of bone resorption and inhibition of bone mass loss and bone strength. In studies on the use of bisphosphonates in humans, it has been shown that they reduce the risk of bone fractures in patients with osteoporosis.
After intravenous administration, zoledronic acid is distributed to the bone, where it binds to hydroxyapatites. It is not metabolised, excreted unchanged in urine. In the case of renal failure, the rate of excretion can be significantly reduced. Very slowly released from the bone into the systemic circulation and eliminated by the kidneys.
When to use Aclasta?
The preparation is indicated for the treatment of osteoporosis:
· In women after menopause
· In men,
who have an increased risk of bone fractures, including those who have recently had a low-energy hip fracture.
The preparation is indicated for the treatment of osteoporosis associated with long-term systemic glucocorticoid therapy:
· In women after menopause
· In men,
who have an increased risk of bone fractures.
The preparation is indicated for the treatment of Paget's disease of bones in adults.
When not to use this preparation?
Unfortunately, even if there are indications to use the preparation, it can not always be used. You must not use the product if you are allergic (you are hypersensitive) to any of the ingredients or other bisphosphonate medicines.
Do not use in people:
· With hypocalcemia
· With severe renal impairment (creatinine clearance less than 35 ml / min).
Do not use in pregnant women or breast-feeding women.
Do not use in children.
Take special care with Aclasta?
Certain diseases and other circumstances may constitute a contraindication to use or indication to change the dosage of the preparation. In some situations it may be necessary to carry out specific check-ups.
In patients with severe renal impairment (creatinine clearance less than 35 ml / min), the use of the preparation is contraindicated. In this group of patients there is an increased risk of renal failure.
The use of the preparation may be associated with the occurrence of renal dysfunction. The increased risk applies to people:
· With previously diagnosed kidney problems
· In parallel with other nephrotoxic drugs
· Taking diuretics or dehydrated.
Renal dysfunction may occur after 1-fold and may occasionally lead to dialysis or be fatal.
To reduce the risk of kidney problems, your doctor will keep the following precautions:
· Each time, before administering the preparation, it calculates the creatinine clearance with regard to the actual body weight
· In patients at risk, may recommend monitoring blood creatinine
· Advise you to take appropriate precautions, as long as other preparations that may affect kidney function are used in parallel
· Recommend proper hydration before the treatment (proper hydration is particularly important in elderly patients and patients receiving diuretics)
· A single dose should not exceed 5 mg and the duration of the infusion should not be shorter than 15 minutes.
Before starting treatment, all calcium and mineral disorders (including vitamin D deficiency, hypoparathyroidism, calcium absorption disorders) should be corr
ected. If necessary, patients in this group should remain under clinical observation.
During the treatment period, bone, joint and / or muscle pain may occur at different times after its start, rarely severe, which may prevent movement. These symptoms usually disappear after discontinuation of the preparation but may recur after resumption of treatment with bisphosphonates.
A characteristic feature of Paget's disease is their quick reconstruction. Due to the rapid onset of zoledronic acid, transient hypocalcaemia (low blood calcium levels) may develop, sometimes symptomatic. The highest intensity of hypocalcaemia usually applies to the first 10 days after administration of the preparation. The most characteristic symptoms of hypocalcaemia are: neuromuscular hyperactivity (muscle cramps, numbness of the lips, laryngeal spasm, eyelid spasms, spasms of the finger vessels, convulsions), tetany, mental changes (depression, excitability, nervousness, coma), skin changes (eczema, fragility nails and hair). If you have any symptoms that may indicate hypocalcemia, you should immediately consult a doctor. It is recommended that people with Paget's disease take calcium supplements for at least 10 days after intravenous injection; dosage of calcium preparations will be recommended by a doctor. Before starting treatment, patients in this group should be tested for calcium levels in the blood.
During the period of application, it is recommended to take appropriate doses of calcium and vitamin D (dosing will be recommended by the attending physician).
The use of the preparation may be associated with the risk of osteonecrosis of the jaw. The risk depends on:
· Potency, dose and route of administration of the bisphosphonate group
· The occurrence of neoplastic disease, the use of radiotherapy, Chemotherapy
, and taking corticosteroid
· Smoking tobacco
· Oral and dental diseases, poor oral hygiene, invasive dental procedures, ill-fitting dentures, periodontal diseases.
Patients with poor dental condition before using the product should consult a dentist. The initiation of the preparation in patients with open lesions in oral soft tissues should be delayed.
During the treatment period, invasive dental procedures should be avoided, and if they are absolutely necessary, they should not be carried out within the time limit given for intravenous administration. Before the dental treatment or the necessary surgery of the maxillary surgery, the dentist should be informed about the use of a bisphosphonate drug.If there is osteonecrosis of the jaw, a dental procedure may worsen the existing condition.
During the period of treatment, care should be taken to ensure proper oral hygiene and to regularly attend dental check-ups and examinations. All symptoms of the oral cavity, such as a moving tooth, pain, mucosa ulceration, numbness or swelling of gums or jaws, should be reported to your doctor immediately.
The use of the preparation may be associated with the risk of osteonecrosis of the external auditory canal. The factors that increase this risk are: corticosteroid use, chemotherapy and local infection or injury. All ear symptoms, including infection and earache, should be immediately consulted with a doctor.
People with bisphosphonates may have atypical femoral fractures (short, oblique) that occur after a minor injury or even without previous injury. Fractures often occur bilaterally and may be preceded by changes visible in imaging studies. Patients who use bisphosphonates who have a femur fracture should have their thigh bones examined in the other limb. Your doctor may decide to stop using zoledronic acid. Any pain, thigh or groin should be reported to the doctor; these symptoms may directly precede the occurrence of a fracture.
To reduce the intensity of side effects occurring within the first 3 days after taking the preparation, your doctor may recommend the use of Paracetamol
Additional information about the other ingredients of the preparation:
· The preparation contains less than 23 mg of sodium ions in 100 ml solution, i.e. it is practically "sodium-free".
Does this preparation affect the ability to drive vehicles?
The preparation may cause side effects, such as dizziness, which may impair psychophysical fitness and ability to drive vehicles and operate equipment / machines.
Dosage of Aclasta
The preparation is a solution for infusion into a vein. If you have any doubts regarding the use of the preparation, consult a physician. In certain special patient groups, additional dosage adjustment is necessary.
Zoledronic acid is mainly excreted through the kidneys and it is therefore important that the patient be properly hydrated before administering the preparation. This is particularly important for elderly people (over 65) and for people taking diuretics.
Osteoporosis: a single infusion of 5 mg once a year.
The optimal duration of treatment has not been established; the doctor will individually assess the need for further treatment after considering the benefits and risks of using the medicine, especially for treatments lasting longer than 5 years.
In patients with low-energy hip fracture, it is recommended to administer the drug not earlier than at least 2 weeks after healing the fracture; in this group of patients, before the first infusion, the doctor will recommend oral or intramuscular administration of 50,000-125,000 IU. vitamin D.
Paget's disease of bone: 5 mg at a time. It is recommended that the treatment be started by a physician experienced in the treatment of this disease. At least 10 days after the start of therapy, it is recommended to use calcium supplementation (the doctor will prescribe the correct dosage, usually at least 500 mg calcium twice daily).
There are only limited data on re-administration after at least one year in patients who have relapsed.
For people with impaired renal function, if the creatinine clearance is greater than 35 ml / min, no dosage adjustment is necessary. If the creatinine clearance is less than 35 ml / min, the use of the preparation is contraindicated.
No dosage adjustment is necessary for people with hepatic impairment.
The use of the preparation in the elderly (after the age of 65) does not require any dosage adjustment.
There are no data on the safety and efficacy of the preparation in children and adolescents up to 18 years of age.
Method of administration:
The preparation can only be given as an intravenous infusion at a constant rate. The infusion time should be at least 15 minutes.
During treatment, adequate calcium and vitamin D supply should be provided.
Can you use Aclasta during pregnancy and breastfeeding?
During pregnancy, do not use any medicine without consulting your doctor!
It is very important that before using any medicine during pregnancy or breastfeeding, consult a physician and explain beyond any doubt the potential risks and benefits associated with the use of the drug. If you are pregnant or planning to become pregnant, please inform your prescribing physician about this medicine.
The use is not recommended in women of childbearing age.
The use of the preparation in pregnant women and in breast-feeding women is contraindicated.
Can I use other preparations in parallel?
Tell your doctor about all medicines you have recently taken, including those that are over the counter. In particular, inform your doctor if you are using any of the following medicines:
Zoledronic acid is excreted through the kidneys. Caution should be exercised if drugs that may affect renal function (such as aminoglycosides, diuretics) are used in parallel.
In people with impaired renal function, systemic exposure to co-administered medicinal products that are excreted through the kidneys may increase.
What side effects can occur?
Like all medicines, Aclasta can also cause side effects, although it will not occur in all patients who use this medicine. Remember that the expected benefits of using the drug are usually greater than the damage resulting from the occurrence of side effects.
Very often: fever. Common or uncommon: bone, muscle and joint pain, sometimes severe, backache, limb, neck pain, flu-like symptoms, chills, malaise, fever, fatigue, swelling of the joints, muscle and joint stiffness, peripheral edema, inflammation nasopharyngeal cavity, headaches, dizziness, lethargy, paresthesia (sensory disturbances, such as numbness, tingling sensations), drowsiness, tremors, fainting, taste disturbances, increased thirst, decreased appetite, gastric uptake into the esophagus, nausea, vomiting , diarrhea, abdominal pain, indigestion, constipation, dry mouth, oesophagitis, toothache, congestion and eye pain, conjunctivitis, anemia, decreased blood calcium (hypocalcemia), hypertension, flushing, atrial fibrillation , palpitation, cough, shortness of breath, rash, excessive sweating, pruritus, relationship kszone blood creatinine levels, urinary frequency, proteinuria, elevated levels of C-reactive protein. Rarely: inflammation of the structures of the eye (the uvea, sclera, episcleritis, iris), unusual fracture of the femur. Very rare: osteonecrosis of the external auditory canal. In addition, possible side effects for which the frequency of their occurrence has not been determined: hypersensitivity reactions (including bronchospasm, urticaria and angioneurotic edema
, very rare Anaphylactic reactions
to symptoms of anaphylactic shock), hypotension, especially in patients with risk factors, osteonecrosis of the jaw , renal dysfunction (in dehydrated patients, using other medicines, with previous renal impairment or with risk factors, rarely possible renal failure requiring dialysis, as well as death-related cases).
Other preparations on the Polish market containing zoledronic acid
Acidum zoledronicum medac (solution for infusion)
Desinobon (concentrate for solution for infusion)
Fayton (solution for infusion)
Fayton (concentrate for solution for infusion)
Osporil (solution for infusion)
Osporil (concentrate for solution for infusion)
Symdronic (concentrate for solution for infusion)
Zerlinda (solution for infusion)
Zoledronic acid Accord (concentrate for solution for infusion)
Zoledronic Acid Actavis (concentrate for solution for infusion)
Zoledronic acid Claris (concentrate for solution for infusion)
Zoledronic Acid Teva (concentrate for solution for infusion)
Zoledronic Acid Zentiva (concentrate for solution for infusion)
Zometa (powder and solvent for solution for infusion)
Zomikos (concentrate for solution for infusion)