Aklasta solution for infusion 5 mg/100 ml bottle 100 ml 1 pc. in Moscow

Aklasta solution for infusion 5 mg/100 ml bottle 100 ml 1 pc. in Moscow

Treatment of various types of osteoporosis, Paget's disease of bone and prevention of new fractures in men and women with fractures of the proximal femur.

With intravenous administration of 5 mg of Aklasta once a year for the treatment of postmenopausal osteoporosis in women, osteoporosis in men, for the prevention of new fractures in men and women with fractures of the proximal femur, for the prevention and treatment of osteoporosis caused by the use of GCS and for treatment of Paget's disease of bone, most adverse events (AEs) were mild or moderate. After intravenous administration of the drug Aklasta, the following AEs were most often observed in these patients: usually lasting no more than 3 days (“post-dose” symptoms) - fever (18.1%), myalgia (9.4%), influenza-like syndrome (7. 8%), arthralgia (6.8%), headache (6.5%). Most of the above-mentioned AEs observed within 3 days after drug administration were mild or moderate. With repeated administration of the drug, the severity of these AEs decreased significantly. Below are AEs that may be associated (in the opinion of the treating physicians) with the use of the drug for the treatment of various types of osteoporosis, Paget's disease of bone and for the prevention of new fractures in men and women with fractures of the proximal femur.

The incidence of these AEs was assessed as follows: very often (≥1/10); often (≥1/100, <1/10); uncommon (≥1/1000, <1/100); rare (≥1/10000, <1/1000), very rare (<1/10000), including isolated reports.

From the nervous system:

often - headache, dizziness; sometimes - lethargy*, paresthesia, drowsiness, tremor, fainting.

From the senses:

sometimes - conjunctivitis, eye pain, vertigo; rarely - uveitis*, episcleritis, iritis.

From the respiratory system:

sometimes - shortness of breath*, cough.

From the digestive system:

often - nausea, vomiting, diarrhea; sometimes - anorexia*, loss of appetite, dyspepsia*, abdominal pain*, dry mouth, esophagitis*, gastroesophageal reflux, pain in the upper abdomen, constipation.

From the skin and subcutaneous tissue:

sometimes - rash, hyperhidrosis*, itching, erythema.

From the musculoskeletal system and connective tissue:

often - arthralgia*, myalgia*; bone pain, pain in the back and limbs; sometimes - pain in the neck, swelling in the joints*, muscle spasms, pain in the shoulder girdle, pain in the chest* of musculoskeletal origin, muscle weakness, stiffness in the muscles* and joints*, arthritis, musculoskeletal pain.

From the urinary system:

sometimes - increased blood creatinine levels, pollakiuria, proteinuria.

From the hematopoietic system:

sometimes - anemia.

From the cardiovascular system:

sometimes - increased blood pressure, sudden redness of the face.

Infections and infestations:

sometimes - flu, nasopharyngitis.

From the body as a whole:

very often - increased temperature; often - flu-like syndrome, chills, increased fatigue*, asthenia, pain*, general malaise; Uncommon: peripheral edema, thirst*, increased excitability*, chest pain (not associated with heart disease).

*Note:

in some studies, the frequency of these AEs increased as follows: very often - myalgia, arthralgia, fatigue, pain; often - lethargy, shortness of breath, dyspepsia, esophagitis, abdominal pain, hyperhidrosis, muscle stiffness, swelling in the joints, pain in the chest area of ​​musculoskeletal origin, stiffness in the joints, anorexia, thirst, increased excitability; infrequently - uveitis.

In separate studies, the following AEs were recorded, the incidence of which in the Aklasta group was lower than in patients who did not receive the drug: redness of the eyes, increased levels of C-reactive protein, hypocalcemia, taste disturbances, toothache, gastritis, palpitations , reactions at the injection site.

When using Aklasta in patients with postmenopausal osteoporosis, the overall incidence of atrial fibrillation during treatment with Aklasta was 2.5% (96 out of 3862 people) compared to 1.9% (75 out of 3852 patients) in patients not treated with the drug (placebo group). In 1.3% of patients (51 out of 3862 patients) receiving Aklasta, and in 0.6% (22 out of 3852) in the placebo group, this adverse event was assessed as serious. The reason for the increased incidence of atrial fibrillation during therapy with Aclasta was not established in this study. The increased incidence of atrial fibrillation compared with placebo observed in this study was not found in other clinical studies of zoledronic acid.

Prevention of postmenopausal osteoporosis

When using Aklasta for the prevention of postmenopausal osteoporosis (PMO), the overall safety profile of the drug was comparable to that in the treatment of PMO, with the exception of AEs that occurred within 3 days after infusion: pain, fever, chills, myalgia, nausea, headache, fatigue , arthralgia, the frequency of which was higher in women receiving the drug to prevent PMO. Most of these AEs were mild or moderate and resolved within 3 days of onset. With repeated administration of the drug, the severity of these AEs decreased significantly.

The following are AEs possibly associated with the use of the drug for the prevention of PMO (according to the attending physicians):

1) AEs that were observed more than once during the administration of Aklasta for the prevention of PMO and were not registered when using the drug for the treatment of various types of osteoporosis, Paget's bone disease and for the prevention of new fractures in men and women with fractures of the proximal femur;

2) AEs, the frequency of which was higher in women receiving the drug to prevent PMO (compared to other categories of patients).

The incidence of these AEs was assessed as follows: very common (≥1/10); often (≥1/100,<1/10); uncommon (≥1/1000, <1/100).

Mental disorders:

sometimes - anxiety.

From the nervous system:

very often - headache; often - tremor, lethargy; infrequently - decreased sensitivity, taste disturbances.

From the side of the organ of vision:

often - conjunctivitis, eye pain, iritis; infrequently - blurred vision.

From the digestive system:

very often - nausea; often - anorexia, abdominal pain, pain in the upper abdomen, constipation.

From the skin and subcutaneous tissue:

often - increased sweating at night.

From the musculoskeletal system and connective tissue:

very often - myalgia; often - musculoskeletal pain, muscle spasm, pain in the chest area of ​​musculoskeletal origin, pain in the jaw area, pain in the neck area; infrequently - pain in the side.

From the body as a whole and reactions at the site of drug administration:

very often - pain, chills; often - peripheral edema, reactions at the injection site, non-cardiac pain in the chest area.

Changes in laboratory results

In patients with postmenopausal osteoporosis, while using Aklasta, a decrease in calcium concentration (<1.87 mmol/l) in the blood serum was observed in 0.2% of cases; clinical signs of hypocalcemia were not observed.

When using the drug in patients with femoral fractures, osteoporosis in men and osteoporosis caused by taking corticosteroids, there was no decrease in the concentration of calcium in the blood plasma <1.87 mmol/l.

When using the drug in patients for the prevention of postmenopausal osteoporosis, there was no decrease in the concentration of calcium in the blood plasma <1.87 mmol/l. In patients with Paget's disease, transient hypocalcemia accompanied by clinical manifestations was found in approximately 1% of cases.

Renal dysfunction.

With intravenous administration of bisphosphonates, including zoledronic acid, there have been cases of renal dysfunction, manifested by an increase in blood creatinine concentrations and, in rare cases, acute renal failure. Impaired renal function with the use of zoledronic acid has been observed in patients with either a history of renal pathology or additional risk factors (for example, cancer requiring chemotherapy, use of nephrotoxic drugs, diuretics or severe dehydration). Most of these patients were treated with zoledronic acid at a dose of 4 mg every 3-4 weeks, but in some cases, renal dysfunction was observed after a single dose of zoledronic acid. When treated with Aklasta for 3 years in patients with postmenopausal osteoporosis, the incidence of increased plasma creatinine and the development of renal failure did not differ from that when using placebo. Patients receiving Aklasta were slightly more likely to experience a transient increase in blood creatinine concentrations within 10 days after infusion compared to placebo (1.8 and 0.8%, respectively).

When using Aklasta for 2 years in men with osteoporosis, the frequency of changes in creatinine clearance and the development of renal dysfunction was similar to that in the alendronic acid group.

In patients with osteoporosis caused by the use of corticosteroids, during therapy with Aklasta, the frequency of changes in creatinine clearance and the development of renal dysfunction was similar to that in the risedronic acid group.

Reactions at the injection site.

When using Aklasta in patients with postmenopausal osteoporosis, redness, swelling and/or pain at the injection site were noted in 0.7% of cases.

In patients with femoral fractures, the incidence of reactions at the injection site was comparable to that in the placebo group. In the treatment of osteoporosis in men, the incidence of reactions at the injection site of Aclasta was 2.6% (compared to 1.4% in the alendronic acid group). In patients with osteoporosis caused by the use of corticosteroids, no reactions were observed at the injection site. When using the drug for the prevention of postmenopausal osteoporosis, the incidence of reactions at the injection site of Aklasta was 1.1% (compared to 2.0% in the placebo group).

Osteonecrosis of the jaw.

Cases of osteonecrosis (most often of the jaw) occurred mainly in cancer patients receiving bisphosphonate treatment after tooth extraction or other dental procedures. Most patients had symptoms of a local infectious and inflammatory process, including osteomyelitis. In clinical studies in patients with osteoporosis, a case of osteonecrosis of the jaw occurred in 1 patient taking Aklasta and in 2 patients taking placebo. In all three cases, resolution of the process was noted. When using the drug Aklasta in patients with femoral fractures, with osteoporosis in men and osteoporosis caused by taking corticosteroids, as well as when using the drug for the prevention of postmenopausal osteoporosis, there were no cases of osteonecrosis of the jaw.

Isolated reports of adverse events

During therapy with Aklasta, the following AEs were observed in clinical practice without indication of a cause-and-effect relationship with the use of the drug (the frequency of AEs has not been established): hypersensitivity reactions, including in rare cases broncho-obstruction, urticaria, angioedema and isolated reports of the development of anaphylactic reactions, in incl. anaphylactic shock. In rare cases, when using Aklasta in clinical practice, patients have experienced renal dysfunction, including renal failure requiring hemodialysis, especially in patients with a history of either renal pathology or additional risk factors (for example, with concomitant therapy with nephrotoxic drugs, diuretics or with severe dehydration).

In very rare cases, the following AEs have been reported:

dehydration due to fever, vomiting and diarrhea occurring after administration of the drug; a pronounced decrease in blood pressure in patients with risk factors, osteonecrosis of the jaw, scleritis and inflammation in the orbital area.

Aclasta

Treatment of various types of osteoporosis, Paget's disease of bone and prevention of subsequent fractures in men and women with fractures of the proximal femur

With intravenous administration of 5 mg of Aklasta once a year for the treatment of postmenopausal osteoporosis in women, osteoporosis in men, for the prevention of subsequent fractures in men and women with fractures of the proximal femur, for the prevention and treatment of osteoporosis caused by the use of glucocorticosteroids and for the treatment of bone Paget's disease, most adverse events (AEs) were mild or moderate. After intravenous administration of Aklasta, the following AEs were most often observed in these patients, usually lasting no more than 3 days (“post-dose” symptoms): fever (18.1%), myalgia (9.4%), influenza-like syndrome (7.8 %), arthralgia (6.8%), headache (6.5%). Most of the above-mentioned AEs observed within 3 days after drug administration were mild or moderate. With repeated administration of the drug, the frequency of these AEs decreased significantly.

Below are AEs associated (according to the treating physicians) with the use of the drug for the treatment of various types of osteoporosis, Paget's disease of bone and for the prevention of new fractures in men and women with fractures of the proximal femur. The frequency of development of these AEs was assessed as follows: very often (> 1/10); often (> 1/100, < 1/10); uncommon (> 1/1,000, < 1/100); rare (> 1/10,000, < 1/1,000); very rare (<1/10,000); frequency unknown (according to individual reports from clinical practice).

Nervous system disorders:

often - headache, dizziness; infrequently - lethargy*, paresthesia, drowsiness, tremor, fainting, dysgeusia. Violations of the organ of vision: often - hyperemia of the sclera; uncommon - conjunctivitis, eye pain; rarely - uveitis*, episcleritis, iritis; frequency unknown - inflammation of the sclera and orbit.

Hearing and labyrinth disorders:

infrequently - vertigo.
Disorders of the respiratory system, chest and mediastinal organs: infrequently - shortness of breath*, cough.
Digestive system disorders:

often - nausea, vomiting, diarrhea; Uncommon: decreased appetite, dyspepsia*, abdominal pain*, dry mouth, esophagitis*, gastroesophageal reflux, upper abdominal pain, constipation, gastritis (in patients receiving glucocorticosteroids), toothache.

Skin and subcutaneous tissue disorders:

Uncommon: rash, hyperhidrosis*, itching, erythema.

Musculoskeletal and connective tissue disorders:

often - arthralgia*, myalgia*, bone pain, pain in the back and limbs; uncommon - neck pain, joint swelling*, muscle spasms, shoulder pain, chest pain* of musculoskeletal origin, muscle weakness, stiffness in muscles* and joints*, arthritis, musculoskeletal pain; frequency unknown - osteonecrosis of the jaw.

Renal and urinary tract disorders:

uncommon - increased concentration of creatinine in the blood, pollakiuria, proteinuria; frequency unknown - renal failure.

Blood and lymphatic system disorders:

infrequently - anemia
.
Cardiac disorders:

often - atrial fibrillation, infrequently - palpitations.

Vascular disorders:

infrequently - increased blood pressure, sudden redness of the face; frequency unknown - marked decrease in blood pressure (in patients with risk factors).

Mental disorders:

infrequently - insomnia.

Infectious and parasitic diseases:

infrequently - influenza, nasopharyngitis.

General disorders and disorders at the injection site:

very often - fever; often - flu-like syndrome, chills, fatigue*, asthenia, pain*, general malaise, reactions at the infusion site; uncommon - peripheral edema, thirst*, acute phase reactions*, chest pain (not associated with heart disease); frequency unknown - dehydration (developing as a result of post-infusion phenomena such as fever, vomiting and diarrhea).

* - In individual studies, the frequency of these adverse events increased as follows: very often

- myalgia, arthralgia, increased fatigue, pain;
often
- lethargy, shortness of breath, dyspepsia, esophagitis, abdominal pain, hyperhidrosis, muscle stiffness, swelling in the joints, pain in the chest area of ​​musculoskeletal origin, stiffness in the joints, decreased appetite, thirst, acute phase reactions;
infrequently -
uveitis.

In separate studies, AEs were recorded, the incidence of which in the Aklasta group was lower than in patients who did not receive the drug.

Cardiac disorders:

atrial fibrillation, palpitations.

Visual disorders:

redness of the eyes.

Digestive system disorders:

gastritis, toothache.

General disorders and disorders at the injection site:

reactions at the injection site.

Laboratory and instrumental data:

increase in C-reactive protein.

Metabolic and nutritional disorders:

hypocalcemia.

Nervous system disorders:

dysgeusia.

Prevention of postmenopausal osteoporosis

When using Aklasta for the prevention of postmenopausal osteoporosis (PMO), the overall safety profile of the drug was comparable to that in the treatment of PMO, with the exception of AEs that occurred within 3 days after infusion: pain, fever, chills, myalgia, nausea, headache, increased fatigue, dizziness, arthralgia, the frequency of which was higher in patients receiving the drug for the prevention of PMO. Most of these AEs were mild or moderate and resolved within three days of onset. With repeated administration of the drug, the severity of these AEs decreased significantly.

Below are the AEs associated with the use of the drug for the prevention of PMO (according to the attending physicians): 1) AEs that were observed more than once when administering the drug Aklasta for the prevention of PMO and not registered when using the drug Aklasta for the treatment of various types of osteoporosis, Paget's bone disease and for the prevention of new fractures in men and women with fractures of the proximal femur; 2) AEs, the frequency of which was higher in women receiving the drug to prevent PMO (compared to other categories of patients). The frequency of development of these AEs was assessed as follows: very often (> 1/10); often (> 1/100, < 1/10); uncommon (> 1/1,000, < 1/100).

Mental disorders:

infrequently - anxiety.

Nervous system disorders:

very often - headache; often - tremor, lethargy; infrequently - hypoesthesia, dysgeusia.

Visual disorders:

often - conjunctivitis, eye pain, iritis; infrequently - blurred vision.

Digestive system disorders:

very often - nausea; often - loss of appetite, abdominal pain, pain in the upper abdomen, constipation.

Skin and subcutaneous tissue disorders

: often - increased sweating at night.

Musculoskeletal and connective tissue disorders:

very often - myalgia; often - muscle pain, muscle spasm, pain in the chest area of ​​musculoskeletal origin, pain in the jaw, pain in the neck; infrequently - pain in the side.

General disorders and disorders at the injection site:

very often - pain, chills; often - peripheral edema, reactions at the injection site, non-cardiac pain in the chest area.

Changes in laboratory results

In patients with postmenopausal osteoporosis, while using the drug Aklasta, in 0.2% of cases there was a decrease in calcium content (<1.87 mmol/l) in the blood serum; no clinical signs of hypocalcemia were observed.

When using the drug in patients with femoral fractures, with male osteoporosis and osteoporosis caused by taking GCS, there were no patients who required urgent therapy with a calcium concentration in the blood plasma <1.87 mmol/l. When using the drug in patients for the prevention of postmenopausal osteoporosis, one patient required urgent therapy with a calcium concentration in the blood plasma <1.87 mmol/l.

In patients with Paget's disease, transient hypocalcemia accompanied by clinical manifestations was found in approximately 1% of cases.

Renal dysfunction

With intravenous administration of bisphosphonates, including zoledronic acid, there have been cases of renal dysfunction with an increase in blood creatinine concentrations, and in rare cases, acute renal failure.

Impaired renal function after a single dose of zoledronic acid has been observed in patients with either a history of renal disease or additional risk factors (eg, advanced age, concomitant use of nephrotoxic drugs, diuretics, cancer patients receiving chemotherapy, or severe dehydration) with a predominance in patients receiving the drug at a dose of 4 mg every 3-4 weeks.

However, in patients with impaired renal function or any of the above risk factors, renal failure requiring hemodialysis or leading to death was rare. Caution should be exercised when using Aklasta in patients with concomitant cancer and chemotherapy due to the increased risk of developing renal failure.

When treated with Aklasta for 3 years in patients with postmenopausal osteoporosis, the incidence of increased plasma creatinine concentrations and the development of renal failure did not differ from that when using placebo. Patients receiving Aklasta were slightly more likely to experience a transient increase in blood creatinine concentrations within 10 days after infusion compared to placebo (1.8% and 0.8%, respectively).

When using Aklasta for 2 years in men with osteoporosis, the frequency of changes in creatinine clearance and the development of renal dysfunction was similar to that in the alendronic acid group.

In patients with osteoporosis caused by the use of corticosteroids, during therapy with Aklasta, the frequency of changes in creatinine clearance and the development of renal dysfunction was similar to that in the risedronic acid group.

When using the drug in patients with femoral fractures, the incidence of changes in creatinine clearance and the development of renal dysfunction was similar to that in the placebo group.

When using the drug in patients for the prevention of postmenopausal osteoporosis, the frequency of changes in creatinine clearance and the development of renal dysfunction was similar to that in the placebo group.

Reactions at the injection site

When using Aklasta in patients with postmenopausal osteoporosis, redness, swelling and/or pain at the injection site were noted in 0.7% of cases.

In patients with femoral fractures, the incidence of local reactions was comparable to that in the placebo group.

In the treatment of osteoporosis in men, the incidence of reactions at the injection site of Aclasta was 2.6% (compared to 1.4% in the alendronic acid group).

In patients with osteoporosis caused by the use of GCS, no reactions were observed at the injection site.

When using the drug for the prevention of postmenopausal osteoporosis, the incidence of reactions at the injection site of Aklasta was 1.1% (compared to 2.0% in the placebo group).

Osteonecrosis of the jaw

Cases of osteonecrosis (most often osteonecrosis of the jaw) occurred mainly in cancer patients receiving treatment with bisphosphonates (including zoledronic acid - infrequently), in most cases after tooth extraction or other dental procedures. Most patients had symptoms of a local infectious and inflammatory process, including osteomyelitis.

In clinical studies in patients with osteoporosis, a case of osteonecrosis of the jaw occurred in 1 patient taking Aclasta and 1 patient taking placebo. In both cases, resolution of the process was noted.

When using the drug Aklasta in patients with femoral fractures, with male osteoporosis and osteoporosis caused by taking corticosteroids, as well as when using the drug for the prevention of postmenopausal osteoporosis, there were no cases of osteonecrosis of the jaw.

Atrial fibrillation

When using Aklasta in patients with postmenopausal osteoporosis, the overall incidence of atrial fibrillation during treatment with Aklasta was 2.5% (96 out of 3862 people) compared to 1.9% (75 out of 3852 patients) in patients not treated with the drug (placebo group) . In 1.3% of patients (51 patients out of 3862) receiving Aklasta, and in 0.6% (22 patients out of 3852) in the placebo group, this adverse event was considered serious. The reason for the increased incidence of atrial fibrillation during therapy with Aclasta was not established in this study. The increased incidence of atrial fibrillation compared with placebo observed in this study was not found in other clinical studies of zoledronic acid.

Isolated reports of adverse events

During therapy with Aklasta, the following adverse events were observed in clinical practice without indication of a cause-and-effect relationship with the use of the drug (the frequency of AEs has not been established): hypersensitivity reactions, including in rare cases bronchoconstriction, urticaria, angioedema and isolated reports of the development of anaphylactic reactions/ shock.

In rare cases, when using Aklasta in clinical practice, patients have experienced renal dysfunction, including renal failure requiring hemodialysis, or cases of death, especially in patients with a history of renal pathology or additional risk factors (for example, advanced age , concomitant therapy with nephrotoxic drugs, diuretics or severe dehydration).

If any of the side effects indicated in the instructions get worse, or you notice any other side effects not listed in the instructions,
tell your doctor.