What is Zoledronsäure Genericon?
Zoledronsäure Genericon (sometimes called zoledronate) is in a group of medicines called bisphosphonates (bis FOS fo nayts). Zoledronsäure Genericon inhibits the release of calcium from bones.
Zoledronsäure Genericon and Zoledronsäure Genericon are two different brands of Zoledronsäure Genericon.
The Zoledronsäure Genericon brand of Zoledronsäure Genericon is used to treat Paget's disease, and to treat or prevent osteoporosis in postmenopausal women or people who take certain steroid medicines. Zoledronsäure Genericon is also used to increase bone mass in men with osteoporosis.
The Zoledronsäure Genericon brand of Zoledronsäure Genericon is used to treat high blood levels of calcium caused by cancer (hypercalcemia of malignancy). Zoledronsäure Genericon also treats multiple myeloma (a type of bone marrow cancer) or bone cancer that has spread from elsewhere in the body.
You should not be treated with Zoledronsäure Genericon if you are already receiving Zoledronsäure Genericon.
Zoledronsäure Genericon may also be used for purposes not listed in this medication guide.
Zoledronsäure Genericon indications
Treatment Of Osteoporosis In Postmenopausal Women
Zoledronsäure Genericon is indicated for treatment of osteoporosis in postmenopausal women. In postmenopausal women with osteoporosis, diagnosed by bone mineral density (BMD) or prevalent vertebral fracture, Zoledronsäure Genericon reduces the incidence of fractures (hip, vertebral and non-vertebral osteoporosis-related fractures). In patients at high risk of fracture, defined as a recent low-trauma hip fracture, Zoledronsäure Genericon reduces the incidence of new clinical fractures.
Prevention Of Osteoporosis In Postmenopausal Women
Zoledronsäure Genericon is indicated for prevention of osteoporosis in postmenopausal women.
Osteoporosis In Men
Zoledronsäure Genericon is indicated for treatment to increase bone mass in men with osteoporosis.
Glucocorticoid-Induced Osteoporosis
Zoledronsäure Genericon is indicated for the treatment and prevention of glucocorticoid-induced osteoporosis in men and women who are either initiating or continuing systemic glucocorticoids in a daily dosage equivalent to 7.5 mg or greater of prednisone and who are expected to remain on glucocorticoids for at least 12 months.
Paget's Disease Of Bone
Zoledronsäure Genericon is indicated for treatment of Paget's disease of bone in men and women. Treatment is indicated in patients with Paget's disease of bone with elevations in serum alkaline phosphatase of two times or higher than the upper limit of the age-specific normal reference range, or those who are symptomatic, or those at risk for complications from their disease.
Important Limitations Of Use
The safety and effectiveness of Zoledronsäure Genericon for the treatment of osteoporosis is based on clinical data of three years duration. The optimal duration of use has not been determined. All patients on bisphosphonate therapy should have the need for continued therapy re-evaluated on a periodic basis. Patients at low-risk for fracture should be considered for drug discontinuation after 3 to 5 years of use. Patients who discontinue therapy should have their risk for fracture re-evaluated periodically.
How should I use Zoledronsäure Genericon?
Use Zoledronsäure Genericon as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Zoledronsäure Genericon comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Zoledronsäure Genericon refilled.
- Zoledronsäure Genericon is usually given as an injection at your doctor's office, hospital, or clinic.
- Drink at least 2 full glasses (16 oz/480 mL) of fluid (eg, water) within a few hours before you receive Zoledronsäure Genericon, as directed by your doctor.
- Do not use Zoledronsäure Genericon if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.
- If you miss a dose of Zoledronsäure Genericon, contact your doctor right away.
Ask your health care provider any questions you may have about how to use Zoledronsäure Genericon.
Uses of Zoledronsäure Genericon in details
Use: Labeled Indications
Bone metastases from solid tumors: Zoledronsäure Genericon: Treatment of documented bone metastases from solid tumors (in conjunction with standard antineoplastic therapy); prostate cancer should have progressed following treatment with at least one hormonal therapy.
Hypercalcemia of malignancy: Zoledronsäure Genericon: Treatment of hypercalcemia (albumin-corrected serum calcium ≥12 mg/dL) of malignancy.
Limitations of use: Safety and efficacy for treatment of hypercalcemia associated with hyperparathyroidism or with other non-tumor-related conditions have not been established.
Multiple myeloma: Zoledronsäure Genericon: Treatment of osteolytic lesions of multiple myeloma.
Osteoporosis: Zoledronsäure Genericon, Zoledronsäure Genericon [Canadian product]: Treatment and prevention of osteoporosis in postmenopausal females; treatment to increase bone mass in males with osteoporosis; treatment and prevention of glucocorticoid-induced osteoporosis in males and females who are initiating or continuing systemic glucocorticoids with a prednisone dosage of ≥7.5 mg/day (or equivalent) and who are expected to remain on glucocorticoids for at least 12 months.
Paget disease: Zoledronsäure Genericon, Zoledronsäure Genericon [Canadian product]: Treatment of Paget disease of bone in males and females. Note: Zoledronsäure Genericon is considered the most efficacious bisphosphonate with respect to treating bone pain as well as suppressing metabolic bone activity. In patients without contraindications, Endocrine Society guidelines as well as some international guidelines recommend Zoledronsäure Genericon as the treatment of choice (Endocrine Society [Singer 2014]; Ralston 2019).
Off Label Uses
Breast cancer, early (adjuvant therapy)
A systematic review which included studies in women with early breast cancer demonstrated an advantage (reduced risk of bone metastases) with the adjuvant use of bisphosphonate therapy (including Zoledronsäure Genericon) in postmenopausal females.
Zoledronsäure Genericon description
Each vial contains Zoledronic Acid monohydrate equivalent to Zoledronsäure Genericon 4 mg.
Zoledronsäure Genericon belongs to the chemotherapy drug class of bisphosphonates. It is an inhibitor of osteoclastic bone resorption and is designated chemically as (1-Hydroxy-2-imidazol-1-yl-phosphonoethyl) phosphonic acid monohydrate. It is highly soluble in 0.1N sodium hydroxide solution, sparingly soluble in water and 0.1N hydrochloric acid and practically insoluble in organic solvents. 0.7% solution of Zoledronsäure Genericon in water has a pH approximately 2.0. The molecular formula and molecular weight of Zoledronsäure Genericon is C5H10N2O7P2•H2O and 290.1 g/mol, respectively.
Zoledronsäure Genericon dosage
Treatment of Postmenopausal Osteoporosis: The recommended dose is a single IV infusion of Zoledronsäure Genericon 5 mg administered once a year. The infusion time must not be <15 min.
Treatment of Paget's Disease: The recommended dose is a single IV infusion of Zoledronsäure Genericon 5 mg.
Re-treatment of Paget's Disease: After treatment with Zoledronsäure Genericon in Paget's disease an extended remission period is observed. At present, specific treatment data are not available. However, re-treatment with Zoledronsäure Genericon may be considered in patients who have relapsed, based on increases in serum alkaline phosphatase, in patients who failed to achieve normalization of serum alkaline phosphatase, or in patients with symptoms, as dictated by medical practice 12 months after the initial dose.
Zoledronsäure Genericon (5 mg in 100 mL ready-to-infuse solution) is administered IV via a vented infusion line, given at a constant infusion rate. The infusion must not be <15 min.
Patients must be appropriately hydrated prior to administration of Zoledronsäure Genericon. This is especially important for patients receiving diuretic therapy.
Adequate calcium and vitamin D intake is important in women with osteoporosis if dietary intake is inadequate.
Elevated bone turnover is a characteristic of Paget's disease of bone. It is strongly advised that patients with Paget's disease receive the recommended daily allowance of supplemental calcium and vitamin D and this should be ensured during the initial 10 days following Zoledronsäure Genericon administration.
For information on the infusion of Zoledronsäure Genericon.
Patients with Renal Impairment: The use of Zoledronsäure Genericon in patients with creatinine clearance <30 mL/min is not recommended due to lack of adequate clinical experience in this population.
No dose adjustment is necessary in patients with creatinine clearance ≥30 mL/min.
Patients with Hepatic Impairment: No dose adjustment is required.
Elderly (≥65 years): No dose adjustment is necessary since bioavailability, distribution and elimination were similar in elderly patients and younger subjects.
Children and Adolescents: Zoledronsäure Genericon has not been tested in children and adolescents and therefore should not be used in these age groups.
Zoledronsäure Genericon interactions
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What other drugs will affect Zoledronsäure Genericon?
In vitro studies indicate that the plasma protein binding of Zoledronsäure Genericon is low, with the unbound fraction ranging from 60%–77%. In vitro studies also indicate that Zoledronsäure Genericon does not inhibit microsomal CYP450 enzymes. In vivo studies showed that Zoledronsäure Genericon is not metabolized, and is excreted into the urine as the intact drug.
Aminoglycosides And Calcitonin
Caution is advised when bisphosphonates are administered with aminoglycosides or calcitonin, since these agents may have an additive effect to lower serum calcium level for prolonged periods. This effect has not been reported in Zoledronsäure Genericon clinical trials.
Loop Diuretics
Caution should also be exercised when Zoledronsäure Genericon is used in combination with loop diuretics due to an increased risk of hypocalcemia.
Nephrotoxic Drugs
Caution is indicated when Zoledronsäure Genericon is used with other potentially nephrotoxic drugs.
Thalidomide
No dose adjustment for Zoledronsäure Genericon 4 mg is needed when coadministered with thalidomide. In a pharmacokinetic study of 24 patients with multiple myeloma, Zoledronsäure Genericon 4 mg given as a 15-minute infusion was administered either alone or with thalidomide (100 mg once daily on days 1-14 and 200 mg once daily on days 15-28). Coadministration of thalidomide with Zoledronsäure Genericon did not significantly change the pharmacokinetics of Zoledronsäure Genericon or creatinine clearance.
Zoledronsäure Genericon side effects
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What are the possible side effects of Zoledronsäure Genericon?
Postmenopausal Osteoporosis: In HORIZON-PFT, the Phase III randomized, double-blind, placebo-controlled, multinational study of 7736 women aged 65-89 years, there were no significant differences in the overall incidence of serious adverse events compared to placebo and most adverse events were mild to moderate. Zoledronsäure Genericon was administered once yearly for 3 consecutive years for a total of 3 doses.
Consistent with the IV administration of bisphosphonates, Zoledronsäure Genericon has been most commonly associated with the following post-dose symptoms: Fever (18.1%), myalgia (9.4%), flu-like symptoms (7.8%), arthralgia (6.8%) and headache (6.5%), the majority of which occur within the first 3 days following Zoledronsäure Genericon administration. The majority of these symptoms were mild to moderate in nature and resolved within 3 days of the event onset. The incidence of these symptoms decreased markedly with subsequent doses of Zoledronsäure Genericon.
The incidence of post-dose symptoms occurring within the first 3 days after administration of Zoledronsäure Genericon, can be reduced by approximately 50% with the administration of paracetamol or ibuprofen shortly following Zoledronsäure Genericon administration.
Very common (≥1/10), common (≥1/100, <1/10), uncommon (>1/1000, <1/100), rare (>1/1000, <1/10,000) adverse reactions suspected (investigator assessment) to be associated with Zoledronsäure Genericon are shown as follows: Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Adverse drug reactions suspected* (at least 1%) to be associated with Zoledronsäure Genericon in postmenopausal osteoporosis in HORIZON-PFT study:
Nervous System Disorders: Common: Headache, dizziness. Uncommon: Lethargyb, paresthesia, somnolence, tremor, syncope, dysgeusia.
Eye Disorders: Uncommon: Conjunctivitis, eye pain, uveitis. Rare: Episcleritis, iritis.
Ear and Labyrinth Disorders: Uncommon: Vertigo.
Respiratory, Thoracic and Mediastinal Disorders: Common: Dyspneaa.
Gastrointestinal Disorders: Common: Nausea, vomiting, diarrhea. Uncommon: Dyspepsiab, abdominal pain, dry mouth, esophagitis.
Skin and Subcutaneous Tissue Disorders: Uncommon: Rash.
Musculoskeletal Disorders: Common: Myalgia, arthralgia, bone pain, back pain, pain in extremity. Uncommon: Joint swelling.
Renal and Urinary Disorders: Uncommon: Increase blood creatinine.
General Disorders and Administration Site Conditions: Very common: Fever. Common: Hypocalcemiaa, flu-like symptomsc, chills, fatigue, asthenia, pain, malaise, rigorsa. Uncommon: Anorexia, peripheral edema, thirst.
*Incidence based on investigator assessment of causality and includes those events with a greater frequency than placebo.
Key deviations in the adverse events in the Paget's disease clinical trials compared to the postmenopausal HORIZON-PFT trial are summarized as follows:
a Common in Paget's disease only.
b Common in Paget's disease.
c Very common in Paget's disease.
In one 3-year trial in postmenopausal osteoporosis women (HORIZON-PFT), the overall incidence of atrial fibrillation was low, reported in 2.5% of patients (96 out of 3862) in the Zoledronsäure Genericon group versus 1.9% of patients (75 out of 3852) in the placebo group. The increased incidence observed in this trial has not been observed in other clinical trials with Zoledronsäure Genericon.
Class Effects: Renal Dysfunction: Treatment with IV bisphosphonates, including Zoledronsäure Genericon, has been associated with renal dysfunction manifested as deterioration in renal function (ie, increased serum creatinine) and in rare cases, acute renal failure. Renal dysfunction has been observed following the administration of Zoledronsäure Genericon, especially in patients with preexisting renal compromise or additional risk factors (eg, oncology patients with chemotherapy, concomitant nephrotoxic medications, severe dehydration), the majority of whom received a 4-mg dose every 3-4 weeks, but it has been observed in patients after a single administration.
In the HORIZON-PFT trial, the change in creatinine clearance (measured annually prior to dosing), and the incidence of renal failure and impairment was comparable for both the Zoledronsäure Genericon and placebo treatment groups over 3 years. There was a transient increase in serum creatinine observed within 10 days in 1.8% of Zoledronsäure Genericon-treated patients versus 0.8% of placebo-treated patients.
Laboratory Findings: In the HORIZON-PFT trial, approximately 0.2% of patients had notable declines of serum calcium levels (<1.87 mmol/L) following Zoledronsäure Genericon administration. No symptomatic cases of hypocalcemia were observed.
In the Paget's disease trials, symptomatic hypocalcemia was observed in approximately 1% of patients, all of which resolved.
Local Reactions: Local reactions at the infusion site eg, redness, swelling and/or pain were reported (0.7%) following the administration of Zoledronsäure Genericon.
Osteonecrosis of the Jaw: Cases of osteonecrosis (primarily of the jaw) have been reported predominantly in cancer patients treated with bisphosphonates, including Zoledronsäure Genericon (uncommon). Many of these patients had signs of local infection including osteomyelitis, and the majority of the reports refer to cancer patients following tooth extractions or other dental surgeries. Osteonecrosis of the jaw has multiple well documented risk factors including a diagnosis of cancer, concomitant therapies (eg, chemotherapy, radiotherapy, corticosteroids) and co-morbid conditions (eg, anemia, coagulopathies, infection, preexisting dental disease). Although causality has not been determined, it is prudent to avoid dental surgery as recovery may be prolonged. In the HORIZON-PFT trial in 7736 patients, ONJ has been reported in 1 patient treated with Zoledronsäure Genericon and 2 patients treated with placebo. All 3 cases resolved.
Zoledronsäure Genericon contraindications
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What is the most important information I should know about Zoledronsäure Genericon?
Zoledronsäure Genericon can harm your kidneys. This effect is increased when you also use other medicines harmful to the kidneys, such as: chemotherapy, antiviral medication, pain or arthritis medicine, injected antibiotics, or medicines to treat a bowel disorder or prevent organ transplant rejection. You may need dose adjustments or special tests if you use any of these medications.
Do not receive Zoledronsäure Genericon without telling your doctor if you have had an allergic reaction to Zoledronsäure Genericon or similar medicine such as alendronate (Fosamax), etidronate (Didronel), ibandronate (Boniva), pamidronate (Aredia), risedronate (Actonel), or tiludronate (Skelid).
Do not use Zoledronsäure Genericon if you are pregnant. It could harm the unborn baby.
Your doctor may recommend you have a dental exam for preventive tooth and gum care before you start your treatment with Zoledronsäure Genericon. This is especially important if you have cancer, if you are undergoing chemotherapy or using steroids, or if you have poor dental health.
Some people using medicines similar to Zoledronsäure Genericon have developed bone loss in the jaw, also called osteonecrosis of the jaw. Symptoms of this condition may include jaw pain, swelling, numbness, loose teeth, gum infection, or slow healing after injury or surgery involving the gums. You may be more likely to develop osteonecrosis of the jaw if you have cancer or have been treated with chemotherapy, radiation, or steroids. Other conditions associated with osteonecrosis of the jaw include blood clotting disorders, anemia (low red blood cells), and pre-existing dental problems.
Avoid having any type of dental surgery while you are being treated with Zoledronsäure Genericon. It may take longer than normal for you to recover.
Active ingredient matches for Zoledronsäure Genericon:
Zoledronic Acid in Austria.
List of Zoledronsäure Genericon substitutes (brand and generic names) | Sort by popularity |
| Unit description / dosage (Manufacturer) | Price, USD |
| Zoledronsyre SUN (Denmark) | |
| Zolegen (Turkey) | |
| Zolemed (Slovakia) | |
| Zolenat (Turkey) | |
| Zolenat IV | |
| Zolenate IV (Vietnam) | |
| Zolenate IV 4 mg/5 mL x 1 Bottle | |
| Zolendronska Kiselina (Bosnia & Herzegowina) | |
| Zolenia (Netherlands) | |
| Zolenic (Bangladesh) | |
| Zolenic 4mg x 1mL VIAL / 1 (Cytogen) | |
| ZOLENIC inj 4 mg x 1 mL x 1ml (Cytogen) | |
| Zolenic 4mg Injection (Cytogen) | $ 35.08 |
| Zolenico (Argentina) | |
| Zolennic (Thailand) | |
| Zolennic infusion 4 mg/5 mL 1's (Siam Bheasach) | |
| Zolenton (Georgia) | |
| Zolephos (India) | |
| Zolephos 5mg x 100mL INF / 1 (AHPL) | |
| 5 mg x 100 mL x 1's (AHPL) | |
| ZOLEPHOS 5 MG INFUSION 1 bottle / 100 ML infusion each (AHPL) | $ 36.14 |
| ZOLEPHOS infusion conc 5 mg x 100 mL x 100ml (AHPL) | $ 36.14 |
| Zolephos 5mg Infusion (AHPL) | $ 0.36 |
| Zolestad (Netherlands, Sweden) | |
| Zoletalis (Vietnam) | |
| Zoletalis 4 mg/5 mL x 1 Bottle x 5 mL | |
| Zoletech (Argentina) | |
| Zoletrust (India) | |
| Zoletrust 4mg VIAL / 1 (Panacea) | $ 17.47 |
| ZOLETRUST 4MG INJECTION 1 vial / 1 injection each (Panacea) | $ 18.30 |
| Zoletrust 4mg Injection (Panacea) | $ 18.30 |
| Zolibbs (Brazil) | |
| Zolira (Bulgaria) | |
| ZOLIRA inj 40 mg x 2ml (Zenon) | |
| Zolka (Turkey) | |
| Zolmestat (Greece) | |
| Zolnic (Mexico) | |
| Zoloporoz (Turkey) | |
| Zoltasta (Turkey) | |
| Zoltero (India) | |
| Zoltero 4mg x 5mL VIAL / 1 (Novartis India Limited) | $ 183.29 |
| 4 mg x 5 mL x 1's (Novartis India Limited) | $ 183.29 |
| Zoltero 4 mg Injection (Novartis India Limited) | $ 0.18 |
| ZOLTERO inj 4 mg x 5 mL x 5ml (Novartis India Limited) | $ 183.29 |
| Zoltonar (Georgia, Turkey) | |
| ZOLYMAX (India) | |
| Zomebon (Turkey) | |
| Zomedron (South Africa) | |
| Zomegoal (Mexico) | |
| Zomera (Israel) | |
| Injectable; IV / Infusion; Zoledronic Acid Anhydrous 4 mg (Novartis) | |
See 570 substitutes for Zoledronsäure Genericon | |
References
- DailyMed. "ZOLEDRONIC ACID: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
- PubChem. "Zoledronic acid". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
- DrugBank. "Zoledronic acid". http://www.drugbank.ca/drugs/DB00399 (accessed September 17, 2018).
Reviews
The results of a survey conducted on ndrugs.com for Zoledronsäure Genericon are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Zoledronsäure Genericon. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.User reports
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Information checked by Dr. Sachin Kumar, MD Pharmacology
