Aclasta and Denosumab Subcutaneous

In the database of official manuals used in the service creation an interaction registered by statistical results of studies was found, which can either lead to negative consequences for the patient health or strengthen a mutual positive effect. A doctor should be consulted to address the issue of joint drug administration.

Both denosumab and zoledronic acid can cause a rare but serious condition known as osteonecrosis of the jaw (ONJ), and combining these medications may increase the risk. ONJ is the exposure of jaw bone through the gums associated with death of bone tissue and usually occurs after invasive dental procedures such as tooth extraction. Severe cases may require surgery. The risk is generally related to the dose of these medications and the duration of treatment. Because zoledronic acid can remain in the bone for years, the risk may exist for some time even after you have stopped taking it. Good oral hygiene and regular dental care is the best way to lower the risk of ONJ. Talk to your doctor if you have any questions or concerns. Your doctor may already be aware of the risks, but has determined that this is the best course of treatment for you and has taken appropriate precautions and is monitoring you closely for any potential complications. You should seek medical attention if you experience potential signs and symptoms of ONJ such as: pain in the mouth, teeth, or jaw; swelling or sores inside the mouth; numbness or a feeling of heaviness in the jaw; loosening of a tooth; or exposure of bone in the jaw. Also, before you get any type of dental surgery, be sure to let your care provider know you are taking these medications. It is important to tell your doctor about all other medications you use, including vitamins and herbs. Do not stop using any medications without first talking to your doctor.

MONITOR: Osteonecrosis of the jaw (ONJ) has been reported with the use of angiogenesis inhibitors including denosumab, bevacizumab, and sunitinib. Concomitant exposure with other risk factors such as bisphosphonates (potency, route of administration, and cumulative dose), cancer, chemotherapy, corticosteroids, radiotherapy to the head and neck, dental disease, invasive dental procedures, or poor oral hygiene may increase the risk. Most reported cases with bevacizumab have occurred in patients who received prior or concomitant treatment with intravenous bisphosphonates or had a history of dental disease requiring invasive dental procedures. For denosumab, the majority of reported cases of ONJ in clinical trials occurred within 5 months after the last dose; in clinical trials, the incidence increased with duration of exposure. Clinical trials in patients with breast or prostate cancer with an extension treatment phase of open-label denosumab reported a patient-year adjusted incidence of confirmed ONJ of 1.1% in the first year of treatment, 3.7% in the second year, and 4.6% thereafter, with a median time to ONJ onset of approximately 20.6 months. ONJ has been rarely reported in clinical trials with the use of denosumab for osteoporosis.

MANAGEMENT: Caution is advised if bisphosphonates are used simultaneously or sequentially with denosumab or bevacizumab. Prior to initiating treatment, a thorough dental examination and appropriate preventive dentistry should be considered. If possible, invasive dental procedures should be avoided in patients who have previously received or are receiving intravenous bisphosphonates. Good oral hygiene practices should be maintained during treatment. Patients should be advised to seek medical attention if they experience signs and symptoms of osteonecrosis in the jaw, such as: pain in the mouth, teeth, or jaw, swelling or sores inside the mouth, numbness or a feeling of heaviness in the jaw, loosening of a tooth, or exposure of bone in the jaw. Temporary interruption of treatment should be considered if clinically appropriate, until the condition resolves.

Aclasta

Generic Name: zoledronic acid

Brand name: Aclasta, Zometa, Reclast, Zometa Concentrate

Synonyms: n.a.

What is Aclasta?

Denosumab Subcutaneous

Generic Name: denosumab

Brand name: Prolia, Xgeva

Synonyms: Denosumab

What is Denosumab Subcutaneous?