Page 2: Health Product InfoWatch – July 2017

Key messages for healthcare professionals:^Footnote 1,^Footnote 2,^Footnote 3,^Footnote 4,^Footnote 5,^Footnote 6,^Footnote 7,^Footnote 8

For oral and injectable formulations, the following should be considered when evaluating a patient's risk of developing ONJ:

• Potency of the medicinal product that inhibits bone resorption (higher risk for highly potent compounds).
• Route of administration (higher risk for parenteral administration).
• Cumulative dose of bone resorption therapy.
• Co-morbid conditions (e.g., anemia, coagulopathies) and smoking.
• Periodontal disease, poorly fitting dentures, history of dental disease.

In addition, the following has been added to the CPMs of the injectable formulations:

• The start of treatment or of a new course of treatment should be delayed in patients with unhealed open soft tissue lesions in the mouth.
• If ONJ occurs while on treatment, temporary interruption should be considered until the condition resolves and contributing risk factors are mitigated where possible.

Key messages for healthcare professionals:^Footnote 9,^Footnote 10

• Chronic kidney disease (CKD) has been reported in patients treated with atazanavir, with or without ritonavir. Some cases resulted in fatal outcomes or requiring hemodialysis.
• Reyataz and Evotaz should be used with caution, particularly in those patients with other risk factors for CKD.