Patients received Venclexta via a weekly ramp-up schedule starting at 20 mg and ramping to 50 mg, 100 mg, 200 mg and finally 400 mg once daily.
Patients continued to receive 400 mg of Venclexta once daily until disease progression or unacceptable toxicity.
New combination therapy offers reductions in A1C for adults with Type 2 diabetes who are inadequately controlled on basal insulin (less than 50 units) daily or liraglutide (less than or equal to 1.8 mg) daily (liraglutide) injection indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes inadequately controlled on less than 50 units of basal insulin daily or less than or equal to 1.8 mg of liraglutide daily.
100/3.6 enters into a new class of diabetes treatments that combine a basal insulin and a glucagon-like peptide-1 receptor agonist (GLP-1 RA) in a single, once-daily injection.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
XULTOPHY 100/3.6 may affect the way some medicines work and some medicines may affect the way XULTOPHY 100/3.6 works.
You may report side effects to FDA at 1-800-FDA-1088.
Before using XULTOPHY 100/3.6, talk to your healthcare provider about low blood sugar and how to manage it. Ask your healthcare provider what your blood sugars should be and when you should check your blood sugar levels.
Tell your healthcare provider if you are taking other medicines to treat diabetes. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine. Your dose of XULTOPHY 100/3.6 and other diabetes medicines may need to change because of: The most common side effects of XULTOPHY 100/3.6 may include stuffy or runny nose, sore throat, upper respiratory tract infection, increased blood levels of lipase, nausea, diarrhea, and headache.
"With the efficacy observed in this patient population, Venclexta has the potential to be an important and new therapy, advancing our efforts to bring novel treatment options to patients with this type of cancer." CLL is typically a slow-progressing cancer of the bone marrow and blood in which types of white blood cells called lymphocytes become cancerous and multiply abnormally.
The FDA also granted venetoclax three Breakthrough Therapy designations – the first for venetoclax for the treatment of chronic lymphocytic leukemia (CLL) in previously treated (relapsed/refractory) patients with the 17p deletion genetic mutation,, Abb Vie announced that the European Medicines Agency (EMA) had validated its Marketing Authorization Application (MAA) for venetoclax for the treatment of patients with CLL with 17p deletion or TP53 mutation.