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Single-dose autoinjector approved for T2DM

The FDA approved AstraZeneca's exenatide extended-release injectable suspension (Bydureon BCise) as an adjunct to diet and exercise to improve glycemic control in adults with T2DM. Bydureon BCise is a glucagon-like peptide-1 receptor agonist that is a new formulation of the company's exenatide extended-release (Bydureon). It is given as a subcutaneous injection using the single-dose autoinjector device.


Bydureon BCise is dosed once weekly and is intended for self-administration. Patients should be trained on proper mixing and injection technique to ensure the product is adequately mixed and a full dose is delivered.


In clinical trials, treatment with Bydureon BCise resulted in average hemoglobin A1C reductions up to 1.4% and average weight loss up to 3.1 lb (1.4 kg) when used as monotherapy or as an add-on to metformin, a sulfonylurea, a thiazolidinedione, or any two of these agents combined at 28 weeks. The most common adverse reactions reported in clinical trials were nausea and injection-site nodule.


Once-daily extended-release liquid for ADHD approved

The FDA has approved amphetamine (Adzenys ER), a once-daily extended-release liquid, for the treatment of attention-deficit hyperactivity disorder (ADHD) in patients age 6 years and older. The drug does not need to be reconstituted or refrigerated. It is a Schedule II controlled substance and has a box warning for the potential for abuse and dependence. Prior to prescribing Adzenys ER, the patient must be assessed for the risk of abuse, and while on therapy, the patient needs to be monitored for signs of abuse and dependence.


Shingrix vaccine approved for shingles

The FDA approved GlaxoSmithKline's Zoster Vaccine Recombinant, Adjuvanted (Shingrix) for the prevention of herpes zoster (shingles) in adults age 50 years and older. Zoster Vaccine Recombinant, Adjuvanted is a nonlive, recombinant subunit vaccine given intramuscularly in two doses. The first dose is given at month 0, followed by a second dose administered between 2 and 6 months later. The vaccine must be stored in the refrigerator with the temperature maintained between 36[degrees] and 46[degrees] F (2[degrees] and 8[degrees] C). Do not freeze the vaccine. If frozen, the vaccine must be discarded.

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In clinical trials, the vaccine has shown over 90% efficacy across all age-groups in the prevention of herpes zoster. According to GlaxoSmithKline, the vaccine was developed specifically to overcome the age-related decline in immunity. The most common adverse reactions include pain, redness, and swelling at the injection site, muscle pain, tiredness, headache, shivering, fever, and gastrointestinal symptoms.


FDA approves Fiasp insulin for T1DM and T2DM

The FDA has approved Novo Nordisk's insulin aspart injection (Fiasp) 100 units/mL to improve glycemic control in adults with type 1 diabetes mellitus and type 2 diabetes mellitus (T2DM). The rapid-acting human insulin analogue can be dosed at the start of a meal or within 20 minutes after starting a meal. Insulin aspart injection is given subcutaneously into the abdomen, upper arm, or thigh. Subcutaneous injections are generally used with intermediate- or long-acting insulin regimens.

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I.V. infusion of insulin aspart injection is only given under medical supervision with close monitoring of blood glucose and potassium levels to prevent hypoglycemia and hypokalemia. The insulin aspart injection is formulated with niacinamide, which helps the speed of the initial insulin absorption.


Common adverse reactions include hypoglycemia, hypersensitivity, injection site reactions, lipodystrophy, weight gain, nasopharyngitis, upper respiratory tract infection, nausea, diarrhea, and back pain. Fiasp is available in a prefilled 3 mL delivery device (FlexTouch pen) and a 10 mL vial.