KL is a 45 yo male with a PMH of T2DM, myocardial infarction, HLD, obesity, and gout. His current medication list includes atorvastatin 40 mg PO daily, Glucophage 1000 mg PO BID, and allopurinol 300mg PO daily. He presents today to your community pharmacy after a visit at the doctor’s office where he learned his Hemoglobin A1c is 8.5 %. His previous A1c was 7 %, and the doctor has given him a prescription for Ozempic 0.25 mg SQ once weekly for 4 weeks. Which of the following are correct counseling points about Ozempic? Select all that apply
A. Ozempic works by inhibiting SGLT2 in the renal tubules, decreasing the amount of glucose reabsorbed from the tubular lumen
B. If you miss a dose, you can administer the dose as soon as possible within 5 days and resume your normal schedule afterwards
C. Ozempic has a new FDA-approved indication for weight loss in obese patients with T2DM
D. After initial use, Ozempic can be kept at room temperature for up to 56 days
E. Ozempic has a black box warning for an increased risk of amputation
Answers with rationale:
The correct answers are B and D. What to do in case of a missed dose as well as proper storage and administration are important principles for the exam. Answers B and D are correct regarding these principles or Ozempic, an injectable product. It is important to note that an oral form of semaglutide (Rybelsus) also is available for diabetes management. Answer A is incorrect because Ozempic (semaglutide) is a GLP-1 agonist that increases glucose-dependent insulin secretion, decreases inappropriate glucagon secretion, and slows gastric emptying. Answer C is incorrect because Wegovy, another branded product of semaglutide, has an FDA-approval for weight loss. While both Ozempic and Wegovy should be initiated with 0.25mg SQ injections once weekly, Wegovy is titrated every 4 weeks to a target dose of 2.4mg SQ weekly compared to Ozempic, which is approved for diabetes management at a maximum dose of 1mg SQ once weekly. Although Ozempic has show shown evidence for weight loss, it does not have an FDA approval at this time. Answer E is incorrect because Ozempic has a black box warning for Thyroid C-cell tumors. Invokana (canagliflozin), an SGLT2 inhibitor, at one time possessed a boxed warning for increased risk of amputation but that was removed by the FDA in August of 2020.
NAPLEX Competency Statements Assessed:
2.1 Pharmacology, mechanism of action, or therapeutic class
2.3 Boxed warnings or REMS
5.6 Packaging, storage, handling, or disposal
As a reminder, all NAPLEX competency statements can be found here: https://nabp.pharmacy/programs/examinations/naplex/competency-statements-2021/
Until next week!