Pharmacy Bulletin

Pharmacy Bulletin

We share important prescription drug information to help you stay informed about updates concerning particular prescription medicines.

VativoRx Bottle update

On Nov. 8, 2023, the Food and Drug Administration (FDA) approved Eli Lilly’s Zepbound (tirzepatide) injection. It is indicated for weight loss and management in adults who are obese (who have a body mass index [BMI] of at least 30 kg/m²) or who are overweight (a BMI of 27 kg/m² or higher) and who have weight-related medical conditions. Tirzepatide is both a glucose-dependent insulinotropic polypeptide (GIP) and a glucagon-like peptide-1 (GLP-1) hormone receptor agonist and is the same active ingredient found in the company’s Mounjaro®, which was approved last year for treating type 2 diabetes. Starting at 2.5mg/week as a subcutaneous (SC) injection, the recommended dose then doubles to 5mg/week after one month. If further increases are needed, doses may be increased by 2.5mg/week at intervals of no less than one month. The maximum recommended dose is 15mg per week. Zepbound is expected to be available before the end of 2023 with a cost of around $1,060 per month. For full prescribing information see here

At a Glance

  • Brand (Generic) Name: Zepbound (tirzepatide)
  • Manufacturer: Eli Lilly
  • Date Approved: Nov. 8, 2023
  • Indication: in addition to a reduced-calorie diet and increased physical activity for chronic weight management in adult patients who have an initial BMI of 30 kg/m2 or greater or 27 kg/m2 or greater in the presence of at least one weight-related comorbid condition such as hypertension, dyslipidemia, type 2 diabetes, obstructive sleep apnea or cardiovascular disease
  • Dosage Forms Available: single-dose pens containing 2.5mg, 5mg, 7.5mg, 10mg, 12.5mg or 15mg per 0.5mL of Zepbound for SC injection
  • Launch Date: By the end of 2023
  • Estimated Annual Cost: About $12,720 per year for the average list price
  • Tirzepatide is both a glucose-dependent insulinotropic polypeptide (GIP) and a glucagon-like peptide-1 (GLP-1) hormone receptor agonist. It is the same active ingredient found in the company’s Mounjaro®, which was approved in May 2022 for treating type 2 diabetes.
  • The obesity epidemic continues to grow in the U.S. Current estimates are that 42.5% of U.S. adults age 20 years and older were obese in 2018 and 31.1% more were overweight, with no significant difference seen between genders.
  • Obesity is a risk factor for many conditions, including diabetes, high cholesterol, and high blood pressure. When sustained, just a moderate weight loss of 5% to 10% of the starting weight can result in a significant reduction in obesity-related conditions.
  • Guidelines recommend assessing patient readiness to make lifestyle changes to accomplish weight loss, and determine goals and comprehensive lifestyle intervention strategies with a goal of achieving 5% to 10% weight loss and adequate improvement in any health targets.
  • In one of its pivotal trials, SURMOUNT-1, patients taking Zepbound along with a reduced caloric meal plan and increasing physical activity saw a weight loss of 22.5% when taking the highest dose (15mg per week) of the drug versus 2.4% in the control group after 72 weeks.
  • As with other GLP-1 agonists and Mounjaro, the labeling for Zepbound contains a boxed warning about tumors of the thyroid gland (thyroid C-cell tumors) that have occurred among laboratory rodents treated with some GLP-1 receptor agonists in preclinical studies. However, whether the drugs cause humans to develop thyroid C-cell tumors, such as medullary thyroid carcinoma (MTC), is not yet known. Patients who have MTC, individuals with close family members who have thyroid C-cell tumors, and patients who have Multiple Endocrine Neoplasia syndrome type 2 (tumors in more than one gland) should not use any drug in the class.
  • Other prescription drugs marketed in the U.S. for weight loss and management include Novo Nordisk’s injectable products Saxenda® (liraglutide) and Wegovy® (semaglutide), and the oral drugs, Contrave® (bupropion/naltrexone – Currax Pharmaceuticals) extended-release tablets, Qsymia® (phentermine/topiramate – Vivus) extended-release capsules and Xenical® (orlistat – Cheplapharm/H2 Pharma) capsules. Phentermine (generics) tablets and capsules also are available, but just for short-term use. Additionally, a lower-strength form of orlistat, alli® (GlaxoSmithKline), is sold over-the-counter (OTC).
  • Eli Lilly used a Priority Review Voucher to reduce FDA review time for Zepbound.