DOSAGE

Important Administration Instructions

• Instruct patients to take RYBELSUS at least 30 minutes before the first food, beverage, or other oral medications of the day with no more than 4 ounces of plain water only. Waiting less than 30 minutes, or taking RYBELSUS with food, beverages (other than plain water) or other oral medications will lessen the effect of RYBELSUS by decreasing its absorption. Waiting more than 30 minutes to eat may increase the absorption of RYBELSUS.
• Swallow tablets whole. Do not split, crush, or chew tablets.

Recommended Dosage

• Start RYBELSUS with 3 mg once daily for 30 days. The 3 mg dose is intended for treatment initiation and is not effective for glycemic control.
• After 30 days on the 3 mg dose, increase the dose to 7 mg once daily.
• Dose may be increased to 14 mg once daily if additional glycemic control is needed after at least 30 days on the 7 mg dose.
• Taking two 7 mg RYBELSUS tablets to achieve a 14 mg dose is not recommended.
• If a dose is missed, the missed dose should be skipped, and the next dose should be taken the following day.

Switching Patients Between OZEMPIC And RYBELSUS

• Patients treated with RYBELSUS 14 mg daily can be transitioned to OZEMPIC subcutaneous injection 0.5 mg once weekly. Patients can start OZEMPIC the day after their last dose of RYBELSUS.
• Patients treated with once weekly OZEMPIC 0.5 mg subcutaneous injection can be transitioned to RYBELSUS 7 mg or 14 mg. Patients can start RYBELSUS up to 7 days after their last injection of OZEMPIC. There is no equivalent dose of RYBELSUS for OZEMPIC 1 mg.

SIDE EFFECTS

The following serious adverse reactions are described below or elsewhere in the prescribing information:

• Risk of Thyroid C-cell Tumor
• Pancreatitis
• Diabetic Retinopathy Complications
• Hypoglycemia with Concomitant Use of Insulin Secretagogues or Insulin
• Acute Kidney Injury
• Hypersensitivity

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Pool Of Placebo-Controlled Trials

The data in Table 1 are derived from 2 placebo-controlled trials in patients with type 2 diabetes. These data reflect exposure of 1071 patients to RYBELSUS with a mean duration of exposure of 41.8 weeks. The mean age of patients was 58 years, 3.9% were 75 years or older and 52% were male. In these trials, 63% were White, 6% were Black or African American, and 27% were Asian; 19% identified as Hispanic or Latino ethnicity. At baseline, patients had type 2 diabetes for an average of 9.4 years and had a mean HbA1c of 8.1%. At baseline, 20.1% of the population reported retinopathy. Baseline estimated renal function was normal (eGFR ≥90 mL/min/1.73m²) in 66.2%, mildly impaired (eGFR 60 to 90 mL/min/1.73m²) in 32.4% and moderately impaired (eGFR 30 to 60 mL/min/1.73m²) in 1.4% of patients.

Pool Of Placebo-And Active-Controlled Trials

The occurrence of adverse reactions was also evaluated in a larger pool of patients with type 2 diabetes participating in 9 placebo-and active-controlled trials. In this pool, 4116 patients with type 2 diabetes were treated with RYBELSUS for a mean duration of 59.8 weeks. The mean age of patients was 58 years, 5% were 75 years or older and 55% were male. In these trials, 65% were White, 6% were Black or African American, and 24% were Asian; 15% identified as Hispanic or Latino ethnicity. At baseline, patients had type 2 diabetes for an average of 8.8 years and had a mean HbA1c of 8.2%. At baseline, 16.6% of the population reported retinopathy. Baseline estimated renal function was normal (eGFR ≥90 mL/min/1.73m²) in 65.9%, mildly impaired (eGFR 60 to 90 mL/min/1.73m²) in 28.5%, and moderately impaired (eGFR 30 to 60 mL/min/1.73m²) in 5.4% of the patients. buy rybelsus online