Ryzodeg 70/30

RYZODEG 70/30- insulin degludec and insulin aspart injection, solution
Novo Nordisk

1 INDICATIONS AND USAGE

RYZODEG 70/30 is indicated to improve glycemic control in patients 1 year of age and older with diabetes mellitus.

Limitations of Use

Not recommended for the treatment of diabetic ketoacidosis.
Not recommended for pediatric patients requiring less than 5 units of RYZODEG 70/30 daily.

2 DOSAGE AND ADMINISTRATION

2.1 Important Administration Instructions

Always check insulin label before administration [see Warnings and Precautions (5.4)].
Inspect visually for particulate matter and discoloration. Only use RYZODEG 70/30 if the solution appears clear and colorless.
Train patients on proper use and injection technique before initiating RYZODEG 70/30. Training reduces the risk of administration errors such as needle sticks and incomplete dosing.
Inject RYZODEG 70/30 subcutaneously into the thigh, upper arm, or abdomen.
Rotate injection sites within the same region from one injection to the next to reduce the risk of lipodystrophy [see Adverse Reactions (6.1)].
DO NOT administer RYZODEG 70/30 intravenously, intramuscularly, or in an insulin infusion pump.
DO NOT dilute or mix RYZODEG 70/30 with any other insulin products or solutions.

2.2 General Dosing Instructions

In adults, inject RYZODEG 70/30 subcutaneously once or twice daily with any main meal and in pediatric patients once daily with any main meal.
Administer a rapid- or a short-acting insulin at other meals if needed.
Patients with type 1 diabetes will generally require a rapid- or short-acting insulin at meals when RYZODEG 70/30 is not administered for optimal glucose control.
Individualize and titrate the dose of RYZODEG 70/30 based on the patient’s metabolic needs, blood glucose monitoring results, and glycemic control goal [see Warnings and Precautions (5.2)].
Adjust the RYZODEG 70/30 dose according to blood glucose measurements before breakfast (fasting).
The recommended time between dose increases is 3 to 4 days.
Dose adjustments may be needed with changes in physical activity, changes in meal patterns (i.e., macronutrient content or timing of food intake), changes in renal or hepatic function or during acute illness to minimize the risk of hypoglycemia or hyperglycemia [see Warnings and Precautions (5.3)].
If a dose of RYZODEG 70/30 is missed, the next dose should be taken with the next main meal of that day and thereafter resume the usual dosing schedule. Patients should not take an extra dose to make up for a missed dose.

2.3 Starting Dose in Insulin-Naïve Patients

Type 1 Diabetes Mellitus

The recommended starting dose of RYZODEG 70/30 in insulin-naïve patients with type 1 diabetes is approximately one-third to one-half of the total daily insulin dose. The remainder of the total daily insulin dose should be administered as a short- or rapid-acting insulin divided between each daily meal. As a general rule, 0.2 to 0.4 units of insulin per kilogram of body weight can be used to calculate the initial total daily insulin dose in insulin-naïve patients with type 1 diabetes.

Type 2 Diabetes Mellitus

The recommended starting dose of RYZODEG 70/30 in insulin-naïve patients with type 2 diabetes mellitus is 10 units once daily.

2.4 Starting Dose in Patients with Type 1 or Type 2 Diabetes on a Once or Twice Daily Premix or Self-mix Insulin Alone or as Part of a Regimen of Multiple Daily Injections

Adults with Type 1 or Type 2 Diabetes

Start RYZODEG 70/30 at the same unit dose and injection schedule as the premix or self-mix insulin. In patients also using short- or rapid-acting insulin at mealtimes continue the short- or rapid-acting insulin at the same dose for meals NOT covered by RYZODEG 70/30.

Pediatric Patients 1 Year of Age and Older with Type 1 or Type 2 Diabetes

Start RYZODEG 70/30 at 80% of the total daily mixed insulin dose in order to minimize the risk of hypoglycemia [see Warnings and Precautions (5.2)] and administer once daily with the main meal of the day. In patients also using short- or rapid-acting insulin at mealtimes continue the short- or rapid-acting insulin at the same dose for meals NOT covered by RYZODEG 70/30.

2.5 Starting Dose in Patients with Type 1 or Type 2 Diabetes on a Once or Twice Daily Basal Insulin Alone or as Part of a Regimen of Multiple Daily Injections

Adults with Type 1 or Type 2 Diabetes

In patients with type 2 diabetes switching from a regimen that includes only a once- or twice-daily basal insulin, start RYZODEG 70/30 at the same unit dose and injection schedule. For patients switching from once-daily basal insulin to once-daily RYZODEG 70/30, monitor blood glucose after starting therapy due to the rapid-acting insulin component [see Warnings and Precautions (5.2)].

In patients switching from a multiple daily injections regimen that includes a basal and short- or rapid-acting insulin at mealtimes, start RYZODEG 70/30 once daily with the main meal at the same unit dose as the basal insulin. Continue the short- or rapid-acting insulin at the same dose for meals NOT covered by RYZODEG 70/30.

Pediatric Patients 1Year of Age and Older with Type 1 or Type 2 Diabetes

Start RYZODEG 70/30 at 80% of the long- or intermediate-acting insulin component of the daily regimen in order to minimize the risk of hypoglycemia [see Warnings and Precautions (5.2)] and administer once daily with the main meal of the day. In patients also using short- or rapid-acting insulin at mealtimes continue the short- or rapid-acting insulin at the same dose for meals NOT covered by RYZODEG 70/30.

3 DOSAGE FORMS AND STRENGTHS

RYZODEG 70/30 is available as a clear and colorless solution for injection in:

100 units/mL (U-100): 3 mL FlexTouch disposable prefilled pen

4 CONTRAINDICATIONS

RYZODEG 70/30 is contraindicated:

During episodes of hypoglycemia [see Warnings and Precautions (5.3)].
In patients with hypersensitivity to RYZODEG 70/30 or one of its excipients [see Warnings and Precautions (5.5)].

5 WARNINGS AND PRECAUTIONS

5.1 Never Share a RYZODEG 70/30 FlexTouch Pen Between Patients

RYZODEG 70/30 FlexTouch disposable prefilled pen should never be shared between patients, even if the needle is changed. Sharing poses a risk for transmission of blood-borne pathogens.

5.2 Hyperglycemia or Hypoglycemia with Changes in Insulin Regimen

Changes in insulin, manufacturer, type, or method of administration may affect glycemic control and predispose to hypoglycemia or hyperglycemia. These changes should be made cautiously and only under medical supervision and the frequency of blood glucose monitoring should be increased. For patients with type 2 diabetes, adjustments in concomitant oral anti-diabetic treatment may be needed. When converting from other insulin therapies to RYZODEG 70/30 follow dosing recommendations [see Dosage and Administration (2.4, 2.5)].

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