For: Diabetes Type 1, Diabetes Type 2
Ryzodeg 70/30 (insulin degludec and insulin aspart) is a long-acting insulin analog and rapid-acting human insulin analog combination indicated to improve glycemic control in adults with diabetes mellitus. RYZODEG 70/30 is as a clear, and colorless solution available as a 3mL FlexTouch disposable 959 prefilled pen (see Table 11). 960 961 Table 11 Presentations of RYZODEG 70/30 RYZODEG 70/30 Total volume Concentration Total units available in presentation NDC number Max dose per injection Dose increment Packag Size U-100 FlexTouch 3 mL 100 units/mL 300 Units 0169-2770-15 80 Units 1 Unit 5 pens/p 962 963 16.2 Recommended Storage 964 Unused RYZODEG 70/30 should be stored between 36� to 46�F (2� and 8�C). Do not store 965 in the freezer or directly adjacent to the refrigerator cooling element. Do not freeze. Do not use 966 RYZODEG 70/30 if it has been frozen. HIGHLIGHTS OF PRESCRIBING INFORMATION 2 These highlights do not include all the information needed to use 3 RYZODEG 70/30 safely and effectively. See full prescribing information 4 for RYZODEG 70/30. 5 6 RYZODEG� 70/30 (insulin degludec and insulin aspart injection), for 7 subcutaneous use 8 Initial U.S. Approval: [20 15] 9 -----------------------INDICATIONS AND USAGE----------------------------�10 RYZODEG 70/30 is an insulin analog indicated to improve glycemic control 11 in adults with diabetes mellitus (1). 12 13 Limitations of Use: 14 Not recommended for treating diabetic ketoacidosis. 15 -----------------DOSAGE AND ADMINISTRATION-------------------------�16 �DO NOT dilute or mix RYZODEG 70/30 with any other insulin products17 or solutions (2.1).18 �Rotate injection sites to reduce the risk of lipodystrophy (2.1).19 �Individualize dose based on type of diabetes, metabolic needs, blood20 glucose monitoring results and glycemic control goal. (2. 2, 2.3, 2.4, 2.5).21 �Administer subcutaneously once or twice daily with any main meal (s)22 (2.2).23 �Administer a rapid- or short-acting insulin at other meals if needed (2.2).24 �Patients with type 1 diabetes will generally require a rapid-or short-acting25 insulin at meals when RYZODEG 70/30 is not administered (2.2).26 �Adjust the dose according to fasting blood glucose measurements (2.2).27 �The recommended time between dose increases is 3 to 4 days (2.2)28 �Converting from other insulin therapies may require adjustment of timing29 and dose of RYZODEG 70/30 (2.4, 2.5).30 -------------------DOSAGE FORMS AND STRENGTHS-------------------�31 RYZODEG 70/30 100 units/mL (U-100) available in:32 �3 mL FlexTouch� (3)33 --------------------CONTRAINDICATIONS-----------------------------------�34 �During episodes of hypoglycemia (4).35 �Hypersensitivity to RYZODEG 70/30 or one of its excipients (4).36 ------------------WARNINGS AND PRECAUTIONS------------------------�37 �Never share a RYZODEG 70/30 FlexTouch pen between patients, even if38 the needle is changed (5.1).76 77 FULL PRESCRIBING INFORMATION: CONTENTS* 78 79 1 INDICATIONS AND USAGE 80 2 DOSAGE AND ADMINISTRATION 81 82 83 84 85 86 87 88 3 2.1 Important Administration Instructions 2.2 General Dosing Instructions 2.3 Starting Dose in Insulin Na�ve Type 2 Diabetes Patients 2.4 Starting Dose in Patients with Type 1 or Type 2 Diabetes from Once Daily Insulin Therapies 2.5 Starting Dose in Patients with Type 1 or Type 2 Diabetes from More than Once Daily Insulin Therapies DOSAGE FORMS AND STRENGTHS 89 4 CONTRAINDICATIONS 90 5 WARNINGS AND PRECAUTIONS 91 92 93 94 95 96 97 98 99 100 6 5.1 Never Share a RYZODEG 70/30 FlexTouch Pen Between Patients 5.2 Hyperglycemia or Hypoglycemia with Changes in Insulin Regimen 5.3 Hypoglycemia 5.4 Hypoglycemia Due to Medication Errors 5.5 Hypersensitivity and Allergic Reactions 5.6 Hypokalemia 5.7 Fluid Retention and Congestive Heart Failure with Concomitant Use of a PPAR Gamma Agonist ADVERSE REACTIONS 101 102 103 7 6.1 Clinical Trial Experience 6.2 Immunogenicity DRUG INTERACTIONS 104 8 USE IN SPECIFIC POPULATIONS 105 106 107 8.1 8.3 8.4 Pregnancy Nursing Mothers Pediatric Use 108 8.5 Geriatric Use 109 8.6 Renal impairment 39 �Hyper- or hypoglyemia with changes in insulin regimen: Carry out under 40 close medical supervision and increase frequency of blood glucose 41 monitoring (5.2). 42 �Hypoglycemia: May be life-threatening. Increase monitoring with 43 changes to: insulin dosage, co-administered glucose lowering 44 medications, meal pattern, physical activity; and in patients with renal 45 impairment or hepatic impairment or hypoglycemia unawareness (5.3, 5.4, 46 6.1). 47 �Hypoglycemia due to medication errors: Accidental mix-ups between 48 insulin products can occur. Instruct patients to check insulin labels before 49 injection. DO NOT transfer RYZODEG 70/30 into a syringe for 50 administration as overdosage and severe hypoglycemia can result (5.4). 51 �Hypersensitivity reactions: Severe, life-threatening, generalized allergy, 52 including anaphylaxis, can occur. Discontinue RYZODEG 70/30, monitor 53 and treat if indicated (5.5). 54 �Hypokalemia: May be life-threatening. Monitor potassium levels in 55 patients at risk for hypokalemia and treat if indicated (5.6). 56 �Fluid retention and heart failure with concomitant use of 57 Thiazolidinediones (TZDs): Observe for signs and symptoms of heart 58 failure; consider dosage reduction or discontinuation if heart failure occurs 59 (5.7). 60 ---------------------------ADVERSE REACTIONS---------------------------------�61 Adverse reactions commonly associated with RYZODEG 70/30 are: 62 �hypoglycemia , allergic reactions, injection site reactions, lipodystrophy, 63 pruritus, rash, edema and weight gain (6.1). 64 To report SUSPECTED ADVERSE REACTIONS, contact Novo Nordisk 65 at (1-800-727-6500) or FDA at 1-800-FDA-1088 or 66 www.fda.gov/medwatch. 67 ---------------------------DRUG INTERACTIONS---------------------------------�68 �Drugs that affect glucose metabolism: Adjustment of insulin dosage may 69 be needed; closely monitor blood glucose (7). 70 �Anti-Adrenergic Drugs (e.g., beta-blockers, clonidine, guanethidine, and 71 reserpine): Signs and symptoms of hypoglycemia may be reduced or 72 absent (7). 73 See 17 for PATIENT COUNSELING INFORMATION and FDA�74 approved patient labeling. 75 Revised: 09 /2015
