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Ryzodeg 70/30 PI

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Ryzodeg 70/30 PI HIGHLIGHTS OF PRESCRIBING INFORMATION ------------------WARNINGS AND PRECAUTIONS------------------------- These highlights do not include all the information needed to use • Never share a RYZODEG 70/30 FlexTouch pen between patients, even if RYZODEG 70/30 safely and effectively. See full prescribing information the needle is changed (5.1). for RYZODEG 70/30. • Hyperglycemia or hypoglycemia with changes in insulin regimen: Make changes to a patient’s insulin regimen (e.g., insulin strength, manufacturer, RYZODEG® 70/30 (insulin degludec and insulin aspart injection), for type, injection site or method of administration) under close medical subcutaneous use supervision with increased frequency of blood glucose monitoring (5.2). Initial U.S. Approval: 2015 • Hypoglycemia: May be life-threatening. Increase monitoring with ---------------------RECENT MAJOR CHANGES----------------------------- changes to: insulin dosage, co-administered glucose lowering Dosage and Administration (2.1)…………………………………. 11/2019 medications, meal pattern, physical activity; and in patients with renal Warnings and Precautions (5.2)…………………………………... 11/2019 impairment or hepatic impairment or hypoglycemia unawareness (5.3,5.4, 6.1). -----------------------INDICATIONS AND USAGE----------------------------- • RYZODEG 70/30 is a mixture of insulin degludec, a long-acting human Hypoglycemia due to medication errors: Accidental mix-ups between insulin analog, and insulin aspart, a rapid-acting human insulin analog, insulin products can occur. Instruct patients to check insulin labels before indicated to improve glycemic control in patients 1 year of age and older with injection. DO NOT transfer RYZODEG 70/30 into a syringe for diabetes mellitus (1). administration as overdosage and severe hypoglycemia can result (5.4). • Hypersensitivity reactions: Severe, life-threatening, generalized allergy, Limitations of Use: including anaphylaxis, can occur. Discontinue RYZODEG 70/30, monitor • Not recommended for treating diabetic ketoacidosis. and treat if indicated (5.5). • • Not recommended for pediatric patients requiring less than 5 units. Hypokalemia: May be life-threatening. Monitor potassium levels in patients at risk for hypokalemia and treat if indicated (5.6). -----------------DOSAGE AND ADMINISTRATION-------------------------- • Fluid retention and heart failure with concomitant use of • DO NOT dilute or mix RYZODEG 70/30 with any other insulin products Thiazolidinediones (TZDs): Observe for signs and symptoms of heart or solutions (2.1). failure; consider dosage reduction or discontinuation if heart failure occurs • Administer subcutaneously into the thigh, upper arm, or abdomen (2.1). (5.7). • Rotate injection sites to reduce risk of lipodystrophy and localized ---------------------------ADVERSE REACTIONS---------------------------------- cutaneous amyloidosis (2.1). Adverse reactions commonly associated with RYZODEG 70/30 are: • Individualize dose based on type of diabetes, metabolic needs, blood • hypoglycemia, allergic reactions, injection site reactions, lipodystrophy, glucose monitoring results and glycemic control goal. (2.2, 2.3, 2.4, 2.5). pruritus, rash, edema and weight gain (6.1). • Administer subcutaneously once or twice daily with any main meal (s) (2.2). To report SUSPECTED ADVERSE REACTIONS, contact Novo Nordisk • Administer a rapid- or short-acting insulin at other meals if needed (2.2). at (1-800-727-6500) or FDA at 1-800-FDA-1088 or • Patients with type 1 diabetes will generally require a rapid-or short-acting www.fda.gov/medwatch. insulin at meals when RYZODEG 70/30 is not administered (2.2). ---------------------------DRUG INTERACTIONS---------------------------------- • Adjust the dose according to fasting blood glucose measurements (2.2). • Drugs that affect glucose metabolism: Adjustment of insulin dosage may • The recommended time between dose increases is 3 to 4 days (2.2) be needed; closely monitor blood glucose (7). • Converting from other insulin therapies may require adjustment of timing • Anti-Adrenergic Drugs (e.g., beta-blockers, clonidine, guanethidine, and and dose of RYZODEG 70/30 (2.4, 2.5). reserpine): Signs and symptoms of hypoglycemia may be reduced or -------------------DOSAGE FORMS AND STRENGTHS-------------------- absent (7). RYZODEG 70/30 100 units/mL (U-100) available in: • 3 mL single-patient-use FlexTouch® (3). See 17 for PATIENT COUNSELING INFORMATION and FDA- --------------------CONTRAINDICATIONS------------------------------------ approved patient labeling. • During episodes of hypoglycemia (4). Revised: 11/2019 • Hypersensitivity to RYZODEG 70/30 or one of its excipients (4). FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS AND USAGE 7 DRUG INTERACTIONS 2 DOSAGE AND ADMINISTRATION 8 USE IN SPECIFIC POPULATIONS 2.1 Important Administration Instructions 8.1 Pregnancy 2.2 General Dosing Instructions 8.2 Lactation 2.3 Starting Dose in Insulin-Naïve Patients 8.4 Pediatric Use 2.4 Starting Dose in Patients with Type 1 or Type 2 Diabetes on a 8.5 Geriatric Use Once or Twice Daily Premix or Self-mix Insulin Alone or as Part 8.6 Renal Impairment of a Regimen of Multiple Daily Injections 8.7 Hepatic Impairment 2.5 Starting Dose in Patients with Type 1 or Type 2 Diabetes on a 10 OVERDOSAGE Once or Twice Daily Basal Insulin Alone or as Part of a Regimen 11 DESCRIPTION of Multiple Daily Injections 12 CLINICAL PHARMACOLOGY 3 DOSAGE FORMS AND STRENGTHS 12.1 Mechanism of Action 4 CONTRAINDICATIONS 12.2 Pharmacodynamics 5 WARNINGS AND PRECAUTIONS 12.3 Pharmacokinetics 5.1 Never Share a RYZODEG 70/30 FlexTouch Pen Between Patients 13 NONCLINICAL TOXICOLOGY 5.2 Hyperglycemia or Hypoglycemia with Changes in Insulin 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility Regimen 14 CLINICAL STUDIES 5.3 Hypoglycemia 14.1 Type 1 Diabetes - Adult 5.4 Hypoglycemia Due to Medication Errors 14.2 Type 1 Diabetes – Pediatric Patients 1 Year of Age and Older 5.5 Hypersensitivity and Allergic Reactions 14.3 Type 2 Diabetes - Adult 5.6 Hypokalemia 16 HOW SUPPLIED/STORAGE AND HANDLING 5.7 Fluid Retention and Congestive Heart Failure with Concomitant 16.1 How Supplied Use of a PPAR Gamma Agonist 16.2 Recommended Storage 6 ADVERSE REACTIONS 17 PATIENT COUNSELING INFORMATION 6.1 Clinical Trial Experience *Sections or subsections omitted from the full prescribing information are not 6.2 Immunogenicity listed. 6.3 Postmarketing Experience FULL PRESCRIBING INFORMATION 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 and localized cutaneous amyloidosis. Do not inject into areas of lipodystrophy or localized cutaneous amyloidosis [see Warnings and Precautions (5.2), Adverse Reactions (6.1, 6.3)]. • During changes to a patient’s insulin regimen, increase the frequency of blood glucose monitoring [see Warnings and Precautions (5.2)]. • Use RYZODEG 70/30 with caution in patients with visual impairment that may rely on audible clicks to dial their dose. • The single-patient-use RYZODEG 70/30 FlexTouch pen dials in 1 unit increments. • 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
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