Insulin Degludec

Generic Name: insulin degludec

Insulin Analog [EPC]Over-the-Counter (OTC)

Brand Names:

Insulin Degludec

11 DESCRIPTION Insulin degludec is a long-acting basal human insulin analog for subcutaneous injection produced by a process that includes expression of recombinant DNA in Saccharomyces cerevisiae followed by chemical modification. Insulin degludec differs from human insulin in that the amino acid threonine in position B30 has been omitted and a side-chain consisting of glutamic acid and a C16 fatty acid has been attached (chemical name: LysB29(Nε-hexadecandioyl-γ-Glu) des(B30) human insulin).

Overview

Uses

1 INDICATIONS AND USAGE Insulin Degludec 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. Insulin Degludec is a long-acting human insulin analog indicated to improve glycemic control in patients 1 year of age and older with diabetes mellitus ( 1 ). Limitations of Use: • Not recommended for the treatment of diabetic ketoacidosis.

Dosage

2 DOSAGE AND ADMINISTRATION • See Full Prescribing Information for important administration instructions ( 2.1 ). • Inject Insulin Degludec subcutaneously into the thigh, upper arm, or abdomen ( 2.1 ). • Rotate injection sites to reduce risk of lipodystrophy and localized cutaneous amyloidosis ( 2.1 ). • For pediatric patients requiring less than 5 units of Insulin Degludec each day, use an Insulin Degludec U-100 vial ( 2.1 ). • In adults, inject subcutaneously once daily at any time of day ( 2.2 ). • In pediatric patients inject subcutaneously once daily at the same time every day ( 2.2 ). • Individualize dose based on type of diabetes, metabolic needs, blood glucose monitoring results and glycemic control goal ( 2.2 ).

Side Effects

6 ADVERSE REACTIONS The following adverse reactions are also discussed elsewhere: • Hypoglycemia [see Warnings and Precautions ( 5.3 )] • Hypoglycemia due to Medication errors [see Warnings and Precautions ( 5.4 )] • Hypersensitivity reactions [see Warnings and Precautions ( 5.5 )] • Hypokalemia [see Warnings and Precautions ( 5.6 )] Adverse reactions commonly associated with Insulin Degludec are: • hypoglycemia, allergic reactions, injection site reactions, lipodystrophy, pruritus, rash, edema and weight gain ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Novo Nordisk Pharma, Inc. at 1-800-727-6500 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Interactions

7 DRUG INTERACTIONS Table 5 includes clinically significant drug interactions with Insulin Degludec. Table 5: Clinically Significant Drug Interactions with Insulin Degludec Drugs That May Increase the Risk of Hypoglycemia Drugs: Antidiabetic agents, ACE inhibitors, angiotensin II receptor blocking agents, disopyramide, fibrates, fluoxetine, monoamine oxidase inhibitors, pentoxifylline, pramlintide, salicylates, somatostatin analogs (e.g., octreotide), and sulfonamide antibiotics, GLP-1 receptor agonists, DPP-4 inhibitors, SGLT-2 inhibitors. Intervention: Dosage reductions and increased frequency of glucose monitoring may be required when Insulin Degludec is co-administered with these drugs.

Warnings

5 WARNINGS AND PRECAUTIONS • Never share an Insulin Degludec FlexTouch pen, insulin syringe, or needle between patients, even if the needle is changed ( 5.1 ). • Hyperglycemia or hypoglycemia with changes in insulin regimen: Make changes to a patient’s insulin regimen (e.g., insulin strength, manufacturer, type, injection site or method of administration) under close medical supervision with increased frequency of blood glucose monitoring ( 5.2 ). • Hypoglycemia : May be life-threatening. Increase monitoring with changes to: insulin dosage, concomitant drugs, meal pattern, physical activity; and in patients with renal impairment or hepatic impairment or hypoglycemia unawareness ( 5.3 , 5.4 , 6.1 ). 4 CONTRAINDICATIONS Insulin Degludec is contraindicated: • During episodes of hypoglycemia [see Warnings and Precautions ( 5.3 )] . • In patients with hypersensitivity to insulin degludec or any of the excipients in Insulin Degludec [see Warnings and Precautions ( 5.5 )] . • During episodes of hypoglycemia ( 4 ).

Pregnancy

8.1 Pregnancy Risk Summary Available data from one unpublished trial and the published literature with Insulin Degludec use during pregnancy have not identified a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes.

Storage

16 HOW SUPPLIED/STORAGE AND HANDLING Product: 50090-7176 NDC: 50090-7176-0 3 mL in a SYRINGE, PLASTIC / 5 in a CARTON

Frequently Asked Questions

What is Insulin Degludec used for?▼

What are the side effects of Insulin Degludec?▼

Can I take Insulin Degludec during pregnancy?▼

What are the important warnings for Insulin Degludec?▼

Related Medications

Glycerin Ophthalmic Solution

glycerin ophthalmic solution

Non-Standardized Chemical Allergen [EPC]

Purpose Purpose: Eye Lubricant

Aconitum Napellus, Allium Cepa, Anis Barbariae, Bryonia Alba, Echinacea Angustifolia, Eupatorium Perfollatum, Gelsemium Sempervirens, Ipecacauanha, Nux Vomica, Pulsatilla, Rhus Toxicodendron

aconitum napellus, allium cepa, anis barbariae, bryonia alba, echinacea angustifolia, eupatorium perfollatum, gelsemium sempervirens, ipecacauanha, nux vomica, pulsatilla, rhus toxicodendron

Non-Standardized Food Allergenic Extract [EPC]

Purpose* dry cough and wet cough sneezing and runny nose flu symptoms sinus pain, chills and fatigue sore throat and dry throat restless sleep chest congestion headache loss of smell nasal congestion mucus and loss of taste fever and body aches

Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride, Triprolidine Hydrochloride

acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride, triprolidine hydrochloride

Active ingredients (in each caplet) Mucinex Sinus-Max Day Pressure, Pain & Cough Purposes Acetaminophen 325 mg Pain reliever Dextromethorphan HBr 10 mg Cough suppressant Guaifenesin 200 mg Expectorant Phenylephrine HCl 5 mg Nasal decongestant Active ingredients (in each caplet) Mucinex Nightshift Night Sinus Purposes Acetaminophen 325 mg Pain reliever/fever reducer Dextromethorphan HBr 10 mg Cough suppressant Phenylephrine HCl 5 mg Nasal decongestant Triprolidine HCl 1.25 mg Antihistamine

Medical Disclaimer

This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.