insulin degludec/insulin aspart (Rx)

Brand and Other Names:Ryzodeg
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

prefilled pen

  • insulin degludec 70 units/insulin aspart 30 units per mL (ie, 100 units/mL for combination)

Diabetes Mellitus Types 1 & 2

Indicated to improve glycemic control in adults with diabetes mellitus

Starting dose in insulin naïve patients

  • Type 1 diabetes mellitus: ~One third to one half of the total daily insulin dose; as a general rule; the remainder of the total daily insulin dose should be administered as a short- or rapid-acting insulin divided between each daily meal; 0.2-0.4 units/kg can be used to calculate the initial total daily insulin dose in insulin-naïve patients with type 1 diabetes
  • Type 2 diabetes mellitus: 10 units SC once daily

Starting dose in patients with types 1 or 2 diabetes on a once or twice daily premix or self-mix insulin alone or as part of a regimen of multiple daily injections

  • Start insulin degludec/insulin aspart 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 degludec/insulin aspart 70/30

Starting dose in patients with types 1 or 2 diabetes on a once or twice daily basal insulin alone or as part of a regimen of multiple daily injections

  • Patients with T2DM switching from regimen that includes only a once- or twice-daily basal insulin, start insulin degludec/insulin aspart 70/30 at the same unit dose and injection schedule
  • For patients switching from once-daily basal insulin to once-daily insulin degludec/insulin aspart 70/30, monitor blood glucose after starting therapy due to the rapid-acting insulin component
  • In patients switching from a multiple daily injections regimen that includes a basal and short- or rapid-acting insulin at mealtimes, start insulin degludec/insulin aspart 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 insulin degludec/insulin aspart 70/30

Dosing Considerations

Not recommended for treatment of diabetic ketoacidosis

Safety and efficacy not established

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Interactions

Interaction Checker

and insulin degludec/insulin aspart

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            Adverse Effects

            >10%

            Nasopharyngitis (11.1-24.6%)

            Severe hypoglycemia (0.4-13.3%)

            1-10%

            Headache (5.6-9.7%)

            URT infection (5.7-9.1%)

            Influenza (6.9%)

            Peripheral edema (1.8-2.2%)

            Injection site reaction (2%)

            <1%

            Allergic reaction

            Lipodystrophy

            Postmarketing reports

            Localized cutaneous amyloidosis at injection site

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            Warnings

            Contraindications

            During episodes of hypoglycemia

            Documented hypersensitivity

            Cautions

            Do not share, even if the needle is changed; sharing poses a risk for transmission of blood-borne pathogens

            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

            Severe, life-threatening, generalized allergy, including anaphylaxis, can occur

            All insulin products cause a shift in potassium from the extracellular to intracellular space, possibly leading to hypokalemia; monitor potassium levels in patients at risk for hypokalemia including patients using potassium-lowering medications or those taking medications sensitive to serum potassium concentrations; treat if indicated

            Thiazolidinediones, which are peroxisome proliferator-activated receptor (PPAR)-gamma agonists can cause dose-related fluid retention, particularly when used in combination with insulin; this may lead to or exacerbate heart failure

            Hyperglycemia or hypoglycemia with changes in insulin regimen

            • Hypoglycemia is the most common adverse effect and can happen suddenly; severe hypoglycemia can cause seizures, may be life-threatening, or cause death
            • Hypoglycemia can impair concentration ability and reaction time and place an individual and others at risk in situations where these abilities are important (eg, driving or operating other machinery)
            • Risk increases with intensity of glycemic control and is related to the duration of action of the insulin
            • Other factors that may increase the risk of hypoglycemia include changes in meal pattern (eg, macronutrient content or timing of meals), changes in level of physical activity, or changes to coadministered medication
            • Renal or hepatic impairment may increase hypoglycemia risk
            • In patients at higher risk for hypoglycemia and patients who have reduced symptomatic awareness of hypoglycemia, increased frequency of blood glucose monitoring is recommended
            • Accidental mix-ups between basal insulin products and other insulins, particularly rapid-insulins, have been reported
            • Do not transfer insulin degludec from the prefilled pen to a syringe; the markings on the insulin syringe will not measure the dose correctly and can result in overdosage and severe hypoglycemia
            • Changes in insulin, insulin strength, manufacturer, type, or method of administration may affect glycemic control and predispose to hypoglycemia or hyperglycemia
            • Changes should be made cautiously and only under close medical supervision and frequency of blood glucose monitoring should be increased
            • Repeated insulin injections into areas of lipodystrophy or localized cutaneous amyloidosis reported to result in hyperglycemia; a sudden change in the injection site (to unaffected area) has been reported to result in hypoglycemia
            • Make any changes to a patient’s insulin regimen under close medical supervision with increased frequency of blood glucose monitoring
            • Advise patients who have repeatedly injected into areas of lipodystrophy or localized cutaneous amyloidosis to change injection site to unaffected areas and closely monitor for hypoglycemia
            • For patients with type 2 diabetes, dosage adjustments in concomitant oral antidiabetic treatment may be needed
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            Pregnancy

            Pregnancy

            There are no available data in pregnant women to inform a drug-associated risk for major birth defects and miscarriage; available information from published randomized controlled trials with insulin aspart use during second trimester of pregnancy have not reported association with insulin aspart and major birth defects or adverse maternal or fetal outcomes

            Poorly controlled diabetes in pregnancy increases maternal risk for diabetic ketoacidosis, pre-eclampsia, spontaneous abortions, preterm delivery, stillbirth and delivery complications; poorly controlled diabetes increases fetal risk for major birth defects, still birth, and macrosomia related morbidity

            Lactation

            There are no data on presence of drug in human milk, effects on breastfed infant, or effect on milk production; insulin degludec is present in rat milk; one small published study reported that exogenous insulin, including insulin aspart, was present in human milk; however, there is insufficient information to determine effects on the breastfed infant and no available information on effects on milk production; developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for insulin, potential adverse effects on breastfed child therapy or from underlying maternal condition

            Pregnancy Categories

            A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA: Information not available.

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            Pharmacology

            Mechanism of Action

            Insulin degludec: Long-acting basal insulin

            Insulin aspart: Rapid-acting insulin

            Insulin and its analogues lower blood glucose by stimulating peripheral glucose uptake, especially by skeletal muscle and fat, and by inhibiting hepatic glucose production; insulin inhibits lipolysis and proteolysis and enhances protein synthesis; targets include skeletal muscle, liver, and adipose tissue

            Absorption

            Onset of action (insulin aspart): 14 min

            Peak plasma time: 9 hr insulin degludec; 72 min insulin aspart

            Steady state (insulin degludec): 3-4 days

            Distribution

            Protein bound: >99% to albumin insulin degludec; <10% insulin aspart

            Metabolism

            Metabolites: Inactive

            Elimination

            Half-life: ~25 hr insulin degludec

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            Administration

            Preparation

            Inspect visually for particulate matter and discoloration; only use if the solution appears clear and colorless

            Do not dilute or mix with any other insulin products or solutions

            Do not transfer drug from the insulin degludec pen into a syringe for administration

            SC Administration

            Inject SC once or twice 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 insulin degludec/insulin aspart 70/30 is not administered for optimal glucose control

            Individualize and titrate the dose based on the patient’s metabolic needs, blood glucose monitoring results, and glycemic control goal

            Adjust dose according to blood glucose measurements before breakfast (fasting)

            Inject SC into the thigh, upper arm, or abdomen

            The recommended days between dose increases is 3-4 days

            Dose adjustments may be needed with changes in physical activity, changes in meal patterns (ie, 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

            If a dose of insulin degludec/insulin aspart 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

            Storage

            Unopened (not in-use) prefilled pen

            • Refrigerate at 36-46°F (2-8°C)
            • Do not store in the freezer or directly adjacent to the refrigerator cooling element
            • Do not freeze
            • Do not use if it has been frozen

            Open (in-use) prefilled pen

            • Should NOT be refrigerated but should be kept at room temperature (<86°F [30°C])
            • Keep away from direct heat and light
            • The opened pen may be used for up to 28 days (4 wk) after being opened, if it is kept at room temperature
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            Formulary

            FormularyPatient Discounts

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            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.