South Carolina Finance

Feb 9 2018

Lantus, Toujeo (insulin glargine) dosing, indications, interactions, adverse effects, and more

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insulin glargine (Rx)

Cautions

Toujeo and Lantus are not interchangeable

Not recommended for treating diabetic ketoacidosis; use IV short-acting insulin instead

Do not administer IV or via an insulin pump

Do not dilute or mix with other insulin or solution

Never share insulin pens between patients, even if the needle is changed

Decreased insulin requirements: Diarrhea, nausea/vomiting, malabsorption, hypothyroidism, renal impairment, hepatic impairment

Increased insulin requirements include fever, hyperthyroidism, trauma, infection, surgery

Hyper-or hypoglycemia may occur with changes in insulin regimen; carry out under close medical supervision

Increase frequency of glucose monitoring with changes to insulin dosage, co-administered glucose lowering medications, meal pattern, physical activity; and in patients with renal or hepatic impairment and hypoglycemia unawareness

Accidental mix-ups between insulin products can occur; instruct patients to check insulin labels before injection

Rapid changes in serum glucose may induce symptoms of hypoglycemia

Hypoglycemia is the most common cause of adverse reactions (eg, headache, tachycardia)

May cause a shift in potassium from extracellular to intracellular space, possibly leading to hypokalemia; caution when coadministered with potassium-lowering drugs or conditions that may decrease potassium

Frequent glucose monitoring and insulin dose reduction may be required with renal or hepatic impairment; not recommended during periods of rapidly declining renal or hepatic function because of risk for prolonged hypoglycemia

Use cautioin during pregnancy

Thiazolidinediones are peroxisome proliferator-activated receptor (PPAR)-gamma agonists and can cause dose-related fluid retention, particularly when used in combination with insulin; fluid retention may lead to or exacerbate heart failure; monitor for signs and symptoms of heart failure, treat accordingly, and consider discontinuing thiazolidinediones

Cancer risk data inconclusive

  • The FDA reviewed 4 published observational studies, 3 of which suggested an increased risk of cancer associated with insulin glargine
  • It was determined that the evidence presented in these studies is inconclusive due to methodologic limitations
  • The duration of patient follow-up in all 4 studies was shorter than that which is generally considered necessary to evaluate cancer risk from drug exposure
  • Also, the 4 studies provided limited information on patients’ use of insulin products; some studies did not take into account whether the patients used any antidiabetic drugs before the study time period or whether there were any changes in how patients used these drugs during the study period
  • Furthermore, risk factors for cancer (eg, smoking, family history of cancer, obesity) may not have been adequately controlled for in these studies

Instructions

Inject SC once daily into the abdominal area, thigh, or deltoid at the same time each day

Rotate injection sites within the same region from 1 injection to the next to reduce the risk of lipodystrophy

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

The dosage ranges from 1 to 80 units per each injection

To minimize the risk of hypoglycemia titrate the dose no more frequently than every 3-4 day

Dosage 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

To minimize the risk of hypoglycemia, do not administer IV, IM, or via insulin pump

To minimize the risk of hypoglycemia, do not dilute or mix with any other insulin products or solutions

Storage

Unopened vial or pen (not in-use)

  • Refrigerated (36-46°F [2-8°C]): Until expiration date
  • Unrefrigerated and kept from direct heat and light (ie, temperature does not exceed 86°F [30°C]): Up to 28 days
  • Do not freeze

Opened vial or pen (in-use)

  • Vial: 28 days at room temperature or refrigerated
  • Pen: 28 days; store only at room temperature (do not refrigerate)

Prior Authorization
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.

Quantity Limits
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.

Step Therapy
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.

Other Restrictions
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.


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