Insulin Lispro Protamine and Insulin Lispro Injectable Suspension Mix75/25 KwikPen (Page 2 of 5)

5.4 Hypoglycemia Due to Medication Errors

Accidental mix-ups between Insulin Lispro Protamine and Insulin Lispro Injectable Suspension Mix75/25 and other insulin products have been reported. To avoid medication errors between Insulin Lispro Protamine and Insulin Lispro Injectable Suspension Mix75/25 and other insulins, instruct patients to always check the insulin label before each injection.

5.5 Hypersensitivity Reactions

Severe, life-threatening, generalized allergy, including anaphylaxis, can occur with insulin products, including Insulin Lispro Protamine and Insulin Lispro Injectable Suspension Mix75/25. If hypersensitivity reactions occur, discontinue Insulin Lispro Protamine and Insulin Lispro Injectable Suspension Mix75/25; treat per standard of care and monitor until symptoms and signs resolve. Insulin Lispro Protamine and Insulin Lispro Injectable Suspension Mix75/25 is contraindicated in patients who have had hypersensitivity reactions to Insulin Lispro Protamine and Insulin Lispro Injectable Suspension Mix75/25 or any of its excipients [see Contraindications (4)].

5.6 Hypokalemia

All insulin products, including Insulin Lispro Protamine and Insulin Lispro Injectable Suspension Mix75/25, cause a shift in potassium from the extracellular to intracellular space, possibly leading to hypokalemia. Untreated hypokalemia may cause respiratory paralysis, ventricular arrhythmia, and death. Monitor potassium levels in patients at risk for hypokalemia if indicated (e.g., patients using potassium-lowering medications, patients taking medications sensitive to serum potassium concentrations).

5.7 Fluid Retention and Heart Failure with Concomitant Use of PPAR-gamma Agonists

Thiazolidinediones (TZDs), which are peroxisome proliferator-activated receptor (PPAR)-gamma agonists, can cause dose-related fluid retention, particularly when used in combination with insulin. Fluid retention may lead to or exacerbate heart failure. Patients treated with insulin, including Insulin Lispro Protamine and Insulin Lispro Injectable Suspension Mix75/25, and a PPAR-gamma agonist should be observed for signs and symptoms of heart failure. If heart failure develops, it should be managed according to current standards of care, and discontinuation or dose reduction of the PPAR-gamma agonist must be considered.

6 ADVERSE REACTIONS

The following adverse reactions are discussed elsewhere in the labeling:

  • Hypoglycemia [see Warnings and Precautions (5.3)]
  • 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 from Clinical Studies or Postmarketing Reports

The following adverse reactions have been identified during post-marketing use of Insulin Lispro Protamine and Insulin Lispro Injectable Suspension Mix75/25. Because some of these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Adverse reactions associated with insulin initiation and glucose control intensification

Intensification or rapid improvement in glucose control has been associated with a transitory, reversible ophthalmologic refraction disorder, worsening of diabetic retinopathy, and acute painful peripheral neuropathy. Over the long-term, improved glycemic control decreases the risk of diabetic retinopathy and neuropathy.

Hypersensitivity reactions

Severe, life-threatening, generalized allergy, including anaphylaxis.

Hypoglycemia

Hypoglycemia is the most commonly observed adverse reaction in Insulin Lispro Protamine and Insulin Lispro Injectable Suspension Mix75/25.

Hypokalemia

Insulin Lispro Protamine and Insulin Lispro Injectable Suspension Mix75/25 can cause a shift in potassium from the extracellular to intracellular space, possibly leading to hypokalemia.

Injection site reactions

Insulin Lispro Protamine and Insulin Lispro Injectable Suspension Mix75/25 can cause local injection site reactions including redness, swelling, or itching at the site of injection. These reactions usually resolve in a few days to a few weeks, but in some occasions, may require discontinuation. Localized reactions and generalized myalgias have been reported with the use of meta-cresol, which is an excipient in Insulin Lispro Protamine and Insulin Lispro Injectable Suspension Mix75/25.

Lipodystrophy

Administration of insulin subcutaneously, including Insulin Lispro Protamine and Insulin Lispro Injectable Suspension Mix75/25, has resulted in lipoatrophy (depression in the skin) or lipohypertrophy (enlargement or thickening of tissue) [see Dosage and Administration (2.1)] in some patients.

Localized cutaneous amyloidosis

Localized cutaneous amyloidosis at the injection site has occurred. Hyperglycemia has been reported with repeated insulin injections into areas of localized cutaneous amyloidosis; hypoglycemia has been reported with a sudden change to an unaffected injection site.

Medication Errors

Medication errors in which other insulins have been accidentally substituted for Insulin Lispro Protamine and Insulin Lispro Injectable Suspension Mix75/25 have been identified during postapproval use.

Peripheral Edema

Insulin, including Insulin Lispro Protamine and Insulin Lispro Injectable Suspension Mix75/25, may cause sodium retention and edema, particularly if previously poor metabolic control is improved by intensified insulin therapy.

Weight gain

Weight gain can occur with insulin therapy, including Insulin Lispro Protamine and Insulin Lispro Injectable Suspension Mix75/25, and has been attributed to the anabolic effects of insulin and the decrease in glycosuria.

Immunogenicity

As with all therapeutic peptides, insulin administration may cause anti-insulin antibodies to form. The incidence of antibody formation with Insulin Lispro Protamine and Insulin Lispro Injectable Suspension Mix75/25 is unknown.

7 DRUG INTERACTIONS

Table 1: Clinically Significant Drug Interactions with Insulin Lispro Protamine and Insulin Lispro Injectable Suspension Mix75/25
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 analog (e.g., octreotide), and sulfonamide antibiotics.
Intervention: Dose adjustment and increased frequency of glucose monitoring may be required when Insulin Lispro Protamine and Insulin Lispro Injectable Suspension Mix75/25 is co-administered with these drugs.
Drugs that May Decrease the Blood Glucose Lowering Effect of Insulin Lispro Protamine and Insulin Lispro Injectable Suspension Mix75/25
Drugs: Atypical antipsychotics (e.g., olanzapine and clozapine), corticosteroids, danazol, diuretics, estrogens, glucagon, isoniazid, niacin, oral contraceptives, phenothiazines, progestogens (e.g., in oral contraceptives), protease inhibitors, somatropin, sympathomimetic agents (e.g., albuterol, epinephrine, terbutaline), and thyroid hormones.
Intervention: Dose adjustment and increased frequency of glucose monitoring may be required when Insulin Lispro Protamine and Insulin Lispro Injectable Suspension Mix75/25 is co-administered with these drugs.
Drugs that May Increase or Decrease the Blood Glucose Lowering Effect of Insulin Lispro Protamine and Insulin Lispro Injectable Suspension Mix75/25
Drugs: Alcohol, beta-blockers, clonidine, and lithium salts. Pentamidine may cause hypoglycemia, which may sometimes be followed by hyperglycemia.
Intervention: Dose adjustment and increased frequency of glucose monitoring may be required when Insulin Lispro Protamine and Insulin Lispro Injectable Suspension Mix75/25 is co-administered with these drugs.
Drugs that May Blunt Signs and Symptoms of Hypoglycemia
Drugs: Beta-blockers, clonidine, guanethidine, and reserpine.
Intervention: Increased frequency of glucose monitoring may be required when Insulin Lispro Protamine and Insulin Lispro Injectable Suspension Mix75/25 is co-administered with these drugs.

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