insulin lispro protamine/insulin lispro (Rx)

Frequency Not Defined

Hypoglycemia

Insulin resistance

Lipodystrophy

Lipohypertrophy

Local allergic reaction

Hypokalemia

Injection site reactions

Weight gain

Edema

Pruritus

Rash

Contraindications

Hypersensitivity

During episodes of hypoglycemia

Cautions

Never share pen between patients even it needle is changed

Suspension for SC use, do not administer IV

Administer within 15 minutes of meals (rapid onset and peak ~1 hr)

Rapid changes in serum glucose may induce symptoms of hypoglycemia

Early warning symptoms of hypoglycemia may be different or less pronounced under certain conditions (eg, long duration of diabetes, diabetic nerve disease, use of beta-blockers or intensified diabetes control)

Caution in conditions with decreased insulin requirements (eg, diarrhea, nausea, vomiting, malabsorption, hypothyroidism, renal impairment, hepatic impairment)

Caution in conditions with increased insulin requirements (eg, fever, hyperthyroidism, trauma, infection, surgery)

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 and treat accordingly and consider discontinuing thiazolidinediones

Glucose monitoring recommended for all patients with diabetes

Do not mix with other insulins

Do not administer via insulin infusion pump

Hypoglycemia may be life-threatening; increase frequency of blood glucose monitoring with changes to insulin dosage, co-administered glucose lowering medications, meal pattern, physical activity; in patients with renal or hepatic impairment; and in patients with hypoglycemia unawareness

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

Severe, life-threatening, generalized allergy, including anaphylaxis, reported; discontinue therapy, monitor, and treat if indicated

Hypokalemia may occur; may be life-threatening; monitor potassium levels in patients at risk of hypokalemia and treat if indicated

Pregnancy

The limited available data in pregnant women are insufficient to inform a drug-associated risk of adverse developmental outcomes; published studies during pregnancy have not reported association between drug and induction of major birth defects, miscarriage, or adverse maternal or fetal outcomes; there are risks to mother and fetus associated with poorly controlled diabetes in pregnancy

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

Animal data

• Pregnant rats and rabbits exposed to drug during organogenesis showed no adverse effects on embryo/fetal viability or morphology in offsprings administered a dose approximately 3 times the human subcutaneous dose of 1 unit insulin lispro/kg/day; no adverse effects on embryo/fetal development were observed in offspring of rabbits exposed to insulin lispro at doses up to approximately 0.24 times the human subcutaneous dose of 1 unit/kg/day

Lactation

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

Bioavailability: SC, well absorbed (2-3 times faster than regular insulin)

Onset: <15 min

Peak Plasma Time: 30-90 min

Protein Bound: 0-9%; similar to regular human insulin

Metabolism: Liver >50%, kidney 30%, adipose tissue/muscle 20%

Vd: 0.26-0.36 L/kg

Mechanism of Action

Binds insulin receptors; activates mechanisms that lower blood glucose by facilitating cellular uptake of glucose into skeletal muscle and fat, simultaneously inhibits glucose output from liver