HUMALOG KWIKPEN 100/UNITS/ML 5×3ML/PENFILL @

Indications

Approved Uses

To improve glycemic control in adults and pediatric patients with diabetes mellitus (type 1 and type 2).

Off-Label Uses

Hyperkalemia treatment (IV regular insulin is standard; insulin lispro may be used in some institutions with dextrose), and inpatient IV insulin protocols for DKA/HHS are generally off-label for lispro (regular insulin is most commonly referenced). Gestational diabetes use is common in practice but depends on local formulary/pregnancy guidance and is not universally labeled.

Dosage & Administration

Dosing by Condition

Type 1 and Type 2 diabetes: individualized prandial dosing given within 15 minutes before or immediately after meals as part of a basal-bolus regimen or with other glucose-lowering therapy; total daily insulin needs are commonly ~0.4-1 unit/kg/day (varies widely), with prandial component titrated to carbohydrate intake and pre-meal glucose. CSII (pump): may be used with individualized basal rates and bolus dosing per pump protocols.

Initial Dose

Type 1: Individualized; total daily insulin dose typically 0.4-0.6 IU/kg/day with approximately 50% as basal and 50% as bolus. Type 2 (insulin-naive): 4-6 IU per meal

Maintenance Dose

Individualized based on blood glucose monitoring; typical mealtime dose ranges from 4 to 20 IU per meal depending on carbohydrate content and insulin sensitivity

Maximum Dose

No absolute maximum dose; dose is individualized based on glucose monitoring and clinical response.

Children's Dosage

Approved for pediatric patients with diabetes mellitus: dosing individualized based on metabolic needs, blood glucose monitoring, and glycemic control.

Dose Adjustment Notes

Individualize and titrate based on blood glucose monitoring and glycemic targets; adjust with changes in meals/carbohydrate intake, activity, illness/stress, and concomitant medications. Dose reduction may be needed in renal or hepatic impairment; monitor closely during transitions and when rotating injection sites.

How to Take

Subcutaneous injection using the pre-filled KwikPen into abdomen, thigh, upper arm, or buttocks; rotate injection sites within the same region. Administer within 15 minutes before a meal or immediately after a meal. Use a new needle for each injection, prime per pen instructions before each injection, and do not share the pen. Do not inject into areas of lipodystrophy or localized skin abnormalities.

How to Prepare

Inspect solution (should be clear/colorless); use a new needle each time; prime the pen (commonly 2 units) until a drop/stream appears; dial prescribed dose; inject subcutaneously and keep the needle in the skin for ~10 seconds before withdrawing; rotate injection sites and do not share pens.

Side Effects

Common Side Effects

Hypoglycemia, injection site reactions (redness, swelling, itching), lipodystrophy at injection sites, weight gain, peripheral edema

Side Effect Frequency

Hypoglycemia (most common); injection site reactions, lipodystrophy, pruritus/rash, weight gain, peripheral edema (observed); hypersensitivity reactions, hypokalemia (warnings).

Safety & Warnings

Contraindications

Contraindicated during episodes of hypoglycemia and in patients with hypersensitivity to insulin lispro or any excipient.

Warnings & Precautions

Monitor for hypoglycemia; do not share pens between patients; verify insulin type/strength to prevent medication errors; rotate injection sites to reduce lipodystrophy/cutaneous amyloidosis; risk of hypokalemia; caution with TZDs due to edema/heart failure; adjust doses during illness/stress/diet changes; watch for serious allergic reactions.

Age Restriction

Approved for use in adults and pediatric patients (no lower age limit specified) with diabetes mellitus.

Driving Warning

Safe

Drug Interactions

Drug Interactions

Key interactions: (1) Drugs increasing hypoglycemia risk (e.g., ACE inhibitors, MAO inhibitors, salicylates, some fluoroquinolones, other antidiabetics); (2) Drugs decreasing insulin effect/raising glucose (e.g., corticosteroids, thiazide/loop diuretics, sympathomimetics, oral contraceptives, atypical antipsychotics); (3) Beta-blockers may mask hypoglycemia symptoms; (4) Thiazolidinediones with insulin increase fluid retention/heart failure risk; alcohol can increase hypoglycemia risk.

Interaction Severity

MAJOR: Thiazolidinediones (pioglitazone/rosiglitazone) with insulin-risk of fluid retention and heart failure. MODERATE: Drugs that increase hypoglycemia risk (e.g., ACE inhibitors/ARBs, salicylates, MAO inhibitors, some antidepressants such as fluoxetine, sulfonamide antibiotics) and drugs that raise glucose/antagonize insulin (e.g., corticosteroids, thiazide/loop diuretics, thyroid hormones, sympathomimetics, atypical antipsychotics, oral contraceptives). MINOR/CLINICALLY RELEVANT: Alcohol and beta-blockers/clonidine-may increase hypoglycemia risk and/or mask symptoms.

Food Interaction

Administer within 15 minutes before a meal or immediately after a meal; match dose to carbohydrate intake and anticipated activity to reduce hypo-/hyperglycemia.

Special Populations

Pregnancy

Consult Doctor

Breastfeeding

Safe

Children

Approved for pediatric patients with diabetes mellitus: dosing individualized based on metabolic needs, blood glucose monitoring, and glycemic control.

Elderly

Use with caution; hypoglycemia may be less symptomatic and more dangerous. Start at lower doses, titrate slowly, and monitor blood glucose frequently. Renal function decline in elderly may reduce insulin clearance.

Kidney Impairment

No fixed adjustment by eGFR/CrCl; insulin requirements may be reduced in renal impairment-monitor glucose closely and titrate to effect.

Liver Impairment

No fixed adjustment; insulin requirements may be reduced in hepatic impairment-monitor glucose closely and titrate to effect.

Storage & Patient Advice

Storage Conditions

store in a refrigerator (2°c - 8°c)

Preparation Instructions

Inspect solution (should be clear/colorless); use a new needle each time; prime the pen (commonly 2 units) until a drop/stream appears; dial prescribed dose; inject subcutaneously and keep the needle in the skin for ~10 seconds before withdrawing; rotate injection sites and do not share pens.

Missed Dose

If a mealtime dose is missed, check blood glucose and follow the patient’s prescribed correction/bolus plan; if the meal is already finished, a correction dose may be needed based on glucose and clinician instructions-do not double the next dose. If unsure or recurrent, contact the prescriber/diabetes team.

Stopping the Medicine

Do not stop insulin without medical supervision; abrupt discontinuation (especially in type 1 diabetes) can cause severe hyperglycemia and diabetic ketoacidosis.

Overdose

Overdose causes hypoglycemia (and may cause hypokalemia); treat mild/moderate with oral fast-acting carbohydrate, and severe episodes with glucagon IM/SC or IV dextrose with close monitoring and repeat treatment as needed; seek urgent medical care for severe/prolonged events.

Patient Counseling

Verify insulin name and strength (U-100) before each dose; inject within 15 minutes before or immediately after meals; rotate sites and avoid injecting into lipodystrophy/irritated skin; use a new needle each time, prime per pen instructions, and never share the pen. Recognize and treat hypoglycemia, carry fast-acting glucose, and monitor glucose as directed; store unopened pens refrigerated (2-8°C per SFDA) and follow product labeling for in-use storage/time at room temperature.

Monitoring Requirements

Monitor blood glucose regularly (SMBG or CGM) including pre-meal and as clinically indicated; HbA1c about every 3 months (up to every 3-6 months when stable). Monitor for hypoglycemia, weight changes, and injection-site reactions/lipodystrophy; check serum potassium in at-risk patients (e.g., high-dose/IV use, renal impairment) and assess renal/hepatic function periodically when clinically indicated.

Pharmacology

Mechanism of Action

Rapid-acting insulin analog that binds insulin receptors to increase peripheral glucose uptake (muscle/fat) and decrease hepatic glucose production; also inhibits lipolysis and proteolysis and promotes glycogen synthesis. The B28-B29 amino-acid inversion reduces hexamer formation, enabling faster absorption than regular human insulin.

Onset of Action

Approximately 10 to 15 minutes after subcutaneous injection.

Duration of Effect

Approximately 3 to 5 hours (may vary by dose, site, and patient factors).

Half-Life

Approximately 1 hour (about 50-60 minutes) for apparent terminal half-life after subcutaneous dosing; clinical duration of action typically ~3-5 hours.

Bioavailability

Not well-defined/variable after subcutaneous administration (no single reliable % bioavailability reported for insulin lispro).

Metabolism

Proteolytic degradation (insulinase/proteases) primarily in kidney and liver, with additional metabolism in muscle and other tissues; pathways are similar to endogenous human insulin.

Excretion

Primarily renal clearance (kidney is a major site of insulin degradation/clearance), with additional hepatic and peripheral (muscle) degradation; intact drug is not meaningfully excreted unchanged in urine.

Protein Binding

Negligible/low (not significantly protein bound), similar to human insulin.

Product Information

Available Dosage Forms

Injection, solution (insulin lispro) supplied as: 10 mL vial (U-100), 3 mL cartridge (U-100), and 3 mL prefilled pen (KwikPen; U-100 and also a U-200 KwikPen presentation in some markets).

Composition per Dose

Each 3 ml cartridge/pen: Insulin lispro 300 IU (100 IU/ml). Excipients: m-cresol 3.15 mg/ml, glycerol 16 mg/ml, dibasic sodium phosphate 1.88 mg/ml, zinc oxide (sufficient to provide 0.0197 mg zinc/ml), water for injections

Generic Availability

No

OTC Alternatives

No OTC alternative

Diabetes Type

Both

Insulin Type

Rapid-acting

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