HUMALOG KWIKPEN MIX50 100/UNITS/ML 5×3ML/PENFILL @

Indications

Approved Uses

To improve glycemic control in patients with diabetes mellitus (type 1 or type 2) where insulin therapy is indicated.

Dosage & Administration

Dosing by Condition

Type 1 diabetes: use only as part of an insulin regimen that also includes basal insulin; dosing is individualized (often multiple daily injections), and premixed insulin is less commonly used. Type 2 diabetes: individualized dosing; when used as premix, it is commonly given twice daily with meals (e.g., before breakfast and before the evening meal), with titration based on SMBG.

Maximum Dose

No absolute maximum dose; individualize and titrate to glycemic targets while avoiding hypoglycemia.

Children's Dosage

Safety and efficacy not established in pediatric patients.

Dose Adjustment Notes

Dose must be individualized and adjusted based on self-monitored blood glucose and glycemic targets; adjustments are commonly needed with changes in meals, physical activity, intercurrent illness, stress, or concomitant drugs. Renal or hepatic impairment may reduce insulin requirements and increase hypoglycemia risk, so closer monitoring and potential dose reduction are needed.

How to Take

For subcutaneous injection only (abdomen, thigh, upper arm, or buttocks); rotate injection sites within the same region. Because it is a suspension, resuspend before each dose by gently rolling the pen between the hands and inverting it several times until uniformly cloudy-do not shake vigorously. Inject subcutaneously within 15 minutes before a meal or immediately after starting a meal. Do not administer intravenously or intramuscularly. Do not mix with other insulins in the prefilled pen.

How to Prepare

Before each injection, resuspend by rolling the pen between the palms 10 times and inverting 10 times until uniformly cloudy/milky; inspect and do not use if not uniformly mixed or if clumps/particles persist; use a new needle each time and perform a priming/safety test per pen instructions; inject soon after mixing.

Side Effects

Common Side Effects

Hypoglycemia, injection site reactions (redness, swelling, itching), lipodystrophy (pitting or thickening of the skin), weight gain, edema.

Side Effect Frequency

Very common: hypoglycemia. Common: injection-site reactions and lipodystrophy; weight gain and edema are also commonly reported with insulin therapy. Serious allergy/anaphylaxis and hypokalemia are uncommon/rare but clinically important.

Safety & Warnings

Contraindications

During episodes of hypoglycemia; hypersensitivity to insulin lispro, insulin lispro protamine suspension (protamine component), or any excipients.

Warnings & Precautions

Major warnings/precautions: hypoglycemia risk (monitor and educate); medication errors/accidental mix-ups and never share pens; rotate injection sites to reduce lipodystrophy; do not mix in the pen or use in pumps/IV/IM (premixed suspension is SC only); dose adjustments needed with changes in diet/activity/illness and when switching insulin; monitor potassium in at-risk patients (hypokalemia); caution with TZDs due to edema/heart failure; hypersensitivity possible (includes protamine/excipients).

Age Restriction

Indicated for adults with diabetes mellitus; safety and efficacy not established in pediatric patients.

Drug Interactions

Drug Interactions

Key interactions: (1) Thiazolidinediones (pioglitazone/rosiglitazone) + insulin → fluid retention/heart failure risk; (2) Drugs that increase hypoglycemia risk (other antidiabetics, ACE inhibitors, MAOIs, salicylates, some sulfonamide antibiotics, alcohol); (3) Drugs that raise glucose/reduce insulin effect (corticosteroids, thiazide/loop diuretics, sympathomimetics, thyroid hormones, estrogens/oral contraceptives, niacin); (4) Beta-blockers may mask hypoglycemia symptoms; (5) Octreotide/lanreotide can increase or decrease insulin requirements.

Interaction Severity

MAJOR: Thiazolidinediones (pioglitazone/rosiglitazone) with insulin-risk of fluid retention and heart failure; alcohol can increase hypoglycemia risk and impair recognition. MODERATE: Agents that increase glucose (e.g., corticosteroids, thiazide/loop diuretics, sympathomimetics, thyroid hormones, some contraceptives) and agents that increase hypoglycemia risk (e.g., other antidiabetics, ACE inhibitors/ARBs, salicylates, MAO inhibitors). MINOR/CLINICALLY RELEVANT: Beta-blockers may mask adrenergic symptoms of hypoglycemia and can prolong recovery.

Food Interaction

Administer within 15 minutes before a meal or immediately after starting a meal; ensure meal intake is not delayed after dosing to reduce hypoglycemia risk.

Alcohol Interaction

Avoid

Special Populations

Pregnancy

Consult Doctor

Breastfeeding

Consult Doctor

Children

Safety and efficacy not established in pediatric patients.

Elderly

Start at lower doses; titrate slowly with close blood glucose monitoring. Hypoglycemia risk is increased in elderly patients. Renal function decline in elderly may reduce insulin clearance.

Kidney Impairment

No fixed adjustment; insulin requirements may be reduced in renal impairment-monitor glucose closely and individualize/titrate dose.

Liver Impairment

No fixed adjustment; insulin requirements may be reduced in hepatic impairment-monitor glucose closely and individualize/titrate dose.

Storage & Patient Advice

Storage Conditions

Not In-Use (Unopened) Refrigerated (36° to 46°F [2° to 8°C]) Until expiration date; Not In-Use (Unopened) Room Temperature (up to 86°F [30°C]) 10 days; In-Use (Opened) 10 days Room temperature only (Do not refrigerate)

Preparation Instructions

Before each injection, resuspend by rolling the pen between the palms 10 times and inverting 10 times until uniformly cloudy/milky; inspect and do not use if not uniformly mixed or if clumps/particles persist; use a new needle each time and perform a priming/safety test per pen instructions; inject soon after mixing.

Stopping the Medicine

Do not discontinue or change dose abruptly without medical supervision; interruption can cause hyperglycemia and may precipitate diabetic ketoacidosis in insulin-dependent patients.

Overdose

Overdose primarily causes hypoglycemia (may progress to seizures/coma) and can cause hypokalemia; treat mild/moderate with oral fast-acting carbohydrate, and severe with glucagon IM/SC or IV dextrose with monitoring and repeat carbohydrates/infusion as needed; seek urgent/emergency care for severe episodes.

Patient Counseling

Resuspend before each injection by gently rolling and inverting until uniformly cloudy; do not shake vigorously. Inject subcutaneously and rotate sites; dose within 15 minutes before a meal or immediately after starting a meal and do not skip/delay meals. Do not share the pen; use a new needle each time and dispose of sharps safely. Store unopened pens refrigerated (2-8°C) and do not freeze; follow product labeling for in-use room-temperature storage limits. Educate on hypoglycemia recognition/management and to review new medications/illness plans with the clinician.

Monitoring Requirements

Monitor SMBG (fasting and postprandial as appropriate) and HbA1c periodically (typically every ~3 months until stable, then at least twice yearly). Monitor for hypoglycemia, weight, injection-site lipodystrophy, and consider serum potassium in at-risk patients (e.g., on potassium-lowering drugs or with renal impairment).

Pharmacology

Mechanism of Action

Premixed biphasic insulin analog: insulin lispro provides rapid prandial insulin activity and insulin lispro protamine provides intermediate/basal activity; both act via insulin receptor binding to increase peripheral glucose uptake and decrease hepatic glucose output, while inhibiting lipolysis and proteolysis.

Onset of Action

Approximately 10-15 minutes (from the rapid-acting insulin lispro component).

Duration of Effect

Variable; typically up to about 18-24 hours depending on dose, injection site, and patient factors (the protamine component prolongs action).

Half-Life

A meaningful terminal half-life is not clinically useful for Humalog Mix (absorption-limited); describe duration of action instead (biphasic with prolonged effect from the protamine component, typically up to ~24 hours depending on dose/site).

Bioavailability

Subcutaneous absorption is variable; absolute bioavailability is not reliably defined for this premixed suspension and is influenced by injection site, blood flow, and dose.

Metabolism

Metabolized (degraded) in liver, kidney, and peripheral tissues by insulin-degrading enzymes, similarly to human insulin.

Excretion

Cleared mainly by metabolic degradation (hepatic and renal insulinases) rather than excreted unchanged; renal impairment reduces insulin clearance and increases exposure.

Product Information

Available Dosage Forms

Suspension for injection in pre-filled pen (KwikPen), suspension for injection in cartridge, suspension for injection in vial

Composition per Dose

Each 1 mL: Insulin lispro 25 IU (as rapid-acting component) + Insulin lispro protamine suspension 75 IU (as intermediate-acting component); total 100 IU/mL. Each 3 mL pen cartridge contains 300 IU total.

OTC Alternatives

No OTC alternative

Diabetes Type

Adults with diabetes mellitus (type 1 or type 2)

Insulin Type

Pre-mixed

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