HUMALOG 25 PEN SUSP

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 or Type 2 diabetes: dose is individualized; commonly administered twice daily with meals (e.g., before breakfast and before the evening meal), within 15 minutes before or immediately after starting the meal; titrate to glucose targets based on monitoring.

Maximum Dose

No fixed maximum dose; dose is individualized based on glucose monitoring, meals, and metabolic needs.

Children's Dosage

Safety and efficacy in pediatric patients not established in prescribing information for Humalog Mix75/25.

Dose Adjustment Notes

Individualize and titrate based on SMBG/CGM and glycemic targets; adjust with changes in meals, activity, intercurrent illness, or interacting drugs. Use caution and consider dose reduction in renal or hepatic impairment. When switching from another insulin regimen, close glucose monitoring is required during transition.

How to Take

For subcutaneous injection only. Before each dose, resuspend by gently rolling the pen between the hands and inverting it repeatedly until uniformly white/cloudy; do not use if clumps/particles remain. Inject into abdomen, thigh, upper arm, or buttock and rotate sites. Administer within 15 minutes before a meal or immediately after starting a meal. Use a new needle each time and prime the pen per instructions before injecting.

How to Prepare

Immediately before each injection, gently roll the prefilled pen between the palms 10 times and invert it 10 times until uniformly white and cloudy; do not shake vigorously; then attach a new needle, prime/safety test, dial the dose, and inject subcutaneously.

Side Effects

Common Side Effects

Hypoglycemia, injection site reactions (pain, redness, swelling, lipodystrophy), weight gain, peripheral edema

Safety & Warnings

Contraindications

During episodes of hypoglycemia; hypersensitivity to insulin lispro or any excipients (including protamine-containing components).

Warnings & Precautions

Major precautions: hypoglycemia risk (ensure correct timing with meals and monitor glucose); do not administer IV/IM; do not mix with other insulins in the pen; rotate injection sites to reduce lipodystrophy; monitor/consider hypokalemia risk; do not share pens between patients; regimen changes only under medical supervision; TZDs with insulin may cause fluid retention/heart failure; illness/stress/surgery may change insulin needs.

Age Restriction

Indicated to improve glycemic control in adults with diabetes mellitus. Safety and efficacy in pediatric patients not established in the prescribing information for Humalog Mix75/25.

Drug Interactions

Interaction Severity

MAJOR/clinically significant: Thiazolidinediones (pioglitazone/rosiglitazone) with insulin-risk of fluid retention and heart failure; Alcohol-can increase risk of hypoglycemia. MODERATE: Beta-blockers (mask hypoglycemia symptoms), ACE inhibitors/ARBs and salicylates (may increase hypoglycemia), corticosteroids/thiazides/sympathomimetics (may increase glucose and insulin requirements), MAO inhibitors (may increase hypoglycemic effect).

Food Interaction

Must be meal-timed: inject within 15 minutes before a meal or immediately after starting a meal; do not delay/skip the meal after dosing to avoid hypoglycemia.

Special Populations

Children

Safety and efficacy in pediatric patients not established in prescribing information for Humalog Mix75/25.

Kidney Impairment

May require lower insulin doses in renal impairment; monitor glucose more frequently and titrate individually (no specific creatinine/eGFR cutoffs).

Liver Impairment

May require lower insulin doses in hepatic impairment; monitor glucose more frequently and titrate individually.

Storage & Patient Advice

Storage Conditions

store in a refrigerator (2°c - 8°c)

Preparation Instructions

Immediately before each injection, gently roll the prefilled pen between the palms 10 times and invert it 10 times until uniformly white and cloudy; do not shake vigorously; then attach a new needle, prime/safety test, dial the dose, and inject subcutaneously.

Patient Counseling

Resuspend before each injection by gently rolling/inverting until uniformly cloudy; do not shake vigorously. Inject subcutaneously and rotate sites. Dose within 15 minutes before or immediately after starting a meal and do not skip/delay the meal. Use a new needle each time and prime per pen instructions; never share pens. Recognize and treat hypoglycemia; carry fast-acting carbohydrate. Store unopened pens refrigerated (2-8°C per SFDA); do not freeze; follow local labeling for in-use room-temperature limits.

Monitoring Requirements

SMBG/CGM regularly (including pre-meal and as needed for symptoms), HbA1c about every 3 months until stable then at least twice yearly, monitor for hypoglycemia and injection-site lipodystrophy; check serum potassium in at-risk patients and assess renal/hepatic function periodically or when clinically indicated.

Pharmacology

Mechanism of Action

Biphasic insulin analog: 25% insulin lispro provides rapid prandial insulin action and 75% insulin lispro protamine provides intermediate, prolonged action; overall it lowers blood glucose by increasing peripheral glucose uptake and decreasing hepatic glucose output, and also inhibits lipolysis/proteolysis and promotes protein synthesis.

Onset of Action

Approximately 10-20 minutes for the rapid-acting lispro component (overall onset ~15 minutes).

Product Information

Available Dosage Forms

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

Composition per Dose

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

Generic Availability

No

OTC Alternatives

No OTC alternative.

Diabetes Type

Both

Insulin Type

Pre-mixed

Legal Disclaimer - Al Mujtama Pharmacy The product information provided is derived from verified pharmaceutical references and is intended for general health education only. It is not a substitute for professional medical advice, diagnosis, or treatment. Al Mujtama Pharmacy assumes no legal or medical liability for: Any therapeutic decision made based on the information displayed without consulting a licensed physician or pharmacist Any discrepancy between the information provided and the product's package insert or SFDA guidelines Any misuse of medication resulting from personal interpretation of the content displayed Important notice: Drug formulations and instructions may vary between production batches. Always rely on the leaflet included inside the product packaging you have, and consult your pharmacist or physician before starting, adjusting, or discontinuing any medication. By using this content, you acknowledge that you have read this disclaimer and agree that Al Mujtama Pharmacy bears no liability arising from reliance on this information as a substitute for direct medical consultation. Your health is a trust - always consult your doctor first.