APIDRA SOLOSTAR 100/UNITS/ML 5×3ML/PENFILL @

Indications

Approved Uses

To improve glycemic control in adults and pediatric patients aged ≥4 years with type 1 diabetes mellitus, and in adults with type 2 diabetes mellitus.

Off-Label Uses

Hyperkalemia treatment (IV regular insulin is standard; rapid-acting analogs like glulisine may be used off-label in some settings with dextrose under protocol). Continuous subcutaneous insulin infusion (pump) use is practiced off-label in some regions/settings depending on local labeling.

Dosage & Administration

Dosing by Condition

Type 1 diabetes: use as prandial insulin in a basal-bolus regimen, dosed with meals (0-15 minutes before or within 20 minutes after starting) and individualized to carbohydrate intake and glucose; Type 2 diabetes (adults): add as prandial insulin to basal insulin and/or other agents, starting and titrating per SMBG and meal patterns (no single fixed starting dose applies to all patients).

Initial Dose

Highly individualized. Total daily insulin requirement is typically between 0.5 to 1 Unit/kg/day, with a portion administered as mealtime insulin.

Maintenance Dose

Individualized based on blood glucose monitoring; typical range 0.5-1.0 U/kg/day total insulin (basal + prandial combined)

Maximum Dose

No specific maximum dose; dose is individualized and titrated based on metabolic needs, glucose monitoring, and treatment goals.

Children's Dosage

Approved for children ≥4 years with Type 1 diabetes; dosing is individualized based on weight and metabolic needs, administered 0-15 minutes before a meal

Dose Adjustment Notes

Individualize and titrate based on self-monitoring of blood glucose and glycemic targets; adjust with changes in meals, physical activity, intercurrent illness/stress, renal or hepatic impairment, and interacting medications.

How to Take

Administer insulin glulisine subcutaneously in the abdomen, thigh, or upper arm within 0-15 minutes before a meal or within 20 minutes after starting a meal; rotate injection sites within the same region and avoid areas of lipodystrophy/cutaneous amyloidosis. For SoloStar, use a new needle each time, prime per device instructions, and do not mix other insulins in the pen (mixing is only applicable if drawing up from vials per labeling).

How to Prepare

Inspect solution (must be clear, colorless, particle-free); attach a new needle and prime the SoloStar pen (commonly 2 units) until a drop/stream appears; then dial and inject the prescribed dose-no reconstitution required.

Side Effects

Side Effect Frequency

Very common (>10%): Hypoglycemia. Common (1-10%): Injection-site reactions; lipodystrophy/skin changes at injection site. Frequency not known/rare but clinically important: systemic hypersensitivity (including anaphylaxis), hypokalemia; weight gain and edema can occur with insulin therapy.

Safety & Warnings

Contraindications

Contraindicated during episodes of hypoglycemia and in patients with hypersensitivity to insulin glulisine or any excipients.

Warnings & Precautions

Key warnings/precautions: hypoglycemia risk (requires frequent glucose monitoring and dose adjustment with changes in diet/activity/illness); do not share pens/needles; rotate injection sites to prevent lipodystrophy/cutaneous amyloidosis; risk of hypokalemia (monitor in at-risk patients); hypersensitivity reactions; and fluid retention/heart failure risk when used with thiazolidinediones.

Age Restriction

Approved for use in adults and pediatric patients 4 years of age and older; safety and effectiveness have not been established in children <4 years.

Drug Interactions

Drug Interactions

Clinically relevant interactions include: agents that may increase hypoglycemia risk (e.g., other antidiabetics, ACE inhibitors, salicylates, sulfonamides, MAOIs, some antidepressants such as fluoxetine, fibrates, alcohol) and agents that may reduce glucose-lowering effect (e.g., corticosteroids, thiazide/loop diuretics, sympathomimetics, glucagon, estrogens/progestins, atypical antipsychotics); beta-blockers may mask hypoglycemia symptoms; thiazolidinediones with insulin may cause fluid retention/heart failure.

Interaction Severity

MAJOR/clinically significant: alcohol (can increase or decrease glucose; hypoglycemia risk), other glucose-lowering drugs (additive hypoglycemia), and drugs that blunt hypoglycemia awareness (e.g., beta-blockers). MODERATE: agents that increase insulin effect (e.g., ACE inhibitors, salicylates) or decrease it (e.g., corticosteroids, thiazides, sympathomimetics); thiazolidinediones with insulin increase edema/heart failure risk. Macimorelin is not a standard clinically relevant interaction for insulin glulisine.

Food Interaction

Meal timing is essential: inject 0-15 minutes before eating or within 20 minutes after starting a meal; do not inject without ensuring a meal is imminent/started to reduce hypoglycemia risk.

Special Populations

Pregnancy

Consult Doctor

Children

Approved for children ≥4 years with Type 1 diabetes; dosing is individualized based on weight and metabolic needs, administered 0-15 minutes before a meal

Kidney Impairment

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

Storage & Patient Advice

Preparation Instructions

Inspect solution (must be clear, colorless, particle-free); attach a new needle and prime the SoloStar pen (commonly 2 units) until a drop/stream appears; then dial and inject the prescribed dose-no reconstitution required.

Stopping the Medicine

Do not discontinue or markedly reduce insulin without medical supervision; abrupt interruption can cause severe hyperglycemia and may precipitate diabetic ketoacidosis (DKA).

Patient Counseling

Confirm the insulin and dose before each injection; inject 0-15 minutes before meals or within 20 minutes after starting; do not skip meals after dosing. Rotate sites and avoid abnormal skin areas; use a new needle each time and never share pens/needles. Recognize and treat hypoglycemia, carry fast-acting glucose, and monitor glucose as directed. Store unopened pens refrigerated (2-8°C per SFDA); follow product labeling for in-use storage and discard timelines; seek advice regarding alcohol and medication changes.

Pharmacology

Mechanism of Action

Rapid-acting insulin analog that binds insulin receptors to increase peripheral glucose uptake (muscle/adipose) and decrease hepatic glucose production, thereby lowering blood glucose.

Onset of Action

Approximately 10-20 minutes after subcutaneous injection.

Duration of Effect

Approximately 3-5 hours.

Bioavailability

Absolute bioavailability of insulin glulisine after subcutaneous administration is approximately 70%, regardless of injection area (abdomen 73%, deltoid 71%, thigh 68%).

Metabolism

Proteolytic degradation in liver, kidney, and muscle (insulin-degrading enzymes/proteases), similar to endogenous human insulin.

Excretion

Primarily renal (as insulin and peptide metabolites after proteolytic degradation).

Product Information

Available Dosage Forms

Injection, solution (100 units/mL) supplied as: 3 mL SoloStar disposable prefilled pen

Composition per Dose

Each 1 mL: Insulin glulisine 100 Units; Each 3 mL pen/cartridge: Insulin glulisine 300 Units

Generic Availability

No

OTC Alternatives

No OTC alternative

Diabetes Type

Both

Insulin Type

Rapid-acting

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