Insulin glulisine (Apidra)
Pronunciation: IN-suh-lin GLOO-lih-seen.
- Generic name
- insulin glulisine
- Drug class
- Rapid-acting insulin analogue (antidiabetic agent)
- Form
- Solution for injection: vial, cartridge, prefilled pen (SoloStar), 100 units/mL
- Route
- Subcutaneous injection (or intravenous, in a clinical setting)
- Legal status
- Prescription-only
Availability and supply rules vary by country
Trade names by country: United States · United Kingdom · Canada · Australia · New Zealand
Australia: Apidra (5) · Full directory
What insulin glulisine is and how it works
Insulin glulisine is a rapid-acting insulin analogue used by adults and children with diabetes mellitus to help control blood glucose (sugar) levels. It is injected under the skin, usually shortly before a meal, and starts working faster than regular human insulin. (1) (2)
Insulin glulisine helps your body move glucose from the blood into cells for energy, closely mimicking the natural, fast insulin response to a meal. It is prescribed and dosed individually by a clinician, and its rapid onset means timing around meals matters. It carries genuine, serious warnings about low blood sugar (hypoglycaemia), low blood potassium (hypokalaemia), and about never sharing insulin delivery devices between people.
Mechanism of action: how insulin glulisine works
Insulin glulisine is a recombinant human insulin analogue that differs from human insulin by small structural changes that reduce self-association, allowing faster absorption from the subcutaneous injection site and a more rapid onset and shorter duration of action than regular human insulin. (1) (4)
What insulin glulisine is used for
Glycaemic control in diabetes mellitus
Used to improve blood glucose control in adults and children with diabetes mellitus, as part of an insulin regimen individualised by a clinician. The minimum approved age differs by country: 4 years or older in the United States, Australia, and New Zealand; 6 years or older in the United Kingdom, European Union, and Canada. (1) (2) (3) (4) (5) (6)
Before taking insulin glulisine
Do not take / not appropriate for
- Do not use insulin glulisine during an episode of hypoglycaemia (low blood sugar). (all countries where authorised) (1) (2)
- Do not use if you have had a serious allergic reaction to insulin glulisine or any of its ingredients. (all countries where authorised) (1) (2)
Tell your clinician about
- Any history of severe or frequent low blood sugar (hypoglycaemia), or reduced awareness of hypoglycaemia symptoms.
- Any kidney or liver problems, which can affect how much insulin you need.
- Any heart problems, especially if you also take pioglitazone or another PPAR-gamma agonist diabetes tablet, since fluid retention and heart failure have been reported with combined use.
- If you use an insulin pump, and how to recognise and respond to pump malfunction (which can lead to high blood sugar and ketoacidosis).
- All other medicines you take, since many can affect blood sugar control.
- Whether you are pregnant, planning pregnancy, or breastfeeding.
- Which specific Apidra product and strength you have been prescribed, since accidental mix-ups between insulin products have been reported.
How to take insulin glulisine
- Inject under the skin (subcutaneously) in the abdomen, thigh, or upper arm/deltoid as advised by your clinician, usually shortly before a meal because of its fast onset of action.
- Rotate injection sites within the same region to reduce the risk of skin changes (lipodystrophy) and localised cutaneous amyloidosis at the injection site.
- NEVER share prefilled pens, cartridges, or reusable pens with another person, even if you change the needle. If you use vials, NEVER share needles or syringes with another person. Sharing carries a real risk of transmitting blood-borne infections such as hepatitis or HIV. (This specific warning is explicit in the current US and Canadian labels; it was not found verbatim in the current UK, Australia, or New Zealand label text reviewed, but the underlying biological risk applies to any shared injection device.)
- Only your clinician should change your insulin dose, brand, or regimen -- do not switch products or adjust your dose yourself.
- Always check you have the correct Apidra product and strength before injecting.
- If using cartridges, only use pens the manufacturer confirms are compatible -- dosing accuracy has only been established with specific compatible pens.
Procedures and treatment changes
Tell the treating team before surgery, procedures, or any medicine change. Do not alter treatment without the responsible clinician. (1) (2) (3) (4) (5) (6)
Missed dose
Contact your prescriber or diabetes care team for individual guidance on a missed dose, since timing relative to meals and blood glucose matters, and never take an extra dose to make up for a missed one without specific instructions.
Overdose
Seek urgent medical attention if you think you have taken too much insulin glulisine, or if you develop signs of severe low blood sugar (confusion, sweating, shakiness, difficulty speaking, seizures, or loss of consciousness) -- follow your emergency hypoglycaemia plan and treat low blood sugar promptly as advised by your clinician. (1)
Side effects
Side effects and their urgency vary; report severe, persistent, or concerning symptoms.
Low blood sugar (hypoglycaemia) -- the most common side effect of any insulin.
What to notice: Low blood sugar (hypoglycaemia) -- the most common side effect of any insulin.
What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1) (3)
Injection site reactions (redness, swelling, itching).
What to notice: Injection site reactions (redness, swelling, itching).
What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (6)
Weight gain.
What to notice: Weight gain.
What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1)
Skin changes at frequently-used injection sites (lipodystrophy and localised cutaneous amyloidosis) if sites are not rotated.
What to notice: Skin changes at frequently-used injection sites (lipodystrophy and localised cutaneous amyloidosis) if sites are not rotated.
What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (6) (5)
Upper respiratory tract infection and nasopharyngitis were among the most frequently reported adverse reactions in US clinical trials.
What to notice: Upper respiratory tract infection and nasopharyngitis were among the most frequently reported adverse reactions in US clinical trials.
What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1)
Serious warnings
Signs of severe low blood sugar (hypoglycaemia) — emergency
Symptoms: Confusion, sweating, shaking, rapid heartbeat, difficulty speaking, seizures, or loss of consciousness.
Action: Treat promptly following your clinician's hypoglycaemia action plan, and seek emergency medical help immediately for severe symptoms or loss of consciousness -- hypoglycaemia is the most common adverse reaction of insulin therapy and can be life-threatening or fatal. (1) (3)
Sharing insulin delivery devices — high caution
Symptoms: Not applicable -- this is a preventable risk, not a symptom to watch for.
Action: Never share prefilled pens, cartridges, or reusable pens with another person, even if the needle is changed. Never share needles or syringes if using vials. Sharing carries a genuine risk of transmitting blood-borne infections such as hepatitis viruses or HIV, even when the needle itself is changed. This specific warning is explicit in the current US and Canadian product labelling. (1) (4)
Signs of low blood potassium (hypokalaemia) — high caution
Symptoms: Muscle weakness, abnormal heart rhythm, or breathing difficulty.
Action: Contact your clinician promptly or seek emergency help for severe symptoms -- all insulins, including this one, shift potassium into cells and can cause hypokalaemia, which if untreated may cause respiratory paralysis, dangerous heart rhythms, and death, especially in at-risk patients (for example those on potassium-lowering medicines). This specific warning is explicit in the current US and Canadian product labelling. (1) (4)
Signs of a serious allergic reaction — emergency
Symptoms: Widespread rash, swelling of the face/throat, difficulty breathing, wheezing, a rapid drop in blood pressure, or a rapid pulse.
Action: Seek emergency medical help immediately -- severe, generalised allergy, including anaphylaxis, has been reported with insulins including this one. (1) (6)
Signs of high blood sugar or ketoacidosis (insulin pump users) — high caution
Symptoms: Very high blood sugar readings, nausea, vomiting, abdominal pain, fruity-smelling breath, or rapid breathing.
Action: Contact your clinician or seek emergency help promptly -- pump malfunction can cause rapid-onset hyperglycaemia and ketoacidosis in insulin pump users; keep an injectable insulin available as backup. (1)
Interactions
- Many other medicines can affect blood glucose control (raise or lower insulin needs), including some diabetes tablets, ACE inhibitors, angiotensin II receptor blockers, and salicylates -- tell your clinician about all medicines you take so your insulin dose can be adjusted appropriately. (1)
- Pioglitazone and other PPAR-gamma agonist diabetes tablets (thiazolidinediones) combined with insulin can cause fluid retention and heart failure, particularly in patients with existing heart problems. (2) (1)
- Alcohol can affect blood glucose control and increase the risk of hypoglycaemia. (1)
- Beta-blockers, clonidine, and some other medicines can mask or blunt the usual warning symptoms of hypoglycaemia, making it harder to notice. (1)
Pregnancy, breastfeeding, kidney/liver function, age
Pregnancy
Insulin requirements often change during pregnancy; insulin glulisine can be used under close clinician supervision with individualised dose adjustment throughout pregnancy. Poorly controlled diabetes in pregnancy increases risks for both mother and baby, so maintaining good glucose control before and during pregnancy is important. (1) (2) (3) (4) (5) (6)
Breastfeeding
Insulin requirements may change during breastfeeding; use under clinician guidance with monitoring and dose adjustment as needed. (1) (2) (3) (4) (5) (6)
Children
Approved for use in paediatric patients with diabetes mellitus, with a genuine difference in minimum age between markets: 4 years or older (United States, Australia, New Zealand) and 6 years or older (United Kingdom, European Union, current Canadian labelling). Dosing individualised by a paediatric diabetes specialist. (1) (2) (3) (4) (5) (6)
Elderly
No specific dose restriction described in the sources reviewed, but conservative dosing and closer monitoring for hypoglycaemia are generally recommended, since hypoglycaemia can be harder to recognise in older adults. (1) (2) (3) (4) (5) (6)
Hepatic_impairment
May affect insulin requirements (often reduced); individualised monitoring and dose adjustment by a clinician. (1) (2) (3) (4) (5) (6)
Renal_impairment
May affect insulin requirements (often reduced) and increase hypoglycaemia risk; individualised monitoring and more frequent dose adjustment by a clinician. (1) (2) (3) (4) (5) (6)
Source_ids
US-DAILYMED-APIDRA-2026,NZ-MEDSAFE-APIDRA-2026 (1) (2) (3) (4) (5) (6)
Monitoring
Before starting
- Baseline blood glucose control (e.g. HbA1c)
- Kidney and liver function if relevant
- Personal history of hypoglycaemia awareness/severity
- Cardiac status if using with pioglitazone or another PPAR-gamma agonist
During treatment
- Regular self-monitoring of blood glucose as directed by your clinician.
- Prompt recognition and treatment of hypoglycaemia; carry a fast-acting source of sugar.
- Periodic review of injection sites for signs of skin changes.
- Monitoring for signs of hypokalaemia in at-risk patients.
- Insulin pump users: monitoring for signs of pump malfunction and resulting hyperglycaemia/ketoacidosis.
Storage
Store unopened Apidra in a refrigerator (2-8C); do not freeze or expose to excessive heat or direct sunlight, and keep in the outer carton to protect from light. Once in use, vials, cartridges, and prefilled pens can be kept at room temperature (below 25C, away from heat and light) and should be discarded after 28 days, whether or not they were kept refrigerated during that time.
Professional information
Clinician-facing context only, sourced from the current US prescribing information and other current regulator sources reviewed; verify against the current full label before prescribing.
United States, United Kingdom, European Union, Canada, Australia, New Zealand
Indication: Glycaemic control in adult and paediatric patients with diabetes mellitus (minimum age 4 years in the US/Australia/NZ; 6 years in the UK/EU/current Canadian labelling)
Dose summary: Individualised subcutaneous dosing based on blood glucose monitoring, meal content, and activity; given close to mealtime (within about 15 minutes before eating, or within 20 minutes after starting a meal) due to rapid onset. Can also be given intravenously in a clinical/monitored setting or via insulin pump.
Renal context: Insulin requirements may be reduced in renal impairment; monitor closely and adjust dose individually. (1) (4)
Hepatic guidance
Insulin requirements may be diminished in hepatic impairment due to reduced capacity for gluconeogenesis and reduced insulin metabolism; individualise and monitor.
Overdose note
Manage hypoglycaemia per standard protocol (oral carbohydrate for mild/moderate cases; glucagon or IV glucose for severe cases/loss of consciousness), with close monitoring for hypokalaemia; no specific antidote beyond glucose/glucagon and supportive care. (1) (4)
Frequently asked questions
Can I share my Apidra pen with a family member if I change the needle?
No. The current US and Canadian labels are explicit and firm: prefilled pens, cartridges, and reusable pens must never be shared between patients, even if the needle is changed. If you use vials, needles and syringes must never be shared either. This is because sharing carries a real risk of transmitting blood-borne infections such as hepatitis viruses or HIV -- changing only the needle does not remove this risk, since the device itself can still carry contamination from contact with the previous user's skin or blood. (This exact warning was not found verbatim in the current UK, Australia, or New Zealand label text reviewed, but the same real biological risk applies to any insulin delivery device shared between people.) (1) (4)
Does insulin glulisine (Apidra) affect my potassium levels?
Yes, according to the current US and Canadian labelling. All insulins, including Apidra, cause potassium to shift from outside cells to inside cells, which can lower blood potassium levels (hypokalaemia). If this goes untreated, it can cause muscle weakness, dangerous heart rhythm problems, breathing difficulty, and in serious cases can be life-threatening. This risk is higher in certain situations (for example, if you take potassium-lowering medicines), so your clinician may monitor your potassium levels, especially if you have other risk factors. (1) (4)
At what age can Apidra be used in children?
This genuinely differs by country. In the United States, Australia, and New Zealand, current labelling allows use from age 4 years or older. In the United Kingdom, European Union, and the current Canadian product monograph, current labelling states 6 years or older, with insufficient data below that age. Always follow the age guidance your own prescriber and local label give you. (1) (2) (3) (4) (5) (6)
What is the mechanism of action of insulin glulisine?
Insulin glulisine is a recombinant human insulin analogue that differs from human insulin by small structural changes that reduce self-association, allowing faster absorption from the subcutaneous injection site and a more rapid onset and shorter duration of action than regular human insulin. (1) (4)
What is the generic name of Insulin glulisine (Apidra)?
References
- APIDRA (insulin glulisine) injection -- full prescribing informationU.S. Food and Drug Administration / DailyMed (NIH), full prescribing information, Sanofi-Aventis U.S. LLC · United States · accessed 2026-07-31 · source 1
- Apidra 100 Units/ml solution for injection in a vial -- Summary of Product Characteristicselectronic medicines compendium (emc), United Kingdom -- Sanofi (Aventis Pharma Limited) · United Kingdom · accessed 2026-07-31 · source 2
- Apidra, INN-insulin glulisine -- EPAR summary for the public / medicine overviewEuropean Medicines Agency (EMA) -- EPAR for Apidra · European Union · accessed 2026-07-31 · source 3
- APIDRA (insulin glulisine injection, rDNA origin) -- Product Monograph, including Patient Medication InformationHealth Canada product monograph, sanofi-aventis Canada Inc. · Canada · accessed 2026-07-31 · source 4
- APIDRA insulin glulisine (rbe) -- ARTG entries (vial 99145, cartridge 99146, SoloStar pen 132816) and current Product InformationTherapeutic Goods Administration (TGA) / medsinfo.com.au, Australia -- sanofi-aventis australia pty ltd · Australia · accessed 2026-07-31 · source 5
- Apidra / Apidra SoloStar (insulin glulisine) -- New Zealand Data SheetMedsafe (New Zealand regulator) · New Zealand · accessed 2026-07-31 · source 6
Brand names by country
Single-ingredient insulin glulisine names are shown separately by country. Product availability, strengths, and supply rules can change; combination products are not included here.
Priority countries
United States
- Apidra100 [iU]/mL · sanofi-aventis u.s. llc
United Kingdom
- Apidra (2)MHRA licensed emc smpc confirmed · 100 units/ml · Sanofi (Aventis Pharma Limited) · UK indication states 6 years or older, differing from the US/Australia/NZ 4-years-or-older threshold.
Canada
- APIDRA
Australia
- Apidra (5)TGA ARTG registered 2005 current PI 2024-09-30 · sanofi-aventis australia pty ltd · Current PI states 4 years or above, matching the US/NZ threshold. Schedule 4 (Prescription Only Medicine). Cartridges restricted to specific compatible pens (AllStar, AllStar Pro, JuniorSTAR, ClikSTAR).
New Zealand
- Apidra (6)medsafe data sheet confirmed 2022-06-20 · 100 IU/mL · Sanofi-Aventis New Zealand Limited · Current data sheet states 4 years or above, matching the US/Australia threshold.
View brands in additional countries.
European Union
Apidra (3)