Apidra
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Apidra
Apidra Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Apidra (insulin glulisine [rdna origin] inj) is used to treat diabetes in adults and children who are at least 4 years old. It is usually given together with a long-acting insulin. It is a hormone that is produced in the body. Common side effects include injection site reactions (e.g., pain, redness, irritation).
The dosage of Apidra is individualized. Blood glucose monitoring is essential. The total daily insulin requirement may vary and is usually between 0.5 to 1 Unit/kg/day. Apidra may interact with albuterol, clonidine, guanethidine, lanreotide, niacin, octreotide pramlintide, reserpine, or beta-blockers. Many other medicines can increase or decrease the effects of Apidra on lowering your blood sugar. Tell your doctor all prescription and over-the-counter medications and supplements you use. Tell your doctor if you are pregnant before using Apidra. If you are planning pregnancy, discuss a plan for managing your blood sugars with your doctor before you become pregnant. Your doctor may switch the type of insulin you use during pregnancy. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.
Our Apidra (insulin glulisine [rdna origin] inj) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Apidra in Detail - Patient Information: Side Effects
Get emergency medical help if you have any of these signs of insulin allergy: itching skin rash over the entire body, wheezing, trouble breathing, fast heart rate, sweating, or feeling like you might pass out.
Hypoglycemia, or low blood sugar, is the most common side effect of insulin glulisine. Symptoms of low blood sugar may include headache, nausea, hunger, confusion, drowsiness, weakness, dizziness, blurred vision, fast heartbeat, sweating, tremor, trouble concentrating, confusion, or seizure (convulsions). Watch for signs of low blood sugar. Carry a piece of non-dietetic hard candy or glucose tablets with you in case you have low blood sugar.
Insulin glulisine can also cause hypokalemia (low potassium levels in the blood). Call your doctor at once if you have symptoms such as dry mouth, increased thirst, increased urination, uneven heartbeats, muscle pain or weakness, leg pain or discomfort, or confusion.
Tell your doctor if you have itching, swelling, redness, or thickening of the skin where you inject insulin glulisine.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Apidra (Insulin Glulisine [rDNA origin] Inj) »
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Apidra Overview - Patient Information: Side Effects
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor immediately if this unlikely but serious side effect occurs: muscle pain.
This medication can cause low blood sugar (hypoglycemia). This effect may occur if you do not consume enough calories (from food, juices, fruit, etc.) or you have used too much insulin glulisine. The symptoms include chills, cold sweat, blurred vision, dizziness, drowsiness, shaking, rapid heart rate, weakness, headache, fainting, tingling of the hands or feet, or hunger. It is a good habit to carry glucose tablets or gel to treat low blood sugar. If you are in a situation where you don't have these reliable forms of glucose, eat a quick source of sugar such as table sugar, honey, or candy, or drink a glass of orange juice or non-diet soda to quickly raise your blood sugar level. Tell your doctor immediately about the reaction. To help prevent hypoglycemia, eat meals on a regular schedule and do not skip meals. Check with your doctor or pharmacist about what you should do if you miss a meal.
Too little insulin glulisine can cause symptoms of high blood sugar (hyperglycemia). Symptoms include thirst, increased urination, confusion, drowsiness, flushing, rapid breathing, or fruity breath odor. If these symptoms occur, tell your doctor immediately. Your dosage may need to be increased.
A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, fast heartbeat, sweating, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the entire patient information overview for Apidra (Insulin Glulisine [rDNA origin] Inj)»
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Apidra FDA Prescribing Information: Side Effects
(Adverse Reactions)
SIDE EFFECTS
The following adverse reactions are discussed elsewhere:
Hypoglycemia [See WARNINGS AND PRECAUTIONS]
Hypokalemia [See WARNINGS AND PRECAUTIONS]
Clinical trial experience
Because clinical trials are conducted under widely varying designs, the adverse reaction rates reported in one clinical trial may not be easily compared to those rates reported in another clinical trial, and may not reflect the rates actually observed in clinical practice.
The frequencies of adverse drug reactions during APIDRA (insulin glulisine [rdna origin] inj) clinical trials in patients with type 1 diabetes mellitus and type 2 diabetes mellitus are listed in the tables below.
Table 1: Treatment -emergent adverse events in pooled studies
of adults with type 1 diabetes (adverse events with frequency ≥ 5%)
| APIDRA, % (n=950) |
All comparatorsa, % (n=641) |
|
| Nasopharyngitis | 10.6 | 12.9 |
| Hypoglycemiab | 6.8 | 6.7 |
| Upper respiratory tract infection | 6.6 | 5.6 |
| Influenza | 4.0 | 5.0 |
| a Insulin lispro, regular human insulin, insulin
aspart b Only severe symptomatic hypoglycemia |
||
Table 2: Treatment -emergent adverse events in pooled studies
of adults with type 2 diabetes (adverse events with frequency ≥ 5%)
| APIDRA, % (n=883) |
Regular human insulin, % (n=883) |
|
| Upper respiratory tract infection | 10.5 | 7.7 |
| Nasopharyngitis | 7.6 | 8.2 |
| Edema peripheral | 7.5 | 7.8 |
| Influenza | 6.2 | 4.2 |
| Arthralgia | 5.9 | 6.3 |
| Hypertension | 3.9 | 5.3 |
- Pediatrics
Table 3 summarizes the adverse reactions occurring with frequency higher than 5% in a clinical study in children and adolescents with type 1 diabetes treated with APIDRA (insulin glulisine [rdna origin] inj) (n=277) or insulin lispro (n=295).
Table 3: Treatment -emergent adverse events in children and
adolescents with type 1 diabetes (adverse reactions with frequency ≥5%)
| APIDRA, % (n=277) |
Lispro, % (n=295) |
|
| Nasopharyngitis | 9.0 | 9.5 |
| Upper respiratory tract infection | 8.3 | 10.8 |
| Headache | 6.9 | 11.2 |
| Hypoglycemic seizure | 6.1 | 4.7 |
- Severe symptomatic hypoglycemia
Hypoglycemia is the most commonly observed adverse reaction in patients using insulin, including APIDRA [See WARNINGS AND PRECAUTIONS]. The rates and incidence of severe symptomatic hypoglycemia, defined as hypoglycemia requiring intervention from a third party, were comparable for all treatment regimens (see Table 4). In the phase 3 clinical trial, children and adolescents with type 1 diabetes had a higher incidence of severe symptomatic hypoglycemia in the two treatment groups compared to adults with type 1 diabetes. (see Table 4) [See Clinical Studies].
Table 4: Severe Symptomatic Hypoglycemia*
| Type 1 Diabetes Adults 12 weeks wit insulin glargine | Type 1 Diabetes Adults 26 weeks with insulin glargine | Type 2 Diabetes Adults 26 weeks with NPH human insulin | Type 1 Diabetes Pediatrics 26 weeks | ||||||
| APIDRA Pre-meal | APIDRA Post-meal | Regular Human Insulin | APIDRA | Insulin Lispro | APIDRA | Regular Human Insulin | APIDRA | Insulin Lispro | |
| Events per month per patient | 0.05 | 0.05 | 0.13 | 0.02 | 0.02 | 0.00 | 0.00 | 0.09 | 0.08 |
| Percent of patients (n/total N) | 8.4% (24/286) |
8.4% (25/296) |
10.1% (28/278) |
4.8% (16/339) |
4.0% (13/333) |
1.4% (6/416) |
1.2% (5/420) |
16.2% (45/277) |
19.3% (57/295) |
| * Severe symptomatic hypoglycemia defined as a hypoglycemic event requiring the assistance of another person that met one of the following criteria: the event was associated with a whole blood referenced blood glucose < 36mg/dL or the event was associated with prompt recovery after oral carbohydrate, intravenous glucose or glucagon administration. | |||||||||
- Insulin initiation and intensification of glucose control
Intensification or rapid improvement in glucose control has been associated with a transitory, reversible ophthalmologic refraction disorder, worsening of diabetic retinopathy, and acute painful peripheral neuropathy. However, long-term glycemic control decreases the risk of diabetic retinopathy and neuropathy.
- Lipodystrophy
Long-term use of insulin, including APIDRA (insulin glulisine [rdna origin] inj) , can cause lipodystrophy at the site of repeated insulin injections or infusion. Lipodystrophy includes lipohypertrophy (thickening of adipose tissue) and lipoatrophy (thinning of adipose tissue), and may affect insulin absorption. Rotate insulin injection or infusion sites within the same region to reduce the risk of lipodystrophy. [See DOSAGE AND ADMINISTRATION].
- Weight gain
Weight gain can occur with insulin therapy, including APIDRA (insulin glulisine [rdna origin] inj) , and has been attributed to the anabolic effects of insulin and the decrease in glucosuria.
- Peripheral Edema
Insulin, including APIDRA (insulin glulisine [rdna origin] inj) , may cause sodium retention and edema, particularly if previously poor metabolic control is improved by intensified insulin therapy.
- Adverse Reactions with Continuous Subcutaneous Insulin Infusion (CSII)
In a 12-week randomized study in patients with type 1 diabetes (n=59), the rates of catheter occlusions and infusion site reactions were similar for APIDRA (insulin glulisine [rdna origin] inj) and insulin aspart treated patients (Table 5).
Table 5: Catheter Occlusions and Infusion Site Reactions.
| APIDRA (n=29) |
insulin aspart (n=30) |
|
| Catheter occlusions/month | 0.08 | 0.15 |
| Infusion site reactions | 10.3% (3/29) | 13.3% (4/30) |
- Allergic Reactions
Local Allergy
As with any insulin therapy, patients taking APIDRA (insulin glulisine [rdna origin] inj) may experience redness, swelling, or itching at the site of injection. These minor reactions usually resolve in a few days to a few weeks, but in some occasions may require discontinuation of APIDRA (insulin glulisine [rdna origin] inj) . In some instances, these reactions may be related to factors other than insulin, such as irritants in a skin cleansing agent or poor injection technique.
Systemic Allergy
Severe, life-threatening, generalized allergy, including anaphylaxis, may occur with any insulin, including APIDRA (insulin glulisine [rdna origin] inj) . Generalized allergy to insulin may cause whole body rash (including pruritus), dyspnea, wheezing, hypotension, tachycardia, or diaphoresis.
In controlled clinical trials up to 12 months duration, potential systemic allergic reactions were reported in 79 of 1833 patients (4.3%) who received APIDRA (insulin glulisine [rdna origin] inj) and 58 of 1524 patients (3.8%) who received the comparator short-acting insulins. During these trials treatment with APIDRA (insulin glulisine [rdna origin] inj) was permanently discontinued in 1 of 1833 patients due to a potential systemic allergic reaction.
Localized reactions and generalized myalgias have been reported with the use of metacresol, which is an excipient of APIDRA (insulin glulisine [rdna origin] inj) .
Antibody Production
In a study in patients with type 1 diabetes (n=333), the concentrations of insulin antibodies that react with both human insulin and insulin glulisine (cross-reactive insulin antibodies) remained near baseline during the first 6 months of the study in the patients treated with APIDRA (insulin glulisine [rdna origin] inj) . A decrease in antibody concentration was observed during the following 6 months of the study. In a study in patients with type 2 diabetes (n=411), a similar increase in cross-reactive insulin antibody concentration was observed in the patients treated with APIDRA (insulin glulisine [rdna origin] inj) and in the patients treated with human insulin during the first 9 months of the study. Thereafter the concentration of antibodies decreased in the APIDRA (insulin glulisine [rdna origin] inj) patients and remained stable in the human insulin patients. There was no correlation between cross-reactive insulin antibody concentration and changes in HbA1c, insulin doses, or incidence of hypoglycemia. The clinical significance of these antibodies is not known.
APIDRA (insulin glulisine [rdna origin] inj) did not elicit a significant antibody response in a study of children and adolescents with type 1 diabetes.
Postmarketing experience
The following adverse reactions have been identified during post-approval use of APIDRA (insulin glulisine [rdna origin] inj) . Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate reliably their frequency or establish a causal relationship to drug exposure.
Medication errors have been reported in which other insulins, particularly long-acting insulins, have been accidentally administered instead of APIDRA [See Patient Counseling Information].
Read the entire FDA prescribing information for Apidra (Insulin Glulisine [rDNA origin] Inj) »
Additional Apidra Information
Apidra - User Reviews
Apidra User Reviews
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Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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