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LANTUS (INSULIN GLARGINE): ADVERSE REACTIONS / SIDE EFFECTS
The following adverse reactions are discussed elsewhere:
Hypoglycemia
Hypersensitivity and allergic reactions
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 treatment-emergent adverse events during Lantus Insulin clinical trials in patients with type 1 diabetes mellitus and type 2 diabetes mellitus:
Treatment - emergent adverse events in pooled clinical trials up to 28 weeks duration in adults with type 1 diabetes (adverse events with frequency >= 5%): upper respiratory tract infection, body system not specified infection, accidental injury, headache.
Treatment - emergent adverse events in pooled clinical trials up to 1 year duration in adults with type 2 diabetes (adverse events with frequency >= 5%): upper respiratory tract infection, body system not specified infection, retinal vascular disorder.
Treatment - emergent adverse events in a 5-year trial of adults with type 2 diabetes (adverse events with frequency >= 10%): upper respiratory tract infection, edema peripheral, hypertension, influenza, sinusitis, cataract, bronchitis, arthralgia, pain in extremity, back pain, cough, urinary tract infection, diarrhea, depression, headache.
Treatment - emergent adverse events in a 28-week clinical trial of children and adolescents with type 1 diabetes (adverse events with frequency >= 5%): body system not specified infection, upper respiratory tract infection, pharyngitis, rhinitis.
Severe Hypoglycemia
Hypoglycemia is the most commonly observed adverse reaction in patients using insulin, including Lantus (Insulin Glargine). Severe symptomatic hypoglycemia was defined as an event with symptoms consistent with hypoglycemia requiring the assistance of another person and associated with either a blood glucose below 50 mg / dl ( <= 56 mg / dl in the 5-year trial) or prompt recovery after oral carbohydrate, intravenous glucose or glucagon administration. The rates of severe symptomatic hypoglycemia in the Insulin Glargine (Lantus) clinical trials were comparable for all treatment regimens. In the pediatric 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 the adult trials with type 1 diabetes.
Retinopathy
Retinopathy was evaluated in the Lantus (Insulin Glargine) injections clinical studies by analysis of reported retinal adverse events and fundus photography. The numbers of retinal adverse events reported for Lantus insulin injections and NPH insulin treatment groups were similar for patients with type 1 and type 2 diabetes. Lantus insulin injections was compared to NPH insulin in a 5-year randomized clinical trial that evaluated the progression of retinopathy as assessed with fundus photography using a grading protocol derived from the Early Treatment Diabetic Retinopathy Scale (ETDRS). Patients had type 2 diabetes (mean age 55 yrs) with no (86%) or mild (14%) retinopathy at baseline. Mean baseline HbA1c was 8.4%. The primary outcome was progression by 3 or more steps on the ETDRS scale at study endpoint. Patients with pre-specified post-baseline eye procedures (pan-retinal photocoagulation for proliferative or severe nonproliferative diabetic retinopathy, local photocoagulation for new vessels, and vitrectomy for diabetic retinopathy) were also considered as 3-step progressors regardless of actual change in ETDRS score from baseline. Retinopathy graders were blinded to treatment group assignment.
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 Lantus (Insulin Glargine) injections 100 IU / ml, can cause lipodystrophy at the site of repeated insulin injections. 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.
Weight gain
Weight gain can occur with insulin therapy, including Insulin Glargine (Lantus) injections, and has been attributed to the anabolic effects of insulin and the decrease in glucosuria.
Peripheral Edema
Insulin, including Lantus injections, may cause sodium retention and edema, particularly if previously poor metabolic control is improved by intensified insulin therapy.
Allergic Reactions
Local Allergy
As with any insulin therapy, patients taking Insulin Glargine injections may experience injection site reactions, including redness, pain, itching, urticaria, edema, and inflammation. In clinical studies in adult patients, there was a higher incidence of treatment-emergent injection site pain in Lantus-treated patients (2.7%) compared to NPH insulin-treated patients (0.7%). The reports of pain at the injection site did not result in discontinuation of therapy.
Rotation of the injection site within a given area from one injection to the next may help to reduce or prevent these reactions. 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. Most minor reactions to insulin usually resolve in a few days to a few weeks.
Systemic Allergy
Severe, life-threatening, generalized allergy, including anaphylaxis, generalized skin reactions, angioedema, bronchospasm, hypotension, and shock may occur with any insulin, including Lantus and may be life threatening.
Antibody production
All insulin products can elicit the formation of insulin antibodies. The presence of such insulin antibodies may increase or decrease the efficacy of insulin and may require adjustment of the insulin dose. In phase 3 clinical trials of Lantus Insulin, increases in titers of antibodies to insulin were observed in NPH insulin and insulin glargine treatment groups with similar incidences.
Postmarketing experience
The following adverse reactions have been identified during post-approval use of Insulin Glargine. 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 short-acting insulins, have been accidentally administered instead of Lantus (Insulin Glargine). To avoid medication errors between Insulin Glargine (Lantus) and other insulins, patients should be instructed to always verify the insulin label before each injection.
Lantus (Insulin Glargine) related pharmaceutical drugs and medications
|
| Trade name of the drug |
Pharmaceutical forms and doses |
Companies |
| Glumet-XR |
Tablets, Extended Release; Oral; Metformin Hydrochloride 500 mg |
CiplaL.R. Imperial PharmaceuticalsPharmaniagaProtecUnited Laboratories |
| Prugal |
Tablets; Oral; Glipizide 5 mgTablets; Oral; Glipizide 10 mg |
Silanes Laboratorios |
| Glicab Lancer |
Tablets; Oral; Gliclazide 40 mgTablets; Oral; Gliclazide 80 mg |
Lancer Pharmaceuticals |
| M-Pride GM |
Tablets; Oral; Glimepiride 1 mg; Metformin Hydrochloride 500 mg; Pioglitazone Hydrochloride 15 mgTablets; Oral; Glimepiride 2 mg; Metformin Hydrochloride 500 mg; Pioglitazone Hydrochloride 15 mg |
Capital Pharma |
| Spironol Gedeon Richter |
Tablets; Oral; Spironolactone 25 mgTablets; Oral; Spironolactone 50 mgTablets; Oral; Spironolactone 100 mg |
Gedeon Richter |
| Alin Depot |
Injectable; Injection; Dexamethasone Isonicotinate 4 mg / ml |
Chinoin |
| Captopril American Generics |
Tablets; Oral; Captopril 25 mgTablets; Oral; Captopril 50 mg |
American Generics |
| Glyset prescribing information |
Tablets; Oral; Miglitol 25 mg |
PfizerBayer Schering Pharma |
| L-Thyroxin-Na AbZ |
Tablets; Oral; Levothyroxine Sodium 25 mcgTablets; Oral; Levothyroxine Sodium 50 mcgTablets; Oral; Levothyroxine Sodium 75 mcgTablets; Oral; Levothyroxine Sodium 100 mcgTablets; Oral; Levothyroxine Sodium 125 mcgTablets; Oral; Levothyroxine Sodium 150 mcgTablets; Oral; Levothyroxine Sodium 175 mcgTablets; Oral; Levothyroxine Sodium 200 mcg |
AbZ-Pharma |
| Aromasin adverse reactions: advanced breast cancer |
Tablets, Film-Coated; Oral; Exemestane 25 mg |
PfizerThe Glory Medicina |
| Balon |
Tablets, Sugar-Coated; Oral; Metoclopramide Dihydrochloride Monohydrate 5 mg |
Ying Yuan Chemical Pharmaceutical |
| Jardiance adverse reactions |
Tablets, Film-Coated; Oral; Empagliflozin 10 mgTablets, Film-Coated; Oral; Empagliflozin 25 mg |
Boehringer IngelheimEli Lilly |
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