What are the possible side effects of Glarvia?
Glarvia may cause serious side effects that can lead to death, including:
- low blood sugar (hypoglycemia). Signs and symptoms that may indicate low blood sugar include:
- dizziness or light-headedness, sweating, confusion, headache, blurred vision, slurred speech, shakiness, fast heartbeat, anxiety, irritability or mood change, hunger.
- severe allergic reaction (whole body reaction). Get medical help right away if you have any of these signs or symptoms of a severe allergic reaction:
- a rash over your whole body, trouble breathing, a fast heartbeat, or sweating.
- low potassium in your blood (hypokalemia).
- Heart failure. Taking certain diabetes pills called TZDs (thiazolidinediones) with Glarvia may cause heart failure in some people. This can happen even if you have never had heart failure or heart problems before. If you already have heart failure it may get worse while you take TZDs with Glarvia. Your healthcare provider should monitor you closely while you are taking TZDs with Glarvia. Tell your healthcare provider if you have any new or worse symptoms of heart failure including:
- shortness of breath, swelling of your ankles or feet, sudden weight gain.
Treatment with TZDs and Glarvia may need to be changed or stopped by your healthcare provider if you have new or worse heart failure.
Get emergency medical help if you have:
- trouble breathing, shortness of breath, fast heartbeat, swelling of your face, tongue, or throat, sweating, extreme drowsiness, dizziness, confusion.
The most common side effects include:
- low blood sugar (hypoglycemia); weight gain; allergic reactions, including reactions at your injection site; skin thickening or pits at the injection site (lipodystrophy).
These are not all the possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Glarvia side effects (more detail)
Side effects of Glarvia in details
The following adverse reactions are discussed elsewhere:
- Hypoglycemia.
- Hypersensitivity and allergic reactions.
- Hypokalemia.
Clinical Trial Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Two clinical trials with Glarvia were conducted: one in type 1 diabetes and one in type 2 diabetes.
The type 1 diabetes population had the following characteristics: Mean age was 41 years and mean duration of diabetes was 16 years. 58% were male. 75% were Caucasian, 2% Black or African American and 4% American Indian or Alaskan native. 4% were Hispanic. At baseline, mean eGFR was 109 mL/min/1.73m². 73.5 percent of patients had eGFR > 90 mL/min/1.73m². The mean BMI was approximately 26 kg/m². HbA1c at baseline was 7.8%. The data in Table 1 reflect exposure of 268 patients to Glarvia with a mean exposure duration of 49 weeks.
The type 2 diabetes population had the following characteristics: Mean age was 59 years and mean duration of diabetes was 11 years. 50% were male. 78% were Caucasian, 8% Black or African American and 5% American Indian or Alaskan native. 28% were Hispanic. At baseline, mean eGFR was 109 mL/min/1.73m². 67.5 percent of patients had eGFR > 90 mL/min/1.73m². The mean BMI was approximately 32 kg/m². HbA1c at baseline was 8.3%. The data in Table 2 reflect exposure of 376 patients to Glarvia with a mean exposure duration of 22 weeks.
Common adverse reactions were defined as reactions occurring in ≥ 5% of the population studied. Common adverse reactions during clinical trials in patients with type 1 diabetes mellitus and type 2 diabetes mellitus (other than hypoglycemia) are listed in Table 1 and Table 2, respectively.
Table 1: Adverse reactions occurring in ≥ 5% of adult patients with type 1 diabetes treated with Glarvia in a 52-week trial
Glarvia + Insulin Lispro, % (n=268) | |
Infection Infections other than nasopharyngitis or upper respiratory tract infection. |
The frequencies of adverse reactions during a clinical trial of 5 years duration with another Glarvia product, 100 units/mL, in patients with type 2 diabetes mellitus are listed in Table 3.
Table 3: Common adverse reactions in 5-year trial of adult patients with type 2 diabetes (adverse reactions with incidence ≥ 10% and higher with another Glarvia product, 100 units/mL, than comparator)
Another Glarvia Product, % (n=514) | NPH, % (n=503) | |
Hypertension | 20 | 19 |
Sinusitis | 19 | 18 |
Cataract | 18 | 16 |
Bronchitis | 15 | 14 |
Back pain | 13 | 12 |
Cough | 12 | 7 |
Urinary tract infection | 11 | 10 |
Diarrhea | 11 | 10 |
Depression | 11 | 10 |
Headache | 10 | 9 |
The frequencies of adverse reactions during clinical trials with another Glarvia product, 100 units/mL, in children and adolescents with type 1 diabetes mellitus are listed in Table 4.
Table 4: Adverse reactions in a 28-week clinical trial of children and adolescents with type 1 diabetes (adverse reactions with frequency ≥ 5% and the same or higher with another Glarvia product, 100 units/mL, than comparator)
Another Glarvia Product, % (n=174) | NPH, % (n=175) | |
Rhinitis | 5 | 5 |
Severe Hypoglycemia
Hypoglycemia is the most commonly observed adverse reaction in patients using insulin, including Glarvia. The rates of reported hypoglycemia depend on the definition of hypoglycemia used, diabetes type, insulin dose, intensity of glucose control, background therapies, and other intrinsic and extrinsic patient factors. For these reasons, comparing rates of hypoglycemia in clinical trials for Glarvia with the incidence of hypoglycemia for other products may be misleading and also, may not be representative of hypoglycemia rates that will occur in clinical practice.
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 and ≤ 36 mg/dL in the ORIGIN trial) or prompt recovery after oral carbohydrate, intravenous glucose or glucagon administration.
The incidence of severe symptomatic hypoglycemia in patients receiving Glarvia with type 1 diabetes mellitus and type 2 diabetes mellitus was 4% at 52 weeks and 1% at 24 weeks, respectively.
The incidence of severe symptomatic hypoglycemia in a clinical trial with another Glarvia product, 100 units/mL, in children and adolescents age 6 to 15 years with type 1 diabetes was 23% at 26 weeks.
Table 5 displays the proportion of patients experiencing severe symptomatic hypoglycemia in another Glarvia product, 100 units/mL, and Standard Care groups in the ORIGIN Trial.
Table 5: Severe Symptomatic Hypoglycemia in the ORIGIN Trial
ORIGIN Trial Median duration of follow-up: 6.2 years | ||
Another Glarvia Product, 100 units/mL (N=6231) | Standard Care (N=6273) | |
Percent of patients | 6 | 2 |
Allergic Reactions
Some patients taking insulin therapy, including Glarvia have experienced erythema, local edema, and pruritus at the site of injection. These conditions were usually self-limiting. Severe cases of generalized allergy (anaphylaxis) have been reported.
Peripheral Edema
Some patients taking Glarvia have experienced sodium retention and edema, particularly if previously poor metabolic control is improved by intensified insulin therapy.
Lipodystrophy
Administration of insulin subcutaneously, including Glarvia, has resulted in lipoatrophy (depression in the skin) or lipohypertrophy (enlargement or thickening of tissue) in some patients.
Weight Gain
Weight gain has occurred with some insulin therapies including Glarvia and has been attributed to the anabolic effects of insulin and the decrease in glycosuria.
Immunogenicity
As with all therapeutic proteins, there is potential for immunogenicity.
In a 52-week study of type 1 diabetes patients, 42% of patients who received Glarvia once daily were positive for anti-drug antibodies (ADA) at least once during the study, including 17% that were positive at baseline and 25% of patients who developed ADA during the study. Sixty-five percent of the ADA positive patients on Glarvia with antibody testing at week 52 remained ADA positive at week 52.
In a 24-week study of type 2 diabetes patients, 17% of patients who received Glarvia once daily were positive for ADA at least once during the study. Among the subjects who were positive, 5% had ADA at baseline and 12% developed antibodies during the study. The percent binding of patients positive at baseline on Glarvia did not increase significantly during the study. Fifty-one percent of the ADA positive patients on Glarvia with antibody testing at week 24 remained ADA positive at week 24. There was no evidence that these antibodies had an impact on efficacy and safety outcomes.
The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay and may be influenced by several factors such as: assay methodology, sample handling, timing of sample collection, concomitant medication, and underlying disease. For these reasons, comparison of the incidence of antibodies to Glarvia with the incidence of antibodies in other studies or to other products may be misleading.
Postmarketing Experience
The following adverse reactions have been identified during post-approval use of another Glarvia product, 100 units/mL. 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 insulin products, particularly rapid-acting insulins, have been accidentally administered instead of an Glarvia product. To avoid medication errors between Glarvia products and other insulin products, patients should be instructed to always verify the insulin label before each injection.
What is the most important information I should know about Glarvia?
- Glarvia cartridge systems may cause drowsiness, dizziness, blurred vision, or lightheadedness. These effects may be worse if you take it with alcohol or certain medicines. Use Glarvia cartridge systems with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
- Do not drink alcohol without discussing it with your doctor. Drinking alcohol may increase your risk of developing high or low blood sugar.
- Do not exceed the recommended dose, use Glarvia cartridge systems more often than prescribed, or change the type or dose of insulin you are taking without checking with your doctor.
- Proper diet, regular exercise, and regular testing of the blood sugar are important for best results when using Glarvia cartridge systems.
- Illness, especially with nausea and vomiting, emotional problems, stress, or changes in diet or activity level, may cause your insulin requirements to change. Even if you are not eating, you still require insulin. You and your doctor should establish a sick day plan to use in case of illness. When you are sick, test your blood/urine frequently and call your doctor as instructed.
- If you will be traveling across time zones, consult your doctor concerning adjustments in your insulin schedule.
- An insulin reaction resulting from low blood sugar levels (hypoglycemia) may occur if you take too much insulin, skip a meal, or exercise too much. Low blood sugar may make you anxious, sweaty, weak, dizzy, drowsy, or faint. It may also make your heart beat faster; make your vision change; give you a headache, chills, or tremors; or make you more hungry. It is a good idea to carry a reliable source of glucose (eg, tablets or gel) to treat low blood sugar. If this is not available, you should eat or drink a quick source of sugar like table sugar, honey, candy, orange juice, or non-diet soda. This will raise your blood sugar level quickly. Tell your doctor right away if this happens. To prevent low blood sugar, eat meals at the same time each day and do not skip meals.
- Developing a fever or infection, eating significantly more than usual, or missing your dose of insulin may cause high blood sugar (hyperglycemia). High blood sugar may make you feel confused, drowsy, or thirsty. It can also make you flush, breathe faster, or have a fruit-like breath odor. If these symptoms occur, tell your doctor right away. If not treated, loss of consciousness, coma, or death may occur.
- Carry an ID card at all times that says you have diabetes.
- Lab tests, including fasting blood glucose levels or glycosylated hemoglobin levels, may be performed while you use Glarvia cartridge systems. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Use Glarvia cartridge systems with caution in the ELDERLY; they may be more sensitive to its effects, especially low blood sugar.
- Glarvia cartridge systems should be used with extreme caution in CHILDREN younger than 6 years old; safety and effectiveness in these children have not been confirmed.
- PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Glarvia cartridge systems while you are pregnant. Glarvia cartridge systems is found in breast milk. If you are or will be breast-feeding while you use Glarvia cartridge systems, check with your doctor. Discuss any possible risks to your baby.
Glarvia contraindications
Glarvia injection is contraindicated:
- •
- during episodes of hypoglycemia.
- •
- in patients with hypersensitivity to Glarvia products or any of the excipients in Glarvia injection.
Reviews
The results of a survey conducted on ndrugs.com for Glarvia are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Glarvia. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.User reports
Consumer reported side effects
No survey data has been collected yetConsumer reviews
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Information checked by Dr. Sachin Kumar, MD Pharmacology