Lyumjev Side Effects Center

Last updated on RxList: 10/27/2022
Lyumjev Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Lyumjev?

Lyumjev (insulin lispro-aabc) is a rapid-acting human insulin analog indicated to improve glycemic control in adults with diabetes mellitus.

What Are Side Effects of Lyumjev?

Lyumjev may cause serious side effects including:

  • dizziness,
  • irritability,
  • moodiness or sudden changes in behavior,
  • hunger,
  • shakiness,
  • sweating,
  • rapid heartbeats,
  • confusion,
  • headache,
  • poor coordination,
  • fainting and unconsciousness,
  • convulsions (seizures)
  • coma,
  • vomiting, and
  • diarrhea

Get medical help right away, if you have any of the symptoms listed above.

Side effects of Lyumjev include:

  • low blood sugar (hypoglycemia),
  • injection site reactions (rash, redness, inflammation, bruising, or itching),
  • allergic reactions,
  • rash,
  • itching,
  • changes in body fat distribution (lipodystrophy),
  • runny or stuffy nose,
  • upper respiratory tract infection, and
  • weight gain

Seek medical care or call 911 at once if you have the following serious side effects:

  • Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
  • Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in your chest; shortness of breath; and sudden dizziness, lightheadedness, or passing out;
  • Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors.

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

Dosage for Lyumjev

The dosage of Lyumjev is based on the patient's metabolic needs, glucose monitoring results, and glycemic control goal.

Lyumjev In Children

The safety and effectiveness of Lyumjev in pediatric patients have not been established.

What Drugs, Substances, or Supplements Interact with Lyumjev?

Lyumjev may interact with other medicines such as:

  • antidiabetic agents,
  • ACE inhibitors,
  • angiotensin II receptor blocking agents (ARBs),
  • disopyramide,
  • fibrates,
  • fluoxetine,
  • monoamine oxidase inhibitors (MAOIs),
  • pentoxifylline,
  • pramlintide,
  • salicylates,
  • somatostatin analogs (e.g., octreotide),
  • sulfonamide antibiotics,
  • atypical antipsychotics (e.g., olanzapine and clozapine),
  • corticosteroids,
  • danazol,
  • diuretics (water pills),
  • estrogens,
  • glucagon,
  • isoniazid,
  • niacin,
  • oral contraceptives,
  • phenothiazines,
  • progestogens (e.g., in oral contraceptives),
  • protease inhibitors,
  • somatropin,
  • sympathomimetic agents (e.g., albuterol, epinephrine, terbutaline),
  • thyroid hormones,
  • alcohol,
  • beta-blockers,
  • clonidine,
  • lithium salts,
  • guanethidine, and
  • reserpine

Tell your doctor all medications and supplements you use.

Lyumjev During Pregnancy and Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant before using Lyumjev. There are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy. Exogenous human insulin products, including Lyumjev, pass into breast milk. There are no adverse reactions reported in breastfed infants in the literature. Consult your doctor before breastfeeding.

Additional Information

Our Lyumjev (insulin lispro-aabc) Injection, for Subcutaneous or Intravenous Use 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.

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.

SLIDESHOW

Diabetes: What Raises and Lowers Your Blood Sugar Level? See Slideshow
Lyumjev Consumer Information

Get emergency medical help if you have signs of insulin allergy: redness or swelling where an injection was given, itchy skin rash over the entire body, trouble breathing, fast heartbeats, feeling like you might pass out, or swelling in your tongue or throat.

Call your doctor at once if you have:

  • weight gain, swelling in your hands or feet, feeling short of breath;
  • low blood sugar--headache, hunger, sweating, irritability, dizziness, fast heart rate, and feeling anxious or shaky; or
  • low potassium--leg cramps, constipation, irregular heartbeats, fluttering in your chest, increased thirst or urination, numbness or tingling, muscle weakness or limp feeling.

Common side effects may include:

  • low blood sugar;
  • weight gain;
  • swelling in your hands or feet;
  • itching; or
  • thickening or hollowing of the skin where you injected the medicine.

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.

QUESTION

Diabetes is defined best as... See Answer
Lyumjev Professional Information

SIDE EFFECTS

The following adverse reactions are also discussed elsewhere:

  • Hypoglycemia [see WARNINGS AND PRECAUTIONS].
  • Hypoglycemia Due to Medication Errors [see WARNINGS AND PRECAUTIONS]
  • Hypokalemia [see WARNINGS AND PRECAUTIONS].
  • Hypersensitivity Reactions [see WARNINGS AND PRECAUTIONS].

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 actually observed in clinical practice.

The data in Table 1 reflect the exposure of 780 patients with type 1 diabetes to LYUMJEV with a mean exposure duration of 26 weeks [see Clinical Studies]. The mean age was 44 years, the mean duration of diabetes was 19 years, 55% were male, 77% were White, 2% were Black or African American, and 9% were Hispanic. The mean BMI was 26.6 kg/m2 and the mean HbA1c at baseline was 7.3%.

The data in Table 2 reflect the exposure of 336 patients with type 2 diabetes to LYUMJEV with a mean exposure duration of 26 weeks [see Clinical Studies]. The mean age was 60 years, the mean duration of diabetes was 16 years, 55% were male, 69% were White, 4% were Black or African American, and 24% were Hispanic. The mean BMI was 32.1 kg/m2 and the mean HbA1c at baseline was 7.3%.

The data in Table 3 reflect the exposure of 215 patients with type 1 diabetes to LYUMJEV via CSII administration with a mean exposure duration of 16 weeks [see Clinical Studies]. The mean age was 48 years, the mean duration of diabetes was 26 years, 44% were male, 94% were White, 3% were Black or African American, and 8% were Hispanic. The mean BMI was 27.0 kg/m2 and the mean HbA1c at baseline was 7.6%.

Common adverse reactions, excluding hypoglycemia, were defined as events occurring in ≥5% and occurring at the same rate or greater for LYUMJEV-treated patients than HUMALOG®-treated patients.

Table 1. Adverse Reactions Occurring in ≥5% of LYUMJEV-Treated Patients with Type 1 Diabetes

Mealtime LYUMJEV + basal insulin
(N=451)
%
Postmeal LYUMJEV + basal insulin
(N=329)
%
Nasopharyngitis 14.2 14.6

Table 2. Adverse Reactions Occurring in ≥5% of LYUMJEV-Treated Patients with Type 2 Diabetes

Mealtime LYUMJEV + basal insulin
(N=336)
%
Nasopharyngitis 12.5
Upper Respiratory Tract Infection 7.4

Table 3. Adverse Reactions Occurring in ≥5% of LYUMJEV-Treated Patients with Type 1 Diabetes Using

CSII LYUMJEV administration
(N=215)
%
Infusion site reaction 19.1
Infusion site pain 15.8
Nasopharyngitis 6.0

Hypoglycemia

Hypoglycemia is the most commonly observed adverse reaction in patients using insulin, including LYUMJEV. 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 LYUMJEV with the incidence of hypoglycemia for other products may be misleading and also may not be representative of hypoglycemia rates that occur in clinical practice.

Incidence rates for severe hypoglycemia in adults with type 1 and type 2 diabetes mellitus treated with LYUMJEV in clinical trials are shown in Table 4 [see Clinical Studies].

Table 4. Proportion of Patients with Type 1 Diabetes and Type 2 Diabetes Experiencing at Least One Episode of Severe Hypoglycemia in Adult Clinical Trials

PRONTO-T1D (Type 1) PRONTO-T2D (Type 2) PRONTO-Pump-2 (Type 1 CSII)
Mealtime LYUMJEV + basal insulin
(N=451)
%
Postmeal LYUMJEV + basal insulin
(N=329)
%
Mealtime LYUMJEV + basal insulin
(N=336)
%
LYUMJEV
(N=215)
%
Severe hypoglycemiaa 5.5 4.6 0.9 1.4
aSevere hypoglycemia: an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions

Allergic Reactions

Severe, life-threatening, generalized allergy, including anaphylaxis, generalized skin reactions, angioedema, bronchospasm, hypotension, and shock may occur with any insulin, including LYUMJEV, and may be life threatening. Generalized hypersensitivity reactions such as skin rashes and hypersensitivity were reported in patients treated with LYUMJEV: eczema (0.4%), rash (0.4%), dermatitis (0.3%), hypersensitivity (0.2%), and pruritus (0.2%).

Lipodystrophy

Administration of insulin, including LYUMJEV, has resulted in lipohypertrophy (enlargement or thickening of tissue) and lipoatrophy (depression in the skin). Lipodystrophy was reported in 0.2% of patients treated with LYUMJEV [see DOSAGE AND ADMINISTRATION].

Injection/Infusion Site Reactions

Injection or infusion site reactions can occur with insulin therapy. With LYUMJEV, patients have experienced rash, redness, inflammation, pain, bruising, or itching at the site of LYUMJEV injection or infusion. LYUMJEV contains treprostinil sodium and sodium citrate dihydrate as inactive ingredients [see DESCRIPTION] which have been associated with infusion and injection site reactions with other non-insulin products.

Subcutaneous Injection Site-Related Reactions

In studies PRONTO-T1D and PRONTO-T2D, injection site-related reactions occurred in 2.7% of patients treated with LYUMJEV (mild in 2.2% and moderate in 0.5%). with <0.1% of patients discontinuing from treatment due to injection site- related reactions.

Continuous Subcutaneous Insulin Infusion (CSII) Site-Related Reactions

In Study PRONTO-Pump-2, infusion site-related reactions were reported in 37.7% of patients treated with LYUMJEV (mild in 27.9%, moderate in 7.9%, and severe in 1.9%), with 3.3% of patients discontinuing from treatment due to infusion site-related reactions. See Table 3.

Weight Gain

Weight gain can occur with insulin therapy, including LYUMJEV, and has been attributed to the anabolic effects of insulin and the decrease in glucosuria. Patients with type 1 diabetes treated with LYUMJEV gained an average of 0.6 kg and patients with type 2 diabetes treated with LYUMJEV gained an average of 1.5 kg.

Peripheral Edema

Insulin, including LYUMJEV, may cause sodium retention and edema, particularly if previous poor metabolic control is improved by intensified insulin therapy. Peripheral edema occurred in 0.2% of patients treated with LYUMJEV.

Immunogenicity

As with all therapeutic proteins, there is a potential for immunogenicity. 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 LYUMJEV in the studies described below with the incidence of antibodies in other studies or to other products may be misleading.

In a 26-week study in type 1 diabetes patients, 49% were anti-drug (insulin lispro-aabc) antibody (ADA)-positive at baseline, 91% of which were cross-reactive with native insulin. A total of 33% of LYUMJEV-treated patients had treatment-emergent ADA post-baseline (i.e., either new ADA or a 57% increase in assay signal over baseline), 75% of which were cross-reactive with native insulin.

In a 26-week study in type 2 diabetes patients, 35% were ADA-positive at baseline, 81% of which were cross-reactive with native insulin. A total of 31% of LYUMJEV-treated patients had treatment-emergent ADA post-baseline (i.e., either new ADA or a 57% increase in assay signal over baseline), 68% of which were cross-reactive with native insulin.

Presence of antibody did not correlate with reduced efficacy, as measured by HbA1c, or specific adverse reactions.

Postmarketing Experience

The following additional adverse reactions have been identified during post-approval use of insulin lispro. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Localized cutaneous amyloidosis at the injection site has occurred with insulin use. Hyperglycemia has been reported with repeated insulin injections into areas of localized cutaneous amyloidosis; hypoglycemia has been reported with a sudden change to an unaffected injection site.

DRUG INTERACTIONS

Table 5 includes clinically significant drug interactions with LYUMJEV.

Table 5. Clinically Significant Drug Interactions with LYUMJEV

Drugs That May Increase the Risk of Hypoglycemia
Drugs: Antidiabetic agents, ACE inhibitors, angiotensin II receptor blocking agents, disopyramide, fibrates, fluoxetine, monoamine oxidase inhibitors, pentoxifylline, pramlintide, salicylates, somatostatin analogs (e.g., octreotide), and sulfonamide antibiotics.
Intervention: Dose reductions and increased frequency of glucose monitoring may be required when LYUMJEV is co-administered with these drugs.
Drugs That May Decrease the Blood Glucose Lowering Effect of LYUMJEV
Drugs: Atypical antipsychotics (e.g., olanzapine and clozapine), corticosteroids, danazol, diuretics, estrogens, glucagon, isoniazid, niacin, oral contraceptives, phenothiazines, progestogens (e.g., in oral contraceptives), protease inhibitors, somatropin, sympathomimetic agents (e.g., albuterol, epinephrine, terbutaline), and thyroid hormones.
Intervention: Dose increases and increased frequency of glucose monitoring may be required when LYUMJEV is co-administered with these drugs.
Drugs That May Increase or Decrease the Blood Glucose Lowering Effect of LYUMJEV
Drugs: Alcohol, beta-blockers, clonidine, and lithium salts. Pentamidine may cause hypoglycemia, which may sometimes be followed by hyperglycemia.
Intervention: Dose adjustment and increased frequency of glucose monitoring may be required when LYUMJEV is co-administered with these drugs.
Drugs That May Blunt Signs and Symptoms of Hypoglycemia
Drugs: Beta-blockers, clonidine, guanethidine, and reserpine.
Intervention: Increased frequency of glucose monitoring may be required when LYUMJEV is co-administered with these drugs.

Read the entire FDA prescribing information for Lyumjev (Insulin Lispro-aabc Injection)

© Lyumjev Patient Information is supplied by Cerner Multum, Inc. and Lyumjev Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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