Novolog

Last updated on RxList: 4/26/2021
Novolog Side Effects Center

What Is NovoLog?

NovoLog (insulin aspart [rDNA origin] injection) is a form of insulin, a hormone that is produced in the body, used to treat type 1 (insulin-dependent) diabetes in adults and children who are at least 2 years old. NovoLog is usually given together with another long-acting insulin.

What Are Side Effects of NovoLog?

The most common side effect of NovoLog is low blood sugar (hypoglycemia).

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)

Other common side effects of NovoLog include:

  • injection site reactions (e.g., pain, redness, irritation).

Tell your doctor right away if you have any serious side effects of NovoLog including:

Dosage for NovoLog

The dosage of NovoLog is individualized. The total daily insulin requirement may vary and is usually between 0.5 to 1.0 units/kg/day.

What Drugs, Substances, or Supplements Interact with NovoLog?

NovoLog may interact with:

  • albuterol,
  • clonidine,
  • reserpine,
  • guanethidine, or
  • beta-blockers

There are many other medicines that can increase or decrease the effects of insulin.

Tell your doctor about all the prescription and over-the-counter medications you use. This includes:

  • vitamins,
  • minerals,
  • herbal products, and
  • drugs prescribed by other doctors

NovoLog During Pregnancy and Breastfeeding

Tell your doctor if you are pregnant before using NovoLog. Tell your doctor if you become pregnant. Your doctor may switch the type of insulin you use during pregnancy. This medication does not pass into breast milk. Your insulin needs may change while breastfeeding. Consult your doctor before breastfeeding.

Additional Information

Our NovoLog (insulin aspart [rDNA origin] injection) 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.

QUESTION

Diabetes is defined best as... See Answer
Novolog 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:

  • heart problems--swelling, rapid weight gain, feeling short of breath; 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;
  • low potassium;
  • swelling in your hands and feet;
  • skin rash, itching, redness, or swelling; 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.

Read the entire detailed patient monograph for Novolog (Insulin Aspart [rDNA origin] Inj)

SLIDESHOW

Diabetes: What Raises and Lowers Your Blood Sugar Level? See Slideshow
Novolog 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]
  • Hypersensitivity reactions [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 safety of NOVOLOG was evaluated in two treat-to-target trials of 6 months duration, conducted in subjects with type 1 diabetes or type 2 diabetes [see Clinical Studies].

The data in Table 1 reflect the exposure of 596 patients with type 1 diabetes to NOVOLOG in one clinical trial with a mean exposure duration to NOVOLOG of 24 weeks. The mean age was 38.9 years. Fifty-one percent were male, 94% were Caucasian, 2% were Black and 4% were other races. The mean body mass index (BMI) was 25.6 kg/m2. The mean duration of diabetes was 15.7 years and the mean HbA1c at baseline was 7.9%.

The data in Table 2 reflect the exposure of 91 patients with type 2 diabetes to NOVOLOG in one clinical trial with a mean exposure duration to NOVOLOG of 24 weeks. The mean age was 56.6 years. Sixty-three percent were male, 76% were Caucasian, 9% were Black and 15% were other races. The mean BMI was 29.7 kg/m2. The mean duration of diabetes was 12.7 years and the mean HbA1c at baseline was 8.1%.

Common adverse reactions were defined as events occurring in ≥5%, excluding hypoglycemia, of the population studied. Common adverse events occurring at the same rate or greater for NOVOLOG-treated subjects than in comparator-treated subjects 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 Type 1 Diabetes Mellitus Adult Patients treated with NOVOLOG and at the same rate or greater on NOVOLOG than on comparator

NOVOLOG + NPH (%)
(n= 596)
Regular Human Insulin + NPH (%)
(n= 286)
Headache 12 10
Injury accidental 11 10
Nausea 7 5
Diarrhea 5 3

Table 2: Adverse reactions occurring in ≥ 5% of Type 2 Diabetes Mellitus Adult Patients treated with NOVOLOG and at the same rate or greater on NOVOLOG than on comparator

NOVOLOG + NPH (%)
(n= 91)
Human Regular Insulin + NPH (%)
(n= 91)
Hyporeflexia 11 7
Onychomycosis 10 5
Sensory disturbance 9 7
Urinary tract infection 8 7
Chest pain 5 3
Headache 5 3
Skin disorder 5 2
Abdominal pain 5 1
Sinusitis 5 1

Severe Hypoglycemia

Hypoglycemia is the most commonly observed adverse reaction in patients using insulin, including NOVOLOG. 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 NOVOLOG 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 hypoglycemia was defined as hypoglycemia associated with central nervous system symptoms and requiring the intervention of another person or hospitalization.

The incidence of severe hypoglycemia in adult and pediatric patients receiving subcutaneous NOVOLOG with type 1 diabetes mellitus was 17% at 24 weeks and 6% at 24 weeks, respectively [see Clinical Studies]. The incidence of severe hypoglycemia in adult patients receiving subcutaneous NOVOLOG with type 2 diabetes mellitus was 10% at 24 weeks.

The incidence of severe hypoglycemia in adult and pediatric patients with type 1 diabetes mellitus, receiving NOVOLOG via continuous subcutaneous insulin infusion by external pump was 2% at 16 weeks and 10% at 16 weeks respectively.

No severe hypoglycemic episodes were reported in adult patients with type 2 diabetes mellitus receiving NOVOLOG via continuous subcutaneous insulin infusion by external pump at 16 weeks.

Allergic Reactions

Some patients taking insulin, including NOVOLOG 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.

Insulin Initiation And Glucose Control Intensification

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

Administration of insulin, including NOVOLOG, subcutaneously and via subcutaneous insulin infusion by external pump, has resulted in lipoatrophy (depression in the skin) or lipohypertrophy (enlargement or thickening of tissue) in some patients [see DOSAGE AND ADMINISTRATION].

Peripheral Edema

Insulins, including NOVOLOG, may cause sodium retention and edema, particularly if previously poor metabolic control is improved by intensified insulin therapy.

Weight Gain

Weight gain has occurred with insulins, including NOVOLOG, and has been attributed to the anabolic effects of insulin and the decrease in glucosuria.

Immunogenicity

As with all therapeutic proteins, there is potential for immunogenicity. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies to NOVOLOG in the studies described below with the incidence of antibodies in other studies or to other products may be misleading.

In a 6-month study with a 6-month extension in adult subjects with type 1 diabetes, 99.8% of patients who received NOVOLOG were positive for anti-insulin antibodies (AIA) at least once during the study, including 97.2% that were positive at baseline. A total of 92.1% of patients who received NOVOLOG were positive for anti-drug antibodies (ADA) at least once during the study, including 64.6% that were positive at baseline.

In a phase 3 type 1 diabetes clinical trial of NOVOLOG, initial increase in titers of antibodies to insulin, followed by a decrease to baseline values, was observed in regular human insulin and insulin aspart treatment groups with similar incidences. These antibodies did not cause deterioration in glycemic control or necessitate increases in insulin dose.

Post Marketing Experience

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

Medication errors have been reported in which other insulins have been accidentally substituted for NOVOLOG.

Localized cutaneous amyloidosis at the injection site has occurred with insulin aspart. 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

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 analog (e.g., octreotide), and sulfonamide antibiotics.
Intervention: Dose adjustment and increased frequency of glucose monitoring may be required when NOVOLOG is coadministered with these drugs.
Drugs That May Decrease the Blood Glucose Lowering Effect of NOVOLOG
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 adjustment and increased frequency of glucose monitoring may be required when NOVOLOG is coadministered with these drugs.
Drugs That May Increase or Decrease the Blood Glucose Lowering Effect of NOVOLOG
Drugs: Alcohol, beta-blockers, clonidine, and lithium salts. Pentamidine may cause hypoglycemia, which may sometimes be followed by hyperglycemia. Pentamidine may cause hypoglycemia, which may sometimes be followed by hyperglycemia.
Intervention: Dose adjustment and increased frequency of glucose monitoring may be required when NOVOLOG is coadministered 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 NOVOLOG is co-administered with these drugs.

Read the entire FDA prescribing information for Novolog (Insulin Aspart [rDNA origin] Inj)

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

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