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NovoLog Mix 50 / 50 Side Effects

Generic Name: insulin aspart / insulin aspart protamine

Note: This document contains side effect information about insulin aspart / insulin aspart protamine. Some of the dosage forms listed on this page may not apply to the brand name NovoLog Mix 50 / 50.

For the Consumer

Applies to insulin aspart / insulin aspart protamine: subcutaneous suspension

Along with its needed effects, insulin aspart / insulin aspart protamine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking insulin aspart / insulin aspart protamine:

More common
  • Anxiety
  • blurred vision
  • burning, tingling, numbness or pain in the hands, arms, feet, or legs
  • chills
  • cold sweats
  • confusion
  • cool, pale skin
  • depression
  • dizziness
  • fast heartbeat
  • headache
  • increased hunger
  • loss of consciousness
  • nausea
  • nervousness
  • nightmares
  • seizures
  • sensation of pins and needles
  • shakiness
  • slurred speech
  • stabbing pain
  • unusual tiredness or weakness
Incidence not known
  • Bloating or swelling of the face, arms, hands, lower legs, or feet
  • change in vision
  • chest tightness
  • cough
  • difficulty swallowing
  • hives, itching, skin rash
  • puffiness or swelling of the eyelids or around the eyes, face, lips or tongue
  • rapid weight gain
  • redistribution or accumulation of body fat
  • thickening of the skin injection site
  • unusual weight gain or loss

Get emergency help immediately if any of the following symptoms of overdose occur while taking insulin aspart / insulin aspart protamine:

Symptoms of overdose
  • Decreased amount of urine
  • dry mouth
  • increased thirst
  • irregular heartbeat
  • loss of appetite
  • mood changes
  • muscle pain or cramps

Some side effects of insulin aspart / insulin aspart protamine may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Most common
  • Back pain
  • belching
  • bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
  • body aches or pain
  • bone pain
  • diarrhea
  • difficulty in breathing
  • dryness or soreness of throat
  • ear congestion
  • general feeling of discomfort or illness
  • heartburn
  • hoarseness
  • indigestion
  • joint pain
  • loss of voice
  • nasal congestion
  • runny nose
  • shivering
  • sneezing
  • stomach discomfort, upset, or pain
  • stuffy nose
  • tender, swollen glands in the neck
  • trouble sleeping
  • voice changes
  • vomiting

For Healthcare Professionals

Applies to insulin aspart / insulin aspart protamine: subcutaneous suspension

General

The most common adverse reactions observed with insulin therapy include hypoglycemia, allergic reactions, local injection site reactions, lipodystrophy, rash, and pruritus.[Ref]

Metabolic

Hypoglycemia is the most frequently reported adverse reaction with insulin therapy. It occurs if the dose of the insulin is too high in relation to the insulin requirement. In clinical trials, the frequency of hypoglycemia varied with patient population, dose regimens, and level of glycemic control. Weight gain has been attributed to the anabolic effects of insulin and the decrease in glycosuria.[Ref]

Very common (10% or more): Hypoglycemia (69%)
Frequency not reported: Weight gain[Ref]

Hypersensitivity

Very rare (less than 0.01%): Anaphylactic reactions
Frequency not reported: Allergic reactions[Ref]

Local

Frequency not reported: Injection site reactions[Ref]

Injection site reactions including pain, redness, hives, inflammation, bruising, swelling, and itching, may occur. These reactions are usually transitory.[Ref]

Ocular

Frequency not reported: Transient, reversible ophthalmologic refraction disorder, worsening of diabetic retinopathy[Ref]

Rapid improvement or intensification of in glucose control has been associated with transitory, reversible ophthalmologic refraction disorder; however, long-term glycemic control decreases the risk of diabetic retinopathy.[Ref]

Cardiovascular

Insulin may cause sodium retention and edema, especially if previously poor metabolic control is improved by intensified insulin therapy.[Ref]

Frequency not reported: Peripheral edema[Ref]

Dermatologic

Frequency not reported: Lipodystrophy, rash, pruritus[Ref]

Gastrointestinal

Common (1% to 10%): Dyspepsia, diarrhea, abdominal pain[Ref]

Immunologic

Common (1% to 10%): Influenza-like symptoms
Frequency not reported: Anti-insulin antibodies[Ref]

In a 3-month, open-label study, anti-insulin antibodies and cross-reacting anti-insulin antibodies were monitored in patients using this insulin compared with an insulin mix of 70% NPH (human insulin isophane suspension) and 30% regular (human insulin injection). Changes in cross-reactive antibodies were more common after this mix but these changes did not correlate with a change in HbA1c or increase in insulin dose. The clinical significance of these antibodies has not been established. Antibodies did not increase further after long-term exposure (greater than 6 months).[Ref]

Musculoskeletal

Common (1% to 10%): Back pain, skeletal pain[Ref]

Nervous system

Rapid improvement or intensification of in glucose control has been associated with acute and painful peripheral neuropathy; however, long-term glycemic control decreases the risk of neuropathy.[Ref]

Very common (10% or more): Headache (19%)
Common (1% to 10%): Neuropathy[Ref]

Other

Postmarketing reports: Medication errors in which other insulins have been accidentally substituted[Ref]

Respiratory

Common (1% to 10%): Pharyngitis, rhinitis , upper respiratory tract infection[Ref]

References

1. "Product Information. NovoLog Mix 70/30 FlexPen (insulin aspart-insulin aspart protamine)." Novo Nordisk Pharmaceuticals Inc, Princeton, NJ.

2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

3. Cerner Multum, Inc. "Australian Product Information." O 0

4. "Product Information. NovoLog Mix 70/30 (insulin aspart-insulin aspart protamine)." Novo Nordisk Pharmaceuticals Inc, Princeton, NJ.

Some side effects of NovoLog Mix 50 / 50 may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

More about NovoLog Mix 50/50 (insulin aspart / insulin aspart protamine)

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