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Apidra SoloStar Side Effects

Generic Name: insulin glulisine

Note: This document contains side effect information about insulin glulisine. Some of the dosage forms listed on this page may not apply to the brand name Apidra SoloStar.

For the Consumer

Applies to insulin glulisine: subcutaneous solution

Along with its needed effects, insulin glulisine (the active ingredient contained in Apidra SoloStar) 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 glulisine:

More Common

Less Common

  • Pounding in the ears
  • slow or fast heartbeat

Incidence Not Known

  • Difficulty with swallowing
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • fast, pounding, or irregular heartbeat or pulse
  • hives
  • increased sweating
  • itching
  • puffiness or swelling of the eyelids or around the eyes, face, lips or tongue
  • skin rash
  • tightness in the chest

Some side effects of insulin glulisine 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:

More Common

  • Difficulty with moving
  • dry, red, hot, or irritated skin
  • ear congestion
  • loss of voice
  • muscle aches
  • muscle pain or stiffness
  • pain in the joints

Less Common

  • 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
  • redistribution or accumulation of body fat

For Healthcare Professionals

Applies to insulin glulisine: injectable solution, subcutaneous solution

General

The most common adverse reactions reported include hypoglycemia, allergic reactions, injection site reactions, lipodystrophy, pruritus, and rash.[Ref]

Metabolic

Common (1% to 10%): Hypoglycemia, hypoglycemic seizure

Frequency not reported: Weight gain[Ref]

Hypersensitivity

In clinical trials of ups to 12 months duration, potential systemic allergic reactions were reported in 4.3% (79 of 1833) patients receiving insulin glulisine (the active ingredient contained in Apidra SoloStar) compared with 3.8% (58 of 1524) patients receiving comparator short-acting insulins. Permanent discontinuation occurred in 1 patient receiving insulin glulisine.[Ref]

Common (1% to 10%): Local hypersensitivity reactions (redness, swelling, and itching at injection site) Uncommon (0.1% to 1%): Systemic allergic reactions including urticaria, chest tightness, dyspnea, allergic dermatitis, and pruritus

Frequency not reported: Anaphylaxis[Ref]

Local

Among patients using continuous subcutaneous insulin infusion pumps, the rates of catheter occlusions and infusion site reactions were similar with insulin glulisine (the active ingredient contained in Apidra SoloStar) compared with insulin aspart.[Ref]

Common (1% to 10%): Infusion site reactions

Very rare (less than 0.01%): Catheter occlusions[Ref]

Cardiovascular

Common (1% to 10%): Peripheral edema, hypertension[Ref]

Gastrointestinal

Common (1% to 10%): Diarrhea, pharyngitis, vomiting, nausea[Ref]

Dermatologic

Rare (less than 0.1%): Lipodystrophy[Ref]

Immunologic

Common (1% to 10%): Influenza[Ref]

Respiratory

Common (1% to 10%): Nasopharyngitis, upper respiratory tract infection, sinusitis, bronchitis[Ref]

Musculoskeletal

Common (1% to 10%): Arthralgia, back pain[Ref]

Nervous system

Common (1% to 10%): Headache[Ref]

Genitourinary

Common (1% to 10%): Urinary tract infection[Ref]

References

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

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

3. "Product Information. Apidra (insulin glulisine)." Aventis Pharmaceuticals, Bridgewater, NJ.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

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