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Apidra Solostar Side Effects

Generic Name: insulin glulisine

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

Not all side effects for Apidra Solostar may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to insulin glulisine: subcutaneous solution

In addition to its needed effects, some unwanted effects may be caused by insulin glulisine (the active ingredient contained in Apidra Solostar). In the event that any of these side effects do occur, they may require medical attention.

You should check with your doctor immediately if any of these side effects occur when taking insulin glulisine:

More common
  • Anxiety
  • blurred vision
  • body aches or pain
  • chills
  • cold sweats
  • confusion
  • convulsions
  • cool, pale skin
  • cough
  • depression
  • difficulty with breathing
  • dizziness
  • ear congestion
  • fast heartbeat
  • headache
  • increased hunger
  • loss of voice
  • nasal congestion
  • nightmares
  • runny nose
  • shakiness
  • slurred speech
  • sneezing
  • sore throat
  • unconsciousness
  • unusual tiredness or weakness
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 of the side effects that can occur with insulin glulisine may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

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: 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.

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