Apidra SoloStar Pen

Never share an injection pen or syringe with another person, even if the needle has been changed.

You should not use insulin glulisine if you are allergic to it, or if you are having an episode of hypoglycemia (low blood sugar).

Insulin glulisine is not approved for use by anyone younger than 4 years old, and should not be used to treat type 2 diabetes in a child of any age.

To make sure insulin glulisine is safe for you, tell your doctor if you have:

• liver or kidney disease;

• low levels of potassium in your blood (hypokalemia); or

• diabetic ketoacidosis (call your doctor for treatment).

Tell your doctor if you also take pioglitazone or rosiglitazone (sometimes contained in combinations with glimepiride or metformin). Taking certain oral diabetes medicines while you are using insulin may increase your risk of serious heart problems.

Follow your doctor's instructions about using insulin if you are pregnant or breast-feeding a baby. Blood sugar control is very important during pregnancy, and your dose needs may be different during each trimester of pregnancy. Your dose needs may also be different while you are breast-feeding.

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:

• fluid retention--weight gain, swelling in your hands or feet, 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;

• itching, mild skin rash; 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.

Many other medicines can affect your blood sugar, and some medicines can increase or decrease the effects of insulin. Some drugs can also cause you to have fewer symptoms of hypoglycemia, making it harder to tell when your blood sugar is low. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using. This includes prescription and over-the-counter medicines, vitamins, and herbal products.

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]

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