Lantus SoloStar Pens

What are the Indications for Lantus Solostar?

Lantus Solostar is prescribed as part of a treatment plan to manage blood sugar levels consisting of exercise, diet changes, and regular blood sugar testing. Any change in diet and activity can affect blood sugar levels.

This medication is prescribed to treat type 1 diabetes in adult patients and pediatric patients who are 6 years or older; and also prescribed to treat type 2 diabetes patients 18 years or older.

Lantus Solostar is not recommended:

• For treatment of diabetic ketoacidosis.
• If you are allergic or have had an allergic reaction to Lantus or ingredients in Lantus.

How is Lantus Solostar used?

Lantus Solostar is a disposable injectable pan that is to be injected under your skin. You should not share this medication with another person even if you’ve replaced the needle. Sharing may result in a serious infection for yourself or the other person transmitted through the needle.

Storage

Lantus Solostar that has not been opened may be stored at room temperature below 86°F (30°C) for up to 28 days or in the refrigerator between 36° to 46°F (2° to 8°C) indefinitely.

Lantus Solostar should be kept away from direct light and heat. Lantus Solostar should not be stored in the freezer.

If opened and currently in use can be stored at room temperature or in the refrigerator for up to 28 days. After 28 days, any opened remaining medication must be thrown away even if there is still some medication left.

Instructions

Follow the patient information pamphlet that comes with your medication. Patients with vision problems should use Lantus Solostar with the assistance of someone who is trained to use this medication.

Lantus Solostar needs to be injected under the skin of your upper leg, stomach, or upper arm. Lantus Solostar should never be injected into a vein or muscle.

1. Select your injection site and clean with an alcohol swab. The injection site should be rotated so as not to be in the exact same location as the last injection.

• Do not inject in areas with scars, stretch marks, bruises, or where the skin is tender, hard, or red.

1. Inject the medication exactly as directed in the patient information pamphlet to ensure you are using the correct dose.
2. After the injection, dispose of the needle in an FDA-cleared sharps disposal container immediately. Do not reuse or share your needles with other people. You can create a sharps disposable container by using any heavy-duty plastic household container that you have that:

• Is leak-resistant
• Has a tight-fitting, puncture-proof lid so sharps such as needles cannot escape
• Has a label warning there are hazardous materials inside the container

Dosage

Lantus Solostar is a clear, colorless solution available as a 3 mL (300 units) single-patient-use prefilled pen.

Lantus Solostar should be administered once daily as directed by your doctor. Dosages may vary and can change depending on several factors; including weight, current blood sugar level, activity levels, and how well your body responds to insulin.

Initial therapy

If you have:

• Type 1 diabetes, the starting dose will be one-third of your required daily insulin need in combination with short-acting insulins.
• Type 2 diabetes, the starting dose is 0.2 units/kg or up to 10 units daily.

Switching from other insulin

If you are switching from:

• Once-daily NPH insulin to Lantus Solostar, you may be able to continue taking the same unit dose.
• Twice-daily NPH insulin to Lantus Solostar, your doctor may lower your dose to 80% of what your dose was for NPH insulin.
• Once-daily Toujeo to Lantus Solostar, your doctor may lower your dose to 80% of what your dose was for Toujeo.
• Other therapy, the dosage will depend on other short-acting medications and therapies in use.

Side Effects

It’s important to understand that although Lantus Solostar is FDA approved, it comes with side effects that may or may not affect you.

Before starting Lantus Solostar, you should discuss possible side effects with your doctor or pharmacist.

Common Side Effects

Not all side effects require medical attention. As your body adjusts to Lantus Solostar, side effects may go away.

Tell your doctor if you experience the following symptoms, and they become severe or do not go away on their own:

• Low blood sugar
• Reaction at the injection site (e.g. tenderness, redness, skin thickening)
• Weight gain

Serious Side Effects

Severe adverse reactions while taking Lantus Solostar can occur. Seek emergency medical care or call 911 if you experience any of the following symptoms:

• Severe allergic reaction: severe rash or itching, swelling in the face, lips, tongue, or throat, rapid heartbeat, fainting or dizziness, or problems breathing or swallowing.
• Low blood sugar (hypoglycemia): headache, irritability, confusion, blurred vision, slurred speech, dizziness or light-headedness, shakiness, fast heartbeat, mood change, anxiety, or excessive hunger.
• Low potassium (hypokalemia): constipation, fluttering in the chest or irregular heartbeats, leg cramps, increased thirst or need to urinate, muscle weakness or unusual tiredness, or tingling sensation.
• Heart failure: weight gain, shortness of breath even at rest, swelling of the legs and/or stomach, increased tiredness and weakness, nausea, abdominal pain, or persistent cough with blood-tinged mucous.

The information above does not list all possible side effects. Contact your doctor or pharmacist if you experience any side effects not listed. You or your doctor may report side effects to the FDA by calling 1-800-FDA-1088.

Warnings & Precautions

Before using Lantus Solostar, tell your doctor or pharmacist:

• If you are allergic to any medications such as Lantus Solostar
• If you have or have had low levels of potassium such as hypokalemia
• If you have or have had heart failure
• If you are pregnant or plan to become pregnant
• If you are breastfeeding

Heart Failure and Fluid Retention

Taking insulin such as Lantus Solostar with thiazolidinediones (TZDs) can result in fluid retention leading to heart failure. Your doctor will monitor your symptoms and adjust your medications as needed.

Hypoglycemia or Low Blood Sugar

The risks of having low blood sugar levels increase:

• If there is a change in your diet and exercise
• If you consume alcohol
• If you take medications for diabetes such as Lantus Solostar
• If you are over 65 years of age
• If you have liver or kidney problems

Symptoms include the inability to concentrate, irritability, shakiness, fast heartbeat, unusual weakness or tiredness, excessive hunger, and confusion.

Severe low blood sugar may become life-threatening, cause seizures, or result in death. Your doctor will create a treatment plan that includes monitoring your blood sugar level to determine if a change in treatment is necessary.

Hypokalemia

Taking Lantus Solostar can result in low potassium levels, especially if you are taking another medication that may also lower potassium levels. Low potassium levels can be dangerous, resulting in ventricular arrhythmia, respiratory paralysis, or death. Your doctor may monitor your potassium levels to determine if a change in treatment is necessary.

Insulin Mix-up

To avoid mixing up long-acting and short-acting insulins, carefully review labels to ensure you use the correct insulin before making an injection. Using the wrong insulin and/or dose may lead to overdose and severe high blood pressure. There have been reports of accidental insulin mix-ups of patients using different insulins in the incorrect amount.

Pregnant or Plan to Become Pregnant

Having high blood sugar during pregnancy may cause complications during the pregnancy and delivery for both mother and baby. Complications include premature birth, low birth weight, and breathing problems. There is also an increased risk of miscarriage or stillborn. Your doctor will create a treatment plan to monitor your blood sugar levels.

Sharing of Needles, Pens, and Vials

Needles, pens, and vials should never be reused or shared with anyone else. Doing so creates risks of dangerous diseases spread through blood transmission.

Interactions & Contraindications

Before using Lantus Solostar, tell your doctor or pharmacist if you take any medications, herbal supplements, or vitamins.

Increased Risk of Low Blood Sugar

Taking Lantus Solostar with the following types of medications may increase your risk of low blood sugar. Your doctor will monitor your treatment plan and make changes as necessary.

• Aspirin
• Fluoxetine
• Disopyramide
• Pramlintide
• Fibrates

Effectiveness of Blood Sugar Lowering Ability

Taking Lantus Solostar with the following types of medications may decrease the effectiveness of Lantus Solostar to lower blood sugar levels. Your doctor will monitor your treatment plan and make changes as necessary.

• Corticosteroids (e.g., betamethasone, prednisone, and prednisolone).
• Isoniazid
• Niacin
• Estrogens (e.g. Estradiol and Imvexxy)
• Oral contraceptives
• Albuterol

Frequently Asked Questions