Lantus Solostar Pen (Insulin Glargine) 100 Units / mL

Lantus Solostar Pen (Insulin Glargine) 100 Units / mL

It contains an a drug called insulin glargine, classified as a long-acting insulin for improving their glycemic control throughout the day.

Currently Lantus is one of the most prescribed long-acting insulin in the United States.

Lantus is administered through subcutaneous (under the skin) injection using syringe & vial or prefilled pens.

What is the Lantus SoloStar Pen?

The Lantus SoloStar Pen is a disposable single-patient-use prefilled insulin pen that contains insulin glargine.

Each pen contains 3mL of insulin glargine that has 100 units of insulin per mL of solution.

Each Lantus SoloStar pen provides multiple doses with a total of 300 units of insulin. Patients can adjust their dosage from 1 to 80 units in increments of 1 using the products dial.

USAGE & STORAGE

Speak with your doctor and pharmacist about how to properly administer this medication. You should only use this pen unless you have received the proper training & injection technique.

Important information when using the Lantus SoloStar:

• Do not share syringes, injection pens and cartridges as this can lead to spreading disease. This is for single-patient only. Do not share with others even if they have similar symptoms or if the needle on the injection pen has been changed.
• Before each use, always attach a new needle. Needles are available in different gauges and lengths. Use only needs approved by SoloStar.
• Attach a needle first before selecting the dose or pressing the injection button.
• Before each injection you should perform a safety test
• If someone else is administering the injection, ensure they are being careful to avoid possible needle injury and transmission of infection.
• Do not use SoloStar if it isn’t working properly or damaged
• Always keep a spare SoloStar in case your pen gets lost or damaged

Lantus SoloStar Maintenance:

• Keep SoloStar pen away from dirt or dust.
• Clean pen by wiping the outside with a damp cloth.
• Do not soak or wash or it may become damaged.
• Handle your SoloStar pen with care.

How to use Solostar

Step 1. Check the insulin

A. Make sure you using the correct insulin by checking the label on your insulin pen. The Lantus SoloStar pen is grey with a lilac injection button.

B. Remove pen cap.

C. Observe the appearance of the insulin which should be clear. Do not use if insulin appears cloudy, colored or contains particles.

Step 2. Attach needle

To prevent contamination and needle blocks, make sure to use a new needle for each injection.

Read the “instructions for use” before using needles.

A. Clean the rubber seal with alcohol.
B. Remove protective seal from needle.
C. Line up the needle with the pen, and keep it straight as you attach it (screw or push on, depending on the needle type).

• The rubber seal can become damaged if the needle is not kept straight. This can result in leakage or break the needle.

Step 3. Perform Safety Test

Before each injection, perform a safety test to ensure you are getting an accurate dose by:

• ensuring the needle and pen work properly
• removes air bubbles

A. Turn the selector clockwise to choose a dose of 2 units
B. Remove outer needle cap and keep it to remove the needle after it’s been used for injection. Take off inner needle cap and discard.
C. Hold the pen with needle pointing upwards.
D. Tap the insulin reservoir so that bubble rise up towards the needle.
E. Press the injection button. Ensure insulin comes out of needle tip.

Safety test may need to be performed several times before insulin is visible.

• If no insulin comes out check for air bubbles and repeat to remove them.
• If still no insulin comes out, the needle may be blocked. Change needle and try again.
• If no insulin comes out after changing the needle it’s possible the SoloStar may be damaged.

Step 4. Select dosage

The SoloStar dosage can be set by increments of 1. You can set the dose from a minimum of 1 unit to a maximum of 80 units. If you require a dosage greater than 80, you should give multiple injections.

A. Check the dose window displays “0” after performing the safety test.
B. Turn the dosage selector clockwise to choose your required dose. If you happen to turn past your dose you can turn it counter-clockwise.

• Do not push the button while turning as this can release insulin.
• The dosage selector cannot go past the number of units in the pen. Do not force dossage selector to turn. In this case, either you can inject what is remaining in the pen and complete your dose with a new SoloSTAR or use a new SoloSTAR for your full dose.

Step 5. Inject the dose

A. Clean the injection site before administering SoloStar pen.
B. Use the injection technique as explained by your doctor or health professional.
C. Insert needle into skin.
D. Deliver the insulin dose by pressing the injection button all the way.
E. To ensure a full dosage, keep injection button pressed and slowly count to 10 before withdrawing the needle from the skin. The SoloStar pen dial will move with every dose until the maximum of 300 units have been used up.

Step 6. Remove and discard of needle

After every injection dispose of the needle. This prevents contamination and entry of air into the reservoir which can lead to inaccurate dosing.

A. Put the outer needle cap back on the needle, and use it to unscrew the needle from the pen. To reduce the risk of accidental needle injury, never replace the inner needle cap.

• If your injection is given by another person, or if you are giving an injection to another person, special caution must be taken by this person when removing and disposing of the needle. Follow recommended safety measures for removal and disposal of needles (e.g. contact your health professional) in order to reduce the risk of accidental needle injury and transmission of infectious diseases.

B. Dispose of the needle safely. Used needles should be placed in sharps containers (such as biohazard containers), hard plastic containers (such as detergent bottles), or metal containers (such as an empty coffee can). Such containers should be sealed and disposed of properly.

C. Always put the pen cap back on the pen, then store the pen until your next injection

Storage

• Keep Lantus SoloStar away from children and pets.
• Before first use, keep in cool storage (2°C – 8°C).
• Do not allow insulin to freeze.
• Do not keep next to freezer element or freezer pack in the refrigerator. If insulin was previously frozen make sure you allow 1-2 hours to warm up. Injecting cold insulin can be painful to inject.
• Once insulin is removed from cool storage it is good for up to 28 days.
• Out of the refrigerator, SoloStar can be kept at room temperature (15 – 30°C) and not store in the refrigerator. Discard insulin after 28 days.
• Do not use after the date of expiry.
• Keep away from direct sunlight or extreme heat.
• Do not use if solution appears cloudy, color or contains particles.

SIDE EFFECTS

Side effects are unwanted responses when taking medication in regular doses. While side effects can happen, they are usually temporary and go away within days or weeks.

Lantus may cause mild to serious side effects. The following list are side effects when taking the Lantus SoloStar pen but not all.

Common Side Effects

Patients may experience mild to serious side effects when using Lantus. The list below covers some of the key side effects that may be experienced with Lantus.

This list does not cover all side effects. Speak to your doctor or pharmacist for about possible risks and how to manage side effects if they become bothersome.

• hypoglycemia (low blood sugar)
• injection site reactions (itchiness, tenderness, pain, redness around skin injection site)
• itchy skin
• rash
• edema (swelling which usually happens in the ankles, legs or feet)
• upper respiratory infections
• weight gain
• lypodystrophy (change in skin thickness at site of injection)

These side effects are usually temporary and usually go away within days or a couple weeks. If they appear more severe or do not go away, consult your doctor or pharmacist.

Serious side effects

• hypokalemia (low potassium)
• fatigue
• weakness
• muscle cramping
• abnormal heart beat
• paralysis
• respiratory failure
• allergic reaction

Additional information on Lantus Side Effects

If you’re wondering how common side effects associated with taking Lantus or the severity of symptoms, see list below.

Allergic Reactions

With any medication, including insulin, allergic reactions may occur. It’s still unknown how common allergic reactions are found based on the clinical studies. Its important to ensure you do not have an allergy to insulin or any of the ingredients contained in this medication.

Symptoms of mild allergic reactions include:

• skin irritation
• itchiness
• flushing (a feeling of warmth or rapid reddening)

Symptoms of severe allergic reactions include:

• swelling under the skin, typically hands, feet, lips or eye lids
• swelling of mouth, throat or tongue
• difficulty breathing
• body rash

If you think you are having a severe allergic reaction when taking this medication, contact a doctor right away or 911 if you feel the symptoms are life-threatening.

Weight Gain

One of the most common side effects of taking insulin, including Lantus, is weight gain. The results from clinical studies have shown:

• up to 1.5 lbs in adults with type 1 diabetes over 16-28 weeks
• up to 4.8 lbs in children with type 1 diabetes who took regular insulin with Lantus over 28 weeks
• up to 4.4 lbs in adults with type 2 diabetes who took Lantus over 1 year

Weight gain is a sign of a normal healthy process since insulin causes your body to store more sugar to be converted to energy.

If weight gain become a concern, speak to your doctor or diabetes coach about proper diet and fitness guidance.

Hypoglycemia

One of the most common side effects with Lantus and most insulin is low blood sugar or Hypoglycemia.

It’s important to understand the symptoms associated with hypoglycemia so you can address them before they become serious.

Symptoms of mild hypoglycemia include:

• dizziness
• rapid heartbeat
• headache
• hunger
• shakiness
• irritability
• nervousness

If blood sugar levels remain too low this can lead to a severe complications which require immediate medical attention.

Symptoms of severe hypoglycemia include:

• anxiety
• drowsiness
• headache
• confusions
• irritability
• sweating
• rapid heartbeat
• seizures
• coma

Note: Any changes to insulin dosage can result in hypoglycemia or hyperglycemia (high blood sugar levels). If you adjust your insulin dosage, ensure it is done under the guidance of your doctor.

Studies on hypoglycemia and Lantus insulin

• A 16-week clinical study found that 6.5% of adults with type 1 diabetes experienced hypoglycemia. 10.8% of adults experienced severe hypoglycemia at least once during a 28-week clinical study.
• n another study, 23% of children with type 1 diabetes experienced severe hypoglycemia during a 6-month period.
• 7.8% of adults with type 2 diabetes experienced severe hypoglycemia over a 5-year clinical study.

How to manage hypoglycemia

If you experience hypoglycemia, try to consume carbohydrates, a sugary snack or drink. This can include:

• glucose tablet
• sugar
• hard candy
• saltine crackers
• jelly beans
• juice or pop (non diet)

If you are at risk of severe hypoglycemia then your doctor my prescribe glucagon (a hormone) that raises blood glucose levels in emergency that a patient is unconscious.

Close family and friends should be trained when and how to administer a glucagon emergency kit in case of loss of consciousness during hypoglycemia.

Side effects aren’t common but they ca occur. Call your doctor immediately if you experience any side effects. If symptoms feel life-threatening or appear to require medical emergency, contact 911.

The side effects covered above do not include all possible side effects. Consult your doctor pharmacist or diabetes coach about side effects and how to manage them for your individual requirements.

WARNINGS & PRECAUTIONS

Lantus is not approved to treat diabetic ketoacidosis (DKA) which is a common diabetes complication.

Do not share insulin pens, syringes or needles with others as this can spread infection.

Monitor blood sugar levels regularly. Only modify your insulin regimen under medical supervision.

Do not inject into areas of lipodystrophy or localized cutaneous amyloidosis. Repeated injection into these areas may result in hyperglycemia or hypoglycemia. It’s important to rotate injection sites and closely monitor blood sugar for hypoglycemia.

Do not mix or dilute Lantus with other insulin medication as this may effect the action/time to peak effect. Do not administer Lantus SoloStar pen through an insulin pump or intravenously as severe hypoglycemia may result.

Hypoglycemia is the most common side effect with insulin therapy and may be life-threatening.

Always check the insulin label before injection. This will help avoid medication errors such as mix ups with other medications.

Life threatening allergic reactions can occur. Discontinue and consult a doctor if you experience severe allergic reactions.

Patients with hepatic or renal impairment may require a reduced dosage.

As with all insulins, Lantus can lead to hypokalemia (low potassium) which can be life-threatening. If left untreated can result in ventricular arrhythmia, respiratory paralysis and even death. Monitor potassium levels if you are at risk of hypokalemia.

Fluid retention may occur and lead to heart failure with the concomitant use of thiazolidinediones (TZDs) with insulin. Patients using TZD’s must be monitored for heart failure. If heart failure happens this may require a dosage adjustment or discontinuation of TZDs.

Drug interactions

When using Lantus SoloStar, certain meications may effect glucose metabolism and may require adjusting insulin dosage and close blood sugar monitoring.

Most frequently checked interactions

• amlodipine
• aspirin
• Aspirin Low Strength (aspirin)
• atorvastatin
• carvedilol
• furosemide
• gabapentin
• Humalog KwikPen (insulin lispro)
• hydrochlorothiazide
• Januvia (sitagliptin)
• levothyroxine
• lisinopril
• losartan
• metformin
• metoprolol
• NovoLog FlexPen (insulin aspart)
• omeprazole
• pantoprazole
• simvastatin
• Vitamin D3 (cholecalciferol)

Inform your doctor if you are taking any additional prescription medications, over-the-counter medications, herbal supplements, vitamins and minerals.

FREQUENTLY ASKED QUESTIONS

Is there a generic alternative to Lantus?

Lantus is a brand-name medication that currently does not have a generic form. Although there is no generic version of Lantus, there is a “follow-on” insulin glargine called Basaglar. Follow-on insulins (also known as biosimilar) may be highly similar to the original drug but are not true copies of the original drug. The are “expected” to produce the same clinical result.