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Generic Name: insulin glargine and lixisenatide
Dosage Form: Injection
Date of Approval: November 21, 2016
Company: Sanofi

Treatment for: Type 2 Diabetes

FDA Approves Soliqua 100/33

The U.S. Food and Drug Administration (FDA) approved once-daily Soliqua (insulin glargine and lixisenatide), a fixed-ratio combination of the long-acting human insulin analog insulin glargine (Lantus) and the glucagon-like peptide-1 (GLP-1) receptor agonist lixisenatide (Adlyxin), as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.

Medication Guide

Read this Medication Guide before you start treatment. This information does not take the place of talking with your healthcare provider about your medical condition or your treatment.

Important information

Do not share your Soliqua 100/33 pen with other people, even if the needle has been changed. You may give other people a serious infection, or get a serious infection from them.

Soliqua 100/33 can cause serious side effects including inflammation of the pancreas (pancreatitis), which may be severe and lead to death.

Before you start treatment, tell your healthcare provider if you have had:

  • pancreatitis
  • stones in your gallbladder (cholelithiasis)
  • a history of alcoholism

These medical problems may make you more likely to get pancreatitis.

Stop using Soliqua 100/33 and call your healthcare provider right away if you have pain in your stomach area (abdomen) that is severe, and will not go away. The pain may be felt going from your abdomen through to your back. The pain may happen with or without vomiting. These may be symptoms of pancreatitis.

What is Soliqua 100/33?

Soliqua 100/33 is an injectable prescription medicine that contains 2 diabetes medicines, insulin glargine and lixisenatide, that may improve blood sugar (glucose) control in adults with type 2 diabetes when used with diet and exercise in people who are not controlled with long-acting (basal) insulin (less than 60 units daily) or lixisenatide.
Soliqua 100/33:

  • has not been studied in people with a history of pancreatitis.
  • is not recommended for people who also take lixisenatide or other medicines called GLP-1 receptor agonists.
  • is not for use in people with type 1 diabetes or people with diabetic ketoacidosis.
  • has not been studied in people who have a stomach problem that causes slow emptying of the stomach (gastroparesis). Soliqua 100/33 is not for people with slow emptying of the stomach.
  • has not been studied in people who also take a short-acting (prandial) insulin.

It is not known if Soliqua 100/33 is safe and effective in children under 18 years of age.

Who should not use Soliqua 100/33?

Do not use Soliqua 100/33 if you:

  • are having an episode of low blood sugar (hypoglycemia).
  • are allergic to insulin glargine, lixisenatide or any of the other ingredients. See the end of this Medication Guide for a complete list of ingredients.

Symptoms of a severe allergic reaction with Soliqua 100/33 may include swelling of your face, lips, tongue, or throat, problems breathing or swallowing, severe rash or itching, fainting or feeling dizzy and very rapid heartbeat.

Before you start treatment, tell your healthcare provider about all your medical conditions including if you:

  • have or have had symptoms of acute pancreatitis, stones in your gallbladder, or a history of alcoholism.
  • have or have had liver or kidney problems.
  • have heart failure or other heart problems. If you have heart failure, it may get worse while you take a TZD (thiazolidinediones).
  • have severe problems with your stomach, such as slowed emptying of your stomach (gastroparesis) or problems with digesting food.
  • are pregnant, or plan to become pregnant. It is not known if Soliqua 100/33 will harm your unborn baby. Tell your healthcare provider if you are pregnant or plan to become pregnant during treatment.
  • are breastfeeding or plan to breastfeed. It is not known if Soliqua 100/33 passes into your breast milk. Talk with your healthcare provider about the best way to feed your baby during treatment.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Soliqua 100/33 may affect the way some medicines work and vice versa.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist each time you get a new medicine.

How should I use Soliqua 100/33?

  • Read all the detailed Instructions for Use that come with your prescription for instructions on using the pen and injecting the injection.
  • Use this medicine exactly as your healthcare provider tells you to.
  • Do not change your dose unless your healthcare provider has told you to change your dose.
  • Your healthcare provider should teach you how to inject Soliqua 100/33 before you use it for the first time. If you have questions or do not understand the instructions, talk to your healthcare provider.
  • Inject Soliqua 100/33 only one time each day within one hour before the first meal of the day.
  • If you miss a dose, take your next scheduled dose at your regular time. Do not take an extra dose or increase your dose to make up for the missed dose.
  • Check the label on the pen each time you give your injection to make sure you are using the correct medicine.
  • Do not inject more than 60 units each day. Soliqua 100/33 contains two medicines: insulin glargine and lixisenatide. If you take too much Soliqua 100/33, it can cause severe nausea and vomiting. Do not take this medicine with other GLP-1 receptor agonists. If you inject too much or overdose, call your healthcare provider or go to the nearest hospital emergency room right away.
  • Only use Soliqua 100/33 that is clear, colorless to almost colorless. If you see small particles, return it to your pharmacy for a replacement.
  • Change (rotate) your injection sites within the area you chose with each dose. Do not use the same spot for each injection to avoid skin thickening or pits at the injection site (lipodystrophy).
  • Inject your dose under the skin (subcutaneously) of your abdomen, thigh or upper arm. Do not use this medicine in an insulin pump or inject it into your vein (intravenously) or muscle (intramuscularly).
  • Do not mix Soliqua 100/33 in any other type of insulin or liquid medicine prior to injection.
  • Do not remove Soliqua 100/33 from the throw away (disposable) prefilled pen with a syringe.
  • Do not reuse or share your needles with other people. You may give other people a serious infection, or get a serious infection from them.
  • Check your blood sugar levels. Ask your healthcare provider what your blood sugar should be and when you should check your blood sugar levels.

Your dose may need to change because of a change in level of physical activity or exercise, weight gain or loss, increased stress, illness, change in diet, or because of other medicines you take.

Soliqua side effects

Soliqua 100/33 may cause serious side effects including:

  • See Important information.
  • Severe allergic reactions. Severe allergic reactions can happen during treatment with Soliqua 100/33. Stop using this medicine and get medical help right away if you have any symptoms of a severe allergic reaction. See Who should not use Soliqua 100/33?
  • Low blood sugar (hypoglycemia). Your risk for getting low blood sugar is higher if you take another medicine that can cause low blood sugar. Signs and symptoms of low blood sugar include:
    • headache
    • weakness
    • fast heartbeat
    • dizziness
    • irritability
    • feeling jittery
    • drowsiness
    • hunger
    • confusion
    • sweating
    Talk with your healthcare provider about how to treat low blood sugar.
  • Kidney problems (kidney failure). In people who have kidney problems, the occurrence of diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration) which may cause kidney problems to get worse.
  • Low potassium in your blood (hypokalemia).
  • Heart failure. Taking certain diabetes pills called TZDs with Soliqua 100/33 may cause heart failure in some people. This can happen even if you have never had heart failure or heart problems before. If you already have heart failure it may get worse while you take TZDs with Soliqua 100/33. Your healthcare provider should monitor you closely while you are taking both medicines. Tell your healthcare provider if you have any new or worse symptoms of heart failure including shortness of breath, swelling of your ankles or feet, sudden weight gain.
    Treatment with TZDs and Soliqua 100/33 may need to be changed or stopped by your healthcare provider if you have new or worse heart failure.

The most common side effects may include:

  • low blood sugar (hypoglycemia)
  • allergic reactions
  • nausea
  • headache
  • stuffy or runny nose and sore throat
  • diarrhea
  • upper respiratory tract infection

Nausea and diarrhea usually happen more often when you start treatment.

These are not all the possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Storage information

  • Store your new, unused pen in the refrigerator at 36°F to 46°F (2°C to 8°C). Protect the pen from light.
  • After first use, store your pen at room temperature no higher than 86°F (30°C).
  • Do not freeze the pens and do not use the injection if it has been frozen.
  • Replace the pen cap after each use to protect from light.
  • After first use, use the pen for up to 14 days. Throw away the used pen after 14 days, even if there is some medicine left in the pen.
  • Do not use the injection past the expiration date printed on the label of the carton and pen.
  • Do not store the pen with the needle attached. If the needle is left on, this might lead to contamination and cause air bubbles which might affect your dose of medicine.
  • See the Instructions for Use about the right way to throw away the pen.
  • Keep your pen, pen needles, and all medicines out of the reach of children.

General information about the safe and effective use of Soliqua 100/33.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use this medicine for a condition for which it was not prescribed. Do not give it to other people, even if they have the same symptoms that you have. It may harm them.

You can ask your pharmacist or healthcare provider for information that is written for health professionals.

What are the ingredients in Soliqua 100/33?

Active ingredients: insulin glargine and lixisenatide

Inactive ingredients: 3 mg of methionine, 2.7 mg of metacresol, 20 mg of glycerol, 30 mcg of zinc, hydrochloric acid, sodium hydroxide and water for injection.

More about Soliqua (insulin glargine / lixisenatide)

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