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.
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.
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.
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.
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.
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:
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.
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.
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.
Source: drugs.com
