Victoza

SC Administration

Administer SC in abdomen, thigh, or upper arm; rotate injection site

Administer SC qDay at any time, independent of meals

Injection site and time of administration can be changed without dose adjustment

If dose missed, resume the once-daily regimen with the next scheduled dose; do not give an extra dose or a higher dose; if missed dose more than 3 days, initiate therapy at 0.6 mg/day to avoid GI symptoms

Storage

Store in refrigerator (36-46°F); do not freeze; do not use if frozen

After first use, may store at room temperature (59-86°F) or refrigerate (36-46°F)

Injection pen expires 30 days after first use

It's especially important to tell your doctor about all other medications you take by mouth while on Victoza. The drug can change the way your body absorbs other medicine.

You should tell your doctor about all prescription, non-prescription, illegal, recreational, herbal, nutritional, or dietary drugs you're taking, especially insulin or oral medications for diabetes including:

• Sulfonylureas
• Chlorpropamide (Diabinese)
• Glimepiride (Amaryl, in Avandaryl, in Duetact)
• Glipizide (Glucotrol, in Metaglip)
• Glyburide (DiaBeta, in Glucovance, Glycron, Glynase, Micronase)
• Tolazamide
• Tolbutamide

Victoza may cause serious side effects, including:

• Low blood sugar (hypoglycemia). Your risk for getting low blood sugar is higher if you take Victoza with another medicine that can cause low blood sugar, such as a sulfonylurea or insulin. In some people, the blood sugar may get so low that they need another person to help them. The dose of your sulfonylurea medicine or insulin may need to be lowered while you use Victoza. Signs and symptoms of low blood sugar may include:
  • shakiness
  • sweating
  • headache
  • drowsiness
  • weakness
  • dizziness
  • confusion
  • irritability
  • hunger
  • fast heartbeat
  • feeling jittery

Talk to your healthcare provider about how to recognize and treat low blood sugar. Make sure that your family and other people who are around you a lot know how to recognize and treat low blood sugar.

• Kidney problems (kidney failure). Victoza may cause nausea, vomiting or diarrhea leading to loss of fluids (dehydration). Dehydration may cause kidney failure which can lead to the need for dialysis. This can happen in people who have never had kidney problems before. Drinking plenty of fluids may reduce your chance of dehydration.
• Serious allergic reactions. Serious allergic reactions can happen with Victoza. Stop using Victoza, and get medical help right away if you have any symptom of a serious allergic reaction. Symptoms of a serious allergic reaction may include:
  • swelling of your face, lips, tongue, or throat
  • fainting or feeling dizzy
  • very rapid heartbeat
  • problems breathing or swallowing
  • severe rash or itching

Common side effects of Victoza include:

• headache
• nausea
• diarrhea

Nausea is most common when first starting Victoza, but decreases over time in most people as their body gets used to the medicine. Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the side effects with Victoza. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Victoza falls into category C. In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

If you take too much Victoza, call your healthcare provider right away. Too much Victoza may cause severe nausea and vomiting.

Liraglutide is similar to a hormone that occurs naturally in the body and helps control blood sugar, insulin levels, and digestion.

The Victoza brand of liraglutide is used together with diet and exercise to improve blood sugar control in adults with type 2 diabetes mellitus. Victoza may also help reduce the risk of serious heart problems such as heart attack or stroke in adults with type 2 diabetes and heart disease. Victoza is usually given after other diabetes medicines have been tried without success. Victoza is not for treating type 1 diabetes.

The Saxenda brand of liraglutide is used together with diet and exercise to help people lose weight when they have certain health conditions. Saxenda is not for treating type 1 or type 2 diabetes. Saxenda is not a weight-loss medicine or appetite suppressant.

Liraglutide may also be used for purposes not listed in this medication guide.

Liraglutide injection is used to treat a type of diabetes mellitus (sugar diabetes) called type 2 diabetes. Liraglutide is to be used when diet and exercise do not result in good blood sugar control. This medicine is a glucagon-like peptide-1 (GLP-1) receptor agonist.

Liraglutide injection is also used together with a reduced-calorie diet and proper exercise to help you lose weight and help keep the lost weight from returning. It is may be used in overweight people who may also have diabetes, high blood pressure, high cholesterol, or heart disease.

This medicine is available only with your doctor's prescription.

• It is used to lower blood sugar in patients with high blood sugar (diabetes).
• It is used to lower the chance of heart attack, stroke, and death in some people.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Headache.
• Loose stools (diarrhea).
• Hard stools (constipation).
• Upset stomach or throwing up.
• Not hungry.
• Irritation where the shot is given.
• Nose or throat irritation.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Victoza is indicated:

• as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus,

• to reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction, or

non-fatal stroke) in adults with type 2 diabetes mellitus and established cardiovascular disease [see Clinical Studies (14.2)].

Limitations of Use:

How Supplied

Victoza is available in the following package sizes containing disposable, pre-filled, multi-dose pens. Each individual pen delivers doses of 0.6 mg, 1.2 mg, or 1.8 mg (6 mg/mL, 3 mL).

2 x Victoza pen NDC 0169-4060-12

3 x Victoza pen NDC 0169-4060-13

Each Victoza pen is for use by a single patient. A Victoza pen must never be shared between patients, even if the needle is changed.

Recommended Storage

Prior to first use, Victoza should be stored in a refrigerator between 36ºF to 46ºF (2ºC to 8ºC) (Table 13). Do not store in the freezer or directly adjacent to the refrigerator cooling element. Do not freeze Victoza and do not use Victoza if it has been frozen.

After initial use of the Victoza pen, the pen can be stored for 30 days at controlled room temperature (59°F to 86°F; 15°C to 30°C) or in a refrigerator (36°F to 46°F; 2°C to 8°C). Keep the pen cap on when not in use. Victoza should be protected from excessive heat and sunlight. Always remove and safely discard the needle after each injection and store the Victoza pen without an injection needle attached. This will reduce the potential for contamination, infection, and leakage while also ensuring dosing accuracy. Always use a new needle for each injection to prevent contamination.

Usual Adult Dose of Victoza for Diabetes Type 2:

Initial dose: 0.6 mg subcutaneously once a day for 1 week; this dose is intended to reduce gastrointestinal symptoms and is not an effective dose for glycemic control.
Maintenance dose: Inject 1.2 mg subcutaneously once a day; if acceptable glycemic control is not achieved, may increase to 1.8 mg subcutaneously once a day
Maximum dose: 1.8 mg once a day

Comments:
-Consider dose reduction of the insulin secretagogue to reduce the risk of hypoglycemia.
-This drug is not recommended as a first-line therapy for patients with inadequate glycemic control on diet and exercise.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Victoza can slow your digestion, and it may take longer for your body to absorb any medicines you take by mouth.

Tell your doctor about all your current medicines and any you start or stop using, especially:

• insulin; or

• oral diabetes medicine - Glucotrol, Metaglip, Amaryl, Avandaryl, Duetact, DiaBeta, Micronase, Glucovance, and others.

This list is not complete. Other drugs may interact with liraglutide, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.