Victoza

Victoza is a prescription medication used to control blood glucose (sugar) in people with type 2 diabetes and 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. 

Victoza belongs to a group of drugs called glucagon-like peptide-1 (GLP-1) receptor agonists. These control blood glucose (sugar) in people with type 2 diabetes by causing the pancreas to release insulin when blood sugar levels are high.

This medication comes in an injectable form in a prefilled pen. Victoza is given just under the skin, once daily.

Common side effects of Victoza include headache, nausea, and diarrhea.

Victoza is a prescription medicine used with diet and exercise to control blood sugar (glucose) levels in adults with type 2 diabetes and 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.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Novo Nordisk, Inc.

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 healthcare provider about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your healthcare provider if you take medicines that increase insulin production such as:

• any type of insulin
• chlorpropamide (Diabinese)
• glimepiride (Amaryl), glimepiride/pioglitazone (Duetact) and glimepiride/rosiglitazone (Avandaryl)
• glipizide (Glucotrol, Glucotrol XL) and glipizide/metformin (Metaglip)
• glyburide (DiaBeta, Micronase, Glynase) and glyburide/metformin (Glucovance)
• nateglinide (Starlix)
• repaglinide (Prandin)
• tolazamide (Tolinase)
• tolbutamide (Orinase)

This is not a complete list of Victoza drug interactions. Victoza can potentially interact with oral medicines as it slows gastric (stomach) emptying. This can impact the absorption of oral medications that are taken at the same time. Ask your healthcare provider or pharmacist for more information.

Serious side effects may happen in people who take Victoza, including:

1. Possible thyroid tumors, including cancer. During the drug testing process, the medicine in Victoza caused rats and mice to develop tumors of the thyroid gland. Some of these tumors were cancers. It is not known if Victoza will cause thyroid tumors or a type of thyroid cancer called medullary thyroid cancer in people. If medullary thyroid cancer occurs, it may lead to death if not detected and treated early. If you develop tumors or cancer of the thyroid, your thyroid may have to be surgically removed.

• Before you start taking Victoza, tell your healthcare provider if you or any of your family members have had thyroid cancer, especially medullary thyroid cancer, or Multiple Endocrine Neoplasia syndrome type 2. Do not take Victoza if you or any of your family members have medullary thyroid cancer, or if you have Multiple Endocrine Neoplasia syndrome type 2. People with these conditions already have a higher chance of developing medullary thyroid cancer in general and should not take Victoza.
• While taking Victoza, tell your healthcare provider if you get a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath. These may be symptoms of thyroid cancer.

2. Inflammation of the pancreas (pancreatitis), which may be severe and lead to death.

Before taking Victoza, tell your healthcare provider if you have had:

• pancreatitis
• stones in your gallbladder (gallstones)
• a history of alcoholism
• high blood triglyceride levels

These medical conditions can make you more likely to get pancreatitis in general. It is not known if having these conditions will lead to a higher chance of getting pancreatitis while taking Victoza.

Stop taking Victoza 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 happen with or without vomiting. The pain may be felt going from your abdomen through to your back. This type of pain may be a symptom of pancreatitis.

Do not use Victoza if:

• you or any of your family members have a history of medullary thyroid cancer.
• you have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). This is a disease where people have tumors in more than one gland in their body.
• you are allergic to Victoza or any of the ingredients in Victoza. 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

Talk with your healthcare provider if you are not sure if you have any of these conditions.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Victoza, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Victoza, tell your healthcare provider if you:

• or any of your family members have a history of medullary thyroid cancer
• have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)
• are allergic to Victoza or any of the other ingredients in Victoza
• have severe problems with your stomach, such as slowed emptying of your stomach (gastroparesis) or problems with digesting food
• have or have had kidney or liver problems
• have any other medical conditions
• are pregnant or breastfeeding

Tell your healthcare provider about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

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.

It is not known if Victoza crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Victoza.

• Use Victoza exactly as prescribed by your healthcare provider. Your dose should be increased after using Victoza for one week. After that, do not change your dose unless your healthcare provider tells you to.
• Victoza is injected 1 time each day, at any time during the day.
• You can take Victoza with or without food.
• Victoza comes in a prefilled pen.
• Your healthcare provider must teach you how to inject Victoza before you use it for the first time. If you have questions or do not understand the instructions, talk to your healthcare provider or pharmacist. 
• Pen needles are not included. You may need a prescription to get pen needles from your pharmacist. Ask your healthcare provider which needle size is best for you.
• Inject your dose of Victoza under the skin (subcutaneous injection) in your stomach area (abdomen), upper leg (thigh), or upper arm, as instructed by your healthcare provider. Do not inject into a vein or muscle.
• If you also give yourself insulin injections in addition to Victoza, never mix insulin and Victoza together. Give yourself 2 separate injections. You may give both injections in the same body area (for example, your stomach area), but you should not give the injections right next to each other.
• If you take too much Victoza, call your healthcare provider right away. Too much Victoza may cause severe nausea and vomiting.
• If you miss your daily dose of Victoza, use Victoza as soon as you remember. Then take your next daily dose as usual on the following day. Do not take an extra dose of Victoza or increase your dose on the following day to make up for your missed dose. If you miss your dose of Victoza for 3 days or more, call your healthcare provider to talk about how to restart your treatment.
• Follow your healthcare provider’s instructions for diet, exercise, how often to test your blood sugar, and when to get your HbA1c checked. If you stop using Victoza your blood sugar levels may increase. First talk to your healthcare provider if you want to stop taking Victoza.
• Your dose of diabetes medicines may need to be changed if your body is under certain types of stress. Tell your healthcare provider if you:
  • have a fever
  • have trauma
  • have an infection
  • plan to have or have had surgery

• Never share your Victoza pen or needles with another person. You may give an infection to them, or get an infection from them.

For all patients, Victoza should be initiated with a dose of 0.6 mg per day for one week. The 0.6 mg dose is a starting dose intended to reduce gastrointestinal symptoms during initial titration, and is not effective for glycemic control.

After one week at 0.6 mg per day, the dose should be increased to 1.2 mg. If the 1.2 mg dose does not result in acceptable glycemic control, the dose can be increased to 1.8 mg.

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

Before use:

• Store your new, unused Victoza pen in the refrigerator at 36ºF to 46ºF (2ºC to 8ºC).
• Do not freeze Victoza or use Victoza if it has been frozen. Do not store Victoza near the refrigerator cooling element.

Pen in use:

• Store your Victoza pen for 30 days either at 59ºF to 86ºF (15ºC to 30ºC), or in a refrigerator at 36ºF to 46ºF (2°C to 8°C).
• When carrying the pen away from home, store the pen at a temperature between 59ºF to 86ºF (15ºC to 30ºC) and keep it dry.
• If Victoza has been exposed to temperatures above 86ºF (30ºC), it should be thrown away.
• Protect your Victoza pen from heat and sunlight.
• Keep the pen cap on when your Victoza pen is not in use.
• Use your Victoza pen within 30 days after the first day it is stored outside the refrigerator. After these 30 days, throw away your Victoza pen even if some medicine is left in the pen.
• Do not use Victoza after the expiration date printed on the carton.

Do not store the Victoza pen with the needle attached. Always safely remove and safely throw away the needle after each injection. This may help prevent contamination, infection and leakage. It also helps to make sure that you get the correct dose of Victoza. 

Keep your Victoza pen, pen needles, and all medicines out of the reach of children.

WARNING: RISK OF THYROID C-CELL TUMORS

Victoza causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice. It is unknown whether Victoza causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans, as human relevance could not be ruled out by clinical or nonclinical studies. Victoza is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Based on the findings in rodents, monitoring with serum calcitonin or thyroid ultrasound was performed during clinical trials, but this may have increased the number of unnecessary thyroid surgeries. It is unknown whether monitoring with serum calcitonin or thyroid ultrasound will mitigate human risk of thyroid C-cell tumors. Patients should be counseled regarding the risk and symptoms of thyroid tumors.