Saxenda

Saxenda is a prescription medication used as a treatment option for chronic weight management in addition to a reduced-calorie diet and physical activity.

Saxenda belongs to a group of drugs called glucagon-like peptide-1 (GLP-1) receptor agonists. Saxenda works becuase it is similar to naturally occurring human GLP-1, a hormone that is released in response to the intake of food. Like human GLP-1, Saxenda regulates appetite and food intake by decreasing hunger and increasing feelings of fullness and satiety after eating.

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

Common side effects of Saxenda include headache, nausea, diarrhea, constipation, vomiting, and low blood sugar.

Saxenda is a prescription medicine for chronic weight management in addition to a reduced-calorie diet and physical activity.

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

• Novo Nordisk, Inc.

Saxenda may cause serious side effects, including:

Common side effects of Saxenda include:

• headache
• nausea
• diarrhea
• constipation
• vomiting
• low blood sugar
• decreased appetite
• upset stomach
• tiredness
• dizziness
• stomach pain
• changes in enzyme (lipase) levels in your blood

Nausea is most common when first starting Saxenda, 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 Saxenda. 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 Saxenda drug interactions. Saxenda 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 Saxenda, including:

1. Possible thyroid tumors, including cancer. During the drug testing process, the medicine in Saxenda caused rats and mice to develop tumors of the thyroid gland. Some of these tumors were cancers. It is not known if Saxenda 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 Saxenda, 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 Saxenda 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 Saxenda.
• While taking Saxenda, 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 Saxenda, 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 Saxenda.

Stop taking Saxenda 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.

3. Low blood sugar (hypoglycemia). Your risk for getting low blood sugar is higher if you take Saxenda 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 Saxenda. 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.

4. Kidney problems (kidney failure). Saxenda 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.  Call your healthcare provider right away if you have nausea, vomiting, or diarrhea that does not go away, or if you cannot drink liquids by mouth.

5. Serious allergic reactions. Serious allergic reactions can happen with Saxenda. Stop using Saxenda, 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

Do not use Saxenda 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 Saxenda or any of the ingredients in Saxenda. 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 Saxenda, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Saxenda, 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 Saxenda or any of its ingredients 
• 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.

Saxenda falls into category X. Saxenda is contraindicated during pregnancy because weight loss offers no potential benefit to a pregnant woman and may result in fetal harm. There are no adequate and well-controlled studies of Saxenda in pregnant women. Saxenda should not be used during pregnancy. If a patient wishes to become pregnant, or pregnancy occurs, treatment with Saxenda should be discontinued.

It is not known if Saxenda 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 Saxenda.

Use Saxenda exactly as prescribed by your healthcare provider.

• Saxenda is given in addition to a reduced-calorie diet and physical activity.
• Saxenda is injected 1 time each day, at any time during the day.
• Your dose should be increased after using Saxenda for 1 week until you reach the 3 mg dose. After that, do not change your dose unless your healthcare provider tells you to.
• You can take Saxenda with or without food.
• Saxenda comes in a prefilled pen.
• Your doctor should start you on a diet and exercise program when you start taking Saxenda.  Stay on this program while you are taking Saxenda.
• Your healthcare provider must teach you how to inject Saxenda 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. Use the Saxenda pen with Novo Nordisk disposable needles. You may need a prescription to get pen needles from your pharmacist. Ask your healthcare provider which needle size is best for you.

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

The recommended dose of Saxenda (liraglutide) for weight management is 3 mg, once daily.

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

Before use:

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

Pen in use:

• Store your Saxenda 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 Saxenda has been exposed to temperatures above 86ºF (30ºC), it should be thrown away.
• Protect your Saxenda pen from heat and sunlight.
• Keep the pen cap on when your Saxenda pen is not in use.
• Use your Saxenda pen within 30 days after the first day it is stored outside the refrigerator. After these 30 days, throw away your Saxenda pen even if some medicine is left in the pen.
• Do not use Saxenda after the expiration date printed on the carton.

Do not store the Saxenda 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 Saxenda. 

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

WARNING: RISK OF THYROID C-CELL TUMORS

Saxenda 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 Saxenda 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. Saxenda 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.