Saxenda

Never share an injection pen with another person. Sharing injection pens can allow disease such as hepatitis or HIV to pass from one person to another.

Liraglutide 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:

• 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.

Saxenda is part of the drug class:

• Other blood glucose lowering drugs, excl. insulins

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.

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.

• When starting a new prefilled Saxenda pen, you must follow the “Check the Saxenda flow with each new pen. You only need to do this 1 time with each new pen. You should also do this if you drop your pen. If you do the “Check the Saxenda flow with each new pen” before each injection, you will run out of medicine too soon.

• Inject your dose of Saxenda 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 take too much Saxenda call your healthcare provider right away. Too much Saxenda may cause severe nausea and vomiting.
• If you miss your daily dose of Saxenda, use Saxenda as soon as you remember. Then take your next daily dose as usual on the following day. Do not take an extra dose of Saxenda or increase your dose on the following day to make up for your missed dose. If you miss your dose of Saxenda for 3 days or more, call your healthcare provider to talk about how to restart your treatment.

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

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

• Bladder pain
• bloody or cloudy urine
• cough or hoarseness
• diarrhea
• difficult, burning, or painful urination
• fever or chills
• frequent urge to urinate
• general feeling of discomfort or illness
• headache
• joint pain
• loss of appetite
• lower back or side pain
• muscle aches and pains
• nausea
• runny nose
• shivering
• sore throat
• sweating
• trouble sleeping
• unusual tiredness or weakness
• vomiting

• Blurred vision
• dizziness
• nervousness
• pounding in the ears
• slow or fast heartbeat

• Anxiety
• cold sweats
• coma
• confusion
• cool, pale skin
• depression
• hives or welts, itching, or skin rash
• increased hunger
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• nightmares
• redness of the skin
• seizures
• shakiness
• slurred speech

• Agitation
• clay-colored stools
• confusion
• dark urine
• decreased urine output
• depression
• difficulty with swallowing
• hostility
• irritability
• lethargy
• muscle twitching
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• rapid weight gain
• stupor
• swelling of the face, ankles, or hands
• tightness in the chest
• unpleasant breath odor
• vomiting of blood
• yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Abdominal or stomach cramps, discomfort, or pain
• acid or sour stomach
• back pain
• belching
• body aches or pain
• constipation
• decreased appetite
• heartburn
• indigestion
• loss of voice
• pain or tenderness around the eyes and cheekbones
• sneezing
• stuffy nose
• swollen mouth and tongue
• unpleasant taste
• urge to have bowel movement
• weight loss

• Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

• Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• Talk with your doctor before you drink alcohol.
• Kidney problems have happened with Saxenda. Sometimes, kidney problems may need to be treated in the hospital. Dialysis may also be needed. Talk with your doctor.
• Gallbladder problems have happened with this medicine. Sometimes, gallbladder problems needed to be treated in the hospital. Surgery was needed in some cases to have the gallbladder taken out. Talk with your doctor.
• If you cannot drink liquids by mouth or if you have upset stomach, throwing up, or diarrhea that does not go away, you need to avoid getting dehydrated. Contact your doctor to find out what to do. Dehydration may lead to new or worse kidney problems.
• If you have high blood sugar (diabetes), you will need to watch your blood sugar closely.
• Do not share pen or cartridge devices with another person even if the needle has been changed. Sharing these devices may pass infections from one person to another. This includes infections you may not know you have.
• Do not give to a child. Talk with your doctor.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.
• Weight loss during pregnancy may cause harm to the unborn baby. If you get pregnant while taking Saxenda or if you want to get pregnant, call your doctor right away.

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• It is given as a shot into the fatty part of the skin on the top of the thigh, belly area, or upper arm.
• Move the site where you give the shot with each shot.
• Take with or without food.
• Drink lots of noncaffeine liquids unless told to drink less liquid by your doctor.
• If you will be giving yourself the shot, your doctor or nurse will teach you how to give the shot.
• Follow how to use as you have been told by the doctor or read the package insert.
• Do not use if the solution is cloudy, leaking, or has particles.
• Do not use if solution changes color.
• Wash your hands before and after use.
• Prepare pen before first use as you have been told. You will also need to do this if you drop the pen.
• Keep taking Saxenda as you have been told by your doctor or other health care provider, even if you feel well.
• Throw away needles in a needle/sharp disposal box. Do not reuse needles or other items. When the box is full, follow all local rules for getting rid of it. Talk with a doctor or pharmacist if you have any questions.
• Attach new needle before each dose.
• Follow the diet and workout plan that your doctor told you about.

What do I do if I miss a dose?

• Skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.
• If you miss 3 days of this medicine, call your doctor to find out what to do.

Overdoses have been reported in clinical trials and post-marketing use of liraglutide. Effects have included severe nausea and severe vomiting. In the event of overdosage, appropriate supportive treatment should be initiated according to the patient’s clinical signs and symptoms.

Mechanism of Action

Liraglutide is an acylated human glucagon-like peptide-1 (GLP-1) receptor agonist with 97% amino acid sequence homology to endogenous human GLP-1(7-37). Like endogenous GLP-1, liraglutide binds to and activates the GLP-1 receptor, a cell-surface receptor coupled to adenylyl cyclase activation through the stimulatory G-protein, Gs. Endogenous GLP-1 has a half-life of 1.5-2 minutes due to degradation by the ubiquitous endogenous enzymes, dipeptidyl peptidase 4 (DPP-4) and neutral endopeptidases (NEP). Unlike native GLP-1, liraglutide is stable against metabolic degradation by both peptidases and has a plasma half-life of 13 hours after subcutaneous administration. The pharmacokinetic profile of liraglutide, which makes it suitable for once-daily administration, is a result of self-association that delays absorption, plasma protein binding, and stability against metabolic degradation by DPP-4 and NEP.

GLP-1 is a physiological regulator of appetite and calorie intake, and the GLP-1 receptor is present in several areas of the brain involved in appetite regulation. In animal studies, peripheral administration of liraglutide resulted in the presence of liraglutide in specific brain regions regulating appetite, including the hypothalamus. Although liraglutide activated neurons in brain regions known to regulate appetite, specific brain regions mediating the effects of liraglutide on appetite were not identified in rats.

Pharmacodynamics

Liraglutide lowers body weight through decreased calorie intake. Liraglutide does not increase 24-hour energy expenditure.

As with other GLP-1 receptor agonists, liraglutide stimulates insulin secretion and reduces glucagon secretion in a glucose-dependent manner. These effects can lead to a reduction of blood glucose.

Cardiac Electrophysiology (QTc) in healthy volunteers

The effect of liraglutide on cardiac repolarization was tested in a QTc study. Liraglutide at steady-state concentrations after daily doses up to 1.8 mg did not produce QTc prolongation. The maximum liraglutide plasma concentration (Cmax) in overweight and obese subjects treated with liraglutide 3 mg is similar to the Cmax observed in the liraglutide QTc study in healthy volunteers.

Pharmacokinetics

Absorption - Following subcutaneous administration, maximum concentrations of liraglutide are achieved at 11 hours post dosing. The average liraglutide steady state concentration (AUCτ/24) reached approximately 116 ng/mL in obese (BMI 30-40 kg/m2) subjects following administration of Saxenda. Liraglutide exposure increased proportionally in the dose range of 0.6 mg to 3 mg. The intra-subject coefficient of variation for liraglutide AUC was 11% following single dose administration. Liraglutide exposures were considered similar among three subcutaneous injection sites (upper arm, abdomen, and thigh). Absolute bioavailability of liraglutide following subcutaneous administration is approximately 55%.

Distribution - The mean apparent volume of distribution after subcutaneous administration of liraglutide 3 mg is 20-25 L (for a person weighing approximately 100 kg). The mean volume of distribution after intravenous administration of liraglutide is 0.07 L/kg. Liraglutide is extensively bound to plasma protein (greater than 98%).

Metabolism - During the initial 24 hours following administration of a single [3H]-liraglutide dose to healthy subjects, the major component in plasma was intact liraglutide. Liraglutide is endogenously metabolized in a similar manner to large proteins without a specific organ as a major route of elimination.

Elimination - Following a [3H]-liraglutide dose, intact liraglutide was not detected in urine or feces. Only a minor part of the administered radioactivity was excreted as liraglutide-related metabolites in urine or feces (6% and 5%, respectively). The majority of urine and feces radioactivity was excreted during the first 6-8 days. The mean apparent clearance following subcutaneous administration of a single dose of liraglutide is approximately 0.9-1.4 L/h with an elimination half-life of approximately 13 hours, making liraglutide suitable for once daily administration.

Specific Populations

Elderly - No dosage adjustment is required based on age. Age had no effect on the pharmacokinetics of liraglutide based on a pharmacokinetic study in healthy elderly subjects (65 to 83 years) and population pharmacokinetic analyses of data from overweight and obese patients 18 to 82 years of age [see Use in Specific Populations (8.5)].

Gender - Based on the results of population pharmacokinetic analyses, females have 24% lower weight adjusted clearance of Saxenda compared to males. Based on the exposure response data, no dose adjustment is necessary based on gender.

Race and Ethnicity - Race and ethnicity had no effect on the pharmacokinetics of liraglutide based on the results of population pharmacokinetic analyses that included overweight and obese patients of Caucasian, Black, Asian and Hispanic/Non-Hispanic groups.

Body Weight - Body weight significantly affects the pharmacokinetics of liraglutide based on results of population pharmacokinetic analyses conducted in patients with body weight range of 60-234 kg. The exposure of liraglutide decreases as baseline body weight increases.

Pediatric - Saxenda has not been studied in pediatric patients [see Use in Specific Populations (8.4)].

Renal Impairment - The single-dose pharmacokinetics of liraglutide were evaluated in subjects with varying degrees of renal impairment. Subjects with mild (estimated creatinine clearance 50-80 mL/min) to severe (estimated creatinine clearance less than 30 mL/min) renal impairment and subjects with end-stage renal disease requiring dialysis were included in the trial. Compared to healthy subjects, liraglutide AUC in mild, moderate, and severe renal impairment and in end-stage renal disease was on average 35%, 19%, 29% and 30% lower, respectively [see Use in Specific Populations (8.6)].

Hepatic Impairment - The single-dose pharmacokinetics of liraglutide were evaluated in subjects with varying degrees of hepatic impairment. Subjects with mild (Child Pugh score 5-6) to severe (Child Pugh score greater than 9) hepatic impairment were included in the trial. Compared to healthy subjects, liraglutide AUC in subjects with mild, moderate and severe hepatic impairment was on average 11%, 14% and 42% lower, respectively [see Use in Specific Populations (8.7)].

Drug Interactions

In vitro assessment of drug−drug interactions

Liraglutide has low potential for pharmacokinetic drug-drug interactions related to cytochrome P450 (CYP) and plasma protein binding.

In vivo assessment of drug−drug interactions

The drug-drug interaction studies were performed at steady state with liraglutide 1.8 mg/day. The effect on rate of gastric emptying was equivalent between liraglutide 1.8 mg and 3 mg (acetaminophen AUC0-300min). Administration of the interacting drugs was timed so that Cmax of liraglutide (8-12 h) would coincide with the absorption peak of the co-administered drugs.

Oral Contraceptives

A single dose of an oral contraceptive combination product containing 0.03 mg ethinylestradiol and 0.15 mg levonorgestrel was administered under fed conditions and 7 hours after the dose of liraglutide at steady state. Liraglutide lowered ethinylestradiol and levonorgestrel Cmax by 12% and 13%, respectively. There was no effect of liraglutide on the overall exposure (AUC) of ethinylestradiol. Liraglutide increased the levonorgestrel AUC0-∞ by 18%. Liraglutide delayed Tmax for both ethinylestradiol and levonorgestrel by 1.5 h.

Digoxin

A single dose of digoxin 1 mg was administered 7 hours after the dose of liraglutide at steady state. The concomitant administration with liraglutide resulted in a reduction of digoxin AUC by 16%; Cmax decreased by 31%. Digoxin median time to maximal concentration (Tmax) was delayed from 1 h to 1.5 h.

Lisinopril

A single dose of lisinopril 20 mg was administered 5 minutes after the dose of liraglutide at steady state. The co-administration with liraglutide resulted in a reduction of lisinopril AUC by 15%; Cmax decreased by 27%. Lisinopril median Tmax was delayed from 6 h to 8 h with liraglutide.

Atorvastatin

Liraglutide did not change the overall exposure (AUC) of atorvastatin following a single dose of atorvastatin 40 mg, administered 5 hours after the dose of liraglutide at steady state. Atorvastatin Cmax was decreased by 38% and median Tmax was delayed from 1 h to 3 h with liraglutide.

Acetaminophen

Liraglutide did not change the overall exposure (AUC) of acetaminophen following a single dose of acetaminophen 1000 mg, administered 8 hours after the dose of liraglutide at steady state. Acetaminophen Cmax was decreased by 31% and median Tmax was delayed up to 15 minutes.

Griseofulvin

Liraglutide did not change the overall exposure (AUC) of griseofulvin following co-administration of a single dose of griseofulvin 500 mg with liraglutide at steady state. Griseofulvin Cmax increased by 37% while median Tmax did not change.

Insulin Detemir

No pharmacokinetic interaction was observed between liraglutide and insulin detemir when separate subcutaneous injections of insulin detemir 0.5 Unit/kg (single-dose) and liraglutide 1.8 mg (steady state) were administered to patients with type 2 diabetes mellitus.

How Supplied

Saxenda 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, 1.8 mg, 2.4 mg or 3 mg (6 mg/mL, 3 mL).

3 x Saxenda pen NDC 0169-2800-13
5 x Saxenda pen NDC 0169-2800-15

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

Recommended Storage

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

After initial use of the Saxenda 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. Saxenda should be protected from excessive heat and sunlight. Always remove and safely discard the needle after each injection and store the Saxenda pen without an injection needle attached. This will reduce the potential for contamination, infection, and leakage while also ensuring dosing accuracy.

FDA-Approved Medication Guide

Advise the patient to read the FDA-approved patient labeling (Medication Guide and Instructions for Use).

Instructions

Saxenda is indicated for chronic weight management in conjunction with a reduced-calorie diet and increased physical activity.

Advise patients to take Saxenda exactly as prescribed. Patients should be instructed to follow the dose escalation schedule and not to take more than the recommended dose of Saxenda.

Instruct patients to discontinue use of Saxenda if they have not achieved 4% weight loss by 16 weeks of treatment.

Risk of Thyroid C-cell Tumors

Inform patients that liraglutide causes benign and malignant thyroid C-cell tumors in mice and rats and that the human relevance of this finding has not been determined. Counsel patients to report symptoms of thyroid tumors (e.g., a lump in the neck, hoarseness, dysphagia or dyspnea) to their physician [see Boxed Warning and Warnings and Precautions (5.1)].

Acute Pancreatitis

Patients should be informed of the potential risk for acute pancreatitis. Explain that persistent severe abdominal pain that may radiate to the back and which may or may not be accompanied by vomiting, is the hallmark symptom of acute pancreatitis. Instruct patients to discontinue Saxenda promptly and contact their physician if persistent severe abdominal pain occurs.

Acute Gallbladder Disease

Patients should be informed that substantial or rapid weight loss can increase the risk of cholelithiasis. Cholelithiasis may also occur in the absence of substantial or rapid weight loss. Patients should be instructed to contact their physician if cholelithiasis is suspected for appropriate clinical follow-up.

Hypoglycemia in Patients with Type 2 Diabetes Mellitus on Anti-Diabetic Therapy

Patients with type 2 diabetes mellitus on anti-diabetic therapy should be advised to monitor their blood glucose levels and report symptoms of hypoglycemia to their physician.

Heart Rate Increase

Patients should be informed to report symptoms of sustained periods of heart pounding or racing while at rest to their physician. For patients who experience a sustained increase in resting heart rate while taking Saxenda, Saxenda should be discontinued.

Dehydration and Renal Impairment

Patients treated with Saxenda should be advised of the potential risk of dehydration due to gastrointestinal adverse reactions and take precautions to avoid fluid depletion. Patients should be informed of the potential risk for worsening renal function, which in some cases may require dialysis.

Hypersensitivity Reactions

Patients should be informed that serious hypersensitivity reactions have been reported during use of liraglutide. If symptoms of hypersensitivity reactions occur, patients must stop taking Saxenda and seek medical advice promptly.

Suicidal Behavior and Ideation

Patients treated with Saxenda should be advised to report emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior. Patients should be informed that if they experience suicidal thoughts or behaviors, Saxenda should be discontinued.

Jaundice and Hepatitis

Inform patients that jaundice and hepatitis have been reported during postmarketing use of liraglutide. Instruct patients to contact their physician if they develop jaundice.

Never Share a Saxenda Pen Between Patients

Patients should be informed that they should never share a Saxenda pen with another person, even if the needle is changed. Sharing of the pen between patients may pose a risk of transmission of infection.

Version: 4

Saxenda® and Victoza® are registered trademarks of Novo Nordisk A/S.

PATENT Information:http://novonordisk-us.com/patients/products/product-patents.html

© 2014-2017 Novo Nordisk

Manufactured by:
Novo Nordisk A/S
DK-2880 Bagsvaerd, Denmark

For information about Saxenda contact:
Novo Nordisk Inc.
800 Scudders Mill Road
Plainsboro, NJ 08536

1-844-363-4448

You should not use Saxenda if you are allergic to liraglutide, or if you have:

• multiple endocrine neoplasia type 2 (tumors in your glands);

• a personal or family history of medullary thyroid carcinoma (a type of thyroid cancer); or

• diabetic ketoacidosis (call your doctor for treatment).

You should not use Saxenda if you also use insulin or other medicines like liraglutide (albiglutide, dulaglutide, exenatide, Byetta, Bydureon, Tanzeum, Trulicity).

To make sure Saxenda is safe for you, tell your doctor if you have:

• stomach problems causing slow digestion;

• kidney or liver disease;

• high triglycerides (a type of fat in the blood);

• heart problems;

• a history of problems with your pancreas or gallbladder; or

• a history of depression or suicidal thoughts.

In animal studies, liraglutide caused thyroid tumors or thyroid cancer. It is not known whether these effects would occur in people using regular doses. Ask your doctor about your risk.

It is not known whether Saxenda will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether liraglutide passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

Saxenda is not approved for use by anyone younger than 18 years old.

Usual Adult Dose of Saxenda for Weight Loss:

Dose escalation should be followed to reduce the likelihood of gastrointestinal symptoms; dose escalation may be delayed by 1 additional week if necessary:
Week 1: Inject 0.6 mg subcutaneously once a day
Week 2: Inject 1.2 mg subcutaneously once a day
Week 3: Inject 1.8 mg subcutaneously once a day
Week 4: Inject 2.4 mg subcutaneously once a day
Week 5: Inject 3 mg subcutaneously once a day
Maintenance dose: 3 mg subcutaneously once a day

Comments:
-Consider dose reduction of the insulin secretagogue to reduce the risk of hypoglycemia; conversely when discontinuing use in a patient with type 2 diabetes, monitor for an increase in blood glucose.
-If a dose of 3 mg once daily is not tolerated, discontinuation is recommended; efficacy for chronic weight management has not been established at lower doses.
-Evaluate weight loss at 16 weeks; if at least 4% of body weight has not been lost, it is unlikely the patient will achieve and sustain clinically meaningful weight loss with continued treatment.

Use: In adult patients with an initial BMI of 30 kg/m2 or greater (obese) or an initial BMI of 27 kg/m2 (overweight) or greater in the presence of at least 1 weight-related comorbid condition (e.g., hypertension, type 2 diabetes mellitus, or dyslipidemia), this drug is indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management.

BMI=Body Mass Index is calculated by dividing weight in kilograms by height in meters squared. Charts are available for determining BMI based on height and weight, including a chart in Saxenda product labeling.

Get emergency medical help if you have signs of an allergic reaction to Saxenda: hives; fast heartbeats; dizziness; trouble breathing or swallowing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• racing or pounding heartbeats;

• sudden changes in mood or behavior, suicidal thoughts;

• severe ongoing nausea, vomiting, or diarrhea;

• signs of a thyroid tumor - swelling or a lump in your neck, trouble swallowing, a hoarse voice, feeling short of breath;

• gallbladder problems - fever, upper stomach pain, clay-colored stools, jaundice (yellowing of your skin or eyes);

• symptoms of pancreatitis - severe pain in your upper stomach spreading to your back, nausea with or without vomiting, fast heart rate;

• severely low blood sugar - extreme weakness, confusion, tremors, sweating, fast heart rate, trouble speaking, nausea, vomiting, rapid breathing, fainting, and seizure (convulsions); or

• kidney problems - little or no urination; painful or difficult urination; swelling in your feet or ankles; feeling tired or short of breath.

Common Saxenda side effects may include:

• nausea (especially when you start using Saxenda), vomiting, stomach pain;

• diarrhea, constipation;

• headache, dizziness; or

• feeling tired.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.