Ozempic

Semaglutide injection is used to treat type 2 diabetes. It is used together with diet and exercise to help control your blood sugar. This medicine is a glucagon-like peptide-1 (GLP-1) receptor agonist.

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

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of semaglutide injection in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of semaglutide injection in the elderly. However, elderly patients are more sensitive to the effects of this medicine than younger adults.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Diabetic ketoacidosis (ketones in the blood) or
• Type 1 diabetes—Should not be used in patients with these conditions. Insulin is needed to control these conditions.

• Multiple endocrine neoplasia syndrome type 2 (MEN 2) or
• Thyroid cancer, history of—Should not be used in patients with these conditions.

• Pancreatitis (inflammation of the pancreas), history of—It is not known if this medicine will be safe in patients with this condition.

• Diabetic retinopathy, history of or
• Digestion problems or
• Kidney disease—Use with caution. May make these conditions worse.

When you start using this medicine, it is very important that you check your blood sugar often, especially before and after meals and at bedtime. This will help lower the chance of having very low blood sugar.

Carefully follow the special meal plan your doctor gave you. This is the most important part of controlling your diabetes, and is necessary if the medicine is to work properly. Also, exercise regularly and test for sugar in your blood or urine as directed.

This medicine comes with a Medication Guide and patient instructions. Read and follow these instructions carefully. Ask your doctor if you have any questions.

If you will be using semaglutide at home, your doctor will teach you how the injections will be given. Be sure you understand exactly how the medicine is to be injected.

This medicine is given as a shot under the skin of your stomach, thighs, or upper arm. Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas.

If you use this medicine with insulin, do not mix them into the same syringe. It is acceptable to inject these in the same body area, but the shots should not be right next to each other.

Check the liquid in the pen. it should be clear and colorless. Do not use it if it is cloudy, discolored, or has particles in it.

Use a new needle each time you inject your medicine.

Never share medicine pens with others under any circumstances. It is not safe for one pen to be used for more than one person. Sharing needles or pens can result in transmission of infection.

Use this medicine on the same day each week, at any time of the day, with or without meals.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For type 2 diabetes:
  • For injection dosage form (solution):
    • Adults—0.25 milligrams (mg) injected under the skin once a week for 4 weeks. Your doctor may increase your dose as needed. However, the dose is usually not more than 1 mg once a week.
    • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If you miss a dose, use it as soon as possible within 5 days after your missed dose. If you miss a dose for more than 5 days, skip the missed dose and go back to your regular dosing schedule.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store in the refrigerator. Do not freeze.

Store your new, unused medicine pen in its original carton in the refrigerator. Do not freeze. You may store the opened medicine pen in the refrigerator or at room temperature for 56 days. Throw away the pen after you use it for 56 days, even if it still has medicine in it.

Throw away used needles in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

It is very important to carefully follow any instructions from your health care team about:

• Alcohol—Drinking alcohol may cause severe low blood sugar. Discuss this with your health care team.
• Other medicines—Do not take other medicines during the time you are using semaglutide unless they have been discussed with your doctor. This especially includes nonprescription medicines such as aspirin, and medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems.
• Counseling—Other family members need to learn how to prevent side effects or help with side effects if they occur. Also, diabetic patients may need special counseling about diabetes medicine dosing changes that might occur because of lifestyle changes, such as changes in exercise and diet. Furthermore, counseling on contraception and pregnancy may be needed because of the problems that can occur during pregnancy in patients with diabetes.
• Travel—Keep a recent prescription and your medical history with you. Be prepared for an emergency as you would normally. Make allowances for changing time zones and keep your meal times as close as possible to your usual meal times.

In case of emergency—There may be a time when you need emergency help for a problem caused by your diabetes. You need to be prepared for these emergencies. It is a good idea to wear a medical identification (ID) bracelet or neck chain at all times. Also, carry an ID card in your wallet or purse that says that you have diabetes and a list of all of your medicines.

This medicine may increase the risk of having thyroid tumors. Tell your doctor right away if you have a lump or swelling in your neck or throat, trouble swallowing or breathing, or if your voice gets hoarse.

Pancreatitis (swelling of the pancreas) may occur while you are using this medicine. Check with your doctor right away if you have sudden and severe stomach pain, chills, constipation, nausea, vomiting, fever, or lightheadedness.

This medicine may cause diabetic retinopathy. Check with your doctor if you have blurred vision or any other changes in vision.

This medicine does not cause hypoglycemia (low blood sugar). However, low blood sugar can occur when you use semaglutide with other medicines, such as insulin or sulfonylureas, that can lower blood sugar. Low blood sugar also can occur if you delay or miss a meal or snack, exercise more than usual, drink alcohol, or cannot eat because of nausea or vomiting.

• Symptoms of low blood sugar include anxiety, behavior change similar to being drunk, blurred vision, cold sweats, confusion, cool, pale skin, difficulty with thinking, drowsiness, excessive hunger, fast heartbeat, headache (continuing), nausea, nervousness, nightmares, restless sleep, shakiness, slurred speech, or unusual tiredness or weakness.
• If symptoms of low blood sugar occur, eat glucose tablets or gel, corn syrup, honey, or sugar cubes, or drink fruit juice, non-diet soft drink, or sugar dissolved in water to relieve the symptoms. Also, check your blood for low blood sugar. Glucagon is used in emergency situations when severe symptoms such as seizures (convulsions) or unconsciousness occur. Have a glucagon kit available, along with a syringe and needle, and know how to use it. Members of your family should also know how to use it.

This medicine may cause serious allergic reactions, including anaphylaxis and angioedema. These can be life-threatening and require immediate medical attention. Check with your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, mouth, or throat while you are using this medicine.

This medicine may cause acute kidney injury. Check with your doctor right away if you have a bloody urine, decreased urine output, muscle twitching, nausea, rapid weight gain, seizures, stupor, swelling of the face, ankles, or hands, or unusual tiredness or weakness.

Hyperglycemia (high blood sugar) may occur if you do not take enough or skip a dose of your antidiabetic medicine, overeat or do not follow your meal plan, have a fever or infection, or do not exercise as much as usual.

• Symptoms of high blood sugar include blurred vision, drowsiness, dry mouth, flushed, dry skin, fruit-like breath odor, increased urination (frequency and amount), ketones in the urine, loss of appetite, stomachache, nausea or vomiting, tiredness, troubled breathing (rapid and deep), unconsciousness, or unusual thirst.
• If symptoms of high blood sugar occur, check your blood sugar level and then call your doctor for instructions.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

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:

• Gaseous abdominal pain
• recurrent fever
• stomach fullness
• yellow eyes or skin

• Burning feeling in the chest or stomach
• indigestion
• stomach upset
• tenderness in the stomach area

• Anxiety
• blurred vision
• chills
• cold sweats
• confusion
• cool, pale skin
• discouragement
• dizziness
• fast heartbeat
• feeling sad or empty
• headache
• increased heart rate
• increased hunger
• irritability
• lack of appetite
• loss of consciousness
• loss of interest or pleasure
• nausea
• nervousness
• nightmares
• seizures
• shakiness
• slurred speech
• tiredness
• trouble concentrating
• trouble sleeping
• unusual tiredness or weakness

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:

• Diarrhea
• stomach pain
• vomiting

• Belching
• bloated, full feeling
• constipation
• excess air or gas in the stomach or intestines
• heartburn
• passing gas
• stomach discomfort or upset

• Bleeding, blistering, burning, coldness, discoloration of 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
• change in taste
• loss of taste

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.
• Wear disease medical alert ID (identification).
• Check your blood sugar as you have been told by your doctor.
• Do not drive if your blood sugar has been low. There is a greater chance of you having a crash.
• It may be harder to control your blood sugar during times of stress like when you have a fever, an infection, an injury, or surgery. A change in level of physical activity or exercise and a change in diet may also affect your blood sugar. Talk with your doctor.
• 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 Ozempic. Sometimes, kidney problems may need to be treated in the hospital. Dialysis may also be needed. 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.
• 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.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this medicine while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

Get emergency medical help if you have signs of an allergic reaction to Ozempic: hives, itching; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

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

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

• low blood sugar--headache, confusion, blurred vision, trouble speaking, hunger, sweating, irritability, dizziness, drowsiness, weakness, fast heart rate, and feeling anxious or shaky; or

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

Common Ozempic side effects may include:

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

• diarrhea; or

• constipation.

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.

Applies to semaglutide: subcutaneous solution

General

The most commonly reported adverse reactions have included nausea, vomiting, diarrhea, abdominal pain, and constipation.[Ref]

Oncologic

GLP- 1 Receptor Agonist:
Postmarketing reports: Medullary thyroid cancer

Cases of Medullary thyroid cancer (MTC) have been reported in patients treated with liraglutide in the postmarketing period; the data in these reports is insufficient to establish or exclude a causal relationship between MTC and GLP-1 receptor agonist use in humans.

Gastrointestinal

Very common (10% or more): Nausea (up to 20%), increased amylase (up to 13%), increased lipase (up to 22%)
Common (1% to 10%): Vomiting, diarrhea, abdominal pain, constipation, dyspepsia, eructation, flatulence, gastroesophageal reflux disease
Uncommon (0.1% to 1%): Gastritis
Frequency not reported: Acute pancreatitis, chronic pancreatitis

In clinical trials, acute pancreatitis was confirmed by adjudication in 7 (0.3 cases per 100 patient years) and 8 patients (0.27 per 100 patient years) in 2 separate trials (compared to 3 and 10 placebo treated patients, respectively) One case of chronic pancreatitis was confirmed.

Hypersensitivity

GLP-1 Receptor Agonists:
Frequency not reported: Serious hypersensitivity reactions such as anaphylaxis, angioedema

Ocular

In a 2-year trial among patients with type 2 diabetes and high cardiovascular risk, patients treated with this drug experienced a great incidence of diabetic retinopathy complications (3% vs 1.8%). The absolute risk was greater in patients with a history of diabetic retinopathy at baseline (8.2%[drug] vs 5.2%[placebo]) than those without (0.7%[drug] vs 0.4%[placebo]).

Common (1% to 10%): Diabetic retinopathy complications

Metabolic

Very common (10% or more): Hypoglycemia (up to 30% when used in combination with basal insulin)
Common (1% to 10%): Hypoglycemia

Local

Uncommon (0.1% to 1%): Injection site reactions

Immunologic

Frequency not reported: Development of anti-semaglutide (the active ingredient contained in Ozempic) antibodies

As with other protein and peptide pharmaceuticals, patients receiving this drug have developed anti-semaglutide antibodies. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay, as well as other factor in handling of the sample. For these reason, the incidence of antibodies cannot be directly compared with other products. Anti-drug antibodies to semaglutide have been reported in up to 1% of patients during clinical trials.

Hepatic

Common (1% to 10%): Cholelithiasis

Cholelithiasis has been reported in 1.5% and 0.4% of patients receiving 0.5 mg and 1 mg weekly, respectively

Other

Fatigue was reported in greater than 0.4% of patients.

Frequency not reported: Fatigue

Nervous system

Frequency not reported: Dysgeusia, dizziness

Dysgeusia and dizziness have been reported in greater than 0.4% of patients.

Renal

GLP-1 Receptor Agonists:
Postmarketing reports: Acute kidney injury, worsening of chronic renal failure

Cardiovascular

A mean increase in heart rate of 2 to 3 beats per minute was reported in clinical trials.

Frequency not reported: Increase in heart rate