Ozempic (Semaglutide)

What is Ozempic (Semaglutide)?

Ozempic is a brand name for Semaglutide which is used in the treatment of type 2 diabetes. It belongs to a class of drugs called anti-diabetics, Glucagon-like Peptide-1 Agonists.

• Ozempic is not an insulin
• Ozempic is not indicted for treatment with type 1 diabetes
• Ozempic has not been studied in patients with pancreatitis and should not be used by patients who have had a history of this condition (pancreatitis).
• It is not known if it is safe and effective for adults under the age of 18 years of age

Ozempic is used in combination with diet and exercise to help improve glycemic control and reduce the risk of cardiovascular complications (CV death, nonfatal stroke, and nonfatal myocardial infarction).

In addition to lowering blood glucose levels, Ozempic aids patients with weight loss, appetite suppression, and lowering blood pressure levels.

How is Ozempic used?

Ozempic can be used alone or with other medications. It is administered as a weekly injection. It is available as a single-use injection pen that is safe and easy to use.

Storage

Does Ozempic need to be refrigerated?

Yes. If you have excess Ozempic injectable pens, they should be stored in the refrigerator. The ideal storage is the top shelf of the refrigerator and away from cooling elements. Semaglutide may degrade if the injectable pen is exposed to extreme cold. This can impact the effectiveness of the medication and potentially higher blood sugar levels.

Ozempic should be stored in the refrigerator between 36-47°F (2-8°C). After the pen has been used it can be kept within room temperature 59-86°F (5-30°C).

Instructions

Patients should be informed by their doctors about the potential risks and benefits of using Ozempic. It’s important for patients to maintain a proper diet, regular exercise, regularly monitor glucose levels and perform A1c testing, and understand the symptoms of hyperglycemia and hypoglycemia as part of their treatment. While using Ozempic, if patients experience periods of stress, fever, infection, trauma, or surgery they should seek medical advice as the dosage may need to be adjusted.

Doctors should instruct their patients to read the Medication Guide each time their prescription is renewed.

It’s important to understand the side effects as explained by your doctor or pharmacist. Side effects of Ozempic typically include nausea, vomiting and diarrhea.

If a dose is missed, it should be administered immediately within 5 days of the missed dose If more than 5 days have elapsed then the dose should be skipped.

SIDE EFFECTS

Although Ozempic is FDA approved and considered safe when taken as instructed however this does not mean it comes without side effects.

Before you start Ozempic, you should discuss the possible side effects with your doctor or pharmacist. You should also review the FDA-approved labeling and instructions that come with your prescription.

Ozempic has a boxed warning about the risk of C-cell tumors that have occurred in rodents. Even though it is unknown about the effects on humans, it isn’t advised for those who have a history of thyroid cancer in their family.

Common Side Effects

Patients using Ozempic have experienced mild or serious side effects. Side effects typically go away within a few days or weeks. If they do not go away, consult your doctor or pharmacist.

The list below does not include all possible side effects:

• Nausea
• Vomiting
• Diarrhea
• Abdominal pain
• Constipation
• Upset Stomach
• Flatulence (passing gas)

Serious Side Effects

Serious adverse reactions while taking Ozempic aren’t common. If you experience any serious side effects while taking this medication, inform your doctor or call 911 if you feel the symptoms are life-threatening.

Serious side effects and symptoms while taking Ozempic may include:

• Symptoms of pancreatitis (inflammation of the pancreas):

  • back and abdominal pain
  • nausea
  • vomiting
  • unintended weight loss
  • fever
  • swollen belly

• Symptoms of Hypoglycemia (low blood sugar):

  • confusion
  • dizziness
  • drowsiness
  • fast heart rate
  • feeling jittery
  • headache
  • hunger
  • irritability
  • sweating
  • weakness

• Symptoms of diabetic retinopathy (diabetes-related eye complication):

  • blurred vision
  • poor night vision
  • seeing dark spots
  • vision loss

• Symptoms of kidney damage:

  • confusion
  • fatigue
  • reduced urination
  • nausea
  • swelling in legs or ankles

• Thyroid cancer*
• Allergic reaction*

Side Effect Details

The following provides detailed information on the potential side effects caused by this medication.

Allergic reaction

Although rare, patients may experience allergic reactions while taking Ozempic if they are allergic to any of its ingredients. Symptoms of allergic reactions may include:

• skin rash
• itchiness
• flushing ( redness, warmth, swelling of skin)

More serious allergic reactions may include:

• difficulty breathing
• swelling of the skin, particularly lips, eyelids, hands, or feet
• swelling of mouth, tongue, or throat

Allergic reactions may differ between patients and it’s unclear how often allergic reactions occur. If you feel that you are experiencing a severe allergic reaction, seek medical attention immediately.

Nausea

The most common side effect reported in clinical studies is nausea. You may first experience symptoms of nausea when you begin taking Ozempic and during increased doses.

With continued use, symptoms of nausea may decrease or go away entirely. Speak to your doctor if symptoms do not go away.

Thyroid cancer

As mentioned previously, Ozempic has a boxed warning, which is the strongest warning by the FDA regarding thyroid cancer.

Ozempic has been found to increase thyroid tumors during animal studies however this has not been concluded in humans.

Cases of thyroid cancer have been reported in patients taking liraglutide (Victoza) which is a similar class of drugs to Ozempic. However, it has not been concluded if it is due to liraglutide or other factors.

You should not take Ozempic if you have a family history of thyroid cancer, specifically a rare endocrine condition called multiple endocrine neoplasia syndrome type 2 or medullary thyroid carcinoma (MTC).

If you are showing symptoms of thyroid tumors while taking Ozempic, contact your doctor immediately. These symptoms can include:

• difficulty breathing
• a hoarse voice
• difficulty swallowing
• a mass or lump in your neck

Injection Site Reactions

Injection site reactions (ie injection-site discomfort, erythema) have been reported in 0.2% of patients in placebo-controlled trials.

Increase in Amylase and Lipase

In a placebo-controlled study, patients experienced an increase of Amylase and Lipase from baseline. These changes were not found in the placebo-treated patients.

Cholelithiasis

In placebo-controlled studies that involved treating patients with Ozempic 0.5mg and 1mg reported 1.5% and 0.4% of Cholelithiasis were reported respectively. Placebo-treated patients did not report symptoms of cholelithiasis.

Increased Heart Rate

In placebo-controlled studies, patients using Ozempic 0.5mg and 1mg reported a mean increase of 2-3 beats per minute. Those in the placebo group reported a decrease in heart rate by 0.3 beats per minute.

Dizziness, Dysgeusia & Fatigue

Less than 0.4% of patients experienced dizziness, dysgeusia, and fatigue taking Ozempic.

Immunogenicity

Patients treated with Ozempic may develop anti-semaglutide antibodies which are consistent with immunogenic properties of peptide and protein pharmaceuticals.

Hypoglycemia

Even though Ozempic (semaglutide) does not cause hypoglycemia (low blood sugar), it may occur happen if taken with other diabetes medications. Speak to your doctor or pharmacist about whether you need to have your other medication doses adjusted. Hypoglycemia may also be caused by consuming alcohol, not enough exercise, or not getting enough calories. Symptoms of hypoglycemia may include blurred vision, headache, dizziness, hunger, increased heartbeat, sweating, or tingling hands/feet. It is recommended that patients who experience hypoglycemia carry glucose tablets, hard candy, jelly beans, fruit drinks or soda (non-diet) in case of low blood sugar.

Hyperglycemia

Hyperglycemia (high blood sugar) may occur. Symptoms include increased thirst or urination. Speak to your doctor or pharmacist if you experience these symptoms.

The information above does not include all possible side effects. Consult your doctor or pharmacist if you experience any side effects not listed above.

DRUG INTERACTIONS

Concomitant use with insulin and insulin secretagogue (ie Sulfonylurea) or insulin may change how your medications work or result in potential complications. A doctor may choose to adjust dosage, exercise, and diet.

Since Ozempic causes a delay in gastric emptying, this may cause a potential impact on the absorption of other oral drugs.

Inform your doctor of all possible prescription medications, over-the-counter medications, vitamins, and herbal supplements.

Check your blood sugar regularly and share the results with your doctor. Let your doctor know if you are experiencing high or low blood sugar levels.

Do not modify your dosage without the approval of your doctor.

WARNINGS & PRECAUTIONS

Injecting insulin

When administering Ozempic, the following points should be considered:

• Do not inject into the same location each time. Rotate injection sites.
• Do not inject where the skin is thickened, or has pits or lumps as this can affect the effectiveness of the medication.
• Do not inject where the skin is bruised, scaly, hard, tender, or damaged.

Risk of Thyroid C-Cell Tumors

If serum calcitonin is measured and found to be showing elevated or thyroid nodules from a physical examination or neck imaging, patients should be referred to an endocrinologist. Patients should be informed that Semaglutide causes thyroid C-cell tumors in rodents and that this has not been conclusive in humans. Patients must report any symptoms of hoarseness, dysphagia, dyspnea, or a lump in the neck to their physician.

Pancreatitis

Patients should be informed of the risks of pancreatitis. In glycemic control trials, acute and chronic pancreatitis has been reported. Patients need to be aware of the signs and symptoms of pancreatitis which can include ongoing severe abdominal pain and vomiting. If signs of pancreatitis are confirmed, Ozempic treatment should be discontinued and your doctor should be consulted.

Diabetic Retinopathy

In a 2-year trial, more complications of diabetic retinopathy occurred in patients taking Ozempic (3.0%) vs those taking the placebo (1.8%). Patients in the trial had type 2 diabetes and high cardiovascular risk. It was found that the patients who had a high risk of diabetic retinopathy were predisposed based on their family history compared to those without. This is why patients with a history of diabetic retinopathy should be monitored closely.

If patients experience a rapid improvement in glucose control, this may indicate a worsening of diabetic retinopathy.

Hypoglycemia

When Ozempic is used in combination with insulin or insulin secretagogues (ie sulfonylureas), patients were at higher risk of hypoglycemia (high blood sugar levels).

Do not share Ozempic pens

Ozempic pens should not be shared among patients even if they show similar symptoms and the needle has been changed. Sharing pens can lead to spreading infection and transmission of blood-borne pathogens.

Acute Kidney Injury

Reports have shown that patients treated with GLP-1 receptor agonists experienced acute kidney injury and worsening chronic renal failure. As a result, patients would require hemodialysis. Most of the reported events that happened with patients who have shown symptoms of vomiting, diarrhea, nausea, and dehydration have occurred. Renal function should be monitored closely in patients for severe adverse gastrointestinal reactions in patients taking escalated doses.

Hypersensitivity

If hypersensitivity occurs, patients should discontinue use and monitor until symptoms are resolved. Serious symptoms of hypersensitivity include angioedema and anaphylaxis. Patients with a history of these two reactions should be treated with caution and treated with another GLP-1 receptor agonist. Patients who have a history of angioedema or anaphylaxis with other GLP-1 receptors should be treated with caution.

Pregnancy

Pregnant women or those planning pregnancy should be advised of the potential risks to a fetus. Consult your doctor if you are pregnant or planning pregnancy. If diabetes is poorly managed during pregnancy, this can increase the risk of complications such as ketoacidosis, preeclampsia, birth defects, macrosomia, preterm delivery, spontaneous abortions, delivery complications, and stillbirth.

Renal Failure and Dehydration

Patients should be advised by their physicians about the possible risk of dehydration due to gastrointestinal adverse reactions if they are using Ozempic. Patients should avoid fluid depletion. Doctors should explain the possible symptoms of renal impairment and the possible requirement of dialysis if renal failure occurs.

FREQUENTLY ASKED QUESTIONS