Ozempic Semaglutide Injection (4mg/3mL)

Warnings and Precautions

Ozempic is not meant to be used by patients with type 1 diabetes.

Before taking Ozempic, inform your doctor about your complete health history. Be sure to let them know of any insulin pens or vials that you are taking. Ozempic may not be prescribed if you have pre-existing issues such as an allergy to GLP-1 agonists, if you’ve had diabetic retinopathy in the past, or have kidney disease. If you have severe kidney issues, your doctor may not prescribe Ozempic.

Regardless of whether the needle has been changed, Olympic pens should not be shared. Sharing can lead to serious infections spreading.

A boxed warning on Ozempic warns patients and doctors about serious side effects that may result from the FDA’s thyroid cancer warning. Consult your doctor for more information.

You should wear identification such as a bracelet or necklace to show others that you have diabetes and that you are taking medication to control your blood sugar.

Taking Ozempic can potentially worsen your existing conditions.

Kidney Function

In some cases, Semaglutide (Ozempic) may cause kidney failure. Your doctor should be able to help you determine if special monitoring is needed if you have kidney disease or reduced kidney function.

Heart Problems

Ozempic may increase your heart rate and function. Speak to your doctor if you have an abnormal heart condition (i.e., heart block, arrhythmia) or heart disease. They may choose to adjust the dosage of medications and require close monitoring.

Hypoglycemia (low blood sugar)

Patients currently taking a sulfonylurea (i.e., gliclazide, glyburide) or insulin along with Ozempic may be at risk of hypoglycemia. If you are experiencing symptoms of hypoglycemia such as increased heart rate, headache, cold sweat, nervousness, numbness or tingling of tongue/lips, lightheadedness, confusion, hunger, or weakness, consult your doctor. Your doctor may choose to adjust the dosage of medications you are taking.

Pancreatitis (inflammation of the pancreas)

Pancreatitis may be caused by Ozempic. This symptom may indicate pancreatitis if you experience severe abdominal pain. As Ozempic may affect your medical condition if you have had pancreatitis in the past, tell your doctor immediately if you have had this condition before.

Thyroid Cancer

The use of this medication should be avoided by people who have thyroid cancer in the family or multiple endocrine neoplasia syndrome type 2. When you experience difficulty breathing, hoarseness, or a mass on your neck, see your doctor as soon as possible. A thyroid tumor such as medullary thyroid carcinoma (MTC) cannot be caused by semaglutide.

Children

The effectiveness and safety of Ozempic have not been established for children.

How to Use Ozempic Pens

Ozempic should be applied subcutaneously to the abdomen, thighs, or upper arms.

When injecting in the same body region each week, patients should use a different injection site every week.

Before using Ozempic, inspect it visually. The liquid should appear clear and colorless. Ozempic should not be used if particulate matter and coloration are present.

Ozempic and insulin should be administered separately and not mixed when being used together. Ozempic and insulin can both be injected simultaneously in the same body region, but the injections should not be adjacent.

Ozempic is used to help with weight loss management. Do not rely solely on Ozempic for losing weight. Follow a proper diet and exercise plan to maximize results.

Side Effects of Ozempic

As with most medications, Ozempic may cause common or severe side effects in patients prescribed this drug. Please speak to your doctor about your medical history, lifestyle, and medication intake in great detail before administrating Ozempic.

Common Side Effects

Nausea, vomiting, diarrhea, abdominal pain, and constipation are among the most common side effects of Ozempic. Any side effect that bothers you or doesn’t go away should be discussed with your healthcare provider.

Severe Side Effects

The inflammation of your pancreas (pancreatitis) is one of the severe side effects. Whenever you experience severe stomach pain (abdomen) that persists, with or without vomiting, stop using Ozempic and consult your healthcare provider immediately. The pain may extend down your spine as well.

Other server-side effects include vision changes. If you notice any changes in vision while taking Ozempic, tell your healthcare provider.

Ozempic may cause hypoglycemia. Dizziness or lightheadedness, blurred vision, anxiety, irritability, mood changes, sweating, slurred speech, hunger, confusion or drowsiness, shakiness, weakness, headache, fast heartbeat, feeling jittery, and kidney problems (kidney failure) are all signs of low blood sugar.

Diarrhea, nausea, and vomiting may cause dehydration in people with kidney problems, which may worsen their kidney problems. Drinking fluids will help to keep you hydrated and help reduce your risk of dehydration.

Allergic Reactions

Ozempic may also give severe allergic reactions. Stop using Ozempic and get medical help right away if you have any symptoms of a severe allergic reaction, including swelling of your face, lips, tongue, or throat, problems breathing or swallowing, severe rash or itching, fainting or feeling dizzy, very rapid heartbeat.

The active ingredient in Ozempic is semaglutide. The inactive ingredients are disodium phosphate dihydrate, propylene glycol, phenol, and water for injection.

Pregnancy

There are limited data on semaglutide use in pregnant women to inform a drug-associated risk for adverse developmental outcomes.

There are clinical considerations regarding the risks of poorly controlled diabetes in pregnancy.

Based on animal reproduction studies, the fetus may have potential risks from exposure to semaglutide during pregnancy. Ozempic should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

In pregnant rats administered semaglutide during organogenesis, embryofetal mortality, structural abnormalities, and alterations to growth occurred at maternal exposures below the maximum recommended human dose (MRHD) based on AUC.

In rabbits and cynomolgus monkeys administered semaglutide during organogenesis, early pregnancy losses and structural abnormalities were observed below the MRHD (rabbit) and ≥5-fold the MRHD (monkey). These findings coincided with a marked maternal body weight loss in both animal species (see Data).

The estimated background risk of significant congenital disabilities is 6–10% in women with pre-gestational diabetes with an HbA1c >7 and has been reported to be as high as 20–25% in women with an HbA1c >10. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively

Breastfeeding

There are no data on the presence of semaglutide in human milk, the effects on the breastfed infant, or the effects on milk production. Semaglutide was present in the milk of lactating rats, however, due to species-specific differences in lactation physiology, the clinical relevance of these Data is not clear. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Ozempic and any potential adverse effects on the breastfed infant from Ozempic or the underlying maternal condition.

Overdose

In the event of overdose, appropriate supportive treatment should be initiated according to the patient’s clinical signs and symptoms. A prolonged period of observation and treatment for these symptoms may be necessary, taking into account the long half-life of Ozempic of approximately one week.