Ozempic

Description

What is Ozempic?

Ozempic is used for type 2 diabetes to improve blood sugar levels and lower the risk of stroke, heart attack, or death for adults with type 2 diabetes and heart disease. Ozempic (semaglutide) has been shown to help weight loss and maintain the lost weight in clinical trials. Ozempic is given as a once-weekly injection under the skin of the belly, the thigh, or the upper arm using an autoinjector (pen).

Ozempic works by helping the pancreas release more insulin, decreasing the amount of sugar your liver makes, and slowing the rate food passes through your body, making you feel full longer. This helps to lower blood sugar levels and lowers the risk of a major cardiovascular event.

Ozempic is a GLP-1 agonist that works the same way as a natural hormone made in our gut called GLP-1. GLP-1 controls insulin release and gut emptying and regulates appetite and food intake. Ozempic mechanism of action (MOA) is binding to GLP-1 receptors, which results in lower blood sugar and A1C levels and may also reduce appetite to help with weight loss.

Ozempic is FDA-approved to improve glycemic control in adults with type 2 diabetes mellitus and to lower the risk of major cardiovascular events in adults with type 2 diabetes. It should be used together with diet and exercise.

Ozempic (semaglutide) should not be used for type 1 diabetes mellitus.

Ozempic for weight loss

Ozempic’s active ingredient, semaglutide, works for weight loss and is approved for weight loss under the brand name Wegovy. In clinical trials, semaglutide patients’ weight loss was 2.6 kg more than the placebo group for the 0.5mg dose, and for the 1mg dose, the amount of weight loss was 3.5 kg more than the placebo group after the 30-week trial. Ozempic and Wegovy are both made by Novo Nordisk.

The difference between the two is that Ozempic is used for diabetes and cardiac protection; doses are usually lower and is covered by health insurance compared to Wegovy, which is used for weight loss and weight management, has higher doses, and is typically not covered by insurance.

Ozempic is not an FDA-approved weight loss medicine.

Ozempic side effects

Common Ozempic side effects

Common Ozempic side effects include nausea, vomiting, diarrhea, stomach pain, constipation, upset stomach, heartburn, burping, gas, bloating, loss of appetite, runny nose or sore throat, stomach flu symptoms or headache, dizziness, tiredness and low blood sugar (in people with type 2 diabetes).

Stomach or gastrointestinal Ozempic side effects are common but tend to be mild and clear up in a few weeks in most people and will not interfere with long-term treatment. Stomach side effects can be more common with higher doses.

The most common gastrointestinal Ozempic side effect is nausea, which occurs in about 15% to 20% of people.

• Others include vomiting (5% to 9%), diarrhea (8%), stomach-area pain (6% to 7%), and constipation (3% to 7%).
• These side effects occurred at rates higher than the placebo-treated groups (receiving an inactive treatment).

More patients receiving Ozempic 0.5 mg (3.1%) and 1 mg (3.8%) discontinued treatment due to stomach side effects than patients receiving placebo (0.4%).

Stomach side effects usually occur at the beginning of treatment and if your dose is increased too quickly. Because of this, your healthcare provider will slowly increase your dose every 4 weeks as needed until you reach your target dose. You can take Ozempic with or without meals.

Tips for managing stomach Ozempic side effects

Following these tips may help you manage stomach Ozempic side effects:

• eat more slowly
• consume smaller meals
• select more bland, low-fat foods (like crackers, toast and rice)
• avoid greasy, fried foods or sugar treats
• eat foods that contain water (like soup or gelatin)
• don’t lie down right after eating
• drink clear or ice-cold liquids
• if possible, go outside for fresh air if you feel sick to your stomach

Serious Ozempic side effects.

Get emergency medical help if you have signs of an allergic reaction, such as hives, itching, dizziness, fast heartbeats, difficult breathing, or swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• vision changes;
• unusual mood changes, thoughts about hurting yourself;
• pounding heartbeats or fluttering in your chest;
• a light-headed feeling, like you might pass out;
• 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;
• gallbladder problems – upper stomach pain, fever, clay-colored stools, jaundice (yellowing of the skin or eyes);
• low blood sugar–headache, hunger, weakness, sweating, confusion, irritability, dizziness, fast heart rate, or feeling jittery;
• kidney problems – swelling, urinating less, blood in urine, feeling tired or short of breath
• stomach flu symptoms – stomach cramps, vomiting, loss of appetite, diarrhea (may be watery or bloody)
• symptoms of ileus (stomach paralysis) – bloating, stomach cramps or pain, nausea or vomiting, constipation or diarrhea, loss of appetite.

Pulmonary aspiration during general anesthesia or deep sedation has been reported in patients receiving GLP-1 receptor agonists undergoing elective surgeries or procedures. Instruct patients to inform healthcare providers of any planned surgeries or procedures.

Warnings

Call your doctor at once if you have signs of a thyroid tumor, such as swelling or a lump in your neck, trouble swallowing, a hoarse voice, or shortness of breath.

You should not use this medicine if you have multiple endocrine neoplasia type 2 (tumors in your glands), or a personal or family history of medullary thyroid cancer.

Postmarketing data has shown an association between Ozempic use and ileus (stomach paralysis). Because these reports are voluntary it is not possible to estimate the frequency of these effects. Talk to a healthcare provider if you develop symptoms such as bloating, stomach cramps or pain, nausea or vomiting, constipation or diarrhea, or loss of appetite.

Before taking this medicine

You should not use this medicine if you are allergic to semaglutide or any other ingredients in this medicine, or if you have:

• multiple endocrine neoplasia type 2 (tumors in your glands); or
• a personal or family history of medullary thyroid carcinoma (a type of thyroid cancer).

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

• a stomach or intestinal disorder;
• pancreatitis;
• are planning surgery or other procedure that uses anesthesia or deep sedation;
• kidney disease; or
• eye problems caused by diabetes (retinopathy).

This medicine caused thyroid tumors or thyroid cancer in animal studies. It is not known whether these effects would occur in people. Ask your doctor about your risk.

Pregnancy

Tell your healthcare professional if you are pregnant or plan to become pregnant. It is not known if Ozempic will harm your unborn baby. Stop using this medicine at least 2 months before you plan to get pregnant. Talk to your healthcare provider about the best way to control your blood sugar if you plan to become pregnant or while you are pregnant. Controlling diabetes is very important during pregnancy, as is gaining the right amount of weight. Even if you are overweight, losing weight during pregnancy could harm the unborn baby.

Breastfeeding

Tell your healthcare provider if you are breastfeeding or plan to breastfeed. It is not known if Ozempic passes into your breast milk. You should talk with your healthcare provider about the best way to feed your baby while using this medicine.

How should I use Ozempic?

Use this medicine exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. It is usually started at a low dose that is gradually increased every 4 weeks to 30 days. Follow your doctor’s dosing instructions very carefully, and ask your doctor or pharmacist if you need help.

Ozempic Instructions

Ozempic is injected under the skin (subcutaneous injection), usually once per week at any time of the day, with or without food. It should be used on the same day each week.

Prepare an injection only when you are ready to give it. Call your pharmacist if the medicine looks cloudy, has changed colors, or has particles in it.

Your healthcare provider will show you where to inject this medicine. It is usually injected into the abdomen, thigh, or upper arm. Do not inject into the same place two times in a row.

If you choose a different weekly injection day, start your new schedule after at least 2 days have passed since the last injection you gave.

Do not use different brands of semaglutide (Wegovy or Rybelsus) at the same time.

Blood sugar can be affected by stress, illness, surgery, exercise, alcohol use, or skipping meals.

Low blood sugar (hypoglycemia) can make you feel very hungry, dizzy, irritable, or shaky. To quickly treat hypoglycemia, eat or drink hard candy, crackers, raisins, fruit juice, or non-diet soda. Your doctor may prescribe glucagon injections in case of severe hypoglycemia.

Tell your doctor if you have frequent symptoms of high blood sugar (hyperglycemia), such as increased thirst or urination. Ask your doctor before changing your dose or medication schedule.

Your treatment may also include diet, exercise, weight control, medical tests, and special medical care.

You may get dehydrated during prolonged illness. Call your doctor if you are sick with vomiting or diarrhea, or if you eat or drink less than usual.

The Ozempic injection pen contains more than one dose. After your first use, store the pen with the needle removed in a refrigerator or at room temperature. Protect from heat and light. Keep the cap on when not in use. Throw the pen away 56 days after the first use, or if less than 0.25 mg is shown on the dose counter.

Do not reuse a needle. Place it in a puncture-proof “sharps” container and dispose of it following state or local laws. Keep out of the reach of children and pets.

Store unopened injection pens in the original carton in a refrigerator, protected from light. Do not use past the expiration date. Throw away an injection pen that has been frozen.

Ozempic Dosing Information

• Start Ozempic with a 0.25 mg subcutaneous injection (injection under the skin) once weekly for 4 weeks. The 0.25 mg dosage is intended for treatment initiation and is not effective for glycemic control.
• After 4 weeks on the 0.25 mg dosage, increase the dosage to 0.5 mg once weekly.
• If additional glycemic control is needed after at least 4 weeks on the 0.5 mg dosage, the dosage may be increased to 1 mg once weekly.
• ​If additional glycemic control is needed after at least 4 weeks on the 1 mg dosage, the dosage may be increased to 2 mg once weekly. The maximum recommended dosage is 2 mg once weekly.
• Administer Ozempic once weekly, on the same day each week, at any time of the day, with or without meals.
• The day of weekly administration can be changed if necessary as long as the time between two doses is at least 2 days (>48 hours).
• If a dose is missed, administer your injection as soon as possible within 5 days after the missed dose. If more than 5 days have passed, skip the missed dose and administer the next dose on the regularly scheduled day. In each case, patients can then resume their regular once weekly dosing schedule

Other brands of semaglutide

Ozempic contains the active ingredient semaglutide, other products that contains semaglutide are:

• Wegovy injections, which are FDA-approved for weight loss in adults and teenagers who have obesity or adults who are overweight (excess weight) and also have weight-related medical problems. Wegovy is also FDA-approved to reduce the risk of heart attack, stroke, and cardiovascular death in adults who are obese or overweight and have cardiovascular disease.
• Rybelsus tablets, which are FDA-approved to lower blood sugar levels for type 2 diabetic patients along with diet and exercise.

Compounded Ozempic

Compounded Ozempic is allowed to be made while there is a shortage of the injection, so patients can still  access to the medicine they have been using. Compounded medicines are not FDA-approved which means for compounded semaglutide the safety, effectiveness or quality is not checked before it is marketed or sold. The FDA has identified some areas of concern for compounded Ozempic regarding dosing errors, adverse reactions and compounders may be using salt forms of semaglutide. Using the semaglutide salt forms semaglutide sodium and semaglutide acetate are different active ingredient to semaglutide which is in the FDA approved manufactured products. There is no generic approved medicines for Ozempic, Wegovy or Rybelsus

What happens if I miss a dose?

Use Ozempic as soon as you can and then go back to your regular schedule. If you are more than 5 days late for the injection, skip the missed dose and return to your regular schedule.

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, trouble 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 use two doses of this medicine at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose may cause severe nausea, vomiting, or low blood sugar.

What should I avoid while using Ozempic?

Never share an injection pen, even if you changed the needle. Sharing this device can pass infection or disease from person to person.

What other drugs will affect Ozempic?

This medicine 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 other medicines, especially insulin or other diabetes medicines, such as dulaglutide, exenatide, liraglutide, Byetta, Trulicity, Victoza, and others. There is an increased risk of hypoglycemia (low blood sugar) when Ozempic is used in combination with insulin or other diabetes medications such as glyburide, glipizide, glimepiride, or gliclazide. The dose of these other agents may need to be reduced to lower the risk of hypoglycemia.

Other drugs may affect this medicine, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.

Storage

• Keep this medication in the container it came in and out of reach of children. Store it away from light and heat, with the pen cap on.
• Store unused this medicine in the refrigerator (36°F to 46°F [2°C to 8°C]) but do not place them near the refrigerator cooling element.
• Once a pen is in use you can store it at room temperature (59°F to 86°F [15°C to 30°C]) or in the refrigerator.
• Do not freeze.
• Do not use this medicine if it has been frozen.
• When traveling, pens that are in use can be stored at room temperature (59°F to 86°F [15°C to 30°C]) (not in a car glove compartment or other hot place).
• Make a note of the date you first use a Ozempic pen, and dispose of the pen after 56 days, even if there is some solution left in the pen.

What are the ingredients in Ozempic?

Active Ingredient: semaglutide

Inactive Ingredients: disodium phosphate dihydrate, propylene glycol, phenol and water for injection.