Ozempic Semaglutide Injection (2mg/1.5mL)
How Does Ozempic Work?
OZEMPIC® is indicated to improve glycemic control in adults with type 2 diabetes mellitus when used with:
- metformin is contraindicated or intolerant for a patient, diet and exercise may be appropriate.
- metformin, when lifestyle changes and a maximally tolerated dose of metformin do not provide adequate glycemic control.
- sulfonylureas and metformin, when diet and exercise along with dual therapy with a sulfonylurea are insufficient to achieve adequate glycemic control.
- sulfonylureas and sodium-glucose cotransporter 2 inhibitors (SGLT2i), when diet and exercise together with metformin or a sulfonylurea are not enough to achieve adequate glycemic control.
- metformin in combination with basal insulin when diet and exercise are insufficient to achieve adequate glycemic control
No studies have been conducted with OZEMPIC® and prandial insulin (short acting). It is not an alternative to insulin.
In patients with type 1 diabetes mellitus (formerly known as insulin-dependent diabetes mellitus or IDDM) or diabetic ketoacidosis, OZEMPIC® should not be used.
There is no generic for OZEMPIC® and OZEMPIC® can only be purchased with a prescription. When adding OZEMPIC® to a treatment regimen, the dose of concomitant medications should be adjusted.
OZEMPIC® is also available in 4mg/3ml injectable pens.
The ingredient in Ozempic (oh-ZEM-pick) injection is semaglutide, an oral agonist (or analog) of the human GLP-1 receptor. Yeast fermentation produces the peptide backbone. Albumin binding is semaglutide’s primary mechanism of protraction, which is enhanced by modifying position 26 lysine with a hydrophilic spacer and a C18 fatty di-acid. In addition, what makes semaglutide stable is its modification in position 8 to provide protection against degradation by the enzyme dipeptidyl-peptidase 4. In position 34, one fatty diacid was attached to ensure that only one was attached.
A colorless, clear, sterile solution, Ozempic is aqueous, clear, and sterile. Ozempic is a 1.5 mL solution equivalent to 2 mg semaglutide in each pre-filled pen. The inactive ingredients included with one mL of Ozempic solution are: disodium phosphate dihydrate, 1.42 mg; propylene glycol, 14.04 mg; phenol, 5.50 mg; and water for injection. Ozempic acid has a pH of approximately 7.4. It can be adjusted by adding hydrogen chloride or sodium hydroxide.
Ozempic is indicated as an adjunct to diet and exercise for improving glycemic control in adults with type 2 diabetes mellitus.
Especially when associated with type 2 diabetes mellitus and established cardiovascular disease, to reduce the likelihood of major adverse cardiovascular events (heart attacks, non-fatal strokes, and myocardial infarctions).
Restrictions on Use
Patients with a history of pancreatitis have not been studied with OZEMPIC. Patients who have a history of pancreatitis should consider other antidiabetic therapies.
Diabetes mellitus type 1 is not recommended for use of OZEMPIC.
Precautions and Warnings
Risk of Thyroid C-cell Tumours
Thyroid C-cell tumours develop in rats and mice exposed to clinically relevant doses of semaglutide. It has not been determined whether semaglutide causes thyroid C-cell tumors in humans, including medullary thyroid carcinoma (MTC) because clinical or nonclinical studies have been inconclusive.
A personal history of MTC or MEN type 2 (Multiple Endocrine Neoplasia syndrome) or a family history of MTC may contraindicate OZEMPIC®.Human thyroid C-cell tumor risk can be mitigated by monitoring thyroid calcitonin or thyroid ultrasound. Patients should be counseled regarding the risk and symptoms of thyroid tumors
The heart rate increases when taking OZEMPIC®. In patients with cardiac conditions that may worsen when their heart rate increases, such as tachyarrhythmias, caution should be exercised.
Endocrine and Metabolism
When OZEMPIC® is used with sulfonylurea or basal insulin, it may cause hypoglycemia in some patients. When starting OZEMPIC® treatment, sulfonylurea (or other concomitantly administered insulin secretagogues) or insulin can be reduced to reduce the risk of hypoglycemia.
The use of GLP-1 receptor agonists has been associated with acute pancreatitis. Compared to patients treated with another GLP-1 receptor agonist (0.2 cases per 100 patient years) in a glycemic control trial, seven cases of acute pancreatitis were confirmed by adjudication in OZEMPIC®-treated patients (0.3 cases per 100 patient years) and no cases in patients treated with placebo or with other classes of drugs. An OZEMPIC®-treated patient was diagnosed with chronic pancreatitis. OZEMPIC®-treated patients had 0.27 cases of acute pancreatitis per 100 patient years of observation, while the placebo-treated patients had 0.33 cases per 100 patient years of observation in a 2-year trial (SUSTAIN 6). Chronic pancreatitis was not reported.
Acute pancreatitis presents with specific symptoms that patients should be made aware of. If symptoms of pancreatitis arise after starting OZEMPIC®, observe patients carefully. It is recommended that OZEMPIC® be discontinued if pancreatitis is suspected. If confirmed, OZEMPIC® should not be restarted. When a patient with a history of pancreatitis has diabetes, other options should be considered in addition to OZEMPIC®.
All GLP-1 receptor agonists, including OZEMPIC®, may cause a severe, life-threatening allergy, including anaphylaxis. The patient should stop taking OZEMPIC® immediately if they experience a hypersensitivity reaction.
The use of Ozempic is contraindicated for the following conditions:
In patients with multiple endocrine neoplasia type 2 (MEN 2) or an individual with medullary thyroid carcinoma (MTC) or MEN 2, there is a personal or family history of medullary thyroid carcinoma.
The previous occurrence of a serious hypersensitivity reaction to semaglutide or any of the excipients in Ozempic. Ozempic has been associated with serious hypersensitivity reactions, including anaphylaxis and angioedema
The following side effects may occur with Ozempic: neck lump, swallowing problems, cough, breathlessness, difficulty breathing, pain in the upper abdomen, nausea, vomiting, hazy vision, dark spots in your vision, blurred vision, vision loss, trembling, uneasiness, agitation, sweating, goose bumps, clamminess, restlessness, impatience, disorientation, fast heartrate, lightheadedness, fainting, dizziness, appetite, inability to urinate, swelling of your legs, feet, ankles, fatigue, rashes, discomfort, and shock.
In case of any of these symptoms, seek medical care as soon as possible.
Ozempic can cause stomach pain, diarrhea, nausea, vomiting, bloating, and constipation, among other side effects.
In case you have any side effects that don’t seem to be going away, tell the doctor.
Ozempic may also have other side effects. Your doctor or pharmacist can provide you with more information.
Consult your doctor if you experience side effects. You can contact FDA at 1-800-FDA-1088 if you experience side effects.
You should take OZEMPIC® once a week, after meals or without. It is not recommended to take OZEMPIC® every day. If necessary, the day of weekly administration can be changed, as long as there is at least a 48-hour gap between two doses.
In addition to OZEMPIC®, metformin can also be used to treat diabetes in combination with one or more antidiabetic agents (metformin, sulfonylurea [SU], basal insulin, and SGLT2I). Combining OZEMPIC® with other GLP-1 analogs is not recommended. Combining OZEMPIC® with DPP-4 inhibitors has not been studied.
It is possible to continue taking metformin at the same dose when OZEMPIC® is added to existing metformin therapy.
The injection is administered subcutaneously in the abdomen, the thigh, or the upper arm. There is no adjustment in dosage when the injection site changes.
Visually inspect OZEMPIC® before use. OZEMPIC® should appear clear and colourless. OZEMPIC® should not be used if particulate matter and coloration are present.
Patients should administer OZEMPIC® with insulin separately and never mix the two products together. OZEMPIC® and insulin can be injected in the same body region, but the injections should not take place in the same area. If possible, rotate the injection sites with each injection. Use a different injection site each time.
It is best to administer the missed dose within 5 days of missing it. It is recommended to skip the missed dose if more than 5 days have passed and to administer the next dose on the regular schedule day. In each case, patients can then resume their regular once weekly dosing schedule.
In clinical trials, overdoses of up to 4 mg have been reported in a single dose, as well as up to 4 mg per week. A common side effect was nausea. However, no complications were reported.
In case of overdose, OZEMPIC® does not have a specific antidote. According to the patient’s clinical signs and symptoms, supportive treatment should be initiated in the event of overdose. Due to OZEMPIC®’s long half-life of approximately 1 week, a prolonged period of observation and treatment may be necessary.
Pregnancy and Breastfeeding
Reproductive toxicity has been demonstrated in animal studies. There have been no human clinical trials. It is not recommended to take semaglutide during pregnancy. Semaglutide is not recommended for women who are expecting or planning to become pregnant. Semaglutide should be discontinued if a patient becomes pregnant or if pregnancy occurs. Because of semaglutide’s long half-life, you should discontinue it 2 months before you expect to become pregnant.
OZEMPIC® is not known to be excreted in human milk. Rat milk was found to contain semaglutide. In view of the fact that OZEMPIC® is excreted in human milk and the possible effects on an infant are unknown, it should not be used during breastfeeding.
Storage, Stability and Disposal
Children should not see or touch this medicine. Once the expiry date has passed, which is noted on the label.
A single patient may use an OZEMPIC® pen. Regardless of whether the needle is replaced, OZEMPIC® pens should not be shared among patients.
Keep refrigerated (2°C – 8°C) before opening. Avoid freezing. Avoid exposing yourself to the cooling element. When you store the pen in a refrigerator (2°C – 8°C) or at a temperature below 30°C, it will last up to 8 weeks. It should not be frozen.To prevent the pen from being damaged by light, keep the pen cap on when not in use.
In the absence of a clear, colourless solution, do not use this medicine.
Do not flush this medicine down the toilet or dispose of it in your household trash. If you no longer need the medicine, you can dispose of it with your pharmacist’s help. The process helps protect the environment. According to local requirements, the patient should be instructed to throw away the injection needle after every injection.
OZEMPIC® can be degraded by the addition of substances. Other medicines, such as infusion fluids, cannot be mixed with OZEMPIC®.
In the absence of clear and colourless OZEMPIC®, it should not be used.
As long as the needle is no longer than 8 mm to 8 millimeters in length.can be administered. NovoFine and NovoTwist disposable needles can be used with the pen.
Clinical Studies Overview
Patients with type 2 diabetes mellitus have been studied with OZEMPIC either as a monotherapy or in combination with metformin, metformin and sulfonylureas, metformin and/or thiazolidinedione, and basal insulin. The efficacy of OZEMPIC was compared with placebo, sitagliptin, exenatide extended-release (ER), and insulin glargine.
Only the 1 mg dose of OZEMPIC was studied in trials comparing OZEMPIC and exenatide ER where both 0.5 mg and 1 mg doses were evaluated.
OZEMPIC produced a clinically relevant reduction in HbA1c from baseline in patients with type 2 diabetes mellitus.
It does not appear that age, gender, race, ethnicity, baseline BMI, baseline body weight, baseline diabetes duration, and baseline renal impairment affected the efficacy of OZEMPIC.
Ozempic should not be used if:
The condition Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) or medullary thyroid carcinoma (MTC) has ever affected you or your family member.
The ingredient semaglutide or any ingredient in OZEMPIC has caused you a serious allergic reaction.
Severe allergic reactions can cause the following symptoms: swollen lips, face, tongue, or throat, difficulty breathing, intense rash, dizziness or fainting, as well as rapid heartbeat.