Ozempic 1 mg 1 pen

Ozempic 1 mg 1 pen

Composition:

Active substance: semaglutide.

Each pre-filled pen delivers 1 mg of semaglutide per dose.

Description:

Ozempic® is a medicine containing the active substance semaglutide, which belongs to a group of medicines called GLP-1 analogues. It works by mimicking the action of a natural hormone (GLP-1) that is released after eating. It helps your body lower blood sugar levels only when they are too high by.

Stimulating the release of insulin from the pancreas when blood sugar is high.

Reducing the release of glucagon, a hormone that raises blood sugar.

Slowing down the emptying of the stomach, which helps to control appetite and reduce food intake after meals.

In addition to controlling blood sugar, Ozempic® has been shown to help prevent major cardiovascular events (like heart attack or stroke) in adults with type 2 diabetes and known heart disease.

It is used as a treatment for adults with type 2 diabetes mellitus when diet and exercise alone are not sufficient to achieve adequate glycemic control.

Indications:

Treatment of adults (aged 18 years and older) with type 2 diabetes mellitus to control blood sugar levels:

As monotherapy: When diet and exercise do not provide adequate glycemic control and when metformin is not suitable due to intolerance or contraindications.

In combination with other medicinal products: When used with other glucose-lowering medicinal products, including insulin, when these, together with diet and exercise, do not provide adequate glycemic control.

Posology and Method of Administration:

The starting dose is 0.25 mg once a week for the first 4 weeks. This is a non-therapeutic dose to help your body get used to the medicine and reduce gastrointestinal side effects.

After 4 weeks, the dose should be increased to 0.5 mg once a week.

If additional glycemic control is needed after at least 4 weeks on the 0.5 mg dose, the dose may be increased to 1 mg once a week.

If further control is needed after at least 4 weeks on the 1 mg dose, the dose may be increased to the maximum dose of 2 mg once a week.

Method of Administration:

Ozempic® is administered by subcutaneous injection (under the skin). It must not be administered intravenously or intramuscularly.

Injection sites: The front of the thigh, abdomen, or upper arm.

It can be injected at any time of the day, with or without meals.

The day of the weekly administration can be changed if necessary, as long as the time between two doses is at least 3 days (>72 hours).

Contraindications:

Hypersensitivity to the active substance (semaglutide) or to any of the excipients.

Patients with type 1 diabetes.

Patients with diabetic ketoacidosis.

This medicine must not be used as a substitute for insulin.

Warnings:

Pancreatitis: Patients should be informed of the characteristic symptoms of acute pancreatitis (severe and persistent abdominal pain, possibly radiating to the back). If pancreatitis is suspected, the medicine should be discontinued.

Diabetic Retinopathy: Patients with diabetic retinopathy should be monitored closely. Rapid improvement in glucose control has been associated with a temporary worsening of diabetic retinopathy.

Hypoglycaemia: The risk of hypoglycaemia is increased when Ozempic® is used in combination with a sulfonylurea or insulin. The dose of the sulfonylurea or insulin may need to be reduced to lower the risk of hypoglycaemia.

Dehydration: Nausea, vomiting, and diarrhoea can lead to dehydration, which may cause renal impairment. Patients should be advised to maintain adequate fluid intake.

Acute Kidney Injury: There have been reports of acute kidney injury and worsening of chronic renal failure, which may sometimes require haemodialysis, in patients treated with GLP-1 receptor agonists. These events often occurred in patients who experienced nausea, vomiting, diarrhoea, or dehydration.

Gastroparesis: This medicine slows gastric emptying and may impact the absorption of orally administered drugs. It has not been studied in patients with pre-existing gastroparesis.

Undesirable Effects:

Very common (≥1/10):

Nausea

Diarrhoea

Hypoglycaemia (when used with sulfonylurea or insulin).

Common (≥1/100 to <1/10):

Vomiting

Abdominal pain

Constipation

Dyspepsia (indigestion)

Gastritis

Gastroesophageal reflux disease

Abdominal distension (bloating)

Eructation (burping)

Hypoglycaemia (when used with other oral antidiabetic drugs)

Dizziness

Fatigue

Decreased appetite

Gallstones

Increased pancreatic enzymes (amylase, lipase).

Uncommon (≥1/1,000 to <1/100):

Acute Pancreatitis

Injection site reactions (e.g., bruising, pain, itching, rash)

Allergic reactions (e.g., rash, urticaria)

Tachycardia (fast pulse)

Dysgeusia (taste disturbance)

Delayed gastric emptying.

Pregnancy and Lactation:

Pregnancy: This medicine should not be used during pregnancy. Women of childbearing potential should use contraception while using Ozempic®. Treatment should be discontinued at least 2 months before a planned pregnancy due to the long half-life of semaglutide.

Breast-feeding: It is unknown if semaglutide is excreted in human milk. A risk to the newborn/infant cannot be excluded. Ozempic® should not be used while breast-feeding.

Storage Conditions:

Store in a refrigerator (2°C – 8°C). Do not freeze.

Keep the pen in the outer carton to protect it from light.

After first use, the pen can be stored for up to 56 days at room temperature (below 30°C) or in a refrigerator. 

Package:

1 pre-filled pen (with 2 disposable NovoFine® needles).