OZEMPIC 0.5mg Solution for Injection in Pre-Filled pen

What is OZEMPIC 0.5mg

OZEMPIC 0.5mg is a prescription medication that contains the active ingredient Semaglutide. It belongs to a class of drugs known as GLP-1 receptor agonists (glucagon-like peptide-1). This medication is commonly used for:

• Managing type 2 diabetes mellitus in adults, particularly when lifestyle interventions (diet and exercise) are not enough to control blood glucose.
• Reducing the risk of major cardiovascular events such as heart attack and stroke in patients with type 2 diabetes and established cardiovascular disease.

OZEMPIC is not insulin. It mimics the natural hormone GLP-1 to regulate blood sugar levels, reduce appetite, and support weight loss.

This medication is administered once weekly via a pre-filled pen, which includes disposable NovoFine Plus needles. The 0.5mg dose is typically part of a treatment plan that may start at a lower dose (e.g., 0.25mg) to minimize gastrointestinal side effects.

How to use OZEMPIC 0.5mg

OZEMPIC 0.5mg is supplied as a pre-filled injection pen, intended for subcutaneous use only. It should be used as instructed by your healthcare provider. Here's how to use it correctly:

• Frequency: Inject once weekly, on the same day each week, with or without meals.
• Injection sites: The preferred sites are the front of your thighs, abdomen, or upper arm. Rotate the site each week to avoid skin irritation.
• Pen preparation: Attach a new disposable NovoFine Plus needle before each use. Do not reuse needles.
• Priming the pen: Before the first use, follow the instructions for priming the pen to ensure proper dose delivery.
• Administration: Turn the dose selector to 0.5mg, insert the needle under the skin, and press the injection button. Hold for 6 seconds to ensure complete dose delivery.
• Missed dose: If a dose is missed, administer it within 5 days. If more than 5 days have passed, skip the dose and continue with the next scheduled dose.

Important tips:

• Never share your pen with others.
• Dispose of used needles in a sharps container.
• Do not inject into a vein or muscle.

Mode of Action OZEMPIC 0.5mg

Semaglutide, the active ingredient in OZEMPIC, is a long-acting analogue of human glucagon-like peptide-1 (GLP-1), a hormone involved in glucose regulation. Its mechanism of action is multifaceted:

• Stimulates insulin secretion: In response to high blood glucose levels, semaglutide enhances the release of insulin from the pancreatic beta cells.
• Suppresses glucagon: It inhibits the release of glucagon, a hormone that increases glucose production in the liver, particularly when blood glucose levels are high.
• Delays gastric emptying: Slows the rate at which food leaves the stomach, leading to better postprandial blood glucose control and prolonged satiety.
• Appetite regulation: Semaglutide acts on appetite centers in the brain, reducing food intake and promoting weight loss.

The combination of these effects leads to improved glycemic control, reduced body weight, and decreased cardiovascular risk, especially in patients with type 2 diabetes.

It is important to note that Semaglutide is glucose-dependent in its activity, meaning it does not cause hypoglycemia on its own, but may increase the risk when combined with other antidiabetic drugs like sulfonylureas or insulin.

OZEMPIC 0.5mg Interactions OZEMPIC 0.5mg

While Semaglutide is generally well-tolerated, it may interact with several types of medications. These interactions could either diminish its effectiveness or increase the risk of side effects.

• Insulin and Sulfonylureas: Co-administration can increase the risk of hypoglycemia. Dosage adjustments may be necessary.
• Oral medications: Due to delayed gastric emptying, Semaglutide may affect the absorption of oral drugs. Caution should be taken especially with medications requiring fast onset (e.g., antibiotics, thyroid hormones).
• Warfarin and anticoagulants: Monitor INR closely when starting or stopping OZEMPIC.
• Diuretics: May enhance the risk of dehydration due to gastrointestinal side effects such as vomiting or diarrhea.

Clinical considerations:

• Always inform your healthcare provider of all medications you are taking, including OTC drugs and supplements.
• If using other injectables, space out injections in different sites to avoid localized reactions.
• Monitor for signs of hypoglycemia when combining OZEMPIC with other glucose-lowering agents.

Dosage of OZEMPIC 0.5mg

OZEMPIC dosing is individualized and typically follows a titration schedule to reduce gastrointestinal side effects and improve tolerability.

• Initial dose: 0.25 mg once weekly for the first 4 weeks. This dose is not intended for glycemic control but for initiation and tolerance development.
• Maintenance dose: After 4 weeks, the dose is increased to 0.5 mg once weekly, which is the therapeutic dose for most patients.
• Maximum dose: If additional glycemic control is needed, the dose may be increased to 1 mg weekly after evaluating patient response and tolerability.

Special populations:

• Renal impairment: No dose adjustment needed for mild to moderate impairment; caution in severe cases.
• Hepatic impairment: Use with caution due to limited data.
• Elderly: No specific dosage adjustments, but monitor renal function and side effects more closely.

Dosing should be done on the same day each week. If needed, the day of administration can be changed, provided the time between two doses is at least 3 days (72 hours).

Possible side effects of OZEMPIC 0.5mg

Like all medications, OZEMPIC may cause side effects, though not everyone experiences them. Most side effects are mild to moderate and improve over time.

• Very common side effects:
  • Nausea
  • Vomiting
  • Diarrhea
  • Constipation
• Common side effects:
  • Decreased appetite
  • Indigestion or bloating
  • Fatigue
  • Abdominal pain
• Less common but serious side effects:
  • Hypoglycemia (especially when used with insulin)
  • Pancreatitis (severe stomach pain that may radiate to the back)
  • Kidney problems (due to dehydration from vomiting or diarrhea)
  • Allergic reactions (rash, itching, difficulty breathing)

Rare but severe risks:

• Thyroid C-cell tumors (observed in animal studies; human risk unknown)
• Gallbladder issues (cholelithiasis or cholecystitis)

Patients should be monitored for signs of pancreatitis and thyroid issues during treatment.

OZEMPIC 0.5mg Contraindications OZEMPIC 0.5mg

While OZEMPIC (Semaglutide) can be highly effective in managing type 2 diabetes, it is not suitable for everyone. The following conditions represent contraindications—situations where the drug should not be used, due to the potential for serious harm:

• Personal or family history of medullary thyroid carcinoma (MTC):

  Patients with a personal or family history of MTC or individuals with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) should not use OZEMPIC, due to an observed risk of thyroid C-cell tumors in animal studies. Though the relevance to humans is uncertain, this remains a serious safety concern.

• Hypersensitivity to Semaglutide or any excipients:

  Patients with known allergic reactions or hypersensitivity to Semaglutide or any component of the formulation (e.g., phenol, disodium phosphate) should not use this medication. Signs may include rash, itching, dizziness, or difficulty breathing.

• Type 1 Diabetes Mellitus or Diabetic Ketoacidosis (DKA):

  OZEMPIC is not indicated for the treatment of type 1 diabetes or DKA, as it does not substitute for insulin therapy. Using it in these settings can result in inadequate glucose control and severe metabolic imbalance.

• Pediatric patients:

  OZEMPIC is not approved for use in individuals under 18 years of age. Safety and effectiveness in this population have not been established.

• Severe gastrointestinal disease:

  Patients with a history of severe gastrointestinal disorders (especially gastroparesis) may experience worsening symptoms due to Semaglutide’s effect on gastric emptying.

Clinical caution is advised in individuals with the following:

• Pancreatitis (history of or current)
• Impaired renal function (monitor closely if vomiting/diarrhea occurs)
• Concurrent use of insulin or sulfonylureas (due to hypoglycemia risk)

Before starting OZEMPIC, a thorough medical history and risk assessment should be conducted by a healthcare professional to rule out these contraindications and determine patient suitability.

Storage of OZEMPIC 0.5mg

Proper storage of OZEMPIC (Semaglutide) is essential to maintain its effectiveness and ensure patient safety. The medication contains a biologically active compound that may degrade if not stored correctly.

Here are the key storage guidelines for OZEMPIC 0.5mg in its pre-filled injection pen form:

• Before first use:
  • Store the pen in the refrigerator at a temperature between 2°C to 8°C (36°F to 46°F).
  • Keep it in the original carton to protect it from light.
  • Do not freeze. If the pen has been frozen, even once, it should be discarded.
• After first use:
  • The pen may be stored at room temperature (up to 30°C or 86°F) or in the refrigerator (2°C to 8°C).
  • Always keep the pen capped when not in use to protect it from light and contamination.
  • Do not store the pen with the needle attached to prevent contamination or leakage.
• In-use shelf life:
  • Once opened, the pen must be discarded 56 days (8 weeks) after the first use, even if some medication remains.
  • Mark the date you first use the pen to track expiration.
• Transport considerations:
  • When traveling, use an insulated bag with a cold pack if refrigeration is not available, but avoid direct contact with ice.
  • Do not expose the pen to extreme heat or direct sunlight.

Disposal recommendations:

• Used pens and needles should be disposed of in a proper sharps container.
• Do not throw the pen into household waste or recycling bins.

Always follow your pharmacist’s or healthcare provider’s instructions on how to store and handle your medication safely.