Product Information:

SEM-P 4mg Pre-filled Pen contains Semaglutide 4mg, a once-weekly GLP-1 receptor agonist. However, this strength is not aligned with globally approved dosing standards.

⚠️ Critical Clarification:

1. For type 2 diabetes (e.g., Ozempic®), the maximum approved dose is 2.0 mg once weekly.
2. For chronic weight management (e.g., Wegovy®), the full maintenance dose is 2.4 mg once weekly.
3. Semaglutide 4mg is not an approved or recognized dose by the FDA, EMA, or WHO.

This product likely represents a local labeling error or misrepresentation in Pakistan. Possible explanations include:

1. Misprint (intended to be 0.4 mg or 2.0 mg)
2. Dilution/concentration misunderstanding (e.g., 4mg/mL concentration, but delivered as 0.5 mL = 2mg dose)
3. Unapproved high-dose formulation (not supported by clinical evidence)

Using 4mg semaglutide is not recommended, as safety and efficacy beyond 2.4mg have not been established, and it may significantly increase the risk of severe gastrointestinal and systemic side effects.

Assumed Intended Use (If Dose Is Corrected to Standard):

1. Type 2 diabetes mellitus
2. Chronic weight management (at 2.4mg)
3. Cardiovascular risk reduction in high-risk patients

Key Benefits (At Approved Doses: 0.5–2.4mg):

1. Once-weekly subcutaneous injection
2. HbA1c reduction up to 2.0%
3. Weight loss of 10–15% (at 2.4mg)
4. Proven reduction in major adverse cardiovascular events (MACE)

How To Use (Standard Protocol – Not for 4mg):

1. Inject once weekly subcutaneously (abdomen, thigh, or upper arm)
2. Dose escalation is mandatory:
3. Start: 0.25 mg/week × 4 weeks
4. Then: 0.5 mg → 1.0 mg → 1.7 mg → 2.4 mg (for weight management)
5. Max for diabetes: 2.0 mg/week
6. Never self-inject without medical supervision

When Not to Use:

1. Personal/family history of medullary thyroid carcinoma (MTC)
2. MEN 2 syndrome
3. Hypersensitivity to semaglutide
4. Type 1 diabetes

⚠️ Black Box Warning:

Semaglutide causes thyroid C-cell tumors in rodents—contraindicated in patients at risk for MTC.

Side Effects (Likely Exaggerated at 4mg):

Common:

1. Severe nausea, vomiting, diarrhea
2. Dehydration, dizziness
3. Loss of appetite, fatigue

Serious (High Risk at Unapproved Dose):

1. Acute pancreatitis
2. Gallbladder disease (cholecystitis, gallstones)
3. Acute kidney injury (from dehydration)
4. Diabetic retinopathy complications
5. Severe hypoglycemia (if combined with insulin)

Dosage Recommendation:

1. Do not use 4mg.
2. Confirm with your physician or pharmacist whether this is a labeling error.
3. The maximum safe and approved dose is 2.4mg weekly (for weight management).

Warnings & Precautions:

1. Never exceed prescribed dose
2. Ensure proper dose escalation to minimize GI side effects
3. Monitor for signs of pancreatitis, gallbladder disease, or renal impairment
4. Use only under specialist supervision

Additional Information:

Store unopened pens refrigerated (2–8°C). After first use, store at room temperature (<30°C) for up to 56 days. Do not freeze. Keep out of reach of children. Available by prescription in Pakistan.