Saxenda Pen (Liraglutide)

1. Components
Qualitative and Quantitative Components:

Active Ingredient:

• Each 1 ml of solution contains 6 mg of Liraglutide*. A pre-filled pen contains 18 mg of Liraglutide in 3 ml.
• *A recombinant DNA-derived glucagon-like peptide-1 (GLP-1) analog produced in Saccharomyces cerevisiae cells.

Excipients:

• Disodium phosphate dihydrate, propylene glycol, phenol, hydrochloric acid (for pH adjustment), sodium hydroxide (for pH adjustment), water for injection.

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2. Indications
Saxenda is indicated as an adjunct to a reduced-calorie diet and increased physical activity for weight management in adults with an initial Body Mass Index (BMI) of:

• ≥ 30 kg/m² (obesity), or
• ≥ 27 kg/m² and < 30 kg/m² (overweight), with at least one weight-related comorbidity such as impaired glucose tolerance (pre-diabetes or type 2 diabetes), hypertension, dyslipidemia, or obstructive sleep apnea.
  Treatment with Saxenda should be discontinued after 12 weeks at a dose of 3.0 mg/day if the patient has not lost at least 5% of their initial body weight.

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3. Administration & Dosage
Administration:

• Saxenda is administered by subcutaneous injection only. It should not be injected intravenously or intramuscularly.
• Saxenda is injected once daily at any time, irrespective of meals. The injection should be made into the abdominal area, thigh, or upper arm. Injection sites can be rotated, and the timing of the injection can be changed without adjusting the dose. However, it is best to inject at a convenient time.
• If a dose is missed and it is within 12 hours, the patient should inject as soon as possible. If the next scheduled dose is less than 12 hours away, they should skip the missed dose and proceed with the regular dosing schedule. The dose should never be doubled to make up for a missed dose.

Dosage:

• The starting dose is 0.6 mg once daily. The dose should be gradually increased to 3.0 mg once daily with increments of 0.6 mg at weekly intervals to improve gastrointestinal tolerance. If the dose is increased to the next level but not tolerated for two consecutive weeks, treatment should be reconsidered.
• Doses greater than 3.0 mg/day are not recommended.

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Instructions for Using the Saxenda Pre-filled Pen 6 mg/ml:

1. Preparing Your Pen with a New Needle:

• Check the name and label color of the pen to ensure it contains Saxenda. This is particularly important if using multiple injectable medications.
• Remove the pen cap.
• Check that the solution in the pen is clear and colorless. If it appears cloudy or discolored, do not use the pen.
• Attach a new needle by removing its paper cover and securing it onto the pen.
• Remove the outer needle cap and keep it for later use.
• Remove the inner needle cap and dispose of it. If the pen is being used for the first time, check for flow by pressing the dose button.
• Always use a new needle for each injection to avoid clogging, contamination, infection, and incorrect dosing.
• Never use a bent or damaged needle.

2. Checking Dose and Flow:
Before the first use, always check the dose setting by selecting the dose button and pressing it until the dose counter reads 0 mg. Ensure a drop of medication appears at the needle tip. If no drop appears, change the needle and repeat the process.

3. Selecting Your Dose:

• Turn the dose selector until the dose counter shows the desired dose (0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg, or 3.0 mg).
• If you accidentally select the wrong dose, you can adjust it by turning the dose selector forward or backward.

4. Injecting the Medication:

• Insert the needle into your skin as directed by your doctor.
• Press the dose button and hold it until the dose counter reads 0.
• After injecting, hold the needle in your skin for 6 seconds before removing it to ensure the full dose is delivered.

5. After Injection:

• Dispose of the needle by pushing it into the outer needle cap and removing it carefully.
• Store the pen with the cap on after each use to protect the medication from light.
• Always dispose of the needle after each use to ensure proper and safe administration.

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Storage Instructions:

• Store in the refrigerator (2°C – 8°C). Do not freeze.
• Keep away from the freezer compartment.
• After first use, store below 30°C or as instructed by your healthcare provider.