EXDENSUR Solution for injection Ref.[116117] Active ingredients: Depemokimab

2.1 Recommended Dosage

The recommended dosage is 100 mg once every 6 months administered by subcutaneous (SC) injection into the upper arm, thigh, or abdomen avoiding 2 inches (5 cm) around the navel [see Dosage and Administration (2.2)].

Missed Dose(s)

If a dose is missed, administer the missed dose as soon as possible and resume the once every 6-month injection schedule from the date of when the missed dose was given.

2.2 Preparation and Administration Instructions for EXDENSUR

• EXDENSUR is for subcutaneous (SC) use only.
• EXDENSUR should be administered by a healthcare provider.

Do not use EXDENSUR prefilled pen or syringe if the security seal on the carton has been broken.

Do not use EXDENSUR prefilled pen or syringe if it has been dropped or damaged.

Preparation Instructions

1. Remove the prefilled pen or prefilled syringe from the refrigerator. Holding the middle of the prefilled pen or prefilled syringe, take it out from the tray and allow it to sit at room temperature for 30 minutes prior to injection. Do not warm EXDENSUR injection in any other way. Do not remove the needle cap until you are ready to inject. Do not use the pen or syringe if it has been left out of the carton for more than 8 hours.

2. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. EXDENSUR should be colorless to yellow to brown, clear to opalescent in color. Do not use EXDENSUR if the product exhibits discoloration, cloudiness, or particulate matter. It is normal to see an air bubble. Do not expel the air bubble prior to administration. Do not shake the device.

3. Choose the Injection Site. Administer the injection into upper arm, thigh, or abdomen, avoiding the 2 inches (5 cm) around the navel. Do not give injections into areas where the skin is tender, bruised, red, or hard.

Administration Instructions for Single-Dose Prefilled Pen

Figure 1. EXDENSUR Prefilled Pen Components:

1. Pull Off the Clear Cap

Remove the clear cap by pulling it straight off, away from the yellow needle guard.

Do not press the yellow needle guard.

Do not put the cap back on the pen. This could accidentally start the injection.

Inject within 5 minutes after removing the clear cap.

2. Position the Pen at the Injection Site and Press Firmly to Start the Injection:

Place the yellow needle guard flat against the skin (at a 90 degree angle to the skin).

Make sure you can see the inspection window.

The yellow needle guard will slide up into the pen.

You may hear a "click" that tells you the injection has started.

Do not use the pen if the yellow needle guard does not slide up into the pen.

3. Continue to Hold Down:

Keep the pen held down against the skin. Do not lift or move the pen during the injection.

The yellow indicator will move down through the inspection window during the injection.

The injection is done when you hear the second click. Injection may take up to 20 seconds.

If you do not hear the second click, check that:

• The inspection window is filled with the yellow indicator.
• The black stopper has stopped moving.

4. Lift Pen After Injection Completes

5. Throw Away

Dispose of used pen and clear cap according to local health and safety laws.

Administration Instructions for Single-Dose Prefilled Syringe

Figure 2. EXDENSUR Prefilled Syringe Components:

1. Pull Off the Gray Needle Cap:

Remove the gray needle cap from the syringe by pulling it straight off, away from the needle.

Do not handle the syringe by the white plunger while removing the gray needle cap.

Do not put the gray needle cap back onto the syringe.

Inject within 5 minutes after removing the gray needle cap.

2. Position the Syringe at the Injection Site

Use your free hand to gently pinch the skin around the cleaned injection site.

Do not handle the syringe by the white plunger while inserting the needle into the pinched skin.

Hold the middle of the syringe and insert the entire needle into the pinched skin at a 45 degree angle, as shown.

3. Start the Injection and Fully Press the White Plunger

Slowly push down on the white plunger with your thumb to inject the full dose.

Make sure the white plunger is pushed all the way down until the stopper reaches the bottom of the syringe and all of the medication is injected.

4. Slowly Lift Thumb After Injection Completes:

Slowly lift your thumb up. This will allow the white plunger to come up and the needle to automatically pull up (retract) into the needle guard.

After removing the syringe from the injection site, release the pinched skin.

5. Throw Away:

Dispose of used syringe according to local health and safety laws.

If an overdosage occurs, the patient should be treated supportively with appropriate monitoring as necessary. Consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdose management recommendations.

Store refrigerated at 36°F to 46°F (2°C to 8°C) in the original carton to protect from light.

Do not freeze. Do not shake. Avoid exposure to heat.

The prefilled pen and prefilled syringe can be removed from the refrigerator and kept in the unopened carton, protected from light for up to 7 days at room temperature up to 86°F (30°C). Discard if left out of the refrigerator for more than 7 days.

The prefilled pen or prefilled syringe must be administered within 8 hours once removed from the carton. Discard if not administered within 8 hours.