Nucala (mepolizumab) is a biologic therapy used for the treatment of severe eosinophilic asthma, eosinophilic granulomatosis with polyangiitis (EGPA), and hypereosinophilic syndrome (HES). It is given by subcutaneous injection every four weeks.

Nucala is an interleukin-5 (IL-5) antagonist monoclonal antibody indicated for:

• Severe Eosinophilic Asthma - add-on maintenance treatment of patients aged 6 years and older with severe eosinophilic asthma whose asthma is not controlled with their current asthma medicines. Nucala helps prevent severe asthma attacks (exacerbations). Nucala is not used to treat sudden breathing problems that occur with asthma.
• Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) - add-on maintenance treatment of adult patients 18 years and older with chronic rhinosinusitis with nasal polyps whose disease is not controlled with nasal corticosteroids. Nucala helps reduce symptoms (e.g., nasal congestion, nasal discharge, mucus in the throat, loss of smell). Nucala also helps reduce the size of nasal polyps and the use of oral corticosteroid medicines. Nucala helps prevent surgery for nasal polyps.
• Eosinophilic Granulomatosis with Polyangiitis (EGPA) - treatment of adult patients with eosinophilic granulomatosis with polyangiitis (EGPA). Nucala helps reduce symptoms and flares and may allow for a reduction in their oral corticosteroid medicine.
• Hypereosinophilic Syndrome (HES) - treatment of patients 12 years of age and older with hypereosinophilic syndrome. Nucala helps reduce symptoms and prevent flares.

Nucala is an injectable medication given by subcutaneous injection (under the skin) every 4 weeks.

Nucala is supplied as a single-dose prefilled autoinjector or a single-dose prefilled syringe. The injection may be administered by a health care provider or patient caregiver, or self-administered by patients who are 12 years of age and older.

Patients should inject Nucala into their thigh or stomach (abdomen). A health care provider or patient caregiver may also give the injection in the upper arm.

Instructions for Use

Prefilled Autoinjector

Important information - Nucala is a prescription medicine that is injected under the skin (subcutaneous) from a single-dose prefilled autoinjector. You and your caregiver should be trained on how to prepare and perform your injection before trying to do it yourself.

The following instructions provide the information you need to correctly use the prefilled autoinjector with yellow needle guard.

1. Take out the prefilled autoinjector

• Take the carton out of the refrigerator and make sure the security seals are not broken.
• Remove the tray from the carton.
• Peel off the clear plastic cover from the corner of the tray.
• Holding the middle of the prefilled autoinjector (near the inspection window), carefully take the prefilled autoinjector out of the tray.
• Place the prefilled autoinjector on a clean, flat surface at room temperature away from direct sunlight and out of the reach of children.

2. Inspect and wait 30 minutes before use

• Check that the expiration date on the label of the prefilled autoinjector has not passed.
• Look at the medicine in the inspection window. It should be clear to pale yellow to pale brown in color and without cloudiness or particles.
• It is normal to see 1 or more air bubbles.
• Wait 30 minutes (and no more than 8 hours) before use.

3. Choose your injection site

• You can inject in your thighs or abdomen.
• If you are giving the injection to someone else as a caregiver or healthcare provider, you can also inject into their upper arm.
• If you need more than 1 injection to complete your dose, leave at least 2 inches between each injection site.

4. Clean your injection site

• Wash your hands with soap and water.
• Clean your injection site by wiping your skin with an alcohol swab and allowing your skin to air dry.
• Do not touch your cleaned injection site again until you have finished your injection.

5. Remove the clear needle cap

• Remove the clear needle cap from the prefilled autoinjector by pulling it straight off, away from the yellow needle guard. It may take some force to remove the clear needle cap.
• You may see a drop of medicine at the end of the needle. This is normal.
• Make sure you inject within 5 minutes after you remove the clear needle cap.

6. Start your injection

• Hold the prefilled autoinjector with its inspection window facing you.
• Place the prefilled autoinjector straight onto your injection site with the yellow needle guard flat on the surface of your skin.
• To start your injection, push the autoinjector all the way down and keep the autoinjector held down against your skin. This will make the yellow needle guard slide up into the autoinjector.
• You should hear the 1st click to let you know your injection has started.
• The yellow indicator will move down through the inspection window as you receive your dose.

7. Complete your injection

• Your injection may take up to 15 seconds to complete.
• Continue to hold the autoinjector down until you hear the 2nd click, the stopper has stopped moving, and the inspection window is filled with the yellow indicator.
• After you hear the 2nd click, continue to hold and count to 5 before you lift the autoinjector away from your skin.
• If you do not hear the 2nd click: check that the inspection window is filled with the yellow indicator, or hold the autoinjector down for 15 seconds to make sure the injection is complete.
• There may be a small drop of blood at the injection site. This is normal. Press a cotton ball or gauze on the area and apply an adhesive bandage if you need it.

8. Throw away your used autoinjector

• Put your used autoinjector and clear needle cap in an FDA-cleared sharps disposal container right away after use.

Prefilled Syringe

Important information - Nucala is a prescription medicine that is injected under the skin (subcutaneous) from a single-dose prefilled syringe. You and your caregiver should be trained on how to prepare and perform your injection before trying to do it yourself.

The following instructions provide the information you need to correctly use the prefilled syringe with automatic needle guard.

1. Take out the prefilled syringe

• Take the carton out of the refrigerator and make sure the security seals are not broken.
• Remove the tray from the carton.
• Peel off the clear plastic cover from the corner of the tray.
• Holding the middle of the prefilled syringe (near the inspection window), carefully take the prefilled syringe out of the tray.
• Place the prefilled syringe on a clean, flat surface at room temperature away from direct sunlight and out of the reach of children.

2. Inspect and wait 30 minutes before use

• Check that the expiration date on the label of the prefilled syringe has not passed.
• Look at the medicine in the inspection window. It should be clear to pale yellow to pale brown in color and without cloudiness or particles.
• It is normal to see 1 or more air bubbles.
• Wait 30 minutes (and no more than 8 hours) before use.

3. Choose your injection site

• You can inject in your thighs or abdomen.
• If you are giving the injection to someone else as a caregiver or healthcare provider, you can also inject into their upper arm.
• If you need more than 1 injection to complete your dose, leave at least 2 inches between each injection site.

4. Clean your injection site

• Wash your hands with soap and water.
• Clean your injection site by wiping your skin with an alcohol swab and allowing your skin to air dry.

5. Remove the gray needle cap

• Remove the gray needle cap from the prefilled syringe by pulling it straight off, away from the needle (as shown). It may take some force to remove the gray needle cap.
• You may see a drop of medicine at the end of the needle. This is normal.
• Make sure you inject within 5 minutes after you remove the gray needle cap.

6. Start your injection

• Use your free hand to pinch the skin around your injection site. Keep pinching the skin throughout your injection.
• Insert the entire needle into the pinched skin at a 45° angle, as shown.
• Move your thumb to the white plunger and use your other fingers to hold onto the white finger grip.
• Slowly push down on the white plunger to inject your full dose.

7. Complete your injection

• Make sure the white plunger is pushed all the way down until the stopper reaches the bottom of your syringe and all of the medicine is injected.
• Slowly lift your thumb up. This will allow the white plunger to come up and the needle to automatically retract (pull up) into the body of your syringe.
• After your injection is complete, release the pinched skin.
• There may be a small drop of blood at the injection site. This is normal. Press a cotton ball or gauze on the area and apply an adhesive bandage if you need it.

8. Throw away your used syringe

• Put your used syringe and gray needle cap in an FDA-cleared sharps disposal container right away after use.