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PERSERIS® (risperidone) for extended-release injectable suspension, for subcutaneous use, 90 mg and 120 mg.

INDICATION: PERSERIS is indicated for the treatment of schizophrenia in adults.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS: PERSERIS is contraindicated in patients with a known hypersensitivity to risperidone, its metabolite, paliperidone, or to any of its components. Hypersensitivity reactions, including anaphylactic reactions and angioedema, have been reported in patients treated with risperidone or paliperidone.

Additional Important Safety Information is provided throughout this video transcript.

PERSERIS Instructions for Use Video

Desiree Matthews, Patient Actor, Voiceover

Desiree Matthews:

Today, I get the opportunity to cover a really salient topic for our practices, which is preparation and administration of a long-acting injectable treatment for adults with schizophrenia. My name is Desiree Matthews, and I have worked in community mental health since 2016 as a psychiatric mental health nurse practitioner. Much of that time has been spent working with individuals living with schizophrenia. I am being compensated for my time by Indivior.

Voiceover Talent:

Preparation and Administration Instructions for PERSERIS.PERSERIS is indicated for the treatment of schizophrenia in adults. The PERSERIS prescribing information includes a boxed warning regarding an increased risk of death in elderly patients with dementia-related psychosis who are treated with antipsychotic drugs. Also note that PERSERIS isn’t approved in patients with dementia-related psychosis. PERSERIS is contraindicated when there is a known hypersensitivity to risperidone or its metabolite, paliperidone, or any of the components. Hypersensitivity reactions include anaphylactic reactions and angioedema. Both have been reported with risperidone as well as paliperidone. Please see additional Safety Information and full prescribing information, including BOXED WARNING, accompanying this presentation and at www.PERSERISHCP.com.

Desiree Matthews:

Hello again! Now I would like to demonstrate the appropriate preparation and administration of PERSERIS. We will also show options for appropriate subcutaneous injection sites and provide direction to additional resources for information not covered in this video. Next we will look at key points in the PERSERIS Instructions for Use.

PERSERIS must be administered by a healthcare provider. PERSERIS should be administered only by subcutaneous injection in the abdomen or back of the upper arm. It should not be administered by any other route. Only prepare the medication when you are ready to administer the dose. As a universal precaution, always wear gloves before giving an injection. PERSERIS should be refrigerated at 36 to 46 degrees Fahrenheit. The PERSERIS kit should be brought to room temperature and kept at room temperature for at least 15 minutes before mixing. PERSERIS can remain at room temperature for up to 30 days in its original packaging. After 30 days, it should be discarded appropriately. For complete information on how to administer PERSERIS in the abdomen or back of the upper arm, please refer to Section 2.4, Preparation and Administration Instructions, of the full Prescribing Information, or visit www.PERSERISHCP.com. Now, let’s look at how to prepare PERSERIS for use. I always have my supplies laid out ahead of time, such as my sharps container, gloves, alcohol prep pads, and the medication.

To prepare PERSERIS for use, first ensure that you have one Liquid Syringe prefilled with the delivery system, one Powder Syringe prefilled with risperidone powder, and one sterile 18-gauge, 5/8-inch safety needle. Then inspect the liquid solution for foreign particles. The solution should be colorless to yellow. The syringe containing the liquid solution is the syringe that will be used to administer the injection. Now inspect the Powder Syringe for consistency of powder color and foreign particles. The powder should be white to yellow.

Hold the Powder Syringe upright and tap the barrel of the syringe to dislodge the packed powder. The powder can become packed during shipping.

Remove the cap from the Liquid Syringe. Remove the cap from the Powder Syringe. Holding both syringes in your nondominant hand can help with this step.

Place the Liquid Syringe on top of the Powder Syringe to prevent powder spillage. Connect the syringes by twisting approximately three-quarters of a turn. Do not overtighten as the syringes are being twisted. Keep your fingers off the plungers during this step to avoid spillage of the medication.

For premixing, you will need to transfer the contents of the Liquid Syringe into the Powder Syringe. Gently push the Powder Syringe plunger until you feel resistance, in order to wet the powder and avoid compacting. Pushing the Liquid Syringe plunger then the Powder Syringe plunger completes one cycle. Repeat this gentle back-and-forth process for 5 cycles. Now to do the complete mixing, continue mixing the syringes for an additional 55 cycles, making the complete mixing process 60 full cycles. This mixing can be more vigorous than when premixing. After the mixing is completed, the mixture should be a cloudy suspension that is uniform in color. The color can vary from white to yellow-green in color. If you see any clear areas in the mixture, continue to mix until the distribution of the color is uniform. Failure to fully mix the medication could result in incorrect dosage.

Now, let’s prepare the syringe. First, transfer all contents into the Liquid Syringe. Then, simultaneously maintain slight pressure on the Powder Syringe plunger and pull back gently on the Liquid Syringe plunger while twisting the syringes apart. Finally, attach the safety needle by twisting until finger tight. Check that the medication is uniform in color and free of foreign particles. Failure to aspirate the liquid from the Powder Syringe may result in incorrect dosage.

Hi Hunter, it’s good to see you today. I am going to give you a few minutes to relax before I give your injection. Do you have any questions before we begin?

Patient Actor:

No ma’am.

Desiree Matthews:

A recommendation based on my clinical experience is to always acknowledge a patient’s concern if they ask “will the injection hurt” and don’t minimize their fear of needles or pain. Discuss ways that may help to manage pain.

Now that you have prepared the medication, it’s time to prepare the site of injection. For the purposes of this video, we will review how to give a subcutaneous injection in the back of the upper arm. I work with the patient to determine the best choice of administration, either the back of the upper arm or the abdomen. For information on how to administer PERSERIS in the abdomen, please refer to Section 2.4, Preparation and Administration Instructions, of the full Prescribing Information, or visit www.PERSERISHCP.com. Hunter, would you please stand up? May I touch the back of your arm?

Patient Actor:

Sure.

Desiree Matthews:

Choose an injection site with adequate subcutaneous tissue that is free of skin conditions such as nodules, lesions, and excessive pigment. Do not inject into an area where the skin is irritated, reddened, bruised, infected, or scarred in any way. Clean the injection site well with an alcohol pad. Regardless of whether you choose the back of the upper arm or abdominal administration, to help minimize irritation it is important to rotate the injection sites each dosing cycle following a pattern similar to the illustration. If you want to use the same injection site, make sure it is not the same spot on the injection site that you used the last time. Please see the illustration on screen for all subcutaneous injection site options.

Prior to injection, remove excess air from the syringe by holding the syringe upright for several seconds to allow air bubbles to rise. The medication is viscous so bubbles will not rise as quickly as they would in an aqueous solution. Once bubbles have risen to the top of the medication, remove the needle cover and slowly depress the plunger to push out excess air from the syringe. If medication is seen at the needle tip, pull back slightly on the plunger to prevent medication spillage.

To prepare for injecting the medication, pinch the skin around the injection area. Be sure to pinch enough skin to accommodate the size of the needle. Lift the adipose tissue, or fat, from the underlying muscle to prevent accidental intramuscular injection.

My clinical practice is to ask the patient to do deep breathing or engage them in conversation as a distraction when giving the injection. To inject the medication, insert the needle fully into the back of the upper arm subcutaneous tissue at about a 45- degree angle. The actual angle of injection will depend on the amount of subcutaneous tissue present. Use a slow, steady push to inject the medication and continue pushing until all the medication has been administered. PERSERIS is for subcutaneous administration only. Do not inject by any other route.

After the medication has been administered, withdraw the needle at the same angle used for insertion, and release the pinched skin. Do not rub the injection area after the injection. If there is bleeding, apply a gauze pad or bandage, but use minimal pressure.

Lock the needle back into place by pushing it against a hard surface such as a table then dispose of all syringe components in a secure sharps container.

Hunter, remember, you may have a lump for several weeks that will decrease in size over time. Don’t rub or massage the injection site and be aware of any placements of belts, waistbands, sleeves, cuffs, or other parts of clothing. Thank you for coming in today and if you have any questions or concerns when you get home, please reach out and call the office. We look forward to seeing you back in 4 weeks for your next injection and to discuss your treatment plan. Please remember that PERSERIS should only be given by a healthcare provider or a trained pharmacist certified to give long-acting injectables.

I hope this video demonstration has been helpful to illustrate the steps to prepare and administer PERSERIS. For more information about PERSERIS, see the full Prescribing Information, including BOXED WARNING, or visit www.PERSERISHCP.com.

P-RAG-US-00552 EXPIRY: September 2025