INSTRUCTIONS FOR USE

ZTALMY® (zuh-tal' mee)
(ganaxolone)
oral suspension, CV
50 mg/mL

Be sure that you read, understand, and follow these instructions carefully to ensure proper dosing of the oral suspension.

Important:

Follow your healthcare provider's instructions for how to take or give ZTALMY.
ZTALMY should always be given with food.
Ask your healthcare provider or pharmacist if you are not sure how to prepare, take, or give the prescribed dose of ZTALMY.
Always use the oral syringe provided by your pharmacist to make sure you measure the right amount of ZTALMY.
Do not use ZTALMY after the expiration date on the package and each bottle.
Use ZTALMY within 30 days of first opening the bottle.
After 30 days of first opening the bottle, safely throw away (dispose of) any ZTALMY that has not been used.

Each package contains:

1 bottle of ZTALMY with a child resistant cap:

Supplies not included in the package:

press-in bottle adapter
oral syringe

You can get a press-in bottle adapter and oral syringes from your pharmacy. Your pharmacist can help you choose the right press-in bottle adapter and oral syringe to use with ZTALMY.

Call your pharmacist right away if you do not have a press-in bottle adapter and the right sized oral syringe to use with your medicine.

Note: If you lose or damage an oral syringe, or cannot read the markings, contact your pharmacist for a new oral syringe.

Follow the instructions below to use the press-in bottle adapter and oral syringe to measure and take or give ZTALMY.

Prepare the bottle

1. Hold the bottle in your hand and shake it up and down well for 1 minute. Always shake the bottle well for 1 minute then let the bottle stand for 1 minute so that any foam build up during shaking can settle before measuring and giving each dose of ZTALMY. This helps you measure the correct amount of medicine. Note: This step is for each dose of the medicine.
2. Remove the child-resistant cap by pushing down while turning the cap to the left (counter-clockwise).
3. Puncture and peel off the induction seal from the bottle. Note: This step is only for the first use of the bottle.
4. Push the press-in-bottle adapter firmly into the bottle. Firmly grasp the bottle in one hand and insert the press-in bottle adapter all the way in the bottle with the other hand using constant pressure. Make sure the press-in bottle adaptor is fully inserted. If not fully inserted, small parts such as the press-in bottle adaptor may become a choking hazard for children and pets. Note: Do not remove the press-in bottle adapter from the bottle after it is inserted.

Prepare the dose

Your healthcare provider will tell you how much ZTALMY to take or give.

5. Gather the oral syringe, push the plunger all the way down then insert the tip of the oral syringe fully into the press-in bottle adapter. With the oral syringe in place, turn the bottle upside down.
6. Slowly pull the plunger of the oral syringe to withdraw the dose of ZTALMY needed. Line up the end of the plunger with the marking for your dose of ZTALMY. What to do if you see air bubbles: If there are air bubbles in the oral syringe, keep the bottle upside down and slowly push the plunger so that all of the liquid flows back into the bottle. Repeat step 6 until air bubbles are gone.
7. When you have measured the correct amount of ZTALMY, leave the oral syringe in the press-in bottle adapter and turn the bottle right side up.
8. Carefully remove the oral syringe from the press-in bottle adapter.

Take or give ZTALMY

9. Place the tip of the oral syringe against the inside of the cheek and gently push the plunger until all of the ZTALMY in the oral syringe is taken or given. Do not forcefully push the plunger. Do not direct the medicine to the back of the mouth or throat. This may cause choking.
10. Screw the child-resistant cap back on the bottle tightly by turning the cap to the right (clockwise). Do not remove the press-in bottle adapter. The child-resistant cap will fit over it.

How should I store ZTALMY?

Store ZTALMY at 68°F to 77°F (20°C to 25°C).
Always store ZTALMY in its original bottle in an upright position.
Keep the child-resistant cap tightly closed.
Use within 30 days of first opening the bottle. Throw away (dispose of) any unused medicine after 30 days.

Keep ZTALMY and all medicines out of the reach of children.

Helpline Details

For additional assistance, call the toll-free helpline at 844-MARINUS (844-627-4687). Hours: Monday - Friday 8:00 am to 6:00 pm EST

Frequently asked Questions:

Q:	What if there are air bubbles in the oral syringe?
A:	Slowly push the liquid back into the bottle and repeat step 6 until the air bubbles are gone.

Marketed by Marinus Pharmaceuticals, Inc. 5 Radnor Corporate Center, 100 Matsonford Rd., Suite 500, Radnor, PA 19087 USA
For more information, go to www.ZTALMY.com or call 484-801-4670.
© 2022 Marinus Pharmaceuticals, Inc. All rights reserved.
ZTALMY is a registered trademark of Marinus Pharmaceuticals, Inc.

This Instructions for Use has been approved by the U.S. Food and Drug Administration.

Issued: 11/2022