Important Safety Information
Before taking Evrysdi, tell your doctor if you are pregnant or plan to become pregnant, or are breastfeeding or plan to breastfeed. Evrysdi may harm an unborn or breastfed baby. Evrysdi may affect a man’s ability to have children (fertility). Tell your doctor about all the medicines you take.
These are not all the possible side effects of Evrysdi. Please refer to additional Important Safety Information at the end of this video.
Before preparing your first dose, please be sure to familiarize yourself with the Patient Information and Instructions for Use that come with your prescription.
Hi! I’m Susan and today I’ll be your guide as we review getting, preparing, and taking Evrysdi, or risdiplam. Together, we’ll learn about the first and only medication for the treatment of spinal muscular atrophy, or SMA, that can be taken at home.
First, the basics: Evrysdi is a liquid medication that’s taken once a day by mouth or through a feeding tube, after a meal. Evrysdi should always be taken at the same time each day, so schedule a regular dosing time that fits into your daily routine.
Now, we’re ready to learn about getting and storing Evrysdi. After your healthcare provider prescribes Evrysdi, a specialty pharmacy, will make sure the medication is delivered right to your door. Each month, you’ll receive a package containing everything you need to administer Evrysdi for the next 30 days.
Each package will contain 2 reusable oral syringes and up to 3 amber-colored bottles of medication with bottle adapters and caps, depending on the dose of Evrysdi chosen by your healthcare provider. Make sure the medication you receive is a liquid, and do not use it if it is a powder. If you do receive the medication as a powder, or if the package is damaged, call your specialty pharmacy.
Regardless of the amount of Evrysdi you receive, store the glass bottles of medication upright in a refrigerator. And don’t forget to check the expiration date on the bottle before using it. Evrysdi is good for 64 days after it has been prepared for you by a pharmacist. If you don’t see a Discard After date on the bottle label, call your specialty pharmacy immediately. When you’re not using the medication, always return bottles to the refrigerator, upright and with the cap closed tightly. Never freeze Evrysdi, and always keep it out of the reach of children.
Now, let’s talk about preparing a dose of Evrysdi. To start, find the syringes that came with your shipment. Always take or give the dose exactly as prescribed by your healthcare provider, do not take a partial dose, even if that is all you have left in a bottle, and only use the oral syringes that come with your prescription.
Take off the child-safety cap by pushing it down and twisting to the left. Place the cap to the side for now. Then, set the bottle of Evrysdi upright on a flat surface, like a table or countertop.
Push the syringe plunger all the way down to remove any air inside, then insert the syringe tip into the bottle adapter.
Next, carefully turn the bottle upside down, making sure the syringe tip is still firmly inserted. Using the plunger, slowly withdraw medication into the syringe until the black stopper lines up with the correct milliliter line. After the correct dose is withdrawn, hold the plunger in place to keep it from moving.
Then, leave the syringe in the bottle as you turn it upright again. Place the bottle back on a flat surface and remove the syringe filled with medication, always keeping the tip of the syringe pointing up while the medication is in it and holding the plunger in place.
Check to make sure the medication in the filled syringe doesn’t contain any air bubbles. If you see them, especially larger ones, start from the beginning. You will have to put the syringe tip firmly back into the bottle adapter while the bottle is in an upright position and use the plunger to push the medication back inside.
It’s important to note that Evrysdi needs to be taken no more than 5 minutes after the dose has been drawn into the syringe. Otherwise, you’ll need to empty the syringe, discarding the unused medication in the household trash, and prepare it from the beginning again. Now, I’ll show you how oral administration with Evrysdi works.
Once you’re ready, insert the syringe filled with Evrysdi into the mouth, place the tip against either cheek, then slowly push down on the plunger until the syringe is empty. Check to make sure there is no Evrysdi left inside.
To prevent choking during dosing, the person taking Evrysdi should be sitting in an upright position. Also make sure the medication is administered slowly, and toward the front of the mouth.
Evrysdi has a strawberry flavor, but it’s not made with real strawberries. Do not mix it directly with any food, liquids, formula, or milk, and it should only be taken with the approved syringe.
Drink about 1 tablespoon of water afterwards to help ensure that the full dose has been swallowed. When you’re done, remember to screw the cap back onto the bottle and put it back in the refrigerator.
Evrysdi can also be taken via G-tube, also known as a gastrostomy tube, or through an NG-tube, also known as a nasogastric tube. To take Evrysdi by G- or NG-tube, simply place the syringe into the tube, then slowly push the plunger all the way down until the syringe is empty. Check to make sure there is no Evrysdi left inside. Then, flush the tube following the manufacturer’s direction with 10 to 20 milliliters of water or about 2 to 4 teaspoons. When you’re done, remember to screw the cap back onto the bottle and put it back in the refrigerator.
No matter how Evrysdi is taken, the oral syringe can be reused. Separate the barrel and plunger by pulling the plunger away from the syringe tip until it comes out of the syringe completely before rinsing both pieces well by hand under clean water. Then, let them dry on a clean, safe surface, and wash your hands with soap and water.
Put the plunger back into the oral syringe barrel, reassemble the syringe when both pieces are dry and store the syringe with your medicine. You will get new oral syringes with each shipment of Evrysdi.
Avoid getting Evrysdi on your skin. If Evrysdi gets on your skin, wash the area with soap and water.
If you spill Evrysdi, dry the area with a dry paper towel and then clean with water. Throw away the paper towel in the trash and wash your hands well with soap and water. You do not need to wear gloves.
Whether you’re someone taking Evrysdi by G- or NG-tube, or orally, I hope you find this information helpful when starting Evrysdi.
If you’d like a Genentech representative to go over this information with you, contact your Partnership and Access Liaison, or PAL, or call your specialty pharmacy. If you need medical advice, always contact your healthcare provider.
What is Evrysdi?
Evrysdi is a prescription medicine used to treat spinal muscular atrophy (SMA) in adults and children.
It is not known if Evrysdi is safe in children under 2 months of age.
Important Safety Information
Before taking Evrysdi, tell your healthcare provider about all of your medical conditions, including if you:
are pregnant or plan to become pregnant. If you are pregnant, or are planning to become pregnant, ask your healthcare provider for advice before taking this medicine. Evrysdi may harm your unborn baby.
are a woman who can become pregnant:
Before you start your treatment with Evrysdi, your healthcare provider may test you for pregnancy. Because Evrysdi may harm your unborn baby, your healthcare provider will decide if taking Evrysdi is right for you during this time
Talk to your healthcare provider about birth control methods that may be right for you. Use birth control while on treatment and for at least 1 month after stopping Evrysdi
are an adult male planning to have children: Evrysdi may affect a man’s ability to have children (fertility). If this is of concern to you, make sure to ask a healthcare provider for advice
are breastfeeding or plan to breastfeed. It is not known if Evrysdi passes into breast milk and may harm your baby. If you plan to breastfeed, discuss with your healthcare provider about the best way to feed your baby while on treatment with Evrysdi
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine
You should receive Evrysdi from the pharmacy as a liquid that can be given by mouth or through a feeding tube. The liquid solution is prepared by your pharmacist. If the medicine in the bottle is a powder, do not use it. Contact your pharmacist for a replacement
Avoid getting Evrysdi on your skin or in your eyes. If Evrysdi gets on your skin, wash the area with soap and water. If Evrysdi gets in your eyes, rinse your eyes with water
The most common side effects of Evrysdi include:
For infantile-onset SMA:
These are not all of the possible side effects of Evrysdi. For more information on the risk and benefits profile of Evrysdi, ask your healthcare provider or pharmacist.
You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at 1-888-835-2555.
Please see full Prescribing Information for additional Important Safety Information.