Evrysdi
Pronunciation: ev-RIZ-dee
Generic name: risdiplam
Dosage form: oral solution (0.75 mg/mL after constitution), oral tablet (5 mg)
Drug class: Miscellaneous uncategorized agents
What is Evrysdi?
Evrysdi is used to treat spinal muscular atrophy (SMA) in adults, children, and infants. It is given once a day as an oral solution or tablet.
- Evrysdi tablets, whether swallowed whole or dispersed in water, have bioequivalence to the oral solution at equivalent doses.
Evrysdi first gained FDA approval on August 7, 2020. There is no generic.
FDA approvals and indications
Evrysdi is approved to treat spinal muscular atrophy (SMA) in pediatric and adult patients.
Mechanism
Evrysdi is designed to treat patients with SMA caused by mutations in chromosome 5q that lead to SMN protein deficiency. It works by increasing exon 7 inclusion in SMN2 messenger RNA transcripts and production of full-length SMN protein in the brain. By increasing levels of the SMN protein throughout the brain, spinal cord, and body, Evrysdi helps improve muscle strength and movement in adults, children, and infants with SMA.
Evrysdi belongs to the drug class called survival of motor neuron 2 (SMN2) splicing modifiers.
Side effects
The most common side effects of Evrysdi for later-onset SMA are:
- fever
- diarrhea
- rash.
The most common side effects of Evrysdi for infantile-onset SMA are:
- fever
- diarrhea
- rash
- runny nose, sneezing, sore throat, and cough (upper respiratory infection)
- lung infection
- constipation
- vomiting
- cough.
Evrysdi may harm an unborn baby.
These are not all the possible side effects of Evrysdi. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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Before taking
Before taking Evrysdi, tell your healthcare provider about all of your medical conditions, including if you are:
- Pregnant or planning to become pregnant
- An adult male planning to have children
- Breastfeeding, or planning to breastfeed.
Pregnancy
Evrysdi may harm your unborn baby. If you are a woman who can become pregnant, before you start your treatment with Evrysdi, your healthcare provider may test you for pregnancy. Because this medicine may harm your unborn baby, you and 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.
Pregnancy Registry. There is a pregnancy registry for women who take Evrysdi during pregnancy. The purpose of this registry is to collect information about the health of the pregnant woman and her baby. If you are pregnant or become pregnant while receiving Evrysdi, tell your healthcare provider right away. Talk to your healthcare provider about registering with the Evrysdi Pregnancy Registry. Your healthcare provider can enroll you in this registry, or you can enroll by calling 1-833-760-1098 or visiting https://www.evrysdipregnancyregistry.com.
Adult males 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.
Breastfeeding
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.
How is Evrysdi administered?
Your healthcare provider will prescribe either Evrysdi for oral solution or Evrysdi tablets.
- Your healthcare provider will tell you how long you or your child needs to take Evrysdi.
- Do not stop treatment with Evrysdi unless your healthcare provider tells you to.
Take Evrysdi exactly as your healthcare provider tells you to take it. Do not change the dose without talking to your healthcare provider.
- Avoid getting Evrysdi on your skin or in your eyes. If it gets on your skin, wash the area with soap and water. If it gets in your eyes, rinse your eyes with water.
Evrysdi oral solution:
If you are taking Evrysdi for oral solution, see the detailed Instructions for Use that comes with it for information on how to take or give Evrysdi for oral solution.
- Take Evrysdi one time daily with or without a meal at about the same time each day.
- Drink water afterwards to make sure Evrysdi has been completely swallowed.
- 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 or other healthcare provider. If the medicine in the bottle is a powder, do not use it. Contact your pharmacist for a replacement.
- In infants who are breastfed, Evrysdi can be given before or after breastfeeding.
- Do not mix Evrysdi with formula or milk.
- If you are unable to swallow and have a nasogastric (NG-tube) or gastrostomy tube (G-tube), Evrysdi for oral solution can be given through the tube.
Reusable Oral Syringes for Evrysdi for Oral Solution
Your pharmacist will provide you with the reusable oral syringes that are needed for taking your Evrysdi for Oral Solution and explain how to use them. You should receive 1 or 2 identical oral syringes, depending on your prescribed daily dose.
- From the bottle, draw up (measure) the dose of Evrysdi with these syringes, as they are made to protect the medicine from light.
- Take Evrysdi right away after it has been drawn into the syringe. Do not store the Evrysdi solution in the syringe. If Evrysdi is not taken within 5 minutes of when it is drawn up, throw away the solution by pressing the plunger and prepare a new dose with the same syringe.
- Do not throw the syringes away because they are reusable.
- Wash the syringes per instructions after use.
- Contact your healthcare provider or pharmacist if your oral syringes are lost or damaged.
Evrysdi Tablets:
Take Evrysdi one time daily with or without a meal at about the same time each day.
- Do not chew, cut, or crush the tablet.
- Swallow the Evrysdi tablet whole with some water.
Or
- You can take an Evrysdi tablet by mouth after it is mixed with a teaspoon (5 mL) of room temperature non-chlorinated drinking water (such as filtered water). See the instructions below for taking Evrysdi this way.
Evrysdi Tablets Mixed with Non-chlorinated Drinking Water (such as Filtered Water)
Wash your hands before and after preparing or taking Evrysdi tablets.
- Put Evrysdi tablets in a small cup with a teaspoon (5 mL) of room temperature non-chlorinated drinking water (such as filtered water).
- Do not mix Evrysdi tablets with any liquids other than non-chlorinated drinking water.
- Do not expose the Evrysdi tablet mixture to sunlight.
- Swirl the cup gently until the tablet and non-chlorinated drinking water are fully mixed (though some particles may remain). This may take up to 3 minutes.
- Take the Evrysdi tablet mixture right away after mixing with non-chlorinated drinking water. If you do not take it within 10 minutes of adding non-chlorinated drinking water, throw the mixture away, and make a new dose.
- After taking Evrysdi tablet mixture, to make sure there is no medicine left, refill the small cup with at least a tablespoon (15 mL) of non-chlorinated drinking water, swirl, and take right away.
If the Evrysdi tablet mixture is spilled, use a dry paper towel to dry the area and then clean with soap and water. Throw the paper towel away in the trash and wash your hands with soap and water.
Do not give the Evrysdi tablet mixture via a nasogastric (NG-tube) or gastrostomy tube (G-tube).
What happens if I miss a dose?
If you miss a dose of Evrysdi:
- If you remember the missed dose within 6 hours of when you normally take Evrysdi, then take the dose. Continue taking Evrysdi at your usual time the next day
- If you remember the missed dose more than 6 hours after you normally take Evrysdi, skip the missed dose. Take your next dose at your usual time the next day
If you do not fully swallow the dose, or you vomit after taking a dose, do not take another dose to make up for that dose. Wait until the next day to take the next dose at your usual time.
Dosing information
Infants and children:
For infants and children, your healthcare provider will determine the daily dose of Evrysdi needed based on your child’s age and weight.
Age and Body Weight | Recommended Daily Dosage | Dosage Form |
---|---|---|
Less than 2 months | 0.15 mg/kg | Evrysdi for oral solution |
2 months to less than 2 years | 0.2 mg/kg | |
2 years and older weighing less than 20 kg | 0.25 mg/kg | |
2 years and older weighing 20 kg or more | 5 mg | Evrysdi for oral solution or Evrysdi tablets |
Adults:
- Evrysdi 5 mg once daily.
Storage
Evrysdi oral solution:
Store Evrysdi in the refrigerator between 36°F to 46°F (2°C to 8°C). Do not freeze.
- If necessary, Evrysdi can be kept at room temperature up to 104°F (up to 40°C) for a combined total of 5 days.
- Evrysdi can be removed from and returned to a refrigerator. The total combined time out of refrigeration should not be more than 5 days.
- Keep Evrysdi in an upright position in the original amber bottle to protect it from light.
Throw away (discard) any unused portion of Evrysdi 64 days after it is mixed by the pharmacist or if it has been kept at room temperature (below 104°F [40˚C]) for more than a total combined time of 5 days.
Discard Evrysdi if it has been kept above 104˚F (40˚C).
Please see the Discard After date written on the bottle label. (See the Instructions for Use that comes with Evrysdi for oral solution).
Keep out of the reach of children.
Evrysdi oral tablets:
Store at room temperature. Keep the bottle tightly closed to protect the tablets from moisture.
Keep out of the reach of children.
What other drugs will affect this medicine?
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.
Ingredients
Active ingredient: risdiplam
Inactive ingredients (Evrysdi oral solution): ascorbic acid, disodium edetate dihydrate, isomalt, mannitol, polyethylene glycol 6000, sodium benzoate, strawberry flavor, sucralose, and tartaric acid.
Inactive ingredients (Evrysdi oral tablets): colloidal silicon dioxide, crospovidone, mannitol, microcrystalline cellulose, polyethylene glycol 3350, polyvinyl alcohol, sodium stearyl fumarate, strawberry flavor, talc, tartaric acid, titanium dioxide, and yellow iron oxide.
Manufacturer
Evrysdi (risdiplam) is manufactured by Genentech, Inc., a member of the Roche Group, based in South San Francisco, CA.
Popular FAQ
Evrysdi vs Spinraza: How do they compare?
Evrysdi (risdiplam) and Spinraza (nusinersen) work in different ways to increase the level of functional SMN (survival of motor neuron) protein in people with spinal muscular atrophy (SMA). A key difference between the two drugs is that Evrysdi is taken orally, whereas Spinraza needs to be given via intrathecal injection. Continue reading
How does Evrysdi work for SMA?
Evrysdi (risdiplam) works by targeting the SMN2 gene (survival motor neuron gene 2), causing it to make more functional SMN protein. This increases SMN protein levels throughout the central nervous system and body, helping to improve motor nerve and muscle function in children and adults with SMA. Continue reading
How effective is Evrysdi?
Several major trials have reported that Evrysdi significantly improves survival motor neuron (SMN) protein levels in newborns, children, and adults with SMA, allowing an increase in muscle strength and the achievement of milestones, such as being able to sit independently for 5 or more seconds at a time. Continue reading
Does Evrysdi cure spinal muscular atrophy (SMA)?
Evrysdi does not cure spinal muscular atrophy (SMA), it just replaces a protein that is low or missing in children or adults with the condition, improving muscle strength and allowing some relief from some of the symptoms of SMA. Evrysdi must be taken for a person’s lifetime; if Evrysdi is stopped the newborn, child, or adult’s SMA symptoms will progressively worsen at a faster rate. Continue reading
How is Evrysdi administered?
Evrysdi (risdiplam) is available as an oral tablet or an oral solution that is administered via an oral syringe. The oral solution can be given orally or via a gastrostomy or nasogastric tube. Continue reading
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