What Evrysdi Is and What It Is Used For

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  Active ingredient: Risdiplam

  
  


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  Indication: Prescription medicine used to treat Spinal Muscular Atrophy (SMA) in children and adults

  
  

 What You Need to Know Before Taking Evrysdi

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  Pregnancy warning: May harm the unborn baby; pregnancy test may be needed before treatment

  
  


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  Fertility: May affect male fertility

  
  


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  Breastfeeding: It is unknown if Evrysdi passes into breast milk; consult your doctor

  
  


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  Other medications: Inform your doctor of all medications, including OTC and supplements

  
  

Contraception:

• Use effective birth control during treatment and for at least 1 month after stopping


• Men with partners of childbearing potential should consult about fertility risks


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  Driving/machinery: Unlikely to affect ability to drive or operate machinery

  
  

How Evrysdi Is Given

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  Form: Oral liquid (prepared from powder by a pharmacist); do not use if powder is not mixed

  
  

Administration:

• Once daily after a meal or breastfeeding at the same time each day


• Do not mix with milk or formula


• Can be given orally or via feeding tube


• Drink water after taking to ensure full ingestion

Dosage:

• Determined by age and weight for children


• Adults typically take 5 mg once daily

Missed dose:

• Within 6 hours: Take the missed dose


• After 6 hours: Skip dose, take the next as scheduled


• Vomited dose: Do not retake, wait until next day

Reusable oral syringes:

• Provided by pharmacist


• Designed to protect medicine from light


• Wash after use, do not discard


• Use dose within 5 minutes after drawing into syringe

Possible Side Effects

Common Side Effects (Later-onset SMA):

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  Fever

  
  


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  Diarrhea

  
  


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  Rash

  
  

Common Side Effects (Infantile-onset SMA):

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  Fever

  
  


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  Diarrhea

  
  


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  Rash

  
  


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  Upper respiratory infection (runny nose, sore throat)

  
  


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  Lower respiratory infection (lung infection)

  
  


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  Constipation

  
  


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  Vomiting

  
  


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  Cough

  
  

Not all side effects are listed; report any unexpected reactions to your healthcare provider.

 How to Store Evrysdi

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  Refrigeration required: Store at 2°C to 8°C (36°F to 46°F)

  
  


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  Do not freeze

  
  


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  Keep in original amber bottle, upright, to protect from light

  
  


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  Discard after 64 days from constitution or if out of fridge for more than 5 cumulative days

  
  


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  If exposed to >40°C (104°F), discard immediately

  
  


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  Keep out of reach of children

  
  


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  Ask pharmacist how to safely dispose of unused medicine

  
  

 Contents of the Pack

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  Active substance: Risdiplam 0.75 mg/mL

  
  


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  Excipients: Ascorbic acid, sodium benzoate, isomalt, mannitol, tartaric acid, and others

  
  

Kit includes:

• 1 bottle (with 60 mg risdiplam in 2.0 g powder for oral solution)


• 1 press-in bottle adapter


• 2 x 1 mL oral syringes


• 2 x 6 mL oral syringes


• 2 x 12 mL oral syringes