For Patients and Caregivers

Evrysdi is

Proven to make a difference in infants, children, and adults with SMA1


In patients 2 months and older

Learn about efficacy in infantile-onset SMA

Learn about efficacy in later-onset SMA

Evrysdi is

Proven to make a difference in infants, children, and adults with SMA1


In patients 2 months and older

Learn about efficacy in infantile-onset SMA

Learn about efficacy in later-onset SMA

Evrysdi®️ (risdiplam) patients
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Indication

Evrysdi® (risdiplam) is indicated for the treatment of spinal muscular atrophy (SMA) in patients 2 months of age and older.

Interactions with Substrates of MATE Transporters

  • Based on in vitro data, Evrysdi may increase plasma concentrations of drugs eliminated via MATE1 or MATE2-K, such as metformin
  • Avoid coadministration of Evrysdi with MATE (multidrug and toxin extrusion) substrates. If coadministration cannot be avoided, monitor for drug-related toxicities and consider dosage reduction of the coadministered drug if needed

Pregnancy

  • Evrysdi may cause embryofetal harm when administered to a pregnant woman. In animal studies, administration of Evrysdi during pregnancy or throughout pregnancy and lactation resulted in adverse effects on development
  • Based on animal data, advise pregnant women of the potential risk to the fetus. Pregnancy testing is recommended for females of reproductive potential prior to initiating Evrysdi. Advise female patients of reproductive potential to use effective contraception during treatment with Evrysdi and for at least 1 month after the last dose

Breastfeeding

  • There is no data on the presence of Evrysdi in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Evrysdi and any potential adverse effects on the breastfed infant

Potential Effects on Male Fertility

  • Male fertility may be compromised by treatment with Evrysdi. Counsel male patients on the potential effects on fertility. Male patients may consider sperm preservation prior to treatment

Most Common Adverse Reactions

  • The most common adverse reactions in later-onset SMA (incidence in at least 10% of patients treated with Evrysdi and more frequent than control) were fever, diarrhea, and rash
  • The most common adverse reactions in infantile-onset SMA were similar to those observed in later-onset SMA patients. Additionally, adverse reactions with an incidence of at least 10% were upper respiratory tract infection, pneumonia, constipation, and vomiting

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.

 

 

    • Evrysdi® (risdiplam) Prescribing Information. Genentech, Inc.

      Evrysdi® (risdiplam) Prescribing Information. Genentech, Inc.

    • Hamilton G, Gillingwater TH. Spinal muscular atrophy: going beyond the motor neuron. Trends Mol Med. 2013;19(1):40-50.

      Hamilton G, Gillingwater TH. Spinal muscular atrophy: going beyond the motor neuron. Trends Mol Med. 2013;19(1):40-50.

    • Park G-H, Maeno-Hikichi Y, Awano T, et al. Reduced survival of motor neuron (SMN) protein in motor neuronal progenitors functions cell autonomously to cause spinal muscular atrophy in model mice expressing the human centromeric (SMN2) gene. J. Neurosci. 2010;30(36):12005-12019.

      Park G-H, Maeno-Hikichi Y, Awano T, et al. Reduced survival of motor neuron (SMN) protein in motor neuronal progenitors functions cell autonomously to cause spinal muscular atrophy in model mice expressing the human centromeric (SMN2) gene. J. Neurosci. 2010;30(36):12005-12019.

    • Cruz R, Lenz M, Belter L, et al. The Voice of the Patient Report for Spinal Muscular Atrophy. Cure SMA website. Published January 10, 2018. https://curesma.wpengine.com/wp-content/uploads/2018/01/SMA-VoP-for-publication-1-22-2018.pdf. Accessed April 13, 2020.

      Cruz R, Lenz M, Belter L, et al. The Voice of the Patient Report for Spinal Muscular Atrophy. Cure SMA website. Published January 10, 2018. https://curesma.wpengine.com/wp-content/uploads/2018/01/SMA-VoP-for-publication-1-22-2018.pdf. Accessed April 13, 2020.

    • Farrar MA, Park SB, Vucic S, et al. Emerging therapies and challenges in spinal muscular atrophy. Ann Neurol. 2017;81:355-368.

      Farrar MA, Park SB, Vucic S, et al. Emerging therapies and challenges in spinal muscular atrophy. Ann Neurol. 2017;81:355-368.

    • A study of risdiplam (Ro7034067) in adult and pediatric participants with spinal muscular atrophy (Jewelfish). ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03032172. Accessed April 13, 2020.

      A study of risdiplam (Ro7034067) in adult and pediatric participants with spinal muscular atrophy (Jewelfish). ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03032172. Accessed April 13, 2020.

    • Chiriboga CA, Bruno C, Duong T, et al. JEWELFISH: safety and pharmacodynamic data in non-naïve patients with spinal muscular atrophy receiving treatment with risdiplam. Presentation at: 2020 Virtual SMA Conference; June 8-12, 2020; Virtual.

      Chiriboga CA, Bruno C, Duong T, et al. JEWELFISH: safety and pharmacodynamic data in non-naïve patients with spinal muscular atrophy receiving treatment with risdiplam. Presentation at: 2020 Virtual SMA Conference; June 8-12, 2020; Virtual.

    • Data on file. Genentech, Inc.

      Data on file. Genentech, Inc.

    • Day JW, Annoussamy M, Baranello G, et al. SUNFISH part 1: 24-month safety and exploratory outcomes of risdiplam (RG7916) treatment in patients with Type 2 or 3 spinal muscular atrophy (SMA). Presentation at: 2020 Virtual SMA Conference; June 8-12, 2020; Virtual.

      Day JW, Annoussamy M, Baranello G, et al. SUNFISH part 1: 24-month safety and exploratory outcomes of risdiplam (RG7916) treatment in patients with Type 2 or 3 spinal muscular atrophy (SMA). Presentation at: 2020 Virtual SMA Conference; June 8-12, 2020; Virtual.

    • Bérard C, Payan C, Hodgkinson I, et al, and the MFM Collaborative Study Group. A motor function measure scale for neuromuscular diseases. Construction and validation study. Neuromuscul Disord. 2005;15:463-470.

      Bérard C, Payan C, Hodgkinson I, et al, and the MFM Collaborative Study Group. A motor function measure scale for neuromuscular diseases. Construction and validation study. Neuromuscul Disord. 2005;15:463-470.

    • Trundell D, Le Scouiller S, Servaid L, et al. Using Rasch analysis to estimate thresholds associated with gain/loss of daily function on the Motor Function Measure (MFM). Poster presented at: 23rd International SMA Research Meeting; June 28-July 1, 2019; Anaheim, CA.

      Trundell D, Le Scouiller S, Servaid L, et al. Using Rasch analysis to estimate thresholds associated with gain/loss of daily function on the Motor Function Measure (MFM). Poster presented at: 23rd International SMA Research Meeting; June 28-July 1, 2019; Anaheim, CA.

    • Mazzone ES, Mayhew A, Montes J, et al. Revised upper limb module for spinal muscular atrophy: development of a new module. Muscle Nerve. 2017;55:869-874.

      Mazzone ES, Mayhew A, Montes J, et al. Revised upper limb module for spinal muscular atrophy: development of a new module. Muscle Nerve. 2017;55:869-874.

    • Darras BT, Baranello G, Boespflug-Tanguy O, et al. FIREFISH Part 1: 24-month safety and exploratory outcomes of risdiplam in infants with Type 1 spinal muscular atrophy (SMA). Presentation at: 2021 Virtual MDA Conference; March 15-18, 2021; Virtual.

      Darras BT, Baranello G, Boespflug-Tanguy O, et al. FIREFISH Part 1: 24-month safety and exploratory outcomes of risdiplam in infants with Type 1 spinal muscular atrophy (SMA). Presentation at: 2021 Virtual MDA Conference; March 15-18, 2021; Virtual.

    • Oskoui M, Day JW, Deconinck N, et al. SUNFISH Part 2: 24-month efficacy and safety of risdiplam in patients with Type 2 or non-ambulant Type 3 spinal muscular atrophy (SMA). Presentation at: 2021 Virtual MDA Conference; March 15-18, 2021; Virtual.

      Oskoui M, Day JW, Deconinck N, et al. SUNFISH Part 2: 24-month efficacy and safety of risdiplam in patients with Type 2 or non-ambulant Type 3 spinal muscular atrophy (SMA). Presentation at: 2021 Virtual MDA Conference; March 15-18, 2021; Virtual.