Treatment your patients can take from home

Treatment your patients can take from home

Evrysdi®️ (risdiplam) patients with caretakers

Optimized dosing based on safety and efficacy across SMA types studied1

The recommended dose is based on patient age and weight

Use this table to determine the recommended once-daily dose (in mg) for each patient

Age Weight Recommended once-daily dose
<2 months 0.15 mg/kg × weight (kg)
2 months
to <2 years
0.2 mg/kg × weight (kg)
≥2 years <20 kg 0.25 mg/kg × weight (kg)
≥20 kg 5 mg
  • Modify dose to reflect changes in the weight of children <2 years of age or in individuals <20kg
  • The maximum recommended dose of Evrysdi is 5 mg once daily

Since Evrysdi is administered as a solution, the calculated recommended daily dose needs to be converted from mg to a dosing volume in mL. Using the concentration of the 0.75 mg/mL constituted solution, the calculation would be:

Recommended daily dose (mg) ÷ 0.75 mg/mL = dosing volume (mL)

  • Evrysdi powder must be constituted to the oral solution by a pharmacist or other healthcare provider prior to dispensing
  • The specialty pharmacy will provide the patient with 1 or 2 reusable oral syringe(s)
    • They will select the appropriate oral syringe (1 mL, 6 mL, or 12 mL) based on the patient’s dose
    • They will remove the other oral syringes from the carton
  • Dose changes must be made under the supervision of the physician

Before prescribing, review the dosing and administration instructions for Evrysdi with your patients or their caregiver

Types 1, 2, 3, and presymptomatic SMA.

Instruct your patients to:

Patients should take Evrysdi®️ (risdiplam) at the same time each day

Take their medication at approximately the same time each day after a meal or breastfeeding

  • Evrysdi cannot be mixed with formula or milk
  • Evrysdi must be taken within 5 minutes of when it is drawn up into the syringe; otherwise it should be discarded and a new dose should be prepared
  • If a planned dose is missed and 6 hours or less have passed, Evrysdi should be taken as soon as possible, and the regular dosing schedule should be resumed on the next day. If 6 hours or more have passed, the missed dose should be skipped, and the regular dosing schedule should be resumed on the next day
Patients should drink water after taking Evrysdi®️ (risdiplam)

Drink water after administration to ensure the drug has been completely swallowed

  • If the patient is unable to swallow and has a nasogastric or gastrostomy tube, Evrysdi can be administered via the tube. The tube should be flushed with water after delivering Evrysdi
  • If a dose is not fully swallowed or vomiting occurs after administration, another dose should not be taken to make up for the lost dose; the next dose should be taken the following day at the regularly scheduled time
Instructions for use on how to take or administer Evrysdi®️ (risdiplam)

Please refer your patients or their caregivers to the Instructions for Use for complete information on how to take or administer Evrysdi.

93% of patients taking Evrysdi remain adherent to treatment at 1 year32*†

93% of patients taking Evrysdi remain adherent to treatment at 1 year32*†

*Adherence was calculated using US specialty pharmacy data for patients initiating Evrysdi between August 2020 and September 2022 using proportion of days covered (PDC) and a variable interval analysis. These data cannot confirm whether the medication was taken as prescribed.
Evrysdi dispensed via the Genentech Patient Foundation or other third parties is not captured, which may underestimate adherence estimates.

Evrysdi®️ (risdiplam) dosing guide for information on how to dose and store

Dosing guide

Find helpful information on how to dose and store Evrysdi

Important Safety Information and Indication

Indication

Evrysdi is indicated for the treatment of spinal muscular atrophy (SMA) in pediatric and adult patients.

 

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 & Breastfeeding

  • Evrysdi may cause embryofetal harm when administered to a pregnant woman. In animal studies, administration of Evrysdi during pregnancy and/or lactation resulted in adverse effects on development. Advise pregnant women of the potential risk to the fetus
  • Pregnancy testing is recommended prior to initiating Evrysdi. Advise female patients to use contraception during treatment with Evrysdi and for at least 1 month after the last dose
  • There is a pregnancy exposure registry that monitors pregnancy and fetal/neonatal/infant outcomes in women exposed to Evrysdi during pregnancy. Physicians are encouraged to register patients and pregnant women are encouraged to register themselves by calling 1-833-760-1098 or visiting www.evrysdipregnancyregistry.com
  • 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

  • Counsel male patients that fertility may be compromised by treatment with Evrysdi. 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 (including nasopharyngitis, rhinitis), lower respiratory tract infection (including pneumonia, bronchitis), constipation, vomiting, and cough
  • The safety profile for presymptomatic patients is consistent with the safety profile for symptomatic SMA patients treated with Evrysdi in clinical trials

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.

    • Data on file. Genentech USA, Inc.

      Data on file. Genentech USA, Inc.

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