EVRYSDI .75 mg/mL
Risdiplam · POWDER, FOR SOLUTION · Genentech, Inc.
EVRYSDI is a powder, for solution containing risdiplam at .75 mg/mL, taken oral. Manufactured by Genentech, Inc..
Key Facts
- Brand Name
- EVRYSDI
- Generic Name
- Risdiplam
- NDC Code (Product)
50242-175- Manufacturer
- Genentech, Inc.
- Strength
- .75 mg/mL
- Dosage Form
- POWDER, FOR SOLUTION
- Route
- ORAL
- Marketing Status
- Application #
- NDA213535
- Drug Class
- Survival of Motor Neuron 2 Splicing Modifier [EPC]
- Marketing Start
- 08/07/2020
Recall History
Genentech Inc
Defective Container: complaints received regarding some incorrect press-in-bottle-adapters (PIBA), the incorrect PIBAs have a female instead of male fit so they cannot be used in combination with co-packed syringes.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE EVRYSDI is indicated for the treatment of spinal muscular atrophy (SMA) in pediatric and adult patients. EVRYSDI is a survival of motor neuron 2 (SMN2) splicing modifier indicated for the treatment of spinal muscular atrophy (SMA) in pediatric and adult patients. ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Administer once daily with or without food per the table below ( 2.1 ): Age and Body Weight Recommended Daily Dosage Dosage Form Less than 2 months of age 0.15 mg/kg EVRYSDI for Oral Solution 2 months to less than 2 years of age 0.2 mg/kg 2 years of age and older weighing less than 20 kg 0.25 mg/kg 2 years of age and older weighing 20 kg or more 5 mg EVRYSDI for Oral Solution or EVRYSDI Tablet Swallow EVRYSDI tablet whole with water or dispersed in non-chlorinated drinking water (e.g., filtered water). ( 2.2 ) Administer EVRYSDI for oral solution with the provided oral syringe. ( 2.2 ) EVRYSDI for oral solution must be constituted by a healthcare provider prior to dispensing. ( 2.4 ) See Full Prescribing Information for important preparation and administration instructions. ( 2.2 , 2.4 ) 2.1 Dosing Information EVRYSDI is administered orally once daily with or without food at approximately the same time each day. The recommended dosage is determined by age and body weight (see Table 1 ). EVRYSDI tablets are available for patients prescribed the 5 mg dose. Table 1 Adult and Pediatric Dosing Regimen by Age and Body Weight Age and Body Weight Recommended Dai…
Contraindications
4 CONTRAINDICATIONS None. None. ( 4 )
Drug Interactions
7 DRUG INTERACTIONS Avoid coadministration with drugs that are substrates of multidrug and toxin extrusion (MATE) transporters. ( 7.1 ) 7.1 Effect of EVRYSDI on Substrates of Multidrug and Toxin Extrusion (MATE) Protein Transporters Based on in vitro data, EVRYSDI may increase plasma concentrations of drugs eliminated via MATE1 or MATE2-K [see Clinical Pharmacology (12.3) ] , such as metformin. Avoid coadministration of EVRYSDI with MATE substrates. If coadministration cannot be avoided, monitor for drug-related toxicities and consider dosage reduction of the coadministered drug (based on the labeling of that drug) if needed.
Adverse Reactions
6 ADVERSE REACTIONS The most common adverse reactions in later-onset SMA (incidence at least 10% of patients treated with EVRYSDI and more frequent than control) were fever, diarrhea, and rash. ( 6.1 ) 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, lower respiratory tract infection, constipation, vomiting, and cough. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Genentech at 1-888-835-2555 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in clinical trials of another drug and may not reflect the rates observed in practice. In clinical trials including patients with infantile-onset SMA, later-onset SMA, and pre-symptomatic SMA, a total of 491 patients (51% female, 74% Caucasian) were exposed to EVRYSDI for up to a median duration of 48.1 months (range: 0.6 to 63.4 months), with 231 patients receiving…
Frequently Asked Questions
What is EVRYSDI used for?
EVRYSDI contains Risdiplam. It is a powder, for solution taken oral. Consult your doctor for specific uses.
Is EVRYSDI a controlled substance?
EVRYSDI is not classified as a controlled substance by the DEA.
What is the generic name for EVRYSDI?
The generic name for EVRYSDI is Risdiplam. There are no other listed brand versions of Risdiplam.
What is the NDC code for EVRYSDI .75 mg/mL?
The NDC (National Drug Code) for EVRYSDI .75 mg/mL is 50242-175, listed by Genentech, Inc..
Other EVRYSDI Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)