Drug Safety-related Labeling Changes (SrLC)

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Drug Safety-related Labeling Changes (SrLC) Database

ANDA	Abbreviated New Drug Application
BLA	Biologics License Application
CDER	Center for Drug Evaluation and Research
MG	Medication Guide
NDA	New Drug Application
PCI	Patient Counseling Information
PI	Patient Information
PLR	Physician Labeling Rule
PLLR	Pregnancy and Lactation Labeling Rule
Italics	For the most part, italics indicate an FDA comment such as: Additions and/or revisions underlined These italics usually appear at the beginning of the section. In some cases, italics may be an inherent part of the label, and will most often appear in the body of the section.
Underlines	Any text that is underlined indicates text that has been added or revised. There are exceptions where underlining occurs in a section subtitle or heading. This is the case when there is just one word underlined in the body of the text.

Sections

BW	Box Warning
WP	Warnings and Precautions all in one section (PLR-format) Warnings as one section (pre-PLR format) Precautions as one section (pre-PLR format)
AR	Adverse Reactions (in pre-PLR format, this may be a subheading under precautions).
DI	Drug Interactions (in pre-PLR format, this may be a subheading under precautions).
USP	Use in Specific Populations (Inclusive on one or more of the following: Pregnancy; Lactation (PLLR- format); Nursing Mothers (pre-PLLR format); Females and Males of Reproductive Potential (PLLR format only); Pediatric Use, Geriatric Use, Renal Impairment, Hepatic Impairment, Sex, Race (these last six may be a subheading of precautions if label in pre-PLLR format.
PCI/PI/MG	Patient Counseling Information (PLR format only) - summarizes the information that a health care provider should convey to a patient (or caregiver when applicable) when a counseling discussion is taking place (e.g., a physician prescribing a drug during an office visit, a nurse providing discharge instructions at a hospital, or a pharmacist conveying information at a pharmacy). Patient Information - FDA approved patient labeling. Medication Guide - paper handouts that come with many prescription medicines. The guides address issues that are specific to particular drugs and drug classes, and they contain FDA-approved information that can help patients avoid serious adverse events.

Only NDAs and CDER regulated BLAs are included in this database. ANDAs are not included.

Applications that remain active, even if the product has been discontinued, undergo safety-related labeling changes.

EVRYSDI (NDA-213535)

(RISDIPLAM)

Safety-related Labeling Changes Approved by FDA Center for Drug Evaluation and Research (CDER)

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02/10/2026 (SUPPL-17)

Approved Drug Label (PDF)

17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)

PATIENT INFORMATION

Additions and/or revisions underlined:

…

If you are taking EVRYSDI Tablets:

See the detailed Instructions for Use that comes with it for information on how to take or give EVRYSDI tablets.
Wash your hands before and after preparing or taking 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.
If you cannot swallow tablets whole or if you have a nasogastric (NG-tube) or gastrostomy (G-tube), see the detailed Instructions for Use that comes with it for information on how to take or give EVRYSDI tablets.
…
How should I store EVRYSDI?
…
EVRYSDI Tablets:

Store at room temperature between 68°F to 77°F (20°C to 25°C).
Keep the tablets in their original bottle with the cap tightly closed to protect from moisture.
…

02/11/2025 (SUPPL-14)

Approved Drug Label (PDF)

17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)

PATIENT COUNSELING INFORMATION

Additions and/or revisions underlined:

. . .

Instructions for Preparation of Oral Solution

Advise patients/caregivers to ensure that EVRYSDI oral solution is in liquid form when received from the pharmacy.

Instruct patients/caregivers to take EVRYSDI oral solution with or without food or before or after breastfeeding at approximately the same time each day. However, instruct caregivers not to mix EVRYSDI with formula or milk.

Instruct patients/caregivers to take EVRYSDI oral solution immediately after it is drawn up into the reusable oral syringe [see Dosage and Administration (2.1)].

Instructions for EVRYSDI Tablets

Advise patients/caregivers to swallow EVRYSDI tablets whole with water. Do not chew, cut, or crush the tablets.

Alternatively, the tablet can be dispersed in one teaspoon (5 mL) of room temperature non- chlorinated drinking water (e.g., filtered water) and taken immediately. EVRYSDI tablets must not be dispersed in any liquid other than non-chlorinated drinking water. Instruct the patient/caregivers that the dispersion must be administered within 10 minutes of adding non-chlorinated drinking water, or it must be discarded.

Advise patients/caregivers that the EVRSYDI tablet dispersion is for oral administration only. If administration through a nasogastric/gastrostomy tube is required, EVRYSDI for oral solution should be used.

Advise patients/caregivers to wash their hands before and after preparing or taking EVRYSDI tablets.

Advise patients/caregivers to avoid getting the dispersed tablet on their skin or in their eyes. Advise patients/caregivers to wash the area with soap and water if the dispersed tablet gets on the skin. Advise patients/caregivers to rinse their eyes with water if the dispersed tablet gets in the eyes.

Advise patients/caregivers to use a dry paper towel to dry the area if the dispersion is spilled and then clean with soap and water. Advise patients/caregivers to throw the paper towel away in the trash and wash their hands with soap and water.

PATIENT INFORMATION

Additions and/or revisions underlined:

. . .

How should I take EVRYSDI?

. . .

Your healthcare provider will either prescribe: EVRYSDI for oral solution Or EVRYSDI tablet

. . .

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.
In infants who are breastfed, EVRYSDI can be given before or after breastfeeding.

. . .

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

. . .

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.

If you are taking 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.

You can take an EVRYSDI tablet by mouth after it is mixed with a teaspoon (5 mL) of room temperature non-chlorinated drinking water (e.g., filtered water). See the instructions below for taking EVRYSDI this way.

EVRYSDI Tablets Mixed with Non-chlorinated Drinking Water (e.g., 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 (e.g., 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 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).

. . .

How should I store EVRYSDI?

EVRYSDI for 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 from light.
Throw away (discard) any unused portion of EVRYSDI 64 days after it is mixed by the pharmacist (constitution) or if EVRYSDI 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).

EVRYSDI Tablets:

Store at room temperature between 68°F to 77°F (20°C to 25°C).
Keep the bottle tightly closed in order to protect from moisture.

Keep EVRYSDI, all medicines and syringes out of the reach of children.

What are the ingredients in EVRYSDI? Active ingredient: risdiplam

Inactive ingredients:

EVRYSDI for Oral Solution: ascorbic acid, disodium edetate dihydrate, isomalt, mannitol, polyethylene glycol 6000, sodium benzoate, strawberry flavor, sucralose, and tartaric acid.

EVRYSDI 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.

09/17/2024 (SUPPL-13)

Approved Drug Label (PDF)

6 Adverse Reactions

6.1 Clinical Trials Experience

Additions and revisions underlined:

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 treatment for more than 24 months. At the time of first EVRYSDI dose, 90 (18%) patients were 18 years and older, 119 (24%) were 12 years to less than 18 years, 189

(39%) were 2 years to less than 12 years, 67 (14%) 2 months to less than 2 years, and 26 (5%) were less than 2 months.

. . .

The safety of EVRYSDI therapy for pre-symptomatic SMA is based on data from an open-label, single-arm study in 26 patients (Study 3) [see Clinical Studies (14.3)].

03/24/2023 (SUPPL-8)

Approved Drug Label (PDF)

8 Use in Specific Populations

8.1 Pregnancy

Newly added information:

Pregnancy Exposure Registry

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 https://www.evrysdipregnancyregistry.com.

17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)

Patient Counseling Information

Newly added information:

Pregnancy Registry

Encourage patients to enroll in the EVRYSDI Pregnancy Registry if they become pregnant while taking EVRYSDI [see Use in Specific Populations (8.1)].

Patient Information

Newly added information:

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.

Additions and revisions underlined:

Reusable Oral Syringes

Your pharmacist will provide you with the reusable oral syringe(s) that are needed for taking your medicine and explain how to use them. Wash the syringes per instructions after use. Do not throw them away.
Use the reusable oral syringe(s) provided by your pharmacist (you should receive 1 or 2 identical oral syringes depending on your prescribed daily dose) to measure your or your child’s dose of EVRYSDI, as they are designed to protect the medicine from light. Contact your healthcare provider or pharmacist if your oral syringe(s) are lost or damaged.

05/27/2022 (SUPPL-3)

Approved Drug Label (PDF)

6 Adverse Reactions

6.1 Clinical Trials Experience

Additions and/or revisions underlined

…

In clinical trials including patients with infantile-onset SMA, later-onset SMA, and pre- symptomatic SMA, a total of 483 patients (50% female, 74% Caucasian) were exposed to EVRYSDI for up to a median duration of 22.8 months (range: 0.5 to 46.9 months), with

221 patients receiving treatment for more than 24 months. At the time of first EVRYSDI dose, 90 (19%) patients were 18 years and older, 119 (25%) were 12 years to less than 18 years, 189 (39%) were 2 years to less than 12 years, 67 (14%) 2 months to less than 2 years, and 18 (4%) were less than 2 months.

…

Clinical Trial in Infantile-Onset SMA

…

The most frequent adverse reactions reported in infantile-onset SMA patients treated with EVRYSDI in Study 1 were similar to those observed in later-onset SMA patients in Study 2. Additionally, the following adverse reactions reported in greater than or equal to 10% of patients were: upper respiratory tract infection (including nasopharyngitis, rhinitis), lower respiratory tract infection (including pneumonia, bronchitis), constipation, vomiting, and cough.

Clinical Trial in Pre-Symptomatic SMA

The safety of EVRYSDI therapy for pre-symptomatic SMA is based on data from an open-label, single-arm study (Study 3) [see Clinical Studies (14.3)]. At the time of interim analysis, the study had enrolled 18 patients with pre-symptomatic SMA between 16 and 40 days of age at the time of the first dose (weight range 3.1 to 5.7 kg). The median exposure duration was 8.7 months (range: 0.5 to 22.8 months). The safety profile of EVRYSDI in pre-symptomatic patients in Study 3 is consistent with the safety profile for symptomatic SMA patients treated with EVRYSDI in clinical trials.

05/27/2022 (SUPPL-5)

Approved Drug Label (PDF)

6 Adverse Reactions

6.1 Clinical Trials Experience

Additions and/or revisions underlined

…

Clinical Trial in Infantile-Onset SMA

…

Clinical Trial in Pre-Symptomatic SMA

8 Use in Specific Populations

8.4 Pediatric Use

Additions and/or revisions underlined

The safety and effectiveness of EVRYSDI in pediatric patients (neonates and older) have been established. Use of EVRYSDI for SMA is supported by evidence from adequate and well- controlled studies of EVRYSDI in patients 2 months of age and older with SMA. Use of EVRYSDI for SMA in patients 2 months of age and younger is supported by pharmacokinetic and safety data from pediatric patients 16 days and older, and pharmacokinetic modeling and simulation to identify the dosing regimen [see Clinical Pharmacology (12.3) and Clinical Studies (14)].

…

17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)

PATIENT INFORMATION

Additions and/or revisions underlined

…

What are the possible side effects of EVRYSDI?

The most common side effects of EVRYSDI include:

For later-onset SMA:
o fever o diarrhea o rash
For infantile-onset SMA:
- fever
- runny nose, sneezing, and sore throat
- constipation (upper respiratory infection)
- diarrhea
- lung infection (lower respiratory infection)
- vomiting
- rash
- cough
  …

04/30/2021 (SUPPL-1)

Approved Drug Label (PDF)

8 Use in Specific Populations

8.5 Geriatric Use

(Additions and/or revisions underlined)

Clinical studies of EVRYSDI did not include patients aged 65 years and older to determine whether they respond differently from younger adult patients.