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.

DOJOLVI (NDA-213687)

(TRIHEPTANOIN)

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

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10/30/2023 (SUPPL-3)

Approved Drug Label (PDF)

8 Use in Specific Populations

8.1 Pregnancy

Additions and/or revisions underlined:

…

There is a pregnancy safety study for DOJOLVI. If a patient becomes pregnant while receiving DOJOLVI, healthcare providers should report DOJOLVI exposure by calling Ultragenyx Pharmaceutical Inc. at 1-888-756-8657.

…

8.2 Lactation

Additions and/or revisions underlined:

Risk Summary

There are no data on the presence of triheptanoin or its metabolites in human or animal milk, the effects on the breastfed infant, or the effects on milk production. Medium-chain triglycerides and other fatty acids are normal components of breastmilk and the composition of breastmilk varies within feedings, over stages of lactation, and between mothers and populations due to maternal factors including genetics, environment, and diet. The developmental and health benefits of breastfeeding should be considered along with the clinical need for DOJOLVI and any potential adverse effect on the breastfed infant from DOJOLVI or from the underlying maternal condition.

8.5 Geriatric Use

Additions and/or revisions underlined:

Clinical studies of DOJOLVI did not include patients 65 years of age and older to determine if they respond differently from younger adult patients.

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

PATIENT COUNSELING INFORMATION

Additions and/or revisions underlined:

Advise the patient and/or caregiver to read the FDA-approved patient labeling (Patient Information and Instructions for Use).

Preparation and Administration Instruct the patient or caregiver:

To read the Instructions for Use for appropriate preparation and administration instructions on oral versus feeding tube administration.
Before administration, to mix DOJOLVI thoroughly into semi-solid food/liquid (oral) or medical food/formula (feeding tube) at mealtimes or with snacks.

To not prepare or administer DOJOLVI using containers, oral syringes, or measuring cups made of polystyrene or polyvinyl chloride (PVC) plastics.

…

Feeding Tube Dysfunction

Advise the patient or caregiver to regularly monitor the feeding tube for proper functioning and integrity and report to the healthcare provider if any issues are identified [see Warnings and Precautions (5.1)].

…

Pregnancy

Advise a patient who is exposed to DOJOLVI during pregnancy that there is a pregnancy safety study that monitors pregnancy outcomes. Encourage the patient to report the pregnancy to Ultragenyx Pharmaceutical Inc. at 1-888-756-8657 [see Use in Specific Populations (8.1)].

PATIENT INFORMATION

Additions and/or revisions underlined:

How should I take DOJOLVI?

See the detailed “Instructions for Use” at the end of this Patient Information Leaflet for instructions about how to mix and take DOJOLVI by mouth in soft food or drink or how to mix and give DOJOLVI in medical food or formula through feeding tubes.
Take DOJOLVI exactly as your healthcare provider tells you.
Your healthcare provider may start you on a low dose of DOJOLVI and slowly increase your dose to help avoid side effects. If you are taking another medium chain triglyceride (MCT) product, stop taking the MCT before starting DOJOLVI.

Do not mix or give DOJOLVI using containers, oral syringes, or measuring cups made of polystyrene (a type of plastic that can be solid or foam) or polyvinyl chloride (PVC), a solid plastic material.

Take DOJOLVI at least 4 times a day with meals or snacks, and always mix well with soft food or drink or medical food or formula before taking.

What are the possible side effects of DOJOLVI?

Feeding tube problems. Feeding tubes may not work as well or stop working over time when taking DOJOLVI. Do not use DOJOLVI in feeding tubes made of polyvinyl chloride (PVC). Check the feeding tube to make sure it is working properly and not breaking down.

…

How should I store DOJOLVI?

Store DOJOLVI at room temperature between 68°F to 77°F.
Do not freeze DOJOLVI.
When the bottle of DOJOLVI has been opened, use within 9 months or by the expiration date on the bottle, whichever comes first.