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.

BILTRICIDE (NDA-018714)

(PRAZIQUANTEL)

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

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12/19/2023 (SUPPL-20)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.6 Concomitant Administration with Cytochrome P450 Enzyme Inducers

Additions and/or revisions underlined:

Strong Cytochrome P450 3A Enzyme (CYP 3A) Inducers

Concomitant administration of strong CYP 3A inducers, such as rifampin, with Biltricide is contraindicated since therapeutically effective levels of praziquantel are unlikely to be achieved. [see Contraindications (4), Drug Interactions (7.1), and Clinical Pharmacology (12.3)].

Moderate CYP 3A Inducers

Avoid concomitant administration of Biltricide with moderate CYP 3A inducers, such as efavirenz, due to risk of a clinically significant decrease in praziquantel plasma concentrations which may lead to reduced therapeutic effect of Biltricide. [see Drug Interactions (7.1)].

In patients receiving a clinically significant CYP 3A inducer drug who need immediate treatment for schistosomiasis, alternative agents for schistosomiasis should be considered, where possible. If Biltricide is necessary immediately, increase monitoring for reduced anthelmintic efficacy associated with Biltricide [see Drug Interactions (7.1)].

In patients receiving a clinically significant CYP 3A inducer drug whose treatment could be delayed, discontinue the CYP 3A inducer drug at least 2 weeks to 4 weeks before administration of Biltricide and, where possible, consider starting alternative medications that are not CYP 3A inducers. The CYP 3A inducer drug can be restarted one day after completion of Biltricide treatment, if needed [see Drug Interactions (7.1)]

7 Drug Interactions

Additions and/or revisions underlined:

7.1 CYP 3A Inducers

Strong and Moderate CYP 3A Inducers

Concomitant administration of Biltricide with Strong and Moderate CYP 3A inducers decrease praziquantel AUC and Cmax [see Clinical Pharmacology (12.3)] which may reduce the efficacy of Biltricide. Concomitant administration of a Strong CYP 3A inducer, such as rifampin, with Biltricide is contraindicated [see Contraindications (4)].

Concomitant administration of a Moderate CYP 3A inducer, such as efavirenz, should be avoided unless the benefit outweighs the risks [see Warnings and Precautions (5.6) and Clinical Pharmacology (12.3).]

7.2 CYP450 inhibitors

Additions and/or revisions underlined:

Concomitant administration of drugs that decrease the activity of drug metabolizing liver enzymes (CYP450 inhibitors), for example, cimetidine, ketoconazole, itraconazole, erythromycin, and ritonavir may increase plasma concentrations of praziquantel. In addition, grapefruit juice was also reported to produce a 1.6-fold increase in the Cmax and a 1.9-fold increase in the AUC of praziquantel. The effect of this exposure increase on the safety of Biltricide has not been systematically evaluated [see Dosage and Administration (2.2)].

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

PATIENT COUNSELING INFORMATION

Additions and/or revisions underlined:

…

Advise patients not to take Biltricide if they are taking efavirenz [see Warnings and Precautions (5.6), Drug Interactions (7.1

01/08/2019 (SUPPL-18)

Approved Drug Label (PDF)

5 Warnings and Precautions

(PLR conversion: subsections created as below, please see label for complete information)

5.1 Clinical Deterioration

(addition underlined)

The use of Biltricide in patients with schistosomiasis may be associated with clinical deterioration (for example, paradoxical reactions, serum sickness Jarisch-Herxheimer like reactions: sudden inflammatory immune response suspected to be caused by the release of schistosomal antigens). These reactions predominantly occur in patients treated during the acute phase of schistosomiasis. They may lead to potentially life-threatening events, for example, respiratory failure, encephalopathy, papilledema, and/or cerebral vasculitis.

5.2 Central Nervous System (CNS) Effects

5.3 Potential Lack of Efficacy During the Acute Phase of Schistosomiasis

5.4 Cardiac Arrhythmias

5.5 Hepatic Impairment in Hepatosplenic Schistosomiasis Patients

5.6 Concomitant Administration with Strong Cytochrome P450 Inducers

6 Adverse Reactions

(additions underlined)

…

Additional adverse reactions reported from worldwide post marketing experience and from publications with Biltricide and various formulations of praziquantel include:

…

Ear and labyrinth disorders: vertigo, tinnitus

Eye disorders: visual disturbance

…

General disorders and administration site conditions: polyserositis, asthenia, fatigue, gait disturbance

Hepatobiliary disorders: hepatitis

…

Immune system disorders: allergic reaction, generalized hypersensitivity, anaphylactic reaction

…

Nervous system disorders: convulsion, somnolence, intention tremor

Respiratory, thoracic and mediastinal disorders: pneumonitis, dyspnea, wheezing

Skin and subcutaneous tissue disorders: pruritus, rash, Stevens-Johnson syndrome

7 Drug Interactions

(PLR conversion: subsections created as below, please see label for complete information)

7.1 CYP450 Inducers

7.2 CYP450 inhibitors

8 Use in Specific Populations

8.1 Pregnancy

(PLLR conversion, please refer to label)

8.2 Lactation

(PLLR conversion)

Risk Summary

Limited data from published literature reports the presence of praziquantel in human milk at low concentrations. There is no information on the effects of praziquantel in the breastfed infant or effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Biltricide and any potential adverse effects on the breastfed infant from Biltricide or from the underlying maternal condition.

8.4 Pediatric Use

(subsection revised)

Safety and dosing recommendations of Biltricide in pediatric patients 1 to 17 years have been established. Safety of Biltricide in pediatric patients younger than 1 year of age has not been established.

Post-marketing experience and published literature indicates that pediatric patients 1 to 17 years of age treated with praziquantel experience similar adverse reactions as adults treated with praziquantel.

8.5 Geriatric Use

(PLR conversion, please refer to label)

8.6 Hepatic Impairment

(PLR conversion, please refer to label)

8.7 Renal Impairment

(PLR conversion, please refer to label)

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

PATIENT COUNSELING INFORMATION

(new section added per PLR format, please refer to label)