Regulatory product record
BRAVECTO
Product identity, ingredients and source provenance from the regulatory catalogue. Linked clinical evidence has a separate review status.
Product identity
- Brand name
- BRAVECTO
- DIN
- 02454971
- DPD drug code
- 94179
- Regulatory category
- APPROVED_VET_DRUG
- Market status
- MARKETED
- Route(s)
- TOPICAL
- Pharmaceutical form(s)
- SOLUTION
- Ingredients
- FLURALANER (1000 MG)
- Species (DPD record)
- DOGS
- Company
- INTERVET CANADA CORP (DIN owner)
Source and provenance
- Source dataset
- health_canada_dpd_marketed
- Source snapshot date
- Not available in this source
- Source record key
- 94179
- Archive fingerprint (SHA-256)
- 85cc3ce208af3aa57018c3d14d83f90220c436baef7455384b6d48d9774e1c88
Linked clinical reference
Clinical entries are linked through the active molecule. Check their species, formulation, source and review status separately from this product record.
Clinical evidence
Pending clinical review (PROPOSED)Rule-based (RULE_BASED)— applies to the facts and dose entries in this species selection; individual source records retain their own status.
Indications1
Cochliomyia hominivorax Rhipicephalus microplus Exzolt Cattle-CA1 is indicated for the prevention and treatment of infestations caused by New World screwworm () larvae (myiasis) and treatment and control of cattle fever tick () in beef cattle 2 months of age and older and replacement dairy heifers less than 20 months of age. Not for use in bulls intended for breeding 1 year of age and older, dairy calves, and veal calves.
Species not recordedOn-label (ON_LABEL)United States1 source record · View provenance
- Species not recorded · SPL section 34067-9 (INDICATIONS & USAGE SECTION) · United States · On-label (ON_LABEL) · Pending clinical review (PROPOSED) · Rule-based
Dose regimens1
This calculator performs arithmetic only on the sourced dosing field shown for each result — it does not verify the field's accuracy, does not select which field to use for a patient, and does not replace a veterinarian's order. Not for clinical use. Confirm every result against the primary source before dispensing.
Dose calculation
Species: Species not recorded. Results use the source regimens shown below.
- Review the source route shown below.
- Enter patient weight and its unit.
- For volume, optionally enter a matching label concentration.
Source route: Route not specified
Manual verification required — this source did not state a per-weight dose this calculator can compute from.
- Source regimen: Not available in this source
- Source formulation
- Not specified in this source
- Dose basis
- Not specified in this source
Indication: Not specified in this source field
Manual verification required — this source did not state a per-weight dose this calculator can compute from.
SPL section 34068-7 (DOSAGE & ADMINISTRATION SECTION)
Adverse effects201
In a well-controlled U.S. field study, 225 dogs were administered two doses of BRAVECTO QUANTUM at a 1-year interval and 96 dogs were administered an oral active control every 12 weeks for a total of 6 doses. Over the 455-day study period, all observations of potential adverse reactions were recorded. One dog treated in the BRAVECTO QUANTUM group had a hypersensitivity reaction which included hives, facial edema, vomiting, and heavy breathing within the first 12 hours following the initial treatment. The dog was treated with oral antihistamines and recovered within 24 hours of treatment. No additional hypersensitivity reactions were observed in subsequent dosing 12 months later when premedicated with diphenhydramine. In well-controlled foreign laboratory effectiveness studies, after administration of BRAVECTO QUANTUM, two dogs exhibited slight mucosal hyperemia the day following administration that resolved the following day, one dog exhibited transient erythema 10 minutes post-injection that resolved within 1 hour, and one dog had a nonpainful swollen upper eyelid observed 24 hours post treatment. In a large European field study, pain on injection of BRAVECTO QUANTUM was reported in 5 dogs. Percentage of Dogs with Adverse Reactions in the Field Study Adverse Reaction (AR) BRAVECTO QUANTUM(n = 225 dogs) Active Control(n = 96 dogs) Lethargy 4.9% 3.1% Decreased appetite 4.4% 4.2% Vomiting 4.0% 0% Diarrhea 2.7% 3.1% Alanine aminotransferase (ALT); Alkaline phosphatase (ALP) Liver enzymes (serum ALT or ALP) greater than twice the upper reference range 2.7% 2.1% Pruritus 1.8% 2.1% Mild injection site reactions, described as a lump, bump or knot, occurred in three BRAVECTO QUANTUM treated dogs and were all observed within 3 days of the injection. All injection site reactions were self-limiting and resolved following 1, 4, and 27 days after the initial observation. Injection site lumps or swelling 1.3% 0% Two dogs treated with BRAVECTO QUANTUM experienced seizures during the study. One dog with a history of at least one seizure within three months prior to the start of the study, reported 6 seizures in 9 months starting 23 days after the initial dose. Although anticonvulsant medications were not started, no additional seizures were observed during the study following the second dose administered 12 months after the initial dose. A second dog reported 8 seizures starting 57 days after the initial dose. The dog was removed from the study on Day 84 and managed with anticonvulsant medications. Seizures 0.9% 0%
Species not recordedOn-label (ON_LABEL)United States1 source record · View provenance
- Species not recorded · SPL section 34084-4 (ADVERSE REACTIONS SECTION) · United States · On-label (ON_LABEL) · Pending clinical review (PROPOSED) · Rule-based
These are counts of spontaneously reported events, not proven adverse effects, causal relationships, or incidence rates.
Bars compare report counts within each species; they do not show incidence.
More reportsFewer reportsDog
- Vomiting19,858 reports
- Lack of efficacy (ectoparasite) - flea13,545 reports
- Emesis (multiple)5,521 reports
- Lethargy (see also Central nervous system depression in 'Neurological')4,881 reports
- Lack of efficacy (ectoparasite) - tick NOS4,826 reports
- Diarrhoea4,374 reports
- Seizure NOS3,102 reports
- Lack of efficacy (tick)1,564 reports
- Lack of efficacy (bacteria) - NOS1,493 reports
- Drug administration error1,479 reports
- Decreased appetite1,467 reports
- Lack of efficacy (flea)1,462 reports
Cat
- Lack of efficacy (ectoparasite) - flea3,556 reports
- Application site hair loss2,465 reports
- Lethargy (see also Central nervous system depression in 'Neurological')1,233 reports
- Drug administered at inappropriate site1,030 reports
- Emesis (multiple)819 reports
- Foaming at the mouth658 reports
- Application site alopecia583 reports
- Behavioural disorder NOS567 reports
- Hypersalivation497 reports
- Vomiting491 reports
- Application site reddening436 reports
- Drooling431 reports
Contraindications1
There are no known contraindications for the use of the product.
Species not recordedOn-label (ON_LABEL)United States1 source record · View provenance
- Species not recorded · SPL section 34070-3 (CONTRAINDICATIONS SECTION) · United States · On-label (ON_LABEL) · Pending clinical review (PROPOSED) · Rule-based
Precautions3
Federal law restricts this drug to use by or on the order of a licensed veterinarian.
Species not recordedOn-label (ON_LABEL)United States1 source record · View provenance
- Species not recorded · SPL section 42232-9 (PRECAUTIONS SECTION) · United States · On-label (ON_LABEL) · Pending clinical review (PROPOSED) · Rule-based
Fluralaner is a member of the isoxazoline class. This class has been associated with neurologic adverse reactions including tremors, ataxia, and seizures. Seizures have been reported in dogs receiving isoxazoline class drugs, even in dogs without a history of seizures. Use with caution in dogs with a history of seizures or neurologic disorders. Amblyomma americanum Effectiveness BRAVECTO QUANTUM is not effective againstticks beyond 8 months after dosing (see). Effectiveness Prior to administration of BRAVECTO QUANTUM, owners should be informed that this product may take 3-5 days to see a notable reduction in ticks (see). Adverse Reactions Hypersensitivity reactions, including anaphylaxis, have been reported with the use of this product and should be treated immediately with the same measures used to treat hypersensitivity reactions to vaccines and other injectable products (see). The safety and effectiveness of BRAVECTO QUANTUM has not been evaluated in dogs less than 6 months of age. The safety of BRAVECTO QUANTUM has not been evaluated in breeding, pregnant and lactating dogs. Reproductive adverse events have been reported following use of Bravecto (fluralaner) Chews in breeding females including birth defects (including limb deformities and cleft palate), stillbirth, and abortion. Target Animal Safety Before use in breeding female dogs, refer to thesection.
Species not recordedOn-label (ON_LABEL)United States1 source record · View provenance
- Species not recorded · SPL section 42232-9 (PRECAUTIONS SECTION) · United States · On-label (ON_LABEL) · Pending clinical review (PROPOSED) · Rule-based
Federal law restricts this drug to use by or on the order of a licensed veterinarian. Conditionally approved by FDA pending a full demonstration of effectiveness under application number 141-617. It is a violation of Federal law to use this product other than as directed in the labeling.
Species not recordedOn-label (ON_LABEL)United States1 source record · View provenance
- Species not recorded · SPL section 42232-9 (PRECAUTIONS SECTION) · United States · On-label (ON_LABEL) · Pending clinical review (PROPOSED) · Rule-based
Pharmacokinetics1
Clinical Pharmacology:
Species not recordedOn-label (ON_LABEL)United States1 source record · View provenance
- Species not recorded · SPL section 34090-1 (CLINICAL PHARMACOLOGY SECTION) · United States · On-label (ON_LABEL) · Pending clinical review (PROPOSED) · Rule-based
Literature references15
References are linked to this drug. Species applicability is not recorded here, so the species filter does not narrow this list. Imported dates do not retain their original precision; confirm dates in the original citation.
- Pharmacokinetics, Absolute Bioavailability, and Nonlinear Topical Absorption of a Fluralaner-Moxidectin Spot-On Formulation in Cats.
Study summary not available in the imported record. Open the original citation to review the study.
- Efficacy of a single oral administration of a formulation of fluralaner, moxidectin and pyrantel (BRAVECTO® TriUNO) in dogs for the treatment and prevention of angiostrongylosis.
Study summary not available in the imported record. Open the original citation to review the study.
- Effect of fluralaner administration to domestic dogs on the bloodmeal profile of Triatoma infestans in a cluster-randomized trial in the Argentine Chaco.
Study summary not available in the imported record. Open the original citation to review the study.
- Overcoming doramectin failure: field efficacy of pour-on 5% fluralaner and an experimental 1% oral formulation for the prevention of Cochliomyia hominivorax-associated umbilical myiasis in newborn calves.
Study summary not available in the imported record. Open the original citation to review the study.
- Determination and stereoselective pharmacokinetics of fluralaner enantiomers in broiler chickens by liquid chromatography-tandem mass spectrometry.
Study summary not available in the imported record. Open the original citation to review the study.
Sources: DailyMed, U.S. National Library of Medicine; PubMed, National Library of Medicine; openFDA, U.S. Food and Drug Administration.