Regulatory product record
SOLENSIA
Product identity, ingredients and source provenance from the regulatory catalogue. Linked clinical evidence has a separate review status.
Product identity
- Brand name
- SOLENSIA
- DIN
- 02518449
- DPD drug code
- 100775
- Regulatory category
- APPROVED_VET_DRUG
- Market status
- MARKETED
- Route(s)
- SUBCUTANEOUS
- Pharmaceutical form(s)
- SOLUTION
- Ingredients
- FRUNEVETMAB (7 MG)
- Species (DPD record)
- CATS
- Company
- ZOETIS CANADA INC (DIN owner)
Source and provenance
- Source dataset
- health_canada_dpd_marketed
- Source snapshot date
- Not available in this source
- Source record key
- 100775
- 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
SOLENSIA is indicated for the control of pain associated with osteoarthritis in cats.
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.
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- Enter patient weight and its unit.
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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 effects116
The safety of SOLENSIA was evaluated in a masked, controlled 112‑day field study to evaluate the effectiveness of SOLENSIA for the control of pain associated with osteoarthritis in cats. Enrollment included 275 cats weighing 2.5‑to 11.4 kg and 1.6‑to 22.4 years old; 182 cats were treated with SOLENSIA and 93 cats were administered a vehicle control. Cats were dosed at 28‑day intervals and received up to three injections. The most common adverse reactions reported during the field study are presented below. 1 Table 2. Adverse Reactions Reported in the Field Study 1 2 3 4 5 6 7 If a cat experienced the same event more than once, only the first occurrence is reportedThe control product was the vehicle without active ingredientBehavior abnormal for the individual catIndividual cats had at least one of the following behavior changes: anxiety (1), hiding (1), hypersomnia (1), inappropriate urination (5), sleeping with owner (1), vocalization (3), increased aggressive behavior (1)Individual cats had at least one of the following behavior changes: anxiety (2), disorientation (1), inappropriate urination (2), and vocalization (1)Worsening of existing diseaseNew lameness or worsening of previous lameness The safety of SOLENSIA was also evaluated in a masked, controlled 56-day exploratory field study to evaluate the effectiveness of SOLENSIA for the control of pain associated with osteoarthritis in cats. Enrollment included 126 cats; 85 cats were treated with frunevetmab injection manufactured similar to SOLENSIA and 41 cats were administered a vehicle control. Cats were dosed at 28-day intervals and received up to two injections. The most frequently reported adverse reactions were digestive tract disorders, including vomiting and diarrhea, and skin disorders, including dermatitis/eczema and alopecia that were mostly attributed to irritation by an activity monitor collar required for the study. Immunogenicity EFFECTIVENESS All therapeutic proteins, including monoclonal antibodies, have the potential for immunogenicity, including the production of antibodies that bind to the therapeutic protein and may decrease effectiveness. Such hostderived antibodies are termed anti‑drug antibodies (ADA). SOLENSIA, therefore has the potential to cause the cat to produce ADAs against frunevetmab.The presence of binding antibodies to frunevetmab in cats was assessed using a screening and confirmatory assay approach. In controlled field effectiveness studies in cats with osteoarthritis (see), four out of 259 cats that received SOLENSIA once monthly developed anti‑drug antibodies (ADAs). One cat tested positive for ADAs on Days 0, 28, 56, and 84. This cat had non-detectable plasma drug concentration levels of SOLENSIA on Days 28 and 56, and was a treatment failure in the effectiveness analysis, suggesting that the ADAs may have clinical significance. No assessment for neutralizing antibodies was performed.The observed incidence of antibody positivity in an assay is highly dependent on several factors including assay sensitivity and specificity, assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies to SOLENSIA with the incidence of antibodies to other products may not be appropriate. Adverse Reaction SolensiaN=182 (%) VehicleControlN=93 (%) Vomiting 24 (13.2%) 10 (10.8%) 2 Injection site pain 20 (10.9%) 13 (14%) Diarrhea 12 (6.6%) 5 (5.4%) 3 Abnormal behavior and behavioral disorders 4 12 (6.6%) 5 5 (5.4%) 6 Renal insufficiency 12 (6.6%) 4 (4.3%) Anorexia 12 (6.6%) 4 (4.3%) Lethargy 11 (6.0%) 3 (3.2%) Dermatitis 11 (6.0%) 1 (1.1%) Alopecia 10 (5.5%) 2 (2.2%) Dehydration 8 (4.4%) 0 (0.0%) 7 Lameness 8 (4.4%) 2 (2.2%) Pruritus 7 (3.8%) 0 (0.0%) Weight loss 6 (3.3%) 5 (5.4%) Scabbing on head/neck 6 (3.3%) 1 (1.1%) Gingival disorder 5 (2.7%) 0 (0.0%) Bacterial skin infection 4 (2.2%) 1 (1.1%) Otitis externa 4 (2.2%) 0 (0.0%)
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
- General illness2 reports
- Lethargy (see also Central nervous system depression in Neurological)2 reports
- Prescribing error2 reports
- Anorexia1 reports
- Behavioural disorder NOS1 reports
- Confusion1 reports
- Death by euthanasia1 reports
- Emesis1 reports
- Medication error NOS1 reports
- Restlessness1 reports
- Shaking1 reports
- Skin sore1 reports
Cat
- Skin scab837 reports
- Vomiting802 reports
- Lethargy (see also Central nervous system depression in Neurological)693 reports
- Lack of efficacy - NOS641 reports
- Pruritus637 reports
- Weight loss501 reports
- Death by euthanasia496 reports
- Diarrhoea445 reports
- Not eating428 reports
- Skin lesion NOS369 reports
- Decreased appetite347 reports
- Partial lack of efficacy322 reports
Contraindications1
SOLENSIA should not be administered to cats with known hypersensitivity to frunevetmab. SOLENSIA should not be used in breeding cats or in pregnant or lactating queens because it may pass through the placental blood barrier and be excreted in milk. Fetal abnormalities, increased rates of stillbirths and increased postpartum fetal mortality were noted in rodents and primates receiving anti‑NGF mAbs.
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
Precautions2
User Safety Warnings Not for use in humans. Keep out of reach of children. Hypersensitivity reactions, including anaphylaxis, could potentially occur in the case of accidental self-injection. In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician. Pregnant women, women trying to conceive, and breastfeeding women should take extreme care to avoid accidental self-injection. The importance of NGF in ensuring normal fetal nervous system development is well-established and laboratory studies conducted on nonhuman primates with human anti‑NGF antibodies have shown evidence of reproductive and developmental toxicity
Species not recordedOn-label (ON_LABEL)United States1 source record · View provenance
- Species not recorded · SPL section 34071-1 (WARNINGS SECTION) · United States · On-label (ON_LABEL) · Pending clinical review (PROPOSED) · Rule-based
Administration of mAbs may be associated with hypersensitivity reactions and delayed hypersensitivity reactions. If anaphylaxis or other hypersensitivity reaction occurs, discontinue use and institute appropriate therapy. ADVERSE REACTIONS TARGET ANIMAL SAFETY Administration of SOLENSIA may be associated with scabbing on the head and neck, dermatitis, and pruritus; however, preapproval data suggest that these signs do not require cessation of SOLENSIA administration (seeand). Evaluations were not made to determine if interactions occurred between SOLENSIA and veterinary vaccines. Immunogenicity Treatment with SOLENSIA may result in the formation of anti-frunevetmab antibodies and potentially the loss of product effectiveness (see). The safe use of SOLENSIA with concurrent non-steroidal anti-inflammatory drugs (NSAIDs) has not been established in cats. In human clinical trials, rapidly progressing osteoarthritis (RPOA) has been reported in a small number of patients receiving humanized anti‑NGF mAb therapy. The incidence of these events increased in human patients receiving NSAID treatment long term in combination with an anti‑NGF mAb. RPOA has not been characterized or reported in cats. SOLENSIA has not been evaluated in cats less than 7 months or 5.5 lbs. Long term effects, which may occur more than 6 months after the use of SOLENSIA, have not been evaluated. Primates receiving high doses of anti-NGF mAbs had reduced cell size in postganglionic neuronal cell bodies. The change in cell body size returned to normal after anti-NGF mAb administration was discontinued. NGF is involved in the normal development of sensory and sympathetic nerve fibers in developing animals. This may be important with use of SOLENSIA in young growing cats. The safe use of this product with other mAbs has not been evaluated.
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
Literature references6
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.
- Safety assessment of frunevetmab for osteoarthritis pain in cats: disproportionality analysis of the Food and Drug Administration Animal Drug Adverse Events database.
Study summary not available in the imported record. Open the original citation to review the study.
- Clinical therapeutics in feline medicine: updates for old and new drugs.
Study summary not available in the imported record. Open the original citation to review the study.
- USE OF SOLENSIA (FRUNEVETMAB) IN NONDOMESTIC FELIDS (PANTHERA TIGRIS, LYNX RUFUS, PANTHERA UNCIA) GUIDED BY PROTEIN SEQUENCE ANALYSIS.
Study summary not available in the imported record. Open the original citation to review the study.
- Frunevetmab, a felinized anti-nerve growth factor monoclonal antibody, for the treatment of pain from osteoarthritis in cats.
Study summary not available in the imported record. Open the original citation to review the study.
- Pharmacokinetics and Immunogenicity of Frunevetmab in Osteoarthritic Cats Following Intravenous and Subcutaneous Administration.
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.