frunevetmab

SOLENSIA is indicated for the control of pain associated with osteoarthritis in cats.

SolensiaTM

For the control of pain associated with osteoarthritis in cats.

Solensia™

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.

SolensiaTM

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

SolensiaTM

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. Table 2. Adverse Reactions Reported in the Field Study1 Adverse Reaction Solensia N=182 (%) Vehicle Control N=93 (%) Vomiting 24 (13.2%) 10 (10.8%) Injection site pain2 20 (10.9%) 13 (14%) Diarrhea 12 (6.6%) 5 (5.4%) Abnormal behavior and behavioral disorders3 12 (6.6%)4 5 (5.4%)5 Renal insufficiency6 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%) Lameness7 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%) 1 If a cat experienced the same event more than once, only the first occurrence is reported 2 The control product was the vehicle without active ingredient 3 Behavior abnormal for the individual cat 4 Individual 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) 5 Individual cats had at least one of the following behavior changes: anxiety (2), disorientation (1), inappropriate urination (2), and vocalization (1) 6 Worsening of existing disease 7 New 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 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 EFFECTIVENESS), 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.

SolensiaTM

Cats should be dosed by weight range according to the Dosing Chart (Table 1) below. Cats are given the full content of 1 or 2 vials based on body weight to target a minimum dosage of 0.45 mg/lb. (1 mg/kg) body weight, administered subcutaneously once a month. Aseptically withdraw the total dose into a single syringe and administer immediately. The product does not contain a preservative. The full content of each vial is for single use only. Once punctured, contents of the vial should be used immediately and any remaining solution should be discarded. Table 1. Dosing Chart Weight of Cat (lb.) Weight of Cat (kg) Volume Number of Vials* 5.5‑15.4 2.5‑7 kg 1 mL 1 15.5‑30.8 7.1‑14 kg 2 mL 2 *1 mL frunevetmab injection per vial

SUBCUTANEOUS

SolensiaTM

The full content of 1 or 2 vials based on body weight to target a minimum dosage of 0.45 mg/lb. (1 mg/kg) body weight, administered subcutaneously once a month.

Subcutaneous

Solensia™