Laverdia-CA1 Tablets

How to Order Prescriptions

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Description

LAVERDIA-CA1 is a Selective Inhibitor of Nuclear Export (SINE) that binds to XP01, blocking the transport of tumor suppressor proteins, arresting the cell cycle to inhibit lymphoma cell growth and induce apoptosis. This spares healthy cells, targets mutating cells, and immediately goes into work in the nucleus helping naturally occurring tumor suppressor proteins fight against cancer. 

Indication

LAVERDIA-CA1 (verdinexor) is indicated for the treatment of lymphoma in dogs. 

Dosing Instructions

1.25mg/kg Dose

		Number of Tablets
Dog weight (kg)	Total mg to administer	2.5 mg tablets	10 mg tablets	50 mg tablets
9 — 11.5	12.5	1	1	-
11.6 — 13.5	15	2	1	-
13.6 — 15.5	17.5	3	1	-
15.6 — 17.5	20	-	2	-
17.6 — 19.5	22.5	1	2	-
19.6 — 21.5	25	2	2	-
21.6 — 23.5	27.5	3	2	-
23.6 — 25.5	30	-	3	-
25.6 — 27.5	32.5	1	3	-
27.6 — 29.5	35	2	3	-
29.6 — 31.5	37.5	3	3	-
31.6 — 33.5	40	-	4	-
33.6 — 35.5	42.5	1	4	-
35.6 — 37.5	45	2	4	-
37.6 — 39.5	47.5	3	4	-
39.6 — 41.5	50	-	-	1
41.6 — 43.5	52.5	1	-	1
43.6 — 45.5	55	2	-	1
45.6 — 47.5	57.5	3	-	1
47.6 — 49.5	60	-	1	1
49.6 — 51.5	62.5	1	1	1
51.6 — 53.5	65	2	1	1
53.6 — 55.5	67.5	3	1	1
55.6 — 57.5	70	-	2	1
57.6 — 59.5	72.5	1	2	1
59.6 — 61.5	75	2	2	1

 ** Use an appropriate combination of tablets to dose dogs over 61.5 kg. 

1.5 mg/kg Dose

		Number of Tablets
Dog weight (kg)	Total mg to administer	2.5 mg tablets	10 mg tablets	50 mg tablets
9.7 — 11.3	15	2	1	-
11.4 — 12.9	17.5	3	1	-
13 — 14.6	20	-	2	-
14.7 — 16.3	22.5	1	2	-
16.4 — 17.9	25	2	2	-
18 — 19.6	27.5	3	2	-
19.7 — 21.3	30	-	3	-
21.4 — 22.9	32.5	1	3	-
23 — 24.6	35	2	3	-
24.7 — 26.3	37.5	3	3	-
26.4 — 27.9	40	-	4	-
28 — 29.6	42.5	1	4	-
29.7 — 31.3	45	2	4	-
31.4 — 32.9	47.5	3	4	-
33 — 34.6	50	-	-	1
34.7 — 36.3	52.5	1	-	1
36.4 — 37.9	55	2	-	1
38 — 39.6	57.5	3	-	1
39.7 — 41.3	60	-	1	1
41.4 — 42.9	62.5	1	1	1
43 — 44.6	65	2	1	1
44.7 — 46.3	67.5	3	1	1
46.4 — 47.9	70	-	2	1
48 — 49.6	72.5	1	2	1
49.7 — 51.3	75	2	2	1
51.4 — 52.9	77.5	3	2	1
53 — 54.6	80	-	3	1
54.7 — 56.3	82.5	1	3	1
56.4 — 57.9	85	2	3	1
58 — 59.6	87.5	3	3	1
59.7 — 61.3	90	-	4	1

** Use an appropriate combination of tablets to dose dogs over 61.3 kg. 

1 mg/kg Dose

		Number of Tablets
Dog weight (kg)	Total mg to administer	2.5 mg tablets	10 mg tablets	50 mg tablets
9 — 11.9	10	-	1	-
12 — 14.4	12.5	1	1	-
14.5 — 16.9	15	2	1	-
17 — 19.4	17.5	3	1	-
19.5 — 21.9	20	-	2	-
22 — 24.4	22.5	1	2	-
24.5 — 26.9	25	2	2	-
27 — 29.4	27.5	3	2	-
29.5 — 31.9	30	-	3	-
32 — 34.4	32.5	1	3	-
34.5 — 36.9	35	2	3	-
37 — 39.4	37.5	3	3	-
39.5 — 41.9	40	-	4	-
42 — 44.4	42.5	1	4	-
44.5 — 46.9	45	2	4	-
47 — 49.4	47.5	3	4	-
49.5 — 51.9	50	-	-	1
52 — 54.4	52.5	1	-	1
54.5 — 56.9	55	2	-	1
57 — 59.4	57.5	3	-	1
59.5 — 61.9	60	-	1	1

*** Use an appropriate combination of tablets to dose dogs over 61.9 kg

1. Feed the dog immediately before giving LAVERDIA-CA1.
2. Wear protective disposable chemotherapy resistant gloves when handling LAVERDIA-CA1 (see USERSAFETY WARNINGS).
3. Administer LAVERDIA-CA1 at an initial dose of 1.25 mg/kg administered orally twice per week (e.g., Monday and Thursday or Tuesday and Friday) with at least 72 hours between doses (see Table 1).
4. If tolerated after 2 weeks, increase the dose of LAVERDIA-CA1 to 1.5 mg/kg twice per week with at least 72 hours between doses (see Table 2).
5. Dose reductions of 0.25 mg/kg to a minimum dose of 1 mg/kg twice per week with at least 72 hours between doses (see Table 3) or dose interruptions may be considered as a result of adverse reactions (See ANIMAL SAFETY WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS).
6. Do not split or crush tablets.

 

Contraindications

Do not use in dogs that are pregnant, lactating or intended for breeding. LAVERDIA-CA1 is a possible teratogen and can affect female and male fertility. Laboratory studies in the rat have shown reduced fertility, embryotoxicity, teratogenicity, and maternal toxicity. Administration of LAVERDIA-CA1 caused degeneration/ atrophy and vacuolation in the seminiferous tubules and oligospermia in the epididymides in male dogs in the margin of safety study (see TARGET ANIMAL SAFETY).

Warnings

USER SAFETY WARNINGS: NOT FOR USE IN HUMANS. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. CHILDREN SHOULD NOT COME INTO CONTACT WITH LAVERDIA-CA1. Children should not come in contact with the feces, urine, vomit, or saliva of treated dogs. Pregnant women, women who may become pregnant, and nursing women should not handle or administer LAVERDIA-CA1 or come in contact with the feces, urine, vomit, or saliva from LAVERDIA-CA1-treated dogs. 

Pregnant women, women who may become pregnant, and nursing women should not handle or administer LAVERDIA-CA1 or come in contact with the feces, urine, vomit, or saliva from LAVERDIA-CA1-treated dogs. LAVERDIA-CA1 may cause birth defects and can affect female fertility based on animal studies.

Wear protective disposable chemotherapy resistant gloves when handling LAVERDIA-CA1 to avoid exposure to drug.

Wear protective disposable chemotherapy resistant gloves to prevent direct contact with moistened, broken, or crushed LAVERDIA-CA1 tablets.

Wear protective disposable chemotherapy resistant gloves to prevent contact with feces, urine, vomit, and saliva during treatment and for 3 days after the dog has received the last treatment. Place all waste material in a plastic bag and seal before general disposal. Wash hands immediately and thoroughly with soap and water if contact occurs with the feces, urine, vomit, or saliva from LAVERDIA-CA1 treated dogs.

Any items that come in contact with feces, urine, vomit, or saliva should not be washed with other laundry during treatment and for 3 days after the last treatment with LAVERDIA-CA1.

Wear protective disposable chemotherapy resistant gloves when handling the dog’s toys, food bowl, and water bowl. Wash food and water bowls separately from other items during treatment and for 3 days after the dog has received the last treatment.

If LAVERDIA-CA1 is accidentally ingested, or if there is significant contact with feces, urine, vomit, or saliva of dogs during treatment or within 3 days after the last treatment without proper precautions, seek medical advice immediately. It is important to show the treating physician a copy of the package insert, label, or client information sheet.

How Supplied

LAVERDIA-CA1 is presented as immediate release coated tablets in three dosage strengths, 2.5 mg, 10 mg and 50 mg. Each presentation is supplied 50-count in an HDPE bottle with a heat sealed, child-resistant cap and a desiccant included in each bottle. The bottles are individually packaged into cartons.

Disposal

Dispose of any unused product or waste materials in accordance with proper procedures for cytotoxic drugs.

Storage Information

Store the bottles at controlled room temperature 20° to 25°C (68° – 77°F).