Semintra: Product Information

SEMINTRA- telmisartan solution
Boehringer Ingelheim Animal Health USA Inc.

For oral use in cats only
Angiotensin II Receptor Blocker

Caution:

Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Description:

SEMINTRA (telmisartan oral solution) is a clear, colorless to yellowish viscous solution containing 10 mg/mL telmisartan. Telmisartan is an orally active, non-peptide, selective angiotensin II subtype 1 (AT1) receptor blocker. The chemical name of telmisartan is 4′-[(1,4’-dimethyl-2’propyl[2,6′-bi-1H-benzimidazol]-1′-yl)methyl]-[1,1′-biphenyl]-2-carboxylic acid. Its empirical formula is C33 H30 N4 O2 , its molecular weight is 514.63, and its structural formula is:

Image of Structural FormulaImage of Structural Formula

Indication:

SEMINTRA is indicated for the control of systemic hypertension in cats.

Dosage and Administration:

Always provide the Client Information Sheet with each prescription.

The initial dose of SEMINTRA is 1.5 mg/kg (0.68 mg/lb) orally twice daily for 14 days, followed by 2 mg/kg (0.91 mg/lb) orally once daily. The dose may be reduced by 0.5 mg/kg (0.23 mg/lb) increments to a minimum of 0.5 mg/kg (0.23 mg/lb) orally once daily to manage SEMINTRA-induced hypotension. SEMINTRA can be administered directly into the mouth, or next to or on top of a small amount of food. Do not mix into food.

SEMINTRA should be administered using the dosing syringe provided in the package. The dosing syringe fits onto the bottle and has 0.1 mL incremental marks. The dose should be rounded to the nearest 0.1 mL. After administration close the bottle tightly with the cap. Rinse the dosing syringe with water and let air dry.

If the cat vomits within 30 minutes of dosing, the cat may be re-dosed.

Information for Cat Owners

Always provide the Client Information Sheet with each prescription and review it with the cat owner. Advise cat owners that adverse reactions can occur with use of SEMINTRA. The most common adverse reactions reported during the field studies included vomiting, diarrhea, lethargy, weight loss, anemia and dehydration.

Contraindications:

Do not use in cats with a hypersensitivity to telmisartan.

Human Warnings:

Not for human use. Keep out of reach of children.

SEMINTRA is an angiotensin II antagonist/angiotensin receptor blocker (ARB). Pregnant women should avoid contact with SEMINTRA because substances that act on the renin-angiotensin-aldosterone system (RAAS) such as angiotensin receptor blockers (ARBs) can cause fetal and neonatal morbidity and death during pregnancy in humans.

Precautions:

SEMINTRA has not been evaluated in cats with systolic blood pressure >200 mm Hg.

SEMINTRA can cause mild anemia or non-regenerative anemia. Cats should be monitored for anemia when initiating treatment with SEMINTRA.

SEMINTRA may cause inappetence and weight loss in some cats. Cats should be monitored for weight loss when initiating treatment with SEMINTRA. Use with caution in cats with a history of vomiting, inappetence or weight loss.

The safe use of SEMINTRA in cats with hepatic disease has not been evaluated. SEMINTRA is metabolized by the liver.

The safe use of SEMINTRA has not been evaluated in cats less than 9 months of age.

The safe use of SEMINTRA has not been evaluated in cats that are pregnant, lactating, or intended for breeding. See Human Warnings.

The safe use with other anti-hypertensive medications has not been evaluated.

Adverse Reactions:

28-day Field Effectiveness Study Safety was evaluated in a 28-day field study in 288 cats (192 SEMINTRA group cats, 96 control group cats) that received at least one dose of study drug. The control product was a vehicle control without telmisartan. Cats enrolled in the study had a median age of 14 years (7-20 years), and weighed 1.93-11.4 kg. SEMINTRA was administered orally at 1.5 mg/kg twice daily for 14 days, then 2 mg/kg once daily until study end; the control was administered at a volume equivalent to SEMINTRA. One hundred fourteen (59.4%) SEMINTRA group cats and 42 (43.8%) control group cats had at least one adverse reaction. Adverse reactions that occurred in at least 5% of either treatment group are presented in Table 1 below.

Table 1 Adverse Reactions in the 28-Day Field Study

Clinical Sign

SEMINTRA

N=192

Control

N=96

Vomiting

46 (24.0%)

14 (14.6%)

Diarrhea

18 (9.4%)

4 (4.2%)

Lethargy

13 (6.8%)

3 (3.1%)

Weight loss

13 (6.8%)

5 (5.2%)

Decreased appetite/inappetence

13 (6.8%)

7 (7.3%)

Non-regenerative anemia

11 (5.7%)

2 (2.1%)

Dehydration

10 (5.2%)

4 (4.2%)

Retinal lesions (target organ damage)

4 (2.1%)

6 (6.3%)


Additional adverse reactions that occurred in <5% of the SEMINTRA group included (in order of decreasing frequency): anorexia, gagging, arrhythmia, cough, heart murmur, and regenerative anemia. Additional adverse reactions representing 2-5% of the control group included azotemia, not drinking and renal failure.

Seven cats (five SEMINTRA and two control) either died or were euthanized during the study. None of the SEMINTRA group deaths were considered related to treatment.

5-month Field Effectiveness and Safety Study
The long-term safety of SEMINTRA was evaluated in an open label, 5 month field effectiveness and safety study in 107 cats that received at least one dose of SEMINTRA. Cats enrolled in the study had a mean age of 14.1 years (7-20 years) and weighed 1.92-11.4 kg. SEMINTRA was administered orally at 2 mg/kg once daily. Ninety-four cats (87.9%) had at least one adverse reaction during the study. Adverse reactions that occurred in at least 5% of cats are presented in Table 2 below.

Table 2 Adverse Reactions in the 5-Month Study

Clinical Sign

SEMINTRAN=107

Weight loss

37 (34.6%)

Vomiting

32 (29.9%)

Dehydration

18 (16.8%)

Non-regenerative anemia

17 (15.8%)

Anorexia

14 (13.1%)

Diarrhea

12 (11.2%)

Lethargy

12 (11.2%)

Decreased appetite/inappetence

11 (10.3%)

Heart murmur

10 (9.3%)

Death, Euthanasia, Found dead

9 (8.4%)

Cough

8 (7.5%)

Retinal lesions (target organ damage)

6 (5.6%)

Adverse reactions representing <5% of the study population were (in order of decreasing frequency): elevated liver enzymes, renal failure, tachycardia, arrhythmia, azotemia, depression, loose stool, constipation, gagging, hypotension, regenerative anemia, renal insufficiency, and vocalization.

Nine cats died or were euthanized during the study. Three cats had progressive chronic kidney disease that may have been affected by telmisartan treatment, concurrent disease, or inadequate control of hypertension. The other six cats died of causes unrelated to treatment (e.g. neoplasia).

To report suspected adverse drug events, for technical assistance, or to obtain a copy of the Safety Data Sheet (SDS), contact Boehringer Ingelheim Animal Health USA Inc. at 1-888-637-4251. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or online at www.fda.gov/reportanimalae.

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