Description

VARENZIN CA1 Oral Suspension

Oral HIF-PH inhibitor for management of nonregenerative anemia associated with chronic kidney disease in cats.

Manufactured/Marketed by: Elanco US Inc.
Country of Origin: Germany
Dosage form: Oral Suspension

Presentation:

27 mL bottle with oral dosing syringe (25 mg/mL).

Ingredients & Composition:

Each mL contains:
Molidustat sodium equivalent to 25 mg molidustat.
Oral suspension vehicle q.s.

Description / Action:

Varenzin-CA1 oral suspension contains molidustat, a hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor.
Stabilizes HIF and stimulates endogenous erythropoietin (EPO) production.
Increases red blood cell production.
Improves hematocrit (HCT) and management of CKD-associated anemia.
Provides a non-injectable oral treatment option for feline renal anemia.

Class: HIF-PH Inhibitor / Erythropoiesis Stimulating Agent

Indication / Uses:

Control of nonregenerative anemia associated with chronic kidney disease (CKD) in cats.

Dosage and administration:

Dose: 2.3 mg/lb (5 mg/kg) body weight orally once daily.
Administer for up to 28 consecutive days.
Treatment may be repeated after a minimum 7-day pause.
Shake well before use.
Dose rounded to nearest 0.1 mL.
Use supplied dosing syringe only.

Body Weight Dosing Guide:
3.4–4.4 lb: 0.4 mL
4.5–5.5 lb: 0.5 mL
5.6–6.6 lb: 0.6 mL
6.7–7.7 lb: 0.7 mL
7.8–8.8 lb: 0.8 mL
8.9–9.9 lb: 0.9 mL
10–11 lb: 1.0 mL
11.1–12.1 lb: 1.1 mL
12.2–13.2 lb: 1.2 mL

Overdoses / Side effects / Contraindications /Warnings:

Common adverse effects: vomiting, diarrhea, decreased appetite, hypertension, thrombocytosis, increased potassium, increased creatinine, increased phosphorus, increased sodium, and mild injection-independent hematologic changes.
Serious adverse effects: thromboembolic disease, seizures, severe anemia, dehydration, and worsening CKD.
Contraindicated in cats with hypersensitivity to molidustat or formulation components.
Use cautiously in cats with a history of seizures.
Monitor blood pressure regularly.
Not for human use.
Keep away from children and animals.

Pharmaceutical precautions / Instructions:

Monitor hematocrit (HCT) or packed cell volume (PCV) weekly during treatment.
Recheck HCT/PCV periodically after treatment discontinuation.
Separate administration from phosphate binders or mineral supplements containing calcium, iron, magnesium, or aluminum by at least 1 hour.
Store at 20°C–25°C (68°F–77°F); excursions permitted between 15°C–30°C.
Shake well before each use.

Safety: Age / Pregnancy / Withdrawal:

Safety not established in cats less than 1 year old.
Not evaluated in breeding, pregnant, or lactating cats.
Molidustat is excreted into milk in laboratory animals.
No withdrawal period applicable for companion animals.

Substitute: Supportive CKD anemia management therapies