TERLIVAZ- terlipressin injection, powder, lyophilized, for solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Terlipressin (UNII: 7Z5X49W53P) (Terlipressin - UNII:7Z5X49W53P)

Available from:

Mallinckrodt Hospital Products Inc.

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

TERLIVAZ is indicated to improve kidney function in adults with hepatorenal syndrome with rapid reduction in kidney function. Limitation of Use Patients with a serum creatinine > 5 mg/dL are unlikely to experience benefit. TERLIVAZ is contraindicated in patients experiencing hypoxia or worsening respiratory symptoms. TERLIVAZ is contraindicated in patients with ongoing coronary, peripheral or mesenteric ischemia. Risk Summary Based on findings from the published literature and on its mechanism of action, TERLIVAZ may cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1)] . In small, published studies, administration of a single intravenous dose of terlipressin to pregnant women during the first trimester induced uterine contractions and endometrial ischemia. The limited published data are not sufficient to determine a drug-associated risk for major birth defects or miscarriage. If TERLIVAZ is used during pregnancy, the patient should be informed of the potential risk to the fetus. The background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data In published reproductive toxicity animal studies, administration of terlipressin to pregnant guinea pigs at doses lower than the maximum recommended human dose of 4 mg/day caused a marked decrease in blood flow to the uterus and placenta. In rabbits, terlipressin is both embryotoxic and teratogenic (increased resorptions, increased implantation loss, fetal anomalies and fetal deformities). Risk Summary There are no data on the presence of terlipressin in human or animal milk, the effects on the breastfed infant, or the effect on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for TERLIVAZ and any potential adverse effects on the breastfed child from TERLIVAZ or from the underlying maternal condition. Safety and effectiveness of TERLIVAZ have not been established in pediatric patients. Of the total number of patients in clinical studies treated with TERLIVAZ, 55 (16%) were ≥65 years of age. No overall differences in safety or effectiveness were observed between these subjects and younger subjects; other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. No dose adjustment is required in patients with hepatic impairment [see Clinical Pharmacology (12.3)] .

Product summary:

TERLIVAZ is supplied as a sterile, preservative-free, white to off-white lyophilized powder in single-dose vials containing 0.85 mg of terlipressin. Each vial is supplied in a carton (NDC 43825-200-01). Store TERLIVAZ vials in the carton under refrigerated conditions at 2°C to 8°C (36°F to 46°F). Store in the original carton to protect from light prior to reconstitution.

Authorization status:

New Drug Application

Summary of Product characteristics

TERLIVAZ- TERLIPRESSIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
MALLINCKRODT HOSPITAL PRODUCTS INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
TERLIVAZ SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR TERLIVAZ.
TERLIVAZ (TERLIPRESSIN) FOR INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 2022
WARNING: SERIOUS OR FATAL RESPIRATORY FAILURE
TERLIVAZ MAY CAUSE SERIOUS OR FATAL RESPIRATORY FAILURE. PATIENTS WITH
VOLUME
OVERLOAD OR WITH ACLF GRADE 3 ARE AT INCREASED RISK. ASSESS
OXYGENATION SATURATION
(E.G., SPO ) BEFORE INITIATING TERLIVAZ.
DO NOT INITIATE TERLIVAZ IN PATIENTS EXPERIENCING HYPOXIA (E.G., SPO
<90%) UNTIL
OXYGENATION LEVELS IMPROVE. MONITOR PATIENTS FOR HYPOXIA USING
CONTINUOUS PULSE
OXIMETRY DURING TREATMENT AND DISCONTINUE TERLIVAZ IF SPO DECREASES
BELOW 90%
(2.1, 4, 5.1).
INDICATIONS AND USAGE
TERLIVAZ is a vasopressin receptor agonist indicated to improve kidney
function in adults with hepatorenal
syndrome with rapid reduction in kidney function. (1)
Limitation of Use
Patients with a serum creatinine >5 mg/dL are unlikely to experience
benefit. (1)
DOSAGE AND ADMINISTRATION
Prior to initial dosing, assess patients for ACLF Grade 3 and obtain
patient baseline oxygenation level.
Monitor patient oxygen saturation with pulse oximetry. (2.1)
Recommended Dosage Regimen: (2.2)
Days 1 to 3 administer TERLIVAZ 0.85 mg (1 vial) intravenously every 6
hours.
Day 4: Assess serum creatinine (SCr) versus baseline.
If SCr has decreased by at least 30% from baseline, continue TERLIVAZ
0.85 mg (1 vial)
intravenously every 6 hours.
If SCr has decreased by less than 30% from baseline, dose may be
increased to TERLIVAZ 1.7 mg (2
vials) intravenously every 6 hours.
If SCr is at or above baseline value, discontinue TERLIVAZ.
Continue TERLIVAZ until 24 hours after two consecutive SCr ≤1.5
mg/dL values at least 2 hours
apart or a maximum of 14 days.
See full prescribing information for instructions on preparation and
administration