CYKLOKAPRON- tranexamic acid injection, solution

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

TRANEXAMIC ACID (UNII: 6T84R30KC1) (TRANEXAMIC ACID - UNII:6T84R30KC1)

Dostępny od:

Pfizer Laboratories Div Pfizer Inc

INN (International Nazwa):

TRANEXAMIC ACID

Skład:

TRANEXAMIC ACID 100 mg in 1 mL

Droga podania:

INTRAVENOUS

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

CYKLOKAPRON® is indicated in patients with hemophilia for short-term use (2 to 8 days) to reduce or prevent hemorrhage and reduce the need for replacement therapy during and following tooth extraction. CYKLOKAPRON Injection is contraindicated: Risk Summary Available data from published studies, case series and case reports with tranexamic acid use in pregnant women in the second and third trimester and at the time of delivery have not clarified whether there is a drug-associated risk of miscarriage or adverse maternal or fetal outcomes. There are 2 (0.02%) infant cases with structural abnormalities that resulted in death when tranexamic acid was used during conception or the first trimester of pregnancy; however, due to other confounding factors the risk of major birth defects with use of tranexamic acid during pregnancy is not clear. Tranexamic acid is known to pass the placenta and appears in cord blood at concentrations approximately equal to maternal concentration (see Data) . Reproduction studies performed in mice, rats, and rabbits have not revealed any adverse effects on the fetus due to tranexamic acid administered during organogenesis. Doses examined were multiples of up to 3 times (mouse), 6 times (rat), and 3 times (rabbit) the maximum human dose based on body surface area in the mouse, rat, and rabbit, respectively (see Data) . The estimated background risk for major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in the clinically recognized pregnancies is 2–4% and 15–20%, respectively. It is not known whether tranexamic acid use in pregnant women may cause a drug-associated risk of miscarriage or adverse maternal or fetal outcomes. For decisions regarding the use of CYKLOKAPRON during pregnancy, the potential risk of CYKLOKAPRON administration on the fetus should always be considered along with the mother's clinical need for CYKLOKAPRON; an accurate risk-benefit evaluation should drive the treating physician's decision. Data Human Data Tranexamic acid passes through the placenta. The concentration in cord blood after an intravenous injection of 10 mg/kg to pregnant women is about 30 mg/L, as high as in the maternal blood. There were 13 clinical studies that described fetal and/or neonatal functional issues such as low Apgar score, neonatal sepsis, cephalohematoma and 9 clinical studies that discussed alterations to growth including low birth weight and preterm birth at 22–36 weeks of gestation in fetuses and infants exposed to tranexamic acid in-utero. Animal Data In embryo-fetal development studies, tranexamic acid was administered to pregnant mice from Gestation day (GD) 6 through GD 12 and rats from GD 9 through GD 14 at daily doses of 0.3 or 1.5 g/kg. There was no evidence of adverse developmental outcomes in mice and rats at multiple of 3 and 6 times the maximum recommended human dose based on body surface area in the mouse and rat, respectively. In rabbits, tranexamic acid was administered intravenously at doses of 50, 100, or 200 mg/kg/day or orally at doses of 100, 200, or 400 mg/kg/day from GD 6 through GD 18. There was no evidence of adverse developmental outcomes at dose multiples of 2 or 3 times, respectively, the maximum recommended human dose based on body surface area. Intravenous doses of 200 mg/kg/day showed slightly retarded weight gain in pregnant rabbits. Risk Summary Published literature reports the presence of tranexamic acid in human milk. There are no data on the effects of tranexamic acid on the breastfed child or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for CYKLOKAPRON and any potential adverse effects on the breastfed child from CYKLOKAPRON or from the underlying maternal condition. Contraception Concomitant use of CYKLOKAPRON, which is an antifibrinolytic, with hormonal contraceptives may increase the risk for thromboembolic adverse reactions. Advise patients to use an effective alternative (nonhormonal) contraceptive method [see Warnings and Precautions (5.1), Drug Interactions (7.1)] . There are limited data concerning the use of CYKLOKAPRON in pediatric patients with hemophilia who are undergoing tooth extraction. The limited data suggest that there are no significant pharmacokinetic differences between adults and pediatric patients. Clinical studies of CYKLOKAPRON did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function [see Dosage and Administration (2.2), Clinical Pharmacology (12.3)] . Reduce the dosage of CYKLOKAPRON in patients with renal impairment, based on the patient's serum creatinine [see Dosage and Administration (2.2), Clinical Pharmacology (12.3)] .

Podsumowanie produktu:

CYKLOKAPRON Injection 100 mg/mL   NDC 0013-1114-10 10 × 10 mL single-dose ampules   NDC 0013-1114-15 1 × 10 mL single-dose ampule CYKLOKAPRON Injection 100 mg/mL   NDC 0013-1114-21 10 × 10 mL single-dose vials Store at 20ºC to 25°C (68ºF to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

Status autoryzacji:

New Drug Application

Charakterystyka produktu

CYKLOKAPRON- TRANEXAMIC ACID INJECTION, SOLUTION
PFIZER LABORATORIES DIV PFIZER INC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CYKLOKAPRON SAFELY
AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR CYKLOKAPRON.
CYKLOKAPRON (TRANEXAMIC ACID) INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 1986
INDICATIONS AND USAGE
CYKLOKAPRON is an antifibrinolytic indicated in patients with
hemophilia for short-term use (2 to 8 days) to
reduce or prevent hemorrhage and reduce the need for replacement
therapy during and following tooth
extraction. (1)
DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
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CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
Most common adverse reactions are nausea, vomiting, diarrhea, allergic
dermatitis, giddiness,
hypotension, and thromboembolic events. (6)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT PFIZER INC. AT
1-800-438-1985 OR FDA AT
1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
Prothrombotic Medical Products: Avoid concomitant use, can further
increase the risk of thromboembolic
adverse reactions associated with tranexamic acid. (5.1, 7.1, 8.3)
SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 1/2024
®
Before Extraction: Administer 10 mg/kg actual body weight of
CYKLOKAPRON intravenously with
replacement therapy. (2.1)
After Extraction: Administer 10 mg/kg actual body weight 3 to 4 times
daily for 2 to 8 days. Infuse no
more than 1 mL/minute to avoid hypotension. (2.1).
Reduce the dosage for patients with renal impairment. (2.2, 8.6)
Injection: 1,000 mg tranexamic acid (100 mg/mL) in 10 mL single-dose
ampules (3)
Injection: 1,000 mg tranexamic acid (100 mg/mL) in 10 mL single-dose
vials (3)
In patients with subarachnoid hemorrhage, due to risk of cerebral
edema and cerebral infarction. (4)
In patients with active intravascular clotting. (4)
In patients with severe hypersensitivity reactions to tranexamic acid
or any of the ingredi