DESMOPRESSIN ACETATE injection, solution

দেশ: মার্কিন যুক্তরাষ্ট্র

ভাষা: ইংরেজি

সূত্র: NLM (National Library of Medicine)

সক্রিয় উপাদান:

desmopressin acetate (UNII: XB13HYU18U) (desmopressin - UNII:ENR1LLB0FP)

থেকে পাওয়া:

Avenacy, Inc.

প্রশাসন রুট:

INTRAVENOUS

প্রেসক্রিপশন টাইপ:

PRESCRIPTION DRUG

থেরাপিউটিক ইঙ্গিত:

Desmopressin Acetate Injection is indicated as antidiuretic replacement therapy in the management of central (cranial) diabetes insipidus and for the management of the temporary polyuria and polydipsia following head trauma or surgery in the pituitary region. Limitations of Use Desmopressin Acetate is ineffective and not indicated for the treatment of nephrogenic diabetes insipidus. Desmopressin Acetate Injection is indicated for patients with hemophilia A with factor VIII coagulant activity levels greater than 5% without factor VIII antibodies to: - Maintain hemostasis during surgical procedures and postoperatively - Reduce bleeding with episodes of spontaneous or traumatic injuries such as hemarthroses, intramuscular hematomas, or mucosal bleeding. Desmopressin Acetate Injection is indicated for patients with mild to moderate von Willebrand's disease (Type I) with factor VIII levels greater than 5% to: - Maintain hemostasis during surgical procedures and postoperatively - Reduce bleeding with episodes of spontaneous or traumatic injuries such as hemarthroses, intramuscular hematomas, or mucosal bleeding. Limitations of Use Desmopressin Acetate is not indicated for the treatment of severe von Willebrand's disease (Type I) and when there is evidence of an abnormal molecular form of factor VIII antigen [see Warnings and Precautions (5.2)]. Desmopressin Acetate Injection is contraindicated in patients with known hypersensitivity to desmopressin acetate or to any of the components of Desmopressin Acetate Injection [see Warnings and Precautions (5.4), Adverse Reactions (6), Description (11)]. Desmopressin Acetate Injection is contraindicated in patients with the following conditions due to an increased risk of hyponatremia: - Moderate to severe renal impairment defined as a creatinine clearance below 50 mL/min [see Use in Specific Populations (8.5, 8.6) and Clinical Pharmacology (12.3)]. - Hyponatremia or a history of hyponatremia [see Warnings and Precautions (5.1), Drug Interactions (7.1), Use in Specific Populations (8.4, 8.5)]. - Known or suspected syndrome of inappropriate antidiuretic hormone (SIADH) secretion [see Warnings and Precautions (5.1)] . - Polydipsia [see Warnings and Precautions (5.1)] . - Concomitant use with loop diuretics [see Boxed Warning]. - Concomitant use with systemic or inhaled glucocorticoids [see Boxed Warning] . - During illnesses that can cause fluid or electrolyte imbalance, such as gastroenteritis, salt-wasting nephropathies, or systemic infection [see Boxed Warning] . Desmopressin Acetate Injection is contraindicated in patients with the following conditions because fluid retention increases the risk of worsening the underlying condition: - Heart failure - Uncontrolled hypertension Risk Summary Prolonged experience with Desmopressin Acetate Injection in pregnant women over several decades, based on the available published literature and case reports, have not identified a drug associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. In addition, in vitro studies with human placenta demonstrate poor placental transfer of desmopressin. No adverse developmental outcomes were observed in animal reproductive and developmental studies following administration of desmopressin acetate during organogenesis to pregnant rats and rabbits, at doses 130- and 110- times, respectively, the recommended dose of 18 mcg for a 60 kg patient, based on body surface area (mg/m2 ). The estimated background risk of major birth defects and miscarriage for the indicated population are unknown. In the US 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. Clinical Considerations Disease Associated Maternal and Embryo-fetal Risk Pregnant women with Hemophilia A or von Willebrand's disease may be at an increased risk for bleeding diatheses and hemorrhagic events at delivery. An affected newborn may also be at risk of bleeding diatheses. Data Animal Data In a developmental toxicity study in rats, desmopressin acetate was administered intravenously at doses of 9.68, 48.4, or 241 mcg/kg/day during the period of organogenesis (gestations days 7 to 17). Laparohysterectomy for fetal examinations were conducted on gestation day 20 for twenty females in each group; the remaining 10 females were allowed to litter in order to determine any postnatal effects that might be attributable to pre-natal treatment. No effects were seen on maternal and fetal survival, growth and morphology or post-natal offspring survival, growth, development, behavior and reproductive performance up to 241 mcg/kg/day (130 times the 18 mcg dose received by a 60 kg patient based on body surface area). In an embryo-fetal development study and a pre- and postnatal development study in rabbits, desmopressin acetate was administered subcutaneously at doses of 2, 20 or 200 mcg/kg/day (embryo-fetal development) and 0.1, 1 or 10 mcg/kg/day (pre- and postnatal development) during the period of organogenesis (gestation days 6 to 18). No effects on maternal and fetal survival or morphology were observed in both studies at doses of up to 200 mcg/kg/day (215x the 18 mcg dose received by a 60 kg patient based on body surface area) nor were there effects in the pre- and postnatal development study on parturition, postnatal survival, growth, development or behavior, up to the highest dose tested of 10 mcg/kg/day (11 times the 18 mcg dose received by a 60 kg patient, based on body surface area). Risk Summary Breastfeeding is not expected to result in clinically relevant exposure of the infant to desmopressin following maternal administration. Desmopressin is poorly transferred into human breastmilk at negligible amounts (see Data) . There is no information on the effects of desmopressin on the breastfed child or on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Desmopressin Acetate Injection and any potential adverse effects on the breastfed child from Desmopressin Acetate Injection or from the underlying maternal condition. Data The breast milk of lactating women was collected over 8 hours following administration of 300 mcg desmopressin nasal spray. The expected area under the plasma concentration time curve (AUC) of desmopressin following 300 mcg nasal spray is 2.4-fold higher to that of 4 mcg Desmopressin Acetate Injection. Based on the measured concentrations of desmopressin following intranasal administration, the amounts of desmopressin that may be transferred to a breastfed infant correspond to 0.0001 to 0.005% of the dose administered. The safety and effectiveness of Desmopressin Acetate have been established in pediatric patients 3 months of age and older with hemophilia A and von Willebrand's disease and pediatric patients aged 12 years and older with diabetes insipidus. The safety and effectiveness of Desmopressin Acetate have not been established in infants less than 3 months of age with hemophilia A or von Willebrand's disease or pediatric patients under 12 years of age with diabetes insipidus. Use in infants and pediatric patients will require careful fluid intake restriction to prevent possible hyponatremia and water intoxication. Fluid restriction should be discussed with the patient and/or guardian [see Warnings and Precautions (5.1)]. Clinical studies of Desmopressin Acetate Injection 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. In general, dose selection should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. This drug is known to be substantially excreted by the kidney, and the risk of adverse 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. Desmopressin Acetate is contraindicated in patients with moderate to severe renal impairment (defined as a creatinine clearance below 50 mL/min) [see Contraindications (4), Use in Specific Populations (8.6), Clinical Pharmacology (12.3)]. Use of Desmopressin Acetate Injection in geriatric patients will require careful fluid intake restrictions to prevent possible hyponatremia and water intoxication. Fluid restriction should be discussed with the patient [see Warnings and Precautions (5.1)]. Desmopressin acetate is substantially excreted by the kidney, and the risk of adverse reactions may be greater in patients with renal impairment than patients with normal renal function. Desmopressin Acetate is contraindicated in patients with estimated CLcr by Cockcroft-Gault equation less than 50 mL/min [see Contraindications (4), Clinical Pharmacology (12.3)].

পণ্য সারাংশ:

Desmopressin Acetate Injection, USP 4 mcg per mL is a sterile solution supplied in type 1 glass vials with rubber stopper and flip-off seal as follows: Store refrigerated between 2° and 8°C (36° and 46°F). Sterile, Nonpyrogenic. The container closure is not made with natural rubber latex.

অনুমোদন অবস্থা:

Abbreviated New Drug Application

পণ্য বৈশিষ্ট্য

DESMOPRESSIN ACETATE- DESMOPRESSIN ACETATE INJECTION, SOLUTION
AVENACY, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DESMOPRESSIN ACETATE
INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
DESMOPRESSIN
ACETATE INJECTION.
DESMOPRESSIN ACETATE INJECTION, FOR INTRAVENOUS OR SUBCUTANEOUS USE
INITIAL U.S. APPROVAL: 1978
WARNING: HYPONATREMIA
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
DESMOPRESSIN ACETATE CAN CAUSE HYPONATREMIA, WHICH MAY BE
LIFE-THREATENING IF
SEVERE. (5.1)
DESMOPRESSIN ACETATE IS CONTRAINDICATED IN PATIENTS AT INCREASED RISK
OF SEVERE
HYPONATREMIA, SUCH AS PATIENTS WITH EXCESSIVE FLUID INTAKE, ILLNESSES
THAT CAN CAUSE
FLUID OR ELECTROLYTE IMBALANCES, AND IN THOSE USING LOOP DIURETICS OR
SYSTEMIC OR
INHALED GLUCOCORTICOIDS. (4, 5.1)
ENSURE SERUM SODIUM CONCENTRATION IS NORMAL BEFORE STARTING OR
RESUMING
DESMOPRESSIN ACETATE. MEASURE SERUM SODIUM WITHIN 1 WEEK AND
APPROXIMATELY 1
MONTH AFTER STARTING THERAPY AND PERIODICALLY DURING TREATMENT. MORE
FREQUENTLY
MONITOR SERUM SODIUM IN PATIENTS 65 YEARS OF AGE AND OLDER AND IN
PATIENTS AT
INCREASED RISK OF HYPONATREMIA. (2.1, 5.1)
IF HYPONATREMIA OCCURS, INTERRUPT OR DISCONTINUE DESMOPRESSIN ACETATE.
(5.1)
INDICATIONS AND USAGE
Desmopressin Acetate Injection is a vasopressin analog used for:
Central Diabetes Insipidus - as antidiuretic replacement therapy in
the management of central (cranial)
diabetes insipidus and for the management of the temporary polyuria
and polydipsia following head
trauma or surgery in the pituitary region. (1.1)
Hemophilia A- for patients with factor VIII coagulant activity levels
greater than 5% to maintain
hemostasis during surgical procedures and postoperatively or reduce
bleeding with episodes of
spontaneous or traumatic injuries such as hemarthroses, intramuscular
hematomas, or mucosal
bleeding. (1.2)
von Willebrand's disease (Type I) - for patients with mild to moderate
disease with factor VIII levels
greater th