VENOFER- IRON SUCROSE injection, solution

Страна: Соединенные Штаты

Язык: английский

Источник: NLM (National Library of Medicine)

Активный ингредиент:

IRON SUCROSE (UNII: FZ7NYF5N8L) (FERRIC CATION - UNII:91O4LML611)

Доступна с:

HF Acquisition Co LLC, DBA HealthFirst

Администрация маршрут:

INTRAVENOUS

Тип рецепта:

PRESCRIPTION DRUG

Терапевтические показания :

Venofer is indicated for the treatment of iron deficiency anemia (IDA) in patients with chronic kidney disease (CKD). Known hypersensitivity to Venofer. 8.1 Pregnancy Risk Summary Published studies on intravenous iron sucrose treatment after the first trimester of pregnancy have not shown adverse maternal or fetal outcomes (see Data). Available reports of intravenous iron sucrose use in pregnant women during the first trimester are insufficient to assess the risk of major birth defects and miscarriage. There are risks to the mother and fetus associated with untreated IDA in pregnancy as well as risks to the fetus associated with maternal severe hypersensitivity reactions (see Clinical Considerations). Animal reproduction studies of iron sucrose administered to rats and rabbits during the period of organogenesis at elemental iron doses equivalent to the maximum recommended human dose based on body surface area revealed no evidence of harm to the fetus (see Data). The estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. Adverse outcomes in pregnancy occur regardless of the health of the mother or the use of medications. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically-recognized pregnancies is 2-4% and 15-20%, respectively. Clinical Considerations Disease-associated maternal and/or embryo/fetal risk Iron deficiency anemia during pregnancy should be treated. Untreated IDA in pregnancy is associated with adverse maternal outcomes such as post-partum anemia. Adverse pregnancy outcomes associated with IDA include increased risk for preterm delivery and low birth weight. Fetal/Neonatal adverse reactions Severe adverse reactions including circulatory failure (severe hypotension, shock including in the context of anaphylactic reaction) may occur in pregnant women with parenteral iron products (such as Venofer) which may cause fetal bradycardia, especially during the second and third trimester. Data Human Data Published data from randomized controlled studies and prospective observational studies on the use of Venofer in pregnant women have not reported an association of Venofer and adverse developmental outcomes. However, these studies did not include women exposed during the first trimester of pregnancy and were not designed to assess the risk of major birth defects. Maternal adverse events reported in these studies are similar to those reported during clinical trials in adult males and non-pregnant females [seeAdverse Reactions ( 6.1)]. Animal Data Iron sucrose was administered intravenously to rats and rabbits during the period of organogenesis at elemental iron doses up to 13 mg/kg/day (0.25 times or equivalent to the maximum recommended human dose based on body surface area, respectively) and revealed no evidence of harm to the fetus. 8.2 Lactation Risk Summary Iron sucrose is present in human milk, and available published reports following exposure to 100-300 mg intravenous iron sucrose have not reported adverse reactions in breastfed infants (see Data). There are no data on the effects on milk production. The developmental and health benefits of breastfeeding should be considered, along with the mother’s clinical need for Venofer and any potential adverse effects on the breastfed child from Venofer or from the underlying maternal condition. Data A published study showed no difference in iron concentration in the colostrum of 10 iron deficient breastfeeding women who were 2 to 3 days postpartum and received a single dose of 100 mg of intravenous iron sucrose compared to 5 breastfeeding women who received no iron. These results may underestimate the amount of iron in breastmilk following the standard dose of Venofer. A published report of 78 breastfeeding women who received 300 mg of intravenous iron sucrose over 3 days (infant age not reported) did not report on the safety of iron sucrose in breastfed infants; however adverse reactions in breastfed infants were not reported. Clinical Considerations Monitor breastfed infants for gastrointestinal toxicity (constipation, diarrhea). 8.4 Pediatric Use Safety and effectiveness of Venofer for iron replacement treatment in pediatric patients with dialysis-dependent or non-dialysis-dependent CKD have not been established. Safety and effectiveness of Venofer for iron maintenance treatment in pediatric patients 2 years of age and older with dialysis-dependent or non-dialysis-dependent CKD receiving erythropoietin therapy were studied. Venofer at doses of 0.5 mg/kg, 1 mg/kg, and 2 mg/kg was administered. All three doses maintained hemoglobin between 10.5 g/dL and 14.0 g/dL in about 50% of subjects over the 12-week treatment period with stable EPO dosing [see Clinical Studies ( 14.7)]. Venofer has not been studied in patients younger than 2 years of age. In a country where Venofer is available for use in children, at a single site, five premature infants (weight less than 1,250 g) developed necrotizing enterocolitis and two of the five died during or following a period when they received Venofer, several other medications and erythropoietin. Necrotizing enterocolitis may be a complication of prematurity in very low birth weight infants. No causal relationship to Venofer or any other drugs could be established. 8.5 Geriatric Use Of the 1,051 patients in two post-marketing safety studies of Venofer, 40% were 65 years and older. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and 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. In general, dose administration to an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Обзор продуктов:

16.1 How Supplied Venofer is supplied sterile in 10 mL, 5 mL, and 2.5 mL single-dose vials. Each 10 mL vial contains 200 mg elemental iron, each 5 mL vial contains 100 mg elemental iron, and each 2.5 mL vial contains 50 mg elemental iron (20 mg/mL). 16.2 Stability and Storage Contains no preservatives. Store in original carton at 20°C to 25°C (68° F to 77° F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Do not freeze. Syringe Stability: Venofer, when diluted with 0.9% NaCl at concentrations ranging from 2 mg to 10 mg of elemental iron per mL, or undiluted (20 mg elemental iron per mL) and stored in a plastic syringe, was found to be physically and chemically stable for 7 days at controlled room temperature (25°C ± 2°C) and under refrigeration (4°C ± 2°C). Intravenous Admixture Stability: Venofer, when added to intravenous infusion bags (PVC or non-PVC) containing 0.9% NaCl at concentrations ranging from 1 mg to 2 mg of elemental iron per mL, has been found to be physically and chemically stable for 7 days at controlled room temperature (25°C ± 2°C). Do not dilute to concentrations below 1 mg/mL. Do not mix Venofer with other medications or add to parenteral nutrition solutions for intravenous infusion. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to infusion.

Статус Авторизация:

New Drug Application

Характеристики продукта

VENOFER (IRON SUCROSE)- VENOFER (IRON SUCROSE) INJECTION, SOLUTION
HF ACQUISITION CO LLC, DBA HEALTHFIRST
----------
VENOFER (IRON SUCROSE INJECTION,USP) 100MG ELEMENTAL IRON PER 5ML
(20MG/ML)
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
VENOFER ® safely and effectively. See full prescribing information
for VENOFER.
Venofer (iron sucrose) injection, for intravenous use
Initial U.S. Approval: 2000
INDICATIONS AND USAGE
Venofer is an iron replacement product indicated for the treatment of
iron deficiency
anemia (IDA) in patients with chronic kidney disease (CKD). ( 1 )
DOSAGE AND ADMINISTRATION
DOSAGE FORMS AND STRENGTHS
Injection: 50 mg/2.5 mL, 100 mg/5 mL, or 200 mg/10 mL (20 mg/mL) in
single-dose
vials. ( 3)
CONTRAINDICATIONS
Known hypersensitivity to Venofer ( 4)
WARNINGS AND PRECAUTIONS
Hypersensitivity Reactions: Observe for signs and symptoms of
hypersensitivity during
and after Venofer administration for at least 30 minutes and until
clinically stable
following completion of each administration. Only administer Venofer
when personnel
and therapies are immediately available for the treatment of serious
hypersensitivity
reactions. ( 5.1)
Hypotension: May cause hypotension. Monitor for signs and symptoms of
hypotension
during and following each administration. ( 5.2)
Iron Overload: Regularly monitor hematologic responses during therapy.
Do not
administer to patients with iron overload. ( 5.3)
ADVERSE REACTIONS
Adult patients: The most common adverse reactions (≥2%) are
diarrhea, nausea,
vomiting, headache, dizziness, hypotension, pruritus, pain in
extremity, arthralgia, back
pain, muscle cramp, injection site reactions, chest pain, and
peripheral edema. ( 6.1)
Pediatric patients: The most common adverse reactions (≥2%) are
headache,
respiratory tract viral infection, peritonitis, vomiting, pyrexia,
dizziness, cough, nausea,
arteriovenous fistula thrombosis, hypotension, and hypertension. (
6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Americ