براکتانت
Beractant (Survanta)
براکتانت

نام ژنریک

Beractant

شکل دارویی

اشكال دارويي:


Suspension : 25 mg/ml

موارد مصرف

موارد و مقدار مصرف


پيشگيري و درمان سندرم زجر تنفسي (RDS) در نوزادان نارس


نوزادان: 100 ميلي‌گرم فسفوليپيد به ازاي هر كيلوگرم وزن هنگام تولد
(ml/kg 4) از طريق تزريق داخل تراشه در عرض 15 دقيقه پس از تولد جهت پيشگيري يا در عرض 8 ساعت پس از تولد جهت درمان. در 48 ساعت اول تولد مي‌توان 4 دوز از دارو را تجويز كرد. دوزها بايد با فواصل حداقل 6 ساعت يا بيشتر تجويز شوند.


موارد منع مصرف

موارد منع مصرف و احتياط


موارد منع مصرفي شناخته نشده است.


عوارض جانبی دارو

عوارض جانبي


قلبي ـ عروقي: افت فشارخون، براديكاردي گذرا، تنگي عروق.


خوني: كاهش و افزايش دي‌اكسيدكربن خون.


تنفسي: كاهش اكسيژن اشباع، آپنه، انسداد يا ريفلاكس لوله تراشه.


پوست: رنگ پريدگي.


مسموميت و درمان


مصرف بيش از حد ممكن است باعث انسداد مجاري تنفسي شود. درمان بايد شامل موارد حمايتي و علامتي است.


موارد قابل توجه

-

تداخل دارویی

تداخل دارويي


تداخل دارويي معني‌داري گزارش نشده است.

مکانیزم اثر

تداخل دارويي


تداخل دارويي معني‌داري گزارش نشده است.

فارماكوكینتیك

فارماكوكينتيك


جذب: براكتانت مستقيم در ريه‌ها تجويز مي‌شود.


پخش: دارو در سطح آلوئول‌هاي ريوي توزيع مي‌شود.


متابوليسم: چربي‌هاي آن از طريق مسير داخلي در چرخه حذف و به كارگيري دوباره سورفكتانت قرار مي‌گيرند.


دفع: كليرانس آلوئولي اجزاء ليپيدي سريع است.


سایر اطلاعات

طبقه‌بندي فارماكولوژيك: عصاره ريه گاو


طبقه‌بندي درماني: سورفكتانت ريوي


طبقه‌بندي مصرف در بارداري: مشخص نيست.


نام‌هاي تجاري: Survanta


ملاحظات اختصاصي


1- در صورت استفاده از دوز پيشگيري دارو قبل از تولد نوزاد آماده سازي شود.


2- قبل از تزريق دارو فرآورده را در دماي اتاق به مدت 20 دقيقه يا در دست 8 دقيقه قرار دهيد. از گرم كردن مصنوعي آن خودداري نماييد.


3- پيش از تجويز دارو از قرارگيري مناسب لوله تراشه و كاتتر اطمينان حاصل شود.


4- دوز كلي دارو بايد تعيين و مقادير اضافه از راه كاتتر دور ريخته شود و در نهايت دوز كلي از راه سرنگ تزريق شود. از فيلتر كردن و تكان دادن محتويات سرنگ خودداري شود.


5- به منظور توزيع همگن دارو، هر دوز دارو به 4 قسمت تقسيم شده و هر قسمت در يك وضعيت بدني از نوزاد تجويز شود. از ساكشن نمودن مسير هوايي در عرض يك ساعت پس از تجويز دارو خودداري شود.


6- دارو ممكن است باعث بروز كراكل‌هاي زودگذر شود. تنها در صورت بروز انسداد مجاري تنفسي از ساكشن استفاده شود.


7- نوزاد به طور مكرر از نظر براديكاردي كاهش اشباع اكسيژن مورد بررسي قرار گيرد.


8- در عرض چند دقيقه بهبود مشخصي در اكسيژن رساني مشاهده شده ولي بهبود معني‌دار به طور آهسته در عرضه 72-48 ساعت حاصل مي‌شود.


نكات قابل توصيه به بيمار


1- والدين نوزاد را در رابطه با نياز دارو آگاه نموده و در رابطه با اثر دارو و روش تجويز توضيح دهيد.


2- والدين را تشويق كنيد سوالات خود را بپرسند و نگرانيهايشان را بيان كنند.


اثر بر آزمايشهاي تشخيصي


گزارشي وجود ندارد.


Beractant (Survanta)

SURVANTA®
(beractant) Intratracheal Suspension

Sterile Suspension.

For Intratracheal Administration Only

DRUG DESCRIPTION

SURVANTA® (beractant) Intratracheal Suspension is a sterile, non-pyrogenic pulmonary surfactant intended for intratracheal use only. It is a natural bovine lung extract containing phospholipids, neutral lipids, fatty acids, and surfactant-associated proteins to which colfosceril palmitate (dipalmitoylphosphatidylcholine), palmitic acid, and tripalmitin are added to standardize the composition and to mimic surface-tension lowering properties of natural lung surfactant. The resulting composition provides 25 mg/mL phospholipids (including 11.0-15.5 mg/mL disaturated phosphatidylcholine), 0.5-1.75 mg/mL triglycerides, 1.4-3.5 mg/mL free fatty acids, and less than 1.0 mg/mL protein. It is suspended in 0.9% sodium chloride solution, and heat-sterilized. SURVANTA (beractant) contains no preservatives. Its protein content consists of two hydrophobic, low molecular weight, surfactant-associated proteins commonly known as SP-B and SP-C. It does not contain the hydrophilic, large molecular weight surfactant-associated protein known as SP-A.

Each mL of SURVANTA (beractant) contains 25 mg of phospholipids. It is an off-white to light brown liquid supplied in single-use glass vials containing 4 mL (100 mg phospholipids) or 8 mL (200 mg phospholipids).

What are the possible side effects of beractant (Survanta Intratracheal)?

Get emergency medical help if your child has any of these signs of an allergic reaction: hives; difficulty breathing; swelling of the face, lips, tongue, or throat.

Tell your child's caregivers at once if the child has any of these serious side effects:

  • pale skin;
  • slow heartbeat;
  • breathing that stops;
  • urinating less than usual; or
  • blood in the urine.

Less serious side effects include:

  • noisy breathing;
  • feeding or bowel problems; or
  • bleeding around the endotracheal...

Read All Potential Side Effects and See Pictures of Survanta »

Last reviewed on RxList: 9/9/2008
This monograph has been modified to include the generic and brand name in many instances.

INDICATIONS

SURVANTA (beractant) is indicated for prevention and treatment (“rescue”) of Respiratory Distress Syndrome (RDS) (hyaline membrane disease) in premature infants. SURVANTA (beractant) significantly reduces the incidence of RDS, mortality due to RDS and air leak complications.

Prevention

In premature infants less than 1250 g birth weight or with evidence of surfactant deficiency, give SURVANTA (beractant) as soon as possible, preferably within 15 minutes of birth.

Rescue

To treat infants with RDS confirmed by x-ray and requiring mechanical ventilation, give SURVANTA (beractant) as soon as possible, preferably by 8 hours of age.

DOSAGE AND ADMINISTRATION

For intratracheal administration only.

SURVANTA (beractant) should be administered by or under the supervision of clinicians experienced in intubation, ventilator management, and general care of premature infants.

Marked improvements in oxygenation may occur within minutes of administration of SURVANTA (beractant) . Therefore, frequent and careful clinical observation and monitoring of systemic oxygenation are essential to avoid hyperoxia.

Review of audiovisual instructional materials describing dosage and administration procedures is recommended before using SURVANTA (beractant) . Materials are available upon request from Ross Products Division.

Dosage

Each dose of SURVANTA (beractant) is 100 mg of phospholipids/kg birth weight (4 mL/kg). The SURVANTA (beractant) Dosing Chart shows the total dosage for a range of birth weights.

SURVANTA (beractant) DOSING CHART

WEIGHT
(grams)
TOTAL DOSE
(mL)
WEIGHT
(grams)
TOTAL DOSE
(mL)
600- 650 2.6 1301- 1350 5.4
651- 700 2.8 1351- 1400 5.6
701- 750 3.0 1401- 1450 5.8
751- 800 3.2 1451- 1500 6.0
801- 850 3.4 1501- 1550 6.2
851- 900 3.6 1551- 1600 6.4
901- 950 3.8 1601- 1650 6.6
951- 1000 4.0 1651- 1700 6.8
1001- 1050 4.2 1701- 1750 7.0
1051- 1100 4.4 1751- 1800 7.2
1101- 1150 4.6 1801- 1850 7.4
1151- 1200 4.8 1851- 1900 7.6
1201- 1250 5.0 1901- 1950 7.8
1251- 1300 5.2 1951- 2000 8.0

Four doses of SURVANTA (beractant) can be administered in the first 48 hours of life. Doses should be given no more frequently than every 6 hours.

Directions for Use

SURVANTA (beractant) should be inspected visually for discoloration prior to administration. The color of SURVANTA (beractant) is off-white to light brown. If settling occurs during storage, swirl the vial gently (DO NOT SHAKE) to redisperse. Some foaming at the surface may occur during handling and is inherent in the nature of the product.

SURVANTA (beractant) is stored refrigerated (2-8°C). Date and time need to be recorded in the box on front of the carton or vial, whenever SURVANTA (beractant) is removed from the refrigerator. Before administration, SURVANTA (beractant) should be warmed by standing at room temperature for at least 20 minutes or warmed in the hand for at least 8 minutes. ARTIFICIAL WARMING METHODS SHOULD NOT BE USED. If a prevention dose is to be given, preparation of SURVANTA (beractant) should begin before the infant's birth.

Unopened, unused vials of SURVANTA (beractant) that have been warmed to room temperature may be returned to the refrigerator within 24 hours of warming, and stored for future use. SURVANTA (beractant) SHOULD NOT BE REMOVED FROM THE REFRIGERATOR FOR MORE THAN 24 HOURS. SURVANTA (beractant) SHOULD NOT BE WARMED AND RETURNED TO THE REFRIGERATOR MORE THAN ONCE. Each single-use vial of SURVANTA (beractant) should be entered only once. Used vials with residual drug should be discarded.

SURVANTA (beractant) DOES NOT REQUIRE RECONSTITUTION OR SONICATION BEFORE USE.

Dosing Procedures

General

SURVANTA (beractant) is administered intratracheally by instillation through a 5 French end- hole catheter. The catheter can be inserted into the infant's endotracheal tube without interrupting ventilation by passing the catheter through a neonatal suction valve attached to the endotracheal tube. Alternatively, SURVANTA (beractant) can be instilled through the catheter by briefly disconnecting the endotracheal tube from the ventilator.

The neonatal suction valve used for administering SURVANTA (beractant) should be a type that allows entry of the catheter into the endotracheal tube without interrupting ventilation and also maintains a closed airway circuit system by sealing the valve around the catheter.

If the neonatal suction valve is used, the catheter should be rigid enough to pass easily into the endotracheal tube. A very soft and pliable catheter may twist or curl within the neonatal suction valve. The length of the catheter should be shortened so that the tip of the catheter protrudes just beyond the end of the endotracheal tube above the infant's carina. SURVANTA (beractant) should not be instilled into a mainstem bronchus.

To ensure homogenous distribution of SURVANTA (beractant) throughout the lungs, each dose is divided into four quarter-doses.

Each quarter-dose is administered with the infant in a different position. The recommended positions are:

  • Head and body inclined 5-10° down, head turned to the right
  • Head and body inclined 5-10° down, head turned to the left
  • Head and body inclined 5-10° up, head turned to the right
  • Head and body inclined 5-10° up, head turned to the left

The dosing procedure is facilitated if one person administers the dose while another person positions and monitors the infant.

First Dose

Determine the total dose of SURVANTA (beractant) from the SURVANTA (beractant) dosing chart based on the infant's birth weight. Slowly withdraw the entire contents of the vial into a plastic syringe through a large-gauge needle (eg, at least 20 gauge). DO NOT FILTER SURVANTA (beractant) AND AVOID SHAKING.

Attach the premeasured 5 French end-hole catheter to the syringe. Fill the catheter with SURVANTA (beractant) . Discard excess SURVANTA (beractant) through the catheter so that only the total dose to be given remains in the syringe.

BEFORE ADMINISTERING SURVANTA (beractant) , assure proper placement and patency of the endotracheal tube. At the discretion of the clinician, the endotracheal tube may be suctioned before administering SURVANTA (beractant) . The infant should be allowed to stabilize before proceeding with dosing.

In the prevention strategy, weigh, intubate and stabilize the infant. Administer the dose as soon as possible after birth, preferably within 15 minutes. Position the infant appropriately and gently inject the first quarter-dose through the catheter over 2-3 seconds.

After administration of the first quarter-dose, remove the catheter from the endotracheal tube. Manually ventilate with a hand-bag with sufficient oxygen to prevent cyanosis, at a rate of 60 breaths/minute, and sufficient positive pressure to provide adequate air exchange and chest wall excursion.

In the rescue strategy, the first dose should be given as soon as possible after the infant is placed on a ventilator for management of RDS. In the clinical trials, immediately before instilling the first quarter-dose, the infant's ventilator settings were changed to rate 60/minute, inspiratory time 0.5 second, and FiO2 1.0.

Position the infant appropriately and gently inject the first quarter-dose through the catheter over 2-3 seconds. After administration of the first quarter-dose, remove the catheter from the endotracheal tube and continue mechanical ventilation. 00In both strategies, ventilate the infant for at least 30 seconds or until stable. Reposition the infant for instillation of the next quarter-dose.

Instill the remaining quarter-doses using the same procedures. After instillation of each quarter-dose, remove the catheter and ventilate for at least 30 seconds or until the infant is stabilized. After instillation of the final quarter-dose, remove the catheter without flushing it. Do not suction the infant for 1 hour after dosing unless signs of significant airway obstruction occur.

AFTER COMPLETION OF THE DOSING PROCEDURE, RESUME USUAL VENTILATOR MANAGEMENT AND CLINICAL CARE.

Repeat Doses

The dosage of SURVANTA (beractant) for repeat doses is also 100 mg phospholipids/kg and is based on the infant's birth weight. The infant should not be reweighed for determination of the SURVANTA (beractant) dosage. Use the SURVANTA (beractant) DOSING CHART to determine the total dosage.

The need for additional doses of SURVANTA (beractant) is determined by evidence of continuing respiratory distress. Using the following criteria for redosing, significant reductions in mortality due to RDS were observed in the multiple-dose clinical trials with SURVANTA (beractant) .

Dose no sooner than 6 hours after the preceding dose if the infant remains intubated and requires at least 30% inspired oxygen to maintain a PaO2 less than or equal to 80 torr.

Radiographic confirmation of RDS should be obtained before administering additional doses to those who received a prevention dose.

Prepare Survanta (beractant) and position the infant for administration of each quarter-dose as previously described. After instillation of each quarter-dose, remove the dosing catheter from the endotracheal tube and ventilate the infant for at least 30 seconds or until stable.

In the clinical studies, ventilator settings used to administer repeat doses were different than those used for the first dose. For repeat doses, the FiO2 was increased by 0.20 or an amount sufficient to prevent cyanosis. The ventilator delivered a rate of 30/minute with an inspiratory time less than 1.0 second. If the infant's pretreatment rate was 30 or greater, it was left unchanged during SURVANTA (beractant) instillation.

Manual hand-bag ventilation should not be used to administer repeat doses. DURING THE DOSING PROCEDURE, VENTILATOR SETTINGS MAY BE ADJUSTED AT THE DISCRETION OF THE CLINICIAN TO MAINTAIN APPROPRIATE OXYGENATION AND VENTILATION. AFTER COMPLETION OF THE DOSING PROCEDURE, RESUME USUAL VENTILATOR MANAGEMENT AND CLINICAL CARE.

Dosing Precautions

If an infant experiences bradycardia or oxygen desaturation during the dosing procedure, stop the dosing procedure and initiate appropriate measures to alleviate the condition. After the infant has stabilized, resume the dosing procedure.

Rales and moist breath sounds can occur transiently after administration of Survanta (beractant) . Endotracheal suctioning or other remedial action is unnecessary unless clear-cut signs of airway obstruction are present.

HOW SUPPLIED

Survanta (beractant) Intratracheal Suspension is supplied in single-use glass vials containing 4 mL (NDC 0074-1040-04) or 8 mL of Survanta (beractant) (NDC 0074-1040-08). Each milliliter contains 25 mg of phospholipids suspended in 0.9% sodium chloride solution. The color is off-white to light brown.

Store unopened vials at refrigeration temperature (2-8°C). Protect from light. Store vials in carton until ready for use. Vials are for single use only. Upon opening, discard unused drug.

May, 2004. Manufactured by: Hospira, Inc., Lake Forest, Illinois 60045, USA. FDA revision date: 4/28/2005

Last reviewed on RxList: 9/9/2008
This monograph has been modified to include the generic and brand name in many instances.

SIDE EFFECTS

The most commonly reported adverse experiences were associated with the dosing procedure. In the multiple-dose controlled clinical trials, each dose of SURVANTA (beractant) was divided into four quarter-doses which were instilled through a catheter inserted into the endotracheal tube by briefly disconnecting the endotracheal tube from the ventilator. Transient bradycardia occurred with 11.9% of doses. Oxygen desaturation occurred with 9.8% of doses.

Other reactions during the dosing procedure occurred with fewer than 1% of doses and included endotracheal tube reflux, pallor, vasoconstriction, hypotension, endotracheal tube blockage, hypertension, hypocarbia, hypercarbia, and apnea. No deaths occurred during the dosing procedure, and all reactions resolved with symptomatic treatment.

The occurrence of concurrent illnesses common in premature infants was evaluated in the controlled trials. The rates in all controlled studies are in Table 3.

TABLE 3

  All Controlled Studies
Concurrent Event SURVANTA
(%)
Control
(%)
P-Valuea
Patent ductus arteriosus 46.9 47.1 0.814
Intracranial hemorrhage 48.1 45.2 0.241
Severe intracranial hemorrhage 24.1 23.3 0.693
Pulmonary air leaks 10.9 24.7 <0.001
Pulmonary interstitial emphysema 20.2 38.4 <0.001
Necrotizing enterocolitis 6.1 5.3 0.427
Apnea 65.4 59.6 0.283
Severe apnea 46.1 42.5 0.114
Post-treatment sepsis 20.7 16.1 0.019
Post-treatment infection 10.2 9.1 0.345
Pulmonary hemorrhage 7.2 5.3 0.166
a P-value comparing groups in controlled studies

When all controlled studies were pooled, there was no difference in intracranial hemorrhage. However, in one of the single-dose rescue studies and one of the multiple-dose prevention studies, the rate of intracranial hemorrhage was significantly higher in SURVANTA (beractant) patients than control patients (63.3% v 30.8%, P = 0.001; and 48.8% v 34.2%, P = 0.047, respectively). The rate in a Treatment IND involving approximately 8100 infants was lower than in the controlled trials.

In the controlled clinical trials, there was no effect of SURVANTA (beractant) on results of common laboratory tests: white blood cell count and serum sodium, potassium, bilirubin, creatinine.

More than 4300 pretreatment and post-treatment serum samples from approximately 1500 patients were tested by Western Blot Immunoassay for antibodies to surfactant-associated proteins SP-B and SP-C. No IgG or IgM antibodies were detected.

Several other complications are known to occur in premature infants. The following conditions were reported in the controlled clinical studies. The rates of the complications were not different in treated and control infants, and none of the complications were attributed to SURVANTA (beractant) .

Respiratory: lung consolidation, blood from the endotracheal tube, deterioration after weaning, respiratory decompensation, subglottic stenosis, paralyzed diaphragm, respiratory failure.

Cardiovascular: hypotension, hypertension, tachycardia, ventricular tachycardia, aortic thrombosis, cardiac failure, cardio-respiratory arrest, increased apical pulse, persistent fetal circulation, air embolism, total anomalous pulmonary venous return.

Gastrointestinal:abdominal distention, hemorrhage, intestinal perforations, volvulus, bowel infarct, feeding intolerance, hepatic failure, stress ulcer.

Renal: renal failure, hematuria.

Hematologic: coagulopathy, thrombocytopenia, disseminated intravascular coagulation.

Central Nervous System: seizures.

Endocrine/Metabolic: adrenal hemorrhage, inappropriate ADH secretion, hyperphosphatemia.

Musculoskeletal:inguinal hernia.

Systemic: fever, deterioration.

Follow-Up Evaluations

To date, no long-term complications or sequelae of SURVANTA (beractant) therapy have been found.

Single-Dose Studies

Six-month adjusted-age follow-up evaluations of 232 infants (115 treated) demonstrated no clinically important differences between treatment groups in pulmonary and neurologic sequelae, incidence or severity of retinopathy of prematurity, rehospitalizations, growth, or allergic manifestations.

Multiple-Dose Studies

Six-month adjusted age follow-up evaluations have been completed in 631 (345 treated) of 916 surviving infants. There were significantly less cerebral palsy and need for supplemental oxygen in SURVANTA (beractant) infants than controls. Wheezing at the time of examination was significantly more frequent among SURVANTA (beractant) infants, although there was no difference in bronchodilator therapy.

Final twelve-month follow-up data from the multiple-dose studies are available from 521 (272 treated) of 909 surviving infants. There was significantly less wheezing in SURVANTA (beractant) infants than controls, in contrast to the six-month results. There was no difference in the incidence of cerebral palsy at twelve months.

Twenty-four month adjusted age evaluations were completed in 429 (226 treated) of 906 surviving infants. There were significantly fewer SURVANTA (beractant) infants with rhonchi, wheezing, and tachypnea at the time of examination. No other differences were found.

Read the Survanta (beractant) Side Effects Center for a complete guide to possible side effects »

DRUG INTERACTIONS

No information provided.

Last reviewed on RxList: 9/9/2008
This monograph has been modified to include the generic and brand name in many instances.

WARNINGS

SURVANTA (beractant) is intended for intratracheal use only.

SURVANTA (beractant) CAN RAPIDLY AFFECT OXYGENATION AND LUNG COMPLIANCE. Therefore, its use should be restricted to a highly supervised clinical setting with immediate availability of clinicians experienced with intubation, ventilator management, and general care of premature infants. Infants receiving SURVANTA (beractant) should be frequently monitored with arterial or transcutaneous measurement of systemic oxygen and carbon dioxide.

DURING THE DOSING PROCEDURE, TRANSIENT EPISODES OF BRADY-CARDIA AND DECREASED OXYGEN SATURATION HAVE BEEN REPORTED. If these occur, stop the dosing procedure and initiate appropriate measures to alleviate the condition. After stabilization, resume the dosing procedure.

PRECAUTIONS

General

Rales and moist breath sounds can occur transiently after administration. Endotracheal suctioning or other remedial action is not necessary unless clear-cut signs of airway obstruction are present.

Increased probability of post-treatment nosocomial sepsis in SURVANTA (beractant) -treated infants was observed in the controlled clinical trials (Table 3). The increased risk for sepsis among SURVANTA (beractant) -treated infants was not associated with increased mortality among these infants. The causative organisms were similar in treated and control infants. There was no significant difference between groups in the rate of post-treatment infections other than sepsis.

Use of SURVANTA (beractant) in infants less than 600 g birth weight or greater than 1750 g birth weight has not been evaluated in controlled trials. There is no controlled experience with use of SURVANTA (beractant) in conjunction with experimental therapies for RDS (eg, high-frequency ventilation or extracorporeal membrane oxygenation).

No information is available on the effects of doses other than 100 mg phospholipids/kg, more than four doses, dosing more frequently than every 6 hours, or administration after 48 hours of age.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenicity studies have not been performed with SURVANTA (beractant) . SURVANTA (beractant) was negative when tested in the Ames test for mutagenicity. Using the maximum feasible dose volume, SURVANTA (beractant) up to 500 mg phospholipids/kg/day (approximately one-third the premature infant dose based on mg/m²/day) was administered subcutaneously to newborn rats for 5 days. The rats reproduced normally and there were no observable adverse effects in their offspring.

Last reviewed on RxList: 9/9/2008
This monograph has been modified to include the generic and brand name in many instances.

OVERDOSE

Overdosage with SURVANTA (beractant) has not been reported. Based on animal data, overdosage might result in acute airway obstruction. Treatment should be symptomatic and supportive.

Rales and moist breath sounds can transiently occur after SURVANTA (beractant) is given, and do not indicate overdosage. Endotracheal suctioning or other remedial action is not required unless clear-cut signs of airway obstruction are present.

CONTRAINDICATIONS

None known.

Last reviewed on RxList: 9/9/2008
This monograph has been modified to include the generic and brand name in many instances.

CLINICAL PHARMACOLOGY

Endogenous pulmonary surfactant lowers surface tension on alveolar surfaces during respiration and stabilizes the alveoli against collapse at resting trans-pulmonary pressures. Deficiency of pulmonary surfactant causes Respiratory Distress Syndrome (RDS) in premature infants. SURVANTA (beractant) replenishes surfactant and restores surface activity to the lungs of these infants.

Activity

In vitro, SURVANTA (beractant) reproducibly lowers minimum surface tension to less than 8 dynes/cm as measured by the pulsating bubble surfactometer and Wilhelmy Surface Balance. In situ, SURVANTA (beractant) restores pulmonary compliance to excised rat lungs artificially made surfactant-deficient. In vivo, single SURVANTA (beractant) doses improve lung pressure-volume measurements, lung compliance, and oxygenation in premature rabbits and sheep.

Animal Metabolism

SURVANTA (beractant) is administered directly to the target organ, the lungs, where biophysical effects occur at the alveolar surface. In surfactant-deficient premature rabbits and lambs, alveolar clearance of radio-labelled lipid components of SURVANTA (beractant) is rapid. Most of the dose becomes lung-associated within hours of administration, and the lipids enter endogenous surfactant pathways of reutilization and recycling. In surfactant-sufficient adult animals, SURVANTA (beractant) clearance is more rapid than in premature and young animals. There is less reutilization and recycling of surfactant in adult animals.

Limited animal experiments have not found effects of SURVANTA (beractant) on endogenous surfactant metabolism. Precursor incorporation and subsequent secretion of saturated phosphatidylcholine in premature sheep are not changed by SURVANTA (beractant) treatments.

No information is available about the metabolic fate of the surfactant-associated proteins in SURVANTA (beractant) . The metabolic disposition in humans has not been studied.

Clinical Studies

Clinical effects of SURVANTA (beractant) were demonstrated in six single-dose and four multiple-dose randomized, multi-center, controlled clinical trials involving approximately 1700 infants. Three open trials, including a Treatment IND, involved more than 8500 infants. Each dose of SURVANTA (beractant) in all studies was 100 mg phospho-lipids/kg birth weight and was based on published experience with Surfactant TA, a lyophilized powder dosage form of SURVANTA (beractant) having the same composition.

Prevention Studies

Infants of 600-1250 g birth weight and 23 to 29 weeks estimated gestational age were enrolled in two multiple-dose studies. A dose of SURVANTA (beractant) was given within 15 minutes of birth to prevent the development of RDS. Up to three additional doses in the first 48 hours, as often as every 6 hours, were given if RDS subsequently developed and infants required mechanical ventilation with an FiO2 ≥ 0.30. Results of the studies at 28 days of age are shown in Table 1.

TABLE 1

Study 1 SURVANTA Control P-Value
Number infants studied 119 124  
Incidence of RDS (%) 27.6 63.5 <0.001
Death due to RDS (%) 2.5 19.5 <0.001
Death or BPD due to RDS (%) 48.7 52.8 0.536
Death due to any cause (%) 7.6 22.8 0.001
Air Leaksa (%) 5.9 21.7 0.001
Pulmonary interstitial emphysema (%) 20.8 40 0.001
Study 2b SURVANTA Control P-Value
Number infants studied 91 96  
Incidence of RDS (%) 28.6 48.3 0.007
Death due to RDS (%) 1.1 10.5 0.006
Death or BPD due to RDS (%) 27.5 44.2 0.018
Death due to any causec (%) 16.5 13.7 0.633
Air Leaksa (%) 14.5 19.6 0.374
Pulmonary interstitial emphysema (%) 26.5 33.2 0.298
aPneumothorax or pneumopericardium
bStudy discontinued when Treatment IND initiated c
cNo cause of death in the SURVANTA (beractant) group was significantly increased; the higher number of deaths in this group was due to the sum of all causes.

Rescue Studies

Infants of 600-1750 g birth weight with RDS requiring mechanical ventilation and an FiO2 ≥ 0.40 were enrolled in two multiple-dose rescue studies. The initial dose of SURVANTA (beractant) was given after RDS developed and before 8 hours of age. Infants could receive up to three additional doses in the first 48 hours, as often as every 6 hours, if they required mechanical ventilation and an FiO2 ≥ 0.30. Results of the studies at 28 days of age are shown in Table 2.

TABLE 2

Study 3a SURVANTA Control P-Value
Number infants studied 198 193  
Death due to RDS (%) 11.6 18.1 0.071
Death or BPD due to RDS (%) 59.1 66.8 0.102
Death due to any cause (%) 21.7 26.4 0.285
Air Leaksb(%) 11.8 29.5 <0.001
Pulmonary interstitial emphysema (%) 16.3 34.0 <0.001
Study 4 SURVANTA Control P-Value
Number infants studied 204 203  
Death due to RDS (%) 6.4 22.3 <0.001
Death or BPD due to RDS (%) 43.6 63.4 <0.001
Death due to any cause (%) 15.2 28.2 0.001
Air Leaksb (%) 11.2 2.2 0.005
Pulmonary interstitial emphysema (%) 20.8 44.4 <0.001
a Study discontinued when Treatment IND initiated
b Pneumothorax or pneumopericardium

Acute Clinical Effects

Marked improvements in oxygenation may occur within minutes of administration of SURVANTA (beractant) . 00All controlled clinical studies with SURVANTA (beractant) provided information regarding the acute effects of SURVANTA (beractant) on the arterial-alveolar oxygen ratio (a/APO2), FiO2, and mean airway pressure (MAP) during the first 48 to 72 hours of life. Significant improvements in these variables were sustained for 48-72 hours in SURVANTA (beractant) -treated infants in four single-dose and two multiple-dose rescue studies and in two multiple-dose prevention studies. In the single-dose prevention studies, the FiO2 improved significantly.

Last reviewed on RxList: 9/9/2008
This monograph has been modified to include the generic and brand name in many instances.

PATIENT INFORMATION

No information provided. Please refer to the WARNINGS and PRECAUTIONS sections.

Last reviewed on RxList: 9/9/2008
This monograph has been modified to include the generic and brand name in many instances.

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PATIENT INFORMATION

No information provided. Please refer to the WARNINGS and PRECAUTIONS sections.

Last reviewed on RxList: 9/9/2008
This monograph has been modified to include the generic and brand name in many instances.

SURVANTA®
(beractant) Intratracheal Suspension

Sterile Suspension.

For Intratracheal Administration Only

DRUG DESCRIPTION

SURVANTA® (beractant) Intratracheal Suspension is a sterile, non-pyrogenic pulmonary surfactant intended for intratracheal use only. It is a natural bovine lung extract containing phospholipids, neutral lipids, fatty acids, and surfactant-associated proteins to which colfosceril palmitate (dipalmitoylphosphatidylcholine), palmitic acid, and tripalmitin are added to standardize the composition and to mimic surface-tension lowering properties of natural lung surfactant. The resulting composition provides 25 mg/mL phospholipids (including 11.0-15.5 mg/mL disaturated phosphatidylcholine), 0.5-1.75 mg/mL triglycerides, 1.4-3.5 mg/mL free fatty acids, and less than 1.0 mg/mL protein. It is suspended in 0.9% sodium chloride solution, and heat-sterilized. SURVANTA (beractant) contains no preservatives. Its protein content consists of two hydrophobic, low molecular weight, surfactant-associated proteins commonly known as SP-B and SP-C. It does not contain the hydrophilic, large molecular weight surfactant-associated protein known as SP-A.

Each mL of SURVANTA (beractant) contains 25 mg of phospholipids. It is an off-white to light brown liquid supplied in single-use glass vials containing 4 mL (100 mg phospholipids) or 8 mL (200 mg phospholipids).

Last reviewed on RxList: 9/9/2008
This monograph has been modified to include the generic and brand name in many instances.

SURVANTA®
(beractant) Intratracheal Suspension

Sterile Suspension.

For Intratracheal Administration Only

DRUG DESCRIPTION

SURVANTA® (beractant) Intratracheal Suspension is a sterile, non-pyrogenic pulmonary surfactant intended for intratracheal use only. It is a natural bovine lung extract containing phospholipids, neutral lipids, fatty acids, and surfactant-associated proteins to which colfosceril palmitate (dipalmitoylphosphatidylcholine), palmitic acid, and tripalmitin are added to standardize the composition and to mimic surface-tension lowering properties of natural lung surfactant. The resulting composition provides 25 mg/mL phospholipids (including 11.0-15.5 mg/mL disaturated phosphatidylcholine), 0.5-1.75 mg/mL triglycerides, 1.4-3.5 mg/mL free fatty acids, and less than 1.0 mg/mL protein. It is suspended in 0.9% sodium chloride solution, and heat-sterilized. SURVANTA (beractant) contains no preservatives. Its protein content consists of two hydrophobic, low molecular weight, surfactant-associated proteins commonly known as SP-B and SP-C. It does not contain the hydrophilic, large molecular weight surfactant-associated protein known as SP-A.

Each mL of SURVANTA (beractant) contains 25 mg of phospholipids. It is an off-white to light brown liquid supplied in single-use glass vials containing 4 mL (100 mg phospholipids) or 8 mL (200 mg phospholipids).

Last reviewed on RxList: 9/9/2008
This monograph has been modified to include the generic and brand name in many instances.

SURVANTA®
(beractant) Intratracheal Suspension

Sterile Suspension.

For Intratracheal Administration Only

DRUG DESCRIPTION

SURVANTA® (beractant) Intratracheal Suspension is a sterile, non-pyrogenic pulmonary surfactant intended for intratracheal use only. It is a natural bovine lung extract containing phospholipids, neutral lipids, fatty acids, and surfactant-associated proteins to which colfosceril palmitate (dipalmitoylphosphatidylcholine), palmitic acid, and tripalmitin are added to standardize the composition and to mimic surface-tension lowering properties of natural lung surfactant. The resulting composition provides 25 mg/mL phospholipids (including 11.0-15.5 mg/mL disaturated phosphatidylcholine), 0.5-1.75 mg/mL triglycerides, 1.4-3.5 mg/mL free fatty acids, and less than 1.0 mg/mL protein. It is suspended in 0.9% sodium chloride solution, and heat-sterilized. SURVANTA (beractant) contains no preservatives. Its protein content consists of two hydrophobic, low molecular weight, surfactant-associated proteins commonly known as SP-B and SP-C. It does not contain the hydrophilic, large molecular weight surfactant-associated protein known as SP-A.

Each mL of SURVANTA (beractant) contains 25 mg of phospholipids. It is an off-white to light brown liquid supplied in single-use glass vials containing 4 mL (100 mg phospholipids) or 8 mL (200 mg phospholipids).

Last reviewed on RxList: 9/9/2008
This monograph has been modified to include the generic and brand name in many instances.

Survanta Patient Information Including Side Effects

Brand Names: Survanta Intratracheal

Generic Name: beractant (Pronunciation: ber AK tant)

What is beractant (Survanta)?

Beractant is made from animal lung extract and contains fatty acids and proteins. It works by reducing the surface tension of fluids inside the human lung to keep the lung from collapsing.

Beractant is used to treat or prevent respiratory distress syndrome (RDS) in newborn infants.

Beractant may also be used for purposes other than those listed in this medication guide.

What are the possible side effects of beractant (Survanta)?

Get emergency medical help if your child has any of these signs of an allergic reaction: hives; difficulty breathing; swelling of the face, lips, tongue, or throat.

Tell your child's caregivers at once if the child has any of these serious side effects:

  • pale skin;
  • slow heartbeat;
  • breathing that stops;
  • urinating less than usual; or
  • blood in the urine.

Less serious side effects include:

  • noisy breathing;
  • feeding or bowel problems; or
  • bleeding around the endotracheal tube.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the Survanta (beractant) Side Effects Center for a complete guide to possible side effects »

What is the most important information I should know about beractant (Survanta)?

Beractant is given within minutes or hours after the infant is born. The medication must be given in a neonatal intensive care unit (NICU), a specialized setting for premature babies or newborns who need special care.

Your child will require special care in the hospital during treatment with beractant. Talk with your doctor about any special instructions for handling the infant and watching for side effects while beractant is given.

Follow your doctor's instructions about any restrictions on feeding or other medications after your child has been treated with beractant.

Side Effects Centers

Survanta Patient Information including How Should I Take

What should I discuss with my health care provider before my child receives beractant (Survanta)?

Your child will require special care in the hospital during treatment for RDS. Talk with your doctor about any special instructions for handling the infant and watching for side effects while beractant is given.

How is beractant given (Survanta)?

Beractant is given within minutes or hours after the infant is born. The medication must be given in a neonatal intensive care unit (NICU), a specialized setting for premature babies or newborns who need special care.

This medication is given through an endotracheal (en-doe-TRAY-kee-al) tube. This is a flexible plastic tube placed in the infant's mouth and passed down into the airway. A doctor will insert the tube using a scope to see the inside of the airway while guiding the tube into place.

Beractant is usually given every 6 hours.

To make sure this medication is helping your child's condition and is not causing any harmful effects, your child's lung function will need to be tested often. This will help your doctor determine how long to continue treatment with beractant. Your child may also need blood tests.

Side Effects Centers

Survanta Patient Information including If I Miss a Dose

What happens if my child misses a dose (Survanta)?

Since beractant is given by healthcare professionals in a hospital setting, it is not likely that your child will miss a dose.

What happens if my child receives an overdose (Survanta)?

Overdose with beractant has not been reported. Because this medication is given by a healthcare professional, it is not likely that your child will receive an overdose.

What should be avoided after my child receives beractant (Survanta)?

Follow your doctor's instructions about any restrictions on feeding or other medications after your child has been treated with beractant.

What other drugs will affect beractant (Survanta)?

There may be other drugs that can interact with beractant. However, your child's care providers will be aware of all medications used in your child's treatment. It is not likely that your child will be given other medications that will interact with beractant.

Where can I get more information?

Your doctor or pharmacist can provide more information about beractant.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 1.05. Revision date: 12/15/2010.

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