Survanta

The most commonly reported adverse experiences were associated with the dosing procedure. In the multiple-dose controlled clinical trials, each dose of SURVANTA 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

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 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 on results of common laboratory tests: white blood cell count and serum sodium, potassium, bilirubin, and 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.

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 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 infants than controls. Wheezing at the time of examination was significantly more frequent among SURVANTA 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 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 infants with rhonchi, wheezing, and tachypnea at the time of examination. No other differences were found.

Read the entire FDA prescribing information for Survanta (Beractant)

• Infasurf

• Surfaxin

© Survanta Patient Information is supplied by Cerner Multum, Inc. and Survanta Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

• Natural bovine lung extract containing mostly phospholipids and small amounts of neutral lipids, fatty acids, and surfactant-associated proteins (SP-B, SP-C).1

• Endogenous pulmonary surfactant reduces alveolar surface tension and increases alveolar stability.1

• Beractant compensates for surfactant deficiency in premature neonates.1 Restores pulmonary compliance and improves lung pressure-volume measurements and oxygenation in animals.1

• If your child has an allergy to Survanta (beractant solution) or any part of this medicine.
• If your child is allergic to any drugs like this one or any other drugs, foods, or other substances. Tell the doctor about the allergy and what signs your child had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.

This medicine may interact with other drugs or health problems.

Tell the doctor and pharmacist about all of your child's drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for your child to take Survanta with all of his/her drugs and health problems. Do not start, stop, or change the dose of any drug your child takes without checking with the doctor.

• Tell all of your child's health care providers that your child is taking this medicine. This includes your child's doctors, nurses, pharmacists, and dentists.
• This medicine may raise the chance of a certain type of bad infection (sepsis). Talk with the doctor.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

• If you need to store this medicine at home, talk with your child's doctor, nurse, or pharmacist about how to store it.

Survanta is intended for intratracheal use only.

Survanta 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 should be frequently monitored with arterial or transcutaneous measurement of systemic oxygen and carbon dioxide.

During the dosing procedure, transient episodes of bradycardia 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.

The most commonly reported adverse experiences were associated with the dosing procedure. In the multiple-dose controlled clinical trials, each dose of Survanta 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.

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 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 on results of common laboratory tests: white blood cell count and serum sodium, potassium, bilirubin, and 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.

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 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 infants than controls. Wheezing at the time of examination was significantly more frequent among Survanta 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 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 infants with rhonchi, wheezing, and tachypnea at the time of examination. No other differences were found.

Applies to beractant: intratracheal suspension

General

The most commonly reported adverse experiences were associated with the dosing procedure; transient bradycardia occurred with 11.9% of doses and oxygen desaturation occurred with 9.8% of doses.[Ref]

Cardiovascular

Very common (10% or more): Transient bradycardia (11.9%)
Uncommon (0.1% to 1%): Pallor, vasoconstriction, hypotension, hypertension, hypercarbia, hypocarbia
Frequency not reported: Tachycardia, ventricular tachycardia, aortic thrombosis, cardiac failure, cardio-respiratory arrest, increased apical pulse, persistent fetal circulation, air embolism, total anomalous pulmonary venous return[Ref]

Respiratory

Common (1% to 10%): Oxygen desaturation
Uncommon (0.1% to 1%): Apnea
Frequency not reported: Lung consolidation, blood from the endotracheal tube, deterioration after weaning, respiratory decompensation, subglottic stenosis, paralyzed diaphragm, respiratory failure[Ref]

Gastrointestinal

Uncommon (0.1% to 1%): Endotracheal tube reflux, endotracheal tube blockage
Frequency not reported: Abdominal distension, hemorrhage, intestinal perforations, volvulus, bowel infarct, feeding intolerance, stress ulcer[Ref]

Endocrine

Frequency not reported: Adrenal hemorrhage, inappropriate ADH secretion, hyperphosphatemia[Ref]

Hematologic

Frequency not reported: Coagulopathy, thrombocytopenia, disseminated intravascular coagulation[Ref]

Hepatic

Frequency not reported: Hepatic failure[Ref]

Musculoskeletal

Frequency not reported: Inguinal hernia[Ref]

Nervous system

Frequency not reported: Seizures[Ref]

Renal

Frequency not reported: Renal failure, hematuria[Ref]

Some side effects of Survanta may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.