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Survanta

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Survanta

Survanta

Survanta Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Survanta (beractant) Intratracheal Suspension is made from animal lung extract and is used to treat or prevent respiratory distress syndrome in newborn infants. Common side effects of Survanta include pale skin, slow heartbeat, breathing that stops (apnea), urinating less than usual, and blood in the urine.

Each dose of Survanta is 100 mg of phospholipids/kg birth weight. Talk to your doctor about your baby's individual dosage recommendation. There are no known medications that interact with Survanta. Your child will require special care in the hospital during treatment with Survanta. Talk with your doctor about special care for handling the infant and watching for side effects while Survanta is given. Survanta is not indicated for women of child bearing age and therefore should not be taken if you are pregnant or breastfeeding.

Our Survanta (beractant) Intratracheal Suspension Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Survanta in Detail - Patient Information: Side Effects

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 entire detailed patient monograph for Survanta (Beractant) »

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Survanta FDA Prescribing Information: Side Effects
(Adverse Reactions)

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 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

Concurrent Event All Controlled Studies
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
aP-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 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) »

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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