Patient Medication Information: uses, side effects, how to take - Bles
What is BLES® used for?
- BLES® is used to treat or “rescue” premature babies with Neonatal Respiratory Distress Syndrome (NRDS).
How does BLES® work?
BLES® is an extract of a natural substance (lung surfactant) necessary for effective breathing. Babies with NRDS who lack their own surfactant may have trouble absorbing enough oxygen when they breathe. BLES® spreads through the lungs, allowing the lungs to expand properly and oxygen to enter the blood more easily. This will lower the baby’s need for extra oxygen under pressure.
What are the ingredients in BLES®?
Medicinal ingredients: phospholipids (natural fats) and proteins found in cow lung surfactant.
Non-medicinal ingredients: calcium chloride (salt), sodium chloride (salt) and water.
BLES® comes in the following dosage forms:
BLES® is a suspension that contains 27 milligrams of phospholipids and 0.2 to 0.5 milligrams of surfactant proteins SP-B and SP-C per milliliter.
Do not use BLES® if:
- The infant’s lungs may be bleeding.
To help avoid side effects, talk to your healthcare professional about BLES® use. Talk about any health conditions or problems, including:
- BLES® should only be given by healthcare professionals experienced in treating premature babies with Neonatal Respiratory Distress Syndrome. During and after receiving a dose, the baby will need to be monitored closely for any clinical changes.
Serious Warnings and Precautions
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- There is an increased risk of infections in babies treated with BLES®.
- Studies to show whether BLES® is linked to the development of cancer or genetic mutations have not been performed.
- Studies have shown that BLES® is not expected to cause allergies.
- Before giving BLES®, healthcare professionals should correct high acidity in the blood, low blood pressure, low blood sugar, and low body temperature in the baby.
- Excess oxygen may enter in the lungs after BLES® is given. If this happens, the healthcare professionals will adjust the oxygen intake level to prevent risk of abnormal blood vessel growth in the eye.
- Babies should be monitored closely for oxygen requirements before, during, and after BLES® is given as it can cause oxygen to enter the blood very quickly.
- While BLES® is being administered, the baby’s heart rate may slow down and less oxygen may enter the lungs for a short period of time. If this occurs, the healthcare professional should stop giving BLES® and correct the condition before proceeding.
- BLES® should not be given slowly or in small doses. Unlike other surfactants, BLES® has a “thin” consistency and therefore it travels down into the lungs much more rapidly. If given slowly, BLES® may not spread into the lungs evenly.
- If the baby’s breathing grows shallow after BLES® is administered, liquid from the lungs may have formed a plug in the baby’s airway. If suctioning of the airway is unsuccessful, the blocked tube should be replaced immediately. There is a reduced chance of this plug forming if the baby is suctioned before giving BLES®.
- In 2019, two international studies reported a higher than usual number of cases of bleeding in the lungs, including death; however, the total number of cases is less than the number seen during clinical testing.
The following may interact with BLES®:
- There are no known interactions between BLES® and other drugs.
How to take BLES®:
BLES® is given to babies within several hours of birth by healthcare professionals.
Usual dose:
For each kilogram of birth weight, the baby may receive 135 milligrams of phospholipid. If more than one dose is needed, the dose may be repeated up to three times in the first five days of life.
Overdose:
There is no record of an overdose having been given. Although it is possible that too much BLES® could block the baby’s airway, it can be removed by suction.
| If you think the baby may have been given too much BLES®, contact your healthcare professional, hospital emergency department or regional poison control centre immediately, even if there are no symptoms. |
What are possible side effects from using BLES®?
These are not all the possible side effects the baby may feel when taking BLES®. If the baby experiences any side effects not listed here, contact your healthcare professional.
BLES® is given to babies within several hours of birth by healthcare professionals who will monitor the baby for any side effects. Because the baby’s breathing will be interrupted during dosing, the baby may require more oxygen for a short while.
The baby will receive surfactant as soon as possible after birth. Complications that develop may be due to the baby’s prematurity rather than this treatment. If you should have any concerns or questions about the baby’s condition after a dose, consult with the healthcare professionals who are monitoring the baby.
Serious side effects and what to do about them
| Symptom / effect | Report the event to the healthcare professional | Stop taking drug and get immediate medical help | |
| Only if severe | In all cases | ||
VERY COMMON Decreased pulmonary function: low level of oxygen entering the lungs. This lasts for a very short time after BLES® has been administered. | X | ||
| Intraventricular haemorrhage: bleeding in the brain leading to increased pressure in the head. | X | ||
| Patent ductus arteriosus: increased blood pressure in the lungs causing the lungs and the heart to increase in size. | X | ||
| Retinopathy of prematurity: abnormal growth of blood vessels in the eyes. | X | ||
| Sepsis: severe infection in the body leading to fever and inflammation. | X | ||
COMMON Airways obstruction: liquid plug formation in the surfactant administration tube leading to shortening of breath. This tube is removed after BLES® has been given. | X | ||
| Bradycardia: slow heart rate. | X | ||
| Necrotizing enterocolitis: infection and inflammation in the intestine. | X | ||
| Periventricular leukomalacia: brain injury in areas of brain tissue that may cause mental and physical impairments. | X | ||
| Pneumothorax: a collapsed lung occurs when air leaks into the space between your lung and chest wall leading to chest pain and shortness of breath. | X | ||
| Pulmonary haemorrhage: coughing up blood and shortness of breath. | X | ||
| Pulmonary interstitial emphysema: collection of air outside the air sacs of the lung causing breathing difficulty. | X | ||
RARE Apnoea: interruption or lack of breathing. | X | ||
| Convulsion: rapid shaking or seizure like movement. | X | ||
| Hydrocephalus: build-up of fluid in the brain that may cause bulges on the head. | X | ||
| Hypotension: low blood pressure that may cause dizziness or fainting. | X | ||
| Pneumonia: inflammation in the air sacs in the lungs that may cause coughing, fever and difficulty breathing. | X | ||
| Respiratory acidosis: inability of the lungs to remove carbon dioxide, leading to increased acidity of the blood. | X |
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
NOTE: Contact your health professional if you need information about how to manage side effects. The Canada Vigilance Program does not provide medical advice. |
Storage:
BLES® is stored either frozen or refrigerated at the hospital.
If you want more information about BLES®:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website; by contacting the sponsor, BLES Biochemicals Inc., at info@blesbiochem.com or by calling 1-519-457-2537.
This information is current up to the time of the last revision date shown below, but more current information may be available from the manufacturer.