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Drug information on Brineura (cerliponase alfa) from Alpha Drug India Ltd

Brineura

  
Alpha Drug India Ltd
Generic : cerliponase alfa
 340.00
150mg/5ml
1

Drug Name : cerliponase alfa

Cerliponase alfa generic Cerliponase alfa is recombinant human tripeptidyl peptidase-1 enzyme (TPP1) which is required for normal brain development. It is used to slow down the loss of walking ability in symptomatic pediatric patients from the age group of 3 years and above who suffer from late infantile neuronal ceroid lipofuscinosis type 2 (CLN2), a form of Batten disease. These patients lack the tripeptidyl peptidase-1 enzyme (TPP1) in their central nervous system (CNS). Cerliponase alfa is infused directly into the patient’s brain bypassing the blood brain barrier through a device called an intraventricular device.
More Info about cerliponase alfa


Vijayaganesh Kasinathan
Written & Compiled by Pharmacist Vijayaganesh Kasinathan, B.Pharm, M.Pharm
Dr. Simi Paknikar
Medically Reviewed by Dr. Simi Paknikar, MD
Last Updated on Sep 19, 2017
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Medical Condition(s) for which Brineura may be prescribed


Overview of Brineura

Cerliponase alfa is a recombinant human enzyme, used to treat late infantile neuronal ceroid lipofuscinosis type 2 (CLN2).

Side effects of Brineura

  General: Allergic reaction, fever, vomiting, hematoma (blood clot), infection

  Central Nervous System: Headache, irritability, feeling jittery, decrease or increase of cerebrospinal fluid protein, increased WBC count in the cerebrospinal fluid, seizures

  Cardio vascular system: ECG abnormalities including bradycardia (reduced heart rate), low blood pressure

Dosage & When it is to be taken (Indications)

• The recommended dosage of cerliponase alfa for patients 3 years of age and older is 300mg administered using intraventricular infusion every other week.

• The drug infusion should be followed by intraventricular electrolytes at a rate of 2.5ml per hour. The total time of infusion for both should be approximately 4 and a half hours.

How to use Brineura?

• Cerliponase alfa comes in a concentration of 150mg/5ml in two single dose vials along with intraventricular electrolyte injection of 5ml in a single dose vial.
• It is administered into the cerebral ventricle (central cavity of the brain) through a surgically implanted reservoir connected to the catheter of an intraventricular access device.
• The whole process should be done under aseptic technique and the first dose of infusion should be carried out at least 5 to 7 days after implantation of the device.
• Since allergic reactions can take place, the patients should be pretreated with antihistamines with or without antipyretics or corticosteroids 30-60 minutes before starting the infusion.

When is Brineura not to be taken? (Contraindications)

Cerliponase alfa is contraindicated on the following conditions:

a) Allergy to the drug

b) The presence of intraventricular access device related complications which include:
• Failure of the device
• Leakage
• Signs of device-related infection such as swelling, scalp redness, extravasation of fluid, bulging of scalp around or above intraventricular access device.

c) Patients with ventriculoperitoneal shunts (catheter that connects the brain to the abdomen to reduce the fluid content in the brain) due to the risk of the following:
• Bleeding or blood clot in brain
• Cerebrospinal fluid leakage under the skin in the shunt area
• Brain swelling and damage
• Infection occurring in the shunt, brain or abdomen
Seizures

Warnings and Precautions for Brineura

• The vital signs should be monitored before, during and after the infusion administration.
• Routine CSF samples should be tested regularly to detect the presence of device related infections.

Other Precautions for Brineura

The intraventricular access device should considered for replacement after around 105 perforations or roughly after 4.3 years of regular use.

Storage Conditions for Brineura

• Cerliponase alfa injection and the intraventricular electrolytes should be stored upright in a freezer at a temperature of -25 °C to -15 °C. It should be protected from light.
• Administration sets should be kept in the original carton and should not to be frozen.



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