C1-esterase inhibitor parenteral
- Drugs List
- Therapeutic Indications
- Dosage
- Administration
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Injections/infusions of c1-esterase inhibitor.
Drugs List
Therapeutic Indications
Uses
Hereditary angioedema
Hereditary angioedema,prior to surgery/major dental procedures; prophylaxis
Hereditary angioedema: prophylaxis
Dosage
Adults
Berinert
Treatment of acute angioedema attacks
20 units/kg body weight.
Pre-procedure prevention of angioedema attacks
1,000 units as a single dose less than 6 hours prior to a medical, dental or surgical procedure.
Cinryze
Treatment of angioedema attacks
1,000 units at the first signs of the onset of an acute attack.
A second dose of 1,000 units may be administered if the patient has not responded adequately after 60 minutes.
For patients experiencing severe attacks particularly laryngeal attacks or if initiation of treatment is delayed, the second dose can be given sooner than 60 minutes.
Routine prevention of angioedema attacks
1,000 units every 3 to 4 days. The dosing interval may need to be adjusted according to individual response.
The continued need for regular prophylaxis should be reviewed on a regular basis.
Pre-procedure prevention of angioedema attacks
1,000 units within 24 hours before a medical, dental or surgical procedure.
Children
Berinert
Treatment of acute angioedema attacks
20 units/kg body weight.
Pre-procedure prevention of angioedema attacks
15 to 30 units/kg body weight (maximum 1,000 units) less than 6 hours prior to a medical, dental or surgical procedure. Dose should be selected taking into account clinical circumstances (e.g. type of procedure and disease severity).
Cinryze
Treatment of angioedema attacks
Children 2 to 11 years (over 25kg)
At the first signs of the onset of an acute attack, administer 1,000 units.
A second dose of 1,000 units may be administered if the patient has not responded adequately after 60 minutes.
Children 2 to 11 years (10kg-25kg)
At the first signs of the onset of an acute attack, administer 500 units.
A second dose of 500 units may be administered if the patient has not responded adequately after 60 minutes.
Pre-procedure prevention of angioedema attacks
Children 2 to 11 years (over 25kg)
1,000 units within 24 hours before a medical, dental or surgical procedure.
Children 2 to 11 years (10kg-25kg)
500 units within 24 hours before a medical, dental or surgical procedure.
Routine prevention of angioedema attacks
Children 6 to 11 years
500 units every 3 to 4 days. The dosing interval may need to be adjusted according to individual response.
The continued need for regular prophylaxis should be reviewed on a regular basis.
Administration
Berinert 500 IU
Solution to be administered by slow intravenous injection or infusion at a rate of 4ml per minute.
Berinert 1500
Solution to be administered by slow intravenous injection.
Cinryze 500
Solution to be administered by intravenous injection at a rate of 1ml per minute.
Contraindications
Breastfeeding
Precautions and Warnings
Children under 2 years
Restricted sodium intake
Hereditary fructose intolerance
History of thrombosis
Pregnancy
Allergic disposition: consider prophylactic antihistamine & corticosteroid
Sodium content of formulation may be significant
Not all available brands are licensed for all age groups
Not all available brands are licensed for all indications
Regular use of human derived blood or plasma - consider HAV or HBV vaccine
Treatment to be initiated and supervised by a specialist
Derived from human plasma. Transmission of infective agents possible.
Some formulations contain sucrose
Record name and batch number of administered product
Monitor patients at risk for signs & symptoms of venous thromboembolism
Management of cases of shock should follow current medical standards
Discontinue if serious allergic or anaphylactic reaction occurs
Pregnancy and Lactation
Pregnancy
Use c1-esterase inhibitor injection/infusion with caution during pregnancy.
The manufacturer recommends C1-esterase inhibitor is not used during pregnancy unless the potential benefit to the mother outweighs the potential risk to the foetus. At the time of writing there is limited data that indicates no increased risk from the use of C1-esterase inhibitor in pregnant women. The medication is a physiological component of human plasma. Risks are unknown.
Lactation
C1-esterase inhibitor injection/infusion is contraindicated during breastfeeding.
The manufacturer advises discontinuing breastfeeding or discontinuing C1-esterase inhibitor. It is unknown whether C1-esterase inhibitor is excreted in human milk but due to its high molecular weight, the transfer of this medication into breast milk seems unlikely. However, breastfeeding is questionable in women suffering from hereditary angioedema.
Side Effects
Abdominal pain
Allergic reaction
Anaphylactic reaction
Arthralgia
Chest discomfort
Contact dermatitis
Cough
Diarrhoea
Dizziness
Dyspnoea
Erythema
Flushing
Headache
Hives
Hyperglycaemia
Hypersensitivity reactions
Hypertension
Hypotension
Joint swelling
Local pain (injection site)
Local reaction at injection site
Myalgia
Nausea
Phlebitis
Pruritus
Pyrexia
Rash
Shock
Tachycardia
Venous burning
Venous thrombosis
Vomiting
Overdosage
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Further Information
Last Full Review Date: March 2021
Reference Sources
Summary of Product Characteristics: Berinert 500 IU. CSL Behring UK Limited. Revised January 2019.
Summary of Product Characteristics: Berinert 1500 IU. CSL Behring UK Limited. Revised November 2019.
Summary of Product Characteristics: Cinryze 500 IU powder and solvent for solution for injection. Shire Pharmaceuticals Limited. Revised October 2020.
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
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