Conestat alfa parenteral
- Drugs List
- Therapeutic Indications
- Dosage
- Administration
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Powder for solution for injection containing conestat alfa.
Powder for solution and solvent for injection containing conestat alfa.
Drugs List
Therapeutic Indications
Uses
Hereditary angioedema
Dosage
Adults
Adults up to 84kg body weight
One intravenous injection of 50units per kilogram body weight.
Adults of 84kg body weight or greater
One intravenous injection of 4200units (two vials).
In the majority of cases a single dose of the medication is sufficient to treat an acute angioedema attack.
In the case of an insufficient clinical response, an additional dose (50units/kg body weight up to 4200units) can be administered after 120 minutes in adults and adolescents and 60 minutes in children.
Not more than two doses should be administered within 24 hours.
Dose calculation
Determine the patient's body weight.
Adults up to 84kg body weight
Calculate the volume required to be administered according to the below formula:
Volume to be administered (ml) = Body weight (kg) times 50 (units/kg) divided by 150 (units/ml) = body weight (kg) divided by 3.
Adults of 84kg body weight or greater
28ml, corresponding to 4200units (two vials).
Children
Children aged 2 years and over
See Dosage; Adult
Administration
The reconstituted solution is to be administered by slow intravenous injection over approximately 5 minutes and should be initiated under the supervision of a doctor experienced in the diagnosis treatment of hereditary angioedema.
Reconstitution
Each vial of conestat alfa (2100 units) should be reconstituted with 14 ml water for injections and appears as a clear, colourless solution and should be used immediately. A solution showing particulates or discolouration should not be used.
Contraindications
Children under 2 years
Precautions and Warnings
Breastfeeding
Pregnancy
Contains traces of rabbit protein: check for history of allergy to rabbits
May contain rabbit protein: Cross-reaction with cow's milk allergy possible
Advise ability to drive/operate machinery may be affected by side effects
Treatment to be initiated and supervised by a specialist
Preparation contains sucrose
Record name and batch number of administered product
Monitor for signs and symptoms of allergic reaction
Advise patient to report symptoms of allergic type hypersensitivity
Management of cases of shock should follow current medical standards
Monitor patients during and after administration for symptoms of hypersensitivity, including hives, generalised urticaria, tightness of the chest, wheezing, hypotension and anaphylaxis.
Pregnancy and Lactation
Pregnancy
Use conestat alfa with caution in pregnancy.
The manufacturer notes that this medication should only be used during pregnancy if the treating physician judges the benefits to outweigh the possible risks.
In one animal study reproductive toxicity was observed. Daily single doses of the vehicle or 625 units/kg/administration of rhC1INH were administered intravenously to mated rats and rabbits. In the study, in rats there were no malformed foetuses in either the conestat alfa or the control group. In a rabbit embryotoxicity study, an increase in the incidence of foetal cardiac vessel defects (1.12% in the treatment group versus 0.03% in historical controls) was observed for animals that were administered conestat alfa.
Lactation
Use conestat alfa with caution in breastfeeding.
The manufacturer notes that this medication should only be used during breastfeeding if the treating physician judges the benefits to outweigh the possible risks.
Side Effects
Abdominal discomfort
Anaphylaxis
Auricular swelling
Chest tightness
Diarrhoea
Dizziness
Headache
Hives
Hypersensitivity reactions
Hypoaesthesia
Hypotension
Nausea
Oral paraesthesia
Paraesthesia
Swelling (injection site)
Throat irritation
Urticaria
Vertigo
Wheezing
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 2019
Reference Sources
Summary of Product Characteristics: Ruconest 2100 U powder for solution for injection. Pharming Group N.V. Revised April 2020.
Summary of Product Characteristics: Ruconest 2100 U powder and solvent for solution for injection. Pharming Group N.V. Revised April 2020..
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 11 January 2023
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
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