Risankizumab parenteral
- Drugs List
- Therapeutic Indications
- Dosage
- Administration
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Solution for injection containing risankizumab.
Drugs List
Therapeutic Indications
Uses
Moderate to severe plaque psoriasis
Psoriatic arthritis (unresp to DMARD) monotherapy or combination with MTX
Dosage
Adults
Plaque psoriasis
150mg by subcutaneous injection: Week 0; Week 4; Every 12 weeks thereafter
If no response after 16 weeks of treatment, consider discontinuing treatment.
Patients with initial partial response may improve with continued treatment after 16 weeks.
Psoriatic arthritis
150mg by subcutaneous injection: Week 0; Week 4; Every 12 weeks thereafter
If no response after 16 weeks of treatment, consider discontinuing treatment.
Additional Dosage Information
If dose missed, administer as soon as possible. Resume dosing at the regular scheduled time.
Administration
For subcutaneous injection only.
Contraindications
Children under 18 years
Severe infection
Within 4 weeks of live viral or bacterial vaccination
Breastfeeding
Tuberculosis
Precautions and Warnings
Chronic infection
History of recurrent infection
Predisposition to infection
Hereditary fructose intolerance
Latent or healed tuberculosis
Pregnancy
Avoid live vaccines during and for at least 21 weeks after treatment
Before starting therapy ensure immunisations are up to date
Consider prophylactic anti-tuberculosis therapy if appropriate
Prior to starting therapy screen for latent tuberculosis
Treat and control infections prior to commencing therapy
Treatment to be initiated and supervised by a specialist
Contains polysorbate
Presentations with sorbitol unsuitable in hereditary fructose intolerance
Avoid injection into broken or bruised skin
Do not use if solution is discoloured or particulates are apparent
For subcutaneous use only
Record name and batch number of administered product
Self-admin. - only if adequately trained and have access to expert advice
Vary injection site during prolonged therapy
Warm to room temperature prior to use
Monitor patient for signs of serious infection
Advise patient to report symptoms of infection immediately
Risk of developing opportunistic infections
Discontinue if allergic reaction occurs
Discontinue if no response to treatment after 16 weeks
Interrupt treatment if severe infection develops
Female: Contraception required during and at least 21 weeks after treatment
Pregnancy and Lactation
Pregnancy
Use risankizumab with caution during pregnancy.
The manufacturer notes that it is better to avoid this medication and that there is little data on its use in pregnancy.
Animal studies do not show any direct/indirect harmful effects regarding reproductive toxicity.
Lactation
Risankizumab is contraindicated during breastfeeding.
The manufacturer advises that the patient either discontinues risankizumab or discontinues breastfeeding.
It is unknown if risankizumab is excreted in human milk. It is known that human IgGs are excreted in breast milk during the first few days after birth. This then decreases to low concentrations soon afterwards but a risk to the breastfed infant cannot be excluded during this period.
Side Effects
Fatigue
Folliculitis
Headache
Injection site reactions
Pruritus
Tinea infections
Upper respiratory tract infection
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: June 2021
Reference Sources
Summary of Product Characteristics: Skyrizi 75mg solution for injection in pre-filled syringe. AbbVie Deutschland GmbH & Co. KG. Revised January 2021.
Summary of Product Characteristics: Skyrizi 150mg solution for injection in pre-filled syringe. AbbVie Deutschland GmbH & Co. KG. Revised January 2023.
Summary of Product Characteristics: Skyrizi 150mg solution for injection in pre-filled pen. AbbVie Deutschland GmbH & Co. KG. Revised January 2023.
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