Drugs List

Therapeutic Indications

Uses

Moderate to severe plaque psoriasis

Treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy.

Administration

Administered via subcutaneous injection. Alternate injection sites, and do not inject into tender, bruised, red, hard, thick or scaly areas of skin, or areas affected by plaque psoriasis.

Contraindications

Children under 18 years
Severe infection
Within 4 weeks of live viral or bacterial vaccination
Breastfeeding
Pregnancy
Tuberculosis

Precautions and Warnings

Chronic infection
History of recurrent infection
Hepatic impairment
History of tuberculosis
Renal impairment

Avoid live vaccines during and for 17 weeks after treatment
Administration of live vaccines should occur 4 weeks before initiation
Before starting therapy ensure immunisations are up to date
Consider prophylactic anti-tuberculosis therapy if appropriate
Treat and control infections prior to commencing therapy
Record name and batch number of administered product
Rotate injection site each day when injecting the same region
Treatment to be administered by or under supervision of specialist
Advise patient to report symptoms of infection immediately
Advise patient to seek med advice if signs/symptoms of tuberculosis develop
Consider stopping treatment if severe uncontrolled infections occur
Oversuppression of immune system may increase susceptibility to infection
Discontinue if hypersensitivity reactions occur
Female: Contraception required during and for 17 weeks after treatment

Each pre-filled syringe is for single use only.

Pregnancy and Lactation

Pregnancy

Tildrakizumab is contraindicated during pregnancy.

There is limited data on the use of tildrakizumab during pregnancy. Though there is no evidence of reproductive toxicity in animal studies, the manufacturer contraindicates the use of tildrakizumab during pregnancy as a precautionary measure.

Lactation

Tildrakizumab is contraindicated during breastfeeding.

There is limited data on the use of tildrakizumab in breastfeeding. The manufacturer contraindicates the use of tildrakizumab in breastfeeding, stating that it is unknown whether the drug is excreted in breast milk, and a risk to the nursing infant cannot be excluded. Animal studies suggest that negligible amounts of the drug may be excreted in breast milk.

LactMed suggests that the high molecular weight of tildrakizumab may limit the amount of the drug absorbed by the breastfed infant, and that it may be destroyed in the infant's gastrointestinal tract.

Side Effects

Back pain
Diarrhoea
Gastro-enteritis
Headache
Nasopharyngitis
Nausea
Pain / soreness (injection site)
Upper respiratory tract infection

Presentation

Pre-filled syringe containing tildrakizumab.

Drugs List

Therapeutic Indications

Uses

Moderate to severe plaque psoriasis

Treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy.

Dosage

Adults

Additional Dosage Information

Administration

Administered via subcutaneous injection. Alternate injection sites, and do not inject into tender, bruised, red, hard, thick or scaly areas of skin, or areas affected by plaque psoriasis.

Contraindications

Children under 18 years
Severe infection
Within 4 weeks of live viral or bacterial vaccination
Breastfeeding
Pregnancy
Tuberculosis

Precautions and Warnings

Chronic infection
History of recurrent infection
Hepatic impairment
History of tuberculosis
Renal impairment

Avoid live vaccines during and for 17 weeks after treatment
Administration of live vaccines should occur 4 weeks before initiation
Before starting therapy ensure immunisations are up to date
Consider prophylactic anti-tuberculosis therapy if appropriate
Treat and control infections prior to commencing therapy
Record name and batch number of administered product
Rotate injection site each day when injecting the same region
Treatment to be administered by or under supervision of specialist
Advise patient to report symptoms of infection immediately
Advise patient to seek med advice if signs/symptoms of tuberculosis develop
Consider stopping treatment if severe uncontrolled infections occur
Oversuppression of immune system may increase susceptibility to infection
Discontinue if hypersensitivity reactions occur
Female: Contraception required during and for 17 weeks after treatment

Each pre-filled syringe is for single use only.

Pregnancy and Lactation

Pregnancy

Tildrakizumab is contraindicated during pregnancy.

There is limited data on the use of tildrakizumab during pregnancy. Though there is no evidence of reproductive toxicity in animal studies, the manufacturer contraindicates the use of tildrakizumab during pregnancy as a precautionary measure.

Lactation

Tildrakizumab is contraindicated during breastfeeding.

There is limited data on the use of tildrakizumab in breastfeeding. The manufacturer contraindicates the use of tildrakizumab in breastfeeding, stating that it is unknown whether the drug is excreted in breast milk, and a risk to the nursing infant cannot be excluded. Animal studies suggest that negligible amounts of the drug may be excreted in breast milk.

LactMed suggests that the high molecular weight of tildrakizumab may limit the amount of the drug absorbed by the breastfed infant, and that it may be destroyed in the infant's gastrointestinal tract.

Side Effects

Back pain
Diarrhoea
Gastro-enteritis
Headache
Nasopharyngitis
Nausea
Pain / soreness (injection site)
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: January 2020

Reference Sources

Summary of Product Characteristics: Ilumetri 100mg solution for injection in pre-filled syringe. Almirall Limited. Revised January 2020.

US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
Available at: https://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT
Tildrakizumab Last revised: 3 December 2018
Last accessed: 06 January 2020