Ustekinumab parenteral
- Drugs List
- Therapeutic Indications
- Dosage
- Administration
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Solution for injection containing ustekinumab.
Drugs List
Therapeutic Indications
Uses
Active psoriatic arthritis
Moderate to severe active Crohn's disease: Second line treatment
Moderate to severe plaque psoriasis: Second line treatment
Moderate/severe ulcerative colitis: when other treatment is inappropriate
Treatment of moderate to severe plaque psoriasis in adults who did not respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate and PUVA (psoralen and ultraviolet A).
Treatment of moderate to severe plaque psoriasis in children and adolescents from the age of 6 years and older, who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies.
Treatment of active psoriatic arthritis in adult patients when the response to previous non-biological disease-modifying anti-rheumatic drug (DMARD) therapy has been inadequate.
Treatment of moderately to severely active Crohn's disease in adults who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a TNF alpha antagonist or have medical contraindications to such therapies.
Treatment of moderately to severely active ulcerative colitis in adults who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biological or have medical contraindications to such therapies.
Dosage
Adults
Plaque psoriasis and Psoriatic arthritis
Patients with body weight less than 100kg
The recommended dosage regimen is an initial dose of 45mg administered subcutaneously, followed by 45mg subcutaneously 4 weeks later, then one 45mg dose subcutaneously every 12 weeks thereafter.
Patients with body weight greater than 100kg
The recommended dosage regimen is an initial dose of 90mg administered subcutaneously, followed by 90mg subcutaneously 4 weeks later, then one 90mg dose subcutaneously every 12 weeks thereafter. In these patients 45mg doses were also efficacious, however, 90mg doses resulted in greater efficacy.
In patients who have shown no response to treatment after 28 weeks, discontinue treatment.
Crohn's disease and Ulcerative Colitis
Patients with body weight less than or equal to 55kg
The recommended dosage regimen is an initial dose of 260mg administered intravenously, followed by 90mg subcutaneously 8 weeks later, then one 90mg dose subcutaneously every 12 weeks thereafter.
Patients with body weight greater than 55kg to less than or equal to 85kg
The recommended dosage regimen is an initial dose of 390mg administered intravenously, followed by 90mg subcutaneously 8 weeks later, then one 90mg dose subcutaneously every 12 weeks thereafter.
Patients with body weight greater than 85kg
The recommended dosage regimen is an initial dose of 520mg administered intravenously, followed by 90mg subcutaneously 8 weeks later, then one 90mg dose subcutaneously every 12 weeks thereafter.
Patients who have not shown adequate response at 8 weeks after the first subcutaneous dose, may receive a second subcutaneous dose at this time.
Patients who lose response on dosing every 12 weeks may benefit from an increase in dosing frequency to every 8 weeks. Dosing frequency can be every 8 weeks or 12 weeks according to clinical judgement.
In patients who have shown no response by week 16 or 16 weeks after switching to the 8-weekly dose, consider discontinuing treatment.
During treatment with ustekinumab, immunomodulators and/or corticosteroids may be continued. Corticosteroids may be reduced or discontinued in patients who have responded to treatment with ustekinumab.
In Crohn's disease, if therapy is interrupted, treatment can be resumed with subcutaneous dosing every 8 weeks.
Children
Children aged 6 years and over
Paediatric plaque psoriasis
Body weight less than 60kg: Recommended dose is 0.75mg/kg
Body weight 60kg to less than or equal to 100kg: Recommended dose is 45mg
Body weight greater than 100kg: Recommended dose is 90mg
To calculate the volume of injection (ml) for patients less than 60kg, use the following formula: body weight (kg) x 0.0083 (ml/kg).
Additional Dosage Information
If possible, areas of the skin that show psoriasis should be avoided as injection sites. The preparation should be brought to room temperature before the injection (approximately 30 minutes).
Patients may self-inject ustekinumab 45mg and 90mg if the physician considers it appropriate and the patient is properly trained. The physician should ensure that appropriate follow up is undertaken.
The preparation may contain some translucent to white proteinaceous matter, however, it should not be used if there is foreign particulate matter or if the solution is discoloured or cloudy.
Administration
Ustekinumab 45mg and 90mg is for subcutaneous injection only.
Ustekinumab 130mg should be used for the intravenous induction dose only. It should be administered over at least one hour.
Contraindications
Children under 6 years
Severe infection
Acute untreated tuberculosis
Breastfeeding
Hereditary fructose intolerance
Pregnancy
Precautions and Warnings
Children aged 6 to 18 years
Females of childbearing potential
History of recurrent infection
Infection
Glucose-galactose malabsorption syndrome
Hepatic impairment
History of cancer
Latent or healed tuberculosis
Malignant neoplasm
Renal impairment
Administration of live vaccines is not recommended
Careful supervision of patients with psoriasis required
Advise ability to drive/operate machinery may be affected by side effects
Monitor patients for non-melanoma skin cancer prior to and during treatment
Not all available products are licensed for all age groups
Not all available strengths are licensed for all indications
Treatment to be initiated and supervised by a specialist
Needle cover contains a derivative of latex
Some formulations contain sucrose
For single use only
Record name and batch number of administered product
May cause activation / exacerbation of latent / intercurrent infections
Advise patient to immediately report symptoms of erythrodermic psoriasis
Advise patient to immediately report symptoms of exfoliative dermatitis
Advise patient to report symptoms of infection immediately
Advise patient to seek med advice if signs/symptoms of tuberculosis develop
Discontinue if a serious infection develops
Immunosuppressive drugs may increase risk of malignancy
Discont./investigate/treat using current guidelines if active TB suspected.
Discontinue if alveolitis,eosinophilic or organising pneumonia is diagnosed
Discontinue if psoriasis becomes exacerbated during treatment
Discontinue if serious allergic or anaphylactic reaction occurs
Female: Contraception required during and for 15 weeks after treatment
Ustekinumab should be withheld for at least 15 weeks before vaccination and at least 2 weeks afterwards. The prescriber should consult the relevant product literature for the vaccine for further information. Ustekinumab may be used concurrently with inactivated or non-live vaccines.
As part of the monitoring of the patient's psoriasis, physicians should be alert for symptoms of erythrodermic psoriasis or exfoliative dermatitis. If these symptoms occur, appropriate therapy should be instituted and ustekinumab should be discontinued if a drug reaction is suspected.
Pregnancy and Lactation
Pregnancy
Ustekinumab is contraindicated during pregnancy.
Currently there is very little data concerning exposed human pregnancies and their outcomes. Animal studies did not indicate direct or indirect harmful effects with respect to pregnancy, embryonic/foetal development, parturition or postnatal development. The manufacturer recommends that ustekinumab should be avoided during pregnancy.
The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Lactation
Ustekinumab is contraindicated in breastfeeding.
It is unknown whether ustekinumab is present in human breast milk. Low levels were shown to have been seen in animal milk. It is not known whether ustekinumab is systemically absorbed after ingestion. Due to the potential for adverse reactions in the nursing infant a decision on whether to discontinue treatment or breastfeeding needs to be made, taking into consideration the benefits of breastfeeding for the infant and the benefits of ustekinumab for the mother. If breastfeeding is to be discontinued, it must be discontinued for the duration of the treatment and for 15 weeks after treatment. The mean half life of ustekinumab is about 15 to 46 days. The long half life will assure that the antibody is in the maternal plasma for long periods (Briggs).
Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1
Side Effects
Acne
Allergic alveolitis
Angioedema
Arthralgia
Asthenia
Back pain
Cellulitis
Depression
Diarrhoea
Dizziness
Eosinophilic pneumonia
Erythema at injection site
Exfoliative dermatitis
Facial palsy
Fatigue
Haematoma (injection site)
Haemorrhage (injection site)
Headache
Herpes zoster
Hypersensitivity reactions including anaphylaxis
Induration (injection site)
Infections
Itching (injection site)
Local pain (injection site)
Malignancies
Myalgia
Nasal congestion
Nasopharyngitis
Nausea
Non-infectious organising pneumonia
Pharyngolaryngeal pain
Pruritus
Pustular psoriasis
Rash
Skin exfoliation
Swelling (injection site)
Tooth infection
Upper respiratory tract infection
Urticaria
Vomiting
Vulvovaginal infections
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: November 2015
Reference Sources
Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 10th edition (2015) ed. Briggs, G., Freeman, R. Wolters Kluwer Health, Philadelphia.
Summary of Product Characteristics: Stelara 45mg solution for injection (vials). Janssen-Cilag Ltd. Revised January 2020.
Summary of Product Characteristics: Stelara 45mg solution for injection in pre-filled syringe. Janssen-Cilag Ltd. Revised January 2020.
Summary of Product Characteristics: Stelara 90mg solution for injection in pre-filled syringe. Janssen-Cilag Ltd. Revised January 2020.
Summary of Product Characteristics: Stelara 130mg concentrate for solution for infusion. Janssen-Cilag Ltd. Revised January 2020.
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 12 January 2017
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
FDB Disclaimer : FDB Multilex is intended for the use of healthcare professionals and is provided on the basis that the healthcare professionals will retain FULL and SOLE responsibility for deciding what treatment to prescribe or dispense for any particular patient or circumstance.