Abrocitinib oral
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Oral formulations of abrocitinib.
Drugs List
Therapeutic Indications
Uses
Moderate/severe atopic dermatitis when other therapy unsuitable/ineffective
Dosage
Adults
Initial dose
200mg once daily. However, 100mg once daily is recommended for patients who are less likely to tolerate adverse reactions or have risk factors associated with developing an adverse reaction to abrocitinib.
Maintenance dose
Dose reduction may be considered after disease control, based on tolerability and efficacy. Dose reduction may cause patients to experience a disease flare up.
Maximum dose is 200mg a day.
Elderly
Patients aged 65 years and over
Initial dose
100mg once daily.
Maintenance dose
Dose may be increased or decreased according to tolerability and efficacy. Dose reduction may cause patients to experience a disease flare up.
Maximum dose is 200mg a day.
Children
Patients aged 12 to 17 years old
Initial dose
100mg once daily.
Maintenance dose
Dose may be increased or decreased according to tolerability and efficacy. Dose reduction may cause patients to experience a disease flare up.
Maximum dose is 200mg a day.
Patients with Renal Impairment
Moderate renal impairment (eGFR 30ml/minute to 60ml/minute)
Recommended dose should be halved to 100mg or 50mg once daily.
Severe renal impairment (eGFR less than 30ml/minute)
Initial dose is 50mg once daily. Maximum daily dose is 100mg once daily.
Additional Dosage Information
Missed doses
In the event of a missed dose, the patient should be advised to take the dose as soon as remembered, unless there are less than 12 hours before the next dose, in which case the missed dose should not be taken and dosing should resume at the regular scheduled time.
Patients receiving potent CYP 2C19 inhibitors
The recommended starting dose should be halved to 100mg or 50mg once daily.
Patients who experience nausea
Advise patients who experience nausea, to take abrocitinib with food.
Contraindications
Absolute lymphocyte count below 0.5 x 10 to the power of 9/L
Children under 12 years
Haemoglobin concentration below 8g / dL
Neutrophil count below 1.0 x 10 to the power of 9 / L
Platelet count below 150 x 10 to the power of 9 / L
Severe active systemic infection
Breastfeeding
Galactosaemia
Pregnancy
Severe hepatic impairment - Child-Pugh score greater than or equal to 10
Tuberculosis
Precautions and Warnings
Chronic infection
Females of childbearing potential
History of recurrent infection
Patients over 65 years
Predisposition to infection
Predisposition to thromboembolic disease
Recent exposure to tuberculosis
End stage renal disease
Glucose-galactose malabsorption syndrome
Lactose intolerance
Malignant neoplasm
Renal impairment - eGFR below 60 ml/minute/1.73 m squared
Avoid live vaccines during treatment and until immune recovery
Before initiating screen all patients for viral hepatitis
HBV DNA: Refer to liver specialist to consider interruption
Interrupt therapy if herpes zoster occurs
Advise patient dizziness may affect ability to drive or operate machinery
May be increased risk of skin cancer
Prior to starting therapy screen for latent tuberculosis
Treatment to be initiated and supervised by a specialist
Contains lactose
Monitor blood lipids before and during treatment
Monitor full blood count and differential WBC before and during therapy
Monitor patient for skin cancer during and after treatment
Increased risk of eczema herpeticum
Reactivation of herpes zoster may occur
Risk of developing opportunistic infections
Advise patient to seek advice at first indications of pregnancy
Consider discontinuing treatment if no response after 12 weeks
Consider interrupting therapy if eczema herpeticum occurs
Discontinue if platelet count less than 50x10 to the power of 9/L
Discontinue if thromboembolism occurs
Interrupt if haemoglobin falls below 8 g/dL
Interrupt if lymphocyte count less than 0.5 x 10 to the power of 9/L
Interrupt therapy if neutrophil count <1.0x10 to the power 9/L
Consider interrupting treatment if infection occurs
Reduce dose in elderly
Female: Reduced fertility (reversible) possible with long term use
Female: Contraception required during and for 1 month after treatment
Remind patient of importance of carrying Alert Card with them at all times
Prior to initiating abrocitinib, it is recommended all patients are up to date with all immunisations in line with current immunisation guidelines.
Before starting treatment with abrocitinib, all patients should be screened for viral hepatitis in accordance with clinical guidelines. If hepatitis B DNA is detected, a hepatic specialist should be consulted to establish whether treatment interruption is necessary.
Patients should undergo complete blood counts before initiating treatment and every 4 weeks during treatment, and thereafter.
Dose dependent increases in blood lipid parameters have been reported in patients treated with abrocitinib. Therefore, blood lipids should be monitored before initiation of abrocitinib treatment, and every 4 weeks thereafter. Patients with abnormal blood lipids should be monitored and managed according to clinical guidelines.
Patients should be closely monitored during, and after treatment with abrocitinib for signs of infection. Should the patient develop a new infection, complete diagnostic testing and antimicrobial therapy should be initiated immediately. If the patient does not respond to standard therapy, abrocitinib treatment should be interrupted.
Pregnancy and Lactation
Pregnancy
Abrocitinib is contraindicated during pregnancy.
The manufacturer states that abrocitinib is contraindicated during pregnancy.
Animal studies have shown teratogenic effects such as skeletal variations in the foetuses of rats and rabbits, affecting development. Human data is limited and as such a potential risk cannot be ruled out.
Lactation
Abrocitinib is contraindicated during breastfeeding.
The manufacturer states that abrocitinib should not be used during breastfeeding. Animal data reports have shown levels of abrocitinib in the breast milk however presence in human breast milk is unknown.
Effects on exposed infants are unknown.
Side Effects
Acne
Creatine phosphokinase increased
Deep vein thrombosis (DVT)
Dizziness
Dyslipidaemia
Genital herpes infection
Headache
Herpes dermatitis
Herpes simplex
Herpes zoster
Hypercholesterolaemia
Hyperlipidaemia
Lymphopenia
Nausea
Ophthalmic herpes simplex
Ophthalmic herpes zoster
Oral herpes
Pneumonia
Pulmonary embolism
Thrombocytopenia
Upper abdominal pain
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: December 2021
Reference Sources
Summary of Product Characteristics: Cibinqo 50mg film-coated tablets. Pfizer Limited. Revised September 2021.
Summary of Product Characteristics: Cibinqo 100mg film-coated tablets. Pfizer Limited. Revised September 2021.
Summary of Product Characteristics: Cibinqo 200mg film-coated tablets. Pfizer Limited. Revised September 2021.
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 17 December 2021
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
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