Drugs List

Therapeutic Indications

Uses

Dermatitis - atopic
Severe active rheumatoid arthritis-other regimens unsuitable/ineffective

Rheumatoid arthritis
For the treatment of moderate to severe active rheumatoid arthritis in patients who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs (DMARDs). Baricitinib can be used as monotherapy or in combination with methotrexate.

Atopic dermatitis
For the treatment of moderate to severe atopic dermatitis.

Contraindications

Absolute lymphocyte count below 0.5 x 10 to the power of 9/L
Children under 18 years
Haemoglobin concentration below 8g / dL
Neutrophil count below 1.0 x 10 to the power of 9 / L
Acute untreated tuberculosis
Breastfeeding
Pregnancy
Renal impairment - creatinine clearance below 30 ml/minute
Severe hepatic impairment

Precautions and Warnings

History of recurrent infection
Infection
Predisposition to pulmonary embolism
Predisposition to venous thromboembolism
Risk factors for diverticulitis
Diverticulitis
Hepatitis
Latent or healed tuberculosis
Pulmonary embolism
Renal impairment - creatinine clearance 30-60ml/minute
Venous thromboembolism

Administration of live vaccines is not recommended
Before initiating screen all patients for viral hepatitis
Consider anti-TB therapy in patients with latent TB
HBV DNA: Refer to liver specialist to consider interruption
Interrupt therapy if herpes zoster occurs
Before starting therapy ensure immunisations are up to date
Prior to starting therapy rule out active tuberculosis
Advise patient to report signs of gastrointestinal perforation immediately
Monitor lymphocyte count before and regularly during treatment
Monitor haemoglobin levels
Monitor hepatic function regularly
Monitor neutrophil count
Monitor serum lipids 3 months after initiation
Advise patient to report symptoms of infection immediately
Advise patient to report unexplained nausea,vomiting,abdominal pain
Immunosuppressive drugs may increase risk of malignancy
Reactivation of herpes simplex may occur
Reactivation of herpes zoster may occur
Risk of developing opportunistic infections
Advise patient to seek advice at first indications of pregnancy
Atopic dermatitis: Consider discontinuing if no response after 8 weeks
Discontinue if pulmonary embolism occurs
Discontinue if serious allergic or anaphylactic reaction occurs
Discontinue if there is a rise in liver enzymes
Discontinue if venous thromboembolism develops
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
Suspend if drug induced liver injury is suspected
Consider interrupting treatment if infection occurs
Female: May cause infertility
Female: Contraception required during and for 1 week after treatment
Advise patient to report symptoms of herpes zoster urgently
Give patient package leaflet and patient reminder card
Remind patient of importance of carrying Alert Card with them at all times

It should be noted that there is an increased risk of lymphocytosis in elderly patients with rheumatoid arthritis. Rare cases of lymphoproliferative disorders have been reported. Before starting treatment with baricitinib, 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.

Prior to initiating baricitinib, it is recommended all patients are up to date with all immunisations in line with current immunisation guidelines.
Dose dependent increases in blood lipid parameters have been reported in patients treated with baricitinib. LDL cholesterol levels are expected to decrease to baseline levels in response to statin therapy. Lipid parameters should be assessed 12 weeks following initiation of baricitinib therapy.

In the event that increased alanine transaminase (ALT) and aspartate transaminase (AST) are observed during routine patient observations, consider if this may be due to drug-induced liver injury. If drug induced liver injury is suspected, baricitinib should be temporarily interrupted until this diagnosis is eliminated.

Venous thromboembolism (VTE) and pulmonary embolism (PE) has been reported during baricitinib therapy. If clinical signs of VTE or PE occur, temporarily interrupt baricitinib whilst confirming the diagnosis and initiating any necessary treatment.

Pregnancy and Lactation

Pregnancy

Baricitinib is contraindicated during pregnancy.

The manufacturer states that baricitinib is contraindicated during pregnancy.

The pathways on which baricitinib act are involved in the cell adhesion and cell polarity which affects early embryonic development. Animal studies have indicated that the use of baricitinib during pregnancy is related to reproductive toxicity, including adverse effects on bone development in utero at higher doses. Baricitinib is teratogenic in animals.

Lactation

Baricitinib is contraindicated during breastfeeding.

The manufacturer states that baricitinib should not be used during breastfeeding.

It is unknown whether baricitinib or its metabolites are excreted in human milk. Available animal data has shown baricitinib is excreted in milk. Consequently, a risk to infants cannot be excluded.

Side Effects

Abdominal pain
Acne
Creatine phosphokinase increased
Deep vein thrombosis (DVT)
Diverticulitis
Eczema herpeticum
Epiglottitis
Facial swelling
Gastro-enteritis
Gastro-intestinal perforation
Headache
Herpes simplex
Herpes zoster
Hypercholesterolaemia
Hypertriglyceridaemia
Increase in serum ALT/AST
Laryngitis
Lymphoproliferative disorders
Nasopharyngitis
Nausea
Neutropenia
Ophthalmic herpes simplex
Oral herpes
Oropharyngeal pain
Pharyngitis
Pharyngotonsillitis
Pneumonia
Pulmonary embolism
Rash
Rhinitis
Sinusitis
Thrombocytosis
Tonsillitis
Tracheitis
Upper respiratory tract infection
Urinary tract infections
Urticaria
Weight gain

Presentation

Oral formulations containing baricitinib.

Drugs List

Therapeutic Indications

Uses

Dermatitis - atopic
Severe active rheumatoid arthritis-other regimens unsuitable/ineffective

Rheumatoid arthritis
For the treatment of moderate to severe active rheumatoid arthritis in patients who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs (DMARDs). Baricitinib can be used as monotherapy or in combination with methotrexate.

Atopic dermatitis
For the treatment of moderate to severe atopic dermatitis.

Dosage

Adults

Elderly

Patients with Renal Impairment

Contraindications

Absolute lymphocyte count below 0.5 x 10 to the power of 9/L
Children under 18 years
Haemoglobin concentration below 8g / dL
Neutrophil count below 1.0 x 10 to the power of 9 / L
Acute untreated tuberculosis
Breastfeeding
Pregnancy
Renal impairment - creatinine clearance below 30 ml/minute
Severe hepatic impairment

Precautions and Warnings

History of recurrent infection
Infection
Predisposition to pulmonary embolism
Predisposition to venous thromboembolism
Risk factors for diverticulitis
Diverticulitis
Hepatitis
Latent or healed tuberculosis
Pulmonary embolism
Renal impairment - creatinine clearance 30-60ml/minute
Venous thromboembolism

Administration of live vaccines is not recommended
Before initiating screen all patients for viral hepatitis
Consider anti-TB therapy in patients with latent TB
HBV DNA: Refer to liver specialist to consider interruption
Interrupt therapy if herpes zoster occurs
Before starting therapy ensure immunisations are up to date
Prior to starting therapy rule out active tuberculosis
Advise patient to report signs of gastrointestinal perforation immediately
Monitor lymphocyte count before and regularly during treatment
Monitor haemoglobin levels
Monitor hepatic function regularly
Monitor neutrophil count
Monitor serum lipids 3 months after initiation
Advise patient to report symptoms of infection immediately
Advise patient to report unexplained nausea,vomiting,abdominal pain
Immunosuppressive drugs may increase risk of malignancy
Reactivation of herpes simplex may occur
Reactivation of herpes zoster may occur
Risk of developing opportunistic infections
Advise patient to seek advice at first indications of pregnancy
Atopic dermatitis: Consider discontinuing if no response after 8 weeks
Discontinue if pulmonary embolism occurs
Discontinue if serious allergic or anaphylactic reaction occurs
Discontinue if there is a rise in liver enzymes
Discontinue if venous thromboembolism develops
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
Suspend if drug induced liver injury is suspected
Consider interrupting treatment if infection occurs
Female: May cause infertility
Female: Contraception required during and for 1 week after treatment
Advise patient to report symptoms of herpes zoster urgently
Give patient package leaflet and patient reminder card
Remind patient of importance of carrying Alert Card with them at all times

It should be noted that there is an increased risk of lymphocytosis in elderly patients with rheumatoid arthritis. Rare cases of lymphoproliferative disorders have been reported. Before starting treatment with baricitinib, 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.

Prior to initiating baricitinib, it is recommended all patients are up to date with all immunisations in line with current immunisation guidelines.
Dose dependent increases in blood lipid parameters have been reported in patients treated with baricitinib. LDL cholesterol levels are expected to decrease to baseline levels in response to statin therapy. Lipid parameters should be assessed 12 weeks following initiation of baricitinib therapy.

In the event that increased alanine transaminase (ALT) and aspartate transaminase (AST) are observed during routine patient observations, consider if this may be due to drug-induced liver injury. If drug induced liver injury is suspected, baricitinib should be temporarily interrupted until this diagnosis is eliminated.

Venous thromboembolism (VTE) and pulmonary embolism (PE) has been reported during baricitinib therapy. If clinical signs of VTE or PE occur, temporarily interrupt baricitinib whilst confirming the diagnosis and initiating any necessary treatment.

Pregnancy and Lactation

Pregnancy

Baricitinib is contraindicated during pregnancy.

The manufacturer states that baricitinib is contraindicated during pregnancy.

The pathways on which baricitinib act are involved in the cell adhesion and cell polarity which affects early embryonic development. Animal studies have indicated that the use of baricitinib during pregnancy is related to reproductive toxicity, including adverse effects on bone development in utero at higher doses. Baricitinib is teratogenic in animals.

Lactation

Baricitinib is contraindicated during breastfeeding.

The manufacturer states that baricitinib should not be used during breastfeeding.

It is unknown whether baricitinib or its metabolites are excreted in human milk. Available animal data has shown baricitinib is excreted in milk. Consequently, a risk to infants cannot be excluded.

Side Effects

Abdominal pain
Acne
Creatine phosphokinase increased
Deep vein thrombosis (DVT)
Diverticulitis
Eczema herpeticum
Epiglottitis
Facial swelling
Gastro-enteritis
Gastro-intestinal perforation
Headache
Herpes simplex
Herpes zoster
Hypercholesterolaemia
Hypertriglyceridaemia
Increase in serum ALT/AST
Laryngitis
Lymphoproliferative disorders
Nasopharyngitis
Nausea
Neutropenia
Ophthalmic herpes simplex
Oral herpes
Oropharyngeal pain
Pharyngitis
Pharyngotonsillitis
Pneumonia
Pulmonary embolism
Rash
Rhinitis
Sinusitis
Thrombocytosis
Tonsillitis
Tracheitis
Upper respiratory tract infection
Urinary tract infections
Urticaria
Weight gain

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 2020

Reference Sources

Summary of Product Characteristics: Olumiant 2mg and 4mg Film-Coated Tablets. Eli Lilly and Company Limited. Revised November 2020.

MHRA Drug Safety Update August 2020
Available at: https://www.mhra.gov.uk
Last accessed: 23 October 2020