Abbreviated Prescribing Information:

Jayempi® (azathioprine) 10 mg/ml oral suspension

Please refer to the Summary of Product Characteristics (SmPC) before prescribing.

Presentation: Oral suspension, each 1 ml contains 10 mg azathioprine and 1.5 mg sodium benzoate.
Indication: For the treatment of moderately severe to severe forms of chronic inflammatory bowel disease (IBD) (Crohn’s disease or ulcerative colitis) in patients in whom glucocorticosteroid therapy is necessary, but where glucocorticosteroids are not tolerated, or in whom the disease is untreatable with other common means of first choice.
Jayempi is licensed for other indications. Please refer to the Summary of Product Characteristics (SmPC) for full details.
Dosage and Administration: The starting dose is 1 to 3 mg/kg body weight/day and should be adjusted according to the clinical response and haematological tolerance. When therapeutic response is evident, consideration should be given to reducing the maintenance dose to the lowest level compatible with the maintenance of that response. If no improvement occurs in the patient’s condition within 3 to 6 months, consideration should be given to withdrawing the medicinal product. In patients with IBD, a treatment duration of at least 12 months should be considered, whereby a response to treatment may only be recognisable clinically after three to four months. Elderly Monitoring kidney and liver function and reducing the dose in the case of impaired function is recommended. Dose should be at the lower end of the normal range. Renal and hepatic impairment Dose should be reduced to the lower end of the normal range in patients with hepatic and/or renal impairment. Administration Redisperse by shaking prior to dosing. Jayempi should be taken at least 1 hour before or 2 hours after a meal or milk. Water should be taken after each dose.
Contraindications: Hypersensitivity to the active substance or to any of the excipients. Any live vaccine, especially BCG, smallpox, yellow fever. Lactation.
Warnings and Precautions: Monitoring Therapy with Jayempi in pre-existing, severe infections, severe disorders of the liver and bone marrow function, and in the presence of pancreatitis, should only be initiated subject to a careful benefit/risk analysis and the precautions specified below. Special attention should be given to monitoring the blood count. If necessary, the maintenance dose should be reduced as much as possible, provided there is clinical response. Azathioprine should only be prescribed if the patient can be adequately monitored for haematological and hepatic effects throughout the duration of therapy. During the first 8 weeks of treatment, a complete blood count, including platelet count must be performed at least once weekly. Frequency of blood counts may be reduced after 8 weeks and be repeated monthly or at least at intervals of no longer than 3 months (maximum quarterly). At the first sign of an abnormal change in the blood count, treatment should be discontinued immediately because the number of leucocytes and platelets may continue to decrease after the end of treatment. Patients receiving azathioprine must inform their doctor immediately about any evidence of infection, unexpected bruising or bleeding or other signs of myelosuppression. Myelosuppression is reversible if azathioprine is discontinued promptly. Thiopurine methyltransferase (TPMT) About 10% of patients have decreased TPMT enzyme activity as a result of genetic polymorphism, and have a higher risk of myelotoxic effects. Especially in homozygous individuals, the degradation of azathioprine is impaired, and a substantial dose reduction is required. Testing for TPMT deficiency is recommended before treatment initiation. NUDT15 variant Patients with inherited mutated NUDT15 gene are at increased risk of severe azathioprine toxicity, such as early leucopenia and alopecia, with conventional doses of thiopurine therapy. A dose reduction is generally required, particularly those being homozygous carriers of NUDT15 variants. The frequency of NUDT15 c.415C>T has an ethnic variability of approximately 10% in East Asians, 4% in Hispanics, 0.2% in Europeans and 0% in Africans. Close monitoring of blood counts is necessary. Lesch-Nyhan syndrome Limited data indicate that azathioprine is not effective in patients with hereditary hypoxanthine guanine-phosphoribosyl transferase deficiency. Azathioprine should not be used in these patients. Varicella zoster virus infection (VZV; chickenpox and herpes zoster) Infection with VZV may become severe during administration of immunosuppressants. Before starting administration of immunosuppressants, the prescriber should check to see if the patient has a history of VZV. Patients with no history of exposure should avoid contact with individuals with chickenpox or herpes zoster. If the patient is exposed to VZV, special care must be taken to prevent patients from developing chickenpox or herpes zoster, and passive immunisation with varicella-zoster immunoglobulin (VZIG) may be considered. If the patient is infected with VZV, appropriate measures should be taken, which may include antiviral therapy, discontinuation of treatment with azathioprine and supportive care. Progressive Multifocal Leucoencephalopathy (PML) PML, an opportunistic infection caused by the JC virus, has been reported in patients receiving azathioprine with other immunosuppressive agents. Immunosuppressive therapy should be withheld at first signs or symptoms indicating PML and appropriate evaluation should be undertaken to establish a diagnosis. Mutagenicity Chromosomal abnormalities have been demonstrated in both male and female patients treated with azathioprine. Carcinogenicity Patients are at increased risk of developing lymphoproliferative disorders and other malignancies, notably skin cancers (melanoma and non-melanoma), sarcomas (Kaposi’s and non-Kaposi’s) and uterine cervical cancers in situ. The increased risk appears to be related to the degree and duration of immunosuppression. Concomitant administration with multiple immunosuppressants increases risk of Epstein-Barr virus (EBV)-associated lymphoproliferative disorders. There are reports of hepatosplenic T-cell lymphoma in IBD patients who use azathioprine concomitantly with anti-TNF medicinal products. Exposure to sunlight and UV light should be limited and patients should wear protective clothing and use sunscreen with a high protection factor to minimise the risk of skin cancer and photosensitivity. Macrophage activation syndrome Macrophage activation syndrome (MAS) is a known, life-threatening disorder that may develop in patients with autoimmune conditions, in particular with inflammatory bowel disease (IBD), and there is potentially increased susceptibility for developing the condition with the use of azathioprine. If MAS occurs, or is suspected, evaluation and treatment should be started as early as possible, and treatment with azathioprine should be discontinued. Physicians should be attentive to symptoms of infection such as EBV and cytomegalovirus (CMV), as these are known triggers for MAS. Teratogenicity/contraceptive measures In preclinical studies azathioprine was mutagenic and teratogenic. Neuromuscular blocking agents Special caution is required when azathioprine is given concomitantly with neuromuscular blocking agents such as atracurium, rocuronium, cisatracurium or suxamethonium (also known as succinylcholine). Anaesthesiologists should check whether their patients are administered azathioprine prior to surgery. Vaccines It is recommended that patients are not administered with any live vaccine until at least 3 months after the end of treatment with azathioprine. Ribavirin Concomitant use of ribavirin and azathioprine is not recommended. Myelosuppressive agents Dose should be reduced with concomitant use of azathioprine and myelosuppressive agents. Excipients Contains 1.5 mg sodium benzoate in each 1 ml which is equivalent to 300 mg/200 ml. Contains less than 1 mmol (23 mg) sodium per dose, that is to say essentially ‘sodium-free’.
Interactions: Concomitant administration of cytostatic medicinal products, or medicinal products with myelosuppressive effect, should be avoided. Reduce the dose of 6-mercaptopurine and azathioprine to one quarter of the original dose when allopurinol, oxipurinol and/or thiopurinol are given concurrently. Lower doses of azathioprine should be considered when administered concomitantly with aminosalicylate derivatives, e.g. olsalazine, mesalazine and sulfasalazine. When azathioprine is administered concomitantly with high dose methotrexate, the dose should be adjusted to maintain a suitable white blood cell count. Reduction of anticoagulant effect of warfarin was described following the simultaneous use of azathioprine.
Pregnancy and Lactation: Azathioprine must only be used during pregnancy after a careful benefit/risk analysis. Both men and women of child bearing potential should use contraceptive methods while using azathioprine and for at least 6 months after therapy ends. If treatment with azathioprine is unavoidable, breastfeeding should be discontinued.
Side Effects: Very common Leucopenia. Common Thrombocytopenia, nausea, vomiting. Uncommon Viral, fungal and bacterial infections (in non-transplant patients), anaemia, hypersensitivity, pancreatitis, cholestasis, liver function test abnormal. Unknown Acute febrile neutrophilic dermatosis (Sweet’s Syndrome), photosensitivity reaction, chromaturia. Rare Neoplasms including lymphoproliferative disorders, skin cancers (malignant melanomas and non-melanomas), sarcomas (Kaposi’s and non-Kaposi’s), uterine cancer, cervix carcinoma, acute myeloid leukaemia and myelodysplastic syndrome, agranulocytosis, pancytopenia, aplastic anaemia, anaemia megaloblastic and bone marrow failure, liver injury, alopecia. Very rare Progressive multifocal leucoencephalopathy (PML), hepatosplenic T-cell lymphoma (in IBD patients using other anti-TNF drugs concomitantly), haemolytic anaemia, Stevens-Johnson syndrome and toxic epidermal necrolysis, pneumonitis (reversible), diarrhoea (severe) in patients with inflammatory bowel disease.
Overdose: No specific antidote. Monitor blood count closely, appropriate symptomatic treatment should be initiated, where necessary, and the appropriate blood transfusions be administered. Active measures (such as use of activated charcoal) will probably only be effective if they are carried out within 60 minutes of ingestion.
Pack size: 1 glass bottle containing 200 ml Jayempi (azathioprine) 10 mg/ml oral suspension, 1 adaptor and 2 syringes (3 ml and 10 ml).
Shelf life: 2 years. After first opening: 12 weeks.
Storage: Do not store above 25°C.
Legal Category: POM
Marketing Authorisation Number: PLGB 13581/0005
Marketing Authorisation Holder: Nova Laboratories Limited, Martin House, Gloucester Crescent, Wigston, Leicester, LE18 4YL, United Kingdom
Date of latest revision: August 2023
Job number: JayIBDABVPI001
NHS Price: £250.00
Further information is available from: Nova Laboratories Limited, Martin House, Gloucester Crescent, Wigston, Leicester, LE18 4YL, UK. Tel: +44 (0)116 223 0100