Deucravacitinib

Bristol Myers Squibb

Selective, allosteric tyrosine kinase 2 (TYK-2) inhibitor; inhibition of the signalling cascade of interleukins 12 and 23 and type 1 interferons.

Moderate to severe plaque psoriasis where systemic therapy or phototherapy is indicated.

No

Not yet authorised in Switzerland.

Complete blood count, liver enzymes, lipid profile, creatinine, urinalysis, pregnancy test, CRP/ESR. Screening for HBV, HCV, HIV and tuberculosis (including chest X-ray).

Complete blood count, CRP, transaminases, creatinine, β-hCG; lipid profile.

Month 1, 2, then every 3 months; lipid levels: month 2, then every 6 months.

Tablets, taken by mouth: 5 mg, 10 mg.

5 mg 1-0-1 (for psoriatic arthritis).

Ranging from days to weeks.

Known diverticulitis (CAUTION: bowel perforation). Do not administer live vaccines immediately before or during treatment with JAK inhibitors. In cases of moderate renal impairment, do not exceed a maximum dose of 1 × 5 mg per day (for the indications of psoriatic arthritis or rheumatoid arthritis). In cases of moderate hepatic impairment, do not exceed a dose of 1 × 5 mg tofacitinib per day (for the indications of psoriatic arthritis or rheumatoid arthritis). In cases of severe hepatic impairment, the use of tofacitinib is contraindicated. Caution is advised, particularly in patients over 65 years of age or those with increased risk factors for malignancies. Hormonal contraception or hormone replacement therapy. Risk factors for thromboembolic events. Patients with malignancies. Congenital coagulation disorders. Major surgery.

Tofacitinib 10 mg daily: 15,648.72 CHF

Neoplasms, infections, neutropenia < 0.5 × 10⁹/L (= 1 G/L) (dose reduction from < 1 × 10⁹/L (= 1 G/L)), Hb < 80 g/l or a decrease of > 20 g/l, lymphopenia < 0.5 × 10⁹/l (= 1 G/l); in cases of psoriatic arthritis and moderate impairment of liver function, reduce the dose to 5 mg/day.

Scores specific to each condition.

Hypersensitivity to the relevant JAK inhibitor or to excipients; severe and active infection; severe hepatic impairment (Child-Pugh class C); neutropenia < 1 x 10⁹/L (= 1 G/L),
anaemia < 90 g/l, lymphopenia < 0.5 × 10⁹/L (= 1 G/l), pregnancy and breastfeeding (teratogenic effects have been observed in animal studies), thromboembolic events.

Infections (e.g. nasopharyngitis, urinary tract infection, bronchitis, influenza, pneumonia, sinusitis, etc.), viral infections (e.g. herpes zoster, viral gastroenteritis), bacterial infections (e.g. pyelonephritis, bacteraemia), malignant diseases (e.g. solid tumours, non-melanoma skin cancer, lymphomas), anaemia, leucopenia, hyperlipidaemia, weight gain, insomnia, headache, hypertension, diarrhoea, nausea, abdominal pain, rash, arthralgia, elevated blood creatine phosphokinase levels, musculoskeletal pain, elevated liver enzymes, fever, fatigue, thrombosis/embolism (particularly at doses >10 mg), gastrointestinal perforation, fractures.

Cases of viral reactivation have been reported. Do not initiate treatment in patients with chronic hepatitis B. Hepatitis B virus carriers who require treatment with tofacitinib must be closely monitored for symptoms of reactivated HBV infection throughout the entire course of treatment and for several months after the end of treatment. In the event of HBV reactivation, treatment with tofacitinib must be discontinued and effective antiviral therapy initiated, accompanied by appropriate supportive care.

Insufficient data; no reactivation of the virus has been reported to date. Treatment with tofacitinib should not be administered in the presence of chronic hepatitis C infection.

Insufficient data

Cyclosporine; CYP3A4 inducers (e.g. rifampicin); OCT substrates (e.g. chloroquine). In the case of potent inhibitors of CYP3A4 (such as ketoconazole, itraconazole, voriconazole) or CYP2C19 (e.g. fluconazole), the dose of Xeljanz should be reduced (5 mg/day). No interactions with MTX or biologics have been reported (however, use is not recommended).

Testing prior to treatment. In cases where the medical history indicates latent or active tuberculosis and the treatment history is unclear, as well as in patients with a negative test result for latent tuberculosis but who have risk factors, anti-tuberculosis therapy should be considered. In cases of latent tuberculosis, standard anti-mycobacterial therapy should be administered.

Monitoring of malignant diseases in clinical trials and during post-authorisation use (including lung cancer, lymphoma, breast cancer, melanoma, prostate cancer and pancreatic cancer). Dose-dependent increase in cases of non-melanoma skin cancer (NMSC).