Sorivanib 6, 1 strip

Sorivanib is indicated for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. It is not recommended for use in combination with other potent immunosuppressive medicines.

Recommended Evaluations Before Treatment

• Assess patients for active and latent tuberculosis (TB) before starting treatment.
• If TB infection is identified, initiate appropriate TB treatment before beginning deucravacitinib, as directed by a healthcare professional.
• Review vaccination status before treatment and follow the recommended immunization guidance.

Recommended Dosage

• The recommended adult dose of deucravacitinib is 6 mg orally once daily, with or without food. Swallow the tablet whole. Do not crush, split, or chew it.

1. Pediatric Use: Safety and effectiveness have not been established in children and adolescents.
2. Geriatric Use: No overall differences in treatment effectiveness have been observed between adults aged 65 years and older and younger adults.
3. Hepatic Impairment: Deucravacitinib is not recommended for patients with severe hepatic impairment (Child-Pugh Class C). No dosage adjustment is generally required in mild or moderate hepatic impairment.
4. Renal Impairment: No dosage adjustment is recommended for patients with mild, moderate, or severe renal impairment, including those with end-stage renal disease receiving dialysis.

Clinical studies have not demonstrated clinically significant changes in the pharmacokinetics of deucravacitinib when it is administered with several medicines, including cyclosporine, fluvoxamine, ritonavir, diflunisal, pyrimethamine, famotidine, and rabeprazole.

Similarly, no clinically significant pharmacokinetic changes were observed for certain co-administered medicines, including rosuvastatin, methotrexate, mycophenolate mofetil, and oral contraceptives containing norethindrone acetate and ethinyl estradiol.

Nevertheless, inform your doctor about all prescription medicines, over-the-counter products, and supplements you use before starting treatment.

Sorivanib is contraindicated in patients with a known hypersensitivity to deucravacitinib or any of the other ingredients in the formulation.

Commonly reported side effects include:

1. Upper respiratory tract infections, such as the common cold, sore throat, and sinus infections
2. Cold sores caused by herpes simplex virus
3. Mouth ulcers or canker sores
4. Folliculitis (inflammation of hair follicles)
5. Acne

Serious allergic reactions may also occur. Warning signs include swelling of the face, eyelids, lips, tongue, or throat; difficulty breathing; tightness in the throat or chest; hives; or a widespread rash. Seek emergency medical attention if these symptoms develop.

Available human data on deucravacitinib use during pregnancy are limited and insufficient to determine the risk of major birth defects, miscarriage, or other adverse pregnancy outcomes. Animal studies did not demonstrate adverse effects on embryo-fetal development under the conditions studied.

It is not known whether deucravacitinib passes into human breast milk or how it may affect a breastfed infant or milk production. The potential benefits of breastfeeding should be weighed against the mother's clinical need for treatment and the possible risks to the infant. Consult a healthcare professional before using this medicine during pregnancy or breastfeeding.

1. Hypersensitivity: Allergic reactions, including angioedema, have been reported. Discontinue treatment and seek medical advice if a clinically significant hypersensitivity reaction occurs.
2. Infections: Deucravacitinib may increase the risk of infections. Avoid starting treatment in patients with active, serious infections. If a serious infection develops during treatment, the medicine may need to be interrupted until the infection has resolved.
3. Tuberculosis: Screen for active and latent TB before initiating treatment and manage any identified infection appropriately.
4. Malignancy: Malignancies, including lymphoma, have been reported in clinical trials. Discuss individual risk factors and appropriate monitoring with your doctor.
5. Laboratory Monitoring: Periodically monitor serum triglyceride levels. Assess liver enzymes before treatment and during therapy when liver disease is known or suspected.
6. Immunizations: Avoid administering live vaccines during treatment. Review vaccination requirements with your healthcare professional before therapy begins.

Potential Risks Associated with JAK Inhibition: It remains uncertain whether selective TYK2 inhibition carries the same risks associated with other JAK inhibitors. Studies of certain JAK inhibitors in patients with rheumatoid arthritis have reported increased rates of major cardiovascular events, thrombosis, malignancies, and all-cause mortality compared with TNF blockers. These findings should not automatically be assumed to apply to deucravacitinib, but relevant risks should be considered during treatment decisions.

Muscle-Related Effects: Rhabdomyolysis and elevated creatine phosphokinase (CPK) have been included among reported safety concerns. Seek medical advice if unexplained muscle pain, weakness, or dark urine develops.

Store below 30°C, protected from light and moisture. Keep out of the reach of children.