Deucrava Tablet

Moderate to severe plaque psoriasis

Oral Plaque Psoriasis Indicated for moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy 6 mg once daily

Renal impairment Mild, moderate, or severe or patients with end-stage renal disease on dialysis: No dosage adjustment necessary

Hepatic impairment Mild-to-moderate (Child-Pugh A or B): No dosage adjustment is necessary Severe (Child-Pugh C): Not recommended

Oral Administration Take with or without food

Hypersensitivity to deucravacitinib or any of excipients in drug product

Hypersensitivity reactions (eg, angioedema) have been reported; if a clinically significant reaction occurs, discontinue therapy Evaluate for TB before initiating Malignancies, including lymphomas, were observed; consider the benefits and risk for individual, particularly in patients with a known malignancy (other than a successfully treated non-melanoma skin cancer) and patients who develop a malignancy during treatment Cases of rhabdomyolysis reported resulting in interrupting or discontinuing therapy; discontinue therapy if markedly elevated CPK levels occur or myopathy is diagnosed or suspected; advise patients to promptly report any unexplained muscle pain, tenderness, or weakness, particularly if accompanied by malaise or fever May increase triglyceride levels; monitor and manage according to clinical guidelines for hyperlipidemia Elevated liver enzymes have been reported; evaluate liver enzymes at baseline and then monitor in patients with known or suspected liver disease; if liver enzymes increase or drug-induced liver injury suspected; interrupt therapy until liver injury is ruled out Before initiating, consider completion of all age-appropriate immunizations according to current immunization guidelines including prophylactic herpes zoster vaccination Infections May increase infection risk; avoid use with active or serious infections, including localized infections Closely monitor for developing signs and symptoms of infection during and after treatment If infection develops, promptly evaluate and complete diagnostic testing Initiate appropriate antimicrobial therapy and closely monitor Interrupt therapy if serious infection develops; do not resume until infection resolves or is adequately treated Consider risks and benefits of therapy before initiating in patients With chronic or recurrent infection Who have been exposed to tuberculosis With a history of a serious or an opportunistic infection With underlying conditions that may predispose them to

Not Classi Pregnancy Insufficient data are available from case reports on use during pregnancy to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcome Animal data No effects on embryofetal development were observed with oral administration to rats and rabbits during organogenesis at doses that were at least 91x the maximum recommended human dose of 6 mg once daily Lactation There are no data on drug presence in human milk, effects on breastfed infants, or effects on milk production Present in rat milk; when a drug is present in animal milk, it is likely that it will be present in human milk

Vaccinations Live vaccines: Avoid use Response to live or non-live vaccines not evaluated Serious (1) ublituximab

>10% Infections (29%) Upper respiratory tract infections (19.2%) 1-10% Blood creatine phosphokinase increased (2.7%) Herpes simplex (2%) Mouth ulcers (1.9%) Folliculitis (1.7%) Acne (1.4%) <1% Herpes zoster

Tyrosine kinase 2 (TYK2) inhibitor, which is a member of JAK family, binds to regulatory domain of TYK2 resulting in inhibitor of receptor-mediated active of TYK2 and its downstream activation of signal transducers and activators of transcription TYK2 pairs with JAK1 to mediate multiple cytokine pathways and pairs with JAK2 to transmit signals as shown in cell-based assays Precise mechanism linking inhibition of TYK2 enzyme to therapeutic effectiveness is unknown

Deucrava 6 mg Tablet manufactured by Ziska Pharmaceuticals Ltd.. Its generic name is Deucravacitinib.