Cravacin6 mg

Cravacin is an oral, selective tyrosine kinase 2 (TYK2) inhibitor approved for the following indications:

Established / Approved Uses

• Moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.
• Active psoriatic arthritis in adults, based on regulatory approval and supporting clinical trial data.

Important Notes on Use

• Cravacin is intended for patients whose disease is significant enough to require a systemic (whole-body) treatment rather than topical therapy alone.
• Cravacin is not recommended for use in combination with other potent immunosuppressants, including biologic therapies or other systemic immunosuppressive agents, as this combination has not been studied and may increase risk.
• Cravacin is a relatively new class of medicine (a selective TYK2 inhibitor, distinct from JAK1/2/3 inhibitors); long-term comparative safety data are still accumulating, and use should follow current specialist guidance.

Each film-coated tablet contains Deucravacitinib as the active ingredient, typically available as a 6 mg strength tablet. Tablets also contain standard pharmaceutical excipients (fillers, binders, and coating agents) that support tablet formulation and stability.

Cravacin is a first-in-class, orally administered small-molecule inhibitor of tyrosine kinase 2 (TYK2), an intracellular enzyme in the Janus kinase (JAK) family that is involved in signaling for interleukin-23 (IL-23), interleukin-12 (IL-12), and type I interferons - cytokine pathways central to the inflammation seen in plaque psoriasis and psoriatic arthritis.

Unlike traditional JAK1/2/3 inhibitors, Cravacin binds to the regulatory (pseudokinase, JH2) domain of TYK2 rather than its catalytic active site, giving it a more selective mechanism of action. It is supplied as film-coated tablets for once-daily oral use and does not require reconstitution or refrigeration.

Cravacin belongs to the therapeutic class of selective tyrosine kinase 2 (TYK2) inhibitors, a subclass within the broader Janus kinase (JAK) inhibitor family, used as an oral systemic agent for immune-mediated inflammatory skin and joint disease.

Mechanism

Deucravacitinib is an allosteric inhibitor that binds selectively to the regulatory (pseudokinase) domain of TYK2, locking the enzyme in an inactive conformation. This blocks TYK2-mediated intracellular signaling downstream of IL-23, IL-12, and type I interferon receptors, reducing the production of inflammatory mediators involved in plaque psoriasis and psoriatic arthritis.

Pharmacokinetics

• Absorption: Oral bioavailability is adequate; can be taken with or without food.
• Metabolism: Primarily metabolized via cytochrome P450 1A2 (CYP1A2) and uridine diphosphate glucuronosyltransferases (UGT1A9, UGT1A1), with minor contribution from CYP2B6 and CYP3A4.
• Elimination: Eliminated through a combination of metabolic and renal/fecal pathways; half-life supports once-daily dosing.

Because Deucravacitinib is not primarily dependent on a single major CYP pathway, clinically significant interactions with common CYP inhibitors/inducers have not been consistently demonstrated in studies, though this does not eliminate the need for clinical judgment in complex regimens.

Cravacin tablets should be swallowed whole with water, with or without food, once daily at a consistent time. Do not crush, cut, or chew the tablet. See Dosage and Administration for missed-dose guidance.

Cravacin has a comparatively favorable drug-interaction profile because it is not solely dependent on a single major metabolic pathway. In clinical studies, no clinically significant interaction was seen with:

• Cyclosporine
• Fluvoxamine (a CYP1A2 inhibitor)
• Ritonavir (a strong CYP3A4/other enzyme inhibitor)
• Diflunisal (a UGT inhibitor)
• Methotrexate
• Mycophenolate mofetil
• Metformin
• Oral contraceptives

Points of Caution

• Other immunosuppressants/biologics: Concomitant use with other potent immunosuppressive therapies (including biologic agents for psoriasis/psoriatic arthritis) is not recommended, as combined immune suppression may increase infection risk (see Contraindications and Precautions for related infection risk, which is not repeated here).
• Live vaccines: Avoid administering live or live-attenuated vaccines during treatment with Cravacin.

The most commonly reported adverse effects of Cravacin (occurring in ≥1% of patients in clinical trials) include:

• Upper respiratory tract infections
• Increased blood creatine phosphokinase (CPK)
• Herpes simplex infections (including cold sores)
• Mouth ulcers (aphthous ulcers)
• Folliculitis (inflammation of hair follicles)
• Acne

Less Common but Clinically Important Effects

• Serious infections (see Precautions and Warnings for full discussion)
• Elevations in liver enzymes and triglycerides
• Rhabdomyolysis (muscle breakdown), suggested by marked CPK elevation with muscle pain/weakness

Patients should promptly report any signs of infection, unusual muscle pain/weakness, or dark urine to their physician.

Pregnancy

Data on the use of Cravacin in pregnant women are limited. Animal reproduction studies have not shown embryo-fetal harm at exposures relevant to clinical use, but human data are insufficient to confirm safety. Cravacin should be used during pregnancy only if clearly needed and if the potential benefit justifies the potential risk to the fetus; a physician should be consulted before use in pregnancy or if pregnancy is planned. Patients who become pregnant while taking Cravacin are encouraged to enroll in the manufacturer's pregnancy exposure registry where available, and should notify their physician promptly.

Lactation

It is not known whether Cravacin passes into human breast milk or affects the breastfed infant or milk production. Because many drugs are excreted in breast milk, a decision should be made, in consultation with a physician, whether to discontinue breastfeeding or discontinue Cravacin, weighing the benefits of breastfeeding against the mother's clinical need for treatment.

Infections

Cravacin may increase the risk of serious infections, including bacterial, viral (including herpes zoster/shingles reactivation), and fungal infections, and cases of pneumonia and COVID-19 have been reported in clinical trials. Do not start Cravacin in patients with an active, clinically important infection, including localized infections. Evaluate patients for tuberculosis (TB) risk factors and test for latent TB infection prior to starting treatment; if positive, treat standard anti-TB therapy before initiating Cravacin. Monitor all patients for signs and symptoms of infection during and after treatment.

Malignancy

Lymphomas and other malignancies have been observed in clinical trials with Cravacin. The overall long-term malignancy risk with this more selective TYK2-inhibitor class is not as well characterized as with older, broader JAK1/2/3 inhibitors, which carry class-wide boxed warnings for malignancy and major cardiovascular events; patients should be monitored periodically and any new or changing skin lesions or lymph node swelling evaluated promptly.

Laboratory Abnormalities

• Creatine phosphokinase (CPK): Elevations have been observed; monitor and evaluate for rhabdomyolysis if markedly elevated with muscle symptoms.
• Lipids: Triglyceride elevations may occur; periodic lipid monitoring is advisable, particularly in patients with pre-existing dyslipidemia.
• Liver enzymes: Transaminase elevations have been reported; monitor liver function as clinically indicated.

Vaccinations

Avoid use of live or live-attenuated vaccines during treatment with Cravacin. Bring vaccinations up to date, per current immunization guidelines, before starting therapy.

General Caution on a Newer Drug Class

Cravacin represents a relatively novel, more selective TYK2-inhibitor mechanism with a shorter real-world safety track record compared to long-established systemic psoriasis therapies. While early data suggest a differentiated safety profile from older JAK1/2/3 inhibitors, ongoing long-term safety monitoring is prudent, and treatment decisions should reflect current evidence and specialist guidance.

There is limited clinical experience with overdose of Cravacin. In the event of a suspected overdose, the patient should be monitored for signs and symptoms of adverse effects, including infection, unusual muscle pain/weakness, or bleeding, and supportive care should be provided as needed. There is no specific antidote for Cravacin overdose. Seek immediate medical attention or contact a poison control center/emergency services if an overdose is suspected.

Store at room temperature (below 30°C), away from light and moisture. Keep the tablets in their original packaging until ready to use. Keep out of reach of children.

Pediatric Use

The safety and efficacy of Cravacin in patients younger than 18 years have not been established. Its use is not recommended in the pediatric population outside of clinical trial settings.

Geriatric Use (Elderly)

Clinical trials of Cravacin included a limited number of patients aged 65 years and older. While no overall differences in safety or effectiveness were observed relative to younger adults, caution is advised given generally increased susceptibility to infection and comorbidities in this age group.

Hepatic Impairment

No dose adjustment is needed in mild-to-moderate hepatic impairment. Use is not recommended in severe (Child-Pugh C) hepatic impairment (see Contraindications).

Renal Impairment

Data in severe renal impairment are limited; use with caution and close physician monitoring in this population.

Pregnancy and Breastfeeding

See Pregnancy and Lactation section for full guidance.

The duration of treatment with Cravacin is individualized based on disease severity, treatment response, and physician assessment. It is generally used as a long-term, continuous maintenance therapy for chronic conditions such as plaque psoriasis and psoriatic arthritis. Response to therapy (skin clearance, joint symptom improvement) is typically assessed after approximately 16 weeks; treatment should be reassessed and potentially discontinued if an adequate response is not achieved by that time, per physician judgment.

Deucravacitinib is classified as a selective tyrosine kinase 2 (TYK2) inhibitor, a member of the broader Janus kinase (JAK) inhibitor family, used as a targeted oral systemic immunomodulatory agent.

Deucravacitinib works by selectively and allosterically binding to the regulatory (pseudokinase, JH2) domain of tyrosine kinase 2 (TYK2), stabilizing it in an inactive state. This blocks intracellular signal transduction triggered by interleukin-23 (IL-23), interleukin-12 (IL-12), and type I interferons - key cytokines that drive the inflammatory cascade responsible for plaque psoriasis and psoriatic arthritis - thereby reducing inflammation and disease activity.

The safety and efficacy of Cravacin have not been established in patients under 18 years of age. It should not be used in children or adolescents outside of a clinical trial setting, and no pediatric dosing recommendation is available.