Buy Generic Deucravacitinib (Deucrava)

Description

What is Deucravacitinib (Deucrava)?

Deucravacitinib is a prescription medicine used to treat adults with moderate to severe plaque psoriasis who may benefit from taking injections or pills (systemic therapy) or treatment using ultraviolet or UV light (phototherapy).
It is not known if Deucravacitinib is safe and effective in children under 18 years of age.

Do not take Deucrava if  you are allergic to deucravacitinib or any of the ingredients in Deucrava. See the end of this Medication Guide for a complete list of ingredients in Deucrava.

Before taking Deucrava, tell your healthcare provider about all of your medical conditions, including if you:

• See  “What is the most important information I should know about Deucrava?”
• have liver problems or kidney problems
• have high levels of fat in your blood (triglycerides)
• have recently received or are scheduled to receive an immunization (vaccine). You should avoid receiving live vaccines
during treatment with Deucravacitinib.
• are pregnant or plan to become pregnant. It is not known if Deucravacitinib can harm your unborn baby.
• are breastfeeding or plan to breastfeed. It is not known if Deucravacitinib passes into your breast milk.

Tell your healthcare provider about all the medicines you take,  including prescription medicines, over-the-counter medicines, vitamins, and herbal supplements. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

How should I take Deucravacitinib?

• Take Deucravacitinib exactly as your healthcare provider tells you to take it.
• Take Deucravacitinib 1 time every day.
• Take Deucravacitinib with or without food.
• Do not crush, cut, or chew the Deucravacitinib tablets

Presentation

Deucrava (deucravacitinib) tablets are supplied in 6 mg strength for oral administration. Each tablet contains deucravacitinib as the active ingredient and the following inactive ingredients: anhydrous lactose, croscarmellose sodium, hypromellose acetate succinate, magnesium stearate, microcrystalline cellulose, and silicon dioxide.

INDICATIONS AND USAGE GENERIC DEUCRAVACITINIB

Deucrava is indicated for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.

Limitations of Use:
Deucrava is not recommended for use in combination with other potent immunosuppressants.

DOSAGE AND ADMINISTRATION

Recommended Evaluations and Immunizations Prior to Treatment Initiation Evaluate patients for active and latent tuberculosis (TB) infection prior to initiating treatment with Deucrava. If positive, start treatment for TB prior to Deucrava use.

Recommended Dosage

The recommended dosage of Deucrava is 6 mg taken orally once daily, with or without food. Do not crush, cut, or chew the tablets.

Recommended Dosage in Patients with Hepatic Impairment

Deucrava is not recommended in patients with severe hepatic impairment (Child-Pugh C) No dosage adjustment is needed for patients with mild to moderate hepatic impairment.

CONTRAINDICATIONS

Deucrava is contraindicated in patients with a history of hypersensitivity reaction to deucravacitinib or to any of the excipients in Deucrava.

WARNINGS AND PRECAUTIONS

Hypersensitivity

Hypersensitivity reactions such as angioedema have been reported in subjects receiving Deucrava. If a clinically significant hypersensitivity reaction occurs, institute appropriate therapy and discontinue Deucrava.

Infections

Deucrava may increase the risk of infections. Serious infections have been reported in subjects with psoriasis who received Deucrava. The most common serious infections reported with Deucrava included pneumonia and COVID-19.

Avoid use of Deucrava in patients with an active or serious infection. Consider the risks and benefits of treatment prior to initiating Deucrava 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 infection.

Closely monitor patients for the development of signs and symptoms of infection during and after treatment with Deucrava. A patient who develops a new infection during treatment with Deucrava should undergo prompt and complete diagnostic testing; appropriate antimicrobial therapy should be initiated; and the patient should be closely monitored. Interrupt Deucrava if a patient develops a serious infection. Do not resume Deucrava until the infection resolves or is adequately treated.

Pediatric Use

The safety and effectiveness of Deucrava in pediatric patients have not been established.

Geriatric Use

Of the 1,519 subjects with plaque psoriasis treated with Deucrava, 152 (10%) subjects were 65 years or older and 21 (1.4%) subjects were 75 years or older. During the Week 0-16 period, for those subjects (80 subjects ≥65 years old, including 12 subjects ≥75 years old) who received Deucrava without switching treatment arms, there was a higher rate of overall serious adverse reactions, including serious infections, and discontinuations due to adverse reactions compared with younger adults. No overall differences in effectiveness of Deucrava have been observed between patients
65 years of age and older and younger adult patients.

Renal Impairment

No dose adjustment of Deucrava is recommended in patients with mild, moderate, or severe renal impairment or in patients with end stage renal disease (ESRD) on dialysis.

Hepatic Impairment

No dose adjustment of Deucrava is recommended in patients with mild (Child-Pugh A) or moderate (Child-Pugh B) hepatic impairment. Deucrava is not recommended for use in patients with severe hepatic impairment (Child-Pugh C).

OVERDOSAGE

There is no experience regarding human overdosage with Deucrava. In case of overdose, consider contacting the Poison Help line (1-800-222-1222) for additional overdosage management recommendations. The extent of deucravacitinib elimination by hemodialysis was small (5.4% of dose per dialysis treatment), and thus hemodialysis for treatment of overdose with Deucrava is limited.

CLINICAL PHARMACOLOGY

Mechanism of Action

Deucravacitinib is an inhibitor of tyrosine kinase 2 (TYK2). TYK2 is a member of the Janus kinase (JAK) family. Deucravacitinib binds to the regulatory domain of TYK2, stabilizing an inhibitory interaction between the regulatory and the catalytic domains of the enzyme. This results in allosteric inhibition of receptor-mediated activation of TYK2 and its downstream activation of Signal Transducers and Activators of Transcription (STATs) as shown in cell-based assays. JAK kinases, including TYK2, function as pairs of homo- or heterodimers in the JAK-STAT pathways. TYK2 pairs with JAK1 to mediate multiple cytokine pathways and also pairs with JAK2 to transmit signals as shown in cell-based assays. The precise mechanism linking inhibition of TYK2 enzyme to therapeutic effectiveness in the treatment of adults with moderate-to-severe plaque psoriasis is not currently known.

Pharmacodynamics

In patients with psoriasis, deucravacitinib reduced psoriasis-associated gene expression in psoriatic skin in a dose dependent manner, including reductions in IL-23-pathway and type I IFN pathway regulated genes. Deucravacitinib reduced IL-17A, IL-19 and beta-defensin by 47 to 50%, 72%, and 81 to 84% respectively following 16 weeks of once daily treatment. The relationship between these pharmacodynamic markers and the mechanism(s) by which deucravacitinib exerts its clinical effects is unknown.

Cardiac Electrophysiology

At a dose 6 times the recommended dose of the 6 mg once daily in psoriasis patients, Deucrava does not prolong the QTc interval to any clinically relevant extent.

Pharmacokinetics

Following oral administration, deucravacitinib plasma Cmax and AUC increased proportionally over a dose range from 3 mg to 36 mg (0.5 to 6 times the approved recommended dosage) in healthy subjects. The accumulation of deucravacitinib was <1.4-fold following once daily dosing in healthy subjects. The PK of deucravacitinib and its active metabolite, BMT-153261, were comparable between healthy subjects and subjects with psoriasis. The steady state Cmax and AUC24 of deucravacitinib following administration of 6 mg once daily were 45 ng/mL and 473 ng∙hr/mL, respectively. The steady state Cmax and AUC24 of the active deucravacitinib metabolite, BMT-153261, following administration of 6 mg once daily were 5 ng/mL and 95 ng∙hr/mL, respectively.

Commercial Pack

(Deucrava) 6 MG Container Pack: Each bottles contains 30 tablets.

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