Cibinqo Dosage

Generic Name: abrocitinib
Dosage Form: tablets, for oral use

Medically Reviewed by  A Ras, MD. Last updated  on March 25, 2022

What is the Cibinqo?

Cibinqo can be prescribed that acts as a Janus Kinase (JAK) inhibitor. Cibinqo is prescribed for adults suffering from moderate to severe Atopic skin eczema (eczema) that does not respond to treatments and cannot be managed with prescription treatments which include biologic medicines, or in adults who can’t take these treatments.

Abrocitinib is a white to pale colored powder with the following chemical name: N-((1s,3s)-3-(methyl(7H-pyrrolo[2,3-d]pyrimidin-4-yl)amino)cyclobutyl)propane-1-sulfonamide

The solubility of abrocitinib in water is 0.04 mg/mL at 25ºC.

Abrocitinib has a molecular weight of 323.42 g/mol and a molecular formula of C14H21N5O2S. The structural formula of abrocitinib is:

Cibinqo

Each film-coated tablet contains 50 mg or 100 mg or 200 mg of abrocitinib and the following inactive ingredients: dibasic calcium phosphate anhydrous, hypromellose, iron oxide red, lactose monohydrate, Macrogol, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, titanium dioxide, and triacetin.

It isn’t known whether Cibinqo is safe and effective for children.

In the initial 3 months of your treatment using Cibinqo. Do not combine Cibinqo alongside other medications that stop blood clots. Aspirin can be taken in low doses up to 81 mg daily during this time if recommended by your physician.

Mechanism of Action

It is a Janus kinase (JAK) inhibitor.

By inhibiting the adenosine triphosphate (ATP) binding site, abrocitinib inhibits JAK1 in a reversible manner. Abrocitinib was found to be more selective for JAK1 than JAK2 (28-fold), JAK3 (>340-fold), and tyrosine kinase (TYK) 2 (43-fold) in a cell-free isolated enzyme test. The impact of inhibiting individual JAK enzymes on treatment efficacy is unknown at this time. In vitro, the parent drug and active metabolites both inhibit JAK1 activity with equal selectivity.

Before you take Cibinqo

Inform your doctor about any medications you take that you are taking, including prescription and non-prescription supplements such as vitamins, herbal supplements. Cibinqo and other medications may cause side consequences.

Inform your healthcare provider whether you are taking aspirin or any other antiplatelet therapy. Check out “Do not take this medication when you.” Consult your physician in case you’re unsure.

Take note of the medicines you take. Keep a list to show your doctor and pharmacist each time you receive any new

Indication and usage

This is a Janus kinase (JAK) inhibitor for the treatment of individuals with refractory, moderate-to-severe atopic dermatitis whose illness is not effectively managed with other systemic medication products, including biologics, or when their use is not recommended.

Limitations on Utilization

Use of this medication in combination with other JAK inhibitors, biologic immunomodulators, or other immunosuppressants is not indicated.

Cibinqo Dosage and Administration

Recommendations for Testing, Evaluations, and Methods prior to the beginning of treatment

Conduct one of the tests listed below and evaluates prior to CIBINQO Initiate CIBINQO:

  • Tuberculosis (TB) diagnosis – CIBINQO is not advised for patients suffering from active TB. If you have patients who have latent TB or who have a negative latent TB test, who are at risk of TB Start preventive therapy to treat the presence of latent TB prior to the initiation of CIBINQO.
  • Screening for viral hepatitis is in line with clinical guidelines CIBINQO the initiation of CIBINQO is not recommended in patients suffering from active liver disease B or C.
  • Complete blood counts (CBC) are required to initiate CIBINQO. It is not recommended for patients who have a platelet count less than 150,000/mm3 or the absolute count of lymphocytes less than 500/mm3 or the absolute count of neutrophils less than 1,000/mm3 or a hemoglobin count below 8 g/dL.

Get all vaccinations required for herpes zoster, including vaccinations, as per current guidelines on immunizations prior to CIBINQO beginning.

Recommended Dosage

The recommended dosage for CIBINQO can be 100 mg taken orally every day.

If a sufficient response isn’t achieved using CIBINQO 100 mg taken orally every day over the course of 12 weeks think about raising the dosage to 200 mg once every day. Stop treatment if no response is evident after dose increasing to 200 mg every day.

CIBINQO can be used in conjunction with or without topical corticosteroids.

If a dose is not taken it is important to administer the dose as fast as you can unless it’s shorter than twelve hours prior to the next dose and in that case, you should skip the dose missed. After that, you should resume your dose at the time that you normally schedule.

Dosage Recommendation for Patients suffering from renal Impairment or Hepatic Impairment

Renal Impairment

  • CIBINQO dosage guidelines for patients with impaired renal function are listed in Table 1.
  • For patients with mild or moderate kidney impairments, a satisfactory response is not seen at the end of 12 weeks the dosage of CIBINQO could be increased to double.

Table 1. Dosage Recommendations in Patients with Renal Impairment

Renal Impairment Stage Estimated Glomerular Filtration (eGFR)* Dosage
Mild 60 – 89 mL/minute CIBINQO 100 mg once daily
Moderate 30 – 59 mL/minute CIBINQO 50 mg once daily
Severe 15 – 29 mL/minute Not recommended for use
End-Stage Renal Disease (ESRD) <15 mL/minute

* The rate of filtration by the Glomerular System was determined through formulas such as the Modification of Dietary Reflux disease (MDRD) calculation formula.

+ End-Stage Renal Disease can affect patients receiving renal replacement therapy.

Hepatic Impairment

  • CIBINQO is not advised to patients with significant hepatic impairment

Dosage Recommendation for CYP2C19 poor metabolically active compounds

If you have patients who are recognized as or suspect to have CYP2C19 weak metabolizers, the dosage recommended for CIBINQO should be 50 mg every day. If a satisfactory response is not obtained when using CIBINQO 50 mg taken orally every day over the course of 12 weeks you may consider increasing the dosage to 100 mg once every day. Stop treatment if no response is observed following dosage increasing to 100 mg every day.

Dosage Modifications due to Strong Inhibitors

If you are a patient who is taking strong inhibitors of cytochrome p450 (CYP) 2C19, decrease the dose to 50 mg once a day. If a satisfactory response is not obtained by CIBINQO 50 mg daily over the course of 12 weeks think about raising the dosage up to 100 mg, orally every day. Do not continue therapy if an insufficient response is observed following dosage increasing to 100 mg every day.

Treatment Refusal because of serious infections or Hematologic adverse reactions

  •  Opportunistic or Serious Infections
    • If a patient develops a dangerous or opportunistic infection stop taking CIBINQO and manage the infection. The potential risks and benefits of treatment using CIBINQO must be considered prior to resuming therapy by using CIBINQO
  • Hematologic Abnormalities
    • Guidelines for CIBINQO discontinuation due to abnormalities in the laboratory are summarized in Table 2.
Table 2. Recommendations for CIBINQO Refraining from Hematologic abnormalities
Laboratory Measure Recommendation
Abbreviations: ALC=absolute lymphocyte count; ANC=absolute neutrophil count; CBC=complete blood count; Hb=hemoglobin
Platelet Count: 50,000/mm3 Stop using CIBINQO and continue with CBC until the value is >100,000/mm3.
ALC 500/mm3 Treatment should be stopped temporarily If ALC is lower than 500 cells/mm3. Treatment can be restarted when ALC increases above this level.
ANC 11,000/mm3 Treatment should be stopped temporarily when ANC is lower than 1,000 cells/mm3 and then restarted after ANC increase above this level.
Hb value >8 grams/dL The treatment must be discontinued temporarily when Hb is lower than 8 g/dL. Treatment can be resumed if Hb returns to levels above this level.

CBC tests are recommended at baseline, four weeks following treatment start, and four weeks following the increasing the dose of CIBINQO. Tests for CBC may be delayed in patients receiving chronic CIBINQO treatment who develop hematologic abnormalities.

Administration Instructions

Use CIBINQO in combination with and without meals around the same time throughout the day.

Consume CIBINQO tablets completely in water. Don’t crush, break or chew CIBINQO tablets.

For further information primary care provider instruction on the provided label.

Label

PRINCIPAL DISPLAY PANEL – 50 MG TABLET BOTTLE LABEL

  • ALWAYS DISPENSE WITH
    MEDICATION GUIDE
  • Pfizer
    NDC 0069-0235-30
  • CIBINQO
    (abrocitinib) tablets
  • 50 mg
  • Do not crush, split, or chew the tablets.
  • 30 Tablets
    Rx only
Cibinqo

PRINCIPAL DISPLAY PANEL – 100 MG TABLET BOTTLE LABEL

  • ALWAYS DISPENSE WITH
    MEDICATION GUIDE
  • Pfizer
    NDC 0069-0335-30
  • CIBINQO
    (abrocitinib) tablets
  • 100 mg
  • Do not crush, split, or chew the tablets.
  • 30 Tablets
    Rx only

 

Cibinqo Dosage

 

PRINCIPAL DISPLAY PANEL – 200 MG TABLET BOTTLE LABEL

  • ALWAYS DISPENSE WITH
    MEDICATION GUIDE
  • Pfizer
    NDC 0069-0435-30
  • CIBINQO
    (abrocitinib) tablets
  • 200 mg
  • Do not crush, split, or chew the tablets.
  • 30 Tablets
    Rx only

 

Cibinqo

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