Icotyde (icotrokinra HCl)
Interleukin 23 Antagonists Oral Tablet
Last reviewed · Source: First Databank (FDB) drug data
Overview
Icotrokinra hydrochloride is a peptide that selectively binds to interleukin-23 (IL-23), a proinflammatory cytokine.
Icotrokinra is a peptide that selectively binds to the interleukin-23 receptor (IL-23R), thereby antagonizing the interaction between IL-23 and its receptor. IL-23 is a naturally occurring cytokine involved in the regulation of inflammatory and immune responses. By blocking IL-23/IL-23R signaling, icotrokinra inhibits the release of downstream proinflammatory cytokines.
Icotrokinra reduced serum levels of proinflammatory cytokines, IL-17A, IL-17F, IL-19, IL-22 and beta-defensin-2, relative to pretreatment levels in evaluated subjects with moderate to severe plaque psoriasis based on exploratory analysis of the pharmacodynamic markers.
Steady-state concentrations of icotrokinra are reached in approximately 3 days. The median (range) time to peak plasma concentrations of the drug is 2 (0.25-8) hours. Icotrokinra AUC decreased by 43% and peak plasma concentrations decreased by 59% following administration with a high-fat meal.
Icotrokinra is 52% bound to plasma protein. The median half-life of the drug is 12 hours. Icotrokinra is metabolized by peptide catabolism into smaller peptides.
Following oral administration, approximately 37% to 81% of the dose was recovered in feces within 24 hours as unchanged drug, and 0.001% of the dose was recovered in urine as unchanged drug.
USES: This medication is used to treat a certain skin condition (plaque psoriasis). Icotrokinra may help to reduce the redness, thickening, and scaling of the skin that occurs with this condition. It works by blocking a certain natural protein in your body (interleukin-23) that may cause inflammation and swelling.
Generic name: icotrokinra HCl
Drug class: Interleukin 23 Antagonists
Therapeutic class: Dermatological
Reference product & biosimilars
No reference, biosimilar or interchangeable associated with this drug.
Today’s intelligence on Icotyde
Indications
The following indications are listed for Icotyde:
- Moderate To Severe Plaque Psoriasis
Dosing
No dosing information is available for this tab.
No dosing information is available for this tab.
| Drug label | Dosing type | Instructions |
|---|---|---|
| Icotyde 200 Mg Tablet | Maintenance | Take 1 tablet (200 mg) by oral route once daily upon waking on an empty stomach. |
No dosing information is available for this tab.
Drug interactions
No formal drug-drug interaction studies have been conducted with icotrokinra; however, no clinically significant drug interactions have been identified.
Icotrokinra does not inhibit cytochrome P-450 (CYP) 1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP2E1, and CYP3A4. Icotrokinra does not induce CYP1A2, CYP2B6, and CYP3A4.
Icotrokinra is not a substrate of P-glycoprotein (P-gp), breast cancer resistance protein (BCRP), organic anion transporting polypeptide (OATP) 1B1, OATP1B3, organic anion transporter (OAT) 1, OAT3, organic cation transporter (OCT) 2, multidrug and toxin extrusion transporter (MATE) 1, and MATE2-K. Icotrokinra does not inhibit P-gp, BCRP, OATP1B1, OATP1B3, OAT1, OAT3, OCT2, MATE1, MATE2-K, and bile salt export pump (BSEP).
Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient.
Selected Immunosuppressive Agents/Live Vaccines; Live Bcg
SEVERITY LEVEL: 1-Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient.
MECHANISM OF ACTION: A variety of disease modifying agents suppress the immune system. Immunocompromised patients may be at increased risk for uninhibited replication after administration of live, attenuated vaccines or intravesicular BCG. Immune response to vaccines may be decreased during periods of immunocompromise.(1)
CLINICAL EFFECTS: The expected serum antibody response may not be obtained and/or the vaccine may result in illness.(1) After instillation of intravesicular BCG, immunosuppression may interfere with local immune response, or increase the severity of mycobacterial infection following inadvertent systemic exposure.(2)
PREDISPOSING FACTORS: Immunosuppressive diseases (e.g. hematologic malignancies, HIV disease), treatments (e.g. radiation) and drugs may all increase the magnitude of immunodeficiency.
PATIENT MANAGEMENT: The Centers for Disease Control(CDC) Advisory Committee on Immunization Practices (ACIP) states that live-virus and live, attenuated vaccines should not be administered to patients who are immunocompromised. The magnitude of immunocompromise and associated risks should be determined by a physician.(1) For patients scheduled to receive chemotherapy, vaccination should ideally precede the initiation of chemotherapy by 14 days. Patients vaccinated while on immunosuppressive therapy or in the 2 weeks prior to starting therapy should be considered unimmunized and should be revaccinated at least 3 months after discontinuation of therapy.(1) Patients who receive anti-B cell therapies should not receive live vaccines for at least 6 months after such therapies due to a prolonged duration of immunosuppression. An exception is the Zoster vaccine, which can be given at least 1 month after receipt of anti-B cell therapies.(1) The US manufacturer of abatacept states live vaccines should not be given during or for up to 3 months after discontinuation of abatacept.(2) The US manufacturer of live BCG for intravesicular treatment of bladder cancer states use is contraindicated in immunosuppressed patients.(3) The US manufacturer of daclizumab states live vaccines are not recommended during and for up to 4 months after discontinuation of treatment.(4) The US manufacturer of guselkumab states that live vaccines should be avoided during treatment with guselkumab.(5) The US manufacturer of inebilizumab-cdon states that live vaccines are not recommended during treatment and after discontinuation until B-cell repletion. Administer all live vaccinations at least 4 weeks prior to initiation of inebilizumab-cdon.(6) The US manufacturer of ocrelizumab states that live vaccines are not recommended during treatment and until B-cell repletion occurs after discontinuation of therapy. Administer all live vaccines at least 4 weeks prior to initiation of ocrelizumab.(7) The US manufacturer of ozanimod states that live vaccines should be avoided during and for up to 3 months after discontinuation of ozanimod.(8) The US manufacturer of siponimod states that live vaccines are not recommended during treatment and for up to 4 weeks after discontinuation of treatment.(9) The US manufacturer of ustekinumab states BCG vaccines should not be given in the year prior to, during, or the year after ustekinumab therapy.(10) The US manufacturer of satralizumab-mwge states that live vaccines are not recommended during treatment and should be administered at least four weeks prior to initiation of satralizumab-mwge.(11) The US manufacturer of ublituximab-xiiy states that live vaccines are not recommended during treatment and until B-cell recovery. Live vaccines should be administered at least 4 weeks prior to initiation of ublituximab-xiiy.(12) The US manufacturer of etrasimod states that live vaccines should be avoided during and for 5 weeks after treatment. Live vaccines should be administered at least 4 weeks prior to initiation of etrasimod.(13) The US manufacturer of emapalumab-lzsg states that live vaccines should not be administered to patients receiving emapalumab-lzsg and for at least 4 weeks after the last dose of emapalumab-lzsg. The safety of immunization with live vaccines during or following emapalumab-lzsg therapy has not been studied.(14) The US manufacturer of sibeprenlimab-szsi states live vaccines should not be given within 30 days prior to initiation or during treatment with sibeprenlimab-szsi.(15)
DISCUSSION: Killed or inactivated vaccines do not pose a danger to immunocompromised patients.(1) Patients with a history of leukemia who are in remission and have not received chemotherapy for at least 3 months are not considered to be immunocompromised.(1)
There are no severe interactions for this drug.
There are no moderate interactions for this drug.
Contraindications
*None.
- Active tuberculosis
- Inactive tuberculosis
- Infection
- Chronic kidney disease stage 3A (moderate) GFR 45-59 ml/min
- Chronic kidney disease stage 3B (moderate) GFR 30-44 ml/min
- Chronic kidney disease stage 4 (severe) GFR 15-29 ml/min
- Chronic kidney disease stage 5 (failure) GFr<15 ml/min
Adverse reactions
The most common adverse reactions (>=1%) reported with icotrokinra in clinical studies were headache, nausea, cough, fungal infection, and fatigue.
Rare or Very Rare
- Upper GI bleed
Less Frequent
- Cough
- Fatigue
- Fungal infection
- Headache disorder
- Nausea
Rare or Very Rare
- Acute abdominal pain
- Gastritis
Precautions
No enhanced messaging available.
The safety and effectiveness of icotrokinra have been established in pediatric patients >=12 years of age who weigh >=40 kg with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
There are insufficient data regarding the use of icotrokinra in pregnant women.
In an animal reproduction study, oral administration of icotrokinra to pregnant rabbits during the period of organogenesis at a dose 157 times the maximum recommended human dose (MRHD) based on AUC comparison resulted in maternal body weight loss, low food consumption, late pregnancy loss, and an increased fetal incidence of fused ribs.
There is a pregnancy safety study for icotrokinra. If a patient becomes pregnant while receiving icotrokinra, report icotrokinra exposure by calling 1-800-526-7736 or visiting https://www.icotyde.com/.
It is not known whether icotrokinra is distributed into human milk, or if the drug has any effects on the breastfed infant or on milk production.
When administered to lactating rats, icotrokinra was detected in the plasma of nursing pups; therefore, it is likely that the drug will be present in human milk. Consider the developmental and health benefits of breastfeeding along with the mother's clinical need for icotrokinra and any potential adverse effects on the breastfed infant from icotrokinra or from the underlying maternal condition.
The manufacturer makes no specific dosage recommendations for geriatric patients.
Of the 2367 patients exposed to icotrokinra in clinical trials for moderate to severe plaque psoriasis, 240 (10.1%) were >=65 years of age, and 36 (1.5%) were >=75 years of age. No overall differences in safety and effectiveness of icotrokinra have been observed between patients >=65 years of age and younger adult subjects.
ICD codes
| Code | Type | Description |
|---|---|---|
| Moderate to severe plaque psoriasis | ||
| L40.0 | ICD10CM | Psoriasis vulgaris |
| L40.8 | ICD10CM | Other psoriasis |
| L40.9 | ICD10CM | Psoriasis, unspecified |
ICD code information from First Databank (FDB).
Formulary status
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Last reviewed · Source: First Databank (FDB) drug data
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