Version May 2024
Patients treated with oral Janus kinase inhibitors for inflammatory conditions are at risk for developing serious infections that may lead to hospitalization or death. Reported infections include: active tuberculosis, which may present with pulmonary or extrapulmonary disease; invasive fungal infections, including cryptococcosis and pneumocystosis; bacterial, viral, including herpes zoster, and other infections due to opportunistic pathogens.
Avoid use of topical ruxolitinib in patients with an active, serious infection, including localized infections. If a serious infection develops, interrupt ruxolitinib until the infection is controlled. The risks and benefits of treatment with ruxolitinib should be carefully considered prior to initiating therapy in patients with chronic or recurrent infection. Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with ruxolitinib.
In a large, randomized, postmarketing safety study in rheumatoid arthritis patients ≥50 years of age with at least one cardiovascular risk factor comparing an oral Janus kinase inhibitor to tumor necrosis factor blocker treatment, a higher rate of all-cause mortality, including sudden cardiovascular death, was observed with the Janus kinase inhibitor.
Malignancies were reported in patients treated with topical ruxolitinib. Lymphoma and other malignancies have been observed in patients receiving Janus kinase inhibitors used to treat inflammatory conditions. In rheumatoid arthritis patients treated with an oral Janus kinase inhibitor, a higher rate of malignancies (excluding nonmelanoma skin cancer) was observed when compared with tumor necrosis factor blockers. Patients who are current or past smokers are at additional increased risk.
In rheumatoid arthritis patients ≥50 years of age with at least one cardiovascular risk factor treated with an oral Janus kinase inhibitor, a higher rate of major adverse cardiovascular events (defined as cardiovascular death, myocardial infarction, and stroke) was observed when compared with tumor necrosis factor blockers. Patients who are current or past smokers are at additional increased risk. Discontinue topical ruxolitinib in patients who have experienced a myocardial infarction or stroke.
Thromboembolic events were observed in trials with topical ruxolitinib. Thrombosis, including pulmonary embolism, deep venous thrombosis, and arterial thrombosis, have been reported in patients receiving Janus kinase inhibitors used to treat inflammatory conditions. Many of these adverse reactions were serious and some resulted in death. In rheumatoid arthritis patients ≥50 years of age with at least one cardiovascular risk factor treated with an oral Janus kinase inhibitor, a higher rate of thrombosis was observed when compared with tumor necrosis factor blockers. Avoid topical ruxolitinib in patients at risk. If symptoms of thrombosis occur, discontinue topical ruxolitinib and treat appropriately.
Note: Avoid concomitant use of topical ruxolitinib with therapeutic biologics, other Janus kinase inhibitors, or potent immunosuppressants (eg, azathioprine, cyclosporine).
Atopic dermatitis, mild to moderate (alternative agent):
Topical: Apply a thin layer to affected area(s) twice daily; application area should not exceed 20% BSA. Maximum dose: 60 g per week or 100 g per 2 weeks. Discontinue when signs/symptoms resolve. Reassess therapy if signs/symptoms have not resolved within 8 weeks.
Nonsegmental vitiligo:
Topical: Apply a thin layer to affected area(s) twice daily; application area should not exceed 10% BSA. Maximum dose: 60 g per week or 100 g per 2 weeks. Reassess need for continued therapy if no meaningful improvement with re-pigmentation by 24 weeks.
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
There are no dosage adjustments provided in the manufacturer's labeling.
Ruxolitinib initiation is not recommended in patients with active hepatitis B or hepatitis C. There are no dosage adjustments provided in the manufacturer's labeling.
Cardiovascular events (myocardial infarction, thrombosis, or stroke): Discontinue topical ruxolitinib.
Hematologic toxicity: Discontinue topical ruxolitinib if signs and/or symptoms of clinically significant thrombocytopenia, anemia, or neutropenia occur.
Serious or opportunistic infection: Interrupt topical ruxolitinib therapy if serious infection, opportunistic infection, or sepsis develops. Do not resume ruxolitinib until infection is controlled.
Refer to adult dosing.
(For additional information see "Ruxolitinib (topical): Pediatric drug information")
Atopic dermatitis, mild to moderate: Children ≥12 years and Adolescents: Topical: Cream: Apply a thin layer to affected area(s) twice daily; application area should not exceed 20% of total BSA. Maximum dose: 60 g every week or 100 g every 2 weeks. Discontinue when signs/symptoms resolved. If signs/symptoms not resolved within 8 weeks, reexamination by health care provider is recommended.
Vitiligo, nonsegmental: Children ≥12 years and Adolescents: Topical: Cream: Apply a thin layer to affected area(s) twice daily; application area should not exceed 10% of total BSA.
Maximum dose: 60 g every week or 100 g every 2 weeks. It may require 24 weeks of treatment for a satisfactory response; if after 24 weeks of therapy, meaningful repigmentation has not been observed, reexamination by health care provider is recommended.
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
There are no dosage adjustments provided in the manufacturer's labeling.
Baseline: Use is not recommended in patients with active hepatitis B or C; there are no other dosage adjustments provided in the manufacturer's labeling.
Ruxolitinib is Janus kinase inhibitor; therefore, use may result in infection including bacterial infection, viral infection, fungal infection (including cryptococcosis), and mycobacterial infections (including opportunistic infections). While serious lower respiratory tract infection was reported with topical ruxolitinib, the majority of reported infections were less severe and rarely occurred including folliculitis, bronchitis, nasopharyngitis, tonsillitis, herpes zoster infection (including reactivation of herpes zoster), staphylococcal infection, otitis externa.
Mechanism: Dose-related; inhibition of Janus kinases (JAKs), JAK1 and JAK2 which mediate the signaling of cytokines involved in immune function.
Ruxolitinib is a Janus kinase inhibitor; therefore, use may result in malignancies. Nonmelanoma skin carcinomas, including basal cell carcinoma of skin and squamous cell carcinoma of skin, have been rarely reported in patients treated with topical ruxolitinib.
Mechanism: Dose-related; inhibition of Janus kinases (JAKs), JAK1 and JAK2 which mediate the signaling of cytokines involved in immune function.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Reported incidences are for adolescents and adults.
1% to 10%:
Dermatologic: Folliculitis (≤1%; including application-site) (table 1), urticaria (1%)
|
Drug (Ruxolitinib [Topical]) |
Vehicle |
Indication |
Number of Patients (Ruxolitinib [Topical]) |
Number of Patients (Vehicle) |
Comments | |
|---|---|---|---|---|---|---|
|
1% |
0% |
Atopic dermatitis |
499 |
250 |
N/A | |
|
<1% |
0% |
Nonsegmental vitiligo |
449 |
224 |
Application-site folliculitis | |
Gastrointestinal: Diarrhea (≤1%)
Genitourinary: Urinary tract infection (2%)
Hematologic & oncologic: Eosinophilia (1%)
Local: Application-site erythema (2%), application-site pruritus (5%), local acneiform eruptions (application-site) (6%)
Nervous system: Headache (4%)
Otic: Otic infection (≤1%)
Respiratory: Bronchitis (1%) (table 2), nasopharyngitis (3% to 4%) (table 3), rhinorrhea (1%), tonsillitis (1%) (table 4)
|
Drug (Ruxolitinib [Topical]) |
Vehicle |
Indication |
Number of Patients (Ruxolitinib [Topical]) |
Number of Patients (Vehicle) | |
|---|---|---|---|---|---|
|
1% |
0% |
Atopic dermatitis |
499 |
250 | |
|
Drug (Ruxolitinib [Topical]) |
Vehicle |
Indication |
Number of Patients (Ruxolitinib [Topical]) |
Number of Patients (Vehicle) | |
|---|---|---|---|---|---|
|
4% |
2% |
Nonsegmental vitiligo |
449 |
224 | |
|
3% |
1% |
Atopic dermatitis |
499 |
250 | |
|
Drug (Ruxolitinib [Topical]) |
Vehicle |
Indication |
Number of Patients (Ruxolitinib [Topical]) |
Number of Patients (Vehicle) | |
|---|---|---|---|---|---|
|
1% |
0% |
Atopic dermatitis |
499 |
250 | |
Miscellaneous: Fever (≤1%)
<1%:
Cardiovascular: Hypertension
Dermatologic: Acneiform eruption, contact dermatitis
Gastrointestinal: Gastritis, gastroenteritis, vomiting
Hematologic & oncologic: Bruise, neutropenia
Infection: Herpes zoster infection (including reactivation of herpes zoster), staphylococcal infection
Local: Application-site dermatitis, local skin discoloration (application-site)
Nervous system: Anxiety, insomnia
Ophthalmic: Allergic conjunctivitis, hordeolum
Otic: Otitis externa
Respiratory: Flu-like symptoms, nasal congestion
Frequency not defined:
Cardiovascular: Acute myocardial infarction, thrombosis (including arterial thrombosis, deep vein thrombosis, pulmonary embolism)
Dermatologic: Skin carcinoma (non-melanoma, including basal cell carcinoma of skin, squamous cell carcinoma of skin)
Hematologic & oncologic: Anemia, malignant lymphoma, malignant neoplasm, thrombocytopenia
Infection: Serious infection (including bacterial infection, cryptococcosis, fungal infection [invasive; including infection due to organism in genus Pneumocystis], opportunistic infection, tuberculosis disease, viral infection [reactivation])
Nervous system: Cerebrovascular accident
Respiratory: Lower respiratory tract infection (severe)
There are no contraindications listed in the manufacturer's labeling.
Concerns related to adverse effects:
• Hematologic toxicity: Hematologic toxicity, including thrombocytopenia, anemia, and neutropenia, may occur.
• Lipid abnormalities: Treatment with oral ruxolitinib has been associated with increases in lipid parameters (eg, total cholesterol, low-density lipoprotein cholesterol, triglycerides).
• Malignancies: Consider risks versus benefits prior to initiating or continuing topical ruxolitinib in patients with current or history of malignancy (except successfully treated nonmelanoma skin cancer) or in smokers (current or past; smoking increases risk of malignancy).
• Nonmelanoma skin cancer: Nonmelanoma skin cancers (basal cell and squamous cell carcinoma) have been reported in patients treated with topical ruxolitinib. Minimize exposure to sunlight and UV light (eg, wear protective clothing, apply sunscreen).
Disease-related concerns:
• Immunosuppression: Avoid use in immunocompromised patients.
Some dosage forms may contain propylene glycol; in neonates, large amounts of propylene glycol delivered orally, intravenously (eg, >3,000 mg/day), or topically have been associated with potentially fatal toxicities which can include metabolic acidosis, seizures, renal failure, and CNS depression; toxicities have also been reported in children and adults including hyperosmolality, lactic acidosis, seizures, and respiratory depression; use caution (AAP 1997; Shehab 2009).
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Cream, External, as phosphate:
Opzelura: 1.5% (5 g, 60 g) [contains cetyl alcohol, edetate (edta) disodium, methylparaben, propylene glycol, propylparaben]
No
Cream (Opzelura External)
1.5% (per gram): $40.90
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Topical: For topical use only; not for ophthalmic, oral, or intravaginal use. Wash hands after application.
Topical: For external use only; not for ophthalmic, oral, or vaginal use. Wash hands after application, unless hands are being treated.
An FDA-approved patient medication guide, which is available with the product information and at https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/215309s004lbl.pdf#page=19, must be dispensed with this medication.
Atopic dermatitis, mild to moderate (alternative agent): Topical short-term and noncontinuous chronic treatment of mild to moderate atopic dermatitis in immunocompetent patients ≥12 years of age whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.
Nonsegmental vitiligo: Topical treatment of nonsegmental vitiligo in patients ≥12 years of age.
Limitation of use: Use of topical ruxolitinib in combination with therapeutic biologics, other Janus kinase inhibitors, or potent immunosuppressants such as azathioprine or cyclosporine is not recommended.
Ruxolitinib may be confused with cabozantinib, fedratinib, PONATinib, regorafenib, ripretinib, riTUXimab, rucaparib, tofacitinib.
Substrate of CYP3A4 (major); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
5-Aminosalicylic Acid Derivatives: May enhance the myelosuppressive effect of Myelosuppressive Agents. Risk C: Monitor therapy
Abrocitinib: May enhance the immunosuppressive effect of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid combination
Baricitinib: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Baricitinib. Risk X: Avoid combination
BCG (Intravesical): Myelosuppressive Agents may diminish the therapeutic effect of BCG (Intravesical). Risk X: Avoid combination
BCG Products: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the adverse/toxic effect of BCG Products. Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of BCG Products. Risk X: Avoid combination
Brincidofovir: Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Brincidofovir. Risk C: Monitor therapy
Brivudine: May enhance the adverse/toxic effect of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid combination
Chikungunya Vaccine (Live): Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the adverse/toxic effect of Chikungunya Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Chikungunya Vaccine (Live). Risk X: Avoid combination
Chloramphenicol (Ophthalmic): May enhance the adverse/toxic effect of Myelosuppressive Agents. Risk C: Monitor therapy
Chloramphenicol (Systemic): Myelosuppressive Agents may enhance the myelosuppressive effect of Chloramphenicol (Systemic). Risk X: Avoid combination
Cladribine: May enhance the myelosuppressive effect of Myelosuppressive Agents. Risk X: Avoid combination
Cladribine: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Cladribine. Risk X: Avoid combination
Clofazimine: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk C: Monitor therapy
CloZAPine: Myelosuppressive Agents may enhance the adverse/toxic effect of CloZAPine. Specifically, the risk for neutropenia may be increased. Risk C: Monitor therapy
Coccidioides immitis Skin Test: Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the diagnostic effect of Coccidioides immitis Skin Test. Management: Consider discontinuing these oncologic agents several weeks prior to coccidioides immitis skin antigen testing to increase the likelihood of accurate diagnostic results. Risk D: Consider therapy modification
Corticosteroids (Systemic): May enhance the immunosuppressive effect of Ruxolitinib (Topical). Risk X: Avoid combination
COVID-19 Vaccine (Adenovirus Vector): Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of COVID-19 Vaccine (Adenovirus Vector). Management: Administer a 2nd dose using an mRNA COVID-19 vaccine (at least 4 weeks after the primary vaccine dose) and a bivalent booster dose (at least 2 months after the additional mRNA dose or any other boosters). Risk D: Consider therapy modification
COVID-19 Vaccine (Inactivated Virus): Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of COVID-19 Vaccine (Inactivated Virus). Risk C: Monitor therapy
COVID-19 Vaccine (mRNA): Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of COVID-19 Vaccine (mRNA). Management: Give a 3-dose primary series for all patients aged 6 months and older taking immunosuppressive medications or therapies. Booster doses are recommended for certain age groups. See CDC guidance for details. Risk D: Consider therapy modification
COVID-19 Vaccine (Subunit): Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of COVID-19 Vaccine (Subunit). Risk C: Monitor therapy
COVID-19 Vaccine (Virus-like Particles): Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of COVID-19 Vaccine (Virus-like Particles). Risk C: Monitor therapy
CYP3A4 Inhibitors (Strong): May increase the serum concentration of Ruxolitinib (Topical). Risk X: Avoid combination
Deferiprone: Myelosuppressive Agents may enhance the neutropenic effect of Deferiprone. Management: Avoid the concomitant use of deferiprone and myelosuppressive agents whenever possible. If this combination cannot be avoided, monitor the absolute neutrophil count more closely. Risk D: Consider therapy modification
Dengue Tetravalent Vaccine (Live): Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the adverse/toxic effect of Dengue Tetravalent Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Dengue Tetravalent Vaccine (Live). Risk X: Avoid combination
Denosumab: May enhance the immunosuppressive effect of Immunosuppressants (Miscellaneous Oncologic Agents). Management: Consider the risk of serious infections versus the potential benefits of coadministration of denosumab and immunosuppressants. If combined, monitor patients for signs/symptoms of serious infections. Risk D: Consider therapy modification
Deucravacitinib: May enhance the immunosuppressive effect of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid combination
Dipyrone: May enhance the adverse/toxic effect of Myelosuppressive Agents. Specifically, the risk for agranulocytosis and pancytopenia may be increased Risk X: Avoid combination
Etrasimod: May enhance the immunosuppressive effect of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid combination
Fexinidazole: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk X: Avoid combination
Fexinidazole: Myelosuppressive Agents may enhance the myelosuppressive effect of Fexinidazole. Risk X: Avoid combination
Filgotinib: May enhance the immunosuppressive effect of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid combination
Fusidic Acid (Systemic): May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk X: Avoid combination
Immunosuppressants (Cytotoxic Chemotherapy): May enhance the immunosuppressive effect of Ruxolitinib (Topical). Risk X: Avoid combination
Immunosuppressants (Miscellaneous Oncologic Agents): May enhance the immunosuppressive effect of Ruxolitinib (Topical). Risk X: Avoid combination
Immunosuppressants (Therapeutic Immunosuppressant Agents): May enhance the immunosuppressive effect of Ruxolitinib (Topical). Risk X: Avoid combination
Influenza Virus Vaccines: Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Influenza Virus Vaccines. Management: Administer influenza vaccines at least 2 weeks prior to initiating immunosuppressants if possible. If vaccination occurs less than 2 weeks prior to or during therapy, revaccinate at least 3 months after therapy discontinued if immune competence restored. Risk D: Consider therapy modification
Methotrexate: May enhance the immunosuppressive effect of Ruxolitinib (Topical). Risk X: Avoid combination
Mumps- Rubella- or Varicella-Containing Live Vaccines: May enhance the adverse/toxic effect of Immunosuppressants (Miscellaneous Oncologic Agents). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Mumps- Rubella- or Varicella-Containing Live Vaccines. Risk X: Avoid combination
Nadofaragene Firadenovec: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the adverse/toxic effect of Nadofaragene Firadenovec. Specifically, the risk of disseminated adenovirus infection may be increased. Risk X: Avoid combination
Natalizumab: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Natalizumab. Risk X: Avoid combination
Olaparib: Myelosuppressive Agents may enhance the myelosuppressive effect of Olaparib. Risk C: Monitor therapy
Pidotimod: Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Pidotimod. Risk C: Monitor therapy
Pimecrolimus: May enhance the immunosuppressive effect of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid combination
Pneumococcal Vaccines: Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Pneumococcal Vaccines. Risk C: Monitor therapy
Poliovirus Vaccine (Live/Trivalent/Oral): Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the adverse/toxic effect of Poliovirus Vaccine (Live/Trivalent/Oral). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Poliovirus Vaccine (Live/Trivalent/Oral). Risk X: Avoid combination
Polymethylmethacrylate: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the potential for allergic or hypersensitivity reactions to Polymethylmethacrylate. Management: Use caution when considering use of bovine collagen-containing implants such as the polymethylmethacrylate-based Bellafill brand implant in patients who are receiving immunosuppressants. Consider use of additional skin tests prior to administration. Risk D: Consider therapy modification
Promazine: May enhance the myelosuppressive effect of Myelosuppressive Agents. Risk C: Monitor therapy
Rabies Vaccine: Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Rabies Vaccine. Management: Complete rabies vaccination at least 2 weeks before initiation of immunosuppressant therapy if possible. If combined, check for rabies antibody titers, and if vaccination is for post exposure prophylaxis, administer a 5th dose of the vaccine. Risk D: Consider therapy modification
Ritlecitinib: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Ritlecitinib. Risk X: Avoid combination
Ropeginterferon Alfa-2b: Myelosuppressive Agents may enhance the myelosuppressive effect of Ropeginterferon Alfa-2b. Management: Avoid coadministration of ropeginterferon alfa-2b and other myelosuppressive agents. If this combination cannot be avoided, monitor patients for excessive myelosuppressive effects. Risk D: Consider therapy modification
Sipuleucel-T: Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Sipuleucel-T. Management: Consider reducing the dose or discontinuing the use of immunosuppressants prior to initiating sipuleucel-T therapy. Risk D: Consider therapy modification
Tacrolimus (Topical): Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Tacrolimus (Topical). Risk X: Avoid combination
Talimogene Laherparepvec: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the adverse/toxic effect of Talimogene Laherparepvec. Specifically, the risk of infection from the live, attenuated herpes simplex virus contained in talimogene laherparepvec may be increased. Risk X: Avoid combination
Tertomotide: Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Tertomotide. Risk X: Avoid combination
Tofacitinib: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Tofacitinib. Risk X: Avoid combination
Typhoid Vaccine: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the adverse/toxic effect of Typhoid Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Typhoid Vaccine. Risk X: Avoid combination
Upadacitinib: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Upadacitinib. Risk X: Avoid combination
Vaccines (Inactivated/Non-Replicating): Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Give inactivated vaccines at least 2 weeks prior to initiation of immunosuppressants when possible. Patients vaccinated less than 14 days before initiating or during therapy should be revaccinated at least 3 after therapy is complete. Risk D: Consider therapy modification
Vaccines (Live): Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the adverse/toxic effect of Vaccines (Live). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Vaccines (Live). Risk X: Avoid combination
Yellow Fever Vaccine: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the adverse/toxic effect of Yellow Fever Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Yellow Fever Vaccine. Risk X: Avoid combination
Adverse events were observed in animal reproduction studies following administration of oral ruxolitinib. Agents other than ruxolitinib are preferred for the topical treatment of atopic dermatitis and vitiligo in pregnant patients (Abdelhafez 2021; Vestergaard 2019).
Data collection to monitor pregnancy and infant outcomes following exposure to topical ruxolitinib is ongoing. Health care providers are encouraged to enroll patients exposed to topical ruxolitinib during pregnancy in the Pregnancy Registry (1-855-463-3463).
It is not known if ruxolitinib is present in breast milk following topical application.
Due to the potential for serious adverse reactions in the breastfed infant, breastfeeding is not recommended by the manufacturer during therapy and for ~4 weeks after the last ruxolitinib dose.
Signs/symptoms of infection (including tuberculosis); periodic skin examinations for basal cell and squamous cell carcinoma; CBC as clinically indicated.
Ruxolitinib is a kinase inhibitor that selectively inhibits Janus-associated kinases (JAKs), JAK1 and JAK2. JAK1 and JAK2 mediate signaling of cytokine and growth factors responsible for hematopoiesis and immune function; JAK-mediated signaling involves recruitment of signal transducers and activators of transcription (STATs) to cytokine receptors, which leads to modulation of gene expression. While not fully understood in atopic dermatitis, it is thought that the JAK-STAT signaling pathway is linked to inflammation, itch response, and skin barrier function (Papp 2021).
Absorption: In atopic dermatitis patients, plasma concentrations were quantifiable in all subjects (systemic absorption is dependent on dose and surface area of application); accumulation did not occur with repeated administration (Gong 2021).
Protein binding: ~97%.
Metabolism: Primarily by CYP3A4 and, to a lesser extent, by CYP2C9.
Bioavailability: 6.2% ± 7.7% (Gong 2021).
Half-life elimination: ~116 hours.
Excretion: Urine: 74% (<1% as unchanged drug); feces: 22% (<1% as unchanged drug).
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