JAKAFI, Ruxolitinib Phosphate Form

Ruxolitinib (Jakafi®, Opzelura™) is a Janus kinase (JAK) inhibitor.
FDA Approved Indication(s) Jakafi is indicated for the treatment of: • Intermediate or high-risk myelofibrosis (MF) in adults, including o Primary MF o Post-polycythemia vera MF (post-PV MF) o Post-essential thrombocythemia MF (post-ET MF) • Polycythemia vera (PCV) in adults who have had an inadequate response to or are intolerant to hydroxyurea • Steroid-refractory acute graft-versus-host disease (GVHD) in adults and pediatric patients 12 years and older • Chronic graft-versus-host disease after failure of one or two lines of systemic therapy in adult and pediatric patients 12 years and older.
Opzelura is indicated for the: • Topical short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis in non-immunocompromised patients 12 years of age and older, whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.
• Topical treatment of nonsegmental vitiligo (NVS) in adult and pediatric patients 12 years of age and older. Limitation(s) of use: Use of Opzelura in combination with therapeutic biologics, other JAK inhibitors, or potent immunosuppressants such as azathioprine or cyclosporine is not recommended.
Policy/Criteria Provider must submit documentation (including such as office chart notes, lab results or other clinical information) supporting that member has met all approval criteria.
It is the policy of health plans affiliated with Centene Corporation® that Jakafi and Opzelura are medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. Myelofibrosis (must meet all): Page 1 of 16

CLINICAL POLICY Ruxolitinib

1. Diagnosis of MF (includes primary MF, post-PV MF, post-ET MF);
   2. Request is for Jakafi;
   3. Prescribed by or in consultation with a hematologist or oncologist;
   4. Age ≥ 18 years;
   5. Documentation of a recent (within the last 30 days) platelet count of ≥ 50 × 109/L;
   6. For Jakafi requests, member must use ruxolitinib, if available, unless contraindicated or clinically significant adverse effects are experienced;
2. Request meets one of the following (a or b): a. Dose does not exceed both of the following (i and ii):
   i. 50 mg per day; ii. 2 tablets per day; b. Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence). Prescribed regimen must be FDA-approved or recommended by NCCN
   Approval duration: Medicaid/HIM – 6 months Commercial – 12 months or duration of request, whichever is less B. Polycythemia Vera (must meet all):
3. Diagnosis of PCV;
   
   2. Request is for Jakafi;
   3. Prescribed by or in consultation with a hematologist or oncologist;
   4. Age ≥ 18 years;
   5. For Jakafi requests, member must use ruxolitinib, if available, unless contraindicated or clinically significant adverse effects are experienced;
4. Failure of hydroxyurea, peginterferon, or interferon (see Appendix B), unless clinically significant adverse effects are experienced or all are contraindicated; *Prior authorization may be required for hydroxyurea, peginterferon, and interferon
5. Request meets one of the following (a or b): a. Dose does not exceed both of the following (i and ii):
   i. 50 mg per day; ii. 2 tablets per day;
   b. Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence). Prescribed regimen must be FDA-approved or recommended by NCCN.
   Approval duration: Medicaid/HIM – 6 months Commercial – 12 months or duration of request, whichever is less C. Graft-Versus-Host Disease (must meet all):
6. Diagnosis of steroid-refractory acute or chronic GVHD post hematopoietic cell transplantation;
   2. Request is for Jakafi;
   3. Prescribed by or in consultation with an oncologist, hematologist, or bone marrow transplant specialist;

7. Age ≥ 12 years; Page 2 of 16

   CLINICAL POLICY Ruxolitinib

8. For Jakafi requests, member must use ruxolitinib, if available, unless contraindicated or clinically significant adverse effects are experienced;
9. For acute GVHD, failure of a systemic corticosteroid (e.g., oral prednisone or intravenous methylprednisolone dose equivalent) as defined in Appendix D, unless contraindicated or clinically significant adverse effects are experienced;
10. For chronic GVHD, member meets one of the following (a or b):
    a. Failure of a systemic corticosteroid (see Appendix B) at up to maximally indicated doses, unless contraindicated or clinically significant adverse effects are experienced; b. Failure of a systemic immunosuppressant (see Appendix B) at up to maximally indicated doses, unless contraindicated or clinically significant adverse effects are experienced;
11. Jakafi is not prescribed concurrently with Imbruvica® or Rezurock®;
    9. Request meets one of the following (a or b):
       a. Dose does not exceed both of the following (i and ii):
       i. 20 mg per day; ii. 1 tablet per day; b. Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence). Prescribed regimen must be FDA-approved or recommended by NCCN.
       Approval duration:
       Medicaid/HIM – 6 months
       Commercial – 12 months or duration of request, whichever is less D. Chronic Myelomonocytic Leukemia and Myelodysplastic/Myeloproliferative Neoplasms (MDS/MPN) (off-label use) (must meet all):
    10. Diagnosis of one of the following (a or b): a. Chronic myelomonocytic leukemia; b. MDS/MPN;
    11. Request is for Jakafi;
    12. Prescribed by or in consultation with a hematologist or oncologist;
    13. Age ≥ 18 years;
    14. For Jakafi requests, member must use ruxolitinib, if available, unless contraindicated or clinically significant adverse effects are experienced;
12. Dose is within FDA maximum limit for any FDA-approved indication or is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence).Prescribed regimen must be FDA-approved or recommended by NCCN.
    Approval duration: Medicaid/HIM – 6 months Commercial – 12 months or duration of request, whichever is less E. Pediatric B-Cell Acute Lymphoblastic Leukemia (off-label use) (must meet all):

13. Diagnosis of pediatric “Ph-like” B-cell acute lymphoblastic leukemia:

    2. Request is for Jakafi; Page 3 of 16

    CLINICAL POLICY Ruxolitinib

14. Prescribed by or in consultation with a hematologist or oncologist;
    4. Age < 18 years;
    5. For Jakafi requests, member must use ruxolitinib, if available, unless contraindicated or clinically significant adverse effects are experienced;
15. Prescribed in combination with an induction or consolidation regimen;
    7. Positive for a JAK-STAT pathway mutation, JAK2 fusion, EPOR rearrangement, SH2B3 alteration, or IL7R insertion/deletion;
16. Dose is within FDA maximum limit for any FDA-approved indication or is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence).Prescribed regimen must be FDA-approved or recommended by NCCN.
    Approval duration: Medicaid/HIM – 6 months Commercial – 12 months or duration of request, whichever is less F. Myeloid/Lymphoid Neoplasm with Eosinophilia (off-label use) (must meet all):
    1. Diagnosis of a lymphoid, myeloid or mixed lineage neoplasm with eosinophilia;
    2. Request is for Jakafi;
    3. Prescribed by or in consultation with a hematologist or oncologist;
    4. Age ≥ 18 years;
    5. For Jakafi requests, member must use ruxolitinib, if available, unless contraindicated or clinically significant adverse effects are experienced;
17. Positive for a JAK2 mutation;
    7. Dose is within FDA maximum limit for any FDA-approved indication or is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence).Prescribed regimen must be FDA-approved or recommended by NCCN.
       Approval duration: Medicaid/HIM – 6 months Commercial – 12 months or duration of request, whichever is less G. Essential Thrombocythemia (off-label) (must meet all):
18. Diagnosis of essential thrombocythemia;
    
    2. Request is for Jakafi;
    3. Prescribed by or in consultation with a hematologist or oncologist;
    4. Age ≥ 18 years;
    5. For Jakafi requests, member must use ruxolitinib, if available, unless contraindicated or clinically significant adverse effects are experienced;

19. Failure of hydroxyurea, peginterferon, interferon, or anagrelide (see Appendix B), unless clinically significant adverse effects are experienced or all are contraindicated; *Prior authorization may be required for hydroxyurea, peginterferon, interferon, or anagrelide

    7. Dose is within FDA maximum limit for any FDA-approved indication or is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence).Prescribed regimen must be FDA-approved or recommended by NCCN.
       Approval duration: Page 4 of 16

    CLINICAL POLICY Ruxolitinib Medicaid/HIM – 6 months Commercial – 12 months or duration of request, whichever is less H. Atopic Dermatitis (must meet all):

20. Diagnosis of AD;
    2. Member has ≤ 20% body surface area (BSA) involvement;
    3. Request is for Opzelura;
    4. Age ≥ 12 years;
    5. Prescribed by or in consultation with a dermatologist or allergist;
    6. Member does not have an immunocompromised status;
    7. Member meets one of the following (a or b):
       a. Failure of two formulary medium-to-very high potency topical corticosteroids, each used for ≥ 2 weeks, unless contraindicated or clinically adverse effects are experienced (see Appendix B); b. For face or intertriginous areas use (e.g., genitals, armpits, forearms, and groin);
    8. Failure of a topical calcineurin inhibitor used for ≥ 4 weeks, unless contraindicated or clinically significant adverse effects are experienced (see Appendix B); Prior authorization may be required for topical calcineurin inhibitors
21. Failure of Eucrisa® used for ≥ 4 weeks, unless contraindicated or clinically significant adverse effects are experienced; Prior authorization may be required for Eucrisa
22. Opzelura is not prescribed concurrently with biologic disease-modifying antirheumatic drugs (e.g., Humira®, Enbrel®, Taltz®, Stelara®), JAK inhibitors (e.g., Xeljanz®, Rinvoq®, Olumiant®), or potent immunosuppressants (e.g., azathioprine, cyclosporine);
23. Dose does not exceed one of the following (a or b):
    a. One 60-gram tube per week; b. One 100-gram tube per 2 weeks;
    Approval duration: 8 weeks I. Nonsegmental Vitiligo (must meet all):

24. Diagnosis of NSV;

    2. Documentation of member’s total vitiligo involvement is ≤ 10% BSA;
    3. Request is for Opzelura;
    4. Prescribed by or in consultation with a dermatologist or allergist;
    5. Age ≥ 12 years;
    6. Member meets one of the following (a or b):
       a. Two formulary medium-to-very high potency topical corticosteroids in the previous 6 months, unless contraindicated or clinically adverse effects are experienced (see Appendix B); b. For face or intertriginous areas use (e.g., genitals, armpits, forearms, and groin);
    7. Failure of a topical calcineurin inhibitor used for ≥ 4 weeks, unless contraindicated or clinically significant adverse effects are experienced (see Appendix B); Prior authorization may be required for topical calcineurin inhibitors Page 5 of 16

    CLINICAL POLICY Ruxolitinib

25. Opzelura is not prescribed concurrently with biologic disease-modifying antirheumatic drugs (e.g., Humira, Enbrel, Taltz, Stelara), JAK inhibitors (e.g., Xeljanz, Rinvoq, Olumiant), or potent immunosuppressants (e.g., azathioprine, cyclosporine);
26. Dose does not exceed one of the following (a or b):
    a. One 60-gram tube per week; b. One 100-gram tube per 2 weeks; Approval duration: 6 months J. CAR T-Cell Related Toxicities (off-label) (must meet all):
27. Diagnosis of grade 4 cytokine release syndrome (CRS) (see Appendix E);
    2. Request is for Jakafi;
    3. Prescribed by or in consultation with a hematologist or oncologist;
    4. Age ≥ 18 years;
    5. For Jakafi requests, member must use ruxolitinib, if available, unless contraindicated or clinically significant adverse effects are experienced;
28. Failure of both high-dose systemic corticosteroids and anti-IL-6 therapy (see Appendix B), unless clinically significant adverse effects are experienced or all are contraindicated; Prior authorization may be required for anti-IL-6 therapy
29. Dose is within FDA maximum limit for any FDA-approved indication or is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence).Prescribed regimen must be FDA-approved or recommended by NCCN.
    Approval duration: 1 month K. Other diagnoses/indications (must meet 1 or 2):
30. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.33 for health insurance marketplace, and CP.PMN.255 for Medicaid; or b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace, and CP.PMN.16 for Medicaid; or

31. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid.
    Page 6 of 16

    CLINICAL POLICY Ruxolitinib II. Continued Therapy A. Atopic Dermatitis or Nonsegmental Vitiligo (must meet all):

32. Member meets one of the following (a or b): a. Currently receiving medication via Centene benefit or member has previously met initial approval criteria; b. Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations (refer to state specific addendums for CC.PHARM.03A and CC.PHARM.03B);
33. Member is responding positively to therapy as evidenced by, including but not limited to, reduction in itching and scratching;
    3. Member meets one of the following (a or b):
       a. For AD: Member is responding positively to therapy as evidenced by, including but not limited to, reduction in itching and scratching; b. For NSV: Member is responding positively to therapy as evidence by, including, but not limited to, reduction in lesions;
34. Request is for Opzelura;
    5. Opzelura is not prescribed concurrently with biologic disease-modifying antirheumatic drugs (e.g., Humira, Enbrel, Taltz, Stelara), JAK inhibitors (e.g., Xeljanz, Rinvoq, Olumiant), or potent immunosuppressants (e.g., azathioprine, cyclosporine);
35. If request is for a dose increase, new dose does not exceed one of the following (a or b):
    a. One 60-gram tube per week; b. One 100-gram tube per 2 weeks;
    Approval duration:
    AD – 8 weeks NSV – 6 months B. CAR T-Cell Related Toxicities
36. Re-authorization is not permitted. CAR-T therapy is indicated to be dosed one time only.
    Approval duration: Not applicable C. All Other Indications in Section I (must meet all):
37. Currently receiving medication via Centene benefit, or documentation supports that member is currently receiving Jakafi for a covered indication and has received this medication for at least 30 days;
38. Member is responding positively to therapy;
    3. Request is for Jakafi;
    4. For Jakafi requests, member must use ruxolitinib, if available, unless contraindicated or clinically significant adverse effects are experienced;

39. For GVHD, Jakafi is not prescribed concurrently with Imbruvica or Rezurock;

    6. If request is for a dose increase, request meets one of the following (a, b, or c):* a. For MF, PCV: New dose does not exceed 50 mg (2 tablets) per day; b. For acute GVHD, cGVHD: New dose does not exceed 20 mg (1 tablet) per day; Page 7 of 16

    CLINICAL POLICY Ruxolitinib c. New dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence). *Prescribed regimen must be FDA-approved or recommended by NCCN.
    Approval duration: Medicaid/HIM – 6 months (12 months for MF) Commercial – 12 months or duration of request, whichever is less D. Other diagnoses/indications (must meet 1 or 2):

40. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.33 for health insurance marketplace, and CP.PMN.255 for Medicaid; or b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace, and CP.PMN.16 for Medicaid; or

41. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid.
    III. Diagnoses/Indications for which coverage is NOT authorized:
    A. Non-FDA approved indications, which are not addressed in this policy, unless there is sufficient documentation of efficacy and safety according to the off label use policies – CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid, or evidence of coverage documents. IV. Appendices/General Information Appendix A: Abbreviation/Acronym Key BSA: body surface area CRS: cytokine release syndrome FDA: Food and Drug Administration GVHD: graft-versus-host disease cGVHD: chronic graft-versus-host disease JAK: Janus kinase MDS/MPN: myelodysplastic/myeloproliferative neoplasms
    MF: myelofibrosis NCCN: National Comprehensive Cancer Network NSV: nonsegmental vitiligo PCV: polycythemia vera post-ET MF: post-essential thrombocythemia myelofibrosis post-PV MF: post-polycythemia vera myelofibrosis
    Page 8 of 16

    CLINICAL POLICY Ruxolitinib Appendix B: Therapeutic Alternatives This table provides a listing of preferred alternative therapy recommended in the approval criteria. The drugs listed here may not be a formulary agent for all relevant lines of business and may require prior authorization.
    Drug Name Dosing Regimen Dose Limit/ Maximum Dose PCV, Essential Thrombocythemia, and cGVHD hydroxyurea (Droxia®, Hydrea®) Intron A® (interferon alfa-2b) Pegasys®, Pegasys ProClick® (peginterferon alfa-2a)
    PegIntron®, Sylatron® (peginterferon alfa-2b) anagrelide (Agrylin®) PCV, essential thrombocythemia: Varies Essential thrombocythemia: Varies cGVHD: Varies Varies Varies Varies Systemic corticosteroids (e.g., methylprednisolone, prednisone)
    mycophenolate mofetil (Cellcept®) cyclosporine (Gengraf®, Neoral®, Sandimmune®) tacrolimus (Prograf®) sirolimus (Rapamune®) imatinib (Gleevec®) Imbruvica® (ibrutinib) Rezurock® (belumosudil) Atopic Dermatitis Very High Potency Topical Corticosteroids augmented betamethasone 0.05% (Diprolene AF) cream, ointment, gel, lotion clobetasol propionate 0.05% (Temovate ) cream, ointment, gel, solution diflorasone diacetate 0.05% (Maxiflor, Psorcon E) cream, ointment halobetasol propionate 0.05% (Ultravate) cream, ointment High Potency Topical Corticosteroids augmented betamethasone 0.05% (Diprolene AF) cream, ointment, gel, lotion diflorasone 0.05% (Florone, Florone E, Maxiflor,Psorcon E) cream fluocinonide acetonide 0.05% (Lidex, Lidex E) cream, ointment, gel, solution Page 9 of 16 Apply topically to the affected area(s) BID Varies
    Apply topically to the affected area(s) BID Varies

    CLINICAL POLICY Ruxolitinib Drug Name Dosing Regimen Dose Limit/ Maximum Dose triamcinolone acetonide 0.5% (Aristocort, Kenalog) cream, ointment Medium Potency Topical Corticosteroids desoximetasone 0.05% (Topicort ) cream, ointment, gel fluocinolone acetonide 0.025% (Synalar) cream, ointment mometasone 0.1% (Elocon) cream, ointment, lotion triamcinolone acetonide 0.025%, 0.1% (Aristocort, Kenalog) cream, ointment Low Potency Topical Corticosteroids alclometasone 0.05% (Aclovate) cream, ointment desonide 0.05% (Desowen) cream, ointment, lotion fluocinolone acetonide 0.01% (Synalar) solution hydrocortisone 2.5% (Hytone) cream, ointment Topical Calcineurin Inhibitors tacrolimus (Protopic), pimecrolimus (Elidel) Eucrisa® (crisaborole) CAR T-Cell Related Toxicities Actemra® (tocilizumab) dexamethasone (Decadron®, Dexasone®) Apply topically to the affected area(s) BID Varies Apply topically to the affected area(s) BID Varies Varies Children ≥ 2 years and adults: Apply a thin layer topically to affected skin BID. Treatment should be discontinued if resolution of disease occurs. Topical Phosphodiesterase-4 Inhibitor
    Apply to the affected areas BID Varies 8 mg /kg IV over 1 hour (not to exceed 800 mg/dose).
    800 mg per dose (max 4 doses total) Repeat in 8 hours if no improvement; no more than 3 doses in 24 hours with a maximum of 4 doses total.
    10 mg IV every 6 hours
    Varies Page 10 of 16

    CLINICAL POLICY Ruxolitinib Drug Name Dosing Regimen methylprednisolone (Solumedrol®, Medrol®) 1000 mg IV every 12-24 hours
    Dose Limit/ Maximum Dose Varies Therapeutic alternatives are listed as Brand name® (generic) when the drug is available by brand name only and generic (Brand name®) when the drug is available by both brand and generic. Appendix C: Contraindications/Boxed Warnings • Contraindications: none reported • Boxed warnings:
    o Jakafi: none reported o Opzelura: serious infections, mortality, malignancy, major adverse cardiovascular events (MACE), and thrombosis  Serious infections leading to hospitalization or death, including tuberculosis and bacterial, invasive fungal, viral, and other opportunistic infections, have occurred in patients receiving JAK inhibitors for inflammatory conditions.
     Higher rate of all-cause mortality, including sudden cardiovascular death have been observed in patients treated with JAK inhibitors for inflammatory conditions.
     Lymphoma and other malignancies have been observed in patients treated with JAK inhibitors for inflammatory conditions.
     Higher rate of major adverse cardiovascular events (including cardiovascular death, myocardial infarction, and stroke) has been observed in patients treated with JAK inhibitors for inflammatory conditions.
     Thrombosis, including deep venous thrombosis, pulmonary embolism, and arterial thrombosis, some fatal, have occurred in patients treated with JAK inhibitors for inflammatory conditions.
    Appendix D: Steroid Refractoriness or Resistance: Acute and Chronic GVHD (NCCN) • Acute GVHD o Progression of acute GVHD within 3-5 days of therapy onset with ≥ 2 mg/kg/day of prednisone OR failure to improve within 5-7 days of treatment initiation OR incomplete response after more than 28 days of immunosuppressive treatment including steroids. • Chronic GVHD o Chronic GVHD progression while on prednisone at ≥ 1 mg/kg/day for 1-2 weeks OR stable GVHD disease while on ≥ 0.5 mg/kg/day (or 1 mg/kg every other day) of prednisone for 1-2 months. *Oral prednisone or IV methylprednisolone dose equivalent. Hematopoietic Cell Transplantation (HCT): Graft-Versus-Host-Disease Version 2.2022. National Comprehensive Cancer Network Guidelines. Available at www.nccn.org. Accessed November 16, 2022. Appendix E: CRS Grade (NCCN) • Grade 1: fever ≥ 38o C Page 11 of 16

    CLINICAL POLICY Ruxolitinib • Grade 2: fever with hypotension not requiring vasopressors and/or hypoxia requiring low-flow nasal cannula or blow-by • Grade 3: fever with hypotension requiring vasopressors with or without vasopressin and/or hypoxia requiring high-flow cannula, face mask, nonrebreather mask, or Venturi mask
    • Grade 4: fever with hypotension requiring multiple vasopressors (excluding vasopressin) and/or hypoxia requiring positive pressure (e.g., CPAP, BiPAP, intubation, mechanical ventilation) *Low-flow cannula is defined as oxygen delivered at ≤6 L/min. Low flow also includes blow-by oxygen delivery, sometimes used in pediatrics. High-flow nasal cannula is defined as oxygen delivered at >6 L/min Management of Immunotherapy-Related Toxicities Version 1.2022. National Comprehensive Cancer Network Guidelines. Available at www.nccn.org. Accessed November 16, 2022 V. Dosage and Administration
    Indication Dosing Regimen Drug Name Ruxolitinib (Jakafi) MF PCV acute GVHD cGVHD Starting dose is based on patient’s baseline platelet count: • Greater than 200 × 109/L: 20 mg PO BID • 100 × 109/L to 200 × 109/L: 15 mg PO BID • 50 × 109/L to less than 100 × 109/L: 5 mg PO BID Range: 5 mg to 25 mg PO BID Starting dose: 10mg PO BID Range: 5 mg to 25 mg PO BID Starting dose: 5mg PO BID Range: 5 mg to 10 mg PO BID Starting dose: 10mg PO BID Range: 5 mg to 10 mg PO BID Apply a thin layer twice daily to affected areas of up to 20% body surface area Apply a thin layer twice daily to affected areas of up to 10% body surface area Ruxolitinib (Opzelura) AD NSV Maximum Dose 50 mg/day 50 mg/day 20 mg/day 20 mg/day 60 grams/week or 100 gm per 2 weeks VI. Product Availability
    Drug Name Ruxolitinib (Jakafi) Ruxolitinib (Opzelura) Availability Tablets: 5 mg, 10 mg, 15 mg, 20 mg, 25 mg Cream (tube of 60 grams, 100 grams): 1.5% VII.