Ruxolitinib: Brands, Price & Uses in Bangladesh

Ruxolitinib is an oral Janus kinase (JAK1/JAK2) inhibitor used in adults (and, for certain indications, adolescents) for the following conditions:

• Established, FDA-approved use: Treatment of intermediate or high-risk myelofibrosis (including primary myelofibrosis, post-polycythemia vera myelofibrosis, and post-essential thrombocythemia myelofibrosis) in adults.
• Established, FDA-approved use: Treatment of polycythemia vera in adults who have had an inadequate response to, or are intolerant of, hydroxyurea.
• Established, FDA-approved use: Treatment of steroid-refractory acute graft-versus-host disease (GVHD) in adult and pediatric patients 12 years of age and older.
• Established, FDA-approved use: Treatment of chronic graft-versus-host disease after failure of one or two prior lines of systemic therapy, in adult and pediatric patients 12 years of age and older.

A separate topical cream formulation of Ruxolitinib is approved in some markets for mild-to-moderate atopic dermatitis and for nonsegmental vitiligo in non-immunocompromised patients 12 years and older; this oral-formulation information does not apply to the topical product, which has its own distinct dosing and safety profile.

Ruxolitinib is a specialist hematology-oncology medicine (or, for GVHD, transplant-medicine specialty product) and must only be prescribed and monitored by, or in close consultation with, a qualified specialist.

Standard Adult Dosing by Indication

Dose Modification

The dose of Ruxolitinib is individualized and adjusted by the treating specialist based on platelet counts, absolute neutrophil count, response, and tolerability. Dose interruption or reduction is commonly required for thrombocytopenia, neutropenia, or other significant toxicity; see Precautions and Side Effects.

Renal Impairment

Dose reduction is required for moderate to severe renal impairment (based on indication and platelet count, per specialist dosing tables). In end-stage renal disease requiring hemodialysis, a single adjusted dose is given after each dialysis session only, on dialysis days.

Hepatic Impairment

Dose reduction (generally by about half of the otherwise indicated starting dose) is required for any degree of hepatic impairment, with dosing individualized further based on platelet count and response.

Concomitant Strong CYP3A4 Inhibitors or Fluconazole

The dose of Ruxolitinib should be reduced when co-administered with strong CYP3A4 inhibitors or with fluconazole at doses of 200 mg/day or less; concomitant use with fluconazole doses above 200 mg/day should be avoided (see Interactions).

Missed Dose

If a dose is missed, the next dose should be taken at the regular scheduled time; do not double the dose to make up for a missed one.

Discontinuation

Ruxolitinib should not be stopped abruptly, particularly in myelofibrosis and polycythemia vera, as this can cause a withdrawal-like flare of symptoms (return of splenomegaly, worsening constitutional symptoms, and rarely an acute febrile illness resembling cytokine release). If discontinuation is needed, the treating physician will generally taper the dose gradually.

Very Common

• Thrombocytopenia (low platelet count) and anemia — the most frequent significant laboratory abnormalities; see Precautions for monitoring requirements
• Neutropenia (low neutrophil count)
• Bruising and increased risk of bleeding
• Dizziness and headache
• Diarrhea and nausea
• Elevated liver enzymes and blood lipids (cholesterol/triglycerides)
• Urinary tract infections and other infections
• Edema and weight gain

Less Common but Serious

• Serious infections — bacterial, mycobacterial (including reactivation of latent tuberculosis), fungal, and viral (including reactivation of herpes zoster/shingles); rare cases of progressive multifocal leukoencephalopathy (PML) have been reported
• Increased mortality and major adverse cardiovascular events (MACE) — observed with the JAK-inhibitor drug class in a large trial of another JAK inhibitor in rheumatoid arthritis; this risk is reflected in the class-wide boxed warning
• Thrombosis (deep vein thrombosis, pulmonary embolism, arterial thrombosis)
• Secondary malignancies, including non-melanoma skin cancer and lymphoma
• Withdrawal/discontinuation symptom flare in myeloproliferative disease (see Dosage and Administration)
• Rarely, tumor lysis syndrome

Patients should report any fever, signs of infection, unusual bruising or bleeding, new skin lesions, leg swelling/pain, chest pain, or shortness of breath to their treating physician promptly while taking Ruxolitinib.