Leukemias, lymphomas, and other hematologic cancers:

Indications for UKONIQ:

Relapsed or refractory marginal zone lymphoma (MZL) in patients who have received at least 1 prior anti-CD20-based regimen. Relapsed or refractory follicular lymphoma (FL) in patients who have received at least 3 prior lines of systemic therapy.

Adult Dosage:

Swallow whole. Take with food at the same time each day. 800mg once daily until disease progression or unacceptable toxicity. Give prophylaxis for PJP and consider antivirals for CMV during treatment. Dose modifications for adverse reactions: see full labeling.

Children Dosage:

Not established.

UKONIQ Warnings/Precautions:

Monitor for infection; if Grade 3 or 4 occurs, withhold until resolved; resume at same or a reduced dose. Provide Pneumocystis jirovecii pneumonia (PJP) prophylaxis during therapy; withhold if PJP is suspected; permanently discontinue if PJP is confirmed. History of cytomegalovirus (CMV); monitor during therapy. Consider antiviral prophylaxis to prevent CMV infection or reactivation; withhold if infection or viremia occurs until resolves. Monitor neutrophil counts at least every 2 weeks for the first 2 months, and at least weekly if ANC <1×109/L (Grade 3–4). Monitor for diarrhea or non-infectious colitis; discontinue if life-threatening diarrhea/colitis, recurrent Grade 3 diarrhea, or recurrent colitis of any grade occurs. Monitor liver function at baseline and during therapy; if ALT/AST >5–<20×ULN, withhold until return to <3×ULN and resume at a reduced dose; discontinue if ALT/AST >20×ULN. Monitor for cutaneous reactions; withhold if severe (Grade 3) and monitor at least weekly until resolved; resume at reduced dose. Discontinue if severe cutaneous reaction does not improve, worsens or recurs; or for life-threatening reactions, SJS, TEN, or DRESS of any grade. Asthma. Aspirin hypersensitivity. Severe renal impairment (CrCl <30mL/min). Moderate (total bilirubin >1.5–3×ULN and any AST) or severe hepatic impairment (total bilirubin >3×ULN and any AST). Elderly. Embryo-fetal toxicity. Advise females of reproductive potential and males (w. female partners) to use effective contraception during and for 1 month after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 1 month after the last dose).

UKONIQ Classification:

Kinase inhibitor.

Adverse Reactions:

Diarrhea/colitis, fatigue, nausea, musculoskeletal pain, neutropenia, anemia, thrombocytopenia, upper RTI, vomiting, abdominal pain, decreased appetite, rash, lab abnormalities (increased creatinine, transaminase elevation); hepatotoxicity.

Generic Drug Availability:

NO

How Supplied:

Tabs—120

Pricing for UKONIQ

200mg tablet (Qty: 30)
Appx. price $4064
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