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Umbralisib Dosage

Applies to the following strengths: 200 mg

Usual Adult Dose for Lymphoma

800 mg orally once a day

Comments:
-Patients should be provided with prophylaxis for Pneumocystis jirovecii pneumonia (PJP) during treatment.
-Consideration should be given to provide prophylactic antivirals during treatment with to prevent cytomegalovirus (CMV) infection, including CMV reactivation.
-Treatment should be continued until disease progression or unacceptable toxicity.

Uses:
-For the treatment of adult patients with relapsed or refractory marginal zone lymphoma (MZL) who have received at least one prior anti-CD20-based regimen
-For the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) who have received at least three prior lines of systemic therapy

Usual Adult Dose for Follicular Lymphoma

800 mg orally once a day

Comments:
-Patients should be provided with prophylaxis for Pneumocystis jirovecii pneumonia (PJP) during treatment.
-Consideration should be given to provide prophylactic antivirals during treatment with to prevent cytomegalovirus (CMV) infection, including CMV reactivation.
-Treatment should be continued until disease progression or unacceptable toxicity.

Uses:
-For the treatment of adult patients with relapsed or refractory marginal zone lymphoma (MZL) who have received at least one prior anti-CD20-based regimen
-For the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) who have received at least three prior lines of systemic therapy

Renal Dose Adjustments

Mild or moderate renal dysfunction (CrCl 30 to 89 mL/min): No adjustment recommended.
Severe renal dysfunction (CrCl less than 30 mL/min): Data not available

Liver Dose Adjustments

Mild liver dysfunction (total bilirubin up to the upper limit of normal [ULN] and AST greater than ULN or total bilirubin greater than 1 to 1.5 × ULN and any AST): No adjustment recommended.
Moderate (total bilirubin greater than 3 × ULN and any AST) or severe (total bilirubin greater than 1.5 to 3 × ULN and any AST) liver dysfunction: Data not available

Dose Adjustments

RECOMMENDED DOSE REDUCTION FOR ADVERSE REACTIONS:

-First Reduction: 600 mg orally once a day
-Second Reduction: 400 mg orally once a day
-Subsequent Reductions: Permanently discontinue treatment in patients unable to tolerate the dose of 400 mg once a day.

DOSE MODIFICATIONS FOR ADVERSE REACTIONS
HEMATOLOGIC ADVERSE REACTIONS:
Neutropenia:
-If ANC 0.5 to 1 x 10(9)/L: Maintain initial dose
-If ANC 0.5 to 1 x 10(9)/L returns or persistent: Withhold treatment until ANC 1 x 10(9)/L or greater and resume at same dose.
-If ANC is less than 0.5 x 10(9)/L: Withhold treatment until ANC is 0.5 x 10(9)/L or greater and resume at same dose and if recurrence, resume at reduced dose.
Thrombocytopenia:
-If platelet count less than 25 x 10(9)/L or 25 to less than 50 x 10(9)/L with bleeding: Withhold treatment until platelet count 25 x 10(9)/L or greater and bleeding has resolved, then resume at same dose. If recurrence, withhold until resolution and then resume at a reduced dose.

NONHEMATOLOGIC ADVERSE REACTIONS:
-If Grade 3 or 4 infections: Withhold treatment until resolved and resume at same or reduced dose.
-if suspected Pneumocystis jirovecii pneumonia (PJP): Withhold treatment until evaluation and discontinue treatment if confirmed PJP.
-For cytomegalovirus (CMV) infection or viremia: Withhold treatment until resolution and resume at same or reduced dose.
-If aspartate aminotransferase (AST) or alanine aminotransferase (ALT) are greater than 5 to less than 20 times upper limit of normal (ULN): Withhold treatment until return to less than 3 times UNL and resume at a reduced dose.
-If AST or ALT greater than 20 times ULN: Discontinue treatment.
-If persistent mild or moderate diarrhea (up to 6 stools per day over baseline) or asymptomatic (Grade 1) colitis: Withhold treatment until resolved and resume at same or reduced dose.
-If recurrent mild or moderate diarrhea (up to 6 stools per day over baseline) or asymptomatic (Grade 1) colitis: Withhold until resolution and resume at reduced dose.
-If severe diarrhea (greater than 6 stools per day over baseline) or abdominal pain, stool with mucus or blood, change in bowel habits, or peritoneal signs: Withhold treatment until resolved and resume at reduced dose.
-For recurrent severe diarrhea, recurrent colitis of any grade or for life threatening diarrhea or non-infectious colitis: Discontinue treatment.
-For severe cutaneous reactions: Withhold until resolution and resume at reduced dose or discontinue treatment. Discontinue treatment if recurrence after re-challenge.
-If life threatening severe cutaneous reactions or Stevens-Johnson syndrome, toxic epidermal necrolysis, or drug reaction with eosinophilia and systemic symptoms of any Grade: Discontinue treatment.
-For any other severe adverse reaction: Withhold treatment until resolution and resume at same or reduced dose.
-For any other life-threatening adverse reaction: Discontinue treatment.

Precautions

CONTRAINDICATIONS: None

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration Advice:
-This drug should be taken with food at the same approximate time each day.
-Swallow tablets whole; do not chew, crush, cut or break tablets
-If you missed a dose, take the dose as soon as possible. If it has been more than 12 hours, skip the missed dose and resume with the next scheduled dose.
-If vomit occurs, take the next dose at the next scheduled time.

Storage Requirements:
-Store at 68F to 77F (20C to 25C)
-Excursion permitted to 59F to 86F (15C to 30C)

Monitoring:
-Infections: Monitor for any new or worsening signs and symptoms of infection.
Hematologic: Monitor neutrophil counts at least every 2 weeks for the first months and at least weekly in patients with readings counts below 1 x 10(9)/L (Grade 3 to 4).
Hepatic: Monitor hepatic function at baseline and during treatment.
Dermatologic: Monitor patients for new or worsening cutaneous reactions.

Patient Advice:
-Read the US FDA-approved patient labeling (Patient Information).
-Take this drug once a day with food.
-Advise patients that this drug contains FD&C Yellow No. 5 (tartrazine), which may cause allergic-type reactions in certain susceptible persons.
-Advise males and females of reproductive potential of the potential risk to a fetus and to use effective contraception during treatment and for one month after the last dose.
-Advise females patients not to breastfeed during and for one month after the last dose.
-Advise males of reproductive potential that this drug may impair fertility.
-Advise patients to report any symptoms suggestive of liver dysfunction, including jaundice (yellow eyes or yellow skin), abdominal pain, bruising, or bleeding and to undergo liver function tests to monitor for liver function.
-Advise patients to immediately report any signs and symptoms of infection and to undergo periodic blood count test.
-Advise patients of the possibility of experiencing loose stools, diarrhea or colitis and to report any new or worsening symptoms of diarrhea or abdominal pain/distress.
-Advise patients to immediately report any new or worsening skin rash and to report any history of allergic reactions to any medicine or food color dyes.

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