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Duvelisib Dosage

Medically reviewed by Drugs.com. Last updated on Oct 5, 2020.

Applies to the following strengths: 15 mg; 25 mg

Usual Adult Dose for Chronic Lymphocytic Leukemia

25 mg orally 2 times a day in 28-day cycles until unacceptable toxicity or progressive disease

Comments:
-If a dose is missed by fewer than 6 hours, take the missed dose right away
and take the next dose as usual. If a dose is missed by more than 6 hours, wait
and take the next dose at the usual time.
-Provide prophylaxis for Pneumocystis jirovecii (PJP) during therapy with this drug.
-Withhold therapy in patients with suspected PJP of any Grade and discontinue if PJP is confirmed.
-Consider prophylactic antivirals during therapy to prevent cytomegalovirus
(CMV) infection/reactivation.

Uses: For the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) after at least 2 prior therapies

Renal Dose Adjustments

No adjustment recommended.

Liver Dose Adjustments

No adjustment recommended.

Dose Adjustments

DOSE MODIFICATION LEVELS:
-Initial dose: 25 mg orally 2 times a day
-Dose reduction: 15 mg orally 2 times a day
-Subsequent dose modification: Discontinue therapy if patient is unable to tolerate 15 mg orally 2 times a day.

Nonhematologic Adverse Reactions:
INFECTION:
-Grade 3 or greater infection: Withhold therapy until resolved; resume at the same or reduced dose.
-CMV infection or viremia (positive PCR or antigen test): Withhold therapy until resolved; resume at the same or reduced dose; if therapy is resumed, monitor for CMV reactivation (by PCR or antigen test) monthly.
-Pneumocystis jiroveci pneumonia (PJP): For suspected PJP, withhold therapy until evaluated; for confirmed PJP, discontinue therapy.
NON-INFECTIOUS DIARRHEA OR COLITIS:
-Mild/moderate diarrhea (Grade 1 or 2, up to 6 stools per day over baseline) and
responsive to antidiarrheal agents, OR asymptomatic (Grade 1) colitis: Maintain current dose; initiate antidiarrheals if needed; monitor weekly until resolved.
-Mild/moderate diarrhea (Grade 1 or 2, up to 6 stools per day over baseline) and
unresponsive to antidiarrheals: Withhold therapy until resolved; initiate enteric acting steroids (e.g., budesonide); monitor weekly until resolved; resume at reduced dose.
-Abdominal pain, stool with mucus or blood, change in bowel habits, peritoneal signs, OR severe diarrhea (Grade 3, greater than 6 stools per day over baseline): Withhold therapy until resolved; initiate enteric acting steroids (e.g., budesonide) or systemic steroids; monitor weekly until resolved; resume at reduced dose. For life-threatening recurrent Grade 3 diarrhea or recurrent colitis of any Grade, discontinue therapy.
CUTANEOUS REACTIONS:
-Grade 1 to 2: Maintain dose; initiate emollients, antihistamines, or topical steroids; monitor closely.
-Grade 3: Withhold therapy until resolved; initiate emollients, antihistamines, or topical steroids; monitor weekly until resolved; resume at reduced dose. If severe cutaneous reaction does not improve, worsens, recurs, or becomes life-threatening, discontinue therapy.
-SJS, TEN, DRESS (any Grade): Discontinue therapy.
PNEUMONITIS WITHOUT SUSPECTED INFECTIOUS CAUSE:
-Moderate (Grade 2) symptomatic pneumonitis: Withhold therapy; initiate systemic steroids; if pneumonitis recovers to Grade 0 or 1, resume therapy at reduced dose; if non-infectious pneumonitis recurs or patient does not respond to steroid therapy, discontinue this drug.
-Severe (Grade 3) or life-threatening pneumonitis: Discontinue therapy; initiate systemic steroids.
ALT/AST ELEVATION:
-Grade 2 (3 to 5 x upper limit of normal [ULN]): Maintain dose; monitor weekly until recovery to less than 3 x ULN.
-Grade 3 (greater than 5 to 20 x ULN: Withhold therapy and monitor weekly until recovery to less than 3 x ULN; resume at same dose (first occurrence) or reduce dose for subsequent occurrences.
-Grade 4 (greater than 20 x ULN: Discontinue therapy.

Hematologic Adverse Reactions:
NEUTROPENIA:
-Absolute neutrophil count (ANC) 0.5 to 1 Gi/L: Maintain dose; monitor ANC weekly.
-ANC less than 0.5 Gi/L: Withhold therapy; monitor ANC until greater than 0.5 Gi/L; resume at same dose (first occurrence) or reduce dose for subsequent occurrences.
THROMBOCYTOPENIA:
-Grade 3 (platelet count 25 to less than 50 Gi/L with Grade 1 bleeding: Maintain dose; monitor platelet counts weekly.
-Grade 3 (platelet count 25 to less than 50 Gi/L with Grade 2 bleeding or Grade 4 (platelet count less than 25 Gi/L): Withhold therapy; monitor platelet count until 25 Gi/L or greater and resolution of bleeding; resume at same dose (first occurrence) or reduce dose for subsequent occurrences.

Dose Modification for Concomitant Use with CYP450 3A4 Inhibitors:
-When given with strong CYP450 3A4 inhibitors (e.g., ketoconazole), reduce the dose of this drug to 15 mg orally 2 times a day.

Precautions

US BOXED WARNINGS:
SERIOUS AND/OR FATAL TOXICITIES:
Infections:
-Serious and/or fatal infections occurred in 31% of patients. Monitor for infection. Withhold therapy if infection is suspected.
Diarrhea/Colitis:
-Serious and/or fatal diarrhea or colitis occurred in 18% of patients. Monitor
for severe diarrhea or colitis and withhold therapy.
Cutaneous Reactions:
-Serious and/or fatal cutaneous reactions occurred in 5% of patients. Withhold therapy for these reactions.
Pneumonitis:
-Serious and/or fatal 5% of patients. Monitor for pulmonary symptoms and interstitial infiltrates. Withhold therapy for these reactions.

CONTRAINDICATIONS:
-None

This drug is not recommended for use in children.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:
-This drug may be taken with or without food.
-Capsules should be swallowed whole, not opened, broken, or chewed.

Storage requirements:
-Store at 20C to 25C (68F to 77F), with excursions permitted at 15C to 30C (59F to 86F).
-Retain in original package until dispensing.
-Dispense blister packs in original container.

Monitoring:
-Monitor hepatic function.
-Neutropenia: Monitor blood counts.

Patient advice:
-Read patient labeling for the initial prescription and for all refills.
-This drug can cause serious infections that may be fatal; immediately report symptoms of infection (e.g., fever, chills).
-This drug can cause serious diarrhea or colitis (inflammation of the gut) that may be fatal. Immediately report new or worsening diarrhea, stool with mucus or blood, or abdominal pain.
-This drug can cause a serious skin rash that may be fatal; immediately report new or worsening skin rash.
-This drug can cause pneumonitis (inflammation of the lungs) that may
be fatal; immediately report new or worsening respiratory symptoms such as cough or difficulty breathing.
-Immediately report jaundice (yellow eyes or skin), abdominal pain, bruising, bleeding, or fever.
-Do not become pregnant or breastfeed while taking this drug.
-Males with female partners of reproductive potential should use effective contraception during therapy and for at least one month after the last dose.

Frequently asked questions

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.