Drug information of Duvelisib

Duvelisib


Duvelisib is used to treat adults with chronic lymphocytic leukemia or small lymphocytic leukemia. Duvelisib is also used to treat follicular lymphoma.

Duvelisib is given after at least two other cancer treatments did not work or have stopped working.

Duvelisib can cause serious or fatal side effects, including serious infections, severe diarrhea, or a life-threatening skin rash.

Mechanism of effect

Duvelisib is an oral PI3K inhibitor with dual inhibitory activity primarily against PI3K-δ and PI3K-γ which are expressed in hematologic malignancies. Inhibition of PI3K-δ reduced tumor cell proliferation while allowing survival of normal cells. Inhibition of PI3K-γ reduces differentiation and migration of tumor microenvironment support cells (Flinn 2018). Duvelisib resulted in reduced viability of cell lines derived from malignant B-cells and CLL cells. Additionally, duvelisib inhibits B-cell receptor signaling pathways and CXCR12-mediated chemotaxis of malignant B-cells as well as CXCL12-induced T cell migration and M-CSF and IL-4 driven M2 macrophage polarization.

Pharmacokinetics

Distribution:

Vd: 28.5 L

Metabolism:

Hepatic; primarily via CYP3A4

Excretion:

Feces: 79% (11% as unchanged drug); urine: 14% (<1% as unchanged drug)

Time to Peak:

1 to 2 hours

Half-Life Elimination:

4.7 hours

Protein Binding:

>98%

Drug indications

Use: Labeled Indications

Chronic lymphocytic leukemia/small lymphocytic lymphoma, relapsed or refractory: Treatment of relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) in adult patients after at least 2 prior therapies.

Follicular lymphoma, relapsed or refractory: Treatment of relapsed or refractory follicular lymphoma (FL) in adult patients after at least 2 prior systemic therapies.

Dosage

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

Drug contraindications

 

Side effects

More common

  • Black, tarry stools
  • bleeding gums
  • blistering, peeling, or loosening of the skin
  • blood in the urine or stools
  • body aches or pain
  • chest pain
  • chills
  • cough
  • cracked lips
  • decreased urine
  • difficulty in swallowing
  • dry mouth
  • ear congestion
  • fever
  • headache
  • increased thirst
  • irregular heartbeat
  • itching
  • joint or muscle pain
  • loss of appetite
  • loss of voice
  • lower back or side pain
  • mood changes
  • muscle pain or cramps
  • nasal congestion
  • nausea
  • numbness or tingling in the hands, feet, or lips
  • painful or difficult urination
  • pale skin
  • pinpoint red spots on the skin
  • red skin lesions, often with a purple center
  • red, irritated eyes
  • runny nose
  • seizures
  • sneezing
  • sore throat
  • sores, ulcers, or white spots on the lips, tongue, or inside the mouth
  • stomach cramps or pain
  • swelling
  • tenderness
  • tightness in the chest
  • troubled breathing
  • troubled breathing with exertion
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • watery or bloody diarrhea

Some side effects of duvelisib may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

  • Bone pain
  • constipation
  • decreased appetite
  • difficulty in moving
  • muscle stiffness
  • vomiting

smallpox vaccine 

Alerts

Duvelisib can cause serious or fatal side effects, including serious infections, severe diarrhea, or a life-threatening skin rash.

Call your doctor right away if you have symptoms such as:

fever, chills, cough, breathing problems;

severe stomach pain, diarrhea with blood or mucus

painful mouth sores, or a skin rash with blistering or peeling.

Before taking this medicine:

Tell your doctor if you have ever had:

an intestinal disorder such as ulcerative colitis;

lung disease; or

liver disease.

Both men and women using duvelisib should use effective birth control to prevent pregnancy. Duvelisib can harm an unborn baby or cause birth defects if the mother or father is using this medicine.

Keep using birth control for at least 1 month after your last dose. Tell your doctor right away if a pregnancy occurs while either the mother or the father is using duvelisib.

It is not safe to breast-feed a baby while you are using this medicine. Also do not breast-feed for at least 1 month after your last dose.

 

Points of recommendation

You may take duvelisib with or without food.

Duvelisib can cause severe diarrhea, which can be life-threatening. You may need to take medication to prevent or quickly treat diarrhea.

You may be given other medications to help prevent serious side effects. Keep using these medicines for as long as your doctor has prescribed.

Your doctor will need to check your progress on a regular basis, and you will need frequent medical tests. Your cancer treatments may be delayed based on the results.

Call your doctor right away if you have symptoms such as:

  • fever, chills, cough, breathing problems;
  • severe stomach pain, diarrhea with blood or mucus; o
  • painful mouth sores, or a skin rash with blistering or peeling.
Before taking this medicine

Tell your doctor if you have ever had:

  • an intestinal disorder such as ulcerative colitis;
  • lung disease; or
  • liver disease.

Both men and women using duvelisib should use effective birth control to prevent pregnancy. Duvelisib can harm an unborn baby or cause birth defects if the mother or father is using this medicine.

Keep using birth control for at least 1 month after your last dose. Tell your doctor right away if a pregnancy occurs while either the mother or the father is using duvelisib.

It is not safe to breast-feed a baby while you are using this medicine. Also do not breast-feed for at least 1 month after your last dose.

Along with its needed effects, duvelisib may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Storage:

Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). Store in original package until dispensing. Dispense blister packs in original container.

Pregnancy level

HAVE NOT BEEN ESTABLISHED

US FDA pregnancy category :Not Assigned

Comments:
-If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential harm to the fetus.
-Verify negative pregnancy status in females of reproductive potential prior to initiating therapy.
-Advise females of reproductive potential and males with female partners of reproductive potential to use effective contraception during therapy and for at least one month after the last dose
.

Breast feeding warning

Use is not recommended.
Excreted into human milk: Unknown
Excreted into animal milk: Data not available
Comments:
-This drug may harm a nursing child.
-Women should not breastfeed while taking this drug and for at least one month after.

Drug forms

Copiktra

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