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Treatment Name: Duvelisib (Copiktra®)

Duvelisib (Copiktra®) is a Chemotherapy Regimen for Chronic Lymphocytic Leukemia (CLL)

How does duvelisib work?
Duvelisib is a chemotherapy drug that works by turning off a protein called PI3K (phosphatidylinositol 3-kinase), which stops cancerous B-lymphocytes from growing and dividing, plus kills the cancer cells.

Goals of therapy:
Duvelisib is taken to alleviate symptoms of CLL such as enlarged lymph nodes, enlarged liver or spleen, or symptoms of abnormal bone marrow function, such as frequent infection. It is not commonly given with the goal of cure.

Schedule

  • Usual starting dose: one 25 mg oral capsule by mouth twice daily with or without food

Duvelisib is prescribed by a cancer doctor and usually taken at home until the drug no longer works or until unacceptable side effects occur.

Note: Individual doses may vary based upon your Doctor's recommendation, or drug availability.

Side Effects

In clinical studies, the most commonly reported duvelisib side effects (all grades) are shown here.

  • Diarrhea (51%)
  • Neutropenia [Low white blood cells] (33%)
  • Fever (29%)
  • Nausea (23%)
  • Anemia [low red blood cells] (23%)
  • Cough (21%)
  • Pneumonia (18%)
  • Constipation (17%)
  • Sinus infection (16%)
  • Vomiting (15%)
  • Thrombocytopenia [low platelets] (15%)
  • Bronchitis (13%)
  • Inflammation of the colon (13%)
  • Fatigue (13%)
  • Decreased appetite (13%)
  • Weight loss (11%)
  • Weakness (11%)
  • Stomach pain (10%)
  • Shortness of breath (10%)
  • Rash (10%)
  • Liver injury (3%)

On average, 35% of patients discontinue duvelisib treatment due to unacceptable side effects.

Side effect videos Side Effect Videos
DiarrheaDiarrheaNausea and VomitingNausea and VomitingAnemiaAnemiaConstipationConstipationFatigue Fatigue PainPain

Monitoring

How often is monitoring needed?
Labs (blood tests) may be checked before treatment, every 1 to 2 weeks during the first two months of treatment, then periodically thereafter as directed by your doctor. Labs often include: Complete Blood Count (CBC), Comprehensive Metabolic Panel (CMP), plus any others your doctor may order.

How often is imaging needed?
Imaging may be checked if there are concerns for infection or other side effects. Imaging may include: X-rays, magnetic resonance imaging (MRI), or computerized tomography (CT) scans.

How might blood test results/imaging affect treatment?
Depending upon the results, your doctor may advise to continue duvelisib treatment as planned, reduce the duvelisib dose, delay treatment until the duvelisib side effect goes away, or switch to an alternative therapy.

ChemoExperts Tips

  • Severe diarrhea can occur and may not respond to conventional anti-diarrheal medications such as loperamide (Imodium®). If you are experiencing diarrhea that does not respond to anti-diarrheal treatment, contact your doctor as uncontrolled diarrhea can lead to dehydration and significant blood electrolyte abnormalities
  • Although rare, serious lung injuries can occur. Report and new or increasing shortness of breath, cough, wheezing, or chest pain to your doctor as these could be signs of lung injury and may need treatment with corticosteroids such as prednisone or methylprednisolone (Solu-Medrol®)
  • A very rare fungal infection known as pneumocystis jirovecii (PJP) in the lungs have been reported. Medications such as sulfamethoxazole/trimethoprim (Bactrim®) may be used while on duvelisib to prevent this type of infection. 75% of infections occurred within the first six months of beginning treatment
  • A pharmacist should ALWAYS review your medication list to ensure that drug interactions are prevented or managed appropriately
  • Clinical trials may exist for CLL Ask your doctor if any studies are currently enrolling in your area. If not, go to clinicaltrials.gov to search for other centers offering study medications

Patient Assistance & Co-payment Coverage

Patients under the age of 65 years, or those with private insurance plans:
If you have insurance and are looking for patient assistance or copay assistance for Duvelisib (Copiktra®), we have provided links that may help.

Visit our Patient Assistance page and click the links to various patient assistance programs for help paying for Duvelisib (Copiktra®). Depending upon your income, they may be able to help cover the cost of:

  • Duvelisib

For Branded medications (may be available for generic medications too), check with the manufacturer to determine if a co-pay card is offered and if it could reduce your monthly copay.

  • If you are uninsured, check with the manufacturer to determine if you are eligible to receive medication at no cost.

Medicare and Medicaid patients (Patients 65 years or older):
The clinic providing treatment will likely pre-authorize medications and immune therapies such as Duvelisib (Copiktra®) and are the best source to help you understand drug cost.

  • Ask to speak with a patient assistance technician or financial counselor at the clinic or hospital administering this therapy.

Emotional Wellness

What is Emotional Wellness?
Emotional wellness is having a positive outlook balanced with a realistic understanding of current life events. This requires both an awareness and acceptance of your emotions. It is with this knowledge that you can develop a plan to take the necessary actions to positively impact your life.

Emotional wellness uses an ongoing process to continually reflect on the stressors of life in a constructive manner to move forward and create happiness.

Because emotional wellness is deeply connected with physical, social, and spiritual wellness, pursuing it often becomes particularly difficult in times of major illness. Despite this difficulty, working toward emotional wellness has been connected to improved treatment outcomes and a higher likelihood of achieving goals of therapy.

Learn more about pursuing emotional wellness while receiving treatment with Duvelisib (Copiktra®)

Individual Drug Label Information

Duvelisib ( Copiktra®)

  • ​Is an oral capsule available in 25 mg and 15 mg strengths
  • May be taken with or without food. Swallow whole and do not open, break, or chew capsule
  • If you miss a dose, take the missed dose if it has been less than six hours from the time when it was due. If it has been more than 6 hours, skip the missed dose and take the next dose at the regular scheduled time
  • Should be stored at 20° to 25°C (68° to 77°F) 
  • Dosage adjustments may be required for serious side effects or drug interactions
  • May interact with certain antifungal and seizure medications. Ask your doctor or pharmacist to review your medications for any possible interactions as you may need duvelisib dose adjustments
  • May interact with grapefruit and grapefruit juice, pomegranate, star fruit, or seville oranges (in marmalade) causing increased blood levels of duvelisib. This could increase your risk of duvelisib side effects. Avoid eating or drinking these foods during treatment
  • May cause fetal harm if taken while pregnant. Males and women of childbearing age should use effective contraception during treatment and for at least 1 month after the last dose. Women should not breastfeed while taking duvelisib and for at least 1 month after the last dose
General side effects from duvelisib
  • Diarrhea
  • Low white blood cells, red blood cells, and platelets
  • Infection
  • Liver injury
  • Lung injury
  • Fever
  • Cough 
  • Pneumonia
  • Sinus infection
  • Nausea and vomiting
  • Inflammation of the colon
  • Click on the duvelisib (Copiktra®) package insert link below for reported side effects, possible drug interactions, and other duvelisib prescribing information

Side Effect Videos
Nausea and VomitingNausea and VomitingDiarrheaDiarrheaFatigue Fatigue ConstipationConstipationPainPainAnemiaAnemia

See DailyMed package insert.

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References

Flinn IW, Hillmen P, Montillo M, et al. The phase 3 DUO trial: duvelisib versus ofatumumab in relapsed and refractory CLL/SLL. Blood.2018 Oct 4. [Epub ahead of print]

Created: November 7, 2018 Updated: November 7, 2018

What is Chronic Lymphocytic Leukemia (CLL)?

Chronic Lymphocytic Leukemia (CLL) is the most common type of leukemia diagnosed in adults. It is a cancer of the B-lymphocyte. In rare cases, CLL may be hereditary, but most causes are unknown. The stage of CLL can vary at diagnosis and throughout treatment. Stages of CLL include Rai stage 0, I, II, III, or IV. Many therapies are not curative, however, newer therapies are able to suppress the cancer for many months or even years.

Medications for CLL may include intravenous infusions, oral tablets or capsules, or a combination of IV and oral medications. Patients may be diagnosed with CLL without having any symptoms. Others may go to their doctor with symptoms of fatigue, a large spleen, or decreased appetite. The effectiveness of the treatment may depend upon the stage at diagnosis.

NOTE: Treatment Options listed below are not all-inclusive. Other treatments may be available. ChemoExperts provides drug information and does not recommend any one treatment over another. Only your Doctor can choose which therapy is appropriate for you.

What does Cure mean?

The word “cure” means there are no cancer cells left in the body and cancer will never come back. Depending on the cancer type and stage, this may be the true goal of therapy. However, it is very difficult to prove all cancer cells are gone. Even though images, like X-rays and MRI’s, and blood tests may not show any signs of cancer, there can be a small amount of cancer cells still left in the body. Because of this, the word “remission” is used more often. This means there are no signs or symptoms of cancer. Patients in remission are followed closely for any signs of cancer returning. Sometimes, more chemotherapy may be given while in remission to prevent the cancer from coming back.

Doctors usually do not consider a patient “cured” until the chance of cancer returning is extremely low. If cancer does return, it usually happens within 5 years of having a remission. Because of this, doctors do not consider a patient cured unless the cancer has not come back within 5 years of remission. The five-year cutoff does not apply to all cancers.

What is a CBC?

A Complete Blood Count (CBC) is a frequently ordered blood test that tells clinicians the status of your: 1) White blood cell count, 2) Hemoglobin, and 3) Platelet count at the time the test was taken.

Common uses:
1) White blood cell count (WBC): is used to determine infection risk, or response to chemotherapy. Certain chemotherapy agents may harm our good infection-fighting cells. Sometimes chemotherapy may need to be delayed to allow these cells to recover.

2) Hemoglobin: is used to determine if someone is anemic. Anytime the hemoglobin is below 12 g/dL, the person is said to be anemic. Red blood cell transfusions, and sometimes iron can be given to restore the hemoglobin level, but anemia treatment should always aim at treating the underlying cause or condition.

3) Platelet count: is used to determine if the risk of bleeding is increased or if a platelet transfusion is required to prevent bleeding. Certain medications that increase bleeding risk, such as: aspirin, certain chemotherapy agents, and blood thinners, may need to be stopped temporarily until the platelet count is within a safe range.

What is a CMP?

A Comprehensive Metabolic Panel (CMP) is a frequently ordered blood test that tells clinicians the status of your: 1) Electrolytes & Acid/Base status2) Kidney function, 3) Liver function, 4) Blood sugar, and 5) Calcium at the time the test was taken. It is commonly used to monitor liver and kidney function when beginning new medications such as chemotherapy. A total of 14 tests are run simultaneously and are shown below.

Electrolytes & Acid/Base status:
1) Sodium, 2) Potassium, 3) Carbon dioxide, 4) Chloride

Kidney Function:
5) BUN (blood urea nitrogen), 6) Serum creatinine (Scr)

Liver Function:
7) AST, 8) ALT, 9) Total bilirubin, 10) Alk Phos, 11) Albumin, 12) Total protein

Blood sugar:
13) Serum glucose

Calcium:
14) Serum calcium