Ukoniq

Last updated on RxList: 7/22/2021
Ukoniq Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Ukoniq?

Ukoniq (umbralisib) is a kinase inhibitor indicated 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 and relapsed or refractory follicular lymphoma (FL) who have received at least three prior lines of systemic therapy.

What Are Side Effects of Ukoniq?

Side effects of Ukoniq include:

Dosage for Ukoniq

The recommended dosage of Ukoniq is 800 mg orally once daily with food.

Ukoniq In Children

Safety and effectiveness of Ukoniq have not been established in pediatric patients.

What Drugs, Substances, or Supplements Interact with Ukoniq?

Ukoniq may interact with other medicines.

Tell your doctor all medications and supplements you use.

Ukoniq During Pregnancy and Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant before using Ukoniq; it may harm a fetus. The pregnancy status in females of reproductive potential should be verified prior to starting Ukoniq. Females of reproductive potential and male patients with female partners of reproductive potential are advised to use effective contraception during Ukoniq treatment and for one month after the final dose. It is unknown if Ukoniq passes into breast milk. Breastfeeding is not recommended while using Ukoniq and for one month after the final dose.

Additional Information

Our Ukoniq (umbralisib) Tablets, for Oral Use Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

SLIDESHOW

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Ukoniq Consumer Information

Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Seek medical treatment if you have a serious drug reaction that can affect many parts of your body. Symptoms may include: skin rash, fever, swollen glands, muscle aches, severe weakness, unusual bruising, or yellowing of your skin or eyes.

Call your doctor at once if you have:

  • a severe skin rash, or sores on your skin or mouth;
  • severe or ongoing diarrhea, stools with mucus or blood, or severe stomach pain;
  • liver problems--stomach pain (upper right side), tiredness, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or
  • low blood cell counts--fever, chills, tiredness, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath.

Common side effects may include:

  • low blood cell counts;
  • nausea, vomiting, stomach pain, loss of appetite;
  • cold symptoms such as stuffy nose, sneezing, sore throat;
  • muscle or bone pain;
  • feeling tired; or
  • abnormal kidney function tests.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Ukoniq (Umbralisib Tablets)

Ukoniq Professional Information

SIDE EFFECTS

The following clinically significant adverse reactions are described elsewhere in the labeling:

  • Infections [see WARNINGS AND PRECAUTIONS]
  • Neutropenia [see WARNINGS AND PRECAUTIONS]
  • Diarrhea and Non-infectious Colitis [see WARNINGS AND PRECAUTIONS]
  • Hepatotoxicity [see WARNINGS AND PRECAUTIONS]
  • Severe Cutaneous Reactions [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be compared to rates in the clinical trials of another drug and may not reflect the rates observed in the general patient population.

The pooled safety population described in WARNINGS AND PRECAUTIONS reflects exposure to UKONIQ as monotherapy at a dosage of 800 mg orally once daily in 335 adults with hematologic malignancies in studies TGR-1202-101, TGR-1202-202, UTX-TGR-205, and UTXTGR- 501. Among these 335 patients who received UKONIQ, 52% were exposed for 6 months or longer and 30% were exposed for greater than one year.

Relapsed Or Refractory Follicular Lymphoma And Marginal Zone Lymphoma

The safety of UKONIQ was evaluated in a pooled safety population that included 221 adults with marginal zone lymphoma (37%) and follicular lymphoma (63%) enrolled in three singlearm, open-label trials (Study TGR-1202-101, TGR-1202-202, and UTX-TGR-205) and one open-label extension trial (Study UTX-TGR-501) [see Clinical Studies]. These trials required hepatic transaminases ≤ 2.5 times upper limit of normal (ULN), total bilirubin ≤ 1.5 times ULN, and creatinine clearance ≥ 30 mL/min. No patients had prior exposure to a PI3K inhibitor. Patients received UKONIQ 800 mg orally once daily. Among these 221 patients who received UKONIQ, 60% were exposed for 6 months or longer and 34% were exposed for greater than one year.

The median age was 66 years (range: 29 to 88 years), 43% were female, and 97% had an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. Race was reported in 92% of patients; of these patients, 89% were White, 6% were Black, and 3% were Asian. Patients had a median of 2 prior therapies (range 1 to 10).

Serious adverse reactions occurred in 18% of patients who received UKONIQ. Serious adverse reactions that occurred in ≥2% of patients were diarrhea-colitis (4%), pneumonia (3%), sepsis (2%), and urinary tract infection (2%). Fatal adverse reactions occurred in <1% of patients who received UKONIQ, including exfoliative dermatitis.

Permanent discontinuation of UKONIQ due to an adverse reaction occurred in 14% of patients. Adverse reactions which resulted in permanent discontinuation of UKONIQ in ≥5% of patients included diarrhea-colitis (6%) and transaminase elevation (5%).

Dose reductions of UKONIQ due to an adverse reaction occurred in 11% of patients. Adverse reactions which required dose reductions in ≥4% of patients included diarrhea-colitis (4%).

Dosage interruptions of UKONIQ due to an adverse reaction occurred in 43% of patients. Adverse reactions which required dosage interruption in ≥5% of patients included diarrheacolitis (18%), transaminase elevation (7%), neutropenia (5%), vomiting (5%), and upper respiratory tract infection (5%).

The most common (≥15%) adverse reactions, including laboratory abnormalities, were increased creatinine, diarrhea-colitis, fatigue, nausea, neutropenia, transaminase elevation, musculoskeletal pain, anemia, thrombocytopenia, upper respiratory tract infection, vomiting, abdominal pain, decreased appetite, and rash.

Table 3 provides the adverse reactions in the pooled safety population of 221 patients with marginal zone lymphoma and follicular lymphoma who received the recommended dosage.

Table 3: Adverse Reactions Reported (≥10%) in Patients With Marginal Zone Lymphoma and Follicular Lymphoma Who Received UKONIQ in Pooled Safety Population

Adverse ReactionsUKONIQ
N=221
All Grades
(%)
Grade 3 or 4
(%)
Gastrointestinal Disorders
Diarrhea5810
Nausea38<1
Vomiting21<1
Abdominal paina193
General Disorders and Administration Site Conditions
Fatigueb413
Edemac14<1
Pyrexia100
Musculoskeletal and Connective Tissue Disorders
Musculoskeletal paind272
Infections
Upper respiratory tract infectione21<1
Metabolism and Nutrition Disorders
Decreased appetite192
Skin and Subcutaneous Tissue Disorders
Rashf183
Psychiatric Disorders
Insomnia14<1
aAbdominal pain includes Abdominal pain, abdominal pain upper, abdominal pain lower, abdominal discomfort
bFatigue includes Fatigue, asthenia, lethargy
cEdema includes Edema peripheral, face edema, pulmonary edema, fluid overload, generalized edema
dMusculoskeletal pain includes Back pain, myalgia, pain in extremity, musculoskeletal pain, neck pain, spinal pain, musculoskeletal chest pain, musculoskeletal discomfort
eUpper respiratory tract infection includes Upper respiratory tract infection, sinusitis, nasopharyngitis, rhinitis
fRash includes Rash, rash maculo-papular, rash erythematous, rash pruritic, rash macular, exfoliative dermatitis

Clinically relevant adverse reactions in <10% of patients who received UKONIQ included urinary tract infection (9%), dyspnea (7%), pneumonia (6%), sepsis (3%), colitis (2%), pneumonitis (<1%), and exfoliative dermatitis (<1%).

Table 4 provides the laboratory abnormalities in the pooled safety population of 221 patients with marginal zone lymphoma and follicular lymphoma who received the recommended dosage.

Table 4: Select Laboratory Abnormalities (≥20%) That Worsened from Baseline in Patients with Marginal Zone Lymphoma and Follicular Lymphoma Who Received UKONIQ in Pooled Safety Population

Laboratory ParameterUKONIQ
N=221
All Gradesa
(%)
Grade 3 or 4
(%)
Hematologic
  Neutrophil decreased3316
  Hemoglobin decreased273
  Platelets decreased264
Chemistry
  Creatinine increased790
  Alanine aminotransferase increased338
  Aspartate aminotransferase increased327
  Potassium decreased214
aLaboratory values were categorized using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.03 grading system.

Read the entire FDA prescribing information for Ukoniq (Umbralisib Tablets)

© Ukoniq Patient Information is supplied by Cerner Multum, Inc. and Ukoniq Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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