Zepzelca

Last reviewed on RxList: 3/4/2021
Zepzelca Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Zepzelca?

Zepzelca (lurbinectedin) is an alkylating drug used to treat adult patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy.

What Are Side Effects of Zepzelca?

Side effects of Zepzelca include:

Dosage for Zepzelca

The recommended dosage of Zepzelca is 3.2 mg/m2 every 21 days.

Zepzelca In Children

The safety and effectiveness of Zepzelca in pediatric patients have not been established.

What Drugs, Substances, or Supplements Interact with Zepzelca?

Zepzelca may interact with other medicines such as:

  • strong or moderate CYP3A inhibitors and inducers and
  • grapefruit products

Tell your doctor all medications and supplements you use.

Zepzelca During Pregnancy and Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant before using Zepzelca; it may harm a fetus. Female patients of reproductive potential are advised to use effective contraception during treatment with Zepzelca and for 6 months after the final dose. Males with a female sexual partner of reproductive potential are advised to use effective contraception during treatment with Zepzelca and for 4 months after the final dose. It is unknown if Zepzelca passes into breast milk. Because of the potential for serious adverse reactions, breastfeeding is not recommended while using Zepzelca and for 2 weeks after the final dose.

Additional Information

Our Zepzelca (lurbinectedin) for Injection, for Intravenous 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

Lung Cancer: Early Signs, Symptoms, Stages See Slideshow
Zepzelca Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • easy bruising, unusual bleeding, purple or red spots under your skin;
  • low red blood cells (anemia)--pale skin, unusual tiredness, feeling light-headed or short of breath, cold hands and feet;
  • low white blood cell counts--fever, mouth sores, skin sores, sore throat, cough, trouble breathing;
  • signs of sepsis--confusion, fever or chills, severe drowsiness, fast heartbeats, rapid breathing, feeling very ill; or
  • liver problems--loss of appetite, stomach pain (upper right side), tiredness, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Common side effects may include:

  • low blood cell counts;
  • cough, trouble breathing;
  • nausea, vomiting, loss of appetite;
  • increased thirst or urination;
  • diarrhea, constipation;
  • muscle or joint pain;
  • feeling tired; or
  • abnormal blood 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 Zepzelca (Lurbinectedin for Injection)

QUESTION

Lung cancer is a disease in which lung cells grow abnormally in an uncontrolled way. See Answer
Zepzelca Professional Information

SIDE EFFECTS

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

  • Myelosuppression [see WARNINGS AND PRECAUTIONS]
  • Hepatotoxicity [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 directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The pooled safety population described in the WARNINGS AND PRECAUTIONS reflects exposure to ZEPZELCA as a single agent at a dose of 3.2 mg/m2 intravenously every 21 days in 554 patients with advanced solid tumors. Among 554 patients who received ZEPZELCA, including 105 patients with small cell lung cancer (SCLC) in PM1183-B-005-14 (Study B-005), 24% were exposed for 6 months or longer and 5% were exposed for greater than one year.

Small Cell Lung Cancer (SCLC)

The safety of ZEPZELCA was evaluated in a cohort of 105 patients with previously treated SCLC in Study B-005 [see Clinical Studies]. Patients received ZEPZELCA 3.2 mg/m2 intravenously every 21 days. All patients in this study received a pre-specified anti-emetic regimen consisting of a corticosteroid and serotonin antagonist. Patients could receive G-CSF for secondary prophylaxis (i.e., after patients had an initial decrease in WBC), but not primary prophylaxis. Among patients who received ZEPZELCA, 29% were exposed for 6 months or longer and 6% were exposed for greater than one year.

Serious adverse reactions occurred in 34% of patients who received ZEPZELCA. Serious adverse reactions in ≥ 3% of patients included pneumonia, febrile neutropenia, neutropenia, respiratory tract infection, anemia, dyspnea, and thrombocytopenia.

Permanent discontinuation due to an adverse reaction occurred in two patients (1.9%) who received ZEPZELCA. Adverse reactions resulting in permanent discontinuation in ≥ 1% of patients who received ZEPZELCA, which included peripheral neuropathy and myelosuppression.

Dosage interruptions due to an adverse reaction occurred in 30.5% of patients who received ZEPZELCA. Adverse reactions requiring dosage interruption in ≥ 3% of patients who received ZEPZELCA included neutropenia, and hypoalbuminemia.

Dose reductions due to an adverse reaction occurred in 25% of patients who received ZEPZELCA. Adverse reactions requiring dosage reductions in ≥ 3% of patients who received ZEPZELCA included neutropenia, febrile neutropenia and fatigue.

The most common adverse reactions, including laboratory abnormalities, (≥ 20%) were leukopenia, lymphopenia, fatigue, anemia, neutropenia, increased creatinine, increased alanine aminotransferase, increased glucose, thrombocytopenia, nausea, decreased appetite, musculoskeletal pain, decreased albumin, constipation, dyspnea, decreased sodium, increased aspartate aminotransferase, vomiting, cough, decreased magnesium and diarrhea.

Table 3 summarizes the adverse reactions in the SCLC cohort of Study B-005.

Table 3: Adverse Reactions (≥ 10%) in Patients With SCLC Who Received ZEPZELCA in Study B-005

Adverse ReactionZEPZELCA
(n=105)
All Gradesa,b (%)Grades 3-4 (%)
General disorders
Fatigue7712
Pyrexia130
Chest pain100
Gastrointestinal disorders
Nausea370
Constipation310
Vomiting220
Diarrhea204
Abdominal painc111
Musculoskeletal and connective tissue disorders
Musculoskeletal paind334
Metabolism and nutrition disorders
Decreased appetite331
Respiratory, thoracic and mediastinal disorders
Dyspnea316
Coughe200
Infections and infestations
Respiratory tract infectionf185
Pneumoniag107
Nervous system disorders
Peripheral neuropathyh111
Headache101
a Graded per NCI CTCAE 4.0.
b No grade 5 adverse reactions were reported.
c Includes abdominal pain, abdominal pain upper and abdominal discomfort.
d Includes musculoskeletal pain, back pain, arthralgia, pain in extremity, musculoskeletal chest pain, neck pain, bone pain and myalgia.
e Includes cough and productive cough.
f Includes upper respiratory tract infection, viral upper respiratory tract infection, respiratory tract infection and bronchitis.
g Includes pneumonia and lung infection.
h Includes neuropathy peripheral, neuralgia, paresthesia, peripheral sensory neuropathy, hypoesthesia, and hyperesthesia.

Clinically relevant adverse reactions in < 10% of patients who received ZEPZELCA include dysgeusia, febrile neutropenia and pneumonitis.

Table 4 summarizes the laboratory abnormalities in Study B-005.

Table 4: Select Laboratory Abnormalities (≥ 20%) Worsening from Baseline in Patients With SCLC Who Received ZEPZELCA in Study B-005

Laboratory AbnormalityZEPZELCAa
(n=105)
All Gradesb (%)Grades 3-4 (%)
Hematology
Decreased leukocytes7929
Decreased lymphocytes7943
Decreased hemoglobin7410
Decreased neutrophils7146
Decreased platelets377
Chemistry
Increased creatinine690
Increased alanine aminotransferase664
Increased glucose525
Decreased albumin321
Decreased sodium317
Increased aspartate aminotransferase262
Decreased magnesium220
a The denominator used to calculate the rate varied from 95 to 105 based on the number of patients with a baseline value and at least one post-treatment value.
b Graded per NCI CTCAE 4.0.

Read the entire FDA prescribing information for Zepzelca (Lurbinectedin for Injection)

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

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