Applies to lurbinectedin: intravenous powder for solution.

Serious side effects of Lurbinectedin

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

Check with your doctor or nurse immediately if any of the following side effects occur while taking lurbinectedin:

More common

• Black, tarry stools
• bleeding gums
• bloody urine
• bone, joint, or muscle pain
• chest pain or tightness
• chills
• dark urine
• difficult or labored breathing
• fever
• general feeling of discomfort or illness
• hoarseness
• loss of appetite
• lower back or side pain
• nausea
• painful or difficult urination
• pale skin
• pale stools
• pinpoint red spots on the skin
• sneezing
• sore throat
• stomach pain or tenderness
• thickening of bronchial secretions
• trouble breathing
• ulcers, sores, or white spots in the mouth
• unusual bleeding or bruising
• unusual tiredness or weakness
• vomiting
• yellow eyes or skin

Less common

• Swelling of the feet or lower legs

Incidence not known

• Muscle cramps, spasms, or stiffness
• pain, discomfort, itching, redness, or swelling at the injection site

Other side effects of Lurbinectedin

Some side effects of lurbinectedin 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

• Burning, numbness, tingling, or painful sensations
• change in or loss of taste
• constipation
• diarrhea
• headache
• unsteadiness or awkwardness

For Healthcare Professionals

Applies to lurbinectedin: intravenous powder for injection.

Hematologic

Very common (10% or more): Leucocytes decreased (79%), lymphocytes decreased (79%), hemoglobin decreased (74%), neutrophils decreased (71%),

neutropenia (41%), platelets decreased (37%), anemia (17%), thrombocytopenia (10%)

Common (1% to 10%): Febrile neutropenia^[Ref]

Musculoskeletal

Very common (10% or more): Musculoskeletal pain (e.g., musculoskeletal pain, back pain, arthralgia, pain in extremity, musculoskeletal chest pain, neck pain, bone pain, myalgia) (33%)^[Ref]

Metabolic

Very common (10% or more): Glucose increased (52%), anorexia (33%), albumin decreased (32%), sodium decreased (31%), magnesium decreased (22%)^[Ref]

Hepatic

Very common (10% or more): Alanine aminotransferase increased (66%), aspartate aminotransferase increased (26%)

Common (1% to 10%): Grade 3 elevations of ALT and AST, Grade 4 elevations of ALT and AST^[Ref]

Respiratory

Very common (10% or more): Dyspnea (31%), cough (e.g., cough, productive cough) (20%), respiratory infection (e.g., upper respiratory tract infection, viral upper respiratory tract infection, respiratory tract infection, bronchitis) (18%), pneumonia (10%), lung infection (10%)

Common (1% to 10%): Pneumonitis^[Ref]

Other

Very common (10% or more): Fatigue (77%), pyrexia (13%)^[Ref]

General

The most common adverse reactions, including laboratory abnormalities (20% or more) 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.^[Ref]

Nervous system

Very common (10% or more): Peripheral neuropathy (e.g., neuropathy peripheral, neuralgia, paresthesia, peripheral sensory neuropathy, hypoesthesia, hyperesthesia) (11%), headache (10%)

Common (1% to 10%): Dysgeusia^[Ref]

Renal

Very common (10% or more): Creatinine increased (69%)^[Ref]

Cardiovascular

Very common (10% or more): Chest pain (10%)^[Ref]

Gastrointestinal

Very common (10% or more): Nausea (37%), constipation (31%), vomiting (22%), diarrhea (20%), abdominal pain (e.g., abdominal pain, abdominal pain upper, abdominal discomfort) (11%)^[Ref]