Applies to trilaciclib: intravenous powder for solution.

Serious side effects of Trilaciclib

Along with its needed effects, trilaciclib 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 trilaciclib:

More common

• Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the site
• bleeding gums
• blue lips, fingernails, or skin
• blurred vision
• bone pain
• chest pain or tightness
• chills
• confusion
• cough
• coughing up blood
• decreased urine
• dizziness
• dry mouth
• fever
• flushed, dry skin
• fruit-like breath odor
• general feeling of discomfort or illness
• headache
• increased menstrual flow or vaginal bleeding
• increased hunger
• increased thirst
• increased urination
• irregular, fast or slow, or shallow breathing
• lack or loss of strength
• loss of appetite
• mood or mental changes
• muscle cramps in the hands, arms, feet, legs, or face
• nausea or vomiting
• numbness and tingling around the mouth, fingertips, or feet
• nosebleeds
• paralysis
• pinpoint red spots on the skin
• prolonged bleeding from cuts
• red or black, tarry stools
• red or dark brown urine
• seizures or tremors
• sneezing
• sore throat
• stomach cramps or pain
• sweating
• swelling of the hands, ankles, feet, or lower legs
• thickening of bronchial secretions
• trouble breathing
• unexplained weight loss
• unusual bleeding or bruising
• unusual tiredness or weakness

For Healthcare Professionals

Applies to trilaciclib: intravenous powder for injection.

Hematologic

Very common (10% or more): Neutropenia (32%), anemia (16%), thrombocytopenia (18%)

Common (1% to 10%): Thrombosis, febrile neutropenia, leukopenia

Uncommon (0.1% to 1%): Hemoptysis, lymphopenia^[Ref]

Hypersensitivity

Common (1% to 10%): Infusion related reaction, anaphylaxis^[Ref]

Local

Common (1% to 10%): Infusion-related reaction, asthenia^[Ref]

Musculoskeletal

Uncommon (0.1% to 1%): Myositis^[Ref]

Hepatic

Very common (10% or more): Increased aspartate aminotransferase (17%)^[Ref]

Respiratory

Common (1% to 10%): Pneumonia (10%)

Uncommon (0.1% to 1%): Respiratory failure^[Ref]

Other

Fatal adverse reactions included pneumonia, respiratory failure, acute respiratory failure, hemoptysis, and cerebrovascular accident^[Ref]

General

The most common adverse reactions were fatigue, hypocalcemia, hypokalemia, hypophosphatemia, aspartate aminotransferase increased, headache, and pneumonia^[Ref]

Nervous system

Very common (10% or more): Fatigue (34%), headache (13%)^[Ref]

Cardiovascular

Common (1% to 10%): Peripheral edema, thrombosis

Uncommon (0.1% to 1%): Cerebrovascular accident, ischemic stroke^[Ref]

Dermatologic

Common (1% to 10%): Skin rash, urticaria^[Ref]

Endocrine

Very common (10% or more): Hypocalcemia (24%), hypokalemia (22%), hypophosphatemia (21%)

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

Gastrointestinal

Common (1% to 10%): Upper abdominal pain^[Ref]