Applies to sacituzumab govitecan: intravenous powder for solution.

Serious side effects

Along with its needed effects, sacituzumab govitecan 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 sacituzumab govitecan:

More common

• Agitation
• black, tarry stools
• bladder pain
• bleeding of the gums
• bloody or cloudy urine
• blurred vision
• bone pain
• burning, itching, and pain in the hairy areas, pus at the root of hair
• burning, tingling, numbness or pain in the hands, arms, feet, or legs
• coma
• confusion
• cough
• decreased urine output
• depression
• difficult or labored breathing with exertion
• difficult, burning, or painful urination
• dizziness
• drowsiness
• dry mouth
• fainting
• fast heartbeat
• fever or chills
• flushed, dry skin
• fruit-like breath odor
• hostility
• increased hunger
• increased thirst
• increased urination
• irregular heartbeat
• irritability
• lethargy
• lightheadedness
• loss of appetite
• lower back or side pain
• mood or mental changes
• muscle pain, spasms, or twitching
• pale skin
• pinpoint red spots on the skin
• rapid, shallow breathing
• rapid weight gain
• seizures
• severe diarrhea
• severe nausea and vomiting
• sneezing
• sore throat
• stomach pain or tenderness
• stuffy or runny nose
• stupor
• sweating
• swelling
• swelling of the face, ankles, or hands
• tightness in the chest
• trembling
• ulcers, sores, or white spots in the mouth
• unexplained weight loss
• unusual bleeding or bruising
• unusual tiredness or weakness

Less common

• Chest pain
• pain in the groin or legs, especially the calves
• severe, sudden headache
• slurred speech
• sudden loss of coordination
• sudden, severe weakness or numbness in the arm or leg
• vision changes

Rare

• Difficulty swallowing
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

Other side effects

Some side effects of sacituzumab govitecan 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

• Change in taste
• constipation
• cracked lips
• hair loss
• loss of taste
• rash
• swelling or inflammation of the mouth
• trouble sleeping

For Healthcare Professionals

Applies to sacituzumab govitecan: intravenous powder for injection.

General

In the pooled safety population (which included patients with metastatic triple-negative breast cancer [mTNBC] and patients with metastatic urothelial cancer [mUC]), the most common side effects were neutropenia, vomiting, nausea, diarrhea, fatigue, alopecia, anemia, constipation, decreased appetite, rash, and abdominal pain. In a study in patients with mUC, the most common side effects were diarrhea, fatigue, neutropenia, nausea, alopecia, anemia, decreased appetite, constipation, vomiting, and abdominal pain.

In studies in patients with mTNBC, serious side effects included febrile neutropenia, vomiting, nausea, dyspnea, diarrhea, anemia, pleural effusion, neutropenia, pneumonia, and dehydration; fatal side effects included respiratory failure and pneumonia. In a study in patients with mUC, serious side effects included infection, neutropenia (including febrile neutropenia), acute kidney injury, urinary tract infection, sepsis/bacteremia, diarrhea, anemia, venous thromboembolism, small intestinal obstruction, pneumonia, abdominal pain, pyrexia, and thrombocytopenia; fatal side effects included sepsis, respiratory failure, epistaxis, and completed suicide.^[Ref]

Hematologic

Very common (10% or more): Decreased hemoglobin (up to 94%), decreased leukocytes (up to 91%), decreased lymphocytes (up to 88%), decreased neutrophils (up to 82%), neutropenia (included neutropenia, neutrophil count decreased; up to 64%), increased activated partial thromboplastin time (up to 60%), anemia (included anemia, hemoglobin decreased, RBC count decreased; up to 52%), granulocyte-colony stimulating factor used (up to 47%), decreased platelets (up to 30%), leukopenia (included leukopenia, WBC count decreased; up to 17%), thrombocytopenia (up to 14%)

Common (1% to 10%): Lymphopenia (included lymphopenia, lymphocyte count decreased), febrile neutropenia^[Ref]

Neutropenia has been reported in up to 62% of patients; Grade 3 to 4 neutropenia and febrile neutropenia occurred in 47% and 7% of patients, respectively.

Among 701 patients who received this drug and had UGT1A1 genotype results, 87 patients were homozygous for the UGT1A1*28 allele, 301 were heterozygous for UGT1A1*28, and 313 were homozygous for the wild-type allele. In these 3 groups, the incidences of Grade 3 to 4 neutropenia were 67%, 46%, and 46%, respectively, and the incidences of Grade 3 to 4 anemia were 25%, 10%,

and 11%, respectively.^[Ref]

Gastrointestinal

Very common (10% or more): Diarrhea (up to 72%), nausea (up to 69%), vomiting (up to 49%), constipation (up to 37%), abdominal pain (included abdominal pain, distention, upper abdominal pain, abdominal discomfort, tenderness, lower abdominal pain, gastrointestinal pain; up to 31%), stomatitis (included stomatitis, glossitis, mouth ulceration, mucosal inflammation; up to 17%), mucositis (included stomatitis, esophagitis, mucosal inflammation; up to 14%)

Common (1% to 10%): Small intestinal obstruction

Uncommon (0.1% to 1%): Neutropenic colitis

Frequency not reported: Intestinal perforation^[Ref]

This drug caused nausea in up to 67% of all patients and was Grade 3 to 4 severity in 4% of patients; vomiting occurred in up to 40% of all patients and was Grade 3 to 4 severity in 3% of patients.

Diarrhea occurred in up to 65% of all patients; Grade 3 to 4 diarrhea occurred in 12% of patients. At least 1 patient had intestinal perforation after diarrhea; neutropenic colitis occurred in 0.5% of patients.^[Ref]

Other

Very common (10% or more): Fatigue (included fatigue, asthenia; up to 68%), increased alkaline phosphatase (up to 57%), decreased magnesium (up to 51%), decreased albumin (up to 51%), any infection (included bacteremia, body tinea, bronchitis, Candida infection, cellulitis, Clostridioides difficile infection, coronavirus infection, device-related infection, diverticulitis, Escherichia bacteremia, Escherichia pyelonephritis, folliculitis, gastroenteritis, Escherichia coli gastroenteritis, herpes zoster, kidney infection, Klebsiella sepsis, lung infection, nasopharyngitis, oral candidiasis, oral herpes, pneumonia, pyelonephritis, acute pyelonephritis, respiratory tract infection, rhinitis, sepsis, sinusitis, skin infection, tooth abscess, upper respiratory tract infection, urinary tract infection, urosepsis, vascular device infection, viral infection, viral pharyngitis, vulvovaginal mycotic infection; up to 50%), decreased calcium (up to 49%), decreased sodium (up to 43%), decreased phosphate (up to 41%), decreased potassium (up to 30%), increased lactate dehydrogenase (up to 28%), increased magnesium (up to 24%), edema (included edema, peripheral edema, localized edema, periorbital edema, genital edema, peripheral swelling; up to 19%), pyrexia (up to 19%), infection (up to 18%), weight loss (included failure to thrive, weight decreased; up to 17%)

Common (1% to 10%): Sepsis/bacteremia^[Ref]

Metabolic

Very common (10% or more): Increased glucose (up to 59%), decreased appetite (up to 41%), hyperglycemia (up to 24%), hypomagnesemia (up to 21%), hypokalemia (up to 19%), decreased glucose (up to 19%), hypophosphatemia (up to 16%), dehydration (up to 13%)

Frequency not reported: Anorexia^[Ref]

Dermatologic

Very common (10% or more): Alopecia (up to 49%), rash (included rash, maculopapular rash, erythematous rash, generalized rash, dermatitis acneiform, skin disorder, skin irritation, skin exfoliation, dermatitis bullous, erythema, lichen planus, photosensitivity reaction, pruritus, generalized pruritus, macular rash, pruritic rash, skin papilloma, skin toxicity; up to 32%), pruritus (up to 17%), dry skin (up to 15%)^[Ref]

Hepatic

Very common (10% or more): Increased AST (up to 45%), increased ALT (up to 35%)^[Ref]

Hypersensitivity

Hypersensitivity reactions within 24 hours of dosing occurred in 37% of patients. Grade 3 to 4 hypersensitivity occurred in 2% of patients; anaphylactic reactions were reported in 0.3% of patients. Permanent discontinuation of this drug due to hypersensitivity reactions occurred in 0.3% of patients.^[Ref]

Very common (10% or more): Hypersensitivity reactions

Uncommon (0.1% to 1%): Anaphylactic reactions

Frequency not reported: Serious hypersensitivity reactions (including life-threatening anaphylactic reactions)^[Ref]

Renal

Very common (10% or more): Increased creatinine (up to 32%); acute kidney injury (included acute kidney injury, increased blood creatinine, toxic nephropathy, renal failure, renal impairment; up to 24%)^[Ref]

Respiratory

Very common (10% or more): Respiratory infection (included lower respiratory tract infection, upper respiratory tract infection, pneumonia, influenza, viral upper respiratory infection, bronchitis, respiratory syncytial virus infection; up to 26%), cough (included cough, productive cough, upper-airway cough syndrome; up to 24%), dyspnea (included dyspnea, exertional dyspnea; up to 21%), upper respiratory tract infection (up to 12%)

Common (1% to 10%): Pneumonia, pleural effusion

Frequency not reported: Respiratory failure, epistaxis^[Ref]

Nervous system

Very common (10% or more): Neuropathy (included gait disturbance, hypoesthesia, muscular weakness, paresthesia, peripheral neuropathy, sensory neuropathy; up to 24%), headache (up to 23%), dizziness (up to 22%), peripheral neuropathy (up to 12%), dysgeusia (up to 11%)^[Ref]

Musculoskeletal

Very common (10% or more): Back pain (up to 23%), arthralgia (up to 17%), pain in extremity (up to 11%)^[Ref]

Genitourinary

Very common (10% or more): Urinary tract infection (up to 21%), hematuria (up to 16%)^[Ref]

Psychiatric

Very common (10% or more): Insomnia (up to 13%)

Frequency not reported: Completed suicide^[Ref]

Cardiovascular

Common (1% to 10%): Venous thromboembolism (included deep vein thrombosis, embolism, pulmonary embolism)^[Ref]

Immunologic

Common (1% to 10%): Anti-drug antibodies developed^[Ref]