Sacituzumab Govitecan Side Effects

Medically reviewed by Drugs.com. Last updated on Nov 30, 2023.

Applies to sacituzumab govitecan: intravenous powder for solution.

Important warnings This medicine can cause some serious health issues

Intravenous route (powder for solution)

Severe or life-threatening neutropenia may occur.

Withhold sacituzumab govitecan-hziy for absolute neutrophil count below 1500/mm(3) or neutropenic fever.

Monitor blood cell counts periodically during treatment during treatment.

Consider G-CSF for secondary prophylaxis.

Initiate anti-infective treatment in patient with febrile neutropenia without delay.Severe diarrhea may occur.

Monitor patients with diarrhea and give fluid and electrolytes as needed.

At the onset of late diarrhea, evaluate for infectious causes and, if negative, promptly initiate loperamide.

If severe diarrhea occurs, withhold sacituzumab govitecan-hziy until resolved to less than or equal to Grade 1 and reduce subsequent doses.

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 side effects

• 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 side effects

• 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 side effects

• 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 side effects

• 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 adverse events

In the pooled safety population (which included patients with metastatic triple-negative breast cancer [mTNBC], patients with hormone receptor [HR]-positive/human epidermal growth factor receptor 2 [HER2]-negative breast cancer, and patients with metastatic urothelial cancer [mUC]), the most common adverse reactions were decreased leukocyte count, decreased neutrophil count, decreased hemoglobin, diarrhea, nausea, decreased lymphocyte count, fatigue, alopecia, constipation, increased glucose, decreased albumin, vomiting, decreased appetite, decreased CrCl, increased alkaline phosphatase, decreased magnesium, decreased potassium, and decreased sodium.

In patients with mTNBC, serious adverse reactions included febrile neutropenia, vomiting, nausea, dyspnea, diarrhea, anemia, pleural effusion, neutropenia, pneumonia, and dehydration; fatal adverse reactions included respiratory failure and pneumonia. In patients with HR-positive/HER2-negative breast cancer, serious adverse reactions included diarrhea, febrile neutropenia, neutropenia, abdominal pain, colitis, neutropenic colitis, pneumonia, and vomiting; fatal adverse reactions included arrhythmia, pneumonia, coronavirus disease 2019 (COVID-19), nervous system disorder, pulmonary embolism, and septic shock. In patients with mUC, serious adverse reactions 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 adverse reactions included sepsis, respiratory failure, epistaxis, and completed suicide.^[Ref]

Cardiovascular

• Common (1% to 10%): Venous thromboembolism, hypotension
• Frequency not reported: Arrhythmia, septic shock

Venous thromboembolism included deep vein thrombosis, embolism, and pulmonary embolism.

Dermatologic

• Very common (10% or more): Alopecia (up to 49%), rash (up to 32%), pruritus (up to 17%), dry skin (up to 15%)
• Common (1% to 10%): Skin hyperpigmentation, maculopapular rash, acneiform dermatitis

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, and skin toxicity.

Gastrointestinal

• Very common (10% or more): Diarrhea (up to 72%), nausea (up to 69%), vomiting (up to 49%), constipation (up to 37%), abdominal pain (up to 31%), stomatitis (up to 17%), mucositis (up to 14%), dyspepsia (up to 12%)
• Common (1% to 10%): Small intestinal obstruction, neutropenic colitis, colitis, upper abdominal pain, abdominal distension, gastroesophageal reflux disease
• Uncommon (0.1% to 1%): Enteritis
• Frequency not reported: Intestinal perforation

Diarrhea occurred in 64% of all patients; grade 3 to 4 diarrhea occurred in 11% of all patients. At least 1 patient had intestinal perforation after diarrhea. Diarrhea that led to dehydration and subsequent acute kidney injury occurred in 0.7% of all patients.

Nausea occurred in 64% of all patients and was grade 3 to 4 severity in 3% of patients; vomiting occurred in 35% of all patients and was grade 3 to 4 severity in 2% of patients.

Abdominal pain included abdominal pain, abdominal distention, upper abdominal pain, abdominal discomfort, abdominal tenderness, lower abdominal pain, and gastrointestinal pain.

Stomatitis included stomatitis, glossitis, mouth ulceration, and mucosal inflammation.

Mucositis included stomatitis, esophagitis, and mucosal inflammation.

Dyspepsia included dyspepsia and gastroesophageal reflux disease.

Neutropenic colitis included neutropenic colitis and typhlitis.

Genitourinary

• Very common (10% or more): Urinary tract infection (up to 21%), hematuria (up to 16%)
• Common (1% to 10%): Proteinuria

Hematologic

• Very common (10% or more): Decreased hemoglobin (up to 94%), decreased leukocyte count (up to 91%), decreased lymphocyte count (up to 88%), decreased neutrophil count (up to 83%), neutropenia (up to 71%), increased activated partial thromboplastin time (up to 60%), granulocyte-colony stimulating factor used (up to 47%), anemia (up to 43.4%), decreased platelet count (up to 30%), leukopenia (up to 17%), eosinophilia (up to 13%), lymphopenia (up to 12%)
• Common (1% to 10%): Febrile neutropenia, thrombocytopenia

Neutropenia has been reported in 64% of patients; grade 3 to 4 neutropenia and febrile neutropenia occurred in 49% and 6% of patients, respectively. The median time to first onset of neutropenia (including febrile neutropenia) was 16 days and has occurred earlier in some patient populations.

Among 948 patients who received this drug and had UGT1A1 genotype results, 112 patients were homozygous for the UGT1A1*28 allele, 420 were heterozygous for UGT1A1*28, and 416 were homozygous for the wild-type allele. In these 3 groups, the incidences of grade 3 to 4 neutropenia were 58%, 49%, and 43%, respectively, and the incidences of grade 3 to 4 anemia were 21%, 10%, and 9%, respectively. In these 3 groups, median time to first neutropenia (including febrile neutropenia) was 9 days, 15 days, and 20 days, respectively, and median time to first anemia was 21 days, 25 days, and 28 days, respectively.

Neutropenia included neutropenia and neutrophil count decreased.

Anemia included anemia, hemoglobin decreased, and RBC count decreased.

Leukopenia included leukopenia and WBC count decreased.

Lymphopenia included lymphopenia and lymphocyte count decreased.

Thrombocytopenia included thrombocytopenia and platelet count decreased.

Hepatic

• Very common (10% or more): Increased AST (up to 45%), increased ALT (up to 35%)

Hypersensitivity

• Very common (10% or more): Hypersensitivity (up to 27%)
• Uncommon (0.1% to 1%): Anaphylactic reactions
• Frequency not reported: Serious hypersensitivity reactions (including life-threatening anaphylactic reactions)

Hypersensitivity reactions within 24 hours of dosing occurred in 35% of patients. Grade 3 to 4 hypersensitivity occurred in 2% of patients; anaphylactic reactions were reported in 0.2% of patients. Permanent discontinuation of this drug due to hypersensitivity reactions occurred in 0.2% of patients.

Hypersensitivity events were reported up to the end of the day after treatment was administered. Hypersensitivity included cough, dyspnea, rash, pruritus, stomatitis, hypotension, maculopapular rash, flushing, erythema, chest discomfort, hypersensitivity, infusion-related reaction, allergic rhinitis, wheezing, localized edema, acneiform dermatitis, eczema, conjunctivitis, generalized edema, pruritic rash, edema, macular rash, pustular rash, swelling, swelling face, urticaria, blister, cheilitis, contrast media allergy, dermatitis, generalized exfoliative dermatitis, drug hypersensitivity, eye edema, sneezing, mouth ulceration, periorbital edema, erythematous rash, anaphylactic reaction, asthma, bronchospasm, allergic conjunctivitis, contact dermatitis, eye pruritus, scrotal edema, seasonal allergy, skin exfoliation, swollen tongue, tachypnea, throat tightness, type IV hypersensitivity reaction, and choking.

Immunologic

• Common (1% to 10%): Antidrug antibodies developed
• Uncommon (0.1% to 1%): Neutralizing antibodies

During the median 4-month treatment period across clinical studies, 1.1% of patients developed antibodies to this drug; 0.8% of all patients had neutralizing antibodies against this drug. Insufficient data were available to determine the impact these antibodies on the efficacy, safety, or pharmacokinetics of this drug.

Metabolic

• Very common (10% or more): Increased glucose (up to 59%), decreased appetite (up to 41%), hypomagnesemia (up to 21%), hypokalemia (up to 19%), decreased glucose (up to 19%), dehydration (up to 13%), hyperglycemia
• Common (1% to 10%): Hypocalcemia, hyponatremia, hypophosphatemia
• Frequency not reported: Anorexia

Musculoskeletal

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

Nervous system

• Very common (10% or more): Neuropathy (up to 24%), headache (up to 23%), dizziness (up to 22%), peripheral neuropathy (up to 12%), dysgeusia (up to 11%)
• Frequency not reported: Nervous system disorder

Neuropathy included gait disturbance, hypoesthesia, muscular weakness, paresthesia, peripheral neuropathy, and sensory neuropathy.

Other

• Very common (10% or more): Fatigue (up to 68%), increased alkaline phosphatase (up to 57%), decreased magnesium (up to 51%), decreased albumin (up to 51%), any infection (up to 50%), decreased calcium (up to 49%), decreased sodium (up to 43%), decreased phosphate (up to 41%), decreased potassium (up to 33%), increased albumin (up to 32%), increased lactate dehydrogenase (up to 28%), increased magnesium (up to 24%), edema (up to 19%), pyrexia (up to 19%), infection (up to 18%), weight loss (up to 17%), increased phosphate (up to 16%), increased potassium (up to 14%)
• Common (1% to 10%): Sepsis/bacteremia, pain, chills
• Uncommon (0.1% to 1%): Sepsis, infusion-related reactions
• Frequency not reported: Asthenia, general physical health deterioration

Fatigue included fatigue and asthenia.

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, and vulvovaginal mycotic infection.

Edema included edema, peripheral edema, localized edema, periorbital edema, genital edema, and peripheral swelling.

Weight loss included failure to thrive and weight decreased.

Psychiatric

• Very common (10% or more): Insomnia (up to 13%)
• Frequency not reported: Completed suicide

Renal

• Very common (10% or more): Increased creatinine (up to 32%), acute kidney injury (up to 24%), decreased CrCl (up to 24%)

Acute kidney injury included acute kidney injury, increased blood creatinine, toxic nephropathy, renal failure, and renal impairment.

Respiratory

• Very common (10% or more): Respiratory infection (up to 26%), cough (up to 24%), dyspnea (up to 21%), upper respiratory tract infection (up to 12%)
• Common (1% to 10%): Pneumonia, pleural effusion, rhinorrhea, nasal congestion, bronchitis, epistaxis
• Frequency not reported: Respiratory failure, COVID-19, pulmonary embolism, COVID-19 pneumonia

Respiratory infection included lower respiratory tract infection, upper respiratory tract infection, pneumonia, influenza, viral upper respiratory infection, bronchitis, and respiratory syncytial virus infection.

Cough included cough, productive cough, and upper-airway cough syndrome.

Dyspnea included dyspnea and exertional dyspnea.

Further information

Sacituzumab govitecan side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

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