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Sacituzumab govitecan Side Effects

Medically reviewed by Drugs.com. Last updated on Mar 5, 2021.

For the Consumer

Applies to sacituzumab govitecan: intravenous powder for solution

Warning

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. Administer atropine, if not contraindicated, for early diarrhea of any severity. 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.

Side effects requiring immediate medical attention

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

Side effects not requiring immediate medical attention

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

For Healthcare Professionals

Applies to sacituzumab govitecan: intravenous powder for injection

Hematologic

Very common (10% or more): Hemoglobin decreased (93%), leukocytes decreased (91%), neutropenia (83%), activated partial thromboplastin time increased (60%), anemia (52%), platelets decreased (30%), thrombocytopenia (14%)[Ref]

Immunologic

Frequency not reported: Immunogenicity

Musculoskeletal

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

Metabolic

Very common (10% or more): Alkaline phosphatase increased (57%), magnesium decreased (51%), calcium decreased (49%), glucose increased (48%), aspartate aminotransferase increased (45%), albumin decreased (39%), alanine aminotransferase increased (35%), anorexia (30%), potassium decreased (30%), sodium decreased (25%), hyperglycemia (24%), hypomagnesemia (24%), hypokalemia (19%), glucose decreased (19%), hypophosphatemia (16%), dehydration (13%)[Ref]

Psychiatric

Very common (10% or more): Insomnia (13%)[Ref]

Genitourinary

Very common (10% or more): Urinary tract infection (21%)[Ref]

Respiratory

Very common (10% or more): Respiratory infection (e.g., lower and upper respiratory tract infection, pneumonia, influenza, viral upper respiratory infection, bronchitis, respiratory syncytial virus infection) (26%), cough/productive cough (22%), dyspnea/exertional dyspnea (21%)[Ref]

Other

Very common (10% or more): Fatigue/asthenia (57%), edema (e.g., peripheral, localized, periorbital) (19%), pyrexia (14%)[Ref]

General

The most frequent serious adverse reactions (reported in greater than 1%) of patients were febrile neutropenia (6%) vomiting (5%), nausea (3%), dyspnea (3%), diarrhea (4%), anemia (2%), pleural effusion, neutropenia, pneumonia, and dehydration.[Ref]

Nervous system

Very common (10% or more): Headache (23%), dizziness (22%), neuropathy (e.g., gait disturbance, hypoesthesia, muscular weakness, paresthesia, peripheral neuropathy, sensory neuropathy) (24%), dysgeusia (11%)[Ref]

Dermatologic

Very common (10% or more): Alopecia (38%), rash (e.g., maculopapular, erythematous, generalized rash, dermatitis acneiform, skin disorder, irritation, exfoliation) (31%), pruritus (17%), dry skin (15%)[Ref]

Gastrointestinal

Very common (10% or more): Nausea (69%), diarrhea (63%), vomiting (49%), constipation (34%), abdominal pain (e.g., abdominal pain, distention, upper abdominal pain, discomfort, tenderness) (26%), mucositis (e.g., stomatitis, esophagitis, mucosal inflammation) (14%)[Ref]

References

1. "Product Information. Trodelvy (sacituzumab govitecan)." Immunomedics, Morris Plains, NJ.

Further information

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.