Sacituzumab Govitecan

Sacituzumab Govitecan is a prescription medication used for the treatment of breast and urothelial cancer.

• Sacituzumabab Govitecan is available under the following different brand names: Trodelvy, Sacituzumab Govitecan-hziy 

Common side effects of Sacituzumab Govitecan include:

• nausea,
• low white blood cell count (neutropenia),
• diarrhea,
• fatigue,
• anemia,
• vomiting,
• hair loss
• constipation,
• rash,
• decreased appetite, and
• abdominal pain 

Serious side effects of Sacituzumab Govitecan include:

• blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights.
• fast or pounding heartbeats, fluttering in your chest, shortness of breath, and sudden dizziness.
• low levels of sodium in the body with severe headache, confusion, slurred speech, severe weakness, vomiting, loss of coordination, feeling unsteady; or
• severe nervous system reaction with very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, and feeling like you might pass out.

Rare side effects of Sacituzumab Govitecan include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Injection, lyophilized powder for reconstitution

• 180 mg/vial

Breast Cancer

Adult dosage

• Each cycle is 21 days
• Days 1 and 8: 10 mg/kg IV  
• Continue treatment until disease progression or unacceptable toxicity
• Do not administer doses above 10 mg/kg

Urothelial Cancer

Adult dosage

1. Each cycle is 21 days
2. Days 1 and 8: 10 mg/kg Intravenous 
3. Continue treatment until disease progression or unacceptable toxicity
4. Do not administer doses above 10 mg/kg

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Sacituzumab Govitecan has severe interactions with no other drugs.
• Sacituzumab Govitecan has serious interactions with no other drugs.
• Sacituzumab Govitecan has moderate interactions with the following drug:
  • siponimod
• Sacituzumab Govitecan has minor interactions with no other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• Hypersensitivity to Sacituzumab 

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Sacituzumab Govitecan?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Sacituzumab Govitecan?”

Cautions

Therapy is emetogenic; pre-medicate for prevention of chemotherapy-induced nausea and vomiting (CINV)

• Individuals who are homozygous for the uridine diphosphate-glucuronosyl transferase 1A1 (UGT1A1)*28 allele are at increased risk for neutropenia and may be at increased risk for other adverse reactions following initiation of treatment; closely monitor for severe neutropenia; appropriate dose in these patients is unknown and should be based on individual patient tolerance to treatment
• Closely monitor patients with known reduced UGT1A1 activity for adverse reactions; withhold or permanently discontinue the drug based on the severity of observed adverse reactions in patients with evidence of acute early-onset or unusually severe adverse reactions, which may indicate UGT1A1 reduced function
• Teratogenicity and/or embryofetal lethality may occur when administered to pregnant females
• Hypersensitivity
  • Severe and life-threatening hypersensitivity reactions occur
  • Anaphylactic reactions have been observed in clinical trials
• Premedicate and monitor for signs and symptoms of infusion-related reactions during and for 30 min after each infusion
• Neutropenia
  • May cause severe or life-threatening neutropenia
  • Withhold for ANC above 1,500/mm3 on Day 1 or ANC below 1,000/mm3 on Day 8 of any cycle, or neutropenic fever
  • Febrile neutropenia also occurred, including patients with mTNBC after below 2 prior therapies
• Diarrhea
  • Severe diarrhea may occur
  • At the onset of diarrhea, evaluate for infectious causes, and, if negative, promptly initiate loperamide 4 mg initially followed by 2 mg per episode of diarrhea (not to exceed 16 mg/day)
  • Discontinue loperamide 12 hr after diarrhea resolves; consider additional supportive measures (e.g., fluid, and electrolyte substitution) as clinically indicated
  • Patients who exhibit an excessive cholinergic response to treatment (. g, abdominal cramping, diarrhea, salivation) can receive appropriate premedication (. g, atropine) for subsequent treatments
• Drug interaction overview
  • UGT1A1 substrate
  • UGT1A1 inhibitors
  • Avoid coadministration
  • UGT1A1 inhibitors may increase the incidence of adverse reactions due to a potential increase in systemic exposure to SN-38
  • UGT1A1 inducers
  • Avoid coadministration
  • UGT1A1 enzyme inducers may substantially reduce exposure to SN-38

Pregnancy and Lactation

• Based on its mechanism of action, teratogenicity and/or embryofetal lethality may occur when administered to a pregnant female
• No data is available on pregnant women to inform the drug-associated risk
• Sacituzumab contains a genotoxic component, SN-38, and is toxic to rapidly dividing cells
• Advise pregnant females and those of reproductive potential of the potential risk to a fetus
• Verify pregnancy status of females of reproductive potential before initiation
• Contraception
  • Females of reproductive potential: Use effective contraception during treatment and for 6 months after the final dose
  • Males of female partners of reproductive potential: Use effective contraception during treatment and for 3 months final dose
• Infertility
  • Based on findings in animals, fertility may be impaired in females with reproductive potential
• Lactation
  • No information available on the presence of sacituzumab Govitecan-hiz or SN-38 in human milk, effects on breastfed children, or effects on milk production
  • Advise females not to breastfeed during treatment and for 1 month after the final dose