Sacituzumab govitecan-hziy

What is sacituzumab govitecan-hziy?

• sacituzumab govitecan-hziy (Trodelvy) is a Trop-2-directed antibody and topoisomerase inhibitor conjugate.

What are the uses of this medicine?

sacituzumab govitecan-hziy (Trodelvy) is indicated to treat adults with:

• a type of breast cancer that is estrogen and progesterone hormone receptor (HR) negative, and human epidermal growth factor receptor 2 (HER2)-negative (also called triple-negative breast cancer).

Trodelvy may be used: when your breast cancer has spread to other parts of the body (metastatic) or cannot be removed by surgery, and if you previously received two or more prior treatments, including at least one treatment for metastatic disease. bladder cancer and cancers of the urinary tract that have spread or cannot be removed by surgery.

Trodelvy may be used if you have:

• received a platinum-containing chemotherapy medicine and
• also received an immunotherapy medicine.

How does this medicine work?

• Sacituzumab govitecan-hziy is a Trop-2-directed antibody-drug conjugate.
• Sacituzumab is a humanized antibody that recognizes Trop-2.
• The small molecule, SN-38, is a topoisomerase I inhibitor, which is covalently attached to the antibody by a linker.
• Pharmacology data suggest that sacituzumab govitecan-hziy binds to Trop-2-expressing cancer cells and is internalized with the subsequent release of SN-38 via hydrolysis of the linker.
• SN-38 interacts with topoisomerase I and prevents re-ligation of topoisomerase I-induced single strand breaks.
• The resulting DNA damage leads to apoptosis and cell death.
• Sacituzumab govitecan-hziy decreased tumor growth in mouse xenograft models of triple-negative breast cancer.

Who Should Not Use this medicine ?

• This medicine cannot be used in patient:
• who have experienced a severe hypersensitivity reaction to Trodelvy.

What drug interactions can this medicine cause?

• Avoid administering UGT1A1 inhibitors with Trodelvy.
• Avoid administering UGT1A1 inducers with Trodelvy.

Is this medicine FDA approved?

• It was approved for use in the United States in 2020.

How should this medicine be used?

Recommended Dosage

• The recommended dose of Trodelvy is 10 mg/kg administered as an intravenous infusion once weekly on Days 1 and 8 of 21-day treatment cycles. Continue treatment until disease progression or unacceptable toxicity.
• Do not administer Trodelvy at doses greater than 10 mg/kg.
• Premedication for prevention of infusion reactions and prevention of chemotherapy-induced nausea and vomiting is recommended.

Administration

• Your healthcare provider will give you Trodelvy into your vein through an intravenous (IV) line.
• Trodelvy is given 1 time each week, on Day 1 and on Day 8 of a 21-day treatment cycle.
• You will receive the first dose of Trodelvy over 3 hours. If you tolerate the first dose well, future doses may be given over 1 to 2 hours.
• Before each dose of Trodelvy, you will receive medicines to help prevent infusion reactions, and nausea and vomiting.
• You will be monitored for side effects during and for at least 30 minutes after you receive each infusion of Trodelvy.
• Your healthcare provider may slow down or temporarily stop your infusion of Trodelvy if you have an infusion-related reaction, or permanently stop Trodelvy if you have a life-threatening infusion-related reaction.
• Your healthcare provider will decide how long you will continue to receive Trodelvy.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As injection: 180 mg lyophilized powder in single-dose vials for reconstitution.

This medicine is available in fallowing brand namesː

• Trodelvy

What side effects can this medication cause?

Common possible side effects and laboratory abnormalities of this medicine include:

• feeling tired or weak
• hair loss
• decreased red blood cell count
• constipation
• decreased appetite
• rash
• stomach-area (abdominal) pain or discomfort

Trodelvy can cause serious side effects, including:

• Allergic and infusion-related reactions: Serious allergic reactions can happen during treatment with Trodelvy, including life-threatening allergic reactions, and infusion-related reactions).

• Nausea and vomiting: Nausea and vomiting are common with Trodelvy and can sometimes be severe. Before each dose of Trodelvy, you will receive medicines to help prevent nausea and vomiting.

What special precautions should I follow?

• Hypersensitivity reactions including severe anaphylactic reactions have been observed. Monitor patients for infusion-related reactions. Permanently discontinue Trodelvy if severe or life-threatening reactions occur.
• This medicine may cause Nausea/Vomiting. Use antiemetic preventive treatment and withhold Trodelvy for patients with Grade 3 nausea or Grade 3–4 vomiting at the time of scheduled treatment.
• Individuals who are homozygous for the uridine diphosphate-glucuronosyl transferase 1A1 (UGT1A1)*28 allele are at increased risk for neutropenia, febrile neutropenia, and anemia following initiation of Trodelvy treatment.
• Trodelvy can cause fetal harm. Advise patients of potential risk to a fetus and to use effective contraception.

What to do in case of emergency/overdose?

• Overdosage of this medicine may cause severe neutropenia.

Can this medicine be used in pregnancy?

• Based on its mechanism of action, Trodelvy can cause teratogenicity and/or embryo-fetal lethality when administered to a pregnant woman.

Can this medicine be used in children?

• Safety and effectiveness of Trodelvy have not been established in pediatric patients.

What should I know about storage and disposal of this medication?

• Store vials in a refrigerator at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light until time of reconstitution. Do not freeze.
• Trodelvy is a cytotoxic drug. Follow applicable special handling and disposal procedures.

• Dailymed label info on Sacituzumab govitecan-hziy
• FDA Sacituzumab govitecan-hziy

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