Trodelvy

About Sacituzumab Govitecan or Trodelvy

Sacituzumab Govitecan or Trodelvy is a prescribed medicine for adult patients with metastatic triple-negative breast cancer who have received at least two treatments for the metastatic disease. Based on the rate of tumor response and length of response, this indication has been given accelerated approval. The confirmation and description of clinical benefit in confirmatory trials may be a condition for the continuation of authorization for this indication. 

Strength

180 mg of single-dose vial with lyophilized powder. 

Sacituzumab Dosage

Considering the 21-day treatment cycle of Govitecan Sacituzumab, the recommended dosage of 10 mg Trodelvy is administered as an intravenous injection once in a week on Days 1 and 8 until the progression of disease or unacceptable toxicity. It is advised not to administer the patients with a dosage greater than 10 mg. Dosage must be administered as an intravenous infusion and not as a push or bolus. 

Important: If patients experience any adverse reactions from the Trodelvy injection treatment, they must consult their treating doctor. 

Warnings & Precautions

• Severe anaphylactic reactions (Hypersensitivity) have been observed in some cases. Patients must be observed for reactions that may be caused due to infusion. It is advised to discontinue Sacituzumab Govitecan permanently in case of life-threatening or other severe reactions. 
• Discontinue Trodelvy from patients who have Grade 3 nausea or Grade 3–4 vomiting(Nausea) at the time of their scheduled therapy and follow antiemetic preventative medication instead. 
• Those who are homozygous for the UGT1A1 (Uridine Diphosphate Glucuronosyl Transferase)*28 allele are more likely to develop neutropenia after starting Govitecan Sacituzumab treatment.
• Trodelvy may be toxic to developing fetuses (Embryo-fetal toxicity). Inform patients about possible fetal danger and encourage them to use reliable contraception. 

Common Sacituzumab Govitecan Side Effects

• Nausea
• Neutropenia
• Diarrhea
• Fatigue
• Anemia
• Vomiting
• Alopecia
• Constipation
• Rash
• Decreased appetite
• Abdominal pain

Use in specific population 

• Trodelvy poses a risk of fetal harm in pregnant women, and there is inadequate data on its usage in this population. Inform your doctor if you are pregnant or planning to conceive before initiating the medication. 
• Breastfeeding is discouraged during Trodelvy treatment due to the absence of information on the presence of sacituzumab govitecan or its metabolites in human milk and their impact on infants. 
• Lactating women are advised to cease breastfeeding during treatment and for one month after the final dose to mitigate potential adverse reactions in breastfed children. 
• Before starting Trodelvy, assess the pregnancy status of females of reproductive potential and recommend effective contraception during treatment and for at least 6 months post-final dose. 
• Male patients with female partners of reproductive potential should also employ effective contraception during treatment and for 3 months after the final dose. Based on animal studies, Trodelvy may impair fertility in males and females of reproductive potential. 
• Trodelvy’s safety and effectiveness have not been established in pediatric patients, and no dose adjustment is recommended for those with mild to moderate hepatic impairment.

Storage and Handling

Store vials at 2°C to 8°C in the original package until reconstitution to protect them from light.