Trodelvy

Treatment of adult patients w/ unresectable locally advanced or metastatic triple -ve breast cancer who have received ≥2 prior systemic therapies, at least 1 of them for metastatic disease; unresectable locally advanced or metastatic hormone receptor +ve, human epidermal growth factor receptor 2 -ve (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have received endocrine based therapy & at least 2 additional systemic therapies in the metastatic setting.

IV infusion 10 mg/kg once wkly on days 1 & 8 of 21-day treatment cycle. Continue treatment until disease progression or unacceptable toxicity. Max dose: 10 mg/kg. Initial infusion should be administered over 3 hr. If prior infusion was tolerated, subsequent infusions should be administered over 1-2 hr.

Severe hypersensitivity.

Do not administer as IV push or bolus. Serious hypersensitivity reactions may occur. Closely monitor patient for hypersensitivity & infusion-related reactions during & for at least 30 min after completion of each infusion. Premed for infusion reactions is recommended. Permanently discontinue Trodelvy for Grade 4 infusion-related reaction. Severe, life-threatening, or fatal neutropenia can occur; dose modification may be required. Can cause severe diarrhea. Appropriate premed (eg, atropine) for patient who exhibit excessive cholinergic response. Premedicate w/ 2 or 3 drug combination regimen (eg, dexamethasone w/ either 5-HT3 receptor antagonist or NK₁ receptor antagonist as well as other drugs as indicated) for prevention of chemotherapy-induced nausea & vomiting. Increased risk of adverse reactions in patients w/ reduced UGT1A1 activity. Safety has not been established in patients w/ moderate or severe hepatic impairment. Can cause teratogenicity &/or embryo-fetal lethality. Advise pregnant women & females of reproductive potential of the potential risk to a fetus. Advise female of reproductive potential to use effective contraception during treatment & for 6 mth after the last dose. Advise male patient w/ female partner of reproductive potential to use effective contraception during treatment & for 3 mth after the last dose. May impair fertility in female of reproductive potential. Should not breastfeed during treatment & for 1 mth after the last dose. Safety & effectiveness in ped patient have not been established.

Decreased leukocyte/neutrophil/lymphocyte count, decreased Hb/albumin/CrCl, diarrhea, nausea, fatigue, alopecia, constipation, increased glucose/alkaline phosphatase, vomiting, decreased appetite & decreased Mg/K/Na.

Potentially increased systemic exposure to SN-38 w/ UGT1A1 inhibitors. Reduced exposure to SN-38 w/ UGT1A1 inducers.

Targeted Cancer Therapy

L01FX17 - sacituzumab govitecan ; Belongs to the class of other monoclonal antibodies and antibody drug conjugates. Used in the treatment of cancer.

P₁S₁S₃