TIVDAK® Mechanism of Action

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See Select Important Safety Information, including BOXED WARNING full Prescribing Information: https://docs.seagen.com/Tivdak_Full_L.... For US healthcare professionals. Select Important Safety Information does not include all info needed to use TIVDAK (tisotumab vedotin-tftv) for injection safely and effectively. • Indication • TIVDAK is indicated for the treatment of adult patients with recurrent or metastatic cervical cancer (r/mCC) with disease progression on or after chemotherapy. • Select Important Safety Information • BOXED WARNING: OCULAR TOXICITY: TIVDAK can cause severe ocular toxicities resulting in changes in vision, including severe vision loss, and corneal ulceration. Conduct an ophthalmic exam, including assessment of ocular symptoms, visual acuity, and slit lamp exam of the anterior segment of the eye prior to initiation of TIVDAK, prior to every cycle for the first 9 cycles, and as clinically indicated. Follow required premedication and eye care before, during, and after infusion. Withhold TIVDAK until improvement and resume, reduce the dose, or permanently discontinue, based on severity. • Warnings and Precautions • Ocular adverse reactions: TIVDAK can cause severe ocular adverse reactions that may lead to changes in vision and/or corneal ulceration. Follow required premedication and eye care before, during, and after infusion to reduce the risk of ocular adverse reactions. Refer patients to an eye care provider for any new/worsening ocular signs and symptoms. Withhold, reduce, or permanently discontinue TIVDAK based on the severity/persistence of the ocular adverse reaction. • Peripheral neuropathy (PN) occurred in patients treated with TIVDAK; 6% of patients experienced Grade 3 PN. Monitor patients for signs/symptoms of neuropathy. For new/worsening PN, withhold, then dose reduce, or permanently discontinue TIVDAK based on severity. • Hemorrhage occurred in patients treated with TIVDAK. Monitor patients for signs/symptoms of hemorrhage. For patients with pulmonary/central nervous system hemorrhage, permanently discontinue. For Grade ≥2 hemorrhage in any other location, withhold until bleeding has resolved, blood hemoglobin is stable, there is no bleeding diathesis that could increase the risk of continuing therapy, and there is no anatomical or pathologic condition that can increase the risk of hemorrhage recurrence. After resolution, either resume treatment or permanently discontinue. • Pneumonitis that is severe, life-threatening, or fatal can occur in patients treated with TIVDAK. Monitor patients for pulmonary symptoms of pneumonitis. Withhold for patients who develop persistent or recurrent Grade 2 pneumonitis and consider dose reduction. Permanently discontinue TIVDAK in all patients with Grade 3 or 4 pneumonitis. • Severe cutaneous adverse reactions (SCAR), including events of fatal or life-threatening Stevens-Johnson syndrome (SJS), can occur in patients treated with TIVDAK. Monitor patients for signs/symptoms of SCAR. If signs or symptoms of SCAR occur, withhold TIVDAK until the etiology of the reaction has been determined. Permanently discontinue TIVDAK for confirmed Grade 3 or 4 SCAR, including SJS. • Embryo-fetal toxicity: TIVDAK can cause fetal harm when administered to a pregnant woman. Advise patients of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with TIVDAK and for 2 months after the last dose. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with TIVDAK and for 4 months after the last dose. • Adverse Reactions • Across clinical trials of TIVDAK in 425 patients with r/mCC, the most common (≥25%) adverse reactions, including laboratory abnormalities, were hemoglobin decreased (45%), PN (39%), conjunctival adverse reactions (38%), nausea (37%), fatigue (36%), aspartate aminotransferase increased (33%), epistaxis (33%), alopecia (31%), alanine aminotransferase increased (30%), and hemorrhage (28%). • In the innovaTV 301 study in 250 patients with r/mCC with disease progression on or after systemic therapy, serious adverse reactions occurred in 33% of patients receiving TIVDAK; the most common (≥2%) were urinary tract infection (4.8%), small intestinal obstruction (2.4%), sepsis, abdominal pain, and hemorrhage (each 2%). Fatal adverse reactions occurred in 1.6% of patients who received TIVDAK, including acute kidney injury, pneumonia, sepsis, and SJS (each 0.4%). • Use with strong CYP3A4 inhibitors may increase unconjugated monomethyl auristatin E (MMAE) exposure. Monitor patients for adverse reactions. • Moderate/severe hepatic impairment: MMAE exposure and adverse reactions are increased. Avoid use. • Advise lactating women not to breastfeed during TIVDAK treatment and for ≥3 weeks after last dose. • Please see full Prescribing Information, including BOXED WARNING for TIVDAK, https://docs.seagen.com/Tivdak_Full_L...

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