View source for Tisotumab vedotin-tftv

{{DrugProjectFormSinglePage
|authorTag=Tejasvi Aryaputra
|genericName=Tisotumab vedotin-tftv
|aOrAn=a
|drugClass=tissue factor-directed antibody and microtubule inhibitor conjugate
|indicationType=treatment
|indication=recurrent or metastatic cervical cancer with disease progression on or after chemotherapy.
|hasBlackBoxWarning=Yes
|adverseReactions=[[peripheral neuropathy]], [[alopecia]], [[epistaxis]], [[leukocytes]] decreased, [[creatinine]] increased, [[dry eye]], activated partial [[thromboplastin]] time prolonged, [[hemoglobin]] decreased, conjunctival adverse reactions, [[hemorrhage]], [[fatigue]], [[lymphocytes]] decreased, [[nausea]], prothrombin international normalized ratio increased, [[rash]], and [[diarrhea]].
|blackBoxWarningTitle='''<span style="color:#FF0000;">TITLE</span>'''
|blackBoxWarningBody=''<span style="color:#FF0000;">Condition Name:</span>'' (Content)
|fdaLIADAdult=<b>
*2 mg/kg is the recommended dosage of Tisotumab_vedotin-tftv through an intravenous infusion.
*Dosage should be given for 30 minutes every 3 weeks.
|offLabelAdultGuideSupport=There is limited information regarding ''Off-Label Guideline-Supported Use'' of Tisotumab vedotin-tftv in adult patients.
|offLabelAdultNoGuideSupport=There is limited information regarding ''Off-Label Non–Guideline-Supported Use'' of Tisotumab vedotin-tftv in adult patients.
|fdaLIADPed=There is limited information regarding Tisotumab_vedotin-tftv FDA-Labeled Indications and Dosage (Pediatric) in the drug label.
|offLabelPedGuideSupport=There is limited information regarding ''Off-Label Guideline-Supported Use'' of Tisotumab vedotin-tftv in pediatric patients.
|offLabelPedNoGuideSupport=There is limited information regarding ''Off-Label Non–Guideline-Supported Use'' of Tisotumab vedotin-tftv in pediatric patients.
|contraindications=There are no contraindications associated with Tisotumab_vedotin-tftv.
|warnings=<b>Ocular Adverse Reactions </b>
*Clinical studies show that 60% of patients with cervical cancer reported ocular adverse reactions when taking Tisotumab_vedotin-tftv.
*Of the patients with ocular adverse reactions, patients reported corneal adverse reactions (21%), conjunctival adverse reactions (40%), blepharitis (8%), and dry eye (29%) are the most common.
*3.8% of patients reported grade 3 ocular adverse reactions.
*Corneal transplantation was required in one patient with signs of ulcerative keratitis with perforation when taking Tisotumab_vedotin-tftv.
*1.2 months was the median time of onset for patients that had  first ocular adverse.
*55% of patients who had ocular events displayed complete resolution.
*30% of patients who had ocular events partial improvement which is defined as a decrease in severity by one or more grades from the worst grade.
*6% of patients with cervical cancer discontinued use of Tisotumab_vedotin-tftv when patients showed signs of ocular adverse reactions.
*Visual acuity changes to 20/50 or worse was seen in 4% of patients in innovaTV 204 where 75% had resolution this issue.
*Visual acuity change to 20/200 was seen in 1% of patients in innovaTV 204 of the patients that had visual acuity changes to 20/50 or worse.
*Advise patients prior to each dose of Tisotumab_vedotin-tftv to get an ophthalmic exam. 
*Monitor patients slit lamp exam and visual acuity at baseline.
*Advise patients to report any signs and symptoms of new or worsening ocular reactions. 
*Advise patients with adverse reactions to permanently discontinue, withhold, or reduce the dose of Tisotumab_vedotin-tftv based on the severity.

<b>Peripheral Neuropathy </b>
*42% of patients with cervical cancer displayed peripheral neuropathy when taking Tisotumab_vedotin-tftv.
*8% of patients with peripheral neuropathy displayed Grade 3 peripheral neuropathy.
*Of the patients with peripheral neuropathy, peripheral sensory neuropathy (11%), motor neuropathy (3%), demyelinating peripheral polyneuropathy (1%), peripheral neuropathy (20%), peripheral sensorimotor neuropathy (5%), and muscular weakness (3%) are the most common adverse reactions reported in patients.
*Guillain-Barre syndrome was reported in one patient with another tumor type when taking Tisotumab_vedotin-tftv.
*2.4 months is the median time to onset in patients that displayed peripheral neuropathy.
*17% of patients who had ocular events displayed complete resolution.
*17% of patients who had ocular events partial improvement which is defined as a decrease in severity by one or more grades from the worst grade.
*8% of patients with cervical cancer discontinued use of Tisotumab_vedotin-tftv when patients showed signs of peripheral neuropathy.
*Advise patients about signs and symptoms of peripheral neuropathy such as neuropathic pain, muscle weakness, tingling or a burning sensation, dysesthesia, or paresthesia.
*Advise patients with adverse reactions to permanently discontinue, withhold, or reduce the dose of Tisotumab_vedotin-tftv based on the severity.

<b>Hemorrhage </b>
*62% of patients with cervical cancer reported Hemorrhage when taking Tisotumab_vedotin-tftv.
*Of the patients that reported signs of Hemorrhage, hematuria (10%), epistaxis (44%), and vaginal hemorrhage (10%).
|alcohol=Alcohol-Tisotumab vedotin-tftv interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
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