Tisotumab vedotin-tftv
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Tejasvi Aryaputra
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Black Box Warning
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See full prescribing information for complete Boxed Warning.
Condition Name: (Content)
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Overview
Tisotumab vedotin-tftv is a tissue factor-directed antibody and microtubule inhibitor conjugate that is FDA approved for the treatment of recurrent or metastatic cervical cancer with disease progression on or after chemotherapy.. There is a Black Box Warning for this drug as shown here. Common adverse reactions include 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..
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
- 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.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Tisotumab vedotin-tftv in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Tisotumab vedotin-tftv in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding Tisotumab_vedotin-tftv FDA-Labeled Indications and Dosage (Pediatric) in the drug label.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Tisotumab vedotin-tftv in pediatric patients.
Non–Guideline-Supported Use
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
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See full prescribing information for complete Boxed Warning.
Condition Name: (Content)
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Ocular Adverse Reactions
- 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.
Peripheral Neuropathy
- 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.
Hemorrhage
- 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%).
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Tisotumab vedotin-tftv Clinical Trials Experience in the drug label.
Postmarketing Experience
There is limited information regarding Tisotumab vedotin-tftv Postmarketing Experience in the drug label.
Drug Interactions
There is limited information regarding Tisotumab vedotin-tftv Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Tisotumab vedotin-tftv in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Tisotumab vedotin-tftv in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Tisotumab vedotin-tftv during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Tisotumab vedotin-tftv in women who are nursing.
Pediatric Use
There is no FDA guidance on the use of Tisotumab vedotin-tftv in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Tisotumab vedotin-tftv in geriatric settings.
Gender
There is no FDA guidance on the use of Tisotumab vedotin-tftv with respect to specific gender populations.
Race
There is no FDA guidance on the use of Tisotumab vedotin-tftv with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Tisotumab vedotin-tftv in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Tisotumab vedotin-tftv in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Tisotumab vedotin-tftv in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Tisotumab vedotin-tftv in patients who are immunocompromised.
Administration and Monitoring
Administration
There is limited information regarding Tisotumab vedotin-tftv Administration in the drug label.
Monitoring
There is limited information regarding Tisotumab vedotin-tftv Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of Tisotumab vedotin-tftv and IV administrations.
Overdosage
There is limited information regarding Tisotumab vedotin-tftv overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.
Pharmacology
There is limited information regarding Tisotumab vedotin-tftv Pharmacology in the drug label.
Mechanism of Action
There is limited information regarding Tisotumab vedotin-tftv Mechanism of Action in the drug label.
Structure
There is limited information regarding Tisotumab vedotin-tftv Structure in the drug label.
Pharmacodynamics
There is limited information regarding Tisotumab vedotin-tftv Pharmacodynamics in the drug label.
Pharmacokinetics
There is limited information regarding Tisotumab vedotin-tftv Pharmacokinetics in the drug label.
Nonclinical Toxicology
There is limited information regarding Tisotumab vedotin-tftv Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Tisotumab vedotin-tftv Clinical Studies in the drug label.
How Supplied
There is limited information regarding Tisotumab vedotin-tftv How Supplied in the drug label.
Storage
There is limited information regarding Tisotumab vedotin-tftv Storage in the drug label.
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
There is limited information regarding Tisotumab vedotin-tftv Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol-Tisotumab vedotin-tftv interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
There is limited information regarding Tisotumab vedotin-tftv Brand Names in the drug label.
Look-Alike Drug Names
There is limited information regarding Tisotumab vedotin-tftv Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.