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Drug overview for TIVDAK (tisotumab vedotin-tftv):
Generic name: tisotumab vedotin-tftv (tye-SOT-ue-mab ve-DOE-tin)
Drug class: Antineoplas-Tissue Factor Directed Ab-Microtub Disrupt Conj
Therapeutic class: Antineoplastics
Tisotumab vedotin-tftv, a tissue factor (TF)-directed immune globulin (Ig) G1-kappa antibody conjugated with the microtubule inhibitor monomethyl auristatin E (MMAE), is an antineoplastic agent.
No enhanced Uses information available for this drug.
Generic name: tisotumab vedotin-tftv (tye-SOT-ue-mab ve-DOE-tin)
Drug class: Antineoplas-Tissue Factor Directed Ab-Microtub Disrupt Conj
Therapeutic class: Antineoplastics
Tisotumab vedotin-tftv, a tissue factor (TF)-directed immune globulin (Ig) G1-kappa antibody conjugated with the microtubule inhibitor monomethyl auristatin E (MMAE), is an antineoplastic agent.
No enhanced Uses information available for this drug.
DRUG IMAGES
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The following indications for TIVDAK (tisotumab vedotin-tftv) have been approved by the FDA:
Indications:
Carcinoma of cervix
Professional Synonyms:
Cervical carcinoma cancer
Cervical carcinoma
Indications:
Carcinoma of cervix
Professional Synonyms:
Cervical carcinoma cancer
Cervical carcinoma
The following dosing information is available for TIVDAK (tisotumab vedotin-tftv):
If an adverse reaction occurs, treatment interruption, dosage reduction, and/or discontinuance of therapy may be necessary based on type and severity of the adverse effect.
The manufacturer's recommended dosage reduction schedule and dosing modifications for adverse reactions are provided in Tables 1 and 2.
For ocular adverse reactions (keratitis; conjunctival or corneal scarring or symblepharon; conjunctivitis and other ocular adverse reactions), refer patients to an eye care provider promptly for an assessment of new or worsening ocular symptoms.
Table 1: Dosage Reduction Schedule
Tisotumab Vedotin-tftv Dose Level Starting dose 2 mg/kg (up to a maximum of 200 mg for patients >=100 kg). First dose reduction 1.3 mg/kg (up to a maximum of 130 mg for patients >=100 kg).
Second dose reduction 0.9 mg/kg (up to a maximum of 90 mg for patients >=100 kg); permanently discontinue in patients who cannot tolerate 0.9 mg/kg.
Table 2: Dosage Modifications for Adverse Reactions
Adverse Reaction Severity, Occurrence, and Recommendation Keratitis Nonconfluent superficial keratitis (any occurrence): monitor. Confluent superficial keratitis, a corneal epithelial defect, or a 3 line or more loss in best corrected visual acuity (first occurrence): withhold dose until resolution or improvement to nonco nfluent superficial keratitis, then resume treatment at the next lower dose level. Confluent superficial keratitis, a corneal epithelial defect, or a 3 line or more loss in best corrected visual acuity (second occurrence): permanently discontinue.
Ulcerat ive keratitis or perforation (any occurrence): permanently discontinue. Conjunctival or corneal scarring or Any scarring or symblepharon (any symblepharon occurrence): permanently discontinue. Conjunctivitis and other ocular Nonconfluent superficial punctate adverse reactions conjunctival defects, mild vasodilation (any occurrence): monitor.
Confluent superficial punctate conjunctival defects, moderate to severe vasodilation (first occurrence): withhold dose until resolution or improvement to nonconfluent superficial punctate conjunctival defects, mild vasodilation, then resume treatment at the same dose. Confluent superficial punctate conjunctival defects, moderate to severe vasodilation (second occurrence): withhold dose until resolution or improvement to nonconfluent superficial punctate conjunctival defects, mild vasodilation, then resume treatment at the next lower dose level; if no resolution or improvement to nonconfluent superficial punctate conjunctival defects, mild vasodilation, per manently discontinue. Confluent superficial punctate conjunctival defects, moderate to severe vasodilation (third occurrence): permanently discontinue.
Conjunctival ulcer, conjunctival neovascularization, or fibrovascular scarring (any occurrence): perman ently discontinue. Peripheral neuropathy Grade 2 (any occurrence, either initial or worsening of pre-existing condition): withhold dose until grade <=1, then resume treatment at the next lower dose level. Grade 3 or 4 (any occurrence): permanently discontinue.
Hemorrhage Any grade pulmonary or CNS hemorrhage (any occurrence): permanently discontinue. Grade 2 in any other location (any occurrence): withhold until resolved, then resume treatment at the same dose. Grade 3 in any other location (first occurrence): withhold do se until resolved, then resume treatment at the same dose.
Grade 3 in any other location (second occurrence): permanently discontinue. Grade 4 in any other location (any occurrence): permanently discontinue. Pneumonitis Grade 2 (any occurrence): Withhold dose until grade <=1 for persistent or recurrent pneumonitis, consider resuming treatment at next lower dose level. Grade 3 or 4 (any occurrence): permanently discontinue. Severe cutaneous adverse reactions Suspected, any grade (any (including Stevens-Johnson syndrome occurrence): immediately withhold (SJS)) dose and consult a specialist to confirm the diagnosis Confirmed grade 3 or 4: permanently discontinue
The manufacturer's recommended dosage reduction schedule and dosing modifications for adverse reactions are provided in Tables 1 and 2.
For ocular adverse reactions (keratitis; conjunctival or corneal scarring or symblepharon; conjunctivitis and other ocular adverse reactions), refer patients to an eye care provider promptly for an assessment of new or worsening ocular symptoms.
Table 1: Dosage Reduction Schedule
Tisotumab Vedotin-tftv Dose Level Starting dose 2 mg/kg (up to a maximum of 200 mg for patients >=100 kg). First dose reduction 1.3 mg/kg (up to a maximum of 130 mg for patients >=100 kg).
Second dose reduction 0.9 mg/kg (up to a maximum of 90 mg for patients >=100 kg); permanently discontinue in patients who cannot tolerate 0.9 mg/kg.
Table 2: Dosage Modifications for Adverse Reactions
Adverse Reaction Severity, Occurrence, and Recommendation Keratitis Nonconfluent superficial keratitis (any occurrence): monitor. Confluent superficial keratitis, a corneal epithelial defect, or a 3 line or more loss in best corrected visual acuity (first occurrence): withhold dose until resolution or improvement to nonco nfluent superficial keratitis, then resume treatment at the next lower dose level. Confluent superficial keratitis, a corneal epithelial defect, or a 3 line or more loss in best corrected visual acuity (second occurrence): permanently discontinue.
Ulcerat ive keratitis or perforation (any occurrence): permanently discontinue. Conjunctival or corneal scarring or Any scarring or symblepharon (any symblepharon occurrence): permanently discontinue. Conjunctivitis and other ocular Nonconfluent superficial punctate adverse reactions conjunctival defects, mild vasodilation (any occurrence): monitor.
Confluent superficial punctate conjunctival defects, moderate to severe vasodilation (first occurrence): withhold dose until resolution or improvement to nonconfluent superficial punctate conjunctival defects, mild vasodilation, then resume treatment at the same dose. Confluent superficial punctate conjunctival defects, moderate to severe vasodilation (second occurrence): withhold dose until resolution or improvement to nonconfluent superficial punctate conjunctival defects, mild vasodilation, then resume treatment at the next lower dose level; if no resolution or improvement to nonconfluent superficial punctate conjunctival defects, mild vasodilation, per manently discontinue. Confluent superficial punctate conjunctival defects, moderate to severe vasodilation (third occurrence): permanently discontinue.
Conjunctival ulcer, conjunctival neovascularization, or fibrovascular scarring (any occurrence): perman ently discontinue. Peripheral neuropathy Grade 2 (any occurrence, either initial or worsening of pre-existing condition): withhold dose until grade <=1, then resume treatment at the next lower dose level. Grade 3 or 4 (any occurrence): permanently discontinue.
Hemorrhage Any grade pulmonary or CNS hemorrhage (any occurrence): permanently discontinue. Grade 2 in any other location (any occurrence): withhold until resolved, then resume treatment at the same dose. Grade 3 in any other location (first occurrence): withhold do se until resolved, then resume treatment at the same dose.
Grade 3 in any other location (second occurrence): permanently discontinue. Grade 4 in any other location (any occurrence): permanently discontinue. Pneumonitis Grade 2 (any occurrence): Withhold dose until grade <=1 for persistent or recurrent pneumonitis, consider resuming treatment at next lower dose level. Grade 3 or 4 (any occurrence): permanently discontinue. Severe cutaneous adverse reactions Suspected, any grade (any (including Stevens-Johnson syndrome occurrence): immediately withhold (SJS)) dose and consult a specialist to confirm the diagnosis Confirmed grade 3 or 4: permanently discontinue
Tisotumab vedotin-tftv is administered by IV infusion only; do not administer as an IV push or bolus. The drug is commercially available as a lyophilized powder that must be reconstituted and diluted prior to administration. Tisotumab vedotin infusion is administered over 30 minutes through an IV line containing a 0.2
mcm inline filter. Because the drug can cause severe ocular toxicities, clinicians must adhere to the required premedication and eye care recommendations before, during, and after infusion. Do not mix with or administer as an infusion with any other medications.
mcm inline filter. Because the drug can cause severe ocular toxicities, clinicians must adhere to the required premedication and eye care recommendations before, during, and after infusion. Do not mix with or administer as an infusion with any other medications.
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| TIVDAK 40 MG VIAL | Maintenance | Adults infuse 2 mg/kg (up to max 200 mg) by intravenous route every 3 weeks |
No generic dosing information available.
The following drug interaction information is available for TIVDAK (tisotumab vedotin-tftv):
There are 0 contraindications.
There are 0 severe interactions.
There are 2 moderate interactions.
The clinician should assess the patient’s characteristics and take action as needed. Actions required for moderate interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration.
| Drug Interaction | Drug Names |
|---|---|
| COVID-19 Vaccines/Immunosuppressives; Immunomodulators SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: Immunosuppressants and immunomodulators may prevent the immune system from properly responding to the COVID-19 vaccine.(1,2) CLINICAL EFFECTS: Administration of a COVID-19 vaccine with immunosuppressants or immunomodulators may interfere with vaccine-induced immune response and impair the efficacy of the vaccine. However, patients should be offered and given a COVID-19 vaccine even if the use and timing of immunosuppressive agents cannot be adjusted.(1,2) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: In an effort to optimize COVID-19 vaccine response, the American College of Rheumatology (ACR) published conditional recommendations for administration of COVID-19 vaccines with immunosuppressants and immunomodulators.(1) The CDC also provides clinical considerations for COVID-19 vaccination in patients on immunosuppressants.(2) The CDC states that all immunocompromised patients over 6 months of age should receive at least 1 dose of COVID-19 vaccine if eligible. See the CDC's Interim Clinical Considerations for Use of COVID-19 Vaccines for specific recommendations based on age, vaccination history, and vaccine manufacturer.(2) The ACR states that in general, immunosuppressants and immunomodulators should be held for 1-2 weeks after each vaccine dose. See below for specific recommendations for certain agents.(1) The CDC advises planning for vaccination at least 2 weeks before starting or resuming immunosuppressive therapy.(2) Patients should be offered and given a COVID-19 vaccine even if the use and timing of immunosuppressive agents cannot be adjusted.(1,2) B-cell depleting agents, including rituximab: The ACR recommends consulting with the rheumatologist to determine optimal timing of COVID-19 vaccination. Measuring CD19 B cells may be considered to determine need for a booster vaccine dose. If B cell levels are not measured, a supplemental vaccine dose 2-4 weeks before the next scheduled dose of rituximab is recommended.(1) The CDC states that the utility of B-cell quantification to guide clinical care is not known and is not recommended. Patients who receive B-cell depleting therapy should receive COVID-19 vaccines about 4 weeks before the next scheduled dose. For patients who received 1 or more doses of COVID-19 vaccine during treatment with B-cell-depleting therapies that were administered over a limited period (e.g., as part of a treatment regimen for certain malignancies), revaccination may be considered. The suggested interval to start revaccination is about 6 months after completion of the B-cell-depleting therapy.(2) Abatacept: - Subcutaneous abatacept should be withheld for 1-2 weeks after each vaccine dose, as disease activity allows. - For intravenous abatacept, time administration so that vaccination will occur 1 week before the next abatacept infusion.(1) Cyclophosphamide: When feasible, administer cyclophosphamide one week after each COVID-19 vaccine dose.(1) Recipients of hematopoietic cell transplant or CAR-T-cell therapy who received one or more doses of COVID-19 vaccine prior to or during treatment should undergo revaccination following the current CDC recommendations for unvaccinated patients. Revaccination should start at least 3 months (12 weeks) after transplant or CAR-T-cell therapy.(2) TNF-alpha inhibitors and cytokine inhibitors: The ACR was not able to reach consensus on whether to modify dosing or timing of these agents with COVID-19 vaccination.(1) The CDC includes these agents in their general recommendation to hold therapy for at least 2 weeks following vaccination.(2) DISCUSSION: The ACR convened a COVID-19 Vaccine Guidance Task Force to provide guidance on optimal use of COVID-19 vaccines in rheumatology patients. These recommendations are based on limited clinical evidence of COVID-19 vaccines in patients without rheumatic and musculoskeletal disorders and evidence of other vaccines in this patient population.(1) The ACR recommendation for rituximab is based on studies of humoral immunity following receipt of other vaccines. These studies have uncertain generalizability to vaccination against COVID-19, as it is unknown if efficacy is attributable to induction of host T cells versus B cell (antibody-based) immunity.(1) The ACR recommendation for mycophenolate is based on preexisting data of mycophenolate on non-COVID-19 vaccine immunogenicity. Emerging data suggests that mycophenolate may impair SARS-CoV-2 vaccine response in rheumatic and musculoskeletal disease and transplant patients.(1) The ACR recommendation for methotrexate is based on data from influenza vaccines and pneumococcal vaccines with methotrexate.(1) The ACR recommendation for JAK inhibitors is based on concerns related to the effects of JAK inhibitors on interferon signaling that may result in a diminished vaccine response.(1) The ACR recommendation for subcutaneous abatacept is based on several studies suggesting a negative effect of abatacept on vaccine immunogenicity. The first vaccine dose primes naive T cells, naive T cell priming is inhibited by CTLA-4, and abatacept is a CTLA-4Ig construct. CTLA-4 should not inhibit boosts of already primed T cells at the time of the second vaccine dose.(1) |
COMIRNATY 2024-2025, MODERNA COVID 24-25(6M-11Y)EUA, NOVAVAX COVID 2024-2025 (EUA), PFIZER COVID 2024-25(5-11Y)EUA, PFIZER COVID 2024-25(6M-4Y)EUA, SPIKEVAX 2024-2025 |
| Tisotumab/Anticoagulants; Antiplatelets SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: Bleeding, including hemorrhage, has been reported with the use of tisotumab.(1) CLINICAL EFFECTS: Concurrent use of tisotumab with either anticoagulants, antiplatelets, or NSAIDs may increase the risk of hemorrhage.(1) PREDISPOSING FACTORS: The risk for bleeding episodes may be greater in patients with disease-associated factors (e.g. thrombocytopenia). Drug associated risk factors include concurrent use of multiple drugs which inhibit anticoagulant/antiplatelet metabolism and/or have an inherent risk for bleeding (e.g. NSAIDs). PATIENT MANAGEMENT: Patients receiving concurrent therapy with tisotumab and anticoagulants, antiplatelets, and/or NSAIDs should be closely monitored for signs and symptoms of bleeding and changes in platelet count or International Normalized Ratio (INR). For patients experiencing pulmonary or central nervous system (CNS) hemorrhage, permanently discontinue tisotumab. For grade 2 or greater 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. After resolution, either resume treatment or permanently discontinue tisotumab.(1) If concurrent therapy is warranted, monitor patients receiving concurrent therapy for signs of blood loss, including decreased hemoglobin, hematocrit, fecal occult blood, and/or decreased blood pressure and promptly evaluate patients with any symptoms. When applicable, perform agent-specific laboratory tests (e.g. INR, aPTT) to monitor efficacy and safety of anticoagulation. Discontinue anticoagulation in patients with active pathologic bleeding. Instruct patients to report any signs and symptoms of bleeding, such as unusual bleeding from the gums or nose; unusual bruising; red or black, tarry stools; red, pink or dark brown urine; acute abdominal or joint pain and/or swelling. The time of highest risk for a coumarin-type drug interaction is when the precipitant drug is initiated or discontinued. Contact the prescriber before initiating, altering the dose or discontinuing either drug. DISCUSSION: Hemorrhage occurred in 62% of patients with cervical cancer treated with tisotumab across clinical trials. The most common all grade hemorrhage adverse reactions were epistaxis (44%), hematuria (10%), and vaginal hemorrhage (10%). Grade 3 hemorrhage occurred in 5% of patients.(1) |
AA 6%-D10W-CALCIUM-HEPARIN, ACD SOLUTION A, ACD-A, ACETYL SALICYLIC ACID, AGGRASTAT, ANAPROX DS, ANJESO, ANTICOAGULANT SODIUM CITRATE, ARGATROBAN, ARGATROBAN-0.9% NACL, ARIXTRA, ARTHROTEC 50, ARTHROTEC 75, ASA-BUTALB-CAFFEINE-CODEINE, ASCOMP WITH CODEINE, ASPIRIN, ASPIRIN-DIPYRIDAMOLE ER, BISMUTH SUBSALICYLATE, BIVALIRUDIN, BRILINTA, BROMFENAC SODIUM, BUPIVACAINE-KETOROLAC-KETAMINE, BUTALBITAL-ASPIRIN-CAFFEINE, CALDOLOR, CAMBIA, CARISOPRODOL-ASPIRIN, CARISOPRODOL-ASPIRIN-CODEINE, CELEBREX, CELECOXIB, CHOLINE MAGNESIUM TRISALICYLAT, CILOSTAZOL, CITRATE PHOSPHATE DEXTROSE, CLOPIDOGREL, COMBOGESIC, COMBOGESIC IV, CONSENSI, COXANTO, CRRT TRISODIUM CITRATE, DABIGATRAN ETEXILATE, DAYPRO, DICLOFENAC, DICLOFENAC POTASSIUM, DICLOFENAC SODIUM, DICLOFENAC SODIUM ER, DICLOFENAC SODIUM MICRONIZED, DICLOFENAC SODIUM-MISOPROSTOL, DIFLUNISAL, DIPYRIDAMOLE, DISALCID, DOLOBID, DURLAZA, EC-NAPROSYN, EFFIENT, ELIQUIS, ELMIRON, ELYXYB, ENOXAPARIN SODIUM, ENOXILUV, EPTIFIBATIDE, ETODOLAC, ETODOLAC ER, FELDENE, FENOPROFEN CALCIUM, FENOPRON, FLURBIPROFEN, FONDAPARINUX SODIUM, FRAGMIN, HEPARIN LOCK, HEPARIN SODIUM, HEPARIN SODIUM IN 0.45% NACL, HEPARIN SODIUM-0.45% NACL, HEPARIN SODIUM-0.9% NACL, HEPARIN SODIUM-D5W, HYDROCODONE-IBUPROFEN, IBU, IBUPAK, IBUPROFEN, IBUPROFEN LYSINE, IBUPROFEN-FAMOTIDINE, INDOCIN, INDOMETHACIN, INDOMETHACIN ER, INFLAMMACIN, INFLATHERM(DICLOFENAC-MENTHOL), JANTOVEN, KENGREAL, KETOPROFEN, KETOPROFEN MICRONIZED, KETOROLAC TROMETHAMINE, KIPROFEN, LODINE, LOFENA, LOVENOX, LURBIPR, MB CAPS, MECLOFENAMATE SODIUM, MEFENAMIC ACID, MELOXICAM, NABUMETONE, NABUMETONE MICRONIZED, NALFON, NAPRELAN, NAPROSYN, NAPROTIN, NAPROXEN, NAPROXEN SODIUM, NAPROXEN SODIUM CR, NAPROXEN SODIUM ER, NAPROXEN-ESOMEPRAZOLE MAG, NEOPROFEN, NORGESIC, NORGESIC FORTE, ORPHENADRINE-ASPIRIN-CAFFEINE, ORPHENGESIC FORTE, OXAPROZIN, PENTOSAN POLYSULFATE SODIUM, PHENYL SALICYLATE, PHENYLBUTAZONE, PIROXICAM, PLAVIX, PRADAXA, PRASUGREL HCL, R.E.C.K.(ROPIV-EPI-CLON-KETOR), RELAFEN DS, RIVAROXABAN, ROPIVACAINE-CLONIDINE-KETOROLC, ROPIVACAINE-KETOROLAC-KETAMINE, SALSALATE, SAVAYSA, SODIUM CITRATE, SODIUM SALICYLATE, SPRIX, SULINDAC, SUMATRIPTAN SUCC-NAPROXEN SOD, SYMBRAVO, TICAGRELOR, TIROFIBAN HCL, TOLECTIN 600, TOLMETIN SODIUM, TORONOVA II SUIK, TORONOVA SUIK, TOXICOLOGY SALIVA COLLECTION, TRESNI, TREXIMET, TRICITRASOL, TRISODIUM CITRATE CRRT, URIMAR-T, URNEVA, VIMOVO, VIVLODEX, WARFARIN SODIUM, XARELTO, YOSPRALA, ZIPSOR, ZONTIVITY, ZORVOLEX, ZYNRELEF |
The following contraindication information is available for TIVDAK (tisotumab vedotin-tftv):
Drug contraindication overview.
*None.
*None.
There are 1 contraindications.
Absolute contraindication.
| Contraindication List |
|---|
| Lactation |
There are 3 severe contraindications.
Adequate patient monitoring is recommended for safer drug use.
| Severe List |
|---|
| Hemorrhage |
| Peripheral neuropathy |
| Pregnancy |
There are 1 moderate contraindications.
Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.
| Moderate List |
|---|
| Child-pugh class A hepatic impairment |
The following adverse reaction information is available for TIVDAK (tisotumab vedotin-tftv):
Adverse reaction overview.
The most common (>=25%) adverse reactions, including laboratory abnormalities, were decreased hemoglobin, peripheral neuropathy, conjunctival adverse reactions, nausea, fatigue, increased AST, epistaxis, alopecia, increased ALT, and hemorrhage.
The most common (>=25%) adverse reactions, including laboratory abnormalities, were decreased hemoglobin, peripheral neuropathy, conjunctival adverse reactions, nausea, fatigue, increased AST, epistaxis, alopecia, increased ALT, and hemorrhage.
There are 20 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Hemorrhage Leukopenia Lymphopenia Prolonged activated partial thromboplastin time |
Conjunctival hemorrhage Corneal erosion Corneal ulcer Hypomagnesemia Ileus Interstitial pneumonitis Keratitis Multiple organ failure Neutropenic disorder Pneumonia Pulmonary thromboembolism Venous thrombosis |
| Rare/Very Rare |
|---|
|
Blistering skin Maculopapular rash Stevens-johnson syndrome Vision impairment |
There are 27 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Alopecia Blepharitis Conjunctivitis Diarrhea Dry eye Epistaxis Fatigue Nausea Peripheral sensory neuropathy Skin rash Visual changes |
Acute abdominal pain Anorexia Arthralgia Constipation Fever Foreign body sensation of eye Myalgia Ocular itching Pain in extremities Peripheral motor neuropathy Pruritus of skin Urinary tract infection Vomiting Weight loss |
| Rare/Very Rare |
|---|
|
Skin lesion Stomatitis |
The following precautions are available for TIVDAK (tisotumab vedotin-tftv):
Safety and effectiveness of tisotumab vedotin-tftv in pediatric patients have not been established.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
Tisotumab vedotin may cause fetal harm when administered to a pregnant woman based on the mechanism of action and findings from animal studies. Human data are not available to assess the drug-associated risk in pregnant women. In animal studies, the small molecule component of tisotumab vedotin (MMAE) caused embryofetal death and structural abnormalities in pregnant rats at exposure levels lower than those used clinically.
MMAE is a synthetic antineoplastic agent that disrupts the microtubule network in cells, leading to cell cycle arrest and apoptosis. Patients should be informed of the potential risk to a fetus.
MMAE is a synthetic antineoplastic agent that disrupts the microtubule network in cells, leading to cell cycle arrest and apoptosis. Patients should be informed of the potential risk to a fetus.
No data are available on whether tisotumab vedotin is present in human milk or whether the drug has any effects on a breastfed child or on milk production. Due to the potential for serious adverse reactions in a breastfed child, lactating women should be advised not to breastfeed during treatment and for 3 weeks after the final dose.
Among the 425 patients with cervical cancer treated with tisotumab vedotin-tftv in clinical trials, 14% were 65 years of age and older, and 2.4% were older than 75 years of age. Grade 3 or higher adverse reactions occurred in 60% of patients 65 years of age and older, compared to 55% of those younger than 65 years of age.
The drug was discontinued due to adverse reactions in 25% of patients 65 years of age and older, versus 13% of those younger than 65 years. The clinical studies did not include enough patients 65 years of age and older to determine if they respond differently from those younger than 65 years of age.
The drug was discontinued due to adverse reactions in 25% of patients 65 years of age and older, versus 13% of those younger than 65 years. The clinical studies did not include enough patients 65 years of age and older to determine if they respond differently from those younger than 65 years of age.
The following prioritized warning is available for TIVDAK (tisotumab vedotin-tftv):
WARNING: Tisotumab vedotin may cause serious eye problems. You should have regular eye exams before and during treatment with this medication. Follow your doctor's instructions carefully on what eye drops to use before and after your infusion of this medication.
Do not wear contact lenses while you are on treatment with this medication unless directed by the doctor. Tell your doctor right away if you have signs of eye problems, including dry eyes, eye pain/redness/irritation, or blurred/decreased vision. Ask your doctor or pharmacist for more details.
WARNING: Tisotumab vedotin may cause serious eye problems. You should have regular eye exams before and during treatment with this medication. Follow your doctor's instructions carefully on what eye drops to use before and after your infusion of this medication.
Do not wear contact lenses while you are on treatment with this medication unless directed by the doctor. Tell your doctor right away if you have signs of eye problems, including dry eyes, eye pain/redness/irritation, or blurred/decreased vision. Ask your doctor or pharmacist for more details.
The following icd codes are available for TIVDAK (tisotumab vedotin-tftv)'s list of indications:
| Carcinoma of cervix | |
| C53 | Malignant neoplasm of cervix uteri |
| C53.0 | Malignant neoplasm of endocervix |
| C53.1 | Malignant neoplasm of exocervix |
| C53.8 | Malignant neoplasm of overlapping sites of cervix uteri |
| C53.9 | Malignant neoplasm of cervix uteri, unspecified |
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