Antibody–Drug Conjugate for Recurrent or Metastatic Cervical Cancer
Boxed Warning: TIVDAK can cause severe ocular toxicity leading to vision changes or permanent vision loss. Strict adherence to ophthalmic precautions is mandatory before, during, and after infusion.
🧩 Mechanism of Action
Tisotumab vedotin-tftv is an antibody-drug conjugate (ADC) that targets tissue factor (TF) expressed on cervical cancer cells.
The antibody binds to TF → internalized → releases monomethyl auristatin E (MMAE), a microtubule inhibitor.
This disrupts cell division and triggers apoptosis.
🎯 Indication
For the treatment of adult patients with recurrent or metastatic cervical cancer who have disease progression on or after chemotherapy.
💉 Dosing & Administration
Parameter
Recommendation
Dose
2 mg/kg (max 200 mg) IV over 30 min every 3 weeks
Route
IV infusion only — Do NOT give IV push or bolus
Duration
Continue until disease progression or unacceptable toxicity
⚗️ Reconstitution & Preparation
Reconstitute each 40 mg vial with 4 mL Sterile Water for Injection → 10 mg/mL.
Gently swirl; do not shake. Inspect for clarity (clear–slightly opalescent, colorless–brownish-yellow).
Dilute into an infusion bag (D5W / NS / LR) to a final concentration 0.7–2.4 mg/mL.
Infuse through 0.2 µm in-line filter over 30 min.
Protect from light; do not freeze.
🧊 Storage (after dilution):
D5W: up to 24 h refrigerated (2–8 °C)
NS: 18 h refrigerated
LR: 12 h refrigerated
👁️ Required Premedication & Eye Care
To prevent ocular toxicity:
Step
Medication / Action
Timing
1
Ophthalmic exam (visual acuity + slit lamp)
Prior to initiation and before each cycle × 9
2
Topical corticosteroid eye drops
1 drop/eye before infusion → TID × 72 h after
3
Topical vasoconstrictor drops
Immediately before infusion
4
Cold eye pads
During entire infusion
5
Lubricating eye drops
Continuously through therapy + 30 days after
6
Avoid contact lenses
Throughout treatment unless cleared by ophthalmology
🧾 Monitoring Parameters
Parameter
Frequency / Rationale
Ophthalmic exam
Baseline + each cycle × 9 → detect early corneal/conjunctival toxicity
CBC
Monitor for anemia, thrombocytopenia, bleeding risk
LFTs (AST/ALT)
Track for drug-induced hepatotoxicity
Renal function
Assess clearance / MMAE accumulation
Neurologic exam
Screen for peripheral neuropathy
Pulmonary symptoms
Evaluate for pneumonitis if dyspnea/cough develop
Skin exam
Early recognition of Stevens–Johnson Syndrome (SJS)
⚠️ Major Warnings & Precautions
Toxicity
Key Monitoring / Management
Ocular toxicity
Follow strict eye-care protocol; withhold/reduce per severity.
Peripheral neuropathy (39%)
Monitor paresthesia / weakness; dose hold or discontinue Grade ≥ 2.
Hemorrhage (51%)
Observe for epistaxis, hematuria, GI bleeding; Permanently discontinue for CNS/pulmonary bleeds.
Pneumonitis
Monitor for new dyspnea or cough; permanently discontinue Grade 3–4.
Severe cutaneous reactions (SJS)
Withhold if suspected; permanently discontinue if confirmed.
Embryo-fetal toxicity
Contraindicated in pregnancy; advise contraception (f × 2 mo / m × 4 mo after last dose).
🚫 Contraindications
None listed. However, avoid in moderate–severe hepatic impairment (↑ MMAE exposure).
