(tisotumab vedotin-tftv)

Prescribing Information
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2 DOSAGE AND ADMINISTRATION

2 DOSAGE AND ADMINISTRATION

2.1 Recommended Dosage

The recommended dose of TIVDAK is 2 mg/kg (up to a maximum of 200 mg for patients ≥100 kg) administered as an intravenous infusion over 30 minutes every 3 weeks until disease progression or unacceptable toxicity.

2.2 Premedication and Required Eye Care

Adhere to the following recommendations to reduce the risk of ocular adverse reactions [see Warnings and Precautions (5.1)].

•
Ophthalmic exam by eye care provider: Conduct an ophthalmic exam prior to initiation of TIVDAK, prior to every cycle for the first nine cycles, and as clinically indicated. The ophthalmic exam should include visual acuity, slit lamp exam of the anterior segment of the eye, and an assessment of normal eye movement.
•
Topical corticosteroid eye drops: Instruct patients to administer one drop in each eye prior to each infusion and to continue to administer eye drops in each eye three times daily for 72 hours after each infusion. The initial prescription and all renewals of any corticosteroid medication should be made only after examination with a slit lamp.
•
Topical ocular vasoconstrictor drops: Administer in each eye immediately prior to each infusion of TIVDAK.
•
Cold packs: Use cooling eye pads during each infusion of TIVDAK.
•
Topical lubricating eye drops: Instruct patients to administer for the duration of therapy and for 30 days after the last dose of TIVDAK.
•
Contact lenses: Advise patients to avoid wearing contact lenses for the entire duration of therapy unless advised by their eye care provider.

2.3 Dosage Modifications for Adverse Reactions

The recommended TIVDAK dose reduction schedule is provided in Table 1.

Table 1: Dosage Reduction Schedule
*
Permanently discontinue in patients who cannot tolerate 0.9 mg/kg

 

TIVDAK 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)

The recommended dose modifications for adverse reactions are provided in Table 2.

Table 2: Dosage Modifications for Adverse Reactions
*
Refer patients to an eye care provider promptly for an assessment of new or worsening ocular symptoms.

Adverse Reaction

Severity

Occurrence

TIVDAK Dose Modification

Keratitis*

[see Warnings and Precautions (5.1)]

Nonconfluent superficial keratitis

Any

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 nonconfluent superficial keratitis, then resume treatment at the next lower dose level.

Second occurrence

Permanently discontinue.

Ulcerative keratitis or perforation

Any

Permanently discontinue.

Conjunctival or corneal scarring or symblepharon*

[see Warnings and Precautions (5.1)]

Any scarring or symblepharon

Any

Permanently discontinue.

Conjunctivitis and other ocular adverse reactions*

[see Warnings and Precautions (5.1)]

Nonconfluent superficial punctate conjunctival defects, mild vasodilation

Any

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.

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, permanently discontinue.

Third occurrence

Permanently discontinue.

Conjunctival ulcer, conjunctival neovascularization, or fibrovascular scarring

Any

Permanently discontinue.

Peripheral Neuropathy

[see Warnings and Precautions (5.2)]

Grade 2

Any (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

Permanently discontinue.

Hemorrhage

[see Warnings and Precautions (5.3)]

Any grade pulmonary or CNS

Any

Permanently discontinue.

Grade 2 in any other location

Any

Withhold until resolved, then resume treatment at the same dose.

Grade 3 in any other location

First occurrence

Withhold dose until resolved, then resume treatment at the same dose.

Second occurrence

Permanently discontinue.

Grade 4 in any other location

Any

Permanently discontinue.

Pneumonitis

[see Warnings and Precautions (5.4)]

Grade 2

Any

Withhold dose until Grade ≤1 for persistent or recurrent pneumonitis, consider resuming treatment at next lower dose level.

Grade 3 or 4

Any

Permanently discontinue.

Severe cutaneous adverse reactions (including Stevens-Johnson syndrome (SJS))

[see Warnings and Precautions (5.5)]

Suspected (any grade)

Any

Immediately withhold dose and consult a specialist to confirm the diagnosis.

Confirmed Grade 3 or 4

Any

Permanently discontinue.

2.4 Instructions for Preparation and Administration

•
Administer TIVDAK as an intravenous infusion only.
•
TIVDAK is a hazardous drug. Follow applicable special handling and disposal procedures1.
•
DO NOT administer TIVDAK as an intravenous push or bolus.
•
DO NOT mix TIVDAK with, or administer as an infusion with, other medicinal products.

Use appropriate aseptic technique for reconstitution and preparation of dosing solutions. Prior to administration, the TIVDAK vial is reconstituted with Sterile Water for Injection, USP. The reconstituted solution is subsequently diluted in an intravenous infusion bag containing one of the following: 5% Dextrose Injection USP, 0.9% Sodium Chloride Injection, USP, or Lactated Ringer’s Injection, USP.

Reconstitution in Single-dose Vial

1.
Calculate the recommended dose based on the patient’s weight to determine the number of vials needed.
2.
Reconstitute each 40 mg vial with 4 mL of Sterile Water for Injection, USP, resulting in 10 mg/mL TIVDAK.
3.
Slowly swirl each vial until the contents are completely dissolved. Allow the reconstituted vial(s) to settle. DO NOT SHAKE THE VIAL. Do not expose to direct sunlight.
4.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. The reconstituted solution should be clear to slightly opalescent, colorless to brownish-yellow and free of visible particles. Discard any vial with visible particles or discoloration.
5.
Based upon the calculated dose amount, the reconstituted solution from the vial(s) should be added to the infusion bag immediately. This product does not contain a preservative. If not used immediately, reconstituted vials may be stored for up to 24 hours in refrigeration at 2°C to 8°C (36 °F to 46 °F) or at room temperature up to 25°C (77°F) for up to a maximum of 8 hours prior to dilution. DO NOT FREEZE. Do not expose to direct sunlight. Discard unused vials with reconstituted solution beyond the recommended storage time.

Dilution in Infusion Bag

1.
Withdraw the calculated dose amount of reconstituted solution from the vial(s) and transfer into an infusion bag.
2.
Dilute TIVDAK with one of the following: 5% Dextrose Injection, USP, 0.9% Sodium Chloride Injection, USP or Lactated Ringer's Injection, USP. The infusion bag size should allow enough diluent to achieve a final concentration of 0.7 mg/mL to 2.4 mg/mL TIVDAK.
3.
Mix diluted solution by gentle inversion. DO NOT SHAKE THE BAG. Do not expose to direct sunlight.
4.
Visually inspect the infusion bag for any particulate matter or discoloration prior to use. The reconstituted solution should be clear to slightly opalescent, colorless to brownish-yellow and free of visible particles. Discard the infusion bag if particulate matter or discoloration is observed.
5.
Discard any unused portion left in the single-dose vials.

Administration

1.
Confirm administration of steroid and vasoconstrictor eye drops [see Dosage and Administration (2.2)].
2.
Apply cold packs fully over the eyes following administration of the vasoconstrictor eye drops. Change cold packs as needed throughout infusion to ensure eye area remains cold during the entire infusion [see Dosage and Administration (2.2)].
3.
Immediately administer the infusion over 30 minutes through an intravenous line containing a 0.2 µm in-line filter.
4.
If the infusion is not administered immediately, store the diluted TIVDAK solution in refrigeration as specified in Table 3. Discard if storage time exceeds these limits. DO NOT FREEZE. Once removed from refrigeration, complete administration of the diluted infusion solution of TIVDAK within 4 hours (including infusion time).
Table 3: Diluted TIVDAK Solution Refrigeration Storage Conditions

Diluent Used to Prepare Solution for Infusion

Diluted TIVDAK Solution Storage
Conditions (Including Infusion Time)

 5% Dextrose Injection, USP

Up to 24 hours at 2°C to 8°C (36°F to 46°F)

0.9% Sodium Chloride Injection, USP

Up to 18 hours at 2°C to 8°C (36°F to 46°F)

 Lactated Ringer’s Injection, USP

Up to 12 hours at 2°C to 8°C (36°F to 46°F)

Medication Guide

MEDICATION GUIDE

MEDICATION GUIDE

This Medication Guide has been approved by the U.S. Food and Drug Administration.     Revised: 11/2025

MEDICATION GUIDE
TIVDAK (TIV-dack)
(tisotumab vedotin-tftv)
for injection, for intravenous use

What is the most important information I should know about TIVDAK?
TIVDAK can cause serious side effects, including:
Eye problems. Eye problems are common with TIVDAK, and can also be severe. TIVDAK can cause changes to the surface of your eye that can lead to dry eyes, eye redness, eye irritation, corneal ulcers, blurred vision, and severe vision loss. Tell your healthcare provider if you develop new or worsening vision changes or eye problems during treatment with TIVDAK.

•
Your healthcare provider will send you to an eye specialist to check your eyes before you start treatment with TIVDAK, before each infusion for your first 9 infusions of TIVDAK, and as needed for any new or worsening signs or symptoms of eye problems.
•
Your healthcare provider will ask if you have any signs or symptoms of eye problems before each infusion. You will be referred to an eye specialist for any new or worsening signs or symptoms of eye problems.
•
Your healthcare provider will prescribe 3 different types of eye drops before you start treatment with TIVDAK. Bring the eye drops with you to each infusion and use them as directed by your healthcare provider to reduce your risk of eye problems:
o
Use 1 drop of steroid eye drops in each eye before each infusion and continue to use your eye drops 3 times a day for 3 days after each infusion.
o
Use vasoconstrictor eye drops right before each infusion.
o
Use lubricating eye drops throughout treatment and for 30 days after your last dose of TIVDAK.
•
Do not wear contact lenses throughout your treatment with TIVDAK unless you are told to use them by your eye specialist.

See “What are the possible side effects of TIVDAK?” for more information about side effects.

What is TIVDAK?
TIVDAK is a prescription medicine used to treat adults with cervical cancer:

•
that has returned or has spread to other parts of the body, and
•
who have received chemotherapy that did not work or is no longer working.

It is not known if TIVDAK is safe and effective in children.

Before receiving TIVDAK, tell your healthcare provider about all of your medical conditions, including if you:

•
have a history of vision or eye problems
•
have numbness or tingling in your hands or feet
•
have bleeding problems
•
have liver problems
•
are pregnant or plan to become pregnant. TIVDAK can harm your unborn baby. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with TIVDAK.
Females who are able to become pregnant:
o
Your healthcare provider should do a pregnancy test before you start treatment with TIVDAK.
o
You should use an effective birth control during treatment and for 2 months after your last dose of TIVDAK.
 
Males with female partners who are able to become pregnant:
o
You should use an effective birth control during treatment and for 4 months after your last dose of TIVDAK.
•
are breastfeeding or plan to breastfeed. It is not known if TIVDAK passes into your breast milk. Do not breastfeed during treatment and for 3 weeks after your last dose of TIVDAK.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking TIVDAK with certain other medicines may cause side effects.

How will I receive TIVDAK?

•
TIVDAK will be given to you by intravenous (IV) infusion into your vein over 30 minutes.
•
TIVDAK is usually given every 3 weeks.
•
Your healthcare provider will decide how many infusions you need.
•
Your healthcare provider will put cold packs on your eyes during each infusion.
•
Your healthcare provider may decrease your dose, temporarily stop, or completely stop treatment with TIVDAK if you have side effects.

What are the possible side effects of TIVDAK?
TIVDAK can cause serious side effects, including: 

•
See “What is the most important information I should know about TIVDAK?”
•
Peripheral neuropathy. Nerve problems called peripheral neuropathy are common with TIVDAK, and can also be serious. Tell your healthcare provider right away if you get numbness or tingling in your hands or feet or muscle weakness.
•
Bleeding (hemorrhage). Bleeding problems are common with TIVDAK, and can also be serious. Tell your healthcare provider or get medical help right away if you get signs or symptoms of bleeding during treatment with TIVDAK, including:
o
blood in your stools or black stools (looks like tar)
o
blood in your urine
o
cough up or vomit blood
o
unusual vaginal bleeding
o
any unusual or heavy bleeding
•
Lung problems. TIVDAK may cause severe or life-threatening inflammation of the lungs that can lead to death. Tell your healthcare provider right away if you get new or worsening symptoms, including trouble breathing, shortness of breath, or cough.
•
Severe skin reactions. TIVDAK may cause severe or life-threatening skin reactions that can lead to death. Tell your healthcare provider or get medical help right away if you get signs or symptoms of a severe skin reaction during treatment with TIVDAK, including:
o
skin reactions that look like rings (target lesions)
o
rash or itching that continues to get worse
o
blistering or peeling of the skin
o
painful sores or ulcers in your mouth, nose, throat, or genital area
o
fever or flu-like symptoms
o
swollen lymph nodes

The most common side effects of TIVDAK include:

•
decreased red blood cell counts
•
numbness or tingling in your hands or feet
•
eye problems (conjunctival disorders)
•
nausea
•
tiredness
•
changes in liver function blood tests
•
nosebleed
•
hair loss (alopecia)
•
bleeding (hemorrhage)

TIVDAK may cause fertility problems in females and males, which may affect your ability to have children. Talk to your healthcare provider if this is a concern for you.
These are not all of the possible side effects of TIVDAK.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

General information about the safe and effective use of TIVDAK.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. If you would like more information about TIVDAK, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about TIVDAK that is written for healthcare professionals.

What are the ingredients in TIVDAK?
Active ingredient: tisotumab vedotin-tftv
Inactive ingredients: d-mannitol, l-histidine, l-histidine monohydrochloride, and sucrose.
Manufactured by: Seagen Inc., Bothell, WA 98021
Marketed by: Seagen Inc., Bothell, WA 98021 and Genmab US, Inc., Plainsboro, NJ 08536
U.S. License 2257
TIVDAK® is a trademark owned by Seagen Inc.
©2025 Seagen Inc. and Genmab US, Inc.
LAB-1597-1.0
For more information, go to www.tivdak.com or call 1-855-4SEAGEN

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