TIVDAK

Generic Name/API: tisotumab vedotin-tftv

Manufacturer: Seagen Inc.

Dosage Forms & Strength & Pack Size:
For Injection: 40 mg as a lyophilized cake or powder in a single-dose vial for
reconstitution.

Storage:
Store TIVDAK vials refrigerated at 2ºC to 8ºC (36ºF to 46ºF) in the original carton to protect from light. Do
not freeze. Do not shake.

  • INDICATION
  • IMPORTANT SAFETY INFORMATION

INDICATION
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
TIVDAK was FDA approved based on a clinical study that measured how many patients had a tumor response and how long that response lasted. Continued approval is dependent on the results of an ongoing study to confirm the benefit of TIVDAK.

IMPORTANT SAFETY INFORMATION
What is the most important information I should know about TIVDAK?
Eye problems are common with TIVDAK and can be serious. 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.

Your healthcare provider will send you to an eye specialist to check your eyes before you start treatment with TIVDAK, before each dose of TIVDAK, and as needed for any new or worsening signs and 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:

You should use steroid eye drops before each infusion and as prescribed for 72 hours after each infusion

You should use vasoconstrictor eye drops right before each infusion

You should 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.

What are the possible side effects of TIVDAK?
Serious side effects of TIVDAK may include:

Eye Problems. See “What is the most important information I should know about TIVDAK?”

Nerve problems (peripheral neuropathy) are common with TIVDAK and can be serious. Tell your healthcare provider right away if you have new or worsening numbness or tingling in your hands or feet or muscle weakness.

Bleeding problems (hemorrhage) are common with TIVDAK and can be serious. Tell your healthcare provider or get medical help right away if you have signs or symptoms of bleeding during treatment with TIVDAK including blood in your stools or black stools (looks like tar), blood in your urine, cough up or vomit blood, unusual vaginal bleeding, or 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 have 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 have signs or symptoms of a severe skin reaction during treatment with TIVDAK, including:

Skin reactions that look like rings (target lesions)
Rash or itching that continues to get worse
Blistering or peeling of the skin
Painful sores or ulcers in your mouth, nose, throat, or genital area
Fever or flu-like symptoms
Swollen lymph nodes
The most common side effects of TIVDAK include:

Decreased red blood cell and white blood cell counts

Tiredness

Nausea

Numbness or tingling in your hands or feet, or muscle weakness (peripheral neuropathy)

Hair loss (alopecia)

Nosebleed (epistaxis)

Eye problems (conjunctival disorders)

Bleeding (hemorrhage)

Changes in kidney function blood tests

Dry eye

Abnormal blood clotting test results

Diarrhea

Rash

Your healthcare provider may decrease your dose of TIVDAK, temporarily stop, or completely stop treatment if you have side effects.

What should I tell my healthcare provider before receiving TIVDAK?
Tell your healthcare provider about all 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

are breastfeeding (nursing) or plan to breastfeed. It is not known if TIVDAK passes into your breast milk. Do not breastfeed during treatment and for at least 3 weeks after the last dose of TIVDAK

Females who are able to become pregnant:

Your healthcare provider should do a pregnancy test before you start treatment with TIVDAK

You should use an effective method of birth control during your treatment and for at least
2 months after the last dose of TIVDAK

Males with female partners who are able to become pregnant:

You should use effective birth control during treatment and for 4 months after the 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.

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