TIVDAK is a prescription medicine used to treat adult patients with recurrent or metastatic cervical cancer (cancer of the the cervix) whose disease has progressed after chemotherapy.
It is a type of therapy called an antibody-drug conjugate (ADC), which targets cancer cells and delivers a cytotoxic (cell-killing) agent directly to them.
Important Safety Warning
TIVDAK can cause serious eye problems, including injury to the surface of your eye, ulcers, vision changes, or even permanent vision loss.
This is the most important risk to be aware of. You must closely follow the required eye care plan before, during, and after each infusion.
If you develop new or worsening eye symptoms or vision changes, contact your doctor or eye-care provider immediately.
What to Tell Your Doctor Before Starting TIVDAK
Before you start TIVDAK, tell your doctor if you:
Have any eye or vision problems
Wear contact lenses
Have numbness, tingling, or weakness in your hands or feet
Have bleeding or blood clotting problems
Have liver problems
Are pregnant, planning to become pregnant, or breastfeeding
Are taking other medications, especially ones that strongly affect the liver enzyme CYP3A4 (these may increase risk of side effects)
How TIVDAK Is Given / What to Expect
You will get TIVDAK by intravenous (IV) infusion over 30 minutes every 3 weeks, until your disease worsens or you develop unacceptable side effects.
The full infusion appointment may take about 60 minutes, including applying eye drops, cold packs, etc.
Your dose is usually 2.0 mg per kg of body weight, up to a maximum of 200 mg (for patients weighing ≥ 100 kg)
If side effects occur, your doctor may delay, reduce, or stop TIVDAK treatment.
Your eye health is critical while on TIVDAK. The following steps help reduce the risk of eye damage:
Eye Exams
Before you start TIVDAK
Before every dose (for the first 9 cycles)
As your eye doctor recommends after that
Eye Drops & Eye Protection
Use corticosteroid eye drops before, during, and after each infusion (as instructed)
Use lubricating (artificial tear) eye drops regularly during treatment and continue for 30 days after stopping TIVDAK
Use cold eye pads during infusion to protect the eyes
Use vasoconstrictor eye drops prior to infusion (as directed)
Do not use contact lenses during treatment unless your eye doctor says it’s okay
Report Eye Symptoms Promptly Tell your doctor or eye-care provider right away if you have new or worsening:
Blurred vision
Eye pain, redness, irritation
Sensation of something in your eye
Changes in tear production or dryness
Possible Side Effects / What to Watch For
Some side effects are common; some can be serious:
Common Side Effects (seen in ≥25% of patients)
Decreased red blood cell counts (anemia)
Numbness or tingling (peripheral neuropathy)
Eye problems (conjunctivitis, dry eye)
Nausea
Feeling tired (fatigue)
Elevated liver enzymes (AST, ALT)
Nosebleed (epistaxis)
Hair loss (alopecia)
Bleeding (hemorrhage)
Serious Side Effects You Should Know About
Severe eye toxicity, including ulcers, vision changes, corneal damage, and possibly permanent vision loss
Peripheral neuropathy (nerve damage) — numbness, tingling, weakness in arms or legs; may require dose changes or stopping treatment
Bleeding / Hemorrhage — nosebleeds are common; more serious bleeding (e.g. GI bleeding) is possible
Pneumonitis (lung inflammation) — may be severe; symptoms include shortness of breath, cough, fever
Severe skin reactions, including Stevens-Johnson syndrome (SJS) — a rare but serious rash that requires immediate medical attention
Death — in clinical trials, some fatal side effects occurred (e.g., sepsis, pneumonitis)
What Your Doctor Will Do to Monitor You
Your medical team will order tests and check for side effects, including:
Eye exams before and during treatment (as described above)
Complete blood counts (CBC) to watch for anemia or low blood cells
Liver function tests (AST, ALT, bilirubin) to detect liver injury
Kidney function tests (creatinine, BUN)
Neurologic assessments (checking for neuropathy)
Pulmonary monitoring (if you develop cough, breathing changes)
Skin checks (for rash or blistering)
If you develop side effects, your doctor might hold, reduce, or permanently stop TIVDAK depending on severity.
Pregnancy, Breastfeeding & Contraception
TIVDAK can harm an unborn baby. Do not use it if you’re pregnant.
Women of reproductive potential must use effective contraception during treatment and for 2 months after the last dose.
Men with female partners of childbearing potential must use effective contraception during treatment and for 4 months after the last dose.
It is unknown if TIVDAK is safe while breastfeeding—do not breastfeed during treatment.
Drug Interactions
TIVDAK’s active part (MMAE) is processed by the CYP3A4 enzyme
Using strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin) at the same time may increase the risk of TIVDAK side effects.
Always tell your doctor or pharmacist about all medicines—prescription, over-the-counter, vitamins, herbal supplements.
What You Can Do to Stay Safe / Tips for Patients
Keep all your eye appointments and follow eye-care instructions exactly
Use all eye drops as instructed
Report any new symptoms right away—vision changes, eye pain, tingling or numbness in hands/feet, bleeding, cough or breathing trouble, rash, or other unexpected problems
Avoid contact lenses during treatment (unless doctor says it’s safe)
Use good skin care—moisturizers, gentle products
Avoid injury and bleeding—use soft toothbrushes, avoid NSAIDs unless approved
Keep a list of all your medications and bring them to your visits
When to Call Your Health Care Team Immediately
Call your doctor or go to the ER if you experience:
Sudden or worsening vision changes
Severe eye pain, redness, or discharge
New or worsening numbness, burning, tingling, or muscle weakness in your arms or legs
Unexpected bleeding (heavy nosebleed, blood in stool/urine, coughing up blood)
New or worsening shortness of breath, cough, or chest pain
Severe skin rash, blisters, peeling, mouth sores, or fever
Signs of infection (fever, chills, sore throat)
Support & Resources
There is a TIVDAK Patient Brochure and a Caregiver Brochure you can request through your doctor or via the official site. https://www.tivdakhcp.com/
A support program called Seagen Secure® may help with access, insurance, and financial support.
You may sign up for TivdakTexts, a text-messaging program to help remind you of infusion and eye care steps.
Summary / Key Points to Remember
TIVDAK is used for certain cervical cancers when chemotherapy no longer works.
The most serious risk is eye damage—strict eye care and monitoring are required
Other risks include nerve damage, bleeding, lung problems, skin reactions
Your medical team will monitor you closely, and may adjust or stop TIVDAK if side effects happen
