Prior to infusion

Prepping for Tivdak Required Eye Care

It's important for patients to protect their eye health while on Tivdak. Tivdak Required Eye Care provides clear steps that may help reduce the risk of ocular adverse reactions.

Prior to getting started with tivdaka

Partner with an eye care provider

Refer patient to an eye care provider for an ophthalmic exam, including visual acuity and slit lamp exam. This exam should occur prior to their first infusion to establish baseline eye health, prior to each treatment of Tivdak, and as clinically indicated.

Prescribe topical eye dropsa

Tivdak Vasoconstrictor Eye Drops Icon

Vasoconstrictor Eye Drops

For use immediately prior to each infusion

Tivdak Corticosteroid Eye Drops Icon

Corticosteroid Eye Dropsb

For use prior to each infusion, after each infusion on infusion day and continue on Days 2-3 (72 hours) following each infusion or as prescribed

Tivdak Lubricating Eye Drops Icon

Lubricating Eye Drops

(available over the counter) For use throughout treatment

General reminders

Tivdak Eye Drops Icon

Eye drops

Remind patients to bring all their topical eye drops to their infusion appointment

Tivdak Avoid Contact Lenses Icon

Avoid contact lenses

Advise patients to avoid wearing contact lenses throughout treatment unless directed to do so by an eye care provider

Tivdak Avoid Eye Irritants Icon

Avoid eye irritants

Instruct patients to avoid eye irritants throughout treatment with Tivdak

Remind patients to bring all of their eye drops to their infusion appointment

aSee full prescribing information for detailed information about eye drops.

bThe initial prescription and all renewals of any corticosteroid medication should be made only after examination with a slit lamp.

Prior to every infusion

Eye Care for Patients on Tivdak Icon
  • Refer patient to an eye care provider for an ophthalmic exam, including visual acuity and slit lamp exam
  • This exam should occur prior to their first infusion to establish baseline eye health, prior to each treatment of Tivdak, and as clinically indicated
  • Promptly refer patients to an eye care provider for any new or worsening ocular signs and symptoms

During and after infusion

Tivdak Required Eye Care

A well-defined protocol to help reduce the risk of ocular adverse reactions.

INFUSION DAY (once every 3 weeks)

Day 1

  • Pre-Infusion (~10 min prior)

Corticosteroid Eye Dropsa

1 drop per eye or as prescribed

Vasoconstrictor Eye Drops

3 drops per eye or as prescribed

Cold Packs

Rotate as needed to keep eyes cool for 60 minutes total

  • During Infusion (~30 min) After Infusion (~20 min)

Infusion

2.0-mg/kg intravenous infusion

Cold Packs

Rotate as needed to keep eyes cool for 60 minutes

  • Remainder of Day

Corticosteroid Eye Dropsa

1 drop per eye 2x throughout the remainder of the day or as prescribed (Patient to self-administer)

  • Pre-Infusion
    (~10 min prior)
  • During Infusion
    (~30 min)
  • After Infusion
    (~20 min)
  • Remainder
    of Day

POST-INFUSION DAY (patient-driven tasks)

Days 2-3 (72 hours post infusion)

Corticosteroid Eye Dropsa

1 drop per eye, 3x per day for Days 2-3 after infusion, or as prescribed

  • Day 2
  • Day 3

Throughout Treatment

Lubricating Eye Drops

Instruct patients to administer for the duration of therapy and for 30 days after the last dose of Tivdak

Eye Self-Check

Patients should monitor their eyes daily and call their eye care provider and/or your office in the event of an ocular adverse reaction

Corticosteroid Eye Drop Prescription Renewal

Refer patients to an eye care provider for a slit lamp exam before the initial prescription and all renewals of any corticosteroid medication

Avoid Contact Lenses

Advise patients to avoid wearing contact lenses throughout treatment unless directed to do so by an eye care provider

Tivdak Required Eye Care: Help reduce the risk of ocular adverse reactions

aThe initial prescription and all renewals of any corticosteroid medication should be made only after examination with a slit lamp.

Ongoing eye care

Remind patients about proper eye care between infusions

Encourage your patients to monitor their eyes daily. In the event of an ocular adverse reaction, your patient may need follow-up care with you and/or their eye care provider to be diagnosed and treated.

Throughout tivdak treatment

  • Eye self-check
    Remind your patients to monitor their eyes daily for any signs or symptoms of new or worsening ocular adverse reactions, including dry eyes, eye redness, eye irritation, corneal ulcers, blurred vision, and severe vision loss
  • Partner with eye care provider
    In the event of an ocular adverse reaction, refer the patient to an eye care provider to assess and grade the severity of the adverse reaction
  • Monitor and assess
    Actively monitor and assess potential ocular adverse reactions throughout treatment with Tivdak
  • Modify dose as needed
    Withhold, reduce the dose, or permanently discontinue Tivdak based on the severity of symptoms
Tivdak Dosing, Administration, and Eye Care Guide Icon

Tivdak Dosing, Administration, and Eye Care Guide

Download

Find an eye care provider

  • You may need to refer your patient to an eye care provider. Use this helpful locator tool to find one.
external-link

For eye care providers

What you need to know as an eye care provider

Most ocular adverse reactions were GRADE 1-2

Tivdak has a BOXED WARNING for ocular toxicity and caused changes in the corneal epithelium and conjunctiva, resulting in changes in vision, including severe vision loss and corneal ulceration.

  • Ocular adverse reactions occurred in 60% of cervical cancer patients treated with Tivdak across clinical trials. The most common ocular adverse reactions were conjunctival adverse reactions (40%), dry eye (29%), corneal adverse reaction (21%), and blepharitis (8%)a
  • Grade 3 ocular adverse reactions occurred in 3.8% of patients, including severe ulcerative keratitis in 3.2% of patientsa
  • The median time to onset of the first ocular adverse reaction was 1.2 months (range: 0-6.5)a
  • Ocular adverse reactions led to discontinuation of Tivdak in 6% of patients with cervical cancera
  • 1 patient experienced ulcerative keratitis with perforation requiring corneal transplantationa
  • Cases of symblepharon were reported in patients with other tumor types treated with Tivdak at the recommended dosea
  • 4% of patients experienced visual acuity changes to 20/50 or worse, including 1% of patients who experienced a visual acuity change to 20/200. Of the patients who experienced decreased visual acuity to 20/50 or worse, 75% resolved, including the patient who experienced decreased visual acuity to 20/200b

aThese data reflect exposure to Tivdak in 158 patients with recurrent or metastatic cervical cancer who received at least one dose of Tivdak at 2 mg/kg intravenously every 3 weeks in 4 clinical trials.

bThese data reflect exposure to Tivdak in 101 patients with recurrent or metastatic cervical cancer who received Tivdak 2 mg/kg intravenously every 3 weeks in the innovaTV 204 clinical trial.

Resolution of ocular adverse reactionsa

At last follow-up, 85% of patients who experienced ocular adverse reactions had either

COMPLETE
RESOLUTION

55%

OR

PARTIAL
IMPROVEMENT

30%

Partial improvement was defined as a decrease in severity by 1 or more grades from the worst grade.

aThese data reflect exposure to Tivdak in 158 patients with recurrent or metastatic cervical cancer who received at least one dose of Tivdak at 2 mg/kg intravenously every 3 weeks in 4 clinical trials.

Conduct a full ophthalmic exam

The patient's oncologist will refer them to you for a full ophthalmic exam at baseline, prior to the patient's first infusion of Tivdak, before every infusion cycle, and as clinically indicated. This exam includes, but is not limited to:

  • Visual acuity
  • Slit lamp exam

Please note: Patients will be referred by their oncologist to you for a slit lamp exam before the initial prescription and all renewals of any corticosteroid medication

Avoid contact lenses and irritants

  • Advise patients to avoid wearing contact lenses throughout treatment unless you specify otherwise
  • Advise patients to avoid putting any irritants near their eyes

There are no contraindications for Tivdak. Patients were excluded from the innovaTV 204 clinical trial if they had active ocular surface disease, any prior episode of cicatricial conjunctivitis, or Stevens Johnson syndrome.

Partner with your patient’s oncologist

Encourage your patients to monitor their eyes daily. In the event of an ocular adverse reaction, your patient may need follow-up care with you and/or their oncologist to be diagnosed and treated

Actively monitor and assess potential Ocular adverse reactions

In the event of an ocular adverse reaction

Eye care provider

  • 1Eye exam
  • 2Ocular adverse reaction grading

Oncologist

  • 3Dosage modification
Tivdak Dosing, Administration, and Eye Care Guide Icon

Tivdak Dosing, Administration, and Eye Care Guide

Download

Important Safety Information
BOXED WARNING: OCULAR TOXICITY

TIVDAK caused changes in the corneal epithelium and conjunctiva resulting in changes in vision, including severe vision loss, and corneal ulceration. Conduct an ophthalmic exam at baseline, prior to each dose, and as clinically indicated. Adhere to premedication and required eye care before, during, and after infusion. Withhold TIVDAK until improvement and resume, reduce the dose, or permanently discontinue, based on severity.

Warnings and Precautions

Ocular Adverse Reactions occurred in 60% of patients with cervical cancer treated with TIVDAK across clinical trials. The most common were conjunctival adverse reactions (40%), dry eye (29%), corneal adverse reactions (21%), and blepharitis (8%). Grade 3 ocular adverse reactions occurred in 3.8% of patients, including severe ulcerative keratitis in 3.2% of patients. One patient experienced ulcerative keratitis with perforation requiring corneal transplantation. Cases of symblepharon were reported in patients with other tumor types treated with TIVDAK at the recommended dose.

In innovaTV 204, 4% of patients experienced visual acuity changes to 20/50 or worse including 1% of patients who experienced a visual acuity change to 20/200. Of the patients who experienced decreased visual acuity to 20/50 or worse, 75% resolved, including the patient who experienced decreased visual acuity to 20/200.

Refer patients to an eye care provider for an ophthalmic exam including visual acuity and slit lamp exam at baseline, prior to each dose, and as clinically indicated. Adhere to premedication and required eye care to reduce the risk of ocular adverse reactions. Promptly refer patients to an eye care provider for any new or worsening ocular signs and symptoms. Withhold dose, reduce the dose, or permanently discontinue TIVDAK based on the severity of the adverse reaction.

Peripheral Neuropathy (PN) occurred in 42% of cervical cancer patients treated with TIVDAK across clinical trials; 8% of patients experienced Grade 3 PN. PN adverse reactions included peripheral neuropathy (20%), peripheral sensory neuropathy (11%), peripheral sensorimotor neuropathy (5%), motor neuropathy (3%), muscular weakness (3%), and demyelinating peripheral polyneuropathy (1%). One patient with another tumor type treated with TIVDAK at the recommended dose developed Guillain-Barre syndrome. Monitor patients for signs and symptoms of neuropathy. For new or worsening PN, withhold, dose reduce, or permanently discontinue TIVDAK based on the severity of PN.

Hemorrhage occurred in 62% of cervical cancer patients treated with TIVDAK 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.

Monitor patients for signs and symptoms of hemorrhage. For patients experiencing pulmonary or CNS hemorrhage, permanently discontinue TIVDAK. For Grade ≥2 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 recurrence. After resolution, either resume treatment or permanently discontinue TIVDAK.

Pneumonitis: Severe, life-threatening, or fatal pneumonitis can occur in patients treated with antibody-drug conjugates containing vedotin, including TIVDAK. Among patients with cervical cancer treated with TIVDAK across clinical trials, 2 patients (1.3%) experienced pneumonitis, including 1 patient who had a fatal outcome.

Monitor patients for pulmonary symptoms of pneumonitis. Infectious, neoplastic, and other causes for symptoms should be excluded through appropriate investigations.

Withhold TIVDAK for patients who develop persistent or recurrent Grade 2 pneumonitis and consider dose reduction. Permanently discontinue TIVDAK in all patients with Grade 3 or 4 pneumonitis.

Embryo-Fetal Toxicity: TIVDAK can cause fetal harm when administered to a pregnant woman. Advise patients of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with TIVDAK and for 2 months after the last dose. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with TIVDAK and for 4 months after the last dose.

Adverse Reactions

Serious adverse reactions occurred in 43% of patients; the most common (≥3%) were ileus (6%), hemorrhage (5%), pneumonia (4%), PN, sepsis, constipation, and pyrexia (each 3%). Fatal adverse reactions occurred in 4% of patients who received TIVDAK, including septic shock, pneumonitis, sudden death, and multisystem organ failure (each 1%).

Adverse reactions leading to permanent discontinuation occurred in 13% of patients receiving TIVDAK; the most common (≥3%) were PN (5%) and corneal adverse reactions (4%). Adverse reactions leading to dose interruption occurred in 47% of patients; the most common (≥3%) were PN (8%), conjunctival adverse reactions (4%), and hemorrhage (4%). Adverse reactions leading to dose reduction occurred in 23% of patients; the most common (≥3%) were conjunctival adverse reactions (9%) and corneal adverse reactions (8%).

The most common (≥25%) adverse reactions, including laboratory abnormalities, were hemoglobin decreased (52%), fatigue (50%), lymphocytes decreased (42%), nausea (41%), PN (39%), alopecia (39%), epistaxis (39%), conjunctival adverse reactions (37%), hemorrhage (32%), leukocytes decreased (30%), creatinine increased (29%), dry eye (29%), prothrombin international normalized ratio increased (26%), activated partial thromboplastin time prolonged (26%), diarrhea (25%), and rash (25%).

Drug interactions

Strong CYP3A4 Inhibitors: Concomitant use with strong CYP3A4 inhibitors may increase unconjugated monomethyl auristatin E (MMAE) exposure, which may increase the risk of TIVDAK adverse reactions. Closely monitor patients for TIVDAK adverse reactions.

Use in Specific Populations

Moderate or Severe Hepatic Impairment: MMAE exposure and adverse reactions are increased. Avoid use.

Lactation: Advise lactating women not to breastfeed during TIVDAK treatment and for at least 3 weeks after the last dose.

Please see full prescribing information, including BOXED WARNING for TIVDAK.

Indication

TIVDAK is indicated for the treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy.

This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

Reference:
  1. TIVDAK [Prescribing Information]. Bothell, WA: Seagen Inc. January 2022
Important Safety Information

BOXED WARNING: OCULAR TOXICITY

TIVDAK caused changes in the corneal epithelium and conjunctiva resulting in changes in vision, including severe vision loss, and corneal ulceration. Conduct anophthalmic examat baseline, prior to each dose, andas clinically indicated.

Important Safety Information
BOXED WARNING: OCULAR TOXICITY

TIVDAK caused changes in the corneal epithelium and conjunctiva resulting in changes in vision, including severe vision loss, and corneal ulceration. Conduct an ophthalmic exam at baseline, prior to each dose, and as clinically indicated. Adhere to premedication and required eye care before, during, and after infusion. Withhold TIVDAK until improvement and resume, reduce the dose, or permanently discontinue, based on severity.

Warnings and Precautions

Ocular Adverse Reactions occurred in 60% of patients with cervical cancer treated with TIVDAK across clinical trials. The most common were conjunctival adverse reactions (40%), dry eye (29%), corneal adverse reactions (21%), and blepharitis (8%). Grade 3 ocular adverse reactions occurred in 3.8% of patients, including severe ulcerative keratitis in 3.2% of patients. One patient experienced ulcerative keratitis with perforation requiring corneal transplantation. Cases of symblepharon were reported in patients with other tumor types treated with TIVDAK at the recommended dose.

In innovaTV 204, 4% of patients experienced visual acuity changes to 20/50 or worse including 1% of patients who experienced a visual acuity change to 20/200. Of the patients who experienced decreased visual acuity to 20/50 or worse, 75% resolved, including the patient who experienced decreased visual acuity to 20/200.

Refer patients to an eye care provider for an ophthalmic exam including visual acuity and slit lamp exam at baseline, prior to each dose, and as clinically indicated. Adhere to premedication and required eye care to reduce the risk of ocular adverse reactions. Promptly refer patients to an eye care provider for any new or worsening ocular signs and symptoms. Withhold dose, reduce the dose, or permanently discontinue TIVDAK based on the severity of the adverse reaction.

Peripheral Neuropathy (PN) occurred in 42% of cervical cancer patients treated with TIVDAK across clinical trials; 8% of patients experienced Grade 3 PN. PN adverse reactions included peripheral neuropathy (20%), peripheral sensory neuropathy (11%), peripheral sensorimotor neuropathy (5%), motor neuropathy (3%), muscular weakness (3%), and demyelinating peripheral polyneuropathy (1%). One patient with another tumor type treated with TIVDAK at the recommended dose developed Guillain-Barre syndrome. Monitor patients for signs and symptoms of neuropathy. For new or worsening PN, withhold, dose reduce, or permanently discontinue TIVDAK based on the severity of PN.

Hemorrhage occurred in 62% of cervical cancer patients treated with TIVDAK 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.

Monitor patients for signs and symptoms of hemorrhage. For patients experiencing pulmonary or CNS hemorrhage, permanently discontinue TIVDAK. For Grade ≥2 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 recurrence. After resolution, either resume treatment or permanently discontinue TIVDAK.

Pneumonitis: Severe, life-threatening, or fatal pneumonitis can occur in patients treated with antibody-drug conjugates containing vedotin, including TIVDAK. Among patients with cervical cancer treated with TIVDAK across clinical trials, 2 patients (1.3%) experienced pneumonitis, including 1 patient who had a fatal outcome.

Monitor patients for pulmonary symptoms of pneumonitis. Infectious, neoplastic, and other causes for symptoms should be excluded through appropriate investigations.

Withhold TIVDAK for patients who develop persistent or recurrent Grade 2 pneumonitis and consider dose reduction. Permanently discontinue TIVDAK in all patients with Grade 3 or 4 pneumonitis.

Embryo-Fetal Toxicity: TIVDAK can cause fetal harm when administered to a pregnant woman. Advise patients of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with TIVDAK and for 2 months after the last dose. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with TIVDAK and for 4 months after the last dose.

Adverse Reactions

Serious adverse reactions occurred in 43% of patients; the most common (≥3%) were ileus (6%), hemorrhage (5%), pneumonia (4%), PN, sepsis, constipation, and pyrexia (each 3%). Fatal adverse reactions occurred in 4% of patients who received TIVDAK, including septic shock, pneumonitis, sudden death, and multisystem organ failure (each 1%).

Adverse reactions leading to permanent discontinuation occurred in 13% of patients receiving TIVDAK; the most common (≥3%) were PN (5%) and corneal adverse reactions (4%). Adverse reactions leading to dose interruption occurred in 47% of patients; the most common (≥3%) were PN (8%), conjunctival adverse reactions (4%), and hemorrhage (4%). Adverse reactions leading to dose reduction occurred in 23% of patients; the most common (≥3%) were conjunctival adverse reactions (9%) and corneal adverse reactions (8%).

The most common (≥25%) adverse reactions, including laboratory abnormalities, were hemoglobin decreased (52%), fatigue (50%), lymphocytes decreased (42%), nausea (41%), PN (39%), alopecia (39%), epistaxis (39%), conjunctival adverse reactions (37%), hemorrhage (32%), leukocytes decreased (30%), creatinine increased (29%), dry eye (29%), prothrombin international normalized ratio increased (26%), activated partial thromboplastin time prolonged (26%), diarrhea (25%), and rash (25%).

Drug interactions

Strong CYP3A4 Inhibitors: Concomitant use with strong CYP3A4 inhibitors may increase unconjugated monomethyl auristatin E (MMAE) exposure, which may increase the risk of TIVDAK adverse reactions. Closely monitor patients for TIVDAK adverse reactions.

Use in Specific Populations

Moderate or Severe Hepatic Impairment: MMAE exposure and adverse reactions are increased. Avoid use.

Lactation: Advise lactating women not to breastfeed during TIVDAK treatment and for at least 3 weeks after the last dose.

Please see full prescribing information, including BOXED WARNING for TIVDAK.

Indication

TIVDAK is indicated for the treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy.

This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

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