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TIVDAK (tisotumab vedotin-tftv)
- carcinoma cancer of the cervix
40 mg intravenous solution
- Infuse 2 mg/kg (up to max 200 mg) by intravenous route every 3 weeks
Default screening record
- Infuse 2 mg/kg (up to max 200 mg) by intravenous route every 3 weeks
- Infuse 1.3 mg/kg (up to max 200 mg) by intravenous route every 3 weeks
- Infuse 0.9 mg/kg (up to max 200 mg) by intravenous route every 3 weeks
- None
Contraindicated
- None
Severe
Moderate
- None
- Lactation
Contraindicated
- Hemorrhage
- Interstitial pneumonitis
- Peripheral neuropathy
- Pregnancy
Severe
Moderate
- Child-pugh class A hepatic impairment
TIVDAK (tisotumab vedotin-tftv)
- carcinoma cancer of the cervix
- Hemorrhage
- Leukopenia
- Lymphopenia
- Prolonged activated partial thromboplastin time
- Alopecia
- Blepharitis
- Conjunctivitis
- Diarrhea
- Dry eye
- Epistaxis
- Fatigue
- Nausea
- Peripheral neuropathy
- Skin rash
- Visual changes
More Frequent
Severe
Less Severe
- Conjunctival hemorrhage
- Corneal ulcer
- Hypomagnesemia
- Ileus
- Interstitial pneumonitis
- Multiple organ failure
- Neutropenic disorder
- Pneumonia
- Pulmonary thromboembolism
- Venous thrombosis
- Acute abdominal pain
- Anorexia
- Arthralgia
- Constipation
- Fever
- Myalgia
- Ocular itching
- Pain in extremities
- Pruritus of skin
- Urinary tract infection
- Vomiting
- Weight loss
Less Frequent
Severe
Less Severe
Rare / Very Rare
Severe
- Vision loss
Less Severe
- None
Contraindicated
None
Severe Precaution
None
Management or Monitoring Precaution
Tisotumab vedotin-tftv
Safety and effectiveness not established for pediatric patients.
- 1 Day – 18 Years
- Safety and effectiveness not established for pediatric patients.
Tisotumab Vedotin-tftv
- Severity Level:
D
- Additional Notes: Based on drug pharmacology developmental toxicity is possible
Contraindicated
Tisotumab Vedotin-tftv
Mfr rec to avoid breastfeeding during tx and for 3 wks after last do
| General | Excretion Potential | Effect on Infant | Notes |
| Drug should not be given to breast feeding mothers | Unknown | Not known; no or inclusive data | Mfr rec to avoid breastfeeding during tx and for 3 wks after last do |
Precaution Exists
None
| General | Excretion Potential | Effect on Infant | Notes |
| None |
No Known Risk
None
| General | Excretion Potential | Effect on Infant | Notes |
| None |
Contraindicated
None
Precaution Exists
Tisotumab Vedotin-tftv
General- In clinical trials, serious adverse reactions occurred more frequency in patients > 65 years compared to younger patients. In clinical trials, no patients aged > 65 years experienced a tumor response with tisotumab. Evaluate risk vs benefit. Sensory Nervous System-Monitor for ocular events including vision loss. Conduct opthalmic exam routinely.
| Organ / System | HEP | REN | CARD | ENDO | NEURO / PSYCH | PULM |
| Increased Risk / Adverse Effects | N | N | N | Y | N | N |
BEERS: N HEDIS: N STOPP: N
No Known Risk
None
- Tisotumab vedotin may cause serious eye problems. You should have regular eye exams before and during treatment with this medication. Follow your doctor's instructions carefully on what eye drops to use before and after your infusion of this medication.<br /><br />Do not wear contact lenses while you are on treatment with this medication unless directed by the doctor. Tell your doctor right away if you have signs of eye problems, including dry eyes, eye pain/redness/irritation, or blurred/decreased vision. Ask your doctor or pharmacist for more details.
| Carcinoma of cervix | |
| C53 | Malignant neoplasm of cervix uteri |
| C53.0 | Malignant neoplasm of endocervix |
| C53.1 | Malignant neoplasm of exocervix |
| C53.8 | Malignant neoplasm of overlapping sites of cervix uteri |
| C53.9 | Malignant neoplasm of cervix uteri, unspecified |
| 0-9 | A-Z |
|---|---|
| C53 | Malignant neoplasm of cervix uteri |
| C53.0 | Malignant neoplasm of endocervix |
| C53.1 | Malignant neoplasm of exocervix |
| C53.8 | Malignant neoplasm of overlapping sites of cervix uteri |
| C53.9 | Malignant neoplasm of cervix uteri, unspecified |
Formulary Reference Tool