tisotumab vedotin

High Alert

Recurrent or metastatic cervical cancer with disease progression during or after chemotherapy.

Contraindicated in:

Moderate or severe hepatic impairment;
OB: Pregnancy;
Lactation: Lactation.

Use Cautiously in:

Rep: Women of reproductive potential and men with female partners of reproductive potential;
Pedi: Safety and effectiveness not established in children.

Derm: alopecia, pruritus, rash, STEVENS-JOHNSON SYNDROME (SJS)

EENT: conjunctival abrasion/erosion, conjunctival hemorrhage, conjunctival hyperemia, conjunctival scar, conjunctivitis, corneal bleeding, corneal scar, corneal ulceration, dry eye, epistaxis, keratitis, ocular hyperemia, blepharitis

Endo: hypoglycemia

F and E: hypomagnesemia, hyponatremia

GI: ↑liver enzymes, abdominal pain, constipation, diarrhea, hypoalbuminemia, nausea, vomiting, ileus

GU: ↑serum creatinine, urinary tract infection, ↓fertility (males)

Hemat: ↑activated partial thromboplastin time, ↑prothrombin time, anemia, hemorrhage, leukopenia, lymphocytopenia, neutropenia

Metab: ↓appetite, hyperuricemia, weight loss

MS: ↑creatine kinase, arthralgia, myalgia, muscle weakness

Neuro: fatigue, peripheral neuropathy

Resp: pneumonia, PNEUMONITIS, PULMONARY EMBOLISM

Misc: fever

Drug-drug:

Strong CYP3A4 inhibitors, including ketoconazole, may ↑ levels and risk of toxicity of MMAE; monitor closely.

Lyophilized powder for injection: 40 mg/vial

IV (Adults ≥100 kg): 200 mg every 3 wk; continue until disease progression or unacceptable toxicity.
IV (Adults <100 kg): 2 mg/kg every 3 wk; continue until disease progression or unacceptable toxicity.

Tivdak

Acts as an antibody-drug conjugate (ADC) composed of a human IgG1 monoclonal antibody that is directed against tissue factor (located on the cell surface of cancer cells). Monomethyl auristatin E (MMAE) (an agent that disrupts microtubles and subsequently causes apoptosis) is attached to the antibody via a cleavable linker. The ADC binds to tissue factor on the cancer cells; the complex is then internalized, and then the MMAE is cleaved and released inside the cancer cells.

Therapeutic effects:

Reduced progression of recurrent or metastatic cervical cancer.

Therapeutic Classification: antineoplastics

Pharmacologic Classification: antimicrotubulars, tissue factor directed antibody drug conjugates

Absorption: IV administration results in complete bioavailability.

Distribution: Minimally distributed to tissues.

Metabolism/Excretion: Monoclonal antibody component is degraded into smaller peptides via catabolism. MMAE is primarily metabolized in the liver via the CYP3A4 isoenzyme. 17% of MMAE excreted in feces, and 6% excreted in urine, primarily as unchanged drug.

Half-Life: ADC: 4 days; MMAE: 2.5 days.

(plasma concentrations)

ROUTE	ONSET	PEAK	DURATION
IV	unknown	ADC: end of infusion; MMAE: 2–3 days	unknown

Explain purpose and side effects of medication to patient. Advise patient to read Patient Information before starting therapy and periodically during therapy in case of changes.
Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and consult health care professional before taking any new medications.
Inform patient about the eye exams they will receive before starting therapy, before each of the first 9 cycles, and as clinically indicated.
Advise patient about ocular adverse reactions and to contact a health care professional if any occur.
Instruct patient to bring their eye drops to each infusion, and advise on how to administer the eye drops throughout treatment.
Advise patients to avoid wearing contact lenses, unless advised by their eye care provider, for the entire duration of therapy.
Advise patient to notify health care professional immediately if signs and symptoms of bleeding (blood in stools or black stools, blood in urine, cough up or vomit blood, unusual vaginal bleeding, any unusual or heavy bleeding), lung problems (trouble breathing, shortness of breath, cough), severe skin reactions (skin reactions that look like rings [target lesions]; worsening rash or itching; blistering or peeling of skin; painful sores or ulcers in mouth, nose, throat, or genital area; fever or flu-like symptoms; swollen lymph nodes), or peripheral neuropathy (numbness in hands or feet, muscle weakness) occur.
Discuss with patient the possibility of hair loss. Explore methods of coping. May also cause darkening of skin and fingernails.
Rep: May cause fetal harm. Advise women of reproductive potential to use effective contraception during and for 2 mo after last dose and to avoid breastfeeding during therapy and for 3 wk after last dose. Advise men with female partners of reproductive potential to use effective contraception during and for 4 mo after last dose. May impair male fertility.

tye-SOT-ue-mab ve-DOE-tin

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Indications ⬇

Contraind./Precautions ⬆ ⬇

Adv. Reactions/Side Effects ⬆ ⬇

Interactions ⬆ ⬇

Availability ⬆ ⬇

Route/Dosage ⬆ ⬇

US Brand Names ⬆ ⬇

Action ⬆ ⬇

Classifications ⬆ ⬇

Pharmacokinetics ⬆ ⬇

Time/Action Profile ⬆ ⬇

Patient/Family Teaching ⬆ ⬇

Pronunciation ⬆