Tisotumab Vedotin Side Effects

Medically reviewed by Drugs.com. Last updated on Sep 7, 2023.

Applies to tisotumab vedotin: intravenous powder for solution.

Important Warnings This medicine can cause some serious health issues

Intravenous route (Powder for Solution)

WARNING: OCULAR TOXICITYTisotumab vedotin-tftv 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 tisotumab vedotin-tftv until improvement and resume, reduce the dose, or permanently discontinue, based on severity.

Serious side effects of tisotumab vedotin

Along with its needed effects, tisotumab vedotin may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking tisotumab vedotin:

More common

• bladder pain
• bleeding from the rectum
• bleeding gums
• bloody eye
• bloody nose
• bloody or cloudy urine
• blurred vision or any other change in vision
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• burning, dry or itching eyes
• burning, numbness, tingling, or painful sensations
• coughing or spitting up blood
• difficult, burning, or painful urination
• difficulty breathing or swallowing
• discharge, excessive tearing
• dizziness
• dry eyes
• eye redness, irritation, or pain
• frequent urge to urinate
• headache
• increased menstrual flow or vaginal bleeding
• increased sensitivity to pain
• increased sensitivity to touch
• lower back or side pain
• nerve pain
• nosebleeds
• painful irritation of the clear front part of the eye
• paralysis
• prolonged bleeding from cuts
• red or black, tarry stools
• red or dark brown urine
• redness, pain, swelling of eye, eyelid, or inner lining of the eyelid
• redness of the white part of eyes or inside of the eyelids
• tingling in the hands and feet
• trouble breathing
• unsteadiness or awkwardness
• walking in unusual manner
• weakness in the arms, hands, legs, or feet

Less common

• anxiety
• chest pain
• chills
• dizziness or lightheadedness
• fainting
• fast heartbeat
• general feeling of discomfort or illness
• tenderness, pain, swelling, warmth, skin discoloration, and prominent superficial veins over the affected area
• thickening of bronchial secretions

Incidence not known

• blistering, peeling, or loosening of the skin
• diarrhea
• joint or muscle pain
• red irritated eyes
• red skin lesions, often with a purple center
• sore throat
• sores, ulcers, white spots in the mouth or on the lips
• unusual tiredness or weakness

Other side effects of tisotumab vedotin

Some side effects of tisotumab vedotin may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• arm or leg pain
• constipation
• decreased appetite
• decreased weight
• difficulty in moving
• lack or loss of strength
• loss or thinning of the hair
• muscle or bone pain
• stomach pain or cramps
• vomiting

For Healthcare Professionals

Applies to tisotumab vedotin: intravenous powder for injection.

General

The most common (25% or greater) adverse reactions, including laboratory abnormalities, were hemoglobin decreased, fatigue, lymphocytes decreased, nausea, peripheral neuropathy, alopecia, epistaxis, conjunctival adverse reactions, hemorrhage, leukocytes decreased, creatinine increased, dry eye, prothrombin international normalized ratio increased, activated partial thromboplastin time prolonged, diarrhea, and rash.^[Ref]

Musculoskeletal

• Very common (10% or more): Myalgia (e.g., myalgia, musculoskeletal discomfort, musculoskeletal pain) (21%), arthralgia (16%), pain in extremity/limb discomfort (13%)^[Ref]

Ocular

• Very common (10% or more): Conjunctival adverse reactions (e.g., conjunctivitis, conjunctival abrasion, conjunctival erosion, conjunctival hyperemia, conjunctival scar, noninfective conjunctivitis, ocular hyperemia, conjunctival hemorrhage) (37%), dry eye/lacrimation increased (29%), corneal adverse reactions (e.g., keratitis, punctate keratitis, ulcerative keratitis, corneal erosion, corneal scar, keratopathy, corneal bleeding) (21%), periorbital adverse reactions (e.g., blepharitis, meibomianitis, eye pruritus, entropion, trichiasis, chalazion, meibomian gland dysfunction) (16%)^[Ref]

Metabolic

• Very common (10% or more): Weight loss (10%)^[Ref]

Respiratory

• Very common (10% or more): Epistaxis (39%)^[Ref]

Other

• Very common (10% or more): Creatinine increased (29%), alanine aminotransferase increased (24%), lactate dehydrogenase increased (22%), urate increased (20%), sodium decreased (20%), glucose decreased (19%), aspartate aminotransferase increased (18%), alkaline phosphatase increased (17%), magnesium decreased (17%), creatinine kinase increased (16%), albumin decreased (16%)^[Ref]

Very common (10% or more): Fatigue/asthenia (50%), pyrexia (16%)^[Ref]

Hematologic

• Very common (10% or more): Hemoglobin decreased (52%), lymphocytes decreased (42%), leukocytes decreased (30%), neutrophils decreased (21%)^[Ref]

Nervous system

• Very common (10% or more): Peripheral neuropathy (e.g., neuropathy peripheral, peripheral sensorimotor neuropathy, polyneuropathy, peripheral sensory neuropathy, paresthesia, hypoesthesia, burning sensation, neuralgia, sensory loss, peripheral motor neuropathy, muscular weakness, gait disturbance, hyperesthesia) (39%)^[Ref]

Renal

• Very common (10% or more): Urinary tract infection (e.g., urinary tract infection, urinary tract infection bacterial, cystitis) (24%)^[Ref]

Cardiovascular

• Very common (10% or more): Hemorrhage (e.g., vaginal hemorrhage, hematuria, rectal hemorrhage, cystitis hemorrhagic, lower GI hemorrhage, urinary bladder hemorrhage, hematochezia, gingival bleeding, postprocedural hemorrhage, radiation associated with hemorrhage, metrorrhagia, large intestinal hemorrhage, paranasal sinus hemorrhage, hemoptysis (50%)^[Ref]

Dermatologic

• Very common (10% or more): Alopecia (39%), Rash (e.g., ash, rash maculo-papular, rash macular, dermatitis acneiform, dermatitis allergic, erythema) (25%), pruritus (13%)^[Ref]

Gastrointestinal

• Very common (10% or more): Nausea/retching (41%), diarrhea/gastroenteritis/colitis (25%), constipation (23%), Abdominal pain (e.g., abdominal pain, abdominal pain upper, abdominal pain lower, abdominal distention, abdominal discomfort) (23%), vomiting (17%)^[Ref]

Further information

Tisotumab vedotin side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

Medical Disclaimer