Tisotumab Vedotin Side Effects

Medically reviewed by Drugs.com. Last updated on Apr 7, 2025.

Applies to tisotumab vedotin: intravenous powder for solution.

Precautions

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.

This medicine may cause eye or vision problems (eg, dry eye, blepharitis, ulcerative keratitis). Check with your doctor right away if you have dry eyes, eye redness, irritation, or pain, or redness, swelling, and/or itching of the eyelid. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).

Receiving this medicine while you are pregnant can harm your unborn baby. If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before starting treatment. Use an effective form of birth control to prevent pregnancy while you are receiving this medicine and for at least 2 months after the last dose. Males with female partners who can become pregnant must use an effective birth control during treatment and for at least 4 months after the last dose. If a pregnancy occurs while you are using this medicine, tell your doctor right away.

Check with your doctor right away if you are having burning, numbness, tingling, or painful sensations, weakness in the arms, hands, legs, or feet, or unsteadiness. These could be symptoms of a condition called peripheral neuropathy.

This medicine may cause bleeding problems (eg, epistaxis, hematuria, and vaginal hemorrhage). Check with your doctor right away if you have blood in the urine, bloody nose, or heavy nonmenstrual vaginal bleeding.

This medicine may cause pneumonitis (swelling of the lungs). Check with your doctor right away if you have chest pain, chills, cough, fever, general feeling of discomfort or illness, thickening of bronchial secretions, or trouble breathing

This medicine may cause serious skin reaction, including Stevens-Johnson syndrome. Check with your doctor right away if you have blistering, peeling, or loosening of the skin, chills, cough, diarrhea, itching, joint or muscle pain, red irritated eyes, red skin lesions, often with a purple center, sore throat, sores, ulcers, or white spots in the mouth or on the lips, or unusual tiredness or weakness.

This medicine could cause infertility (unable to have children) in some men. Talk with your doctor before using this medicine if you plan to have children.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

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:

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:

For healthcare professionals

Applies to tisotumab vedotin: intravenous powder for injection.

General adverse events

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): Fatigue/asthenia (50%), pyrexia (16%)^[Ref]
• 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]

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]

See also:

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.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer