Applies to tisotumab vedotin: intravenous powder for injection.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• new or worsening vision changes;

• eye redness, dryness, or irritation;

• white or red patches on the surface of your eye;

• new or worsening cough, trouble breathing;

• stomach cramps, bloating, nausea, vomiting, severe constipation;

• nosebleeds, blood in your urine, abnormal vaginal bleeding, any bleeding that will not stop;

• nerve problems--numbness, tingling, pain, burning sensation in your hands or feet, weakness;

• low hemoglobin (red blood cells)--pale skin, weakness, feeling tired or short of breath, fast heartbeats; or

• low white blood cell counts--fever, mouth sores, skin sores, sore throat, cough.

Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

Common side effects may include:

• dry eyes;

• fever, low red or white blood cells;

• nausea, diarrhea;

• feeling tired;

• nosebleeds;

• numbness or tingling;

• hair loss;

• rash; or

• abnormal kidney function or blood-clotting tests.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to tisotumab vedotin: intravenous powder for injection.

Hematologic

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

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]

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]