Applies to mirvetuximab soravtansine: intravenous solution.
Warning
Intravenous route (Solution)
Warning: Ocular ToxicityMirvetuximab soravtansine-gynx can cause severe ocular toxicities, including visual impairment, keratopathy, dry eye, photophobia, eye pain, and uveitis.Conduct an ophthalmic exam including visual acuity and slit lamp exam prior to initiation of mirvetuximab soravtansine-gynx, every other cycle for the first 8 cycles, and as clinically indicated.Administer prophylactic artificial tears and ophthalmic topical steroids.Withhold mirvetuximab soravtansine-gynx for ocular toxicities until improvement and resume at the same or reduced dose.Discontinue mirvetuximab soravtansine-gynx for Grade 4 ocular toxicities.
Serious side effects
Along with its needed effects, mirvetuximab soravtansine 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 mirvetuximab soravtansine:
More common
- Black, tarry stools
- blindness
- blurred vision
- burning, numbness, tingling, or painful sensations
- change in vision
- chills
- cough
- decreased vision
- difficulty seeing at night
- double vision
- dry eye
- eye redness, irritation, or pain
- fever
- increased sensitivity of the eyes to sunlight
- lower back or side pain
- nausea
- painful, irritation of the clear front part of the eye
- painful or difficult urination
- pale skin
- seeing double
- severe constipation
- sore throat
- stomach pain
- trouble breathing
- ulcers, sores, or white spots in the mouth
- unsteadiness or awkwardness
- unusual bleeding or bruising
- unusual tiredness or weakness
- vomiting
- watering of the eyes
- weakness in the arms, hands, legs, or feet
Less common
- Bleeding gums
- blood in the urine or stools
- chest pain
- cough or hoarseness
- general feeling of discomfort or illness
- pinpoint red spots on the skin
- stomach bloating
- thickening of bronchial secretions
Other side effects
Some side effects of mirvetuximab soravtansine 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
- Decreased appetite
- diarrhea
- muscle or joint pain
For Healthcare Professionals
Applies to mirvetuximab soravtansine: intravenous solution.
Gastrointestinal
Very common (10% or more): Abdominal distension (11%), abdominal pain (36%), constipation (30%), diarrhea (31%), nausea (40%), vomiting (19%)[Ref]
General
-The most common adverse reactions with a frequency of 20% or more, including laboratory abnormalities, were vision impairment, fatigue, increased aspartate aminotransferase, nausea, increased alanine aminotransferase, keratopathy, abdominal pain, decreased lymphocytes, peripheral neuropathy, diarrhea, decreased albumin, constipation, increased alkaline phosphatase, dry eye, decreased magnesium, decreased leukocytes, decreased neutrophils, and decreased hemoglobin.
-The most common side effects resulting in discontinuation were intestinal obstruction (2%) and thrombocytopenia (2%).
-Serious adverse reactions were reported in 31% of patients, of which the most common were intestinal obstruction, ascites, infection, and pleural effusion.[Ref]
Hematologic
Common (1% to 10%): Thrombocytopenia[Ref]
Hypersensitivity
Common (1% to 10%): Infusion related reactions/hypersensitivity[Ref]
Musculoskeletal
Very common (10% or more): Arthralgia (17%), myalgia (10%)[Ref]
Nervous system
Very common (10% or more): Peripheral neuropathy (33%)[Ref]
Ocular
Very common (10% or more): Cataract (18%), dry eye (27%), eye pain (10%), keratopathy (37%), photophobia (17%), vision impairment (50%)
Common (1% to 10%): Uveitis[Ref]
Other
Very common (10% or more): Fatigue (49%)[Ref]
Respiratory
Very common (10% or more): Dyspnea (12%)
Common (1% to 10%): Pneumonitis[Ref]
Metabolic
Very common (10% or more): Decreased appetite (18%)[Ref]
