Summary

Commonly reported side effects of ado-trastuzumab emtansine include: increased serum bilirubin, increased serum transaminases, cough, decreased platelet count, dyspnea, fatigue, fever, peripheral neuropathy, and thrombocytopenia. Other side effects include: chills. Continue reading for a comprehensive list of adverse effects.

Applies to ado-trastuzumab emtansine: intravenous powder for solution.

Serious side effects

Along with its needed effects, ado-trastuzumab emtansine 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 ado-trastuzumab emtansine:

More common

• Black, tarry stools
• bladder pain
• bleeding gums
• bloating or swelling of the face, arms, hands, lower legs, or feet
• bloody or cloudy urine
• blurred vision
• burning, numbness, tingling, or painful sensations
• chills
• cough
• decreased urine
• difficult or labored breathing
• difficult, burning, or painful urination
• dizziness
• dry mouth
• fever
• frequent urge to urinate
• headache
• increased thirst
• irregular heartbeat
• loss of appetite
• lower back or side pain
• mood changes
• muscle pain or cramps
• nausea
• nervousness
• nosebleeds
• numbness or tingling in the hands, feet, or lips
• pale skin
• pinpoint red spots on the skin
• pounding in the ears
• rapid weight gain
• seizures
• slow or fast heartbeat
• sore throat
• stomach pain
• tightness in the chest
• troubled breathing with exertion
• ulcers, sores, or white spots in the mouth
• unsteadiness or awkwardness
• unusual bleeding or bruising
• unusual tiredness or weakness
• unusual weight gain or loss
• vomiting
• weakness in the arms, hands, legs, or feet

Less common

• Chest pain
• dilated neck veins
• extreme tiredness or weakness
• general feeling of discomfort or illness
• irregular breathing
• skin rash
• thickening of bronchial secretions

Rare

• Dark urine
• general feeling of tiredness or weakness
• light-colored stools
• stomach bloating
• vomiting blood
• yellow eyes or skin

Incidence not known

• Agitation
• confusion
• decreased awareness or responsiveness
• depression
• hostility
• irritability
• itching
• joint pain, stiffness, or swelling
• loss of consciousness
• muscle twitching
• severe sleepiness
• stomach tenderness or cramps

Other side effects

Some side effects of ado-trastuzumab emtansine 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

• Belching
• change in taste
• constipation
• diarrhea
• difficulty with moving
• heartburn
• indigestion
• lack or loss of strength
• loss of taste
• muscle stiffness
• stomach discomfort or upset
• swelling or inflammation of the mouth
• trouble sleeping

Less common

• Burning, dry, or itching eyes
• discharge or excessive tearing
• redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid

For Healthcare Professionals

Applies to ado-trastuzumab emtansine: intravenous powder for injection.

Cardiovascular

Common (1% to 10%): Left ventricular dysfunction, hypertension, peripheral edema^[Ref]

Dermatologic

Very common (10% or more): Rash (12%)

Common (1% to 10%): Pruritus, alopecia, nail disorder, palmar-plantar erythrodysesthesia syndrome, urticaria^[Ref]

Gastrointestinal

Very common (10% or more): Nausea (40%), constipation (24%), vomiting (20%), diarrhea (20%), dry mouth (16%), abdominal pain (16%), stomatitis (15%), stomatitis

Common (1% to 10%): Dyspepsia, gingival bleeding^[Ref]

Genitourinary

Very common (10% or more): Urinary tract infection (12%)^[Ref]

Hematologic

Very common (10% or more): Hemorrhage (35%), thrombocytopenia (25%), anemia (15%), hemorrhage

Common (1% to 10%): Neutropenia, leucopenia^[Ref]

Hepatic

Very common (10% or more): Transaminases increased (12%)

Common (1% to 10%):

Uncommon (0.1% to 1%): Hepatotoxicity, hepatic failure, nodular regenerative hyperplasia, portal hypertension

Rare (0.01% to 0.1%): Portal hypertension, hepatic failure, nodular regenerative hyperplasia^[Ref]

Hypersensitivity

Common (1% to 10%): Hypersensitivity^[Ref]

Immunologic

Common (1% to 10%): Immunogenicity^[Ref]

Metabolic

Very common (10% or more): Hypokalemia (11%)

Common (1% to 10%): Blood alkaline phosphatase increased^[Ref]

Musculoskeletal

Very common (10% or more): Musculoskeletal pain (36%), arthralgia (19%), myalgia (13%)^[Ref]

Nervous system

Very common (10% or more): Headache (28%), peripheral neuropathy (23%), asthenia, chills

Common (1% to 10%): Dizziness, dysgeusia, memory impairment^[Ref]

Ocular

Common (1% to 10%): Dry eye, conjunctivitis, blurred vision, lacrimation increased^[Ref]

Other

Very common (10% or more): Fatigue (37%), pyrexia (23%), asthenia (16%), chills (10%)^[Ref]

Psychiatric

Very common (10% or more): Insomnia (12%)^[Ref]

Respiratory

Very common (10% or more): Epistaxis (24%), cough (20%), dyspnea (13%)

Uncommon (0.1% to 1%): Pneumonitis^[Ref]

Local

Uncommon (0.1% to 1%): Injection site extravasation, infusion-related reactions^[Ref]