Ado-trastuzumab emtansine Side Effects

For the Consumer

Applies to ado-trastuzumab emtansine: intravenous powder for solution

In addition to its needed effects, some unwanted effects may be caused by ado-trastuzumab emtansine. In the event that any of these side effects do occur, they may require medical attention.

If any of the following side effects occur while taking ado-trastuzumab emtansine, check with your doctor or nurse immediately:

• 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
• convulsions
• 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 or vomiting
• 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
• slow or fast heartbeat
• sore throat
• 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
• weakness in the arms, hands, legs, or feet

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

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

• Abdominal or stomach tenderness
• itching

Minor Side Effects

Some of the side effects that can occur with ado-trastuzumab emtansine may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

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

• 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

General

The most frequently reported side effects included nausea, fatigue, musculoskeletal pain, thrombocytopenia, increased transaminases, headache, and constipation.^[Ref]

Cardiovascular

Common (1% to 10%): Hypertension (5.1%), left ventricular dysfunction (1.8%)^[Ref]

Dermatologic

Very common (10% or more): Rash (11.6%)
Common (1% to 10%): Pruritus (5.5%)^[Ref]

Gastrointestinal

Very common (10% or more): Nausea (39.8%), constipation (26.5%), diarrhea (24.1%), vomiting (19.2%), abdominal pain (18.6%), dry mouth (16.7%), stomatitis (14.1%)
Common (1% to 10%): Dyspepsia (9.2%)^[Ref]

Genitourinary

Common (1% to 10%): Urinary tract infection (9.4%)^[Ref]

Hematologic

Very common (10% or more): Decreased platelet count (83%), decreased hemoglobin (60%), decreased neutrophils (39%), thrombocytopenia (31.2%), anemia (14.2%)
Common (1% to 10%): Neutropenia (6.7%)^[Ref]

Hepatic

Very common (10% or more): Increased AST (98%), increased ALT (82%), increased transaminases (28.8%), increased bilirubin (17%)
Uncommon (0.1% to 1%): Nodular regenerative hyperplasia (0.4%), portal hypertension (0.4%)^[Ref]

Hypersensitivity

Common (1% to 10%): Drug hypersensitivity (2.2%)^[Ref]

Immunologic

Common (1% to 10%): Positive test for anti-ado-trastuzumab emtansine antibodies (5.3%)^[Ref]

Metabolic

Very common (10% or more): Decreased potassium (33%), hypokalemia (10.2%)
Common (1% to 10%): Alkaline phosphatase increased (4.7%)^[Ref]

Musculoskeletal

Very common (10% or more): Musculoskeletal pain (36.1%), arthralgia (19.2%), myalgia (14.1%)^[Ref]

Nervous system

Very common (10% or more): Headache (28.2%), peripheral neuropathy (21.2%), dizziness (10.2%)
Common (1% to 10%): Dysgeusia (8.0%)^[Ref]

Ocular

Common (1% to 10%): Vision blurred (4.5%), dry eye (3.9%), conjunctivitis (3.9%), lacrimation increased (3.3%)^[Ref]

Other

Very common (10% or more): Fatigue (36.3%), pyrexia (18.6%), asthenia (17.8%)
Common (1% to 10%): Chills (7.6%), peripheral edema (7.1%), infusion related reaction (1.4%)^[Ref]

Psychiatric

Very common (10% or more): Insomnia (12.0%)^[Ref]

Respiratory

Very common (10% or more): Epistaxis (22.5%), cough (18.2%), dyspnea (12.0%),
Common (1% to 10%): Pneumonitis (1.2%)^[Ref]

Not all side effects for ado-trastuzumab emtansine may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

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