Note: This document contains side effect information about trastuzumab. Some dosage forms listed on this page may not apply to the brand name Ontruzant.
Applies to trastuzumab: intravenous powder for solution.
Warning
Intravenous route (Powder for Solution)
CardiomyopathyAdministration of trastuzumab products can result in subclinical and clinical cardiac failure. The incidence and severity were highest in patients receiving trastuzumab with anthracycline-containing chemotherapy regimens. Evaluate left ventricular function in all patients prior to and during treatment with trastuzumab-dttb. Discontinue trastuzumab-dttb treatment in patients receiving adjuvant therapy and withhold trastuzumab-dttb in patients with metastatic disease for clinically significant decrease in left ventricular function.Infusion Reactions, Pulmonary ToxicityAdministration of trastuzumab products can result in serious and fatal infusion reactions and pulmonary toxicity. Symptoms usually occur during or within 24 hours of administration. Interrupt trastuzumab-dttb infusion for dyspnea or clinically significant hypotension. Monitor patients until symptoms completely resolve. Discontinue trastuzumab-dttb for anaphylaxis, angioedema, interstitial pneumonitis, or acute respiratory distress syndrome.Embryo-Fetal ToxicityExposure to trastuzumab products during pregnancy can result in oligohydramnios and oligohydramnios sequence manifesting as pulmonary hypoplasia, skeletal abnormalities, and neonatal death. Advise patients of these risks and the need for effective contraception.
Serious side effects of Ontruzant
Along with its needed effects, trastuzumab (the active ingredient contained in Ontruzant) 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 trastuzumab:
More common
- Black, tarry stools
- bleeding gums
- bloating or swelling of the face, arms, hands, lower legs, or feet
- bloody urine
- body aches or pain
- chest pain
- chills
- cough
- decreased frequency or amount of urine
- diarrhea
- difficulty in breathing
- dilated neck veins
- dry mouth
- dryness or soreness of the throat
- ear congestion
- extreme tiredness or weakness
- fever
- general feeling of discomfort or illness
- headache
- hoarseness
- increased blood pressure
- increased cough
- increased thirst
- irregular breathing
- irregular heartbeat
- joint pain
- loss of appetite
- loss of voice
- lower back or side pain
- mood changes
- muscle pain or cramps
- nausea
- numbness or tingling in the hands, feet, or lips
- pain or tenderness around the eyes and cheekbones
- painful or difficult urination
- pale skin
- pinpoint red spots on the skin
- rapid weight gain
- seizures
- shivering
- sneezing
- sore throat
- stuffy or runny nose
- sweating
- tender, swollen glands in the neck
- tightness in the chest
- trouble in swallowing
- trouble sleeping
- troubled breathing with exertion
- ulcers, sores, or white spots in the mouth
- unusual bleeding or bruising
- unusual tiredness or weakness
- unusual weight gain or loss
- voice changes
- vomiting
Less common
- Bladder pain
- blindness or vision changes
- blurred vision
- burning of the face or mouth
- burning, crawling, itching, numbness, painful, prickling, "pins and needles", or tingling feelings
- cloudy urine
- clumsiness or unsteadiness
- dizziness
- fast, pounding, or irregular heartbeat or pulse
- frequent urge to urinate
- nervousness
- nosebleed
- painful cold sores or blisters on the lips, nose, eyes, or genitals
- pounding in the ears
- slow heartbeat
- weakness in the hands or feet
Rare
- Decreased ability to exercise
- fainting
- hives, itching, skin rash
- irritation
- joint stiffness or swelling
- neck tenderness or swelling
- redness of the skin
Other side effects of Ontruzant
Some side effects of trastuzumab 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
- Back pain
- bone pain
- change in or loss of taste
- cracked lips
- depression
- difficulty in moving
- lack or loss of strength
- stomach pain
- swelling or inflammation of the mouth
- trouble sleeping
- weight decreased
Less common
- Belching
- heartburn
- indigestion
- muscle spasm
- stabbing pain
- stomach discomfort or upset
- upper stomach pain
For Healthcare Professionals
Applies to trastuzumab: intravenous powder for injection.
General
The most common adverse events were fever, nausea, vomiting, infusion reactions, diarrhea, infections, increased cough, headache, fatigue, dyspnea, rash, neutropenia, anemia, stomatitis, weight loss, thrombocytopenia, mucosal inflammation, nasopharyngitis, dysgeusia, and myalgia.[Ref]
Hematologic
Very common (10% or more): Neutropenia (78%), leukopenia (52%), anemia (36%), febrile neutropenia (23%), thrombocytopenia (16%)
Frequency not reported: Hypoprothrombinemia[Ref]
Cardiovascular
Very common (10% or more): LVEF decrease (44%), congestive heart failure (28%), cardiomyopathy (15%), peripheral edema (10%), tachycardia (10%)
Common (1% to 10%): Hypertension, hypotension, asymptomatic cardiac dysfunction, ejection fraction decreased, palpitation, cardiac arrhythmia, cardiac failure, heart beat irregular, cardiac flutter, lymphedema, hot flush, thrombotic adverse event, supraventricular tachyarrhythmia, vasodilation
Uncommon (0.1% to 1%): Ventricular dysfunction, pericardial effusion
Frequency not reported: Cardiogenic shock, pericarditis, bradycardia, gallop rhythm present, S3 gallop[Ref]
Hypersensitivity
Very common (10% or more): Infusion-related reactions (54%)
Common (1% to 10%): Hypersensitivity, allergic reaction
Frequency not reported: Anaphylactic reaction, anaphylactic shock[Ref]
Respiratory
Very common (10% or more): Cough (43%), dyspnea (42%), rhinitis (22%), Grade 2 to 5 pulmonary toxicity (14%), nasopharyngitis (13%), wheezing, epistaxis, rhinorrhea
Common (1% to 10%): Pharyngolaryngeal pain, sinusitis, epistaxis, upper respiratory infection, rhinitis, asthma, lung disorder, pleural effusion
Uncommon (0.1% to 1%): Pulmonary infiltrates, pulmonary hypertension, interstitial pneumonitis
Frequency not reported: Pulmonary insufficiency, pulmonary fibrosis, respiratory distress, respiratory failure, lung infiltration, acute pulmonary edema, acute respiratory distress syndrome, bronchospasm, hypoxia, oxygen saturation decreased, laryngeal edema, pulmonary edema, orthopnea
Postmarketing reports: Bronchospasm, hypoxia, pleural effusions, non-cardiogenic pulmonary edema[Ref]
Immunologic
Very common (10% or more): Infection (47%), herpes simplex (38%), antibody to trastuzumab (the active ingredient contained in Ontruzant) (15%), flu syndrome (12%)
Common (1% to 10%): Neutropenic sepsis, postoperative wound infection, herpes zoster
Uncommon (0.1% to 1%): Sepsis[Ref]
Renal
Very common (10% or more): Renal impairment/failure (18%)
Common (1% to 10%): Grade 3 or 4 renal failure, renal disorder, hyperbilirubinemia
Frequency not reported: Glomerulonephritis membranous, glomerulonephropathy, renal failure
Postmarketing reports: Nephrotic syndrome with pathological evidence of glomerulopathy[Ref]
Gastrointestinal
Very common (10% or more): Nausea (76%), vomiting (53%), diarrhea (45%), abdominal pain (34%), stomatitis (24%), anorexia (14%)
Common (1% to 10%): Constipation, dyspepsia, dysphagia, lip swelling, pancreatitis, hemorrhoids, dry mouth[Ref]
Nervous system
Very common (10% or more): Headache (44%), asthenia (42%), fatigue (35%), insomnia (29%), dizziness (24%), paresthesia (23%), peripheral neuritis (23%), neuropathy (13%), dysgeusia (10%), dizziness (13%), tremor, hypoesthesia
Common (1% to 10%): Hypertonia, somnolence, ataxia
Rare (less than 0.1%): Paresis
Frequency not reported: Brain edema[Ref]
Dermatologic
Very common (10% or more): Rash (38%), nail changes (12%), acne (11%), rash/desquamation (11%), erythema, swelling face, palmar-plantar erythrodysesthesia syndrome, alopecia
Common (1% to 10%): Pruritus, dry skin, ecchymosis, hyperhidrosis, maculopapular rash, onychoclasis, dermatitis, contusion, skin infection, erysipelas, cellulitis
Uncommon (0.1% to 1%): Urticaria
Frequency not reported: Angioedema[Ref]
Musculoskeletal
Very common (10% or more): Arthralgia (37%), back pain (34%), bone pain (24%), muscle tightness, myalgia
Common (1% to 10%): Muscle spasm, neck pain, pain in extremity, arthritis[Ref]
Metabolic
Very common (10% or more): Anorexia (31%), hypokalemia (28%), weight loss (23%)
Frequency not reported: Hyperkalemia
Postmarketing reports: Volume overload[Ref]
Other
Very common (10% or more): Asthenia (62%), pain (61%), fever (56%), chills (41%), accidental injury (13%)
Common (1% to 10%): Malaise
Uncommon (0.1% to 1%): Deafness
Rare (less than 0.1%): Sudden death
Postmarketing reports: Oligohydramnios or oligohydramnios sequence (including pulmonary hypoplasia, skeletal abnormalities, and neonatal death)[Ref]
Hepatic
Common (1% to 10%): Hepatocellular injury, hepatitis, liver tenderness
Rare (less than 0.1%): Jaundice
Frequency not reported: Hepatic failure[Ref]
Ocular
Very common (10% or more): Conjunctivitis, lacrimation increased
Common (1% to 10%): Dry eye
Frequency not reported: Papilledema, retinal hemorrhage[Ref]
Genitourinary
Common (1% to 10%): Breast inflammation/mastitis, urinary tract infection, cystitis[Ref]
Psychiatric
Very common (10% or more): Depression (20%), insomnia (14%)
Common (1% to 10%): Anxiety, thinking abnormal
Uncommon (0.1% to 1%): Depression[Ref]
Endocrine
Uncommon (0.1% to 1%): Autoimmune thyroiditis[Ref]
Oncologic
Frequency not reported: Malignant neoplasm progression, neoplasm progression[Ref]
