ONTRUZANT (trastuzumab-dttb)

There are 0 contraindications.

There are 5 severe contraindications. Adequate patient monitoring is recommended for safer drug use.

Severe List
Cardiomyopathy
Heart failure
Interstitial pneumonitis
Pregnancy
Pulmonary disease

There are 1 moderate contraindications. Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.

Moderate List
Neutropenic disorder

There are 32 severe adverse reactions.

More Frequent	Less Frequent
Anemia Dyspnea Infection Neutropenic disorder Skin rash Thrombocytopenic disorder	Cardiomyopathy Chronic heart failure Dehydration Influenza Peripheral edema Pneumonia Thromboembolic disorder

Rare/Very Rare

Acute respiratory distress syndrome Anaphylaxis Angioedema Bronchospastic pulmonary disease Cardiac arrhythmia Glomerulonephritis Hypotension Hypoxia Idiopathic thrombocytopenic purpura Interstitial lung disease Interstitial pneumonitis Kidney disease with reduction in glomerular filtration rate (GFr) Left ventricular failure Leukopenia Pleural effusions Pulmonary edema Pulmonary infiltrates Respiratory depression Tumor lysis syndrome

There are 47 less severe adverse reactions.

More Frequent	Less Frequent
Chills Cough Diarrhea Dizziness Dysgeusia Fatigue Fever General weakness Headache disorder Insomnia Nausea Pain Pharyngitis Stomatitis Upper respiratory infection Vomiting Weight loss	Acne vulgaris Acute abdominal pain Anorexia Arthralgia Back pain Blurred vision Bone pain Constipation Depression Dyspepsia Dysphagia Edema Epistaxis Flu-like symptoms Hypokalemia Injection site sequelae Muscle spasm Myalgia Nail disorders Palpitations Paresthesia Peripheral neuritis Peripheral neuropathy Rhinitis Sinusitis Skin pigmentation enhancement Tachycardia Urinary tract infection

Rare/Very Rare
Hypertension Pruritus of skin

Oligohydramnios has been reported in women receiving trastuzumab during pregnancy. Placental transfer of trastuzumab has been observed in monkeys. Although reproduction studies in cynomolgus monkeys using trastuzumab dosages up to 25 times the weekly human maintenance dosage of 2 mg/kg have not revealed evidence of harm to the fetus, the important role of the HER2 receptor in embryonic development of the cardiac and central nervous systems raises concerns about possible teratogenic effects of trastuzumab.

The HER2 receptor is expressed at high levels in many embryonic tissues, including cardiac and neural tissues, and death of embryos in early gestation has been observed in mice lacking the HER2 protein. Further study is needed to determine whether trastuzumab has teratogenic effects in humans. The possibility that trastuzumab may persist in maternal tissues for up to 5-6 months after the last dose should be considered. There are no adequate and controlled studies to date using trastuzumab in pregnant women, and the drug should be used during pregnancy only when the potential benefits justify the possible risks to the fetus.

When trastuzumab was administered in lactating cynomolgus monkeys at dosages 25 times the usual human maintenance dosage of 2 mg/kg weekly, distribution of the drug in milk was demonstrated. No adverse effects on growth or development from birth to 3 months of age were observed in infant monkeys with measurable serum trastuzumab concentrations. It is not known whether trastuzumab is distributed into human milk. Because human IgG is distributed in milk, and because of the potential for absorption of trastuzumab and adverse reactions to the drug in nursing infants, women should be advised to discontinue nursing during trastuzumab therapy and for 6 months following the last dose of the drug.

Precaution Exists
Precaution exists. (No data or inconclusive human data.) Use of this drug by breast feeding mothers should be evaluated carefully.

Drug Name	Excretion Potential	Effect on Infant	Notes
Trastuzumab	Unknown. It is unknown whether the drug is excreted in human breast milk.	It is not known whether this drug has an adverse effect on the nursing infant. (No data or inconclusive human data)	Drug properties suggest excretion amnt negligible; infant absorption unlikely

No enhanced Geriatric Use information available for this drug.

Precaution Exists
Geriatric management or monitoring precaution exists.

Drug Name	Narrative	REN	HEP	CARDIO	NEURO	PULM	ENDO
Trastuzumab	Cardiovascular-Risk of CHF. Increased cardiac dysfunction reported in the elderly.	N	N	Y	N	N	N