Trastuzumab

Trastuzumab is a prescription medication used for the treatment of breast and gastric cancer.

• Trastuzumab is available under the following different brand names: Herceptin, Ogivri, Herzuma, Ontruzant, Trazimera, Kanjinti, trastuzumab-dkst, trastuzumab-pkrb, trastuzumab-dttb, trastuzumab-qyyp, trastuzumab-anns

Adult dosage

Injection, powder for reconstitution

• 150mg/single-dose vial (Herceptin, Ontruzant)
• 420mg/multidose vial (Herceptin, Ogivri, Herzuma, Trazimera, Kanjinti, Ontruzant)

Biosimilars to Herceptin

• Ogivri (trastuzumab-dkst)
• Herzuma (trastuzumab-pkrb)
• Ontruzant (trastuzumab-dttb)
• Trazimera (trastuzumab-qyyp)
• Kanjinti (trastuzumab-anns)

Breast Cancer

Adult dosage

Adjuvant treatment

• In combination with doxorubicin, cyclophosphamide, and either paclitaxel or docetaxel
• Herceptin, Ogivri, Herzuma, Ontruzant, Trazimera, Kanjinti
• 4 mg/kg IV over 90 min, THEN  
• 2 mg/kg IV over 30 min every week during chemotherapy for the first 12 weeks (paclitaxel or docetaxel)
• One week following the last weekly dose, initiate 6 mg/kg IV every 3 weeks; infuse over 30-90 min
• Administer for a total of 52 weeks

In combination with docetaxel and carboplatin

• Herceptin, Ogivri, Herzuma, Ontruzant, Trazimera, Kanjinti
• 4 mg/kg IV over 90 min, THEN  
• 2 mg/kg IV over 30 min every week during chemotherapy for the first 18 weeks (docetaxel/carboplatin)
• One week following the last weekly dose, initiate 6 mg/kg IV every 3 weeks; infuse over 30-90 min
• Administer for a total of 52 weeks

As a single agent following completion of multi-modality, anthracycline-based chemotherapy

• Herceptin, Ogivri, Ontruzant, Trazimera, Kanjinti
• 8 mg/kg IV over 90 min, THEN  
• 6 mg/kg as an IV over 30−90 min every 3 weeks
• Administer for a total of 52 weeks
• Extending adjuvant treatment beyond one year not recommended

Metastatic breast cancer

• Herceptin, Ogivri, Herzuma, Ontruzant, Trazimera, Kanjinti
• 4 mg/kg IV over 90 min, THEN  
• 2 mg/kg IV over 30 min every week, continue until disease progression

Gastric Cancer

Adult dosage

• Herceptin, Ogivri, Ontruzant, Trazimera, Kanjinti
• 8 mg/kg IV over 90 min, THEN  
• 6 mg/kg IV every 3 weeks; infuse IV over 30-90 min, continue until disease progression

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

Common side effects of Trastuzumab include:

• heart problems,
• nausea,
• diarrhea,
• weight loss,
• headache,
• trouble sleeping,
• feeling tired,
• rash,
• mouth sores,
• fever,
• chills,
• cough,
• other signs of infection,
• altered sense of taste, and
• cold symptoms (stuffy nose, sinus pain, sore throat).

Serious side effects of Trastuzumab include:

• dizziness,
• nausea,
• itchiness,
• lightheadedness,
• weak,
• shortness of breath,
• headache,
• fever,
• chills,
• chest pain,
• new or worsening cough,
• wheezing,
• chest tightness,
• trouble breathing,
• fever with shortness of breath,
• rapid breathing,
• pounding heartbeats,
• fluttering in the chest,
• severe headache,
• blurred vision,
• pounding in your neck or ears,
• blisters or ulcers in the mouth,
• red or swollen gums,
• trouble swallowing,
• swelling,
• rapid weight gain,
• tiredness,
• skin sores,
• easy bruising,
• unusual bleeding,
• pale skin,
• cold hands and feet,
• feeling lightheaded,
• confusion,
• weakness,
• muscle cramps,
• vomiting,
• fast or slow heart rate,
• decreased urination, and
• tingling in the hands and feet or around the mouth.

Rare side effects of Trastuzumab include:

• none 

This is not a complete list of side effects and other serious side effects or health problems that may occur as a result of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Trastuzumab has severe interactions with no other drugs.
• Trastuzumab has serious interactions with the following drugs:
  • axicabtagene ciloleucel
  • brexucabtagene autoleucel
  • ciltacabtagene autoleucel
  • daunorubicin
  • doxorubicin
  • doxorubicin liposomal
  • epirubicin
  • idarubicin
  • idecabtagene vicleucel
  • lisocabtagene maraleucel
  • ropeginterferon alfa 2b
  • tisagenlecleucel
• Trastuzumab has moderate interactions with at least 154 other drugs.
• Trastuzumab has minor interactions with no other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions, concerns.

Contraindications

• Hypersensitivity to drug/class/component or hamster protein

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Trastuzumab?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Trastuzumab?”

Cautions

• Use extreme caution in cardiac disease, cardiotoxic agent history, ejection fraction decreased, pulmonary disease, elderly (see Black Box Warnings)
• Verify pregnancy status of females of reproductive potential prior to the initiation of therapy (see Pregnancy)
• CHF: At a median follow-up duration of 8 yr, the incidence of severe CHF (NYHA III and IV) was 0.8%, and the rate of mild symptomatic and asymptomatic left ventricular dysfunction was 4.6%
• Exposure to trastuzumab during pregnancy or within 7 months prior to conception can result in fetal harm; females of reproductive potential should use effective contraception during treatment and for 7 months following the last dose of trastuzumab
• Tumor lysis syndrome (TLS) reported; patients with significant tumor burden (eg, bulky metastases) may be at a higher risk; patients could present with hyperuricemia, hyperphosphatemia, and acute renal failure which may represent possible TLS; providers should consider additional monitoring and/or treatment as clinically indicated
• Cardiomyopathy
  • Therapy can cause left ventricular cardiac dysfunction, arrhythmias, hypertension, disabling cardiac failure, cardiomyopathy, and cardiac death
  • Can also cause an asymptomatic decline in left ventricular ejection fraction (LVEF); there is a 4−6 fold increase in the incidence of symptomatic myocardial dysfunction among patients receiving the drug as a single agent; the highest absolute incidence occurs when the drug is administered with an anthracycline; withhold therapy for above 16% absolute decrease in LVEF from pretreatment values or an LVEF value below institutional limits of normal and more than 10% absolute decrease in LVEF from pretreatment values
  • The safety of continuation or resumption of therapy in patients with therapy-induced left ventricular cardiac dysfunction has not been studied
  • Patients who receive anthracycline after stopping Herceptin may also be at increased risk of cardiac dysfunction
• Cardiac monitoring
  • Conduct thorough cardiac assessment, including history, physical examination, and determination of LVEF by echocardiogram or MUGA scan; the following schedule is recommended
  • Baseline LVEF measurement immediately before initiation of therapy
  • LVEF measurements every 3 months during and upon completion of therapy
  • Repeat LVEF measurement at 4-week intervals if the drug is withheld for significant left ventricular cardiac dysfunction
  • LVEF measurements every 6 months for at least 2 years following completion of therapy as a component of adjuvant therapy
• Infusion reactions
  • Infusion reactions consist of a symptom complex characterized by fever and chills, and on occasion included nausea, vomiting, pain (in some cases at tumor sites), headache, dizziness, dyspnea, hypotension, rash, and asthenia
  • Interrupt infusion in all patients experiencing dyspnea, clinically significant hypotension, and intervention of medical therapy administered (which may include epinephrine, corticosteroids, diphenhydramine, bronchodilators, and oxygen)
  • Patients should be evaluated and carefully monitored until complete resolution of signs and symptoms; permanent discontinuation should be strongly considered in all patients with severe infusion reactions
  • There are no data regarding the most appropriate method of identification of patients who may safely be retreated after experiencing a severe infusion reaction
  • Before resumption of infusion, the majority of patients who experience a severe infusion reaction may be pre-medicated with antihistamines and/or corticosteroids; while some patients may tolerate the infusions, others may have severe infusion reactions despite pre-medications
• Pulmonary toxicity
  • Therapy can result in serious and fatal pulmonary toxicity; toxicity includes dyspnea, interstitial pneumonitis, pulmonary infiltrates, pleural effusions, non-cardiogenic pulmonary edema, pulmonary insufficiency and hypoxia, acute respiratory distress syndrome, and pulmonary fibrosis
  • Such events can occur as sequelae of infusion reactions; patients with symptomatic intrinsic lung disease or with extensive tumor involvement of the lungs, resulting in dyspnea at rest, appear to have more severe toxicity
• Exacerbation of chemotherapy-induced neutropenia
  • In randomized, controlled clinical trials, the per-patient incidences of NCI-CTC Grade 3−4 neutropenia and of febrile neutropenia were higher in patients receiving therapy in combination with myelosuppressive chemotherapy as compared to those who received chemotherapy alone; incidence of septic death was similar among patients who received therapy and those who did not
• Preinfusion treatment
  • Symptoms such as chills and/or fever were observed in ~40% of patients
  • Usually mild-to-moderate severity
  • Pretreat with acetaminophen, diphenhydramine, and meperidine (with or without reduction in infusion rate)

Pregnancy and Lactation

• May cause fetal harm when administered to a pregnant woman
• In postmarketing reports, use of trastuzumab during pregnancy resulted in cases of oligohydramnios and of oligohydramnios sequence, manifesting as pulmonary hypoplasia, skeletal abnormalities, and neonatal death
• Advise patient of the potential risks to a fetus
• Herceptin pregnancy registry
  • If administered during pregnancy, or if a patient becomes pregnant while receiving trastuzumab or within 7 months following the last dose, health care providers and patients should immediately report exposure to Genentech at 1-888-835-2555
• Contraception
  • Verify pregnancy status of females of reproductive potential before initiating
  • Advise pregnant women and females of reproductive potential that exposure during pregnancy or within 7 months before conception can result in fetal harm
  • Advise females of reproductive potential to use effective contraception during treatment and for 7 months following the last dose
• Lactation
  • No information regarding the presence of trastuzumab in human milk, the effects on breastfed infants, or the effects on milk production
  • Published data suggest human IgG is present in human milk but does not enter neonatal and infant circulation in substantial amounts
  • Trastuzumab was present in the milk of lactating cynomolgus monkeys but not associated with neonatal toxicity
  • Assess the developmental and health benefits of breastfeeding along with the mother’s clinical need for treatment and any potential adverse effects on the breastfed child from the drug or the underlying maternal condition (unwrap)
  • Consider trastuzumab washout period of 7 months