Trastuzumab-Hyaluronidase

Trastuzumab-Hyaluronidase is a combination medication used for the treatment of breast cancer.

• Trastuzumab-Hyaluronidase is available under the following different brand names: Herceptin Hylecta, trastuzumab-hyaluronidase-oysk.

Common side effects of Trastuzumab-Hyaluronidase include:

• nausea,
• vomiting,
• diarrhea,
• fever,
• chills,
• tiredness,
• cough,
• breathing problems,
• swelling,
• hair loss,
• flushing (sudden warmth, redness, or tingly feeling),
• headache,
• muscle or joint pain,
• stuffy nose,
• sneezing,
• sore throat,
• sleep problems (insomnia),
• rash, and
• pain, burning, itching, swelling, warmth, redness, bruising, bleeding, skin changes, or a hard lump at the injection site

Serious side effects of Trastuzumab-Hyaluronidase include:

• hives,
• difficulty breathing,
• swelling of the face, lips, tongue, or throat,
• dizziness,
• nausea,
• fever,
• chills,
• shortness of breath,
• diarrhea,
• rash,
• chest pain,
• new or worsening cough,
• wheezing,
• rapid breathing,
• swelling in your face or lower legs,
• rapid weight gain,
• fast or pounding heartbeats,
• fluttering in your chest,
• lightheadedness,
• blisters or ulcers in the mouth,
• red or swollen gums,
• trouble swallowing,
• pain while breathing,
• gasping for breath,
• cough foamy mucus,
• sore throat,
• tiredness,
• skin sores,
• cold hands and feet, and
• lightheadedness

Rare side effects of Trastuzumab-Hyaluronidase include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because 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.

Adult and pediatric dosage

Injectable solution, single-dose vial

• (120 mg/2,000 units)/mL
• Ready-to-use SC solution contains trastuzumab and hyaluronidase human

Adjuvant Breast Cancer

Adult dosage

• 600 mg trastuzumab/10,000 units hyaluronidase SC every 3 weeks
• Continue treatment for 52 weeks or until disease recurrence, whichever occurs first; extending treatment in adjuvant breast cancer for more than 1 year is not recommended

Metastatic Breast Cancer

Adult dosage

• 600 mg trastuzumab/10,000 units hyaluronidase SC every 3 weeks
• Continue until disease progression

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

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-Hyaluronidase has severe interactions with no other drugs.
• Trastuzumab-Hyaluronidase has serious interactions with the following drugs:
  • axicabtagene ciloleucel
  • beclomethasone, inhaled
  • brexucabtagene autoleucel
• Trastuzumab-Hyaluronidase has moderate interactions with at least 182 other drugs.
• Trastuzumab-Hyaluronidase has minor interactions with the following drugs:
  • bupivacaine
  • mepivacaine
  • prilocaine
  • ropivacaine

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 about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• None

Effects of drug abuse

• None

Short-Term Effects

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

Long-Term Effects

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

Cautions

• Left ventricular cardiac dysfunction, arrhythmias, hypertension, disabling cardiac failure, cardiomyopathy, and cardiac death may occur as well as asymptomatic decline in LVEF (see Black Box Warnings)
• Fetal harm may occur when administered to a pregnant woman (see Black Box Warnings and Pregnancy)
• Pulmonary toxicity (e.g., dyspnea, interstitial pneumonitis, pulmonary infiltrates, pleural effusions, noncardiogenic pulmonary edema, pulmonary insufficiency and hypoxia, acute respiratory distress syndrome, pulmonary fibrosis) reported; 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 (see Black Box Warnings)
• Chemotherapy-induced neutropenia may be exacerbated
• Severe administration-related reactions (ARRs), including hypersensitivity and anaphylaxis, were  reported; patients experiencing dyspnea at rest due to complications of advanced malignancy and comorbidities may be at increased risk of a severe or fatal ARR
• Drug interaction overview
  • Since Trastuzumab-Hyaluronidase has a long washout period, patients who receive anthracycline after stopping Trastuzumab-Hyaluronidase may be at increased risk of cardiac dysfunction
  • If possible, avoid anthracycline-based therapy for at least 7 months after discontinuing Trastuzumab-Hyaluronidase

Pregnancy and Lactation

• Fetal harm when administered to a pregnant woman
• Verify pregnancy status of females of reproductive potential before initiation
• Female: Use effective contraception during treatment and for 7 months following the last dose
• Pregnancy pharmacovigilance program
• If administered during pregnancy, or if a patient becomes pregnant while during treatment or within 7 months following the last dose, immediately report exposure to Genentech at 1-888-835-2555
• In postmarketing reports, the use of trastuzumab during pregnancy resulted in cases of oligohydramnios and oligohydramnios sequence, manifesting as pulmonary hypoplasia, skeletal abnormalities, and neonatal death
• Advise the patient of the potential risks to a fetus
• Clinical considerations
  • Monitor women who received treatment during pregnancy or within 7 months before conception for oligohydramnios
  • If oligohydramnios occurs, perform fetal testing that is appropriate for gestational age and consistent with community standards of care
• Lactation
  • There is no information regarding the presence of trastuzumab or hyaluronidase in human milk, the effects on the breastfed infant, or the effects on milk production
  • Published data suggest human IgG is present in human milk but does not enter the neonatal and infant circulation in substantial amounts
  • Present in the milk of lactating cynomolgus monkeys but not associated with neonatal toxicity
  • Consider 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 or from the underlying maternal condition; also take into account the trastuzumab wash-out period of 7 months