TA and not ado-trastuzumab emtansine or intravenous trastuzumab.
HERCEPTIN HYLECTA should be administered by healthcare professional.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior toadministration, whenever solution and container permit. Do not use vial if particulates or discoloration ispresent. Discard any unused portion remaining in the vial.
HERCEPTIN HYLECTA is for single use only. The 600 mg/10,000 units (600 mg trastuzumab and 10,000units hyaluronidase) solution is a ready to use solution for injection which does not need to be diluted.
To avoid needle clogging, attach the hypodermic injection needle to the syringe immediately prior toadministration followed by volume adjustment to 5 mL. HERCEPTIN HYLECTA is compatible withpolypropylene and polycarbonate syringe material and stainless steel transfer and injection needles.
Prepare the dosing syringe in controlled and validated aseptic conditions. After the solution of HERCEPTINHYLECTA is withdrawn from the vial and into the syringe, replace the transfer needle with a syringe closingcap. Label the syringe with the peel-off sticker.
Administration
The injection site should be alternated between the left and right thigh. New injections should be given at least2.5 cm from the old previous site on healthy skin and never into areas where the skin is red, bruised, tender, orhard, or areas where there are moles or scars. During the treatment course with HERCEPTIN HYLECTA other
medicinal products for subcutaneous administration should preferably be injected at different sites. The doseshould be administered subcutaneously over approximately 2 to 5 minutes.
Storage
If the syringe containing HERCEPTIN HYLECTA is not used immediately, then the syringe can be stored inthe refrigerator (2°C to 8°C) for up to 24 hours and subsequently at room temperature (20°C to 25°C) for up to4 hours. Protect from light. Do not shake or freeze.
3 DOSAGE FORMS AND STRENGTHS
HERCEPTIN HYLECTA is a colorless to yellowish, clear to opalescent solution for subcutaneous injection:
•Injection: 600 mg trastuzumab and 10,000 units hyaluronidase per 5 mL (120 mg/2,000 units per mL) in asingle-dose vial.
4 CONTRAINDICATIONS
None.
5 WARNINGS AND PRECAUTIONS
5.1 Cardiomyopathy
HERCEPTIN HYLECTA can cause left ventricular cardiac dysfunction, arrhythmias, hypertension, disablingcardiac failure, cardiomyopathy, and cardiac death [see Boxed Warning: Cardiomyopathy]. HERCEPTIN
HYLECTA can also cause asymptomatic decline in LVEF.
There is a 4–6 fold increase in the incidence of symptomatic myocardial dysfunction among patients receivingtrastuzumab as a single agent or in combination therapy compared with those not receiving trastuzumab. Thehighest absolute incidence occurs when trastuzumab is administered with an anthracycline. The incidence of
symptomatic myocardial dysfunction for intravenous trastuzumab and HERCEPTIN HYLECTA was similar inclinical trials [see Adverse Reactions (6)].
Withhold HERCEPTIN HYLECTA for ≥16% absolute decrease in LVEF from pre-treatment values or anLVEF value below institutional limits of normal and ≥10% absolute decrease in LVEF from pretreatmentvalues [see Dosage and Administration (2.3)]. The safety of continuation or resumption of HERCEPTIN HYLECTA in patients with HERCEPTIN HYLECTA induced left ventricular cardiac dysfun |
