eived 4 cycles of HERCEPTIN HYLECTA followed by 4 cycles ofintravenous trastuzumab and 119 patients in arm B received 4 cycles of intravenous trastuzumab followed by 4cycles of HERCEPTIN HYLECTA. Both arms received a total of 18 cycles. After Cycle 8, 199 of 231 patients(86%) reported preferring subcutaneous administration of HERCEPTIN HYLECTA over intravenoustrastuzumab and the most common reason cited was administration required less time (179/231) in the clinic.
After Cycle 8, 29 out of 231 patients (13%) reported preferring intravenous trastuzumab over HERCEPTINHYLECTA and the most common reason was fewer local injection reactions. Three out of 231 patients (1%)had no preference for the route of administration. Nine out of 240 (3.8%) withdrew from treatment prior tocompletion of Cycle 8 and did not complete the post-study preference questionnaire.
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1 How Supplied
HERCEPTIN HYLECTA (trastuzumab and hyaluronidase-oysk) injection for subcutaneous use supplied as sterile, preservative-free, colorless to yellowish, clear to opalescent solution in a single-dose vial. The followingconfiguration is available:
Individually packaged single-dose vials:
•HERCEPTIN HYLECTA 600 mg/10,000 units (NDC: 50242-077-01) providing 600 mg trastuzumab and10,000 units hyaluronidase per 5 mL.
16.2 Storage
Store HERCEPTIN HYLECTA vials in the refrigerator at 2°C to 8°C (36°F to 46°F) in the original carton toprotect from light. Do not freeze. Do not shake. Once removed from the refrigerator, HERCEPTIN HYLECTAmust be administered within 4 hours and should not be kept above 30°C (86°F).
17 PATIENT COUNSELING INFORMATION
Cardiomyopathy
•Advise patients to contact a health care professional immediately for any of the following: new onset orworsening shortness of breath, cough, swelling of the ankles/legs, swelling of the face, palpitations, weightgain of more than 5 pounds in 24 hours, dizziness or loss of consciousness [see Warnings and Precautions(5.1)].
Embryo-Fetal Toxicity [see Warnings and Precautions (5.2)]
•Advise pregnant women and females of reproductive potential that HERCEPTIN HYLECTA exposurduring pregnancy or within 7 months prior to conception can result in fetal harm. Advise female patients
to contact their healthcare provider with a known or suspected pregnancy [see Use in Specific Populations(8.1)].
•Advise females of reproductive potential to use effective contraception during treatment and for 7 monthsfollowing the last dose of HERCEPTIN HYLECTA [see Use in Specific Populations (8.3)].
•Advise women who are exposed to HERCEPTIN HYLECTA during pregnancy or who become pregnantwithin 7 months following the last dose of HERCEPTIN HYLECTA that there is a pregnancypharmacovigilance program that monitors pregnancy outcomes. Encourage these patients to report theirpregnancy to Genentech [see Use in Specific Populations (8.1)].
Hypersensitivity and Administration-Related Reactions
•Advise patients to contact their healthcare provider immediately and to report any symptoms ofhypersensitivity and administration-related reactions including dizziness, nausea, chills, fever, vomitingHERCEPTIN HYLECTA™ [trastuzumab and hyaluronidase-oysk]anufactured by: HERCEPTIN HYLECTA is a trademark of Genentech, Inc.
Genentech, Inc. ©2019 Genentech, Inc.
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