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The final sections of the Prescribing Information provide guidance on the storage and handling of KADCYLA (section 16) and review important counseling points (section 17).

16.1 How Supplied/Storage and Handling

The packaging for KADCYLA is shown in Figure 1. It is supplied in two sizes of vials, 100 mg and 160 mg as shown in Figure 2. Vials need to be stored in a refrigerator at 2°C to 8°C (36°F to 46°F) until time of reconstitution. Do not shake or freeze.

Figure 1. KADCYLA Packaging

Figure 2. KADCYLA Vials and NDC Numbers

17 Patient Counseling Information

Patients should be counseled on the potential for hepatotoxicity, left ventricular dysfunction, embryo-fetal toxicity, and a warning for women who may be lactating.

Patient Counseling Points
Hepatotoxicity

Advise patients of the possibility of severe liver injury and advise patients to immediately seek medical attention if they experience symptoms of acute hepatitis such as:

  • Nausea
  • Vomiting
  • Acute abdominal pain (especially RUQ abdominal pain)
  • Jaundice
  • Dark urine
  • Generalized pruritis
  • Anorexia
Left ventricular dysfunction

Advise patients to contact a healthcare professional immediately for any of the following:

  • New onset or worsening shortness of breath
  • Cough
  • Swelling of the ankles/legs
  • Swelling of the face
  • Palpitations
  • Weight gain of more than 5 pounds in 24 hours
  • Dizziness or loss of consciousness
Embryo-fetal toxicity
  • Advise pregnant women and females of reproductive potential that exposure to KADCYLA during 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.
  • Advise women who are exposed to KADCYLA during pregnancy or within 7 months prior to conception that there is a pregnancy pharmacovigilance program that monitors pregnancy outcomes. Encourage these patients to report their pregnancy to Genentech.
  • Advise females of reproductive potential to use effective contraception during treatment and for 7 months following the last dose of KADCYLA.
  • Advise male patients with female partners of reproductive potential to use effective contraception during treatment and for 4 months following the last dose of KADCYLA
Lactation
  • Advise patients not to breastfeed during treatment and for 7 months after the last dose of KADCYLA

Progress Check