KADCYLA Distribution

Authorized Distributors and Specialty Pharmacies

Genentech has contracted with a network of authorized specialty distributors to service practices choosing to purchase KADCYLA through the buy and bill model. Customers can purchase KADCYLA through authorized specialty distributors and wholesalers that have made a commitment to product integrity. These partners have agreed to distribute only products purchased directly from Genentech and not to distribute KADCYLA through secondary channels.

KADCYLA Access Solutions works with SPs to help patients receive their medicines. SPs can dispense Genentech medicines to your office. The SPs can also provide coverage and reimbursement support.

Distributor Telephone Fax Web Orders
AmerisourceBergen Drug Corporation 844-222-2273 816-464-4140 www.amerisourcebergen.com/abc/
Cardinal Health Specialty Distribution 800-926-3161 
270-219-6000 (KY) 
501-707-2800 (AR)
N/A www.cardinal.com
Dakota Drug 866-210-5887 763-421-0661 www.dakdrug.com/ddos/
DMS Pharmaceutical 877-788-1100 847-518-1105 dmspharma.com/store.htm
McKesson US Pharmaceutical 855-625-4677 
800-364-6198 (VA/DOD)
N/A connect.mckesson.com

 

Distributor Telephone Fax Web Orders
ASD Healthcare 800-746-6273 800-547-9413 www.asdhealthcare.com
BioSolutions Direct 866-860-3565 888-899-0063 www.biosolutionsdirect.com
Cardinal Health Specialty Distribution 800-926-3161 888-345-4916 specialtyonline.cardinalhealth.com
McKesson Plasma and Biologics (MPB) 877-625-2566 888-752-7626 connect.mckesson.com
Morris & Dickson Specialty Distribution 800-710-6100 318-524-3096 www.mdspecialtydist.com

 

Distributor Telephone Fax Web Orders
BioSolutions Direct 866-860-3565 888-899-0063 www.biosolutionsdirect.com
Cardinal Health Specialty Distribution 877-453-3972 888-345-4916 specialtyonline.cardinalhealth.com
CuraScript SD 877-599-7748 800-862-6208 www.curascriptsd.com
McKesson Specialty Health 800-482-6700 
855-477-9700 
(Non-Oncology Customers)
800-289-9285 mscs.mckesson.com
Oncology Supply 800-633-7555 800-248-8205 www.oncologysupply.com

 

Distributor Telephone Fax Web Orders
ASD Healthcare 800-746-6273 800-547-9413 www.asdhealthcare.com
BioSolutions Direct 866-860-3565 888-899-0063 www.biosolutionsdirect.com
Cardinal Health Specialty Distribution 877-453-3972 888-345-4916 specialtyonline.cardinalhealth.com
Humana Specialty Pharmacy
800-486-2668
877-405-7940
www.humanapharmacy.com/specialty
McKesson Specialty Health 800-482-6700 
855-477-9700 
(Non-Oncology Customers)
800-289-9285 mscs.mckesson.com

 

Distributor Telephone Fax Web Orders
Cardinal Health Puerto Rico 800-981-4699
787-625-4200
787-625-4398 N/A
Cesar Castillo 787-999-1616 787-720-1095 www.cesarcastillo.net

 

Genentech does not influence or advocate the use of any one specialty distributor or specialty pharmacy. We make no representation or guarantee of service or coverage of any item.

About Buy and Bill

With buy and bill, the practice purchases the medication in advance, then bills the patient’s health insurance plan for reimbursement. The practice is responsible for storing and handling the drug as well as collecting the patient’s co-pay for both the drug and its administration. With buy and bill, practices can maintain a stock of the drug, giving them the flexibility to treat patients when clinically appropriate.

About Specialty Pharmacies

KADCYLA Access Solutions works with specialty pharmacies (SPs) to help patients receive their medicines.

An SP may provide the following services:

  • Reimbursement resources
  • Clinical services to support patients throughout their treatment
  • The ability to manage the specialty handling and shipping needs linked with many specialty therapies

You can work with your preferred SP or contact KADCYLA Access Solutions to learn which SP the patient’s health insurance plan requires.

Genentech does not influence or advocate the use of any one specialty distributor of specialty pharmacy. We make no representation or guarantee of service or coverage of any item.

Spoilage Replacement Program

The Genentech Spoilage Replacement Program provides for replacement of infused, injected and self-administered products, which are prescribed and prepared for a labeled indication, yet not administered due to unforeseen patient clinical circumstances, subject to certain limitations and conditions set forth by Genentech. The purpose of the program is to support our commitment to protecting patient safety by preventing the use of spoiled, damaged or contaminated products.

Please contact Genentech Customer Service at (800) 551-2231 to submit a request for replacement of spoiled product or to obtain additional information about the Program.

To request replacement product:

  • Contact Genentech Customer Service at (800) 551-2231 to obtain the Genentech Spoilage Replacement Program Form
  • Complete the Genentech Spoilage Replacement Program Form and fax it back to Genentech Customer Service at (877) 329-6737 within 30 days of the spoilage event
  • The request may take up to 3 business days to review. If approved by Genentech, further instructions for returning product or completing a Certificate of Destruction will be provided
  • The spoiled product or completed Certificate of Destruction must be received by Genentech within 60 days of approval of the spoilage request
    • Replacement product generally ships within 11 business days following receipt of the spoiled product or completed Certificate of Destruction 

Important guidelines:

  • Each instance of spoilage replacement requires completion of the Spoilage Replacement Program Form. Replacement is on a case-by-case basis at the sole discretion of Genentech; please retain all original product packaging for returns processing
  • Genentech does not ship replacement product if the spoiled product has been used for an off-label indication
  • Genentech does not ship replacement product if ANY portion of the product has been administered
  • Genentech will only ship replacement product to licensed facilities
  • All spoilage replacement requests are subject to review by Genentech; returned product is subject to analysis
  • Replacement is not available if any amount has been billed to a patient or an insurance claim has been remitted to a payer
  • Requests are subject to certain limitations and conditions. Genentech has the right to modify or discontinue the Spoilage Replacement Program at any time without notice

PAN=Patient Authorization and Notice of Request for Transmission of Health Information to Genentech Access Solutions and Genentech® Access to Care Foundation.

Important Safety Information & Indication

Indication

KADCYLA®(ado-trastuzumab emtansine), as a single agent, is indicated for the treatment of patients with HER2-positive (HER2+), metastatic breast cancer (MBC) who previously received trastuzumab and a taxane, separately or in combination. Patients should have either:

  • Received prior therapy for metastatic disease, or
  • Developed disease recurrence during or within six months of completing adjuvant therapy

Important Safety Information

Boxed WARNINGS: HEPATOTOXICITY, CARDIAC TOXICITY, EMBRYO­-FETAL TOXICITY

  • Do not substitute KADCYLA for or with trastuzumab
  • Hepatotoxicity: Serious hepatotoxicity has been reported, including liver failure and death in patients treated with KADCYLA. Monitor serum transaminases and bilirubin prior to initiation of KADCYLA treatment and prior to each KADCYLA dose. Reduce dose or discontinue KADCYLA as appropriate in cases of increased serum transaminases or total bilirubin
  • Cardiac toxicity: KADCYLA administration may lead to reductions in left ventricular ejection fraction (LVEF). Evaluate left ventricular function in all patients prior to and during treatment with KADCYLA. Withhold treatment for clinically significant decrease in left ventricular function
  • Embryo-fetal toxicity: Exposure to KADCYLA during pregnancy can result in embryo-fetal harm. Advise patients of these risks and the need for effective contraception

Additional Important Safety Information:

Left Ventricular Dysfunction (LVD)

  • Patients treated with KADCYLA are at increased risk of developing LVD. In EMILIA, LVD occurred in 1.8% of patients in the KADCYLA-treated group and in 3.3% in the comparator group. Permanently discontinue KADCYLA if LVEF has not improved or has declined further

Embryo-Fetal Toxicity

  • Verify the pregnancy status of women of reproductive potential prior to the initiation of KADCYLA
  • 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 females of reproductive potential to use effective contraception during treatment and for 7 months following the last dose of KADCYLA
  • If KADCYLA is administered during pregnancy or if a patient becomes pregnant while receiving KADCYLA or within 7 months following the last dose of KADCYLA, immediately report exposure to the Genentech Adverse Event Line at 1-888-835-2555
  • Encourage women who may be exposed to KADCYLA during pregnancy or within 7 months prior to conception, to enroll in the MotHER Pregnancy Registry by contacting 1-800-690-6720 or visiting http://www.motherpregnancyregistry.com/

Pulmonary Toxicity

  • Cases of interstitial lung disease (ILD), including pneumonitis, some leading to acute respiratory distress syndrome or fatal outcome, have been reported in clinical trials with KADCYLA. In EMILIA, the overall frequency of pneumonitis was 1.2%
  • Treatment with KADCYLA should be permanently discontinued in patients diagnosed with ILD or pneumonitis

Infusion-Related Reactions, Hypersensitivity Reactions

  • Treatment with KADCYLA has not been studied in patients who had trastuzumab permanently discontinued due to infusion-related reactions (IRR) and/or hypersensitivity reactions; treatment with KADCYLA is not recommended for these patients. In EMILIA, the overall frequency of IRRs in patients treated with KADCYLA was 1.4%
  • KADCYLA treatment should be interrupted in patients with severe IRRs and permanently discontinued in the event of a life-threatening IRR. Patients should be closely monitored for IRRs, especially during the first infusion

Hemorrhage

  • Hemorrhagic events, sometimes fatal, have been reported in clinical trials. In EMILIA, the incidence of ≥Grade 3 hemorrhage was 1.8% in the KADCYLA-treated group and 0.8% in the comparator group (overall incidence 32.2% and 16.4%, respectively)
  • In some of the observed cases, the patients were also receiving anticoagulation therapy or antiplatelet therapy, or had thrombocytopenia; in others, there were no known additional risk factors. Use caution with these agents and consider additional monitoring when concomitant use is medically necessary

Thrombocytopenia

  • In EMILIA, the incidence of ≥Grade 3 thrombocytopenia was 14.5% in the KADCYLA-treated group and 0.4% in the comparator group (overall incidence 31.2% and 3.3%, respectively)
  • Monitor platelet counts prior to initiation of KADCYLA and prior to each KADCYLA dose. Institute dose modifications as appropriate

Neurotoxicity

  • In EMILIA, the incidence of ≥Grade 3 peripheral neuropathy was 2.2% in the KADCYLA-treated group and 0.2% in the comparator group (overall incidence 21.2% and 13.5%, respectively)
  • Monitor for signs or symptoms of neurotoxicity. KADCYLA should be temporarily discontinued in patients experiencing Grade 3 or four peripheral neuropathy until resolution to ≤Grade 2

HER2 Testing

  • Detection of HER2 protein overexpression or gene amplification is necessary for selection of patients appropriate for KADCYLA. Perform using FDA-approved tests by laboratories with demonstrated proficiency

Extravasation

  • In KADCYLA clinical studies, reactions secondary to extravasation have been observed and were generally mild. The infusion site should be closely monitored for possible subcutaneous infiltration during drug administration. Specific treatment for KADCYLA extravasation is unknown

Nursing Mothers

  • Discontinue nursing or discontinue KADCYLA, taking into consideration the importance of the drug to the mother

Adverse Reactions

  • The most common (frequency >25%) adverse drug reactions (ADR) across clinical trials with KADCYLA were nausea, fatigue, musculoskeletal pain, hemorrhage, thrombocytopenia, increased transaminases, headache, constipation, and epistaxis. In EMILIA, the most common severe adverse reactions Grades ≥3 (frequency >2%) were thrombocytopenia, increased transaminases, anemia, hypokalemia, peripheral neuropathy, and fatigue according to NCI-CTCAE (version 3)

You are encouraged to report side effects to Genentech and the FDA. You may contact Genentech by calling 1-888-835-2555. You may contact the FDA by visiting www.fda.gov/medwatch or calling 1-800-FDA-1088.

Please see full Prescribing Information for additional Important Safety Information, including Boxed WARNINGS.