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
CuraScript SD
877-599-7748 800-862-6208 www.curascriptsd.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
CuraScript SD
877-599-7748 800-862-6208 www.curascriptsd.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:

  • Complete the Online Spoilage Replacement Form found at the Genentech Customer Service website
  • Once the form is complete, you will receive a confirmation number; your request is not complete until you have this number
  • If approved, further instructions for returning product or completing a Certificate of Destruction will be provided within 2 business days of the form submission
  • The Genentech Spoilage Replacement Program will continue to accept submissions via fax
    • You can download the paper form at the Genentech Customer Service website or 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

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

The following additional serious adverse reactions have been reported in clinical trials with KADCYLA:

  • Interstitial lung disease (ILD), including pneumonitis, some leading to acute respiratory distress syndrome or fatality: KADCYLA should be permanently discontinued in patients diagnosed with ILD or pneumonitis
  • Infusion-related reactions (IRR), hypersensitivity: KADCYLA treatment should be interrupted in patients with severe IRR and permanently discontinued in the event of a life-threatening IRR
  • Thrombocytopenia: Monitor platelet counts prior to initiation of KADCYLA and prior to each dose. Institute dose modifications as appropriate
  • Hemorrhage: Fatal cases of hemorrhage occurred in clinical trials among patients with no known identified risk factors, as well as among patients with thrombocytopenia and those receiving anticoagulation and antiplatelet therapy
  • Peripheral neuropathy: KADCYLA should be temporarily discontinued in patients experiencing Grade 3 or 4 peripheral neuropathy until resolution to ≤Grade 2
  • Reactions secondary to extravasation: The infusion site should be closely monitored for possible subcutaneous infiltration during drug administration

Additional Important Safety Information:

  • Detection of HER2 protein overexpression or gene amplification is necessary for selection of patients appropriate for KADCYLA therapy
  • Nursing mothers: Discontinue nursing or discontinue KADCYLA, taking into consideration the importance of the drug to the mother
  • The most common adverse drug reactions (frequency >25%) across clinical trials with KADCYLA were fatigue, nausea, musculoskeletal pain, hemorrhage, thrombocytopenia, headache, increased transaminases, constipation, and epistaxis

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 additional Important Safety Information and accompanying full Prescribing Information, including Boxed WARNINGS.