Tarceva Distribution

Authorized Specialty Distributors and Specialty Pharmacies

Tarceva 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 Tarceva Access Solutions to learn which SP the patient’s health insurance plan requires.

Distributor Telephone Fax Web Orders
AmerisourceBergen Drug Corporation 844-222-2273 816-464-4140 www.amerisourcebergen.com/abc/
Cardinal Health Distribution 800-926-3161 N/A www.cardinal.com
H.D. Smith Wholesale Drug Company 866-232-1222 217-467-8232 hdsmith.com
McKesson US Pharmaceutical 855-625-4677 N/A connect.mckesson.com
Metro Medical 800-768-2002 615-256-4194 www.metromedicalorder.com
Morris & Dickson Co., LLC 800-388-3833 318-798-5237 N/A
Distributor Telephone Fax Web Orders
AmerisourceBergen Drug Corporation 844-222-2273 816-464-4140 www.amerisourcebergen.com/abc/
ASD Healthcare 800-746-6273 800-547-9413 www.asdhealthcare.com
Besse Medical 800-543-2111 800-543-8695 www.besse.com
BioSolutions Direct 866-860-3565 888-899-0063 www.biosolutionsdirect.com
Cardinal Health Distribution 800-926-3161 N/A www.cardinal.com
Cardinal Health Specialty Distribution 855-740-1871 888-345-4916 specialtyonline.cardinalhealth.com
CuraScript SD 877-599-7748 800-862-6208 www.curascriptsd.com
H.D. Smith Wholesale Drug Company 866-232-1222 217-467-8232 hdsmith.com
McKesson Specialty Health 800-482-6700 800-289-9285 mscs.mckesson.com
McKesson US Pharmaceutical 855-625-4677 N/A connect.mckesson.com
Metro Medical 800-768-2002 615-256-4194 www.metromedicalorder.com
Morris & Dickson Co., LLC 800-388-3833 318-798-5237 N/A
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
Besse Medical 800-543-2111 800-543-8695 www.besse.com
BioSolutions Direct 866-860-3565 888-899-0063 www.biosolutionsdirect.com
Cardinal Health Specialty Distribution 855-740-1871 888-345-4916 specialtyonline.cardinalhealth.com
CuraScript SD 877-599-7748 800-862-6208 www.curascriptsd.com
McKesson Specialty Health 800-482-6700 800-289-9285 mscs.mckesson.com
Metro Medical 800-768-2002 615-256-4194 www.metromedicalorder.com
Oncology Supply 800-633-7555 800-248-8205 www.oncologysupply.com
Distributor Telephone Fax Web Orders
AmerisourceBergen Drug Corporation 844-222-2273 816-464-4140 www.amerisourcebergen.com/abc/
ASD Healthcare 800-746-6273 800-547-9413 www.asdhealthcare.com
Besse Medical 800-543-2111 800-543-8695 www.besse.com
BioSolutions Direct 866-860-3565 888-899-0063 www.biosolutionsdirect.com
Cardinal Health Distribution 800-926-3161 N/A www.cardinal.com
Cardinal Health Specialty Distribution 855-740-1871 888-345-4916 specialtyonline.cardinalhealth.com
CuraScript SD 877-599-7748 800-862-6208 www.curascriptsd.com
H.D. Smith Wholesale Drug Company 866-232-1222 217-467-8232 hdsmith.com
Humana Specialty Pharmacy
800-486-2668
877-405-7940
www.humanapharmacy.com/specialty
McKesson Specialty Health 800-482-6700 800-289-9285 mscs.mckesson.com
McKesson US Pharmaceutical 855-625-4677 N/A connect.mckesson.com
Metro Medical 800-768-2002 615-256-4194 www.metromedicalorder.com
Morris & Dickson Co., LLC 800-388-3833 318-798-5237 N/A
Oncology Supply 800-633-7555 800-248-8205 www.oncologysupply.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
Special Care Pharmacy 787-783-8579
787-783-2951 www.scpspr.com
Specialty Pharmacy Service 787-704-2025 787-704-2027 www.spscaguas.com
Distributor Telephone Fax Web Orders
AcariaHealth 800-511-5144 877-541-1503 www.acariahealth.com
Accredo 888-608-9010 888-302-1028 www.accredo.com
Advanced Care Script (ACS) 866-681-7131 866-679-7131 www.acs-rx.com
Aetna Specialty Pharmacy 866-782-2779 866-329-2779 N/A
Amber Pharmacy 888-370-1724 402-896-3774 www.amberpharmacy.com/
Avella Specialty Pharmacy 877-546-5779 877-546-5780 www.avella.com
Biologics 800-850-4306 800-823-4506 www.biologicstoday.com
BioPlus Speciality Pharmacy 888-292-0744 800-269-5493 www.bioplusrx.com
BriovaRx (MedfusionRx/AscendRx/CatamaranRx) 800-850-9122 800-218-3221 www.BriovaRx.com
Caremark 800-237-2767 800-323-2445 www.cvscaremarkspecialtyrx.com
Caremed Pharmaceutical Services 877-227-3405 877-542-2731 www.caremedps.com
Cigna Tel-Drug 800-351-3606 800-351-3616 www.cignaforHCP.com
Commcare Pharmacy 888-203-7973 888-203-7980 www.commcarepharmacy.com
CuraScript Specialty Pharmacy 877-599-7748
888-773-7386 www.curascript.com
Diplomat Specialty Pharmacy 877-977-9118 800-550-6272 www.diplomatpharmacy.com
Exactus Pharmacy Solutions 866-458-9246 866-458-9245 www.ExactusRx.com
ICORE Healthcare, LLC 866-664-2673 866-994-2673 www.icorehealthcare.com
Kroger Specialty Pharmacy
888-355-4191 888-355-4192 krogerspecialtypharmacy.com
Mission Road Pharmacy 866-792-3683 866-227-1948 www.mrpscripts.com
Oncology RX Care Advantage (SP) 888-479-6337 866-423-2979 www.mycareadvantage.com
Oncomed 877-662-6633 877-662-6355 www.oncomed.com
OncoSourceRx 888-662-6779 877-800-4790 www.oncosourcerx.com
Optum RX 888-293-9309 800-853-3844 optumrx.com
Prime Therapeutics Specialty Pharmacy 877-627-6337 877-828-3939 www.primetherapeutics.com/en/PrimeTherapeuticsSpecialtyPharmacy.html
Rightsource Specialty Pharmacy 800-379-0092 800-379-7617 www.rightsourcerx.com
TNH Specialty Pharmacy 877-849-9591 855-356-1096 www.tnhpharmacy.com
US Bioservices 877-757-0667 888-418-7246 www.usbioservices.com
AllianceRx Walgreens Prime 888-347-3416
877-231-8302 www.alliancerxwp.com
Walmart Specialty Pharmacy 877-453-4566 866-537-0877 www.walmart.com

Genentech and Astellas Pharma US do 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.

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

SMN=Statement of Medical Necessity.

Important Safety Information & Indication

Indication

Metastatic Non-Small Cell Lung Cancer (NSCLC)

Tarceva is indicated for:

  • The treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test receiving first-line, maintenance, or second or greater line treatment after progression following at least one prior chemotherapy regimen.

Limitations of use:

  • Safety and efficacy of Tarceva have not been established in patients with NSCLC whose tumors have other EGFR mutations.
  • Tarceva is not recommended for use in combination with platinum-based chemotherapy.

Pancreatic Cancer

Tarceva in combination with gemcitabine is indicated for the first-line treatment of patients with locally advanced, unresectable, or metastatic pancreatic cancer.

Important Safety Information

WARNINGS AND PRECAUTIONS

  • Interstitial Lung Disease (ILD):
    • Cases of serious ILD, including fatal cases, can occur with Tarceva treatment. The overall incidence of ILD in approximately 32,000 Tarceva-treated patients in uncontrolled studies and studies with concurrent chemotherapy was approximately 1.1%. In patients with ILD, the onset of symptoms was between 5 days to more than 9 months (median 39 days) after initiating Tarceva therapy.
    • Withhold Tarceva for acute onset of new or progressive unexplained pulmonary symptoms such as dyspnea, cough, and fever pending diagnostic evaluation. If ILD is confirmed, permanently discontinue Tarceva.
  • Renal Failure:
    • Hepatorenal syndrome, severe acute renal failure including fatal cases, and renal insufficiency can occur with Tarceva treatment. Renal failure may arise from exacerbation of underlying baseline hepatic impairment or severe dehydration.
    • The pooled incidence of severe renal impairment in the 3 monotherapy lung cancer studies was 0.5% in the Tarceva arms and 0.8% in the control arms. The incidence of renal impairment in the pancreatic cancer study was 1.4% in the Tarceva plus gemcitabine arm and 0.4% in the control arm.
    • Withhold Tarceva in patients developing severe renal impairment until renal toxicity is resolved. Perform periodic monitoring of renal function and serum electrolytes during Tarceva treatment.
  • Hepatotoxicity With or Without Hepatic Impairment:
    • Hepatic failure and hepatorenal syndrome, including fatal cases, can occur with Tarceva treatment in patients with normal hepatic function; the risk of hepatic toxicity is increased in patients with baseline hepatic impairment.
      • Hepatic Toxicity: One Tarceva-treated patient experienced fatal hepatic failure and four additional patients experienced grade 3-4 liver test abnormalities.
    • In clinical studies where patients with moderate to severe hepatic impairment were excluded, the pooled incidence of hepatic failure in the 3 monotherapy lung cancer studies was 0.4% in the Tarceva arms and 0% in the control arms. The incidence of hepatic failure in the pancreatic cancer study was 0.4% in the Tarceva plus gemcitabine arm and 0.4% in the control arm.
    • Perform periodic liver testing (transaminases, bilirubin, and alkaline phosphatase) during treatment with Tarceva. Increased frequency of monitoring of liver function is required for patients with pre-existing hepatic impairment or biliary obstruction.
    • Withhold Tarceva in patients without pre-existing hepatic impairment for total bilirubin >3 x ULN or transaminases >5 x ULN. Withhold Tarceva in patients with pre-existing hepatic impairment or biliary obstruction for doubling of bilirubin or tripling of transaminases values over baseline.
    • Discontinue Tarceva in patients whose abnormal liver tests meeting the above criteria do not improve significantly or resolve within 3 weeks.
  • Gastrointestinal Perforation:
    • Gastrointestinal perforation, including fatal cases, can occur with Tarceva treatment. Patients receiving concomitant anti-angiogenic agents, corticosteroids, NSAIDs, or taxane-based chemotherapy, or who have prior history of peptic ulceration or diverticular disease may be at increased risk of perforation.
    • The pooled incidence of gastrointestinal perforation in the 3 monotherapy lung cancer studies was 0.2% in the Tarceva arms and 0.1% in the control arms. The incidence of gastrointestinal perforation in the pancreatic cancer study was 0.4% in the Tarceva plus gemcitabine arm and 0% in the control arm.
    • Permanently discontinue Tarceva in patients who develop gastrointestinal perforation.
  • Bullous and Exfoliative Skin Disorders:
    • Bullous, blistering and exfoliative skin conditions, including cases suggestive of Stevens-Johnson syndrome/toxic epidermal necrolysis, which in some cases were fatal, can occur with Tarceva treatment.
    • The pooled incidence of bullous and exfoliative skin disorders in the 3 monotherapy lung cancer studies was 1.2% in the Tarceva arms and 0% in the control arms. The incidence of bullous and exfoliative skin disorders in the pancreatic cancer study was 0.4% in the Tarceva plus gemcitabine arm and 0% in the control arm.
    • Discontinue Tarceva treatment if the patient develops severe bullous, blistering or exfoliating conditions.
  • Cerebrovascular Accident:
    • In the pancreatic carcinoma trial, 7 patients in the Tarceva plus gemcitabine group developed cerebrovascular accident (incidence 2.5%). One of these was hemorrhagic and was the only fatal event. In comparison, in the placebo plus gemcitabine group there were no cerebrovascular accidents. The pooled incidence of cerebrovascular accident in the 3 monotherapy lung cancer studies was 0.6% in the Tarceva arms and not higher than that observed in the control arms.
  • Microangiopathic Hemolytic Anemia With Thrombocytopenia:
    • The pooled incidence of microangiopathic hemolytic anemia with thrombocytopenia in the 3 monotherapy lung cancer studies was 0% in the Tarceva arms and 0.1% in the control arms. The incidence of microangiopathic hemolytic anemia with thrombocytopenia in the pancreatic cancer study was 1.4% in the Tarceva plus gemcitabine arm and 0% in the control arm.
  • Ocular Disorders:
    • Decreased tear production, abnormal eyelash growth, keratoconjunctivitis sicca or keratitis can occur with Tarceva treatment and can lead to corneal perforation or ulceration.
    • The pooled incidence of ocular disorders in the 3 monotherapy lung cancer studies was 17.8% in the Tarceva arms and 4% in the control arms. The incidence of ocular disorders in the pancreatic cancer study was 12.8% in the Tarceva plus gemcitabine arm and 11.4% in the control arm.
    • Interrupt or discontinue Tarceva therapy if patients present with acute or worsening ocular disorders such as eye pain.
  • Hemorrhage in Patients Taking Warfarin:
    • Severe and fatal hemorrhage associated with International Normalized Ratio (INR) elevations can occur when Tarceva and warfarin are administered concurrently.
    • Regularly monitor prothrombin time and INR during Tarceva treatment in patients taking warfarin or other coumarin-derivative anticoagulants.
  • Embryo-Fetal Toxicity:
  • Based on animal data and its mechanism of action, Tarceva can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus.
  • Advise females of reproductive potential to use effective contraception during therapy and for one month after the last dose of Tarceva.

MOST COMMON ADVERSE REACTIONS

  • Metastatic NSCLC – First-Line Treatment of Patients With EGFR Mutations:
    • Most frequent (≥30%) adverse reactions were diarrhea, asthenia, rash, cough, dyspnea, and decreased appetite.
    • Most frequent Grade 3/4 (NCI-CTC Version 3.0) adverse reactions were rash (14%) and diarrhea (5%). In Tarceva-treated patients, the most frequently reported adverse reactions leading to dose modification were rash (13%), diarrhea (10%), and asthenia (3.6%).
  • Metastatic NSCLC – Maintenance Treatment:
    • Rash and diarrhea.
    • Grade 3/4 (NCI-CTC Version 3.0) rash and diarrhea occurred in 9% and 2%, respectively. Rash and diarrhea resulted in dose reductions or interruption (5% and 3%, respectively) and discontinuation (1% and 0.5%, respectively) of Tarceva-treated patients.
  • Metastatic NSCLC – Second/Third-line Treatment:
    • Rash and diarrhea.
    • Grade 3/4 (NCI-CTC Version 2.0) rash and diarrhea occurred in 9% and 6%, respectively. Rash and diarrhea each resulted in dose reductions (6% and 1%, respectively) and discontinuation in 1% of Tarceva-treated patients.
  • Advanced Pancreatic Cancer – Tarceva Administered Concurrently with Gemcitabine:
    • Fatigue, rash, nausea, anorexia, and diarrhea.
    • Grade 3/4 (NCI-CTC version 2.0) rash and diarrhea were each reported in 5% of patients. Rash and diarrhea each resulted in dose reductions in 2% of patients and discontinuation in up to 1% of patients receiving Tarceva plus gemcitabine.

You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at (888) 835-2555.

For additional Important Safety Information, please see full Prescribing Information at www.tarceva.com.