ACTEMRA Distribution
Authorized Distributors and Specialty Pharmacies for ACTEMRA for Intravenous (IV) Infusion
Genentech has contracted with a network of authorized specialty distributors to service practices choosing to purchase ACTEMRA IV through the buy and bill model. Customers can purchase ACTEMRA IV 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 ACTEMRA IV through secondary channels.
Genentech Rheumatology Access Solutions works with specialty
pharmacies (SPs) to help patients receive their medicines. SPs can
dispense Genentech medicines to your office. The SPs can also provide
coverage and reimbursement support.
Distributors for Federal Accounts
Distributors for Hospitals
Distributors for Physician Offices and Federally Qualified Health Centers
Distributors for Authorized Specialty Pharmacies
Distributors for Puerto Rico
Specialty Pharmacies
Authorized Distributors and Specialty Pharmacies for ACTEMRA for Subcutaneous (SC) Injection
Genentech has contracted with a network of authorized specialty distributors to service practices choosing to purchase ACTEMRA SC through the buy and bill model. Customers can purchase ACTEMRA SC 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 ACTEMRA SC through secondary channels.
Genentech Rheumatology Access Solutions works with SPs to help
patients receive their medicines. SPs can dispense Genentech medicines
directly to your patient. The SPs can also provide coverage and
reimbursement support.
Distributors for Federal Accounts
Distributors for Hospitals
Distributors for Physician Offices and Federally Qualified Health Centers
Distributors for Authorized Specialty Pharmacies
Distributors for Puerto Rico
Specialty Pharmacies
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
Genentech Rheumatology 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 Genentech
Rheumatology 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 or 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.
SMN=Statement of Medical Necessity.
Important Safety Information & Indication
Indication
ACTEMRA is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response to one or more Disease-Modifying Anti-Rheumatic Drugs (DMARDs).
ACTEMRA is indicated for the treatment of giant cell arteritis (GCA) in adult patients.
ACTEMRA is indicated for the treatment of active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older.
ACTEMRA is indicated for the treatment of active systemic juvenile idiopathic arthritis in patients 2 years of age and older.
BOXED WARNING and Additional Important Safety Information
RISK OF SERIOUS INFECTIONS:
Patients treated with ACTEMRA are at increased risk for developing serious infections that may lead to hospitalization or death, including tuberculosis (TB), bacterial, invasive fungal, viral, or other opportunistic infections. If a serious infection develops, interrupt ACTEMRA until the infection is controlled.
Reported infections include:
- Active tuberculosis, which may present with pulmonary or extrapulmonary disease. Patients should be tested for latent tuberculosis before ACTEMRA use and during therapy. Treatment for latent infection should be initiated prior to ACTEMRA use.
- Invasive fungal infections, including candidiasis, aspergillosis, and pneumocystis. Patients with invasive fungal infections may present with disseminated, rather than localized, disease.
- Bacterial, viral and other infections due to opportunistic pathogens.
The risks and benefits of treatment with ACTEMRA should be carefully considered prior to initiating therapy in patients with chronic or recurrent infection.
Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with ACTEMRA, including the possible development of tuberculosis in patients who tested negative for latent tuberculosis infection prior to initiating therapy.
ACTEMRA is contraindicated in patients with known hypersensitivity to ACTEMRA.
Other serious or potentially life-threatening adverse reactions that have been reported in clinical trials with ACTEMRA include gastrointestinal perforations. Use ACTEMRA with caution in patients who may be at risk for GI perforations.
Laboratory monitoring is recommended due to potential consequences of treatment-related laboratory abnormalities in neutrophils, platelets, lipids, and liver function tests.
Hypersensitivity reactions, including anaphylaxis and death, have occurred.
- If anaphylaxis or other hypersensitivity reaction occurs, stop administration of ACTEMRA immediately and discontinue ACTEMRA permanently.
Avoid use of live vaccines concurrently with ACTEMRA, as clinical safety has not been established.
Other potential risks of ACTEMRA include demyelinating disorders and malignancies. Treatment with ACTEMRA is not recommended in patients with active hepatic disease or hepatic impairment.
Most common adverse reactions (≥ 5%) include upper respiratory tract infections, nasopharyngitis, headache, hypertension, increased ALT, injection site reactions (SC only).
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.
Please see accompanying full Prescribing Information, including BOXED WARNING, for additional important safety information.