Terms and Conditions for the ACTEMRA and Rituxan Immunology Co-pay Program for Drug Assistance

This ACTEMRA and Rituxan Immunology Co-pay Program is valid ONLY for patients with commercial (private or non-governmental) insurance who have a valid prescription for a Food and Drug Administration (FDA)-approved indication of a Genentech medication. Patients using Medicare, Medicaid, Medigap, Veteran's Affairs (VA), Department of Defense (DoD), TRICARE or any other federal or state government program (collectively, "Government Programs") to pay for their medications are not eligible. The program is not valid for medications that are eligible to be reimbursed in their entirety by private insurance plans or other programs.

Under the program, the patient will pay a co-pay. After reaching the maximum program benefit, the patient will be responsible for all remaining out-of-pocket expenses. This program is not health insurance or a benefit plan. The program does not obligate the use of any specific product or provider. Patients receiving assistance from charitable assistance programs (such as Genentech Patient Foundation) are not eligible. The co-pay benefit cannot be combined with any other rebate, free trial or similar offer for the medication. No party may seek reimbursement for all or any part of the benefit received through this program.

The program may be accepted by participating pharmacies, physician offices or hospitals. Once a patient is enrolled, this program will not honor claims with date of service or medication dispensing that precede program enrollment by more than 180 days. Use of this program must be consistent with all relevant health insurance requirements. Participating patients, pharmacies, physician offices and hospitals are responsible for reporting the receipt of all program benefits as required by any insurer or by law. Program benefits may not be sold, purchased, traded or offered for sale.

The patient or their guardian must be 18 years or older to receive program assistance. This program is only valid in the United States and U.S. Territories. This program is void where prohibited by law and shall follow state restrictions in relation to AB-rated generic equivalents (e.g., MA, CA) where applicable. Program eligibility is contingent upon the patient's ability to meet and maintain all requirements set forth by the program. Genentech reserves the right to rescind, revoke or amend the program without notice at any time.

Terms and Conditions for the Rituxan Immunology Co-pay Program for Infusion Assistance

The Rituxan Immunology Administration Co-pay Program is valid ONLY for patients with commercial (private or non-governmental) insurance who have a valid prescription for a Food and Drug Administration (FDA)-approved indication of a Genentech medication. Patients using Medicare, Medicaid, Medigap, Veterans Affairs (VA), Department of Defense (DoD), TRICARE or any other federal or state government funded program (collectively, "Government Programs") to pay for their medications and/or administration services are not eligible. If the patient chooses to enroll in the Rituxan Immunology Drug Co-pay Program, the patient must separately enroll and meet all eligibility criteria of that program.

Under the programs, the patient will pay a co-pay. After reaching the maximum per treatment or annual limit, the patient will be responsible for all remaining out-of-pocket expenses. The amount of the program's benefits cannot exceed the patient's out-of-pocket expenses for the cost of the drug or administration fees associated with Rituxan. These programs are not health insurance or a benefit plan. Distribution or use of the programs does not obligate use or continuing use of any specific product or provider. The patient, guardian, prescriber, hospital and any other person using or administering the programs agree not to seek or receive payment or reimbursement from any other source for any of the out of pocket costs that are covered by these programs.

The programs may be accepted by participating pharmacies, physician offices or hospitals. Once a patient is enrolled, the programs will not honor claims with date of service or medication dispensing that precede program enrollment by more than 180 days. Use of these programs must be consistent with all relevant health insurance requirements. Participating patients, pharmacies, physician offices and hospitals are responsible for reporting the receipt of all program benefits as required by any insurer or by law. Program benefits may not be sold, purchased, traded or offered for sale.

The patient or their guardian must be 18 years or older to receive program assistance. The programs are only valid in the United States and U.S. Territories. The programs are void where prohibited by law. The product co-pay program shall follow state restrictions in relation to AB-rated generic equivalents (e.g., MA, CA) where applicable. The administration co-pay program is not valid for Massachusetts or Rhode Island residents.

This program cannot be combined with any other rebate/coupon, free trial or similar offer for the specified prescription. The product program is not available or valid for patients receiving free product from the Genentech Patient Foundation. The administration program is valid for patients receiving free product from the Genentech Patient Foundation. The product and administration programs are not valid for patients receiving support for out-of-pocket costs for product or administration services covered by these programs that are or may be subsidized or reimbursed by an independent charitable organization or a healthcare plan.

Healthcare providers may not advertise or otherwise use the program as a means of promoting their services or Genentech's products to patients. Genentech, Inc. reserves the right to rescind, revoke or amend the program without notice at any time.

Indication and Important Safety Information

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 (PJIA) in patients 2 years of age and older.

ACTEMRA is indicated for the treatment of active systemic juvenile idiopathic arthritis (SJIA) in patients 2 years of age and older.

ACTEMRA is indicated for slowing the rate of decline in pulmonary function in adult patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD).

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.

Monitor patients for signs and symptoms of hepatic injury. Modify or discontinue ACTEMRA if abnormal liver tests persist or worsen or if clinical signs and symptoms of liver disease develop.

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 1-888-835-2555.

Please see additional Important Safety Information in accompanying full Prescribing Information, including BOXED WARNING.

 

  • Rituxan® (rituximab), in combination with methotrexate, 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 TNF antagonist therapies
  • Rituxan® (rituximab), in combination with glucocorticoids, is indicated for the treatment of adult and pediatric patients 2 years of age and older with Granulomatosis with Polyangiitis (GPA) (Wegener's Granulomatosis) and Microscopic Polyangiitis (MPA)
  • Rituxan® (rituximab) is indicated for the treatment of adult patients with moderate to severe pemphigus vulgaris (PV)

Infusion-Related Reactions: Rituxan administration can result in serious, including fatal infusion-related reactions. Deaths within 24 hours of Rituxan infusion have occurred. Approximately 80% of fatal infusion reactions occurred in association with the first infusion. Monitor patients closely. Discontinue Rituxan infusion for severe reactions and provide medical treatment for Grade 3 or 4 infusion-related reactions.

Severe Mucocutaneous Reactions: Severe, including fatal, mucocutaneous reactions can occur in patients receiving Rituxan.

Hepatitis B Virus (HBV) Reactivation: HBV reactivation can occur in patients treated with Rituxan, in some cases resulting in fulminant hepatitis, hepatic failure, and death. Screen all patients for HBV infection before treatment initiation, and monitor patients during and after treatment with Rituxan. Discontinue Rituxan and concomitant medications in the event of HBV reactivation.

Progressive Multifocal Leukoencephalopathy (PML), including fatal PML, can occur in patients receiving Rituxan.

Rituxan administration can also result in additional serious, including fatal, adverse reactions including:

  • Tumor lysis syndrome (TLS): Administer aggressive intravenous hydration, anti-hyperuricemic agents, monitor renal function
  • Infections: Withhold Rituxan and institute appropriate anti-infective therapy. Rituxan is not recommended for use in patients with severe, active infections
  • Cardiovascular adverse reactions: Discontinue infusions in case of serious or life-threatening events
  • Renal toxicity: Discontinue in patients with rising serum creatinine or oliguria
  • Bowel obstruction and perforation: Consider and evaluate for abdominal pain, vomiting, or related symptoms
  • Immunizations: Live virus vaccinations prior to or during Rituxan treatment are not recommended
  • Embryo-Fetal toxicity: Can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and use of effective contraception
  • Patients with RA should be closely observed for signs of infection if biologic agents and/or DMARDs other than methotrexate are used concomitantly
  • The use of Rituxan in patients with RA who have not had prior inadequate response to one or more TNF antagonists is not recommended
  • Use of concomitant immunosuppressants other than corticosteroids has not been studied in GPA, MPA, or PV patients exhibiting peripheral B-cell depletion following treatment with Rituxan

Rheumatoid Arthritis (RA)
Most common adverse reactions (≥10%) were upper respiratory tract infection, nasopharyngitis, urinary tract infection, and bronchitis. Other important adverse reactions include infusion-related reactions, serious infections, and cardiovascular events.

Granulomatosis With Polyangiitis (GPA) (Wegener's Granulomatosis) and Microscopic Polyangiitis (MPA)
Most common adverse reactions (≥15%) were infections, nausea, diarrhea, headache, muscle spasms, anemia, peripheral edema, and infusion-related reactions.

Pemphigus Vulgaris (PV)
Most common adverse reactions (≥15%) were infusion-related reactions, depression, upper respiratory tract infection/nasopharyngitis, and headache. Other important adverse reactions include infections.

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 1-888-835-2555.

For additional Important Safety Information, please see the Rituxan full Prescribing Information, including BOXED WARNINGS.