HCNN-PDR drug alert

The Health Care Notification Network (HCNN) has issued a copy of the following "Dear Healthcare Provider" from Genentech:

IMPORTANT SAFETY INFORMATION
Regarding ACTEMRA® (tocilizumab)

The purpose of this letter is to inform you of important safety information for ACTEMRA® (tocilizumab), a new interleukin-6 (IL-6) receptor inhibitor that has been approved by the Food and Drug Administration (FDA) for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response to one or more tumor necrosis factor (TNF) antagonist therapies.

ACTEMRA targets IL-6. FDA has determined that a Risk Evaluation and Mitigation Strategy (REMS) is necessary for ACTEMRA to ensure that the benefits of the drug outweigh the potential risks of serious infections, gastrointestinal perforations, changes in liver function, decreases in peripheral neutrophil counts, decreases in platelet counts, elevations in lipid parameters in peripheral blood, demyelinating disorders and malignancies.

To read the full letter, click here.

Co-pay support program for patients taking Enbrel (Etanercept)

Amgen and Wyeth Pharmaceuticals have announced the ENBREL Support™ Co-pay Card Program for all eligible patients who take Enbrel (Etanercept). Who's eligible? Well, maybe we should start with those who are not eligible:

This program is not open to uninsured patients or patients receiving prescription reimbursement from federal, state, or government-funded insurance programs (for example, Medicare, Medicaid, etc.) or patients who live in Massachusetts (or where prohibited by law). Restrictions, including monthly maximums, may apply. Offer subject to change or discontinuation without notice.

This co-pay support program may offer:

• 6 months at no co-pay cost, and
• A co-pay of $10 or less per month thereafter (Patients will receive 50% off their co-pay or pay no more than $10 per month—whichever helps more)

The ENBREL Support™ Co-pay Card Program provides patients with up to $750 of assistance per month for months 1-12. For patients with moderate to severe plaque psoriasis who are first starting ENBREL, the program provides up to $1,500 per patient per month for months 1-3. Patient is responsible for costs above these amounts. Participation in the program can be renewed every year.

More than 45,000 people have already used a co-pay card for their ENBREL treatment.
The program is simple for you to share with patients. Direct patients to call 1-888-4ENBREL to enroll today.

Patients who lose their jobs but are covered by private insurance, including COBRA, may receive up to an additional 6 months of ENBREL at no co-pay cost. Potential help for patients who are uninsured or in need of other financial help is also available.

Here are the FDA-approved indications for ENBREL:

• ENBREL is indicated for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in patients with moderately to severely active rheumatoid arthritis. ENBREL can be initiated in combination with methotrexate (MTX) or used alone.
• ENBREL is indicated for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients ages 2 and older.
• ENBREL is indicated for reducing signs and symptoms, inhibiting the progression of structural damage of active arthritis, and improving physical function in patients with psoriatic arthritis. ENBREL can be used in combination with methotrexate in patients who do not respond adequately to methotrexate alone.
• ENBREL is indicated for reducing signs and symptoms in patients with active ankylosing spondylitis.
• ENBREL is indicated for the treatment of adult patients (18 years or older) with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

Click here for additional details of the co-pay support program.

Since Enbrel is a TNF blocker, make sure you read this:

• FDA: Cancer Warnings Required for TNF Blockers

FDA: Cancer Warnings Required for TNF Blockers

Here is the latest news from the FDA regarding TNF blockers and the risk of cancer:

FDA: Cancer Warnings Required for TNF Blockers

The U.S. Food and Drug Administration is requiring stronger warnings in the prescribing information for a class of drugs known as TNF blockers. The warnings, which include an updated boxed warning, highlight the increased risk of cancer in children and adolescents who receive these drugs to treat juvenile rheumatoid arthritis, the inflammatory bowel disorder, Crohn’s disease, and other inflammatory diseases.

In addition, the FDA is working with manufacturers to explore new ways to further define the risk of cancer in children and adolescents who use these drugs.

TNF blockers target and neutralize tumor necrosis factor-alpha (TNF-α), a protein that, when overproduced in the body due to chronic inflammatory diseases, can cause inflammation and damage to bones, cartilage and tissue. The drugs in this class include

• Remicade (infliximab),
  
• Enbrel (etancercept),
  
• Humira (adalimumab),
  
• Cimzia (certolizumab pegol) and
  
• Simponi (golimumab).

Today’s action is based on the completion of an investigation first announced by the FDA in June 2008. An analysis of U.S. reports of cancer in children and adolescents treated with TNF-blockers showed an increased risk of cancer, occurring after 30 months of treatment on average. About half of the cancers were lymphomas, a type of cancer involving cells of the immune system. Some of the reported cancers were fatal.

Additional required updates to the prescribing information include incorporation of reports of psoriasis associated with the use of TNF blockers.

Can you list who manufacturers the medications listed above? Eventually, I think we're going to realize that there's an increased risk of cancer with many of the biologic agents that are out there. The irony is that many biologic agents (different classes of drugs with varying mechanisms of actions) are also used to treat cancer. As we learn more about biologic agents, we may eventually complete the cancer circle. The more we understand about what causes cancer, the better we may be able to treat cancer.

CIMZIA and OXO GOOD GRIPS

I love kitchenware made by OXO GOOD GRIPS®. Who would have thought that they would team up with a pharmaceutical company to develop an innovative syringe filled with a biologic agent?

UCB, the biopharmaceutical company that makes CIMZIA (certolizumab pegol), partnered with OXO GOOD GRIPS® to design a syringe that would be easy to use for many people. Sounds like a great idea to me. A soft, non-slip grip should make this easier to use. Should we expect to see more of these "easy to use" syringes for other injectable drugs?

Cimzia is currently the only PEGylated anti-TNF (Tumor Necrosis Factor) approved by the FDA for reducing signs and symptoms of Crohn's disease and maintaining clinical response in adult patients with moderate to severe active disease who have had an inadequate response to usual treatments. Cimzia is also FDA approved for the treatment of adults who have moderately to severely active rheumatoid arthritis (RA).