Patient-Helpdesk.com

cimzia patient assistance pdf

by Amie Von Published 2 years ago Updated 1 year ago
image

What is Cimzia used to treat?

CIMZIA is indicated for: Reducing signs and symptoms of Crohn’s disease (CD) and maintaining clinical response in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy

What is the cimplicity savings program for Cimzia?

CIMplicity offers comprehensive support for your patients, including insurance, co-pay, and nurse support.* for their CIMZIA prescription with the CIMplicity Savings Program. The CIMplicity program is provided as a service of UCB and is intended to support the appropriate use of CIMZIA.

How do I request the Cimzia $0 co-pay program?

You must request the CIMZIA $0 Co-Pay Program from your healthcare professional.* If you are eligible for the Program, your doctor’s office will activate your CIMplicity Savings Card (which works as a CIMZIA co-pay card) and keep the information with your patient records in their office. If you self-inject CIMZIA (use the prefilled syringe):

What is the cost of Cimzia treatment?

Eligible patients with a valid prescription for CIMZIA can receive treatment with the CIMZIA Prefilled Syringe at no cost until the patient’s coverage is approved.

image

Does Cimzia have a patient assistance program?

The CIMplicity program is provided as a service of UCB and is intended to support the appropriate use of CIMZIA. The CIMplicity program may be amended or canceled at any time without notice. Eligibility and restrictions apply.

What is UCB Patient Assistance Program?

Through the UCB Patient Assistance Program, we provide some medications at no cost to eligible and qualified patients who are uninsured or underinsured who otherwise have no access to the UCB medicines prescribed by their physician.

Does Medicare pay for Cimzia injections?

If you have coverage through traditional Medicare Part B, after you satisfy your deductible, Medicare covers 80% of the drug cost, and you pay the remaining 20% coinsurance. Supplemental Medicare insurance plans may also cover this 20% depending on your plan.

How long does it take for Cimzia to work?

Cimzia injection can work as fast as 1 or 2 weeks in some people for conditions such as rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and non-radiographic axial spondyloarthritis. Its full effectiveness can range from 4 months to 1 year based on your specific medical condition.

What does UCB stand for pharma?

Union Chimique BelgeUCB (Union Chimique Belge) is a multinational biopharmaceutical company headquartered in Brussels, Belgium.

Who makes Keppra?

The branded version Keppra is manufactured by UCB Pharmaceuticals Inc.

Is cimzia covered under Medicare Part B or D?

CIMZIA* is now covered by Medicare Administrative Contractors administering Medicare Part B to patients in all 50 United States and US Territories.

Does Medicare Part D cover biologics?

Biologics—usually large, complex molecules produced in a living system—are some of the most expensive drugs available, and spending for biologics is growing in Medicare Part D because they treat diseases common among Medicare beneficiaries. Biologics are estimated to cost Part D upwards of $12 billion annually.

Does Medicare cover biologic infusions?

If you have an infusion, your doctor will administer the drug through a vein in your arm. Because you obtain infusions outside the home, Part B covers them. If you have a Medigap plan, it will pay the coinsurance costs.

Do you gain weight on CIMZIA?

No, Cimzia isn't known to cause weight changes. Weight loss or weight gain weren't seen in clinical studies of Cimzia. But these may be symptoms of other serious side effects of Cimzia. Weight gain due to fluid retention could be a sign of heart failure.

Does CIMZIA make you tired?

Tiredness. You may feel tired while using Cimzia. In clinical studies, fatigue (lack of energy) was reported in some people who took Cimzia. In people with rheumatoid arthritis, fatigue was reported in 3% of people who took Cimzia with methotrexate.

Is CIMZIA a high risk medication?

Cimzia may raise your risk for blood cancers and skin cancer. In addition, children and adolescents may develop lymphoma (cancer of the lymph nodes) and other cancers while taking drugs called tumor necrosis factor (TNF) inhibitors.

What is the difference between Cimzia and Humira?

Both medicines are approved to treat rheumatoid arthritis, Crohn's disease, plaque psoriasis, and psoriatic arthritis, but Humira also treats several other autoimmune inflammatory diseases as well. For some diseases, Humira is safe for children, while Cimzia is only indicated for adults.

What are the side effects of Cimzia?

Side effects of Cimzia include:stuffy nose,sinus pain,stomach pain,diarrhea,constipation,injection site reactions (pain, redness, itching, swelling, or bleeding),upper respiratory infections (flu, cold),rash, and.More items...

Is cimzia a monoclonal antibody?

Certolizumab pegol (Cimzia®) is currently the only PEGylated anti-TNFα biologic approved for the treatment of rheumatoid arthritis and Crohn disease. The product, developed by UCB, is a humanized antigen-binding fragment (Fab') of a monoclonal antibody that has been conjugated to polyethylene glycol.

Is Cimzia an infusion?

CIMZIA® (certolizumab pegol) is a prescription infusion medication that's known as a tumor necrosis factor (TNF) blocker — which means it helps stop inflammation.

What is CIMZIA used for?

CIMZIA is indicated for: Reducing signs and symptoms of Crohn’s disease (CD) and maintaining clinical response in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy.

What are the side effects of CIMZIA?

Angioedema, anaphylaxis, dyspnea, hypotension, rash, serum sickness, and urticaria have been reported following CIMZIA administration. If a serious allergic reaction occurs, stop CIMZIA and institute appropriate therapy. The needle shield inside the removable cap of the CIMZIA prefilled syringe contains a derivative of natural rubber latex which may cause an allergic reaction in individuals sensitive to latex.

What is a CIMZIA business associate agreement?

The Business Associate Agreement that enables access to CIMplicity. Contact a CIMZIA Representative for submission instructions

Is Cimzia contraindicated?

CIMZIA is contraindicated in patients with a history of hypersensitivity reaction to certolizumab pegol or to any of the excipients. Reactions have included angioedema, anaphylaxis, serum sickness, and urticaria.

Can CImzia cause TB?

Serious and sometimes fatal side effects have been reported with CIMZIA, including tuberculosis (TB), bacterial sepsis, invasive fungal infections (such as histoplasmosis), and infections due to other opportunistic pathogens (such as Legionella or Listeria). Patients should be closely monitored for the signs and symptoms of infection during and after treatment with CIMZIA. Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, of which CIMZIA is a member. CIMZIA is not indicated for use in pediatric patients.

What is a cimplicity program?

The CIMplicity program is provided as a service of UCB and is intended to support the appropriate use of CIMZIA. The CIMplicity program may be amended or canceled at any time without notice. Eligibility and restrictions apply. The CIMplicity Nursing Program does not provide medical advice and does not replace the care of the healthcare provider.

Can you start CIMZIA during an infection?

Do not start CIMZIA during an active infection, including localized infections. Patients older than 65 years, patients with co-morbid conditions, and/or patients taking concomitant immunosuppressants may be at greater risk of infection. If an infection develops, monitor carefully and initiate appropriate therapy.

What is cimplicity for cimzia?

CIMplicity® is available to help you with your CIMZIA treatment. While you are enrolled in the program, you will be provided with tools and support to help empower you to manage your condition.*

How to change reminders for CIMZIA?

If you ever need to change your reminder selections, just log in to your CIMplic ity account to make updates.

How much is CIMZIA out of pocket?

For eligible commercially insured patients, CIMZIA is available for $0 out-of-pocket with the CIMplicity Savings Program.† We are committed to helping you save on your cost of treatment with CIMZIA.

Does CIMplicity provide medical advice?

CIMplicity Nurse Support does not provide you with medical advice and does not replace the care of your healthcare provider. Any questions related to your individual treatment plan or medical treatment will be referred back to your treating healthcare provider. Explore free nurse support. Syringe disposal. The following information is intended only ...

Can you cancel cimplicity?

Any CIMplicity program may be amended or canceled at any time without notice. Some program and eligibility restrictions apply. Please consult your doctor if you have any questions about your condition or treatment. You are encouraged to report negative side effects of prescription drugs to the FDA.

Can CIMplicity be canceled?

The CIMplicity program may be amended or canceled at any time without notice. Some program and eligibility restrictions may apply. †Eligibility: Available to individuals with commercial prescription insurance coverage for CIMZIA.

Can UCB be liable for lost or stolen CIMplicity card?

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088. UCB, Inc., is not liable for unintended or unauthorized use of the CIMplicity Savings Card if it is lost or stolen.

Who administers CIMZIA?

Once you are cleared to receive your treatment, a nurse or medical assistant will generally administer your CIMZIA injection. Talk to your doctor’s office about how much time you should plan for your treatment and whether you might want to bring someone with you. After treatment, the office staff may want to observe you before you leave the office.

How to get CIMZIA injections at home?

You or a caregiver will receive the training you need at your doctor's office to use the CIMZIA prefilled syringe for your CIMZIA therapy.

How to store a cimzia syringe?

If you self-inject your medication, you should receive it in a large package with ice packs that keep the contents cool. Remove the medication from the outer packaging and store it in the refrigerator in its original carton at 36° to 46°F (2° to 8°C) until you are ready to self-inject.

How to contact CIMplicity nurse?

A CIMplicity ® nurse is also available to help with questions about CIMZIA as you begin treatment. You can reach one of our nurses at 1-884-UCBNurse (1-844-822-6877) .†. †CIMplicity Nurse Support does not provide you with medical advice and does not replace the care of your healthcare provider.

What to do if you are not getting medical advice?

replace seeking medical advice from your healthcare provider. Always consult

Can you freeze a cimzia?

Do not put CIMZIA in the freezer; it should never be frozen. When necessary, CIMZIA syringes may be stored at room temperature up to 77°F (25°C) in the original carton to protect from light for a single period of up to 7 days.

Can you put a cimzia syringe back in the refrigerator?

Once a CIMZIA syringe has been stored at room temperature, do not place it back in the refrigerator. Write the date removed from the refrigerator in the space provided on the carton and discard if not used within the 7-day period. For more about proper disposal of your syringes, visit www.fda.gov/safesharpsdisposal.

What is the exchange for health insurance?

Programs and costs vary, especially in terms of coverage, co-pays, and deductibles. About the Health Insurance Marketplace (the Exchange) The Health Insurance Marketplace, also known as the Exchange, was created through the Affordable Care Act (ACA), commonly called Obamacare. The Exchange is your state’s price comparison website ...

What is Medicare for people over 65?

Medicare is a federally funded health insurance program for: People age 65 or older. People younger than 65 with certain disabilities. People of all ages with end-stage renal disease (permanent kidney failure requiring dialysis or a kidney transplant)

What is coinsurance in healthcare?

Coinsurance: Your share of the cost of a covered healthcare service, usually a percentage of the allowed amount for the service (for example, 10%). You pay coinsurance after you’ve met your deductible.

What is exchange plan?

Exchange plan: The insurance you set up through the Healthcare Insurance Marketplace.

What is a copay?

Co-pay: A flat fee you pay for certain covered services such as a doctor’s visit or prescriptions. The amount can vary depending on the type of insurance you have or the service being performed.

How often do you pay your health insurance premium?

Premium: The amount of money that you must pay for health insurance. You (or your employer) may pay your premium every month, every quarter, or once a year.

Does insurance cover Cimzia?

Insurance companies often have special requirements that must be met before they agree to cover your medication. For instance, they may require you to try other medications before trying CIMZIA. That’s where CIMplicity® can help.* We can work with your doctor’s office to verify whether CIMZIA is covered under your insurance plan. This is called a benefits investigation. We can also help your doctor’s office with paperwork the insurance company may require before starting CIMZIA, or prior authorization.

What is CIMZIA used for?

CIMZIA is a prescription medicine called a Tumor Necrosis Factor (TNF) blocker used in adults to: Lessen the signs and symptoms of moderately to severely active Crohn’s disease (CD) in adults who have not been helped enough by usual treatments.

How long does it take to get a call from a CIMZIA nurse?

You'll receive a call within the next 15 minutes.*

How to treat plaque psoriasis?

Treat moderate to severe plaque psoriasis (PsO) in adults who may benefit from taking injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet light alone or with pills)

Can you give yourself a Cimzia injection?

Do not give yourself an injection of CIMZIA unless you have been shown by your healthcare provider, or they can train someone you know to help you with your injection. CIMZIA is given by an injection under the skin. Your healthcare provider will tell you how much and how often to inject CIMZIA.

Can you get cancer from cimzia?

Some people who receive CIMZIA have developed certain types of skin cancer. Tell your healthcare provider if you develop any changes in the appearance of your skin, including growths on your skin, during or after treatment with CIMZIA. You should see your healthcare provider periodically during treatment for skin examinations, especially if you have a history of skin cancer.

Does CIMZIA increase cancer risk?

For people who receive TNF blockers, including CIMZIA, the chances of getting certain types of cancers may increase.

Can you take Cimzia while pregnant?

You and your doctor should decide if you should continue to take CIMZIA while you are pregnant. It is not known if CIMZIA will harm your unborn baby. Pregnancy Registry: If you become pregnant during treatment with CIMZIA, talk to your healthcare provider about registering in the pregnancy exposure registry for CIMZIA.

How is Cimzia administered?

CIMZIA is administered by subcutaneous injection. Injection sites should be rotated and injections should not be given into areas where the skin is tender, bruised, red or hard. When a 400 mg dose is needed (given as two subcutaneous injections of 200 mg), injections should occur at separate sites in the thigh or abdomen. The solution should be carefully inspected visually for particulate matter and discoloration prior to administration. The solution should be a clear colorless to yellow liquid, essentially free from particulates and should not be used if cloudy or if foreign particulate matter is present. CIMZIA does not contain preservatives; therefore, unused portions of drug remaining in the syringe or vial should be discarded.

What is CIMZIA used for?

CIMZIA is a tumor necrosis factor (TNF) blocker indicated for:  Reducing signs and symptoms of Crohn’s disease and maintaining clinical response in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy (1.1)  Treatment of adults with moderately to severely active rheumatoid arthritis (1.2)  Treatment of adult patients with active psoriatic arthritis. (1.3)  Treatment of adults with active ankylosing spondylitis (1.4)  Treatment of adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation (1.5)  Treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy (1.6)

When should CIMZIA be discontinued?

CIMZIA should be discontinued if a patient develops a serious infection or sepsis.

When was CIMZIA approved?

CIMZIA (certolizumab pegol) for injection, for subcutaneous use CIMZIA (certolizumab pegol) injection, for subcutaneous use Initial U.S. Approval: 2008

Is Cimzia lyophilized?

CIMZIA Lyophilized powder should be prepared and administered by a health care professional. CIMZIA is provided in a package that contains everything required to reconstitute and inject the drug [see How Supplied/Storage and Handling (16)]. Step-by-step preparation and administration instructions are provided below.

Is CIMZIA a TNF blocker?

MALIGNANCY Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, of which CIMZIA is a member [see Warnings and Precautions (5.2)]. CIMZIA is not indicated for use in pediatric patients .

Can CIMZIA cause death?

Patients treated with CIMZIA are at increased risk for developing serious infections that may lead to hospitalization or death [see Warnings and Precautions (5.1) and Adverse Reactions (6.1)]. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids.

What is CIMZIA used for?from cimziahcp.com

CIMZIA is indicated for: Reducing signs and symptoms of Crohn’s disease (CD) and maintaining clinical response in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy.

What are the side effects of CIMZIA?from cimziahcp.com

Angioedema, anaphylaxis, dyspnea, hypotension, rash, serum sickness, and urticaria have been reported following CIMZIA administration. If a serious allergic reaction occurs, stop CIMZIA and institute appropriate therapy. The needle shield inside the removable cap of the CIMZIA prefilled syringe contains a derivative of natural rubber latex which may cause an allergic reaction in individuals sensitive to latex.

What is a CIMZIA business associate agreement?from cimziainoffice.com

The Business Associate Agreement that enables access to CIMplicity. Contact a CIMZIA Representative for submission instructions

How to get a patient enrollment form for UCB?from cimziahcp.com

Reach out to your UCB sales representative, or call 1-866-4-CIMZIA (1-866-424-6942), to get a Patient Enrollment Form for your patients.

Can you stop CIMZIA after HBV treatment?from cimziahcp.com

Discontinue CIMZIA and begin antiviral therapy in patients who develop HBV reactivation. Exercise caution when resuming CIMZIA after HBV treatment.

Can you use Cimzia with other DMARDS?from cimziahcp.com

Do not use CIMZIA in combination with other biological DMARDS.

Is CIMZIA safe for children?from cimziahcp.com

Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, of which CIMZIA is a member. CIMZIA is not indicated for use in pediatric patients.

How to activate CIMZIA card?

If you are eligible for the CIMplicity Savings Program, as soon as you receive your card, call the number on the card to activate it so you can start saving on the cost of CIMZIA treatment. When your pharmacy calls, simply give the 10-digit number on the card as method of payment. It is that simple!

What is the phone number for a CIMplicity card?

If the pharmacy approved by your insurance company does not accept or is unable to process your CIMplicity Savings Card, call 1-844-277-6853.

Can you cancel cimplicity?

Any CIMplicity program may be amended or canceled at any time without notice. Some program and eligibility restrictions apply. Please consult your doctor if you have any questions about your condition or treatment. You are encouraged to report negative side effects of prescription drugs to the FDA.

Does CIMZIA have a copay?

You must request the CIMZIA $0 Co-Pay Program from your healthcare professional.* If you are eligible for the Program, your doctor’s office will activate your CIMplicity Savings Card (which works as a CIMZIA co-pay card) and keep the information with your patient records in their office.

What is CIMZIA used for?

CIMZIA is a prescription medicine called a Tumor Necrosis Factor (TNF) blocker. CIMZIA is used in adult patients to: •essen the signs and symptoms of moderately to severely active Crohn’s disease (CD) in patients who L have not been helped enough by usual treatments. •reat moderately to severely active rheumatoid arthritis (RA). T •reat active psoriatic arthritis (PsA). T •reat active ankylosing spondylitis (AS) T

What are the adverse events of CIMZIA?

In controlled Crohn’s clinical trials, the most common adverse events that occurred in ≥5% of CIMZIA patients (n=620) and more frequently than with placebo (n=614) were upper respiratory infection (20% CIMZIA, 13% placebo), urinary tract infection (7% CIMZIA, 6% placebo), and arthralgia (6% CIMZIA, 4% placebo). The proportion of patients who discontinued treatment due to adverse reactions in the controlled clinical studies was 8% for CIMZIA and 7% for placebo. In controlled RA clinical trials, the most common adverse events that occurred in ≥3% of patients taking CIMZIA 200 mg every other week with concomitant methotrexate (n=640) and more frequently than with placebo with concomitant methotrexate (n=324) were upper respiratory tract infection (6% CIMZIA, 2% placebo), headache (5% CIMZIA, 4% placebo), hypertension (5% CIMZIA, 2% placebo), nasopharyngitis (5% CIMZIA, 1% placebo), back pain (4% CIMZIA, 1% placebo), pyrexia (3% CIMZIA, 2% placebo), pharyngitis (3% CIMZIA, 1% placebo), rash (3% CIMZIA, 1% placebo), acute bronchitis (3% CIMZIA, 1% placebo), fatigue (3% CIMZIA, 2% placebo). Hypertensive adverse reactions were observed more frequently in patients receiving CIMZIA than in controls. These adverse reactions occurred more frequently among patients with a baseline history of hypertension and among patients receiving concomitant corticosteroids and non-steroidal anti-inflammatory drugs. Patients receiving CIMZIA 400 mg as monotherapy every 4 weeks in RA controlled clinical trials had similar adverse reactions to those patients receiving CIMZIA 200 mg every other week. The proportion of patients who discontinued treatment due to adverse reactions in the controlled clinical studies was 5% for CIMZIA and 2.5% for placebo. The safety profile for patients with Psoriatic Arthritis (PsA) treated with CIMZIA was similar to the safety profile seen in patients with RA and previous experience with CIMZIA. The safety profile for AS patients treated with CIMZIA was similar to the safety profile seen in patients with RA.

What happens if you get a CIMZIA?

After starting CIMZIA,if you get an infection, any sign of an infection including a fever, cough, flu-like symptoms, or have open cuts or sores on your body, call your healthcare provider right away. CIMZIA can make you more likely to get infections or make any infection that you may have worse.

What is the risk of CIMZIA?

Risk of Serious Infections and Malignancy Patients treated with CIMZIA are at an increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids.

How to fax CIMplicity enrollment form?

CIMplicity Enrollment and Benefits Investigation Form Complete and fax to 1-866-949-2469 By fi lling out this form, your patient will be enrolled in the CIMplicity program.

What medicine should I take for a high chance of infection?

Especially tell your healthcare provider if you take the following medicines due to a higher chance for serious infections: • ®Kineret (anakinra), Orencia®(abatacept), Rituxan®(rituximab), or Tysabri®(natalizumab) •dici nes called Tumor Necrosis Factor (TNF) blockers, such as Remicade ®me (infliximab), Humira®.

What age can you take immunosuppressants?

Patients greater than 65 years of age, patients with co-morbid conditions, and/or patients taking concomitant immunosuppressants (e.g., corticosteroids or methotrexate) may be at a greater risk of infection.

image
A B C D E F G H I J K L M N O P Q R S T U V W X Y Z 1 2 3 4 5 6 7 8 9