The Bridge Program applies to KHONDAYA only. Eligible patients must have private insurance and a valid prescription for KHONDAYA, and a delay or denial of coverage. Program requires the submission of a prior authorization and/or any other payer forms required for consideration of paid fill required as eligibility criteria, or an appeal of the coverage denial within the first 90 days of enrollment to remain eligible. Program provides KHONDAYA for free to eligible patients for up to 12 months, or until they receive insurance coverage approval, whichever occurs earlier. A valid prescription consistent with FDA-approved labeling is required. Program is not available to patients whose medications are reimbursed in whole or in part by Medicare, Medicaid, TRICARE, or any other federal or state program. Patients may be asked to reverify insurance coverage status during the course of the program. No purchase necessary. Program is not health insurance, nor is participation a guarantee of insurance coverage. Additional limitations may apply. Novartis Pharmaceuticals Corporation reserves the right to rescind, revoke, or amend this Program without notice.
IMPORTANT SAFETY INFORMATION
What is the most important information I should know about KHONDAYA
Before using KHONDAYA, tell your healthcare provider about all of your medical conditions, including if you:
- have ever experienced dizziness or fainting (low blood pressure), flushing, rash, fever, shortness of breath or feeling sick after a previous injection, or pain, redness and swelling at the site of injection (possible signs of general and local injection-related reactions or allergic reactions). Your healthcare provider may prescribe you medicines before the first injection of KHONDAYA to reduce your likelihood of getting a general injection-related reaction or allergic reaction.
- suspect you may have an infection. Signs and symptoms of infection may include fever, sweats or chills, muscle aches, cough, shortness of breath, blood in your phlegm, weight loss, warm, red or painful skin or sores on your body, diarrhea or stomach pain, burning when you urinate or the need to urinate more often than normal. Your healthcare provider will check you for signs and symptoms of infections before you start your treatment with KHONDAYA. If you do have an infection, your healthcare provider may wait until it is resolved before giving you KHONDAYA.
- plan to have a vaccination.
You should not be given ‘live’ or ‘live-attenuated’ vaccines during KHONDAYA treatment. These vaccines contain a living but weakened infectious agent.
You should be given ‘live’ or ‘live-attenuated’ vaccines at least 4 weeks before starting KHONDAYA.
Whenever possible, you should be given ‘non-live’ vaccines at least 2 weeks before starting KHONDAYA.
become pregnant during treatment and you plan to have your baby vaccinated, you should discuss this with your healthcare provider and/or with a specialist before having your baby vaccinated.
- have or ever had a hepatitis B virus (HBV) infection or if you are a carrier of HBV. This is because KHONDAYA can cause HBV to become active again. Your healthcare provider will check if you are at risk of HBV infection before starting KHONDAYA.
- If you have HBV infection, you may not be given KHONDAYA until the infection is resolved. Signs and symptoms of HBV infection may include worsening tiredness, yellowing of the skin or the white part of the eyes, dark urine, loss of appetite, nausea and/or pain in the upper right side of the abdomen.
- If you have had hepatitis B or are a carrier of the HBV, you may be referred to a specialist before and during KHONDAYA treatment.
- If you are a carrier of HBV, you may receive antiviral medicines before starting KHONDAYA treatment.
- are pregnant, think that you might be pregnant, or plan to become pregnant. It is not known if KHONDAYA will harm your unborn baby.
- You should use effective birth control (contraception) during treatment with KHONDAYA and for 6 months after your last injection of KHONDAYA. Talk to your healthcare provider about birth control methods that may be right for you.
- Tell your healthcare provider right away if you become pregnant or think you may be pregnant while using KHONDAYA.
- are breastfeeding or plan to breastfeed. It is not known if KHONDAYA passes into your breast milk. However, monoclonal antibodies, the group of medicines to which KHONDAYA belongs, are known to pass into breast milk. Your healthcare provider will discuss with you the benefits of breastfeeding for your baby and the benefits of KHONDAYA treatment for you.
Tell your healthcare provider about all the medicines you take, including prescription medicines, over-the-counter medicines, vitamins, and herbal supplements.
What are the possible side effects of KHONDAYA?
The most common side effects of KHONDAYA include:
- Fever, headache, chills, fatigue, joint pain, diarrhea, nausea, itching, rash (possible signs of general injection site reactions).
- Redness, pain, itching and swelling at the injection site (possible signs of local injection site reactions)
- Nose and throat infections (upper respiratory tract infections)
- Fever, pain, redness, sore throat, and/or difficulty breathing (possible signs of low level of white blood cells, neutropenia)
- These are not all the possible side effects of KHONDAYA. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects.
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.
Please see full Prescribing Information, including Medication Guide.
INDICATIONS
KHONDAYA treat people 18 years of age and older with moderate to severe sjogrens disease.