Frequently asked questions
What is ulcerative colitis?
Ulcerative colitis is a form of inflammatory bowel disease (IBD). It is a long-lasting condition involving inflammation of the large intestine or colon. In patients with ulcerative colitis, small sores or ulcers form along the lining of the colon. These ulcers cause stomach pain and the need to empty your bowls frequently.
What are the symptoms of ulcerative colitis?
The symptoms of ulcerative colitis vary from person to person. About half of all patients with ulcerative colitis experience mild symptoms. Common symptoms include:
- Loose and urgent bowel movements
- Bloody stool
- Belly pain and cramps
- Persistent diarrhea with belly pain and blood in the stool
How is ulcerative colitis diagnosed?
To diagnose ulcerative colitis, your healthcare provider will usually review your medical history and order tests to look for signs of ulcerative colitis and rule out other possible causes of your symptoms. Tests may include laboratory tests, X-rays of your upper and lower digestive tract, and additional tests designed to look inside your colon and rectum.
Is ulcerative colitis hereditary?
Studies have shown that up to 30% of people with ulcerative colitis have a first-degree relative (such as a parent, child, or sibling) who also has the disease. Even though there is a genetic component to IBD, there is no way to predict who may get ulcerative colitis based on family history.
Who is affected by ulcerative colitis?
Ulcerative colitis can affect people of any age, race, or ethnic group. Most people tend to be diagnosed in their mid-30s.
What are flares?
Because ulcerative colitis is a long-term illness, patients will likely experience times when symptoms are active, followed by periods of remission. Active symptoms are known as flares. Remission is when your symptoms get much better or even go away completely.
What is ZYMFENTRA?
ZYMFENTRA™ is a self-injected form of infliximab. Other FDA-approved forms of infliximab include Remicade®, Inflectra®, Renflexis®, or Avsola®. This is the first time that infliximab is available in the United States as a prefilled pen or syringe, potentially giving patients more control over how and where they receive their treatment.
ZYMFENTRA is a prescription medicine used as an injection under the skin (subcutaneous injection) by adults for the maintenance treatment of:
- moderately to severely active ulcerative colitis following treatment with an infliximab product given by intravenous infusion (IV)
- moderately to severely active Crohn’s disease following treatment with an infliximab product given by intravenous infusion (IV)
REMICADE® (infliximab), INFLECTRA® (infliximab-dyyb), RENFLEXIS® (infliximab-abda), and AVSOLA® (infliximab-axxq) are registered trademarks of other companies.
How is ZYMFENTRA provided?
ZYMFENTRA is provided as a single-dose prefilled pen or a single-dose prefilled syringe with
needle shield. Your healthcare provider will prescribe the type that is best for you.
How does ZYMFENTRA work?
ZYMFENTRA targets and blocks a protein in the body called tumor necrosis factor (TNF). In patients with IBD and other diseases, TNF can be overproduced, causing the immune system to attack normal, healthy parts of the body. By blocking TNF, ZYMFENTRA lowers inflammation in the gut to help you feel better.
What should I know about injecting ZYMFENTRA?
ZYMFENTRA is injected under your skin (subcutaneously) 1 time every 2 weeks. If your healthcare provider decides that you or your caregiver can give your injections of ZYMFENTRA at home, you or your caregiver should be shown the right way to prepare and inject ZYMFENTRA. Do not inject ZYMFENTRA without first receiving training from a healthcare provider and reviewing the Instructions for Use.
ZYMFENTRA is injected under the skin (subcutaneous injection), in your upper arms, stomach area (abdomen), or upper legs (thighs). Do not give an injection in an area of the skin that is tender, bruised, red, or hard. Use a different injection site each time you use ZYMFENTRA.
What happens if I miss a dose of ZYMFENTRA?
If you are not able to inject ZYMFENTRA at your regular scheduled time or you miss a dose of ZYMFENTRA, inject the dose as soon as possible. Then, inject your next dose every 2 weeks thereafter. If you are not sure when to inject ZYMFENTRA, call your healthcare provider.
I already receive maintenance therapy with infliximab at an infusion center. Can I shift to ZYFEMTRA?
Patients who receive infliximab at an infusion center can usually be shifted to ZYMFENTRA. Talk with your healthcare provider to see if you’re a good candidate for ZYMFENTRA.
What are the benefits of ZYMFENTRA?
ZYMFENTRA provides an innovative and convenient dosing option, giving patients more control over how and where they receive their treatment. In addition to offering flexibility and convenience, ZYMFENTRA can help minimize travel to infusion centers or doctor’s offices to receive treatment.
What are the side effects of ZYMFENTRA?
The most common side effects include COVID-19, joint pain, respiratory infections, such as sinus infections and sore throat, diarrhea, injection site reactions, high blood pressure, headache, urinary tract infections, abdominal pain, dizziness, and abnormal liver enzymes.
How should I store ZYMFENTRA?
Store ZYMFENTRA prefilled pens and prefilled syringes in a refrigerator at 36°F to 46°F (2°C to 8°C). If needed, you may store ZYMFENTRA at room temperature at 68°F to 77°F (20°C to 25°C) for up to 14 days. Once ZYMFENTRA has been stored at room temperature, it should not be placed back into the refrigerator. Throw away (discard) ZYMFENTRA if not used within the 14 days. Do not freeze ZYMFENTRA. Be sure not to shake ZYMFENTRA. Keep ZYMFENTRA in the original carton until ready to use to protect it from light.
