Inflectra can cause mild to severe side effects. The following lists contain some of the main side effects that can occur during treatment with Inflectra. These lists do not include all possible side effects.
For more information about the possible side effects of Inflectra, talk to your doctor or pharmacist. They can give you advice on how to deal with side effects that may be concerning or bothersome.
To note: The Food and Drug Administration (FDA) tracks the side effects of drugs it has approved. If you would like to notify the FDA about a side effect you have had with Inflectra, you can do so via MedWatch.
Mild side effects
Mild side effects* of Inflectra may include:
Most of these side effects may disappear within a few days or weeks. However, if they get worse or don’t go away, talk to your doctor or pharmacist.
*This is a partial list of mild Inflectra side effects. For more information about other mild side effects, talk to your doctor or pharmacist, or read the Inflectra package leaflet. prescribing information.
Serious side effects
Serious side effects from Inflectra are not common. However, they can happen. Call your doctor right away if you experience any serious side effects. Call 911 or your local emergency number if your symptoms are life-threatening or you think you have a medical emergency.
Serious side effects and their symptoms may include:
- Liver problems, such as hepatitis (inflammation of the liver) or liver failure. Symptoms can include:
- New or worsening heart failure. Symptoms may include:
- Blood disorders, such as low levels of white blood cells or platelets. Symptoms may include:
- Nervous system problems. Symptoms may include:
- Lupus-like syndrome (reaction of the immune system). Symptoms can include:
- rash on the cheeks or arms that gets worse in the sun
- Stroke, heart attack, or irregular heartbeat occurring within 24 hours of receiving an Inflectra infusion. Symptoms can include:
- a feeling of squeezing, pressure, or tightness in the chest
- chest pain that may spread to the jaw, neck, arm, or back
- feeling as if your heart is racing, racing, or skipping beats
- sudden weakness on one side of your body, usually in the face, arm, or leg
- difficulty speaking or walking
- Infusion-related reaction.*
- Risk of serious infection.*†
- Risk of certain cancers.*†
- Allergic reaction.*
Side effects in children
Inflectra is approved to treat ulcerative colitis (UC) or Crohn’s disease in children aged 6 years and older.
Side effects in children receiving Inflectra for UC are generally similar to side effects in adults receiving Inflectra for UC. However, children who receive Inflectra for Crohn’s disease may have different side effects than adults who receive Inflectra for this disease.
In clinical teststhe following side effects were more common in children than in adults who received Inflectra for Crohn’s disease:
If you are concerned about the risk of side effects from Inflectra in your child, talk to their doctor.
Details of side effects
Here are some details about some side effects that this drug can cause. To find out how often side effects occurred in clinical trials, see the prescribing information for Inflectra.
Some people may have infusion-related reactions with Inflectra. These are side effects that occur during or shortly after an infusion. (Inflectra is given by IV infusion. For more information, see the “How is Inflectra given?” section below). In clinical testsinfusion-related side effects were common with Inflectra treatment.
Symptoms of infusion-related reactions may include:
what you can do
Before you receive an Inflectra infusion, your doctor or other healthcare professional may prescribe certain medicines for you. These are intended to help prevent or reduce the risk of infusion reactions. They may include:
Your doctor will monitor you for infusion reactions during and after your infusion. Be sure to tell them immediately if you have any reaction symptoms.
If you have an infusion reaction, your doctor may prescribe medicine to treat the reaction. Also, they will probably slow or stop your Inflectra infusion until your symptoms improve. However, if you have a severe reaction, your doctor will probably recommend that you stop treatment with Inflectra.
Risk of serious infection
Inflectra has a
Inflectra weakens the immune system and makes it less able to fight infections. So if you are infected with a pathogen (germ), the medicine may increase your risk of serious infection. This may require treatment in hospital, and in rare cases they can lead to death. Serious infections were not common in people who received treatment with Inflectra in clinical tests.
Symptoms of serious infections can include:
- flu-like symptoms
- shortness of breath or rapid breathing
- sores on your body
Different types of serious infections have been reported in people receiving treatment with Inflectra. Examples include tuberculosis (TB), pneumonia, hepatitis B and sepsis (an extreme immune response to severe infection). Other bacterial, viral, and fungal infections that form abscess or spread throughout your body have also been reported.
Most people who developed serious infections in clinical trials were also taking other drugs that can weaken the immune system. Examples of these drugs include methotrexate (Trexall, Rasuvo, Otrexup, others) and corticosteroids such as prednisone (Rayos).
what you can do
Before you start Inflectra, your doctor will test you for tuberculosis and hepatitis B virus. They will also check you for other infections. Tell your doctor if you currently have an infection, if you have frequent infections, or if you have infections that keep coming back. If you have an infection, you will probably need to treat it before starting Inflectra.
Also, before starting treatment with Inflectra, talk to your doctor about up-to-date recommended vaccines. (For more information about Inflectra and vaccines, see the “Interactions with Inflectra” section below.)
To help prevent infections during treatment with Inflectra, try to avoid crowds and sick people. And be sure to wash your hands often.
If you get symptoms of an infection while taking Inflectra, tell your doctor straight away. They will likely prescribe medication to treat the infection. If you develop a serious infection, it may need to be treated in hospital. Your doctor will probably ask you to stop receiving treatment with Inflectra.
Risk of certain cancers
Inflectra has a
Cells in your body can become cancerous for a variety of reasons. Your immune system usually targets and kills these cancer cells before they form tumors. However, Inflectra works by weakening your immune system. It can therefore increase the risk of developing certain cancers. In clinical testscancer was not common in people who received treatment with Inflectra.
Symptoms of cancer can include:
- changes in your skin, such as new or changing moles, patches, or growths
- skin sores that do not heal
- unintentional weight loss
- swollen lymph nodes, for example, in the neck, armpits, or groin
- unusual lumps, bumps, or swellings that do not go away
Inflectra is a type of medicine called a tumor necrosis factor (TNF) blocker. Lymphoma, skin cancer and certain other cancers have been reported in children and adults taking TNF blockers, including Inflectra.
Some people taking TNF blockers, including Inflectra, have died of a rare type of cancer called hepatosplenic T-cell lymphoma. This is a type of lymphoma that develops in the lymph nodes, spleen, liver, and other parts of your body. It mainly occurred in adolescents and young adult males* who were taking anti-TNFs for ulcerative colitis or Crohn’s disease. Most of these people were also taking azathioprine (Azasan, Imuran) or 6-mercaptopurine (Purinethol, Purixan) during treatment with Inflectra.
what you can do
If you have had cancer in the past, talk to your doctor about your risk of developing cancer with Inflectra treatment. Your doctor will regularly screen for cancer during treatment with Inflectra. If you experience symptoms of cancer while taking Inflectra, contact your doctor immediately.
To help prevent cancer, you should avoid smoking and try to reach or maintain a weight that’s right for you. You should also avoid exposing your skin to the sun. You can protect your skin from the sun with clothing and high SPF sunscreen.
* Sex and gender exist on spectra. Use of the term “male” in this article refers to sex assigned at birth.
As with most medicines, some people may have an allergic reaction after receiving treatment with Inflectra.
Symptoms of a mild allergic reaction may include:
A more serious allergic reaction is rare. However, it is possible. Symptoms of a severe allergic reaction may include:
- swelling under the skin, usually in the eyelids, lips, hands, or feet
- swelling of the tongue, mouth or throat
- difficulty breathing
Call your doctor right away if you have an allergic reaction to Inflectra, as the reaction could become serious. Call 911 or your local emergency number if your symptoms are life-threatening or you think you have a medical emergency.