Common side effects and what to do

Read the list below so you know what to do if you experience a side effect. These are not all the possible side effects you may feel when taking AMGEVITA®. If you experience any side effects not listed here, contact your healthcare professional.

Tell your doctor IMMEDIATELY if you/your child experiences any of the following:

  • Severe rash, hives, or other signs of allergic reaction
  • Swollen face, hands, feet
  • Trouble breathing, swallowing
  • Sudden weight gain (this is possibly indicative of new or worsening heart failure)
  • Bruising or bleeding very easily, looking very pale; this could mean a blood problem, such as low red blood cells (anemia) or low platelets

Tell your doctor AS SOON AS POSSIBLE if you/your child notices any of the following:

  • Signs of infection such as fever, malaise, wounds, dental problems, burning on urination
  • Feeling weak or tired
  • Coughing
  • Tingling
  • Numbness
  • Double vision
  • Arm or leg weakness
  • Arm or leg pain, swelling, or redness
  • Bump or open sore that does not heal
  • Red scaly patches or raised bumps that are filled with pus (this could be new or worsening hidradenitis suppurativa, new or worsening psoriasis, or a skin infection)
  • Alopecia (loss of hair)
  • Changes in the colour of the skin
  • Changes in the colour of your urine (dark or red)
  • Worsening of the appearance of a scar
  • Night sweats
  • Weight loss
  • Pain in the abdomen or chest

Serious side effects and what to do

Tell your/your child’s healthcare professional every time you/your child experiences one of the following:

  • Injection-site reaction
  • Cough and cold symptoms, including sore throat
  • Rash
  • Nausea
  • Fever

Stop taking AMGEVITA® and get immediate medical help if you/your child experiences one of the following:

  • Pneumonia
  • Tuberculosis (TB)
  • Other serious infections
  • Nerve disorders
  • Appendicitis
  • Blood clots: abdominal pain, chest pain, or leg or arm pain with redness and swelling
  • Bladder infection: painful urination
  • Hepatitis: jaundice (yellow skin, dark urine, abdominal pain, tiredness)

Talk to your/your child’s healthcare professional if you/your child experiences one of the following:

  • Severe headache
  • Severe abdominal pain

BEFORE STARTING, DURING, AND AFTER TREATMENT WITH AMGEVITA ®, YOU SHOULD BE CHECKED FOR ACTIVE OR INACTIVE TUBERCULOSIS INFECTION WITH A TUBERCULIN SKIN TEST.

Like all medicines that affect your immune system, AMGEVITA ® can cause serious side effects. These possible serious side effects include:

Allergic reactions: If you/your child develops a severe rash, swollen face, or difficulty breathing while taking AMGEVITA ®, call your/your child’s healthcare professional right away.

Hepatosplenic T-cell lymphoma: Very rare reports of hepatosplenic T-cell lymphoma (HSTCL), a rare serious lymphoma that is often fatal, have been identified in patients treated with adalimumab. Most patients had also been treated with other medications for Crohn’s disease, and the majority of cases were in adolescent and young adult males. The link between HSTCL and adalimumab is not clear.

Other cancer: There have been very rare cases of certain kinds of cancer in patients taking adalimumab or other TNF-blockers. Some patients receiving adalimumab have developed types of cancer called non-melanoma skin cancer. Tell your/your child’s healthcare professional if you/your child has a bump or open sore that does not heal. People with more serious rheumatoid arthritis that have had the disease for a long time may have a higher-than-average risk of getting a kind of cancer that affects the lymphatic system, called lymphoma. If you/your child takes AMGEVITA® or other TNF-blockers, your/your child’s risk may increase. There have been cases of lymphoma and other cancers, including unusual types, in children, adolescents, and young adults taking TNF-blocking agents, including adalimumab, which sometimes resulted in death. For children and adults taking TNF-blocker medicines, the chances of developing lymphoma or other cancers may increase.

Lupus-like symptoms: Some patients have developed lupus-like symptoms that got better after their treatment was stopped. If you/your child has chest pains that do not go away, shortness of breath, joint pain, or a rash on the cheeks or arms that gets worse in the sun, call your/your child’s healthcare professional right away. Your/your child’s healthcare professional may decide to stop your/your child’s treatment.

Nervous system diseases: There have been rare cases of disorders that affect the nervous system of people taking adalimumab or other TNF-blockers. Signs that you/your child could be experiencing a problem affecting the nervous system include numbness or tingling, vision problems, weakness in the legs, and dizziness.

Serious infections: There have been rare cases where patients taking adalimumab or other TNF-blocking agents have developed serious infections. Some of these cases have been life-threatening. Such infections include tuberculosis, infections caused by bacteria or fungi, and bacterial infections that have spread throughout the body (sepsis). Infection causes include tuberculosis, legionellosis (a serious form of bacterial pneumonia), listeriosis (an infection that usually develops after eating food contaminated by bacteria called listeria), and very rare cases of hepatitis B infection relapse.

Blood problems: In some instances, patients treated with TNF-blocking agents may develop low blood counts, such as anemia (low red blood cells) or low platelets. If you/your child develops symptoms such as persistent fever, bleeding, or bruising, you should contact your/your child’s healthcare professional right away.

For more information on possible side effects, see the Patient Medication Information included in your AMGEVITA® package.

If you are not sure or have any questions about this information, talk to your/your child’s healthcare professional. This is not a complete list of side effects.