Durvalumab

Durvalumab is a prescription injection used to treat certain cases of bladder and urinary tract cancer. It can also be used to treat certain cases of Stage III non-small cell lung cancer. Imfinzi belongs to a group of drugs called monoclonal antibodies. It works by helping your immune system to slow or stop the growth of cancer cells. 

Durvalumab is an injectable solution to be given directly into the vein (IV) by a healthcare professional.

Common side effects of durvalumab include fatigue, muscle/bone pain, constipation, and decreased appetite. 

Durvalumab is a prescription injection used to treat:

• a type of cancer in the bladder and urinary tract and can be given when:
  • cancer has spread or can not be removed with surgery, and
  • you have tried chemotherapy that contains platinum, and it did not work or is no longer working
• Stage III non-small cell lung cancer that
  • has spread outside the chest
  • cannot be removed by surgery, and 
  • has responded or become stable with initial chemotherapy treatment that contains platinum (given at the same time as radiation)

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Durvalumab may be found in some form under the following brand names:

• Imfinzi

Serious side effects of durvalumab have been reported. See the "Durvalumab Precautions" section. 

Common side effects of durvalumab include

• fatigue
• muscle/bone pain
• constipation
• decreased appetite
• nausea
• swelling of the hands or feet
• urinary tract infection

This is not a complete list of durvalumab side effects. Ask your doctor or pharmacist for more information. Tell your doctor if you have any side effects that bother you or that do not go away. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

No drug interactions have been studied by the manufacturer. However, you should tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Not all drug interactions are known or reported and new drug interactions are continually being reported. 

Serious side effects have been reported with durvalumab including the following:

Pneumonia. Durvalumab can cause a severe lung infection. 

Liver and Colon Problems. Tell your healthcare provider about any signs or symptoms of liver damage, including the following:

• loss of appetite
• nausea/vomiting
• feeling tired
• stomach pain or tenderness
• dark urine
• yellowing of white part of the eyes
• fever or rash

Kidney Problems. Your healthcare provider will monitor your kidney function before beginning treatment and periodically during treatment with Imfinzi. Tell your healthcare provider about any signs or symptoms of kidney problems, including:

• pain or a burning sensation while urinating
• pain in the pelvis
• more frequent urination 
• cloudy urine
• blood in the urine
• swelling of your ankles
• loss of appetite 
• high blood pressure

Serious skin reactions. Tell your healthcare provider about any signs or symptoms of skin reactions, including rash, itching or blistering. 

Changes in Endocrine System. Durvalumab can disrupt the endocrine system and lead to diabetes, hyperthyroidism, or adrenal insufficiency.

Infection. Tell your healthcare provider about any signs of infection, including:

• fever
• chills
• fatigue
• rash
• redness

Infusion-Related Reactions. Tell your doctor or get medical help right away if you get any of these symptoms during or after your Imfinzi infusion:

• hives (red itchy welts) or rash
• itching
• swelling of lips, tongue, throat, or face
• sudden cough
• shortness of breath
• weakness
• palpitations (feeling of your heart racing or fluttering)
• chest pain

Harm To Your Unborn Baby. Tell your doctor if you are pregnant or plan to become pregnant.

Do not receive Durvalumab if you are allergic to Imfinzi or to any of its ingredients. 

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of durvalumab, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking durvalumab, tell your doctor about all of your medical conditions. Especially tell them if you:

• are allergic to durvalumab or any of its ingredients
• have ever had an organ transplant
• have an autoimmune disease
• have lung disease
• have a liver disease
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

In animal studies, pregnant animals were given durvalumab, and some babies had problems. There are no well-controlled studies that have been done in pregnant women. Therefore, durvalumab may be used if the potential benefits to the mother outweigh the potential risks to the unborn child. 

f you are able to become pregnant, it is recommended you use an effective method of birth control during your treatment and for at least 3 months after the last dose of durvalumab. Talk to your healthcare provider about which birth control methods are the best options for you. 

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if durvalumab crosses into the breast milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants, a choice should be made whether to stop nursing or to stop the use of durvalumab. The importance of the drug to the mother should be considered.

It is recommended you do not breastfeed during treatment and for at least 3 months after the last dose of durvalumab. 

Durvalumab is an injectable solution to be given directly into the vein (IV) by a healthcare professional. Durvalumab is infused over an hour every 2 weeks.

The durvalumab dose your doctor prescribes is based on your weight and the condition being treated. 

Treatment of bladder cancer: The recommended dose of durvalumab is 10 mg/kg every 2 weeks. 

Treatment of Stage III non-small cell lung cancer: The recommended dose of durvalumab is 10 mg/kg every 2 weeks.

Since durvalumab is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention. 

Keep all appointments with your doctor and the laboratory. Your doctor will order specific lab testing to check your body's response to Imfinzi.