Class: Biological Therapy

Generic Name: durvalumab

Trade Name: Imfinzi™

For which conditions is this drug approved? Durvalumab is used for patients with bladder or urinary tract cancer that cannot be removed by surgery or has spread to other parts of the body after treatment with a platinum-based chemotherapy.

What is the mechanism of action? Durvalumab is a PD-L1 inhibitor. It works by blocking certain proteins on cancer cells which help the cells avoid detection by the immune system. Blocking these proteins helps the immune system find and attack the cancer cells.

How is durvalumab typically given? Durvalumab is administered by intervenous (IV) infusion usually every two weeks. The patient’s healthcare provider will determine how many treatments are needed.

How are patients monitored? Patients will usually have scheduled meetings with their healthcare provider while they are being treated with durvalumab. Typically, blood will be drawn to monitor functions of some organ systems, such as the kidneys or liver. Patients may also undergo physical examinations, scans, or other measures to assess side effects and response to therapy. Patients may be put on corticosteroid or hormone replacement medicines.

What are the most common side effects of treatment with durvalumab?

• Feeling tired
• Muscle and/or bone pain
• Constipation
• Decreased appetite
• Nausea
• Swelling
• Urinary tract infection

What are some of the less common but potentially serious side effects of durvalumab?

• Lung problems (pneumonitis)
• Liver problems (hepatitis)
• Intestinal problems (colitis)
• Hormone gland problems (especially the thyroid, adrenals, pituitary, and pancreas)
• Kidney problems
• Skin problems
• Problems in other organs
• Severe infections
• Severe infusion reactions

This is not a complete list of side effects. Some patients may experience other side effects that are not listed here. Patients may wish to discuss with their physician the other less common side effects of this drug, some of which may be serious.

Some side effects may require medical attention. Other side effects do not require medical attention and may go away during treatment. Patients should check with their physician about any side effects that continue or are bothersome.

What should you tell your healthcare provider before starting treatment with Durvalumab?

Tell your healthcare provider if you:

• Have immune system problems such as Crohn’s disease, ulcerative colitis, or lupus.
• Have had an organ transplant.
• Have lung or breathing problems.
• Are being treated for an infection.
• Are pregnant or plan to become pregnant.
• Are breastfeeding or plan to breastfeed.

Tell your health care provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Durvalumab and other medicines may affect each other causing side effects. Know the medicines you take. Keep a list of them to show your health care provider or pharmacist when you get a new medicine.

When should patients notify their physician?

Contact your healthcare professional immediately in case of any of the following:

• You have symptoms of lung problems. These include: new or worsening cough, shortness of breath, chest pain.
• You have symptoms of hepatitis. These include: yellowing of skin or whites of eyes, severe nausea or vomiting, pain on the right side of your stomach area, drowsiness, dark urine, bleeding or bruising more easily, feeling less hungry than usual.
• You have symptoms of These include: diarrhea or more bowel movements than usual; stools that are black, tarry, sticky, or have blood or mucus; severe stomach area pain or tenderness.
• You have symptoms of hormone gland problems. These include: headaches that will not go away or unusual headaches, extreme tiredness, weight gain or loss, dizziness or fainting, feeling more hungry or thirsty than usual, hair loss, feeling cold, constipation, your voice gets deeper, urinating more often than usual, nausea or vomiting, stomach area pain, changes in mood or behavior such as decreased sex drive, irritability, or forgetfulness.
• You have symptoms of kidney problems. These include: decrease in amount of urine, blood in urine, swelling in ankles, loss of appetite.
• You have symptoms of skin problems. These include: rash, itching, skin blistering.
• You have symptoms of problems in other organs. These include: neck stiffness, headache, confusion, fever, changes in mood or behavior, blurry vision, double vision, eye pain or redness.
• You have symptoms of severe infections. These include: fever, cough, frequent urination, pain when urination, flu-like symptoms.
• You have symptoms of severe infusion reactions. These include: chills or shaking, itching or rash, flushing, shortness of breath or wheezing, dizziness, fever, feel like passing out, back or neck pain, facial swelling.
• You become pregnant.

What is a package insert?

A package insert is required by the FDA and contains a summary of the essential scientific information needed for the safe and effective use of the drug for healthcare providers and consumers. A package insert typically includes information regarding specific indications, administration schedules, dosing, side effects, contraindications, results from some clinical trials, chemical structure, pharmacokinetics and metabolism of the specific drug. By carefully reviewing the package insert, you will get the most complete and current information about how to safely use this drug. If you do not have the package insert for the drug you are using, your pharmacist or physician may be able to provide you with a copy.

Last updated on 05/17.

Important Limitations of Use

The information provided above on the drug you have selected is provided for your information only and is not a substitute for consultation with an appropriate medical doctor. We are providing this information solely as a courtesy and, as such, it is in no way a recommendation as to the safety, efficacy or appropriateness of any particular drug, regimen, dosing schedule for any particular cancer, condition or patient nor is it in any way to be considered medical advice. Patients should discuss the appropriateness of a particular drug or chemotherapy regimen with their physician.

As with any printed reference, the use of particular drugs, regimens and drug dosages may become out-of-date over time, since new information may have been published and become generally accepted after the latest update to this printed information. Please keep in mind that health care professionals are fully responsible for practicing within current standards, avoiding use of outdated regimens, employing good clinical judgment kin selecting drugs and/or regimens, in calculating doses for individual patients, and verifying all dosage calculations.

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