Durvalumab (Intravenous route)
Uses of This Medicine:
Durvalumab injection is used to treat urothelial carcinoma (a type of bladder cancer) that has spread throughout the body (metastatic) or cannot be removed by surgery (advanced). This medicine is given to patients who have received other cancer medicines (eg, platinum) but did not work well.
This medicine is to be given only by or under the supervision of your doctor.
Before Using This Medicine:
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Appropriate studies have not been performed on the relationship of age to the effects of durvalumab injection in the pediatric population. Safety and efficacy have not been established.
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of durvalumab injection in the elderly.
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other medical problems—
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Adrenal problems or
- Diabetes or
- Immune system problems or
- Infection or
- Liver problems or
- Lung or breathing problems or
- Thyroid problems—Use with caution. May make these conditions worse.
Proper Use of This Medicine:
Medicines used to treat cancer are very strong and can have many side effects. Before using this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.
A nurse or other trained health professional will give you this medicine. This medicine is given through a needle placed in one of your veins. It must be given slowly, so the needle will remain in place for 60 minutes and the infusion will be given every 2 weeks.
This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.
Precautions While Using This Medicine:
It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.
Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant during treatment and for at least 3 months after the last dose of this medicine. If you think you have become pregnant while using the medicine, tell your doctor right away.
Tell your doctor right away if you have a cough, chest tightness, or any type of breathing problem with this medicine. These could be symptoms of a serious lung problem.
Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, a loss of appetite, nausea, unusual tiredness or weakness, or yellow eyes or skin. These could be symptoms of a serious liver problem.
Colitis (inflammation of the colon) may occur with this medicine. Tell your doctor right away if you have stomach pain or tenderness, watery or bloody diarrhea, or a fever after using the medicine.
Adrenal, pituitary, or thyroid gland problems may occur while you are using this medicine. Tell your doctor if you have changes in mood or behavior, constipation, dry skin or hair, feeling cold, sensitivity to heat, sweating, trouble sleeping, or weight changes.
Check with your doctor right away if you have severe headache, drowsiness, confusion, general feeling of illness, or stiff neck or back while you are using this medicine. These may be symptoms of meningitis.
Call your doctor right away if you start to have a cough that won't go away, weight loss, night sweats, fever, chills, painful or difficult urination, or flu-like symptoms, such as a runny or stuffy nose, headache, blurred vision, or feeling generally ill. These may be signs that you have an infection.
This medicine may cause a rare but serious type of an allergic reaction called an infusion reaction. This can be life-threatening and requires immediate medical attention. Tell your doctor right away if you start to have a skin rash, dizziness, trouble breathing, chest tightness, swelling in your face or hands, fever or chills while you are receiving this medicine.
Side Effects of This Medicine:
- More common
- Bladder pain
- bloating or swelling of the face, arms, hands, lower legs, or feet
- bloody or cloudy urine
- depressed mood
- difficult, burning, or painful urination
- difficulty having a bowel movement (stool)
- dry skin and hair
- feeling cold
- frequent urge to urinate
- hair loss
- hoarseness or husky voice
- lower back or side pain
- muscle cramps and stiffness
- rapid weight gain
- slowed heartbeat
- stomach cramps
- tingling of the hands or feet
- unusual tiredness or weakness
- unusual weight gain or loss
- watery or bloody diarrhea
- Less common
- Chest pain
- dark urine
- difficult breathing
- general feeling of discomfort or illness
- general tiredness and weakness
- light-colored stools
- nausea and vomiting
- sensitivity to heat
- thickening of bronchial secretions
- trouble sleeping
- upper right abdominal or stomach pain
- weight loss
- yellow eyes and skin
- Less common or rare
- Back, leg, or stomach pains
- black, tarry stools
- bleeding gums
- bloody nose
- blurred vision or other change in vision
- chest tightness
- eye redness, irritation, or pain
- general body swelling
- heavier menstrual periods
- loss of appetite
- pale skin
- pinpoint red spots on the skin
- redness of the eye
- sensitivity of the eye to light
- skin rash
- sore throat
- stiff neck or back
- unusual bleeding or bruising
- Less common
- Decreased appetite
- muscle or joint pain
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor or nurse immediately if any of the following side effects occur:
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Last Updated: 9/4/2017