Description
Durvalumab injection is used in combination with platinum-containing chemotherapy before surgery and then used alone after surgery in patients with non-small cell lung cancer (NSCLC) which can be removed by surgery and do not have an abnormal EGFR or ALK gene. It is also used alone to treat NSCLC that has not spread and cannot be removed by surgery in patients who have received other cancer medicines (eg, platinum) and radiation treatment for their NSCLC. It is also used in combination with tremelimumab-actl and platinum-containing chemotherapy to treat non-small cell lung cancer (NSCLC) that has spread to other parts of the body in patients whose tumors do not have an abnormal EGFR or ALK gene. This medicine is also used alone to treat limited-stage small cell lung cancer (LS-SCLC) that cannot be removed by surgery in patients who have received other cancer medicines (eg, platinum) and radiation treatment for their LS-SCLC. This medicine is also used in combination with etoposide and either carboplatin or cisplatin as first-line treatment for extensive-stage small cell lung cancer (ES-SCLC).
Durvalumab injection is also used in combination with other cancer medicines (eg, gemcitabine and cisplatin) to treat biliary tract cancer (BTC) that has spread to nearby tissues or to other parts of the body.
Durvalumab injection is also used in combination with tremelimumab-actl to treat liver cancer that cannot be removed by surgery (unresectable hepatocellular carcinoma or uHCC).
Durvalumab injection is also used in combination with other cancer medicines (eg, carboplatin and paclitaxel) and then used alone to treat mismatch repair deficient (dMMR) advanced endometrial cancer (cancer of the lining of the uterus or womb) that has spread or has come back.
Durvalumab injection is also used in combination with other cancer medicines (eg, gemcitabine and cisplatin) before surgery and then used alone after surgery to treat muscle invasive bladder cancer (MIBC).
This medicine is to be given only by or under the supervision of your doctor.
This product is available in the following dosage forms:
- Solution
Before Using
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:
Allergies
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.
Pediatric
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.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of durvalumab injection in the elderly.
Breastfeeding
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.
Drug Interactions
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. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
- Bacillus of Calmette and Guerin Vaccine, Live
- Dengue Tetravalent Vaccine, Live
- Measles Virus Vaccine, Live
- Mumps Virus Vaccine, Live
- Rubella Virus Vaccine, Live
- Smallpox Monkeypox Vaccine
- Typhoid Vaccine
- Varicella Virus Vaccine
- Yellow Fever Vaccine
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Adenovirus Vaccine Type 4, Live
- Adenovirus Vaccine Type 7, Live
- Cholera Vaccine
- Ebola Zaire Vaccine, Live
- Influenza Virus Vaccine, Live
- Rotavirus Vaccine, Live
Other Interactions
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 gland problems or
- Diabetes or
- Immune system problems or
- Infection or
- Kidney problems or
- Liver problems or
- Lung or breathing problems or
- Thyroid problems—Use with caution. May make these conditions worse.
- Organ transplant or tissue transplant (eg, cornea transplant), recent—Use with caution. May increase risk for organ or tissue transplant rejection.
- Patients who have had allogeneic hematopoietic stem cell transplant (HSCT)—Use with caution. May cause side effects to become worse.
Proper Use
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. It is given through an IV catheter that is placed into one of your veins. It must be given slowly, so the IV will have to remain in place for at least 60 minutes every 2, 3, or 4 weeks.
This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.
Precautions
It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.
Receiving this medicine while you are pregnant can harm your unborn baby. If you can get pregnant, your doctor may do tests to make sure you are not pregnant before receiving this medicine. Use an effective form of birth control to keep from getting pregnant during treatment with this medicine and for at least 3 months after the last dose. If you think you have become pregnant while receiving 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 (eg, pneumonitis).
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 receiving the medicine.
Adrenal, pituitary, or thyroid gland problems may occur while you are receiving 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 bloody urine, a decrease in frequency or amount of urine, an increase in blood pressure, increased thirst, loss of appetite, lower back or side pain, nausea, swelling of the face, fingers, or lower legs, trouble breathing, unusual tiredness or weakness, vomiting, or weight gain. These could be symptoms of a serious kidney problem.
Serious skin reactions (eg, exfoliative dermatitis, Stevens-Johnson syndrome, drug rash with eosinophilia and systemic symptoms (DRESS), or toxic epidermal necrolysis) can occur with this medicine. Check with your doctor right away if you have blistering, peeling, or loosening of the skin, chills, cough, diarrhea, itching, joint or muscle pain, red irritated eyes, red skin lesions, often with a purple center, severe acne or a skin rash, sore throat, sores or ulcers on the skin, mouth, or lips, swollen glands, unusual bleeding or bruising, or unusual tiredness or weakness with this medicine.
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 receiving 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 inflammation of the heart muscle (myocardium) called myocarditis. Check with your doctor right away if you have chest pain or discomfort, fever, chills, a fast heartbeat, or trouble breathing.
This medicine may cause thrombocytopenic purpura. Check with your doctor right away if you have black, tarry stools, blood in the urine, bloody nose, fever, heavier menstrual periods, pinpoint red spots on the skin, skin rash, unusual bleeding or bruising or unusual tiredness or weakness.
Call your doctor right away if you have difficulty with breathing, swallowing, or talking, muscle weakness, severe tiredness, or sudden numbness and weakness in the arms or legs. These could be symptoms of a nervous system problem.
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, or fever or chills while you are receiving this medicine.
This medicine may increase your risk for possible organ transplant rejection. Talk to your doctor about this risk.
Side Effects
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:
More common
- Bladder pain
- bleeding gums
- bloating or swelling of the face, arms, hands, lower legs, or feet
- bloody or cloudy urine
- blurred vision
- body aches or pain
- burning, numbness, tingling, or painful sensations
- chest pain or tightness
- chills
- constipation
- cough
- coughing up blood
- depressed mood
- diarrhea
- difficult, burning, or painful urination
- difficulty having a bowel movement
- dry skin and hair
- ear congestion
- feeling cold
- fever
- frequent urge to urinate
- general feeling of discomfort or illness
- hair loss
- headache
- hoarseness, husky, or loss of voice
- increased menstrual flow or vaginal bleeding
- loss of taste or smell
- lower back or side pain
- muscle cramps and stiffness
- nausea or vomiting
- nervousness
- nosebleeds
- paralysis
- pounding in the ears
- prolonged bleeding from cuts
- runny or stuffy nose
- sensitivity to heat
- slow or fast heartbeat
- sneezing
- sore throat
- stomach cramps
- sweating
- tenderness
- thickening of bronchial secretions
- tingling of the hands or feet
- trouble breathing
- trouble sleeping
- unsteadiness or awkwardness
- unusual tiredness or weakness
- unusual weight gain or loss
- watery or bloody diarrhea
- weakness in arms, hands, legs, or feet
- weight gain
Less common
- Back, leg, or stomach pains
- black, tarry stools
- bloody nose
- changes in vision
- dark urine
- eye redness, irritation, or pain
- general body swelling
- heavier menstrual periods
- light-colored stools
- loss of appetite
- pale skin
- pinpoint red spots on the skin
- sensitivity of the eye to light
- skin rash
- stiff neck or back
- tearing
- unusual bleeding or bruising
- upper right abdominal or stomach pain
- yellow eyes and skin
Rare
- Blistering, peeling, or loosening of the skin
- dizziness
- drowsiness
- fainting
- joint or muscle pain
- red skin lesions, often with a purple center
- sores, ulcers, or white spots in the mouth or on the lips
- swollen glands
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:
More common
- Decrease appetite
- lack or loss of strength
- muscle or bone pain
- thinning of the hair
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.
DRG-20406270
