Description
Dostarlimab-gxly injection is used in combination with other cancer medicines (eg, carboplatin, paclitaxel), and then may be used alone to treat endometrial cancer (cancer of the lining of the uterus) in patients whose cancer has returned or it has spread. This medicine may also be used alone to treat endometrial cancer that is mismatch repair deficient (dMMR), in patients whose cancer has returned or it has spread, cannot be removed by surgery or radiation, or in patients who have received other cancer medicines (eg, platinum) that did not work well. It is also used to treat mismatch repair deficient (dMMR) solid tumor that has returned or spread, and has progressed during or after treatment that did not work well. Your doctor will perform a test to check for the dMMR tumor before you use this medicine.
Dostarlimab-gxly is a monoclonal antibody that changes the immune system to help control the growth of cancer cells.
This medicine is to be given only by or under the direct 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 dostarlimab-gxly 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 dostarlimab-gxly 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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.
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:
- Colitis (inflammation of the bowels) or
- Diabetic ketoacidosis or
- Hepatitis (inflammation of the liver) or
- Hyperthyroidism (high levels of thyroid hormone) or
- Hypophysitis (inflammation of the pituitary gland) or
- Hypothyroidism (low levels of thyroid hormone) or
- Immune system problems or
- Nephritis (inflammation of the kidneys) or
- Pneumonitis (inflammation of the lungs) or
- Type 1 diabetes—Use with caution. May make these conditions worse.
- Organ transplant (eg, kidney or liver transplant), recent—Use with caution. May increase risk for organ transplant rejection.
- Patients who have had allogeneic hematopoietic stem cell transplant (HSCT)—Use with caution. May cause side effects to become worse.
Proper Use
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 30 minutes. The infusion will be given every 3 or 6 weeks, depending on your dose.
This medicine comes with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.
Missed Dose
This medicine needs to be given on a fixed schedule. If you miss a dose, call your doctor, home health caregiver, or treatment clinic for instructions.
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 give you a pregnancy test before you start using this medicine to make sure you are not pregnant. Use an effective form of birth control to keep from getting pregnant during treatment with this medicine and for at least 4 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.
Colitis (swelling of the colon or bowel) 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.
Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, unusual tiredness or weakness, or yellow eyes or skin. These could be symptoms of a serious liver problem.
Serious problems with the adrenal, pituitary, or thyroid glands (hormone glands) may occur while you are receiving this medicine. Tell your doctor if you start having continuing or unusual headaches, changes in mood or behavior (eg, being irritable or forgetful), lightheadedness, dizziness, or fainting, unusual sluggishness, or an increase in weight.
This medicine may affect blood sugar levels. If you notice a change in the results of your blood or urine sugar tests or if you have any questions, check with your doctor.
This medicine may cause serious kidney problems (eg, nephritis, kidney failure). Tell your doctor right away if you have bloody or cloudy urine, nausea, vomiting, trouble breathing, swelling of the face, feet, or lower legs, unusual tiredness or weakness, or unusual weight gain.
Tell your doctor right away if you have changes in your eyesight, severe or persistent muscle or joint pain, or severe muscle weakness after receiving this medicine.
This medicine may increase your risk for possible organ transplant rejection. Talk to your doctor about this risk.
Serious skin reactions (eg, exfoliative dermatitis, Stevens-Johnson syndrome, drug rash with eosinophilia and systemic symptoms (DRESS), and 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 skin rash, sores or ulcers on the skin, mouth or lips, or swollen glands, unusual bleeding or bruising, or unusual tiredness or weakness with this medicine.
This medicine may cause infusion-related reactions. These can be life-threatening and require immediate medical attention. Tell your doctor right away if you start to have a fever, chills or shaking, dizziness, trouble breathing, itching or rash, lightheadedness or fainting after receiving this medicine.
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
- bloating
- bloody or cloudy urine
- blurred vision or changes in vision
- confusion
- constipation
- dark urine
- darkening of the skin
- depression
- difficult, burning, or painful urination
- difficulty in moving
- dry skin and hair
- eye pain, redness
- fainting
- fast heartbeat
- feeling cold
- frequent urge to urinate
- hair loss
- headache
- hoarseness or husky voice
- indigestion
- irritability
- loss of appetite
- lower back or side pain
- muscle cramps and stiffness
- nausea
- pains in the stomach, side, or abdomen, possibly radiating to the back
- pale skin
- seizures
- sensitivity of the eye to light
- slow heartbeat
- sore tongue
- stiff neck
- swollen joints
- tearing
- trouble breathing
- unusual bleeding or bruising
- unusual tiredness or weakness
- vomiting
- weight gain
- yellow eyes and skin
Less common
- Agitation
- chest pain or tightness
- chills
- coma
- cough
- cough producing mucus
- decreased urine output
- diarrhea
- dizziness
- fever
- general feeling of discomfort or illness
- hostility
- lethargy
- muscle twitching
- nervousness
- rapid weight gain
- sensitivity to heat
- stomach cramps, tenderness, or pain
- stupor
- sweating
- swelling of the face, feet, lower legs, ankles, or hands
- thickening of bronchial secretions
- trouble sleeping
- watery or bloody diarrhea
- weight loss
Rare
- Anxiety
- back or leg pain
- black, tarry stools
- bleeding gums
- blood in the stools
- blue or pale skin
- blurred vision
- burning, tingling, numbness, or pain in the hands, arms, feet, or legs
- burning feeling in the chest or stomach
- change in vision
- chest pain, possibly moving to the left arm, neck, or shoulder
- drowsiness
- dry mouth
- eye pain
- general body swelling
- inability to move the arms and legs
- indigestion
- joint pain
- light-colored stools
- lightheadedness
- loss of consciousness
- loss of strength or energy
- muscle aches, pain, tenderness, or weakness
- nosebleeds
- numbness or tingling in the fingers, face, or feet
- partial or slight paralysis
- pinpoint red spots on the skin
- rapid, shallow breathing
- redness of the eye
- sensation of pins and needles
- sensitivity of the eye to light
- severe headache
- skin rash, redness, soreness, or itching
- sores, welting, or blisters
- stabbing pain
- stiff neck or back
- stomach discomfort or upset
- sudden numbness and weakness in the arms and legs
- swollen, painful, or tender lymph glands in the neck, armpit, or groin
- tearing
- upper right abdominal or stomach pain
Incidence not known
- Blistering, peeling, or loosening of the skin
- cracks in the skin
- flushed, dry skin
- fruit-like breath odor
- increased hunger
- increased thirst
- increased urination
- loss of heat from the body
- red irritated eyes
- red skin lesions, often with a purple center
- red, swollen skin
- scaly skin
- sore throat
- sores, ulcers, or white spots in the mouth or on the lips
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.
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