Pronunciation:

dos-TAR-li-mab - gxly

Brand Names:

• Jemperli

Dosage Forms:

• Solution

Classifications:

Therapeutic—

Antineoplastic Agent

Pharmacologic—

Dostarlimab

Uses of This Medicine:

Dostarlimab-gxly injection is used in combination with other cancer medicines (eg, carboplatin, paclitaxel) or alone to treat endometrial cancer (cancer of the lining of the uterus or womb) that is mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H), 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.

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:

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.

Children—

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.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of dostarlimab-gxly injection in the elderly.

Breast-feeding—

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.

Other medicines—

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 of This Medicine:

A nurse or other trained health professional will give you this medicine. It is given through a needle placed into one of your veins. It must be given slowly, so the needle 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 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 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 are a woman who can bear children, 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 syndrome (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 of This Medicine:

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.