Description
Penpulimab-kcqx injection is used in combination with either cisplatin or carboplatin and gemcitabine as first-line treatment of non-keratinizing nasopharyngeal carcinoma (nose and throat cancer) that has spread throughout the body (metastatic) or has returned. It is also used alone to treat non-keratinizing nasopharyngeal carcinoma in patients who have received other cancer medicines (eg, platinum) that did not work well or no longer working, or whose cancer has spread.
Penpulimab-kcqx 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
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 penpulimab-kcqx 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 penpulimab-kcqx 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 (eg, Crohn's disease, ulcerative colitis, or lupus) or
- Muscle or nerve problems (eg, myasthenia gravis, Guillain-Barré syndrome) 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) 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
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. This medicine is usually given every 2 or 3 weeks.
This medicine comes with a Medication Guide. Read and follow these instructions carefully. Ask your doctor or pharmacist 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 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 (eg, pneumonitis).
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.
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.
Check with your doctor right away if blurred vision, difficulty with reading, eye pain, or any other change in vision occurs while you are receiving this medicine. Your doctor may want your eyes to be checked by an ophthalmologist (eye doctor).
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.
Check with your doctor if you have a headache, confusion, seizures, stiff neck, or vomiting while receiving this medicine. These may be symptoms of encephalitis (inflammation of the brain).
Check with your doctor right away if you are having severe muscle pain or cramps, unusual weakness of the arms or legs, or a burning, numbness, tingling, or painful sensation in the arms, hands, legs, or feet. These could be symptoms of a serious muscle or nerve problem.
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.
This medicine may increase your risk for transplant complications (eg, graft-versus-host-disease [GVHD]) in patients who have received a bone marrow (stem cell) transplant that uses donor stem cells (allogeneic), which can be severe and life-threatening. Check with your doctor right away if you have skin rash, stomach pain, diarrhea, yellow skin or eyes, swelling in the legs or ankles, dark urine, pale stools, nausea, or vomiting.
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
- Agitation
- arm or leg pain
- back pain
- black, tarry stools
- bleeding gums
- blistering, peeling, or loosening of the skin
- blood in the urine or stools
- bone pain
- chest pain or tightness
- coma
- confusion
- cough
- dark urine
- decreased urine output
- depression
- diarrhea
- difficulty in moving
- dizziness
- ear congestion
- fever or chills
- headache
- hostility
- irritability
- itching
- lethargy
- light-colored stools
- loss of taste or smell
- loss of voice
- muscle or body aches
- muscle twitching
- nausea or vomiting
- neck pain
- pain, swelling, or redness in the joints
- painful or difficult urination
- pale skin
- pinpoint red spots on the skin
- rapid weight gain
- red irritated eyes
- red skin lesions, often with a purple center
- sneezing
- sore throat
- sores, ulcers, or white spots in the mouth or on the lips
- spinal pain
- stuffy or runny nose
- stupor
- swelling of the face, ankles, or hands
- swollen glands
- trouble breathing
- unusual bleeding or bruising
- unusual tiredness or weakness
- upper right abdominal or stomach pain
- yellow eyes and skin
Less common
- Blurred vision
- dry mouth
- flushed, dry skin
- fruit-like breath odor
- increased hunger
- increased thirst
- increased urination
- loss of consciousness
- nervousness
- sensitivity to heat
- stomach cramps, tenderness, or pain
- sweating
- trouble sleeping
- watery or bloody diarrhea
- weight loss
Rare
- Anxiety
- bloating
- bloody nose
- blue or pale skin
- blurred vision or other change in vision
- burning feeling in the chest or stomach
- chest discomfort
- constipation
- difficulty in chewing, swallowing, or talking
- double vision
- drooping eyelids
- drowsiness
- eye pain
- fast heartbeat
- heavier menstrual periods
- inability to move the arms and legs
- indigestion
- muscle weakness
- numbness or tingling in the fingers, face, or feet
- pains in the stomach, side, or abdomen, possibly radiating to the back
- redness of the eye
- seeing flashes or sparks of light
- seeing floating spots before the eyes, or a veil or curtain appearing across part of vision
- sensitivity to light
- stiff neck or back
- sudden numbness and weakness in the arms and legs
- swelling of the face, feet, or lower legs
- tearing
- throbbing pain
- unusual weight gain
Incidence not known
- Darkening of the skin
- flushing
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
- Full or bloated feeling
- general feeling of discomfort or illness
- pressure in the stomach
- weight decreased
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-80007468
