Description
Pegfilgrastim-cbqv injection is used to treat neutropenia (low white blood cells) that is caused by cancer medicines. It is a synthetic (man-made) form of a substance that is naturally produced in your body called a colony stimulating factor. Pegfilgrastim-cbqv helps the bone marrow to make new white blood cells.
When certain cancer medicines are used to fight cancer cells, they also affect the white blood cells that fight infections. Pegfilgrastim-cbqv is used to lower the risk of getting an infection while you are being treated with cancer medicines.
This medicine is available only with your doctor's prescription.
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 performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of pegfilgrastim-cbqv injection in the pediatric population.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of pegfilgrastim-cbqv 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:
- Glomerulonephritis (kidney disease) or
- Leukocytosis (high white blood cell count) or
- Lung disease or breathing problems or
- Sickle cell disease (red blood cell disease)—Use with caution. May make these conditions worse.
Proper Use
A nurse or other trained health professional may give you this medicine. It is given as a shot under the skin of your upper arm, upper outer buttock, stomach, or thigh. You or your caregiver may be trained to prepare and inject this medicine at home. Be sure that you understand how to use it.
If you use this medicine at home, you will be shown the body areas where this shot can be given. Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas. This will help prevent skin problems from the injections. Do not inject into skin areas that are tender, red, bruised, hard, or has scars, moles, or birthmarks.
Pegfilgrastim-cbqv comes in 3 forms: a prefilled autoinjector, a prefilled syringe for manual use, and an On-body Injector for Udenyca® . Your doctor will tell you which dosage form you should use.
This medicine comes with a patient information leaflet and patient instructions. Read and follow these instructions carefully. Ask your doctor if you have any questions about:
- How to prepare the injection.
- The proper use of the prefilled autoinjector and prefilled syringe.
- How to give the injection.
- How long the injection can be stored at home.
Allow the medicine to warm to room temperature for 30 minutes before you inject it. If the medicine in the prefilled autoinjector or prefilled syringe has changed color, looks cloudy, or if you see particles in it, do not use it. Do not shake. Use the prefilled autoinjector or prefilled syringe only once. Do not save leftover medicine.
Do not use this medicine between 14 days before and 24 hours after receiving chemotherapy.
Dosing
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For injectable dosage form (prefilled autoinjector or prefilled syringe):
- For neutropenia:
- Adults—6 milligrams (mg) as a single injection under the skin once every cancer treatment cycle.
- Children weighing more than 45 kilograms (kg)—Dose is based on body weight and must be determined by your doctor. It is usually 6 milligrams (mg) as a single injection under the skin once every cancer treatment cycle.
- Children weighing less than 45 kilograms (kg)—Dose is based on body weight and must be determined by your doctor.
- Weighing 31 kg to 44 kg—4 milligrams (mg) as a single injection under the skin once every cancer treatment cycle.
- Weighing 21 kg to 30 kg—2.5 mg as a single injection under the skin once every cancer treatment cycle.
- Weighing 10 kg to 20 kg—1.5 mg as a single injection under the skin once every cancer treatment cycle.
- Weighing less than 10 kg—0.1 mg per kg as a single injection under the skin once every cancer treatment cycle.
- For neutropenia:
Missed Dose
This medicine needs to be given on a fixed schedule. If you miss a dose or forget to use your medicine, call your doctor or pharmacist for instructions.
Storage
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Store in the refrigerator. Do not freeze.
Udenyca® prefilled syringe or prefilled autoinjector: Protect from light. If it is frozen, thaw it in the refrigerator before using it. Throw this medicine away if it has been frozen more than once or if it has been left at room temperature for longer than 48 hours.
Udenyca® Onbody™: Leave the medicine in the carton until you are ready to use it. You may let the medicine warm up to room temperature before you use it. Keep it away from heat or direct light. The medicine can stay out of the refrigerator for up to 12 hours. Discard any medicine that has been out of the refrigerator for more than 12 hours.
Throw away used needles in a hard, closed container where the needles cannot poke through. Keep this container away from children and pets.
Precautions
It is very important that your doctor check your or your child's progress at regular visits to make sure this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.
Check with your doctor right away at the first sign of an infection, including fever, chills, cough, sore throat, or unusual tiredness or weakness.
Check with your doctor right away if you or your child are having pain in the upper left part of your stomach or at the tip of the left shoulder. This could be a symptom of a serious side effect with the spleen.
Check with your doctor right away if you or your child develop a fever, chest pain or tightness, or trouble breathing. These could be symptoms of a serious lung condition called acute respiratory distress syndrome (ARDS).
This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Tell your doctor right away if you or your child has a rash, itching skin, dizziness, lightheadedness, or fainting, swelling of the face, tongue, or throat, trouble breathing, or chest pain after you receive the medicine.
This medicine may cause kidney problems. Call your doctor right away if you or your child has swelling in your face or ankles, blood in the urine, or decrease in how much or how often you urinate.
If you are receiving this medicine via the On-body Injector (OBI) for Udenyca®:
- Tell your doctor if you have an allergy to acrylic adhesives.
- Keep the injector at least 4 inches away from electrical equipment, including cell or cordless phones, microwaves, and other appliances.
- Do not use bathtubs, hot tubs, whirlpools, or saunas while you are wearing the injector. Do not expose the injector to sunlight. Call your doctor if the injector comes off before or during a dose.
- Keep the injector dry at least 3 hours before the dose is scheduled to start. This will help you notice any leaks. Call your doctor if the bandage becomes wet or the medicine is dripping.
- The injector is programmed to deliver your dose about 27 hours after it is placed on your skin. It will take about 5 minutes for the dose to be given. Avoid driving, operating heavy machinery, or traveling during hours 26 to 29 after the injector is placed on your skin. This includes the 5-minute dose delivery period. You must have a caregiver nearby for your first dose.
- You should avoid airport X-ray scans and request a manual pat down instead.
- Do not sleep on, or apply pressure to, the OBI for Udenyca®. Doing so may prevent the OBI from working properly.
- You should avoid getting body lotions, creams, oils, or cleaning agents near the OBI for Udenyca® as these products may loosen the adhesive that holds the OBI onto your body.
This medicine may cause a condition called capillary leak syndrome. It can cause fluid to leak from the blood vessels into your body's tissues. Call your doctor right away if you or your child have swelling or puffiness and are urinating less often, trouble breathing, feeling of fullness, dizziness, or feeling faint.
This medicine lowers the number of some types of blood cells in your body. Because of this, you may bleed more easily. Wash your hands often. Stay away from rough sports or other situations where you could be bruised, cut, or injured. Brush and floss your teeth gently. Be careful when using sharp objects, including razors and fingernail clippers. Check with your doctor right away if you or your child has black or tarry stools, bleeding gums, blood in the urine or stools, pinpoint red spots on the skin, or unusual bleeding or bruising after receiving this medicine.
This medicine may cause aortitis (inflammation of the aorta, the largest artery in the body). Check with your doctor right away if you have fever, stomach pain, unusual tiredness or weakness, or back pain.
This medicine may cause blood or bone marrow problems (eg, myelodysplastic syndrome, acute myeloid leukemia) in patients with breast or lung cancer. Check with your doctor right away if you have chest pain, chills, cough or hoarseness, fever, lower back or side pain, painful or difficult urination, sores, ulcers, or white spots on the lips or in the mouth, swollen glands, unusual bleeding or bruising, or unusual tiredness or weakness.
Before you have any medical tests, tell the medical doctor in charge that you are using this medicine. The results of some tests (eg, bone tests) may be affected by 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 immediately if any of the following side effects occur:
More common
- Bone pain
- pain in the arms or legs
Incidence not known
- Back pain
- black, tarry stools
- bleeding gums
- blood in the urine or stools
- blue lips, fingernails, or skin
- blurred vision
- change in the amount of urine
- chest pain or tightness
- chills
- cloudy or bloody urine
- cough
- difficult or fast breathing
- difficulty swallowing
- dizziness
- eye pain
- fainting or lightheadedness
- fast heartbeat
- feeling of fullness
- fever
- fever sores on the skin
- general feeling of discomfort or illness
- headache
- hives, itching, skin rash
- lower back or side pain
- nausea
- nervousness
- pain spreading to the left shoulder
- painful or difficult urination
- pale skin
- pinpoint red spots on the skin
- pounding in the ears
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- redness, soreness, or itching skin
- slow or fast heartbeat
- sore throat
- sores, welts, or blisters
- stomach pain
- swelling of the hands, ankles, feet, or lower legs
- trouble breathing
- ulcers or white spots on the lips or in the mouth
- unusual bleeding or bruising
- unusual tiredness or weakness
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:
Incidence not known
- Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
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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