Pegfilgrastim-cbqv (peg-fil-GRA-stim - cbqv)

Helps your body make white blood cells after you receive cancer medicines.

Brand Name(s):

Udenyca, Udenyca Onbody

When This Medicine Should Not Be Used:

How to Use This Medicine:

Injectable

• Your doctor will prescribe your exact dose and tell you how often it should be given. This medicine is given as a shot under your skin.
• A nurse or other health provider will give you this medicine.
• You may be taught how to give your medicine at home. Make sure you understand all instructions before giving yourself an injection. Do not use more medicine or use it more often than your doctor tells you to.
• 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.
• 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. Do not inject into skin areas that are tender, red, bruised, hard, or has scars, moles, or birthmarks.
• Allow the medicine to warm to room temperature for 30 minutes before using it. Do not warm it in any other way. Do not shake.
• Check the liquid in the prefilled autoinjector or prefilled syringe. It should be clear and colorless. Do not use it if it is cloudy, discolored, or has particles in it.
• Use the syringe only once. Do not save leftover medicine.
• Use a new needle and syringe each time you inject your medicine.
• Do not use this medicine between 14 days before and 24 hours after receiving chemotherapy.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Missed dose: Call your doctor or pharmacist for instructions.
• Udenyca® prefilled syringe or prefilled autoinjector: If you store this medicine at home, keep it in the refrigerator. Do not freeze. 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™: Keep the medicine in the carton and away from heat or direct light. The medicine can stay out of the refrigerator for up to 12 hours. Throw away any medicine that has been out of the refrigerator for more than 12 hours.
• Throw away used needles in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have kidney disease, lung disease, breathing problems, or sickle cell disease.
• This medicine may cause the following problems:
  • Spleen problems
  • Lung problems, including acute respiratory distress syndrome (ARDS)
  • Kidney problems
  • Capillary leak syndrome
  • Blood or bone marrow problems (including myelodysplastic syndrome, acute myeloid leukemia) in patients with breast or lung cancer
  • Aortitis (swelling of the largest artery in the body)
• On-body Injector (OBI) for Udenyca®:
  • 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 lowers the number of certain blood cells, so you may bleed or bruise more easily. Be careful to avoid injuries.
• Tell any doctor or dentist who treats you that you are using this medicine. This medicine may affect certain medical test results.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Bone, arm, or leg pain
• Decrease in how much or how often you urinate, red or dark brown urine, lower back or side pain
• Fever, chills, cough, sore throat, body aches
• Lightheadedness, dizziness, or fainting
• Pain in your left side or shoulder, feeling unusually full
• Skin redness, blisters, or sores, red or purple spots on your skin
• Swelling in your face, ankles, or feet
• Trouble breathing or fast breathing, blue lips, fingernails, or skin
• Unusual bleeding, bruising, tiredness, or weakness

If you notice these less serious side effects, talk with your doctor:

• Pain, itching, burning, swelling, or a lump under your skin where the shot was given

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088