TM Owner Sandoz
Ziextenzo 6mg/0.6mL Injection
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Indications & Clinical Uses
- Ziextenzo 6 mg/0.6 mL is a single-dose prefilled syringe of pegfilgrastim-bmez, a long-acting leukocyte growth factor (granulocyte colony-stimulating factor, G-CSF) made by Sandoz.
- It is a biosimilar to Neulasta (pegfilgrastim).
- In the US it is used to lower the chance of infection, shown by fever with low neutrophils (febrile neutropenia), in patients with non-myeloid cancer who are receiving chemotherapy that suppresses the bone marrow, and to increase survival after exposure to high doses of radiation that damage the bone marrow (hematopoietic subsyndrome of acute radiation syndrome).
- The single 6 mg prefilled syringe is not for children weighing less than 45 kg because a partial dose cannot be measured.
- It is given as one subcutaneous injection per chemotherapy cycle, and is not given between 14 days before and 24 hours after chemotherapy.
Side Effects
- The most common side effects in clinical studies were bone pain (31% compared with 26% on placebo) and pain in the arms or legs (9% compared with 4%).
- Serious reactions include splenic rupture (report pain in the left upper abdomen or shoulder), acute respiratory distress syndrome (ARDS), serious allergic reactions including anaphylaxis, sickle cell crises in people with sickle cell disorders, glomerulonephritis (kidney inflammation), high white cell counts (leukocytosis), low platelets (thrombocytopenia), capillary leak syndrome, aortitis (inflammation of the aorta), and myelodysplastic syndrome or acute myeloid leukemia in breast and lung cancer patients.
- There is no boxed warning on the US label.
- Seek urgent help for trouble breathing, swelling of the face or throat, severe abdominal or shoulder pain, or fever with back pain.
Precautions & Warnings
- Ziextenzo must not be used if you have had a serious allergic reaction to pegfilgrastim or filgrastim products.
- It should not be given between 14 days before and 24 hours after cytotoxic chemotherapy.
- Splenic rupture, ARDS, capillary leak syndrome and aortitis have been reported, so tell your provider about abdominal pain, breathing problems, or fever and back pain.
- Sickle cell crises can occur in people with sickle cell disease, and kidney inflammation or high white cell counts can develop and are monitored.
- Human data in pregnancy are limited; in animals embryolethality occurred in rabbits at about 4 times the recommended dose, so use it during pregnancy only if clearly needed.
- Ziextenzo can be injected by a healthcare provider, or by you or a caregiver after training, using the prefilled syringe for manual use only.
- Store refrigerated at 2 to 8 degrees C; if it is left at room temperature for more than 120 hours it must be discarded.
Avoid Interactions
- The Ziextenzo prescribing information does not list specific drug interactions, so no medicines are identified that increase or reduce its effect.
- The most important timing rule concerns chemotherapy: because rapidly dividing blood cells are sensitive to cytotoxic drugs, Ziextenzo must not be given between 14 days before and 24 hours after chemotherapy.
- Ziextenzo is a long-acting once-per-cycle product and should not be confused with daily filgrastim products.
- Tell your healthcare provider about all prescription medicines, over-the-counter products and supplements you use, especially other medicines that affect blood counts, and report any new symptoms after each dose.
References
Frequently Asked Questions
Ziextenzo (pegfilgrastim-bmez) is a biosimilar to Neulasta that lowers the risk of infection with fever and low white cells (febrile neutropenia) in people having chemotherapy for non-myeloid cancers. It is also used to improve survival after high radiation exposure that damages the bone marrow.
Ziextenzo (pegfilgrastim-bmez) is a single 6 mg subcutaneous injection given once per chemotherapy cycle. A healthcare provider can give it, or you or a caregiver can after training. It must not be given between 14 days before and 24 hours after chemotherapy.
The most common Ziextenzo (pegfilgrastim-bmez) side effects are bone pain and pain in the arms or legs. Get urgent help for pain in the left upper abdomen or shoulder (possible splenic rupture), trouble breathing, swelling of the face or throat, or a serious allergic reaction.
Do not use Ziextenzo (pegfilgrastim-bmez) if you have had a serious allergic reaction to pegfilgrastim or filgrastim. Do not have it between 14 days before and 24 hours after chemotherapy. Tell your provider if you have sickle cell disease or a history of kidney problems.
Store Ziextenzo (pegfilgrastim-bmez) prefilled syringes in the refrigerator at 2 to 8 degrees C in the carton, protected from light. Let the syringe reach room temperature for 15 to 30 minutes before injecting. Discard it if it has been at room temperature for more than 120 hours.
Ziextenzo (pegfilgrastim-bmez) 6 mg prefilled syringes are only for patients weighing at least 45 kg, because a smaller dose cannot be measured accurately from the syringe. Ask the cancer specialist about the right option for a smaller child. The 6 mg dose is fixed and cannot be split.
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