Nneupogen package insert pdf

Insert the needle into your skin in one quick motion at a 90degree straight up and down angle see figure 3. See 17 for patient counseling information and medication. Use the lowest procrit dose sufficient to reduce the need for red blood cell. Neupogen filgrastim injection side effects, images, uses. Comparison of ep2006, a filgrastim biosimilar, to the reference. If the syringe package is undamaged, open the package and remove the syringe. I dont think the neupogen has many sides but i havent read the package insert yet. Warnings and precautions also include avoiding the drug any time within 24 hours before or after chemotherapy, watching out for potential drug interactions, and being aware that neupogen may cause enlargement and rupture of the spleen. Highlights of prescribing information procrit epoetin. It may occur as early as the first week after start of therapy. Use your thumb whichever thumb is more comfortable to slowly push the plunger all the way down. Patient package insert 29 may 2002 neupogen filgrastim. Neupogen is a prescription medicine used to help reduce the chance of infection due to a low white blood cell count, in people with certain types of cancer nonmyeloid who receive anticancer medicines chemotherapy that can cause fever and a low blood cell count.

Giving yourself an injection of filgrastim neupogen or. Highlights of prescribing information these highlights do not include all the information needed to use neupogen safely and effectively. Us laws currently prohibit generic biologics from being made. Unless the laws change, a generic version of neupogen will not be available. The singleuse vials contain either 300 mcg or 480 mcg filgrastim at a fill volume of 1. Neupogen filgrastim, granix tbofilgrastim, nivestym. Neupogen is a 175 amino acid protein manufactured by recombinant dna technology. This emedtv web page contains more neupogen warnings and precautions, including possible side effects that may occur. Local coverage determination for gcsf filgrastim, neupogen. Find patient medical information for neupogen injection on webmd including its uses, side effects and safety, interactions, pictures, warnings and user ratings. Tbofilgrastim granix national drug monograph december 2014. The purposes of this monograph are to 1 evaluate the available evidence of safety, tolerability, efficacy, cost, and other pharmaceutical issues that would be.

The nccn compendium is a derivative work of the nccn guidelines. Neupogen fda prescribing information, side effects and uses. The following is the recommended dosage and frequency when administering this drug. Highlights of prescribing information these highlights. If youre a physician prescribing procrit, there is product information that could. Neupogen warnings and precautions cancer home page. Sarclisa isatuximabirfc injection, for intravenous use. Do not administer neupogen within the 24hour period prior to chemotherapy see warnings and precautions 5. Procrit package insert pdf see full prescribing information for complete boxed warning. Do not use if neupogen filgrastim injection has been frozen more than once. This patient package insert provides information and instructions for people who will be receiving neupogen and their caregivers. Nov 25, 2019 if neupogen filgrastim injection freezes, let it thaw in the refrigerator before use.

May 17, 2019 provides trustworthy package insert and label information about marketed drugs as submitted by manufacturers to the us food and drug administration. Neupogen should not be used in people undergoing radiation treatments. May 22, 2019 neupogen filgrastim is a 175 amino acid human granulocyte colonystimulating factor gcsf manufactured by recombinant dna technology. I have two kids from my previous marriage both conceived naturally and with ease.

The product contains the identical amino acid sequence of isolated natural erythropoietin. Neupogen filgrastim dose, indications, adverse effects. Pediatric patients weighing less than 45kg the neulasta prefilled syringe is not designed to allow for direct administration of doses less than 0. The package insert instructions for dosage and duration of treatment should not be exceeded. Gardasil is a vaccine indicated in girls and women 9 through 26 years of age for the prevention of the following diseases caused by. Administer neupogenat least 24 hours aftercytotoxic chemotherapy. Tepezza teprotumumabtrbw for injection, for intravenous use.

If the package has been opened or damaged, do not use that syringe. In march 2015, neupogen was also approved by the u. The procrit can make your bones ache too cuz it is stimulating blood cell production. These highlights do not include all the information needed to use zytiga safely and effectively. Dec 02, 2009 this patient package insert provides information and instructions for people who will be receiving neupogen and their caregivers.

Neupogen, neupogen singleject, nivestym, zarxio generic name. Package insert lists common adverse reactions from reference labeling. For more information refer to the neupogen package insert pdf icon external icon. What should i discuss with my healthcare provider before using filgrastim. This patient package insert does not tell you everything about neupogen. The pdfpages package makes it easy to insert pages of external pdf. Nov 18, 2015 twelve plus months of trying to get pregnant, 4 chemical pregnancies and one miscarriage at 7 weeks. Nipent pentostatin dose, indications, adverse effects. Rationale for inclusion in pa program background neupogen is a manmade form of granulocyte colonystimulating factor gcsf, which is made using the bacteria escherichia coli. See full prescribing information for complete boxed warning. Bmt recommended dose following bmt is 10 mcgkgday given as an iv infusion of 4 or 24 hours or sc. Information on who should not take the drug is also included.

If needed, neupogen filgrastim injection can be left out at room temperature for some time. Neupogen filgrastim can lower your risk of infection during chemotherapy, but it can cause a significant amount of bone pain. Manifestations may include generalized signs and symptoms such as fever, abdominal pain, malaise, back pain, and increased inflammatory markers e. Daily white blood cell booster neupogen filgrastim. Pentostatin administration requires an experienced clinician who is qualified and knowledgeable in the use of cancer chemotherapeutic agents.

A transient increase in neutrophil count is typically seen 1 to 2 days after initiation of neupogen therapy. Aortitis has been reported in patients receiving filgrastim products. The amount of air drawn into the syringe should be the same amount ml or cc as the dose of neupogen that your doctor prescribed. Neupogen product monograph page 7 of 51 in studies of neupogen administration following chemotherapy, most reported side effects were consistent with those usually seen as a result of cytotoxic chemotherapy see adverse. Lenvima is indicated for the treatment of patients with. The use of higher than the fdaapproved dosage is not recommended. Patients with cancer receiving strong chemotherapy. Highlights of prescribing information these highlights do not.

The prescribing information included here may not be. Evidence supports dose reduction of pegylated interferon according to fdaapproved. The number of anomalies was also significantly increased over the control group. Review side effects, drug interactions, dosage and pregnancy safety. The needle cap on the prefilled syringes contains dry natural rubber derived from latex. Pediatric use safety and effectiveness in pediatric patients have not been established. The product is available in singleuse vials and prefilled syringes. Projected place in therapy product licensed filgrastimsndz has been shown to be biosimilar the reference filgrastim in the u. What is the most important information i should know about filgrastim. You should discuss any questions you have about treatment with neupogen with your doctor.

My husband and i just got married nearly two years ago. Filgrastim information for patients and caregivers. It stimulates the growth of neutrophils, a type of white blood cell important in the bodys fight against. Sections or subsections omitted from the full prescribing information are not listed. Let your healthcare provider know if you have sickle cell anemia or any allergies before taking neupogen. Feb 06, 2020 drug information on neupogen, neupogen singleject, zarxio filgrastim includes side effects, uses, drug interactions, dosage, drug pictures, overdose symptoms, and what to avoid. Then, pull back the plunger and draw air into the syringe. Zytiga abiraterone acetate tablets 1 highlights of.

If you decide not to selfinject and dont have someone to do it for you, youll need to have your doctor or trained medical staff give you each dose of neupogen filgrastim. Escherichia coli e coli bacteria into which has been inserted the human granulocyte colonystimulating factor gene. Epogen is formulated as a sterile, colorless liquid in an isotonic. However, a shorter duration of administration that is sufficient to achieve clinically adequate neutrophil recovery is a reasonable alternative, considering issues of patient convenience and cost. Gcsf is a substance naturally produced by the body. Easy to read fda package insert, drug facts, dosage and administration, and adverse effects for neupogen filgrastim. Neupogen filgrastim injection, for subcutaneous or intravenous use initial u. Other considerations do not administer to patients with latex allergy. A generic version of neupogen is not currently available in the united states.

Food and drug administration fda to treat those people who have received high doses of radiation. It is not intended as medical advice for individual conditions or treatment. Filgrastim neupogen is a medication prescribed to prevent infectious complications associated with neutropenia, which may be caused by drugs used to treat cancer. Jun 24, 2011 june 24, 2011 new data show that the way procrit, epogen, and aranesp are used in patients with chronic kidney disease ckd may put them at risk of heart attack, stroke, and death, the fda. Highlights of prescribing information neulasta safely and. Highlights of prescribing information these highlights do not include all the information needed to use hydrea safely and effectively.

Neupogen filgrastim information for patients and caregivers. You should discuss any questions you have about treatment with neupogen with your. The pdfpages package makes it easy to insert pages of external pdf documents. Cyramza ramucirumab injection, for intravenous use. Discard product if frozen more than once discard product if it contains particulate matter, is cloudy, or discolored discard product if stored above 77 degrees f for more than 24 hours discard unused portion. See package insert for detailed storage information store in original container zarxio. In controlled trials, patients experienced greater risks for death, serious adverse cardiovascular reactions, and stroke when administered erythropoiesisstimulating agents esas to target a hemoglobin levelof greater than 11 gdl5. Filgrastimsndz zarxio national drug monograph september 2016. Throw away the syringe in the punctureproof disposable container. Neupogen is produced by escherichia coli e coli bacteria into which has been inserted the human granulocyte colonystimulating factor gene. The information contained in the truven health micromedex products as delivered by goodrx is intended as an educational aid only. I had a very hard time with neupogen lots of pain in my hips, legs, ribs, and sternum and a sharp crushing feeling in my chest that sent me in to get an ekg i thought i was having a heart attack.

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