Generic Name
PegFilgrastim
Brand Names
Fulphila, Nyvepria, Udenyca, Neulasta, Stimufend, Ziextenzo, Fylnetra
FDA approval date: April 01, 2002
Classification: Leukocyte Growth Factor
Form: Injection, Kit
What is Fulphila (PegFilgrastim)?
Stimufend is a leukocyte growth factor indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.
Approved To Treat
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Brand Information
Fulphila (pegfilgrastim-jmdb)
1DOSAGE FORMS AND STRENGTHS
Fulphila is a clear, colorless, preservative-free solution available as:
- Injection: 6 mg/0.6 mL in a single-dose prefilled syringe for manual use only.
2CONTRAINDICATIONS
Fulphila is contraindicated in patients with a history of serious allergic reactions to pegfilgrastim products or filgrastim products. Reactions have included anaphylaxis
3ADVERSE REACTIONS
The following clinically significant adverse reactions are discussed in greater detail in other sections of the labeling:
- Splenic Rupture
- Acute Respiratory Distress Syndrome
- Serious Allergic Reactions
- Use in Patients with Sickle Cell Disorders
- Glomerulonephritis
- Leukocytosis
- Thrombocytopenia
- Capillary Leak Syndrome
- Potential for Tumor Growth Stimulatory Effects on Malignant Cells
- Myelodysplastic syndrome
- Acute myeloid leukemia
- Aortitis
3.1Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
Pegfilgrastim clinical trials safety data are based upon 932 patients receiving pegfilgrastim in seven randomized clinical trials. The population was 21 to 88 years of age and 92% female. The ethnicity was 75% Caucasian, 18% Hispanic, 5% Black, and 1% Asian. Patients with breast (n = 823), lung and thoracic tumors (n = 53) and lymphoma (n = 56) received pegfilgrastim after nonmyeloablative cytotoxic chemotherapy. Most patients received a single 100 mcg/kg (n = 259) or a single 6 mg (n = 546) dose per chemotherapy cycle over 4 cycles.
The following adverse reaction data in Table 2 are from a randomized, double-blind, placebo-controlled study in patients with metastatic or non-metastatic breast cancer receiving docetaxel 100 mg/m
The most common adverse reactions occurring in ≥ 5% of patients and with a between-group difference of ≥ 5% higher in the pegfilgrastim arm in placebo-controlled clinical trials are bone pain and pain in extremity.
3.1.1Leukocytosis
In clinical studies, leukocytosis (WBC counts > 100 x 10
3.2Immunogenicity
As with all therapeutic proteins, there is a potential for immunogenicity. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors, including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies in the studies described below with the incidence of antibodies in other studies or to other pegfilgrastim products may be misleading.
Binding antibodies to pegfilgrastim were detected using a BIAcore assay. The approximate limit of detection for this assay is 500 ng/mL. Pre-existing binding antibodies were detected in approximately 6% (51/849) of patients with metastatic breast cancer. Four of 521 pegfilgrastim-treated subjects who were negative at baseline developed binding antibodies to pegfilgrastim following treatment. None of these 4 patients had evidence of neutralizing antibodies detected using a cell-based bioassay.
3.3Postmarketing Experience
The following adverse reactions have been identified during post approval use of pegfilgrastim products. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
- Splenic rupture and splenomegaly (enlarged spleen)
- Acute respiratory distress syndrome (ARDS)
- Allergic reactions/hypersensitivity, including anaphylaxis, skin rash, and urticaria, generalized erythema, and flushing
- Sickle cell crisis
- Glomerulonephritis
- Leukocytosis
- Thrombocytopenia
- Capillary Leak Syndrome
- Injection site reactions
- Sweet’s syndrome, (acute febrile neutrophilic dermatosis), cutaneous vasculitis
- Myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML) in patients with breast and lung cancer receiving chemotherapy and/or radiotherapy
- Aortitis
- Alveolar hemorrhage
4OVERDOSAGE
Overdosage of pegfilgrastim products may result in leukocytosis and bone pain. Events of edema, dyspnea, and pleural effusion have been reported in a single patient who administered pegfilgrastim on 8 consecutive days in error. In the event of overdose, the patient should be monitored for adverse reactions
5DESCRIPTION
Pegfilgrastim-jmdb is a covalent conjugate of recombinant methionyl human G-CSF and monomethoxypolyethylene glycol. Recombinant methionyl human G-CSF is a water-soluble 175 amino acid protein with a molecular weight of approximately 19 kilodaltons (kD). Recombinant methionyl human G-CSF is obtained from the bacterial fermentation of a strain of
Fulphila (pegfilgrastim-jmdb) injection is intended for subcutaneous use only and is supplied in a single-dose prefilled syringe with a 29 gauge needle, with UltraSafe Passive Plus
The delivered 0.6 mL dose from the prefilled syringe contains 6 mg pegfilgrastim-jmdb (based on protein mass only) in a sterile, clear, colorless, preservative-free solution (pH 4.0) containing acetate (0.7 mg), D-sorbitol (30 mg), polysorbate 20 (0.024 mg) and sodium (0.01 mg) in Water for Injection, USP.
6HOW SUPPLIED/STORAGE AND HANDLING
Fulphila single-dose prefilled syringe for manual use
Fulphila (pegfilgrastim-jmdb) Injection is a clear, colorless solution supplied in a prefilled single-dose syringe for manual use containing 6 mg pegfilgrastim-jmdb, supplied with a 29 gauge, 1/2-inch needle with an UltraSafe Passive Plus™ Needle Guard.
Fulphila is provided in a dispensing pack containing one sterile 6 mg/0.6 mL prefilled syringe.
NDC 67457-833-06
Fulphila prefilled syringe does not bear graduation marks and is intended only to deliver the entire contents of the syringe (6 mg/0.6 mL) for direct administration. Use of the prefilled syringe is not recommended for direct administration for pediatric patients weighing less than 45 kg who require doses that are less than the full contents of the syringe.
Store refrigerated between 2° to 8°C (36° to 46°F) in the carton to protect from light or physical damage. Do not shake. Discard syringes stored at room temperature for more than 72 hours. Avoid freezing; if frozen, thaw in the refrigerator before administration. Discard syringe if frozen more than once.
7PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (
Advise patients of the following risks and potential risks with Fulphila:
- Splenic rupture and splenomegaly
- Acute Respiratory Distress Syndrome
- Serious allergic reactions
- Sickle cell crisis
- Glomerulonephritis
- Increased risk of Myelodysplastic Syndrome and/or Acute Myeloid Leukemia in patients with breast and lung cancer who receive pegfilgrastim in conjunction with chemotherapy and/or radiation therapy
- Capillary Leak Syndrome
- Aortitis
Instruct patients who self-administer Fulphila using the single-dose prefilled syringe of the:
- Importance of following the Instructions for Use.
- Dangers of reusing syringes.
- Importance of following local requirements for proper disposal of used syringes.
Manufactured by:
U.S. License No. 2210
8Patient Information
This Patient Information has been approved by the U.S. Food and Drug Administration. Revised: 03/2021
Fulphila is a registered trademark of Mylan Institutional Inc., a Viatris Company.
© 2021 Viatris Inc.
Manufactured by:
U.S. License No. 2210
Product of India
KR/DRUGS/KTK/28D/07/2006
Distributed by:
Revised: 10/2021
This Instructions for Use has been approved by the U.S. Food and Drug Administration.
Manufactured by:
U.S. License No. 2210
KR/DRUGS/KTK/28D/07/2006
Revised: 10/2021
9PACKAGE/LABEL PRINCIPAL DISPLAY PANEL
NDC 67457-833-06 Rx only
Fulphila
(pegfilgrastim-jmdb)
Injection
6 mg/0.6 mL
(pegfilgrastim-jmdb)
Injection
6 mg/0.6 mL
Single-Dose Prefilled Syringe
Pegylated Recombinant Methionyl Human Granulocyte Colony-Stimulating Factor (PEG-r-metHuG-CSF) derived from
For Subcutaneous Use Only
Sterile Solution - No Preservative
One 0.6 mL Single-Dose
Prefilled Syringe
Prefilled Syringe
Each 0.6 mL prefilled syringe contains: 6 mg pegfilgrastim (based on protein mass only) in a sterile, clear, colorless, preservative-free solution (pH 4.0) containing acetate (0.7 mg), D-sorbitol (30 mg), polysorbate 20 (0.024 mg), and sodium (0.01 mg) in water for injection, USP.
No U.S. standard of potency
Store refrigerated at 2° to 8°C (36° to 46°F) in original carton to Protect from Light. Do Not Freeze or Shake.
Keep this and all medication out of the reach of children.
Dosage: See prescribing information for dosage and instructions for use.
Manufactured by:
U.S. License No. 2210
Distributed by:
Product of India
B:833:1C:R10
KR/DRUGS/KTK/28D/07/2006
Mylan.com
