Brand Name
Rolvedon
Generic Name
Eflapegrastim-Xnst
View Brand Information FDA approval date: October 18, 2022
Classification: Leukocyte Growth Factor
Form: Injection
What is Rolvedon (Eflapegrastim-Xnst)?
Rolvedon is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in adult patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with clinically significant incidence of febrile neutropenia. Limitations of Use Rolvedon is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation. Rolvedon is a leukocyte growth factor indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in adult patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with clinically significant incidence of febrile neutropenia. Limitations of Use Rolvedon is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.
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Brand Information
Rolvedon (eflapegrastim-xnst)
1INDICATIONS AND USAGE
Rolvedon is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in adult patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with clinically significant incidence of febrile neutropenia.
Limitations of Use
Rolvedon is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.
2DOSAGE FORMS AND STRENGTHS
Injection: 13.2 mg/0.6 mL as a clear, colorless, preservative-free solution in a single-dose prefilled syringe.
3CONTRAINDICATIONS
Rolvedon is contraindicated in patients with a history of serious allergic reactions to eflapegrastim, pegfilgrastim, or filgrastim products. Reactions may include anaphylaxis
4ADVERSE 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
- Sickle cell crisis in patients with sickle cell disorders
- Glomerulonephritis
- Leukocytosis
- Thrombocytopenia
- Capillary leak syndrome
- Potential for tumor growth stimulatory effects on malignant cells
- Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML) in Patients with Breast and Lung Cancer
- Aortitis
- Nuclear Imaging
4.1Clinical 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 to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
The safety of Rolvedon was evaluated in Study 1 and Study 2
Among patients receiving Rolvedon, a total of 272 patients received four 21-day treatment cycles. The most common adverse reactions (≥20%) were fatigue, nausea, diarrhea, bone pain, headache, pyrexia, anemia, rash, myalgia, arthralgia, and back pain.
Permanent discontinuation due to an adverse reaction occurred in 4% of patients who received Rolvedon. The adverse reaction requiring permanent discontinuation in 3 patients who received Rolvedon was rash.
5OVERDOSAGE
Overdose of Rolvedon may result in leukocytosis and bone pain. In the event of overdose, general supportive measures should be instituted as necessary. Monitor the patient for adverse reactions
6DESCRIPTION
Eflapegrastim-xnst is a granulocyte colony-stimulating factor (G‑CSF) produced by covalent coupling of a human G-CSF analog (18.6 kDa) and an Fc fragment of human immunoglobulin G4 (IgG4) (49.8 kDa), both derived from recombinant
Rolvedon (eflapegrastim-xnst) injection is a sterile, preservative-free, clear, colorless solution supplied in a single-dose prefilled syringe for subcutaneous use. Each 0.6 mL single-dose prefilled syringe contains 13.2 mg of eflapegrastim-xnst, citric acid monohydrate (2.52 mg), mannitol (30 mg), polysorbate 80 (0.72 mg) and sodium chloride (5.26 mg) in Water for Injection. Sodium hydroxide may be used to adjust pH to 5.5 during manufacturing.
7CLINICAL STUDIES
Patients with Cancer Receiving Myelosuppressive Chemotherapy
The efficacy of Rolvedon to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs was evaluated in two 1:1 randomized, open-label, active-controlled non-inferiority studies of similar design (Study 1 [NCT02643420] and Study 2 [NCT02953340]) that enrolled a total of 643 patients with early-stage breast cancer. Docetaxel 75 mg/m
The median age of patients enrolled in the two randomized studies was 60 years (Range: 24 to 88), the majority of patients were female (>99%), 77% were White and 12% were Black or African American.
Study 1 enrolled 406 patients; 196 patients to the Rolvedon arm and 210 patients to the pegfilgrastim arm. Study 2 enrolled 237 patients; 118 patients to the Rolvedon arm and 119 patients to the pegfilgrastim arm. Efficacy for both trials was based on the duration of severe neutropenia (DSN) in Cycle 1.
Efficacy results are shown in
Figure 1. Duration of Severe Neutropenia (DSN) by Day in Cycle 1 (Study 1 and Study 2)
8HOW SUPPLIED/STORAGE AND HANDLING
Rolvedon (eflapegrastim-xnst) injection is a clear, colorless solution supplied in a single-dose prefilled syringe containing 13.2 mg of eflapegrastim-xnst in 0.6 mL solution, with 29-gauge 1/2 inch pre-attached (staked) needle with a needle guard.
Rolvedon is provided in a dispensing pack containing one sterile 13.2 mg/0.6 mL prefilled syringe (NDC 76961‑101-01).
Store refrigerated at 36°F to 46°F (2°C to 8°C) in the carton to protect from light. Do not shake. Discard any prefilled syringe left at room temperature for greater than 72 hours. Do not freeze; discard syringe if frozen.
9PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use). Inform patients to contact their healthcare provider with any questions.
Advise patients of the following risks and potential risks with Rolvedon:
•Splenic rupture and splenomegaly
•Acute respiratory distress syndrome
•Serious allergic reactions
•Sickle cell crisis
•Glomerulonephritis
•Leukocytosis
•Thrombocytopenia
•Capillary leak syndrome
•Potential for tumor growth stimulatory effects on malignant cells
•Increased risk of myelodysplastic syndrome and/or acute myeloid leukemia in patients with breast and lung cancer who receive Rolvedon in conjunction with chemotherapy and/or radiation therapy
•Aortitis
Instruct patients who self-administer Rolvedon 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:
10PACKAGE/LABEL PRINCIPAL DISPLAY PANEL
Rolvedon
(eflapegrastim-xnst)
injection
13.2 mg/0.6 mL
Rolvedon
(eflapegrastim-xnst)
injection
13.2 mg/0.6 mL
For subcutaneous injection
Sterile Solution – No Preservative
One 0.6 mL Single-dose Pre-filled Syringe
Rolvedon
(eflapegrastim-xnst)
injection
13.2 mg/0.6 mL
NDC 76961-101-01
Rx only
For subcutaneous injection
Sterile Solution – No Preservative
One 0.6 mL Single-dose Pre-filled Syringe