Generic Name
PegFilgrastim
Brand Names
Armlupeg, Fulphila, Fylnetra, Neulasta, Nyvepria, Stimufend, Udenyca, Ziextenzo
FDA approval date: April 01, 2002
Classification: Leukocyte Growth Factor
Form: Injection, Kit, Solution
What is Armlupeg (PegFilgrastim)?
Armlupeg 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.
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Brand Information
ARMLUPEG (pegfilgrastim-unne)
1DOSAGE FORMS AND STRENGTHS
Armlupeg 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
Armlupeg is contraindicated in patients with a history of a serious hypersensitivity reaction 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 Hypersensitivity 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 1 are from a randomized, double-blind, placebo- controlled study in patients with metastatic or non-metastatic breast cancer receiving docetaxel 100 mg/m2 every 21 days (Study 3). A total of 928 patients were randomized to receive either 6 mg pegfilgrastim (n=467) or placebo (n=461). The patients were 21 to 88 years of age and 99% female. The ethnicity was 66% Caucasian, 31% Hispanic, 2% Black, and < 1% Asian, Native American, or other.
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.
Leukocytosis
In clinical studies, leukocytosis (WBC counts >100x10
3.2Postmarketing 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, 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-unne 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
Armlupeg (pegfilgrastim-unne) injection is a sterile, clear, colorless, preservative-free solution intended for subcutaneous use only and is supplied in a single-dose prefilled syringe with a 27‑gauge ½" needle and rigid needle shield, with UltraSafe Plus Passive
Each prefilled syringe contains 0.6 mL solution of 6 mg pegfilgrastim-unne (based on protein weight), glacial acetic acid (0.77 mg), polysorbate 20 (0.02 mg), sodium acetate (0.066 mg) and sorbitol (30 mg) in Water for Injection, USP. The pH is 4.
6HOW SUPPLIED/STORAGE AND HANDLING
Armlupeg (pegfilgrastim-unne) injection is a clear, colorless solution supplied in a prefilled single-dose syringe for manual use containing 6 mg pefilgrastim-unne, supplied with a 27-gauge, 1/2-inch needle with an UltraSafe® Plus Passive
The needle cap of the prefilled syringe contains dry natural rubber (a derivative of latex).
Armlupeg is provided in a carton containing one sterile 6 mg/0.6 mL prefilled syringe (NDC 70748-273-01).
Armlupeg 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.
Store refrigerated between 2°C to 8°C (36°F to 46°F) in the original carton to protect from light. Do not shake. Discard syringes stored at room temperature for more than 48 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 (Patient Information and Instructions for Use).
Advise patients of the following risks and potential risks with Armlupeg:
- Splenic rupture and splenomegaly
- Acute Respiratory Distress Syndrome
- Serious hypersensitivity reactions
- Sickle cell crisis
- Glomerulonephritis
- Increased risk of Myelodysplastic Syndrome and/or Acute Myeloid Leukemia in patients with breast and lung cancer who receive Armlupeg in conjunction with chemotherapy and/or radiation therapy.
- Capillary Leak Syndrome
- Aortitis
Advise patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Subsyndrome of Acute Radiation Syndrome) that efficacy studies of pegfilgrastim products for this indication could not be conducted in humans for ethical and feasibility reasons and that, therefore, approval of this use was based on efficacy studies conducted in animals
Instruct patients who self-administer Armlupeg 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.
8INSTRUCTIONS FOR USE SECTION
Instructions for Use
ARMLUPEG
(pegfilgrastim-unne)
injection, for subcutaneous use
Single-Dose Prefilled Syringe
Guide to parts
Important: The needle is covered by the gray needle cap before use.
Important
Read the Patient Information for important information you need to know about Armlupeg before using these Instructions for Use.
Before you use an Armlupeg prefilled syringe, read this important information.
Storing the prefilled syringe
Store Armlupeg in the refrigerator between 36°F to 46° F (2°C to 8°C).
Do not freeze. If Armlupeg is accidentally frozen, allow the prefilled syringe to thaw in the refrigerator before injecting.
Do not use an Armlupeg prefilled syringe that has been frozen more than 1 time. Throw it away and use a new Armlupeg prefilled syringe.
Keep the prefilled syringe in the original carton to protect from light or physical damage.
Take the prefilled syringe out of the refrigerator 30 minutes before use and allow it to reach room temperature, 68°F to 77°F (20°C to 25°C), before preparing an injection.
Throw away (dispose of) any Armlupeg that has been left at room temperature, 68°F to 77°F (20°C to 25°C), for more than 48 hours.
Keep Armlupeg and all medicines out of the reach of children.
Using the prefilled syringe
It is important that you do not try to give the injection unless you or your caregiver has received training from your healthcare provider.
Make sure the name Armlupeg appears on the carton and prefilled syringe label.
Check the carton and prefilled syringe label to make sure the dose strength is 6 mg.
You should not inject a dose of Armlupeg to children weighing less than 99 pounds (45 kg) from an Armlupeg prefilled syringe.
Do not use a prefilled syringe after the expiration date on the label.
Do not shake the prefilled syringe.
Do not remove the gray needle cap from the prefilled syringe until you are ready to inject.
Do not use the prefilled syringe if the carton is open or damaged.
Do not use a prefilled syringe if it has been dropped on a hard surface. The prefilled syringe may be broken even if you cannot see the break. Use a new prefilled syringe.
Do not attempt to activate the needle safety guard prior to injection. Do not use the prefilled syringe if the needle safety guard has been activated. Use another prefilled syringe that has not been activated and is ready to use.
The gray needle cap on the prefilled syringe contains dry natural rubber (made from latex).
Call your healthcare provider if you have any questions.
STEP 1: Prepare
A. Remove the prefilled syringe carton from refrigerator.
Check the expiration date printed on the carton.
Important: Do not use if the expiration date has passed.
Remove the syringe tray from the carton. On a clean, well-lit surface, place the syringe tray at room temperature for
Do not remove the prefilled syringe from the original carton until you are ready to inject.
Do not use the prefilled syringe if the carton is damaged.
Do not try to warm the prefilled syringe by using a heat source such as hot water or microwave.
Do not leave the prefilled syringe in direct sunlight.
Do not shake the prefilled syringe.
Open the tray by peeling away the cover. Grab the safety guard to remove the prefilled syringe from the tray. (See Figure 3)
For Safety reasons:
B. Inspect the medicine and prefilled syringe (See Figure 4).
Make sure the medicine in prefilled syringe is clear and colorless (See Figure 4). It is normal to see one or more air bubbles in the syringe.
Do not use the prefilled syringe if:
The medicine is cloudy or discolored or contains flakes or particles.
Any part appears cracked or broken.
The prefilled syringe has been dropped.
The gray needle cap is missing or not securely attached.
The expiration date printed on the label has passed.
In all cases, use a new prefilled syringe and call your healthcare provider.
C. Gather all materials needed for injection (See Figure 5)
Wash your hands thoroughly with soap and water
On a clean, well-lit work surface, place the:
Prefilled syringe
Alcohol swab
Cotton ball or gauze pad
Adhesive bandage
Sharps disposal container
STEP 2: Get ready
D. Select and clean the injection site (See Figures 6 and 7).
You can use:
Clean the injection site with an alcohol swab (See Figure 7). Let the skin dry.
Do not touch this area again before injecting.
If you want to use the same injection site, make sure it is not the same spot on the injection site you used for a previous injection.
Do not inject into areas where the skin is tender, bruised, red, or hard. Avoid injecting into areas with scars or stretch marks.
E. Hold the prefilled syringe by the syringe body. Carefully pull the gray needle cap straight off and away from the body (See Figure 8).
Do not remove the gray needle cap from the prefilled syringe until you are ready to inject.
Do not twist or bend the needle cap.
Do not hold the prefilled syringe by the plunger rod
Do not put the gray needle cap back onto the syringe or never recap. If the needle cap is removed accidently and you are not ready for the injection, discard (throw away) the opened syringe and use a new syringe when ready.
Important: Throw the gray needle cap into the sharps disposal container (See Figure 9).
Step 3: Subcutaneous (under the skin) injection
F. Point the needle up and gently tap the syringe body with your fingers until the air bubble rises to the top of the syringe (See Figure 10).
G. Pinch the injection site to create a firm surface (See Figure 11).
Important: Keep skin pinched while injecting
H. Hold the pinch. Insert the needle into the skin at 45 to 90 degrees. (See Figure 12)
Do not touch the plunger rod or grasp the syringe above the finger grips.
I. Using slow and constant pressure, push the plunger head until it reaches the bottom. (See Figure 13)
While the needle is still inserted in the skin, slowly move your thumb back, allowing the plunger rod to rise. This will release the needle safety guard to safely cover the needle. Then remove the syringe from the injection site. (See Figure 14)
Important: When you remove the syringe, if it looks like the needle safety guard is not activated or some medicine is still left in the syringe, this means you have not received a full dose. Call your healthcare provider right away.
Step 4: Finish
J. For your safety, make sure that the needle safety guard is activated and fully covers the needle.
Once the needle safety guard is extended, it will lock into position and will not slide back over the needle.
Important: Keep your hands away from the needle at all times.
K. Discard (throw away) the used prefilled syringe.
Put the used prefilled syringe into an FDA-cleared sharps disposal container right away after use (See Figure 15).
If you do not have an FDA-cleared sharps disposal container, you may use a household container that is:
o made of a heavy-duty plastic,
o can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out,
o upright and stable during use,
o leak-resistant, and
o properly labeled to warn of hazardous waste inside the container.
When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles and syringes. For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA's website at:
Do not reuse the prefilled syringe.
Do not recycle prefilled syringes or sharps disposal container or throw them into household trash.
Important: Always keep the sharps disposal container out of the reach of children.
L. Examine the injection site.
If there is blood, press a cotton ball or gauze pad on the injection site.
This Instructions for Use has been approved by the U.S. Food and Drug Administration.
Manufactured for:
Lupin Pharmaceuticals, Inc.
Naples, FL 34108 United States.
Manufactured by:
Lupin Limited (Biotech Division)
Gat No. 1156, 1157, 1158, 1159 and 1160,
Village-Ghotawade, Taluka-Mulshi,
Pune – 412115, Maharashtra, India
Distributed by:
Valorum Biologics, LLC
555 Madison Ave. Suite 11D
New York, NY USA 10022
U.S. License No. 2052
Approved: November 2025
9PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - SYRINGE LABEL
NDC 70748-273-01
Armlupeg
(pegfilgrastim-unne) Injection
6 mg/0.6 mL
For Subcutaneous Use Only
Single-Dose Prefilled Syringe
Rx Only
LOT
NO.
EXP.
M.L.: 28D-PD/Vacc/12
Manufactured by:
Lupin Limited (Biotech Division)
Gat No. 1156, 1157, 1158, 1159 and 1160,
Village-Ghotawade, Taluka-Mulshi,
Pune - 412115,
Maharashtra, India
U.S. License No. 2052
10PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - CARTON LABEL
NDC 70748-273-01
Armlupeg
(pegfilgrastim-unne) Injection
6 mg/0.6 mL
For Subcutaneous Use Only
Pegylated Recombinant Methionyl Human Granulocyte Colony
Stimulating Factor (PEG-r-metHuG-CSF) derived from
One 0.6 mL Single-Dose Prefilled Syringe
R
