Stay on your chemotherapy cycle with support from ROLVEDON®

Help keep infections in check

Why ROLVEDON?

How chemotherapy affects your immune system

Chemotherapy is one of the most common treatments for cancer, but it can weaken your immune system. While chemotherapy is destroying cancer cells or stopping them from growing, it can also decrease the number of white blood cells, called neutrophils, in the body. This reduction in neutrophils is called neutropenia, and it makes you vulnerable to an infection that could interfere with your chemotherapy treatment.

Your doctor has prescribed ROLVEDON to help boost the level of neutrophils in your body to reduce your risk of developing an infection so that you can continue your chemotherapy treatment.

Febrile neutropenia

If you develop a fever (temperature of 100.4 °F (38.0 °C) or higher) when your neutrophils are low, it’s called febrile neutropenia (FN).* FN is a serious side effect of chemotherapy that could result in delays in treatment or reductions in chemotherapy doses.

If you develop a fever while going through chemotherapy, it is considered a medical emergency, and you must call your healthcare team immediately or go to the emergency room at your local hospital.

*NCCN® Guidelines for patients, Anemia and Neutropenia, 2021. Accessed March 26, 2024.

What is ROLVEDON?

About ROLVEDON

ROLVEDON is an FDA-approved medication used to decrease the incidence of infections associated with chemotherapy. It is a man-made, long-acting form of granulocyte colony-stimulating factor (G-CSF), a substance produced by the body. It stimulates the growth of neutrophils, a type of white blood cell important in the body’s fight against infection.

It is not known if ROLVEDON is safe and effective in children.

It is important to follow your healthcare team’s instructions regarding the timing and administration of this medication.

Common side effects

The most common side effects of ROLVEDON include:

  • Tiredness
  • Nausea
  • Diarrhea
  • Bone pain
  • Headache
  • Fever
  • Anemia
  • Rash
  • Muscle and joint pain
  • Back pain

These are not all the possible side effects of ROLVEDON.

Please see additional Important Safety Information for ROLVEDON below.

Contact your healthcare provider for medical advice about these and other possible side effects. You can report side effects to the FDA at 1-800-FDA-1088.

Managing Side Effects: Your healthcare team can help you find ways to manage side effects.

Home Injection

Ask your doctor if you can inject ROLVEDON at home

ROLVEDON is given as an injection under your skin (subcutaneous injection), one time per chemotherapy cycle. You and your doctor may decide that you can administer ROLVEDON at home, either by yourself or by your caregiver.

You and your caregiver will be shown how to prepare and inject ROLVEDON before you use it.

If your healthcare provider decides this is the right option for you, read the Instructions for Use (IFU) and watch the Home Injection Video to see how to administer ROLVEDON at home.

Financial support

ACCESS4ME®
patient support

If you need assistance affording your ROLVEDON medication, we are here to help. ACCESS4Me has a dedicated team of Reimbursement Specialists readily available to assist you and your healthcare provider with the following:**

Checking your insurance to see if you are covered for ROLVEDON

Offering a copay program where you may pay as little as $0 for treatment copays†

Providing ROLVEDON at no cost for those who may be uninsured or underinsured

Learn More

**Patients must be enrolled in ACCESS4Me. Patient consent required. Terms and conditions apply. Please contact ACCESS4Me for complete program rules and eligibility requirements.

†Eligibility criteria apply. Patients are not eligible for commercial copay assistance if the prescription is eligible to be reimbursed, in whole or in part, by any state or federal healthcare program.

Resources

ROLVEDON patient support tools for you and your caregiver

Patient and
Caregiver Guide

View Guide

Instructions
For Use

View Instructions

Home Injection
Video

Watch Video

Patient
Information
Leaflet

View Information

Doctor
discussion
guide

View Guide

Frequently asked questions

  • What is ROLVEDON and why is it used during chemotherapy?

    ROLVEDON is a man-made form of granulocyte colony-stimulating factor (G-CSF). G-CSF is a substance produced by the body. It stimulates the growth of neutrophils, a type of white blood cell important in the body’s fight against infection. During chemotherapy, some people are at higher risk of having a low neutrophil count (low number of white blood cells), this is called neutropenia, and may require treatment with products such as ROLVEDON.

  • How does Long-Acting G-CSF therapy differ from other forms of G-CSF therapy?

    Long-Acting Granulocyte Colony-Stimulating Factor (G-CSF) therapy differs from other forms of G-CSF therapy primarily in its dosing schedule. Traditional G-CSF therapies require frequent injections, often daily, to stimulate the production of white blood cells. In contrast, Long-Acting G-CSF therapy, such as ROLVEDON, is designed to provide the convenience of requiring only a single injection per chemotherapy cycle.

  • What should I tell my healthcare provider before taking ROLVEDON?

    Tell your healthcare provider about all of your medical conditions, including if you:

    • have a sickle cell disorder
    • have kidney problems
    • are pregnant or plan to become pregnant. It is not known if ROLVEDON can harm your unborn baby. Tell your healthcare provider right away if you become pregnant during treatment with ROLVEDON.
    • are breastfeeding or plan to breastfeed. It is not known if ROLVEDON passes into your breast milk.

    Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

  • Who should NOT take ROLVEDON?

    • Do not take ROLVEDON if you have had a serious allergic reaction to eflapegrastim, pegfilgrastim, or filgrastim products.
    • Do not use ROLVEDON for a condition for which it was not prescribed.
    • Do not give ROLVEDON to other people, even if they have the same symptom that you have. It may harm them.
    • Children should not take ROLVEDON.

  • Is ROLVEDON safe for children?

    • No, you should keep ROLVEDON and all medicines out of the reach of children.
    • ROLVEDON is indicated for use in adult patients 18 and older.

  • Could ROLVEDON interact with any other medications I am taking?

    • No studies evaluating the drug interaction potential of eflapegrastim-xnst have been conducted.
    • You should tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
    • Before starting any new medications or supplements, it’s crucial to consult with your healthcare team to ensure they won’t interact negatively with your current treatment regimen.

  • How should I store ROLVEDON?

    • Store ROLVEDON in the refrigerator between 36°F to 46°F (2°C to 8°C).
    • Do not freeze ROLVEDON. Throw away (dispose of) any ROLVEDON that has been frozen.
    • Store ROLVEDON in the original carton to protect from light.
    • Do not shake ROLVEDON.
    • Take the carton out of the refrigerator and place the sealed blister tray on a clean flat surface for at least 30 minutes to allow it to reach room temperature before use.
    • Throw away (dispose of) any ROLVEDON that has been left at room temperature, 68ºF to 77ºF(20ºC to 25ºC), for more than 12 hours.

    Keep ROLVEDON and all medicines out of the reach of children.

  • How will I receive ROLVEDON?

    • ROLVEDON is given as an injection under your skin (subcutaneous injection).
    • ROLVEDON may be administered by a healthcare provider, or by you or a caregiver. Your healthcare provider will decide which is best for you.
    • You will be provided detailed instructions on how to administer ROLVEDON by your healthcare provider.
    • Always follow the detailed “Instructions for Use” included with your information for the storage, preparation and administration of ROLVEDON. You can access this here.

  • When will I receive ROLVEDON?

    • You will receive one injection of ROLVEDON for each cycle of chemotherapy.
    • Your healthcare provider may also decide a different dosing regimen is more appropriate for your treatment plan, always make sure to discuss your therapy schedule with your healthcare provider.

  • How long will I be prescribed ROLVEDON?

    Your healthcare provider will make this decision.

  • Where can I find the patient leaflet?

    This is located in the Resources section and here.

  • Is there a ROLVEDON patient and caregiver guide?

    Yes, there is a comprehensive ROLVEDON patient and caregiver guide containing information about diagnosis, treatment, side effects, and at-home injection instructions. You can access the guide here.

  • Can I self-administer ROLVEDON?

    • Yes, as long as your healthcare provider agrees, and you have received training on how to prepare and inject ROLVEDON before you use it.
    • Make sure to follow the detailed “Instructions for Use” that comes with your ROLVEDON for information on how to prepare and inject a dose of ROLVEDON.
    • You may find the resources here useful.

  • How do I self-administer ROLVEDON?

    • Follow the detailed “Instructions for Use” that comes in your ROLVEDON carton for information on how to prepare and inject a dose of ROLVEDON.
    • You and your caregiver will be shown how to prepare and inject ROLVEDON before you use it.
    • Access the “Instructions for Use” and video here.

  • What should I do if I miss a dose of ROLVEDON?

    If you miss a dose of ROLVEDON, talk to your healthcare provider about when you should receive your next dose.

  • What should I do with the used ROLVEDON syringe after I have self-injected?

    Put the used prefilled syringe and needle cap in an FDA-cleared sharps disposal container right away after use. Do not throw away (dispose of) the prefilled syringe in your household trash. See the list of alternatives and instructions in the ROLVEDON “Instructions for Use”.

  • What should I do if my ROLVEDON carton has an expired date?

    Do not use the prefilled syringe if it is expired or if the carton has been previously opened. Speak to your healthcare provider about getting a new syringe.

  • What should I do if I dropped the ROLVEDON syringe?

    Do not use the ROLVEDON prefilled syringe if it has been dropped on a hard surface. The prefilled syringe may be broken even if you cannot see the break. Contact your healthcare provider or pharmacist to obtain a new syringe, only use a new prefilled syringe.

  • What are the potential side effects of ROLVEDON?

    The most common side effects of ROLVEDON include: tiredness, fever, nausea, anemia, diarrhea, rash, bone pain, muscle and joint pain, headache and back pain.

    • These are not all the possible side effects of ROLVEDON.
    • Report all side effects to your healthcare team. You may also report side effects to FDA at 1-800-FDA-1088.

  • What do I do if I have any side effects?

    Call your healthcare provider for medical advice about any side effects. You may also report side effects to FDA at 1-800-FDA-1088.

  • How will I know if ROLVEDON treatment is working for me?

    • Your healthcare provider will monitor the effectiveness of your treatment through regular blood tests. These blood tests will measure the levels of white blood cells, specifically neutrophils, in your blood.
    • You should attend all scheduled bloodwork and follow-up appointments with your healthcare team to closely monitor your diagnostic results and assess the effectiveness of your oncology treatment.

  • I ran out of medication, how do I get more ROLVEDON syringes?

    If self-administering ROLVEDON at home, speak to your healthcare provider or pharmacist about getting your next prescription for injection. If you are receiving ROLVEDON at your healthcare provider’s office, they will have your prescription ready on the day of your appointment.

  • Is there any financial support available for ROLVEDON patients?

    • If you need assistance affording your ROLVEDON medication, our ACCESS4Me team is here to help. Please visit www.ACCESS4Me.com.
    • Speak with your oncology office financial counselor on how to correctly secure any patient support documentation.

Important Safety Information

Do not take ROLVEDON if you have had a serious allergic reaction to eflapegrastim, pegfilgrastim or filgrastim products.

Before receiving ROLVEDON, tell your healthcare provider about all of your medical conditions, including if you:

What is ROLVEDON?

ROLVEDON is a man-made form of granulocyte colony-stimulating factor (G-CSF). G-CSF is a substance produced by the body. It stimulates the growth of neutrophils, a type of white blood cell important in the body’s fight against infection.

It is not known if ROLVEDON is safe and effective in children.

What is ROLVEDON?

ROLVEDON is a man-made form of granulocyte colony-stimulating factor (G-CSF). G-CSF is a substance produced by the body. It stimulates the growth of neutrophils, a type of white blood cell important in the body’s fight against infection.

It is not known if ROLVEDON is safe and effective in children.

Important Safety Information

Do not take ROLVEDON if you have had a serious allergic reaction to eflapegrastim, pegfilgrastim or filgrastim products.

Before receiving ROLVEDON, tell your healthcare provider about all of your medical conditions, including if you:
  • have a sickle cell disorder
  • have kidney problems
  • are pregnant or plan to become pregnant. It is not known if ROLVEDON can harm your unborn baby. Tell your healthcare provider right away if you become pregnant during treatment with ROLVEDON.
  • are breastfeeding or plan to breastfeed. It is not known if ROLVEDON passes into your breast milk.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

ROLVEDON may cause serious side effects, including:
  • Spleen Rupture. Your spleen may become enlarged and can rupture. A ruptured spleen can cause death. Call your healthcare provider right away if you have pain in the left upper stomach-area or your left shoulder.
  • A serious lung problem called Acute Respiratory Distress Syndrome (ARDS). Call your healthcare provider or get emergency help right away if you have shortness of breath with or without a fever, trouble breathing, or a fast rate of breathing.
  • Serious allergic reactions. ROLVEDON can cause serious allergic reactions. These reactions can cause a rash all over your whole body, shortness of breath, wheezing, dizziness, swelling around your mouth or eyes, fast heart rate, and sweating. If you have any of these symptoms call your healthcare provider or get emergency medical help right away.
  • Sickle cell crises. You may have a serious sickle cell crisis, which could lead to death, if you have a sickle cell disorder and receive ROLVEDON. Call your healthcare provider right away if you develop symptoms of sickle cell crisis such as pain or difficulty breathing.
  • Kidney injury (glomerulonephritis). ROLVEDON can cause kidney injury. Call your healthcare provider right away if you develop any of the following symptoms:
    • swelling of your face or ankles
    • blood in your urine or dark colored urine
    • you urinate less than usual
  • Increased white blood cell count (leukocytosis). Your healthcare provider will check your blood count during treatment with ROLVEDON.
  • Decreased platelet count (thrombocytopenia). Your healthcare provider will check your blood during treatment with ROLVEDON. Tell your healthcare provider if you have unusual bleeding or bruising during treatment with ROLVEDON. This could be a sign of decreased platelet counts, which may reduce the ability of your blood to clot.
  • Capillary Leak Syndrome. ROLVEDON can cause fluid to leak from blood vessels into your body’s tissues. This condition is called “Capillary Leak Syndrome” (CLS). CLS can quickly cause you to have symptoms that may become life-threatening. Get emergency help right away if you develop any of the following symptoms:
    • swelling or puffiness and are urinating less than usual
    • trouble breathing
    • swelling of your stomach area (abdomen) and feeling of fullness
    • dizziness or feeling faint
    • a general feeling of tiredness
  • Myelodysplastic syndrome and acute myeloid leukemia. If you have breast cancer or lung cancer, when ROLVEDON is used with chemotherapy and radiation therapy, or with radiation therapy alone, you may have an increased risk of developing a precancerous blood condition called myelodysplastic syndrome (MDS) or a blood cancer called acute myeloid leukemia (AML). Symptoms of MDS and AML may include tiredness, fever, and easy bruising or bleeding. Call your healthcare provider if you develop these symptoms during treatment with ROLVEDON.
  • Inflammation of the aorta (aortitis). Inflammation of the aorta (the large blood vessel which transports blood from the heart to the body) has been reported in patients who received pegfilgrastim products. Symptoms may include fever, abdominal pain, feeling tired, and back pain. Call your healthcare provider if you experience these symptoms.
The most common side effects of ROLVEDON include:
  • tiredness
  • nausea
  • diarrhea
  • bone pain
  • headache
  • fever
  • anemia
  • rash
  • muscle and joint pain
  • back pain

These are not all the possible side effects of ROLVEDON.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.