Rolvedon
Rolvedon (eflapegrastim or eflapegrastim-xnst) is used to lower your risk of infection while you have low white blood cells due to certain anticancer medications. It's injected under the skin once per chemotherapy cycle. Some common side effects include feeling tired, nausea, diarrhea, and bone pain.
What is Rolvedon (eflapegrastim)?
What is Rolvedon (eflapegrastim) used for?
- Infection prevention in adults receiving anticancer medications (for all cancers, except for myeloid cancers) that can cause low white blood cell counts (or febrile neutropenia)
How Rolvedon (eflapegrastim) works
Rolvedon (eflapegrastim) is a granulocyte colony-stimulating factor (G-CSF). It works like the G-CSF protein that you naturally have in your body. G-CSF triggers your bone marrow to make neutrophils, a type of white blood cell that helps your body fight infections.
Drug facts
Side effects of Rolvedon (eflapegrastim)
The following side effects may get better over time as your body gets used to the medication. Let your healthcare provider know immediately if you continue to experience these symptoms or if they worsen over time.
Common Side Effects
- Feeling tired (58%)
- Nausea (52%)
- Diarrhea (40%)
- Bone pain (38%)
- Headache (29%)
- Fever (28%)
- Low red blood cell count (25%)
- Rash (25%)
- Muscle pain (22%)
- Joint pain (21%)
- Back pain (20%)
Side effects and percentages are listed for Rolvedon (eflapegrastim) in people with cancer receiving bone marrow-suppressing chemotherapy. Therefore, it's not clear if the side effects are due to Rolvedon (eflapegrastim) or the chemotherapy medication.
Less Common Side Effects
- Poor appetite
- Swelling in the arms or legs
- Stomach pain
- Dizziness
- Trouble catching your breath
- Cough
- Pain
- Injection-site reactions
- Flushing (feeling warm all of a sudden)
Rolvedon (eflapegrastim) serious side effects
Contact your healthcare provider immediately if you experience any of the following.
- Acute respiratory distress syndrome (ARDS) fast breathing, trouble catching your breath, crackling sound in the lungs when your breath, fever, feeling very tired, chest pain, feeling confused
- Ruptured spleen: pain in your left upper stomach or shoulder
- Serious allergic reaction: rash, trouble breathing, swelling of your tongue, lips, or throat
- Kidney damage: swelling of face or ankles, dark colored urine, blood in urine, urinating less
- Low platelet count: easy bruising, longer bleeding time, blood in urine or stools
The following Rolvedon (eflapegrastim) side effects have also been reported
Side effects that you should report to your care team as soon as possible:
- Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
- Capillary leak syndrome—stomach or muscle pain, unusual weakness or fatigue, feeling faint or lightheaded, decrease in the amount of urine, swelling of the ankles, hands, or feet, trouble breathing
- High white blood cell level—fever, fatigue, trouble breathing, night sweats, change in vision, weight loss
- Inflammation of the aorta—fever, fatigue, back, chest, or stomach pain, severe headache
- Kidney injury (glomerulonephritis)—decrease in the amount of urine, red or dark brown urine, foamy or bubbly urine, swelling of the ankles, hands, or feet
- Shortness of breath or trouble breathing
- Spleen injury—pain in upper left stomach or shoulder
- Unusual bruising or bleeding
Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):
- Bone pain
- Diarrhea
- Fatigue
- Headache
- Muscle pain
- Nausea
Pros and cons of Rolvedon (eflapegrastim)
Pros
- Works well to shorten the time of having severe low white blood cells after chemotherapy
- Only needs to be given once per chemotherapy cycle
- No known interactions with other medications
Cons
- Injections can be uncomfortable
- Must be given by a trained healthcare provider
- No lower-cost generic available
Pharmacist tips for Rolvedon (eflapegrastim)
- The timing of when you get your Rolvedon (eflapegrastim) dose is important. Use a calendar to keep track of when you should get your injection.
- Rolvedon (eflapegrastim) is injected under the skin by a trained healthcare provider. This can sometimes cause temporary reactions around the site of injection that can be uncomfortable. Talk to your provider about how to treat this if it happens to you.
- If you miss a dose of Rolvedon (eflapegrastim), contact your healthcare provider to schedule your dose right away. Waiting too long can put you at risk for severe low white blood cells and infections.
Common questions about Rolvedon (eflapegrastim)
Yes, the timing of when you receive Rolvedon (eflapegrastim) is important. Typically, your provider will give you Rolvedon (eflapegrastim) least 24 hours after chemotherapy, but not less than 2 weeks before your next dose of chemotherapy. This is because Rolvedon (eflapegrastim) might not work as well if you receive it too close to the time you get your chemotherapy. Chemotherapy medications can kill fast-growing cells. While this is good for getting rid of cancer cells, it can also kill the new white blood cells (WBCs) trigger by Rolvedon (eflapegrastim). To prevent this interaction, your provider will time your Rolvedon (eflapegrastim) with enough of a gap to allow new WBCs to grow.
Some anticancer medications can lower your white blood cell (WBC) count. This puts you at a higher risk of infections, even some that are life-threatening. Studies have shown that each additional day you have very low WBC counts, your risk of infection goes up higher. Medications like Rolvedon (eflapegrastim) work to trigger your body to make more WBCs to replace the ones killed by the anticancer medication. By raising the number of WBCs in your body, you can better fight off infections.
Rolvedon (eflapegrastim) is one of the longer-acting colony-stimulating factor (CSF) medications that's only injected once every chemotherapy cycle, similar to Neulasta (pegfilgrastim) and its biosimilars. One main difference is that Rolvedon (eflapegrastim) is only approved for people with non-myeloid cancers who are receiving certain anticancer medications. But other CSF medications, like Neupogen (filgrastim), can be used for other conditions. Some examples include preparing for bone marrow transplants and in people exposed to radiation. Talk with your provider about which medication is best for you.
In clinical studies, 38% of people taking Rolvedon (eflapegrastim) reported bone pain as a side effect. If this bothers you, ask your provider if you can take acetaminophen (Tylenol) or a non-steroidal anti-inflammatory drug (NSAID) to help with the pain.
A little more than 80% of people in a clinical study who took Rolvedon (eflapegrastim) after chemotherapy had no severe low white blood cells. Other people in the same study experienced severe low white blood cells for only about 1 to 3 days. These results showed that Rolvedon (eflapegrastim) worked similarly well compared to Neulasta (pegfilgrastim) another CSF. Keep in mind that everyone responds differently to medications.
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Risks and warnings for Rolvedon (eflapegrastim)
Rolvedon (eflapegrastim) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Risk of burst in the spleen
Some people have experienced enlarged spleens after receiving colony-stimulating factor medications like Rolvedon (eflapegrastim). This has sometimes led to death because of damage or burst in the spleen. Contact your provider if you notice any pain in the upper left stomach area or in your shoulder.
Breathing problems
Rolvedon (eflapegrastim) can cause a serious breathing condition called acute respiratory distress syndrome (ARDS). It causes fluid to leak in your lungs, which prevents enough oxygen from getting into your blood and to your organs. If you experience ARDS, your provider will ask you to stop Rolvedon (eflapegrastim). Get medical help right away if you have shortness of breath, fever, or fast breathing.
Serious allergic reactions
- Risk factors: Allergy to Rolvedon (eflapegrastim) or similar medications
Rolvedon (eflapegrastim) can cause serious allergic reactions, which can be life threatening. Don't take Rolvedon (eflapegrastim) if you've ever had an allergic reaction to it or a similar medication, like Neupogen (filgrastim). If you experience rash, trouble breathing, or swelling of your lips, tongue, or throat, get medical attention right away.
Sickle cell crisis in people with sickle cell anemia
- Risk factors: Sickle cell anemia
Sickle cell crisis (painful episode) can happen in people with sickle cell anemia while receiving Rolvedon (eflapegrastim). In more severe cases, it could be deadly. If this happens, your healthcare provider will stop the medication.
Risk of kidney injury
Some people taking medications similar to Rolvedon (eflapegrastim) have experienced kidney injury, such as inflammation of the kidneys. If your provider suspects that you have kidney problems, you might need to get blood work done so they can check your kidney health. Then, they can decide if they need to lower your dose of or pause Rolvedon (eflapegrastim). If you have kidney problems from the medication, your condition will usually get better once your provider lower the dose. Let your provider know if you notice red or dark brown urine, or that you're not urinating as much.
Capillary leak syndrome
Colony-stimulating factor medications like Rolvedon (eflapegrastim) can cause capillary leak syndrome (CLS). CLS is a serious condition where fluid leaks out of your small blood vessels. A common sign of this is low blood pressure, but certain lab results can also suggest CLS. Talk to your provider if you notice low blood pressure (e.g., dizziness, fainting), tiredness, stomach pain, extreme thirst, or sudden weight gain. Your provider will need to examine you further and provide treatment if needed.
Cancer risk
Rolvedon (eflapegrastim) is a growth factor that primarily triggers the production of white blood cells in the body. But there's also a possibility for it to promote the growth of other types of tumors. Some people reported developing blood-related cancers and bone marrow problems when they used Rolvedon (eflapegrastim) as part of their treatment plan for breast or lung cancer along with chemotherapy or radiation. Your providers will check your labs closely and might stop Rolvedon (eflapegrastim) if the the benefits no longer outweigh the risks.
Blood vessel damage
Rolvedon (eflapegrastim) has been linked to a condition caused by inflammation of blood vessels called aortitis. This condition could happen as early as the first week after starting treatment. Let your provider know if you experience fever, stomach pain, back pain, or feel unwell so you can be checked out.
Changes in blood cell counts
Your provider will order blood tests regularly to check your blood cell counts. This is because there's a risk that Rolvedon (eflapegrastim) can cause [high white blood cell count] (https://www.ncbi.nlm.nih.gov/books/NBK560882/) and low platelet counts. If you have changes in your blood cell count, your provider might ask to stop Rolvedon (eflapegrastim).
Rolvedon (eflapegrastim) dosage
Typical dosage for Rolvedon (eflapegrastim)
The typical dose is 13.2 mg injected under the skin once per chemotherapy cycle (24 hours after chemotherapy) by a trained healthcare provider. Please see the FAQ section for more details.
Rolvedon (eflapegrastim) contraindications
Contraindications are specific health conditions or situations in which a person should not take a medication due to safety concerns. If you have any of the following conditions or if any of the following apply to you, let your healthcare provider know because Rolvedon (eflapegrastim) will not be safe for you to take.
What are alternatives to Rolvedon (eflapegrastim)?
Prevention of low neutrophil-related complications in:
Preparation for blood collection for your own stem cell transplant (Neupogen, Nivestym, and Zarxio only)
Increase survival in people exposed to bone marrow-suppressing radiation (Neupogen only)
Rolvedon (eflapegrastim) images
