Rolvedon

About Eflapegrastim

• Rolvedon received Food and Drug Administration (FDA) approval  on September 9, 2022.  Rolvedon is a leukocyte growth factor that belongs to the family called colony-stimulating factors. 
• Rolvedon is a type of medicine that helps lower the chance of getting an infection, especially one called febrile neutropenia. It’s meant for adults with certain types of cancer who are receiving treatment with drugs that can suppress the immune system. This medicine is particularly useful when there’s a higher risk of developing a specific kind of infection during cancer treatment.
• Rolvedon is a synthetic form of human granulocyte growth factor designed through genetic engineering. It interacts with G-CSF receptors found on myeloid progenitor cells and neutrophils, initiating signaling pathways that regulate cellular processes such as differentiation, proliferation, migration, and survival.
• Febrile neutropenia (FN) is a critical health condition marked by the presence of a fever when the count of a specific type of white blood cells, called neutrophils, is significantly low. 
• Neutrophils are vital for combating infections, and a decrease in their numbers makes the body more vulnerable to infections. 
• FN often occurs in individuals undergoing cancer treatment, especially those receiving chemotherapy, which can suppress the production of white blood cells in the bone marrow. 
• Key symptoms of FN include a fever of 100.4°F (38°C) or higher, accompanied by chills. Additional signs may involve fatigue, weakness, cough, sore throat, and pain.

Strength: 

The injection is available as a 13.2 mg/0.6 mL solution in a single-dose prefilled syringe.

Recommended Dosage:

Rolvedon is given through subcutaneous injection using a single-dose prefilled syringe, and this procedure is conducted by a healthcare professional. To prepare for use, take the carton containing the prefilled syringe out of the refrigerator and allow it to reach room temperature for at least 30 minutes while keeping it inside the carton. Any prefilled syringe left at room temperature for over 12 hours should be discarded. Do not shake the syringe, and if it accidentally freezes, do not use it. 

Carefully remove the prefilled syringe from the tray after taking it out of the box. If the syringe is dropped on a hard surface, do not use it, and opt for a new syringe for the injection. Before administration, visually inspect the prefilled syringe for particulate matter or discoloration, and do not administer if any such issues are observed. Administer the entire contents of the prefilled syringe as directed. Your doctor will determine the dosage based on your body weight and medical condition.

• The suggested dosage of Rolvedon is 13.2 mg, given as a subcutaneous injection once during each chemotherapy cycle. 
• It should be administered approximately 24 hours after cytotoxic chemotherapy. 
• Importantly, refrain from administering Rolvedon within the timeframe from 14 days before to 24 hours after the cytotoxic chemotherapy session.

Important:

Prior to Rolvedon injection, discuss your medical history and medications with your doctor. Monitor blood pressure, oxygen levels, and kidney function during treatment. Quit smoking, avoid alcohol, and promptly inform your doctor of any new symptoms on Rolvedon.

Warnings & Precautions

• Do not use this medicine if you are allergic to human granulocyte colony-stimulating factors such as eflapegrastim, pegfilgrastim, or filgrastim products as it is contraindicated with Rolvedon.  
• Before starting Rolvedon, it is crucial to be aware of potential risks and side effects. Pay attention to any signs of left upper abdominal or shoulder pain, which could indicate an enlarged spleen or splenic rupture. 
• If you experience fever, lung infiltrates, or respiratory distress, consult your healthcare provider promptly, and Rolvedon may be discontinued if acute respiratory distress syndrome (ARDS) is diagnosed. 
• Serious allergic reactions, including anaphylaxis, require immediate discontinuation of Rolvedon. 
• In patients with sickle cell disorders, if a sickle cell crisis occurs, discontinuation of the medication is advised. 
• Evaluate any potential cases of glomerulonephritis and consider dose reduction or interruption if causality is likely. 
• Regular monitoring of complete blood count (CBC) and platelet counts is recommended during Rolvedon therapy. 
• For patients with breast and lung cancer using Rolvedon alongside chemotherapy and/or radiotherapy, vigilant monitoring for signs and symptoms of myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML) is essential. 
• Always inform your doctor of any concerns or symptoms to ensure a safe and effective treatment. 

Common Rolvedon Side Effects:

• Fatigue
• Nausea
• Diarrhea
• Bone pain
• Headache
• Pyrexia (Fever)
• Anemia
• Rash
• Myalgia (Muscle pain)
• Arthralgia (Joint pain)
• Back pain

Use in Specific Population

• Before commencing treatment with this medication, it is crucial to inform your doctor of any pregnancy plans or if you are currently pregnant. Because it is unknown whether this medicine affects the fetus of pregnant women. 
• If you are breastfeeding or planning to breastfeed, notify your doctor, as it is unclear whether Rolvedon passes into breast milk. Discuss with your doctor the most appropriate way to feed your baby while taking Rolvedon. 
• The safety and effectiveness of Rolvedon have not been established in pediatric patients, although no significant differences were observed in comparison to younger subjects. 
• Reported experiences suggest that both older and younger patients have shown similar responses to Rolvedon. However, it is essential to be aware that some older individuals may be more sensitive to the medication. 
• Always consult with your doctor and communicate any concerns to ensure a safe and well-informed treatment plan.

Storage and Handling

Before and after handling Eflapegrastim-xnst injections, ensure your hands are clean by washing them with soap and water. 

• Store Rolvedon vials in the refrigerator, maintaining a temperature range of 36°F to 46°F (2°C to 8°C), and keep them within the carton to protect from light exposure. 
• It is important not to shake the vials. 
• Additionally, be sure to discard any syringes that have been stored at room temperature for more than 12 hours to maintain the medication’s integrity. 
• Avoid freezing Rolvedon, and if a syringe has been frozen, it should be promptly discarded. These storage practices are essential for preserving the stability and effectiveness of the medication. 
• Remember to follow these tips to ensure the optimal quality of Rolvedon for your treatment