Injections of etranacogene dezaparvovec-drlb are used to treat hemophilia B in some adults who are receiving factor IX replacement therapy to stop bleeding, who have experienced or are experiencing life-threatening bleeding, or who experience frequent, spontaneous bleeding episodes. Hemophilia B is an inherited condition in which the blood does not clot normally because it lacks the blood clotting factor IX. The drug etranacogene dezaparvovec-drlb belongs to the gene therapy drug class. It functions by assisting your body in producing more factor IX, a blood clotting agent that may aid in reducing bleeding.

In a medical context, a doctor or nurse will inject etranacogene dezaparvovec-drlb intravenously (into a vein) using a suspension form of the medication. Usually, a single dose is gently given over the course of 1 to 2 hours.

During or after your infusion, etranacogene dezaparvovec-drlb may produce serious side effects. Tell your doctor right away if you suffer any of the following symptoms: Flu-like symptoms such as fever, chills, flushing, stomach discomfort, headache, disorientation, feeling dizzy, shortness of breath, rash, or hives; breathing problems; or swelling of the face or throat. During the infusion of the drug and for at least three hours afterward, a doctor or nurse will keep a close eye out for these adverse effects in you. If you develop these or other side effects, your doctor may need to reduce the rate of your infusion or temporarily stop it.

For a copy of the manufacturer’s information for the patient, ask your pharmacist or doctor.

Ask your doctor or pharmacist for more details if you believe this drug should be used for something else.

Before receiving etranacogene dezaparvovec-drlb injection,

• If you have an allergy to etranacogene dezaparvovec-drlb, any other drugs, or any of the substances in etranacogene dezaparvovec-drlb injection, notify your doctor right away. Request a list of the components from your pharmacist.
• Inform your doctor and pharmacist about any additional prescription and over-the-counter drugs, vitamins, dietary supplements, and herbal products you are now taking or intend to use. Your physician might need to adjust the dosage of your drugs or keep a close eye on you for side effects.
• Inform your doctor if you consume alcohol frequently or occasionally in significant amounts, or if you currently have or have ever had any liver issues, such as cirrhosis (liver scarring) or hepatitis B or C (a virus that infects the liver and may cause serious liver damage).
• You should be aware that etranacogene dezaparvovec-drlb injection is only meant to be used by adult men. It is not recommended to use entranasogene dezaparvovec-drlb on females. If etranacogene dezaparvovec-drlb injection is taken by women who are pregnant, could become pregnant, or are nursing, it is unknown if this could be harmful to the unborn child.
• Inform the surgeon or dentist that you are receiving an etranacogene dezaparvovec-drlb injection if you are having surgery, including dental surgery.
• After receiving an injection of etranacogene dezaparvovec-drlb, avoid donating blood, organs, tissues, sperm, or cells for transplantation.
• It’s important for you to be aware that etranacogene dezaparvovec-drlb injection can harm the liver. Before and after etranacogene dezaparvovec-drlb injection therapy, your doctor could advise you to get an ultrasound of your liver. An ultrasound is a sort of imaging that allows you to see organs and body structures inside the body. Make a quick call to your doctor if you encounter any of the following signs: intense exhaustion, discomfort in the upper right stomach region, sickness, yellowing of the skin or eyes, dark yellow urine, or light stools.

Keep eating normally unless your doctor instructs you otherwise.

The injection of etranacogene dezaparvovec-drlb could have negative effects. If any of these symptoms are severe or do not go away, let your doctor know right once:

• Headache
• Nausea
• Tiredness
• Sick sensation

Some adverse effects can be very harmful. Call your doctor right away or seek emergency medical attention if you experience any of these symptoms or any of the ones detailed in the SPECIAL PRECAUTIONS section:

• Uncommon bruising or bleeding

Hepatocellular cancer, a form of liver cancer, may rise as a result of etranacogene dezaparvovec-drlb injection. You should discuss the dangers of using this drug with your doctor.

Other negative effects could result from the injection of etranacogene dezaparvovec-drlb. If you experience any strange issues while taking this medicine, contact your doctor right away.

You or your doctor can submit a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting program online at http://www.fda.gov/Safety/MedWatch or by phone at 1-800-332-1088 if you have a serious side event.

Call the poison control hotline at 1-800-222-1222 in the event of an overdose. Additionally, information can be found online at https://www.poisonhelp.org/help. Call 911 right once if the person has collapsed, experienced a seizure, is having difficulty breathing, or cannot be roused.

Keep all of your appointments with your physician and the lab. To monitor your body’s reaction to the etranacogene dezaparvovec-drlb injection, your doctor will request specific lab tests both before and after your therapy.

Inform the lab staff and your doctor that you have gotten an etranacogene dezaparvovec-drlb injection before undergoing any laboratory test.

You should keep a written record of every medication you take, including any over-the-counter (OTC) items, prescription drugs, and dietary supplements like vitamins and minerals. This list should be brought with you whenever you see a doctor or are admitted to the hospital. You should always have this information with you in case of emergencies.