Why is this medication prescribed?

Some adults who are receiving factor IX replacement therapy to prevent bleeding, who have experienced or are experiencing life-threatening bleeding, or who have experienced repeated, spontaneous bleeding episodes are treated for hemophilia B with etranacogene dezaparvovec-drlb injection. Hemophilia B is an inherited condition in which the blood does not clot normally because it lacks the blood clotting factor IX. A group of drugs known as gene therapy includes etranacogene dezaparvovec-drlb. It functions by assisting your body in making more factor IX, a blood clotting agent that may aid in reducing bleeding, available to your body.

How should this medicine be used?

When administered intravenously (into a vein) by a doctor or nurse in a medical setting, etranacogene dezaparvovec-drlb is available as a suspension (liquid). As a single dose, it is typically gently given over 1 to 2 hours.

When receiving your infusion of etranacogene dezaparvovec-drlb, you could have major side effects. Inform your physician right once if you have any of the following signs or symptoms: Flu-like symptoms include fever, chills, flushing, headache, stomachache, disorientation, faintness, shortness of breath, rash, hives, difficulty breathing, and swelling of the face or throat. While the medication is being infused and for at least 3 hours later, a doctor or nurse will keep a close eye out for these adverse effects. If you encounter these or other adverse effects, your doctor may need to reduce or temporarily stop your infusion.

Request a copy of the patient’s information from the manufacturer from your pharmacist or physician.

Other uses for this medicine

Inquire with your doctor or pharmacist for more details if you believe this drug may be prescribed for other purposes.

What special precautions should I follow?

• Inform your doctor and pharmacist if you have any allergies to etranacogene dezaparvovec-drlb, any other drugs, or any of the substances in etranacogene dezaparvovec-drlb injection. Get a list of the components from your pharmacist.
• Inform your doctor and pharmacist about any additional prescription and non-prescription drugs, vitamins, dietary supplements, and herbal products you are now taking or intend to use. Your doctor might need to adjust the dosage of your drugs or keep a close eye on you for side effects.
• Inform your doctor if you frequently consume significant amounts of alcohol, if you previously had liver disease such as cirrhosis (liver scarring), or if you now have hepatitis B or C (a virus that infects the liver and can cause serious liver damage).
• Etranacogene dezaparvovec-drlb injection is only meant to be used by adult men, you should be aware of that. Women are not supposed to use entranacogene dezaparvovec-drlb. It is unknown if using etranacogene dezaparvovec-drlb injection by women who are pregnant, could become pregnant, or are nursing could cause harm to the unborn child.
• The doctor or dentist should be informed if you are receiving an etranacogene dezaparvovec-drlb injection if you are having surgery, including dental surgery.
• Following receiving etranacogene dezaparvovec-drlb injection, refrain from giving blood, tissues, sperm, or cells for transplantation.
• Injection of etranacogene dezaparvovec-drlb may harm the liver, thus you should be aware of it. Before and after your treatment with etranacogene dezaparvovec-drlb injection, your doctor could advise you to have an ultrasound of your liver (a type of imaging to look at organs and structures inside the body) done. Please see your physician right away if you suffer any of the following symptoms: Extreme exhaustion, stomach pain in the upper right area, nausea, yellowing of the skin or eyes, dark yellow urine, or light stools are some symptoms to watch out for.

What special dietary instructions should I follow?

Maintain your regular diet unless your doctor instructs you otherwise.

What side effects can this medication cause?

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
• Feeling unwell
• Unusual bleeding or bruising

Your risk of developing hepatocellular cancer, a form of liver cancer, may increase if you receive etranacogene dezaparvovec-drlb injection. The dangers of using this drug should be discussed with your doctor.

Other negative effects from etranacogene dezaparvovec-drlb injection are possible. If you have any strange side effects while taking this medicine, call your doctor right away.

In case of emergency/overdose

Call emergency services at 911 right away if the sufferer has fallen, experienced a seizure, is having problems breathing, or cannot be roused.

What other information should I know?

Do not miss any of your doctor’s or lab appointments. To determine how well your body has responded to the etranacogene dezaparvovec-drlb injection, your doctor will prescribe a number of lab tests both before and after your therapy.

Tell the lab staff and your doctor that you’ve had an injection of etranacogene dezaparvovec-drlb before you undergo any laboratory testing.

It’s crucial that you keep a written record of every medication you take, including any vitamins, minerals, or other dietary supplements. This list should also include any over-the-counter (OTC) medications you use. When you visit a doctor or are admitted to the hospital, you should always bring this list with you. In case of crises, it is also crucial to have this information on hand.