Genglycos (>=87 kg)

Genglycos (>=87 kg) is a gene therapy that is used together with dietary treatment to reduce the amount of daily cornstarch that adults and children 8 years and older with glycogen storage disease type Ia (GSDIa) need to take.

Genglycos (>=87 kg) may also be used for other reasons that are not mentioned in this medication guide.

You should not receive Genglycos (>=87 kg) if you have severe liver fibrosis or cirrhosis.

You should not receive treatment with Genglycos (>=87 kg) if you have severe liver fibrosis or cirrhosis.

Inform your doctor if you have or have ever had:

• an allergic reaction to Genglycos (>=87 kg); or
• liver problems or an acute liver infection.

Let your doctor know if you have recently received or are scheduled to receive a vaccine. You should not get vaccinated for 1 month before receiving this medicine. Your doctor might need to adjust your vaccination schedule.

Using Genglycos (>=87 kg) may increase your risk of developing a tumor. Discuss your individual risk with your doctor.

Genglycos (>=87 kg) should not be taken during pregnancy. It is unknown if this medicine can harm an unborn baby.

• If you are a woman who can become pregnant, use birth control while taking this medicine and for at least 12 months after your last dose.
• If you are a man, use birth control if your partner can get pregnant. Continue using birth control for at least 6 months after your last dose.
• Inform your doctor immediately if you become pregnant or think you might be pregnant.

Men taking Genglycos (>=87 kg) should not donate semen for at least 6 months after treatment.

Ask your doctor if it is safe to breastfeed while taking this medicine.

Your doctor will conduct medical tests before starting treatment with Genglycos (>=87 kg) to ensure it is suitable for you.

Genglycos (>=87 kg) is given as a single dose through an infusion into a vein. A healthcare provider will administer this infusion.

You will receive other medicines before your infusion to help reduce the risk of infusion reactions, including allergic reactions.

You will also need to take a corticosteroid medicine starting 2 weeks after your infusion to help lower the risk of liver problems. Take it exactly as prescribed for as long as your doctor advises. Do not stop taking it suddenly.

Blood tests will be necessary before and after receiving this medicine to check your liver and adrenal gland function.

Genglycos (>=87 kg) genetic material may be found in your blood, urine, stool, and saliva after treatment. Follow your healthcare provider's instructions for proper hygiene when handling body waste for 3 months after your infusion.

Get emergency medical help if you have signs of an allergic reaction: hives, trouble breathing, swelling of your face, lips, tongue, or throat.

Some side effects may happen during the infusion. Tell your medical caregiver if you feel dizzy, nauseous, light-headed, itchy, sweaty, or have a headache, chest tightness, back pain, trouble breathing, or swelling in your face.

Genglycos (>=87 kg) may cause serious side effects. Call your doctor right away if you have:

• a tumor (an abnormal growth of tissue);
• liver problems—loss of appetite, nausea, vomiting, stomach pain (upper right side), tiredness, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or
• decreased adrenal gland hormones—light-headed feeling like you might faint, muscle or joint pain, loss of consciousness, skin discoloration, craving salty foods.

Common side effects of Genglycos (>=87 kg) may include:

• abnormal liver function tests; or
• nausea.

This is not a complete list of side effects, and others may happen. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Genglycos (>=87 kg) is given in one dose. Contact your doctor for guidance if you miss an appointment for your Genglycos (>=87 kg) infusion.

An overdose of this product is not likely to happen. However, if an overdose does occur in a medical setting, it will be treated promptly.

Drinking alcohol may raise your chances of liver damage.

Do not take any medicine, vitamin, herbal product, or nutritional supplement without your doctor's advice.

Other drugs may impact Genglycos (>=87 kg), including prescription and over-the-counter medicines, vitamins, and herbal products. Inform your doctor about all other medicines you are using.