Genglycos (51-56 kg)

Genglycos (51-56 kg) is a gene therapy that is used together with dietary treatment to reduce daily cornstarch intake in adults and children aged 8 years and older who have glycogen storage disease type Ia (GSDIa).

Genglycos (51-56 kg) may also be used for other reasons that are not mentioned in this medication guide.

Your doctor will perform medical tests before starting treatment with Genglycos (51-56 kg) to ensure it is the right treatment for you.

Genglycos (51-56 kg) is given as one dose through an infusion into a vein. A healthcare provider will administer this infusion.

You will receive other medicines before your infusion to help lower 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 reduce the risk of liver problems. Take it exactly as prescribed for as long as your doctor instructs you. Do not stop taking it suddenly.

You will need blood tests before and after receiving this medicine to check the function of your liver and adrenal glands.

Genglycos (51-56 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.

You must not be treated with Genglycos (51-56 kg) if you have severe liver fibrosis or cirrhosis.

You should not be treated with Genglycos (51-56 kg) if you have severe liver fibrosis or cirrhosis.

Tell your doctor if you have or have ever had:

• an allergic reaction to Genglycos (51-56 kg); or
• liver problems or an acute liver infection.

Tell your doctor if you have recently received or are scheduled to receive a vaccine. You should not receive vaccines for 1 month before receiving this medicine. Your doctor may need to change your vaccination schedule.

Using Genglycos (51-56 kg) may increase your risk of developing a tumor. Ask your doctor about your individual risk.

Genglycos (51-56 kg) should not be used during pregnancy. It is not known if this medicine will harm an unborn baby.

• If you are a woman who can become pregnant, use birth control while using this medicine and for at least 12 months after your last dose.
• If you are a man, use birth control if your sex partner is able to get pregnant. Keep using birth control for at least 6 months after your last dose.
• Tell your doctor right away if you become pregnant or think you are pregnant.

Men using Genglycos (51-56 kg) should not donate semen for at least 6 months after treatment.

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

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

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

Genglycos (51-56 kg) may lead to serious side effects. Contact your doctor immediately if you experience:

• a tumor (an abnormal growth of tissue);
• liver issues—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—feeling light-headed like you might faint, muscle or joint pain, loss of consciousness, skin discoloration, craving salty foods.

Common side effects of Genglycos (51-56 kg) may include:

• abnormal liver function tests; or
• nausea.

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

Genglycos (51-56 kg) is given in one dose. Call your doctor for instructions if you miss an appointment for your Genglycos (51-56 kg) infusion.

An overdose of this product is not likely to happen. However, if an overdose does occur in a medical setting, it would 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 affect Genglycos (51-56 kg), including prescription and over-the-counter medicines, vitamins, and herbal products. Inform your doctor about all other medicines you are using.