Genglycos (27-32 kg)

Genglycos (27-32 kg) is a gene therapy that is used alongside dietary treatment to help reduce daily cornstarch intake in adults and children who are 8 years old and older with glycogen storage disease type Ia (GSDIa).

Genglycos (27-32 kg) may also be used for other reasons that are not mentioned in this medication guide.

Your doctor will do medical tests before starting treatment with Genglycos (27-32 kg) to ensure it is the right treatment for you.

Genglycos (27-32 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 lower the risk of liver problems. Take it exactly as prescribed for as long as your doctor instructs. Do not stop taking it suddenly.

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

Genglycos (27-32 kg) genetic material may be found in your blood, urine, stool, and saliva after treatment. Follow your healthcare provider's instructions for careful hygiene when handling body waste for 3 months after your infusion.

You should not be treated with Genglycos (27-32 kg) if you have severe liver fibrosis or cirrhosis.

You should not be treated with Genglycos (27-32 kg) if you have severe liver fibrosis or cirrhosis.

Tell your doctor if you have or have ever had:

• an allergic reaction to Genglycos (27-32 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 (27-32 kg) may increase your risk of developing a tumor. Ask your doctor about your individual risk.

Genglycos (27-32 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 (27-32 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 have signs of an allergic reaction: hives, difficulty breathing, swelling of your face, lips, tongue, or throat.

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

Genglycos (27-32 kg) may cause serious side effects. Call your doctor immediately 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 pass out, muscle or joint pain, loss of consciousness, skin discoloration, craving salty foods.

Common side effects of Genglycos (27-32 kg) may include:

• abnormal liver function tests; or
• nausea.

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

Genglycos (27-32 kg) is given in one dose. Contact your doctor for instructions if you miss an appointment for your Genglycos (27-32 kg) infusion.

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

Drinking alcohol may raise your risk of liver damage.

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

Other drugs may affect Genglycos (27-32 kg), including prescription and over-the-counter medicines, vitamins, and herbal products. Inform your doctor about all other medicines you are taking.