Mepsevii

Mepsevii contains an enzyme that is normally found in the body of healthy individuals. Some people do not have this enzyme due to a genetic disorder. This medicine helps replace the missing enzyme in these individuals.

Mepsevii is used to treat some symptoms of a genetic condition known as mucopolysaccharidosis VII (MYOO-koe-pol-ee-SAK-a-rye-DOE-sis Seven) or MPS VII, which is also referred to as Sly syndrome.

MPS VII is a metabolic disorder where the body does not produce the enzyme needed to break down certain natural substances. These substances can accumulate in the body, leading to enlarged organs, abnormal bone structure, changes in facial features, breathing difficulties, heart issues, vision or hearing loss, and changes in mental or physical abilities.

Mepsevii may improve walking ability in people with this condition. However, this medication is not a cure for MPS VII.

Mepsevii may also be used for purposes that are not listed in this medication guide.

An allergic reaction may happen during or soon after the infusion of this medicine. Inform your caregivers or seek emergency medical help immediately if you experience any signs of a severe allergic reaction, such as sweating, difficulty breathing, pale skin, blue lips or fingernails, and feeling faint.

Tell your doctor if you have ever had:

• a lung disease or breathing problems.

Tell your doctor if you are pregnant or breastfeeding.

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

An allergic reaction may occur during or shortly after infusion of Mepsevii. Tell your caregivers or get emergency medical help right away if you have any signs of a severe allergic reaction, such as:

• feeling like you might pass out, even while lying down;
• sweating, cold or clammy skin;
• feeling short of breath;
• pale skin; or
• blue lips or fingernails.

Common side effects of Mepsevii may include:

• diarrhea;
• swelling in your hands or feet;
• rash, itching; or
• swelling or irritation around the IV needle.

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.

Mepsevii is given as an infusion into a vein. A healthcare provider will give you this injection.

Mepsevii is usually given once every 2 weeks. Mepsevii must be given slowly, and the infusion can take about 4 hours to complete.

About 30 to 60 minutes before each injection, you will be given other medications to help prevent a serious allergic reaction.

Tell your caregivers if you feel any burning, pain, or swelling around the IV needle when Mepsevii is injected.

You will be watched closely for at least 60 minutes after receiving Mepsevii, to make sure you do not have an allergic reaction.

Mepsevii doses are based on weight. Your dose needs may change if you gain or lose weight.

Call your doctor for instructions if you miss an appointment for your Mepsevii.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Other drugs may affect Mepsevii, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

• What is Mepsevii used to treat?