Apitegromab

Apitegromab is used to treat spinal muscular atrophy (SMA) in adults and children age 2 years of age and older who are already receiving a treatment that targets survival motor neuron 2 (SMN2).

Apitegromab may also be used for purposes not listed in this medication guide.

Apitegromab is given as an infusion into a vein, once every 4 weeks. A healthcare provider will give you this injection.

This medicine must be given slowly, and the infusion can take about 1 to 2 hours to complete.

Doses are based on weight. Your dose may change if you gain or lose weight.

You may be more likely to have a broken bone even without a fall or other injury while using apitegromab. Talk with your doctor about ways to keep your bones healthy.

Do not stop receiving apitegromab unless your healthcare provider tells you to.

Tell your doctor if you use other medicines or have other medical conditions or allergies.

Tell your doctor if you have or have ever had:

• low bone mineral density; or
• bone fractures.

Animal studies suggest that apitegromab may cause harm during pregnancy. It is not known if apitegromab will harm an unborn baby in humans. Tell your doctor if you are pregnant or plan to become pregnant, and contact your doctor right away if you become pregnant during treatment.

Ask a doctor if it is safe to breastfeed while using apitegromab.

Based on animal studies, apitegromab may affect fertility (the ability to have children) in men or women. Talk with your doctor about this risk.

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

Apitegromab may cause serious side effects. Call your doctor at once if you have:

• sudden or unexplained bone pain, especially in your leg or foot, or trouble moving the painful area.

Common side effects of apitegromab may include:

• upset stomach, diarrhea, vomiting (stomach flu symptoms);
• viral infection;
• headache;
• cough; or
• cold symptoms such as stuffy nose, sneezing, sore throat.

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.

Call your doctor for instructions if you miss an appointment for your apitegromab infusion.

Your healthcare provider may give the missed dose as soon as possible and schedule your next dose 4 weeks later, or skip the missed dose and give your next dose as original scheduled.

An overdose of this product is unlikely to occur. However, any overdose in a medical setting would be treated quickly.

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

Other drugs may affect apitegromab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.