Hemgenix (116-120 kg)

Hemgenix (116-120 kg) is used to treat a bleeding disorder called Hemophilia B in adults who are getting preventive treatment for the condition, have frequent serious bleeding episodes, or have had life-threatening bleeding events either currently or in the past.

Hemgenix (116-120 kg) may also be used for other reasons not mentioned in this medication guide.

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:

• unusual bleeding, any bleeding that will not stop;
• hepatitis B or C;
• if you drink large amounts of alcohol; or
• cirrhosis or other liver disease.

Hemgenix (116-120 kg) is not intended for use by women.

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 happen during or right after the injection. Tell your medical caregiver if you feel dizzy, nauseous, light-headed, itchy, sweaty, or have a headache, chest tightness, back pain, trouble breathing, unusual bleeding, or swelling in your face.

Common side effects of Hemgenix (116-120 kg) may include:

• abnormal blood tests;
• headache;
• flu-like symptoms;
• a reaction after receiving the injection; or
• feeling weak or tired, body aches.

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.

Your doctor will perform medical tests before starting treatment with Hemgenix (116-120 kg) to make sure is the right treatment for you.

Hemgenix (116-120 kg) is injected into a vein by a healthcare provider.

You will be watched during and for at least 3 hours after the infusion to make sure you do not have a reaction.

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

You will need weekly blood tests to check your liver function for 3 months after treatment.

You may be prescribed other medications to help treat abnormal liver function tests. Keep taking these medicines for as long as your doctor has prescribed.

You may need other medical tests for a longer period of time if you have certain conditions or if you have certain side effects.

Call your doctor for instructions if you miss an appointment for your Hemgenix (116-120 kg).

In a medical setting, an overdose would be treated quickly.

Do not donate blood, organs, tissues, or cells for transplantation after receiving Hemgenix (116-120 kg).

Other drugs may affect Hemgenix (116-120 kg), including prescription and over-the-counter medicines, vitamins, and herbal products. Inform your doctor about all other medicines you are taking.