Givosiran (giv-oh-SIR-an)

Treats acute hepatic porphyria.

Brand Name(s):

Givlaari

When This Medicine Should Not Be Used:

How to Use This Medicine:

Injectable

• A nurse or other health provider will give you this medicine.
• Your doctor will prescribe your exact dose and tell you how often it should be given. This medicine is given as a shot under your skin.
• Missed dose: This medicine needs to be given on a fixed schedule. If you miss a dose or forget to use your medicine, call your doctor or pharmacist for instructions.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some foods and medicines can affect how givosiran works. Tell your doctor if you are using caffeine or dextromethorphan.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have kidney disease, liver disease, or blood problems.
• This medicine may cause the following problems
  • Liver problems
  • Kidney problems
  • Pancreatitis (swelling of the pancreas)
• This medicine may increase homocysteine (an amino acid) levels in your blood. You may receive vitamin supplements (including vitamin B6 supplement) to treat this blood problem.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Dark urine or pale stools, nausea, vomiting, loss of appetite, yellow skin or eyes
• Decrease in how much or how often you urinate
• Rapid weight gain, swelling in your hands, ankles, or feet
• Sudden and severe stomach pain, fever, lightheadedness

If you notice these less serious side effects, talk with your doctor:

• Pain, itching, burning, swelling, or a lump under your skin where the shot was given

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088