What Is GAMIFANT?
GAMIFANT is a prescription medicine used for the treatment of adults and children (newborn and older) with primary hemophagocytic lymphohistiocytosis (HLH) whose disease has come back or progressed, or other medicines have not worked well enough or cannot be tolerated.
Important Safety Information
GAMIFANT can cause serious side effects, including infections. GAMIFANT is a medicine that affects your immune system and may lower the ability of your immune system to fight infections. GAMIFANT may increase your risk of serious infections that can lead to death. These infections include tuberculosis (TB), histoplasmosis, herpes zoster infection (shingles), and other infections caused by viruses, fungi, or bacteria that can spread throughout the body. Your healthcare provider will:
- Test you for TB before you start treatment with GAMIFANT
- Treat you with a medicine for TB if you are at risk for TB or if you have a known positive TB test. Infections are common in people treated with GAMIFANT
Before starting GAMIFANT, tell your healthcare provider all of your medical conditions and if you:
- Had TB in the past, or if you or a member of your family have been in recent close contact with someone with TB
- Have had a positive TB skin test (purified protein derivative test)
- Currently have an infection or have a history of infections, including histoplasmosis or herpes zoster (shingles)
- Are being treated for an active infection
- Have symptoms of an infection such as fever; sweat and chills; cough; breathing problems; blood in mucus (phlegm); or warm, red painful skin or sores on your body
- Are pregnant or plan to become pregnant. It is not known if GAMIFANT can harm your unborn baby
- Are breastfeeding or plan to breastfeed. It is not known if GAMIFANT passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment with GAMIFANT
Your healthcare provider will give you medicine to help prevent certain infections before you receive GAMIFANT
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements
After starting GAMIFANT, tell your healthcare provider if:
- New symptoms of an infection appear
- Symptoms of an infection that you already had when starting GAMIFANT worsen. Your healthcare provider will monitor you closely for signs and symptoms of infections during treatment with GAMIFANT
GAMIFANT can cause serious infusion reactions.
These are common, can also be severe, and can happen during or shortly after treatment with GAMIFANT. Your healthcare provider may temporarily stop your infusion and treat your symptoms before continuing your infusion if you have severe infusion reactions. Tell your healthcare provider right away if you get any of the following symptoms:
- skin redness
- itching
- fever
- rash
- excessive sweating
- chills
- chest pain
- shortness of breath
- nausea or vomiting
- lightheadedness or dizziness
The most common side effects of GAMIFANT include high blood pressure (hypertension) and fever.
These are not all the possible side effects for GAMIFANT. For more information, ask your healthcare provider. You can also click here to see the Full Prescribing Information for GAMIFANT, including Patient Information.
To report suspected adverse reactions, contact Sobi North America at 1-866-773-5274 or FDA at 1-800-FDA-1088
Please see Patient Medication Guide for Gamifant.
