What is Gamifant (emapalumab-lzsg) for?
Gamifant (emapalumab-lzsg) is a treatment for a rare disease called primary hemophagocytic lymphohistiocytosis (HLH). It helps kids and adults with this disease who haven’t responded well to other treatments.
It comes in a vial, with 10 mg/2 ml or 50 mg/10 ml of emapalumab-lzsg.
How does Gamifant (emapalumab-lzsg) work?
HLH causes too much of a protein called interferon gamma (IFNγ). This leads to too much inflammation in the body.
Gamifant’s active ingredient, emapalumab, is a special antibody. It finds and blocks IFNγ. This helps reduce the inflammation and symptoms of the disease.
Where has Gamifant (emapalumab-lzsg) been approved?
Gamifant has been approved by:
- The Food and Drug Administration (FDA), USA on November 20, 2018.
The FDA reviewed it quickly and gave it special designations for rare diseases.
In July and November 2020, the European Medicines Agency (EMA) didn’t approve it for Europe. They said there wasn’t enough proof it worked well.
This medicine might be approved in other places too. If you have questions, our support team can help.
How is Gamifant (emapalumab-lzsg) taken?
The usual dose is:
- First dose: 1 mg/kg given slowly over 1 hour, twice a week.
- Next doses: can be adjusted based on how well you’re doing.
You’ll keep taking it until you’re cured or get a bone marrow transplant.
It’s best to take it with dexamethasone, starting with 5 to 10 mg/m2 daily.
Before starting, check for infections like TB. Watch for TB, adenovirus, EBV, and CMV every 2 weeks.
Get ready for herpes zoster, Pneumocystis jirovecii, and fungal infections before starting.
Avoid live vaccines for 4 weeks after stopping Gamifant. Its safety with vaccines isn’t known.
For full details on how to take Gamifant, see the official prescribing information. Note: Always talk to your doctor about your specific needs.
Are there any known adverse reactions or side effects of Gamifant (emapalumab-lzsg)?
Common adverse reactions
The most common side effects are:
- Infections
- High blood pressure (hypertension)
- Infusion-related reactions
- Fever (pyrexia)
Serious adverse reactions
The serious side effects listed in the prescribing information include:
- Sepsis
- Lung inflammation (pneumonia)
- Bacteremia
- Disseminated histoplasmosis
- Necrotizing fasciitis
- Viral infections
- Perforated appendicitis
Use in a specific population
It is not known if Gamifant (emapalumab-lzsg) can harm your (unborn) baby. Talk to your doctor if you are breastfeeding or if you are pregnant, suspect to be pregnant or are planning to become pregnant.
For a complete list of side effects and adverse reactions, please refer to the official prescribing information.
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