Buy Gamifant (emapalumab-lzsg)

What is Gamifant (emapalumab-lzsg) for?

Gamifant (emapalumab-lzsg) is an interferon gamma (IFNγ) blocking antibody indicated to treat primary hemophagocytic lymphohistiocytosis (HLH) in paediatric (newborn and older) and adult patients with refractory, recurrent, or progressive disease or intolerance to conventional therapy.^[1]

It is available in vial form, each containing either 10 mg/2 ml or 50 mg/10 ml of emapalumab-lzsg.^[1]

How does Gamifant (emapalumab-lzsg) work?

People with HLH have high levels of the protein interferon gamma (IFNγ), which is thought to cause the excessive inflammatory response associated with the disease.^[2]

The active ingredient in Gamifant, emapalumab, is a monoclonal antibody (a type of protein) that can recognise and bind to IFNγ. It is thereby expected to neutralize its activity and calm hyperinflammatory symptoms of the disease.^[2]

Where has Gamifant (emapalumab-lzsg) been approved?

Gamifant (emapalumab-lzsg) was approved for the treatment of people with HLH by:

• The Food and Drug Administration (FDA), USA on November 20, 2018.^[3]

Gamifant was reviewed under Priority Review and received Orphan Drug Designation, Breakthrough Therapy Designation and Rare Pediatric Disease Designation from the FDA.^[3]

In July 2020, and again in November 2020, the European Medicines Agency (EMA) recommended the refusal of the marketing authorization for Gamifant, based on insufficient proof of efficacy in the treatment of pHLH.^[4]

Please note that this medicine may have also been approved in other regions than the ones we’ve listed. If you have a question about its approval in a specific country feel free to contact our support team.

How is Gamifant (emapalumab-lzsg) taken?

The standard dosage is:^[1]

• Starting dose: 1 mg/kg given as an intravenous infusion over 1 hour twice per week (every 3 to 4 days).
• Following doses: may be increased stepwise (titrated) according to the doctor’s assessment of response.

Gamifant is given until you no longer require therapy for HLH or until you have received hematopoietic stem cell transplantation (HSCT).^[1]

This medicine should be given together with dexamethasone at a starting daily dose (for the steroid) of at least 5 to 10 mg/m2.^[1]

Before starting treatment, you should be evaluated for infection, including latent tuberculosis (TB). During treatment, you should be monitored for TB, adenovirus, Epstein-Barr virus (EBV), and cytomegalovirus (CMV) every 2 weeks and as clinically indicated.^[1]

Before starting treatment, you receive prophylaxis for herpes zoster, Pneumocystis jirovecii, and fungal infections.^[1]

You should not receive live or live attenuated vaccines during treatment and for at least 4 weeks after the last dose of Gamifant, as its safety has not been studied.^[1]

Complete information about Gamifant (emapalumab-lzsg) dosage and administration can be found in the official prescribing information listed in our references section.^[1]

Note: Please consult with your treating doctor for personalised dosing.

Are there any known adverse reactions or side effects of Gamifant (emapalumab-lzsg)?

Common adverse reactions

The most common side effects (≥20% of patients) listed in the prescribing information include:^[1]

• Infections
• High blood pressure (hypertension)
• Infusion-related reactions
• Fever (pyrexia)

Serious adverse reactions

The serious adverse reactions listed in the prescribing information include:^[1]

• 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. Discuss with your treating doctor if you are breastfeeding or if you are pregnant, suspect to be pregnant or are planning to become pregnant.^[1]

For a comprehensive list of side effects and adverse reactions please refer to the official prescribing information.^[1]

References

1. Full prescribing information [FDA]: Gamifant (emapalumab-lzsg) [PDF]
Sobi, Nov 2018

2. Gamifant
Sobi, cited Sep 2021

3. FDA approves Gamifant® (emapalumab), the first and only treatment for primary haemophagocytic lymphohistiocytosis (HLH)
Sobi press release, Nov 2018

4. Gamifant
EMA, Sep 2020