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Indication and Usage

Gamifant® (emapalumab-lzsg) is an IFNγ–blocking antibody indicated for the treatment of adult and pediatric (newborn and older) patients with primary hemophagocytic lymphohistiocytosis (HLH) with refractory, recurrent, or progressive disease or intolerance with conventional HLH therapy.

Indication and Usage

Gamifant® (emapalumab-lzsg) is an interferon gamma (IFNγ)–blocking antibody indicated for the treatment of adult and pediatric (newborn and older) patients with primary hemophagocytic lymphohistiocytosis (HLH) with refractory, recurrent, or progressive disease or intolerance with conventional HLH therapy.

Important Safety Information

Before initiating Gamifant, patients should be evaluated for infection, including latent tuberculosis (TB). Prophylaxis for TB should be administered to patients who are at risk for TB or known to have a positive purified protein derivative (PPD) test result or positive IFNγ release assay.

During Gamifant treatment, patients should be monitored for TB, adenovirus, Epstein-Barr virus (EBV), and cytomegalovirus (CMV) every 2 weeks and as clinically indicated.

Patients should be administered prophylaxis for herpes zoster, Pneumocystis jirovecii, and fungal infections prior to Gamifant administration.

Do not administer live or live attenuated vaccines to patients receiving Gamifant and for at least 4 weeks after the last dose of Gamifant. The safety of immunization with live vaccines during or following Gamifant therapy has not been studied.

Infusion-Related Reactions

Infusion-related reactions, including drug eruption, pyrexia, rash, erythema, and hyperhidrosis, were reported with Gamifant treatment in 27% of patients. In one-third of these patients, the infusion-related reaction occurred during the first infusion.

Adverse Reactions

In the pivotal trial, the most commonly reported adverse reactions (≥10%) for Gamifant included infection (56%), hypertension (41%), infusion-related reactions (27%), pyrexia (24%), hypokalemia (15%), constipation (15%), rash (12%), abdominal pain (12%), CMV infection (12%), diarrhea (12%), lymphocytosis (12%), cough (12%), irritability (12%), tachycardia (12%), and tachypnea (12%).

Additional selected adverse reactions (all grades) that were reported in less than 10% of patients treated with Gamifant included vomiting, acute kidney injury, asthenia, bradycardia, dyspnea, gastrointestinal hemorrhage, epistaxis, and peripheral edema.

Please see full Prescribing Information for Gamifant.

You may also contact Sobi at medinfo.us@sobi.com or 866-773-5274.

References

  1. Gamifant [prescribing information]. Stockholm, Sweden: Swedish Orphan Biovitrum AB.
  2. Locatelli F, Jordan MB, Allen C, et al. Emapalumab in children with primary hemophagocytic lymphohistiocytosis. N Engl J Med. 2020;382(19):1811-1822.
  3. Sepulveda F, de Saint Basile G. Hemophagocytic syndrome: primary forms and predisposing conditions. Curr Opin Immunol. 2017; 49:20-26. http://dx.doi.org/10.1016/j.coi.2017.08.004.
  4. Jordan MB, Allen CE, Weitzman S, Filipovich AH, McClain KL. How I treat hemophagocytic lymphohistiocytosis. Blood. 2011;118(15):4041-4052. doi: https://doi.org/10.1182/blood-2011-03-278127.
  5. Lehmberg K, Nichols KE, Henter J-I, et al. Consensus recommendations for the diagnosis and management of hemophagocytic lymphohistiocytosis associated with malignancies. Haematologica. 2015:100(8):997-1004.
  6. Marsh RA, Haddad E. How I treat primary haemophagocytic lymphohistiocytosis. Br J Haematol. 2018;182(2):185-199. doi: 10.1111/bjh.15274.

TAILOR Gamifant® (emapalumab-lzsg) TREATMENT TO YOUR PATIENT’S NEEDS

Gamifant is administered by intravenous infusion over 1 hour twice a week (every 3-4 days) until the patient no longer requires therapy for the treatment of HLH, until HSCT is performed, or if unacceptable toxicity is reached. Gamifant should be given concomitantly with dexamethasone at a starting daily dose (for the steroid) of at least 5 to 10 mg/m2.1

During Gamifant treatment, monitor for tuberculosis, adenovirus, Epstein-Barr virus (EBV), and cytomegalovirus (CMV) every 2 weeks and as clinically indicated.1

Gamifant offers flexibility of dosing1

Gamifant can be incrementally titrated upward or downward according to the clinician's assessment of patient response.

After the patient’s clinical condition is stabilized, decrease the dose to the previous level to maintain clinical response until HSCT.

Dexamethasone can also be tapered according to the judgment of the treating physician.

From a 1 mg/kg starting dose, Gamifant can be titrated to 3 mg/kg on or after day 3, 6 mg/kg on or after day 6, and a maximum dose of 10 mg/kg on or after day 9.

Response criteria for dose increase1

Gamifant can be increased after 3 days, based on the clinician’s assessment of unsatisfactory improvement in clinical condition, AND at least one of the following:

Fever Persistence or recurrence
Platelet Count
  • If baseline <50,000/mm3 and no improvement to >50,000/mm3
  • If baseline >50,000/mm3 and <30% improvement
  • If baseline >100,000/mm3 and decrease to <100,000/mm3
Neutrophil Count
  • If baseline <500/mm3 and no improvement to >500/mm3
  • If baseline >500-1000/mm3 and decrease to <500/mm3
  • If baseline 1000-1500/mm3 and decrease to <1000/mm3
Ferritin
  • If baseline ≥3000 ng/mL and <20% decrease
  • If baseline <3000 ng/mL and any increase to >3000 ng/mL
Splenomegaly Any worsening
Coagulopathy Both D-dimer and fibrinogen must apply
  • D-dimer: if abnormal at baseline and no improvement
  • Fibrinogen (mg/dL): if baseline levels ≤100 mg/dL and no improvement or if baseline levels >100 mg/dL and any decrease to <100 mg/dL
dosing & Administration guide

Contact A HEALTH SYSTEMS DIRECTOR FOR ADDITIONAL QUESTIONS

Target-mediated clearance

Gamifant exhibits target-mediated clearance dependent on IFNγ production, which can vary between and within patients as a function of time and can affect the recommended dosage.1

  • The pharmacokinetics of emapalumab-lzsg were evaluated in healthy adult subjects and in patients with primary HLH1
     
  • Gamifant steady-state is achieved by the seventh infusion when the IFNγ production is moderate. At high IFNγ production, steady-state is reached earlier due to a shorter half-life1

Dosing flexibility is especially important given this variability, and dose adjustments may be needed to neutralize IFNγ concentrations in each patient.

Identify the right dose of Gamifant with our Dosing Calculator.

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