Emapalumab-lzsg (Intravenous)

Emapalumab-lzsg injection is used to treat a blood disorder known as primary hemophagocytic lymphohistiocytosis (HLH) that is hard to treat (refractory), comes back (recurrent), or has gotten worse (progressive), or when other treatments used did not work well.

This medicine must be given only by or under the direct supervision of your doctor.

It is very important for your doctor to closely monitor you or your child's progress while using this medicine and during regular check-ups to ensure it is working properly. Blood tests may be necessary to check for unwanted side effects.

Before starting this medicine, you or your child must have a skin test or blood test for tuberculosis. Inform your doctor if you or anyone in your home has ever had a positive reaction to a tuberculosis skin or blood test.

Contact your doctor immediately if you or your child develop a persistent cough, weight loss, night sweats, fever, chills, flu-like symptoms (such as a runny or stuffy nose, headache, blurred vision, or feeling generally unwell), painful or difficult urination, or sores, ulcers, or white spots in the mouth or on the lips. These could be signs of an infection.

You should not receive live or live attenuated vaccines during treatment with emapalumab-lzsg and for at least 4 weeks after the last dose.

This medicine may cause infusion-related reactions, which can be life-threatening and need immediate medical attention. Inform your doctor right away if you experience fever, chills or shaking, dizziness, trouble breathing, itching or rash, lightheadedness, or fainting after receiving this medicine.

In deciding to use a medicine, you and your doctor need to weigh the risks against the benefits. For this medicine, consider the following:

Allergies

Let your doctor know if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, inform your healthcare professional about any other allergies you may have, such as to foods, dyes, preservatives, or animals. For non-prescription products, carefully read the label or package ingredients.

Pediatric

Research conducted so far has not shown any specific problems in newborns and children that would limit the usefulness of emapalumab-lzsg injection. Its safety and effectiveness have been confirmed.

Geriatric

Research conducted so far has not shown any specific problems in the elderly that would limit the usefulness of emapalumab-lzsg injection.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication during breastfeeding. Consider the potential benefits and risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines may be used together even if there might be an interaction. In these situations, your doctor may need to adjust the dose, or take other precautions. When you are receiving this medicine, it is very important for your healthcare professional to know if you are taking any of the medicines listed below. The following interactions have been chosen based on their potential significance and may not be all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Adenovirus Vaccine
• Bacillus of Calmette and Guerin Vaccine, Live
• Cholera Vaccine, Live
• Dengue Tetravalent Vaccine, Live
• Influenza Virus Vaccine, Live
• Measles Virus Vaccine, Live
• Mumps Virus Vaccine, Live
• Poliovirus Vaccine, Live
• Rotavirus Vaccine, Live
• Rubella Virus Vaccine, Live
• Smallpox Vaccine
• Typhoid Vaccine, Live
• Varicella Virus Vaccine, Live
• Yellow Fever Vaccine
• Zoster Vaccine, Live

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken around the time of eating food or certain types of food due to possible interactions. Drinking alcohol or using tobacco with certain medicines may also lead to interactions. Discuss with your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical problems may affect how this medicine works. Be sure to tell your doctor if you have any other medical issues, especially:

• Infection (e.g., fungus, herpes zoster, tuberculosis)—This must be treated first before you receive this medicine.

• Weak immune system—Use with caution. This may increase the risk of more side effects.

Along with its needed effects, a medicine may cause some unwanted effects. Not all of these side effects may occur, but if they do, they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

• Agitation
• back pain
• black, tarry stools
• bloating or swelling of the face, arms, hands, lower legs, or feet
• bloody stools
• blurred vision
• chest pain, discomfort, or tightness
• chills
• confusion
• cough
• decreased awareness or responsiveness
• decreased urine
• depression
• difficult or labored breathing
• dry mouth
• fast, pounding, or irregular heartbeat or pulse
• feeling of warmth
• fever
• headache
• hoarseness
• hostility
• increased thirst
• irritability
• lightheadedness, dizziness, or fainting
• loss of appetite
• loss of consciousness
• lower back or side pain
• mood changes
• muscle pain, cramps, or twitching
• nausea
• nervousness
• nosebleed
• numbness or tingling in the hands, feet, or lips
• painful or difficult urination
• pounding in the ears
• rapid weight gain
• rapid, shallow breathing
• redness of the face, neck, arms and occasionally, upper chest
• seizures
• severe sleepiness
• slow heartbeat
• swollen glands
• unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness
• unusual weight gain or loss
• vomiting
• vomiting of blood or material that looks like coffee grounds

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Constipation
• lack or loss of strength
• stomach pain

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

In the U.S.

• Gamifant

Available Dosage Forms:

• Solution

Therapeutic Class: Immunological Agent

Pharmacologic Class: Emapalumab

Find detailed information on biosimilars for this medication.

A nurse or other trained health professional will give you this medicine in a medical facility. It is given through a needle placed into one of your veins. The medicine must be given slowly, so the needle will need to stay in place for at least 1 hour.

You may also be given other medicines (eg, antibiotic, antiviral medicine, steroids) before infusion to prevent serious infections.