Pronunciation:

em-a-PAL-ue-mab - lzsg

Brand Names:

• Gamifant

Dosage Forms:

• Solution

Classifications:

Therapeutic—

Immunological Agent

Pharmacologic—

Emapalumab

Uses of This Medicine:

Emapalumab-lzsg injection is used to treat a blood disorder called primary hemophagocytic lymphohistiocytosis (HLH) that is hard to treat (refractory), recurrent, or has worsened (progressive), or when other treatments that have been used did not work well.

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

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of emapalumab-lzsg injection in newborns and children. Safety and efficacy have been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of emapalumab-lzsg injection in the elderly.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required 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

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Infection (eg, fungus, herpes zoster, tuberculosis)—Must be treated first before receiving this medicine.

• Weak immune system—Use with caution. May increase risk for more side effects.

Proper Use of This Medicine:

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.

Precautions While Using This Medicine:

It is very important that your doctor check your or your child's progress closely while receiving the medicine and at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.

You or your child will need to have a skin test or blood test for tuberculosis before you start receiving this medicine. Tell your doctor if you or anyone in your home has ever had a positive reaction to a tuberculosis skin or blood test.

Call your doctor right away if you or your child start to have a cough that would not go away, weight loss, night sweats, fever, chills, flu-like symptoms (eg, runny or stuffy nose, headache, blurred vision, or feeling generally ill), painful or difficult urination, or sores, ulcers, or white spots in the mouth or on the lips. These may be signs that you have 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 require immediate medical attention. Tell your doctor right away if you start to have a fever, chills or shaking, dizziness, trouble breathing, itching or rash, lightheadedness, or fainting after receiving this medicine.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur 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.