Pronunciation:

el-a-peg-AD-e-mase - lvlr

Brand Names:

• Revcovi

Dosage Forms:

• Solution

Classifications:

Therapeutic—

Endocrine-Metabolic Agent

Pharmacologic—

Elapegademase

Uses of This Medicine:

Elapegademase-lvlr injection is used to treat severe immune deficiency due to adenosine deaminase deficiency, an inherited disorder that lacks all immune protection from bacteria, viruses, and fungi. Patients with this disorder are prone to repeated and persistent infections that can be very serious or life-threatening.

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 elapegademase-lvlr injection in children. Safety and efficacy have been established.

Older adults—

Appropriate studies have not been performed on the relationship of age to the effects of elapegademase-lvlr 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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

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:

• Infections (eg, bacteria, virus, or fungus)—May decrease your body's ability to fight an infection.

• Thrombocytopenia (low levels of platelets in the blood)—Use with caution. May increase risk of bleeding at the injection site.

Proper Use of This Medicine:

A nurse or other trained health professional will give you this medicine in a medical facility. It is given as a shot into one of your muscles.

Precautions While Using This Medicine:

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

Protect yourself or your child from infections until your immune function is improved, usually after 2 to 6 months of treatment. If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever, chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.

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:

Rare

Black, tarry, stools

body aches or pain

burning, dry or itching eyes

change in hearing

chest pain

chills

cough

coughing or spitting up blood

diarrhea

difficulty in breathing

discharge, excessive tearing

ear congestion

ear drainage

earache

fever

general feeling of discomfort or illness

headache

itching in the genitals or other skin areas

itching of the ears

joint pain

loss of appetite

loss of voice

lower back or side pain

muscle aches and pains

nasal congestion

nausea

painful or difficult urination

pale skin

redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid

runny nose

scaling

seizures

severe pain in the side and back

shivering

sneezing

sore mouth or tongue

sore throat

stiff neck

stomach cramps and pain

sweating

swollen, painful, or tender lymph glands in the neck, armpit, or groin

thickening of bronchial secretions

trouble sleeping

ulcers, sores, or white spots in the mouth

unusual bleeding or bruising

unusual tiredness or weakness

vomiting

watery diarrhea

Incidence not known

Back, leg, or stomach pains

bleeding gums

blood in the urine or stools

dark urine

dizziness

general body swelling

nosebleeds

pain, warmth, or burning in the fingers, toes, and legs

pinpoint red spots on the skin

problems with vision or hearing

weight loss

yellowing of the eyes or skin

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:

Rare

Change in walking and balance

clumsiness or unsteadiness

difficulty in moving

ear canal irritation

headache, severe and throbbing

injection site discomfort

lack or loss of strength

mouth or throat pain

muscle pain or stiffness

rash

swelling of the face or nose

tearing of the skin

tooth pain

upper stomach pain

Incidence not known

Redness and itching at the injection site

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.