Elapegademase-lvlr (Intramuscular)

Elapegademase-lvlr injection is used to treat severe immune deficiency caused by adenosine deaminase deficiency, which is an inherited condition that results in a complete lack of immune protection from bacteria, viruses, and fungi. People with this condition often experience repeated and long-lasting infections that can be very serious or life-threatening.

This medicine should only be given by your doctor or under their direct supervision.

It is very important that your doctor monitors you or your child's progress closely to ensure this medicine is working properly. Blood tests may be necessary to check for unwanted effects.

Protect yourself or your child from infections until immune function improves, which usually takes 2 to 6 months of treatment. If possible, avoid contact with people who have infections. Contact your doctor right away if you think you are getting an infection or if you experience fever, chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.

In deciding to use a medicine, it is important to consider the risks of taking it against the benefits it may provide. This is a decision you will make with your doctor. For this medicine, consider the following:

Allergies

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

Pediatric

Studies have not shown any specific problems that would limit the use of elapegademase-lvlr injection in children. It has been found to be safe and effective.

Geriatric

Studies have not been conducted on how age affects the use of elapegademase-lvlr injection in older adults.

Breast Feeding

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

Interactions with Medicines

Some medicines should not be used together at all, while others may be used together even if there is a possibility of an interaction. In such cases, your doctor may need to adjust the dose or take other precautions. Inform your healthcare professional if you are taking any other prescription or over-the-counter (OTC) medicines.

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken around mealtime or with certain foods due to possible interactions. Drinking alcohol or using tobacco with certain medicines may also lead to interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical issues may impact how this medicine works for you. Be sure to inform your doctor if you have any other medical conditions, especially:

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

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

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

Check with your doctor or nurse right away if any of the following side effects happen:

Rare

• Black, tarry stools
• Body aches or pain
• Burning, dry or itchy eyes
• Change in hearing
• Chest pain
• Chills
• Cough
• Coughing or spitting up blood
• Diarrhea
• Difficulty 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 happen that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Your health care professional may also know ways to prevent or lessen some of these side effects. Check with your health care professional if any of the following side effects continue, are bothersome, or if you have any questions about them:

Rare

• Change in walking and balance
• Clumsiness or unsteadiness
• Difficulty moving
• Ear canal irritation
• Severe and throbbing headache
• Discomfort at the injection site
• Lack or loss of strength
• Mouth or throat pain
• Muscle pain or stiffness
• Rash
• Swelling of the face or nose
• Skin tearing
• Tooth pain
• Upper stomach pain

Incidence not known

• Redness and itching at the injection site

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

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

In the U.S.

• Revcovi

Available Dosage Forms:

• Solution

Therapeutic Class: Endocrine-Metabolic Agent

Pharmacologic Class: Elapegademase

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 as a shot into one of your muscles.

• What condition is Revcovi used to treat?