Elapegademase-lvlr (Intramuscular route)

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.


Last Updated: 9/5/2019

The information provided herein should not be used during any medical emergency or for the diagnosis or treatment of any medical condition. A licensed medical professional should be consulted for diagnosis and treatment of any and all medical conditions. Call 911 for all medical emergencies. Links to other sites are provided for information only -- they do not constitute endorsements of those other sites.

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The information provided herein should not be used during any medical emergency or for the diagnosis or treatment of any medical condition. A licensed medical professional should be consulted for diagnosis and treatment of any and all medical conditions. Call 911 for all medical emergencies. Links to other sites are provided for information only -- they do not constitute endorsements of those other sites.
All rights reserved.

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