Elapegademase

Elapegademase is a prescription medicine used for the treatment of adenosine deaminase severe combined immune deficiency (ADA-SCID).

• Elapegademase is available under the following different brand names: Revcovi, elapegademase-lvlr

Common side effects of Elapegademase include:

• vomiting, and
• cough

Serious side effects of Elapegademase include:

• hives,
• difficulty breathing,
• swelling of the face, lips, tongue, or throat,
• bleeding where the medicine was injected,
• other unusual bleeding (nosebleeds, bleeding gums),
• seizure,
• pale or yellowed skin,
• dark-colored urine,
• confusion,
• weakness,
• fever,
• chills,
• unusual tiredness,
• sore throat,
• sinus pain,
• swollen glands,
• skin warmth or swelling,
• stomach cramps,
• vomiting,
• diarrhea,
• red or pink urine,
• black or tarry stools,
• painful or difficult urination,
• breathing problems,
• cough with mucus,
• sores or white patches in the mouth or on the skin,
• problems with balance or walking, and
• problems with the teeth or gums

Rare side effects of Elapegademase include:

• none

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out. 

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult and pediatric dosage

Injectable solution

• 1.6 mg/mL (1.5 mL single-dose vial)

Adenosine Deaminase Severe Combined Immunodeficiency

Adult dosage

• Pegademase naïve
  • Dose based on ideal body weight or actual weight whichever is greater
  • 0.2 mg/kg IM 2 times per week (0.4 mg/kg/week) for at least 12-24 weeks until immune reconstitution achieved
  • Establish optimal long-term dose and schedule for each patient individually
  • Adjust dose gradually down to maintain trough ADA activity above 30 mmol/hr/L, trough dAXP level below 0.02 mmol/L, and/or to maintain adequate immune reconstitution based on clinical assessment
• Transition from pegademase to elapegademase
  • Unknown pegademase dose OR weekly pegademase dose below 30 U/kg: 0.2 mg/kg IM every week
• Weekly pegademase dose above 30 U/kg
  • Calculate an equivalent weekly elapegademase dose (mg/kg) using the following conversion formula
  • Elapegademase weekly dose (mg/kg) = pegademase dose (U/kg)/150
  • May increase subsequent doses by 0.033-mg/kg/week increments if trough ADA activity less than 30 mmol/hr/L, trough dAXP above 0.02 mmol/L, and/or immune reconstitution is inadequate based on clinical assessment
  • May divide total weekly dose into multiple IM administrations during a week

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Elapegademase has no noted severe interactions with any other drugs.
• Elapegademase has no noted serious interactions with any other drugs
• Elapegademase has no noted moderate interactions with any other drugs.
• Elapegademase has no noted minor interactions with any other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• None

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Elapegademase?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Elapegademase?”

Cautions

• Caution with thrombocytopenia; avoid use if thrombocytopenia is severe
• Maintain precautions to protect immune-deficient patients from infections until improvement in immune function achieved; timing and degree of improvement in immune function may vary from patient to patient

Pregnancy and Lactation

• Adequate and well-controlled studies have not been conducted on pregnant women to inform a drug-associated risk
• Unknown whether fetal harm may occur when administered to a pregnant woman or can affect reproduction capacity
• Lactation
  • Unknown if distributed in human breast milk
  • Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for the drug, and any potential adverse effects on the breastfed infant from the drug or from the underlying maternal condition