Medical Editor: John P. Cunha, DO, FACOEP
What Is Revcovi?
Revcovi (elapegademase-lvlr) is a recombinant adenosine deaminase indicated for the treatment of adenosine deaminase severe combined immune deficiency (ADA-SCID) in pediatric and adult patients.
What Are Side Effects of Revcovi?
Revcovi may cause serious side effects including:
- hives,
- difficulty breathing,
- swelling of your 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 your mouth or on your skin,
- problems with balance or walking, and
- problems with your teeth or gums
Get medical help right away, if you have any of the symptoms listed above.
Common side effects of Revcovi include:
- cough and
- vomiting
Dosage for Revcovi
The starting dose of Revcovi for patients transitioning from Adagen to Revcovi is 0.2 mg/kg weekly, intramuscularly.
Seek medical care or call 911 at once if you have the following serious side effects:
- Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
- Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in your chest; shortness of breath; and sudden dizziness, lightheadedness, or passing out;
- 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.
This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.
What Drugs, Substances, or Supplements Interact with Revcovi?
The starting dose of Revcovi for Adagen-naïve patients is 0.4 mg/kg weekly based on ideal body weight, divided into two doses (0.2 mg/kg twice a week), intramuscularly.
Revcovi During Pregnancy and Breastfeeding
Revcovi may interact with other drugs. Tell your doctor all medications and supplements you use. Tell your doctor if you are pregnant or plan to become pregnant before using Revcovi; it is unknown how it would affect a fetus. It is unknown if Revcovi passes into breast milk. Consult your doctor before breastfeeding.
Additional Information
Our Revcovi (elapegademase-lvlr) Injection, for Intramuscular Use Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
QUESTION
About how much does an adult human brain weigh? See AnswerGet emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:
- bleeding where the medicine was injected;
- other unusual bleeding (nosebleeds, bleeding gums);
- a seizure; or
- pale or yellowed skin, dark colored urine; or
- confusion or weakness.
The following symptoms may be signs of infection, which may indicate that elapegademase is not an effective treatment for you. Tell your doctor if you have:
- fever, chills, unusual tiredness;
- sore throat, sinus pain, swollen glands;
- skin warmth or swelling;
- stomach cramps, vomiting, or diarrhea;
- blood in your urine or stools;
- painful or difficult urination;
- breathing problems, cough with mucus;
- sores or white patches in your mouth or on your skin;
- problems with balance or walking; or
- problems with your teeth or gums.
Common side effects may include:
- vomiting; or
- cough.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
SLIDESHOW
Digestive Disorders: Common Misconceptions See SlideshowSIDE EFFECTS
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
REVCOVI was administered intramuscularly in two prospective, open-label, single-arm, multi-center studies to evaluate efficacy, safety, tolerability, and pharmacokinetics in patients with ADA-SCID: Study 1 was performed in the US and Study 2 was performed in Japan [see Clinical Studies]. Overall, 10 patients were treated and adverse reactions reported are summarized below.
Study 1
Study 1 is a one-way crossover study, conducted in the US, to evaluate the safety, efficacy, and pharmacokinetics of REVCOVI in patients with ADA-SCID who were receiving therapy with Adagen. Six patients, 8 to 37 years of age enrolled in the study. Patients’ exposure to REVCOVI ranged from 2 weeks to 146 weeks. No deaths were reported and one patient discontinued treatment due to injection site pain associated with an earlier drug product formulation that was consequently modified.
The most common adverse reactions were cough (3/6 patients) and vomiting (2/6 patients). Other adverse reactions that were reported in one patient each were: abdominal pain upper, arthralgia, asthenia, cerumen impaction, conjunctivitis, convulsion, dental caries, diarrhea, ear canal irritation, ear lobe infection, epistaxis, fatigue, fungal skin infection, gait disturbance, gastrointestinal infection, groin abscess, hematochezia, haemophilus infection (pulmonary), hemoptysis, influenza, injection site discomfort, laceration, lymphadenopathy, migraine, nasal edema, nausea, nephrolithiasis, oral candidiasis, oropharyngeal pain, otitis externa, productive cough, rash, stoma site infection, swelling face, tooth abscess, tooth extraction and upper respiratory tract infection, regardless of investigator causality assessment.
Study 2
Study 2 is a single-arm clinical study that was conducted to assess the safety, efficacy and pharmacokinetics of REVCOVI in patients with ADA-SCID. Four patients 3.4 months to 25 years of age, all Asian, were enrolled in the study and received REVCOVI. Three patients received REVCOVI for 21 weeks and one patient received REVCOVI for 15 weeks. One death due to CMV pneumonitis and respiratory failure was observed in an infant, who had also experienced pulmonary hemorrhage, respiratory failure and upper respiratory tract infection that represented serious adverse events. Neutropenia was a serious adverse reaction reported by one of the patients. There were 22 reported adverse events for four patients. Most common adverse events were respiratory infections (2/4 patients).
Immunogenicity
As with all therapeutic proteins, there is potential for immunogenicity. The immunogenicity results from Study 1 and Study 2 suggest that patients who previously received Adagen may present an immunologic response to REVCOVI. Therefore, monitoring for changes in ADA levels during REVCOVI treatment is recommended. [see DOSAGE AND ADMINISTRATION]
The observed incidence of antibodies (including neutralizing antibodies) is dependent on assay sensitivity and specificity, assay methodology, and concomitant medications. Therefore, the comparison of the incidence of antibodies to REVCOVI with the incidence of antibodies to other products may be misleading.
Postmarketing Experience With ADAGEN
The following postmarketing adverse reactions were voluntarily reported for Adagen, the same class of enzyme replacement therapy used in the treatment of ADA-SCID, and may also be seen with REVCOVI treatment:
- Hematologic: hemolytic anemia, auto-immune hemolytic anemia, thrombocythemia, thrombocytopenia and autoimmune thrombocytopenia
- Dermatological: injection site erythema, urticaria
- Lymphomas
Since these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Read the entire FDA prescribing information for Revcovi (Elapegademase-lvlr)
© Revcovi Patient Information is supplied by Cerner Multum, Inc. and Revcovi Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.
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