Evkeeza
- Generic Name: evinacumab-dgn for injection
- Brand Name: Evkeeza
Evkeeza (Evinacumab-dgn for Injection) side effects drug center
Evkeeza Side Effects Center
What Is Evkeeza?
Evkeeza (evinacumab-dgnb) is an ANGPTL3 (angiopoietin-like 3) inhibitor indicated as an adjunct to other low-density lipoprotein-cholesterol (LDL-C) lowering therapies for the treatment of adult and pediatric patients, aged 12 years and older, with homozygous familial hypercholesterolemia (HoFH).
What Are Side Effects of Evkeeza?
Side effects of Evkeeza include:
- common cold, • influenza-like illness, • dizziness, • runny nose, and • nausea
Dosage for Evkeeza
The recommended dose of Evkeeza is 15 mg/kg administered by intravenous (IV) infusion once monthly (every 4 weeks).
Evkeeza In Children
The safety and effectiveness of Evkeeza as an adjunct to other LDL-C-lowering therapies for the treatment of HoFH have been established in pediatric patients aged 12 years and older.
The safety and effectiveness of Evkeeza have not been established in pediatric patients with HoFH who are younger than 12 years old.
What Drugs, Substances, or Supplements Interact with Evkeeza?
Evkeeza may interact with other medicines.
Tell your doctor all medications and supplements you use.
Evkeeza During Pregnancy and Breastfeeding
Tell your doctor if you are pregnant or plan to become pregnant before using Evkeeza; it may harm a fetus. Pregnancy testing is advised in patients who may become pregnant prior to starting treatment with Evkeeza. Patients who may become pregnant should use effective contraception during treatment with Evkeeza and for at least 5 months following the last dose. It is unknown if Evkeeza passes into breast milk. Consult your doctor before breastfeeding.
Additional Information
Our Evkeeza (evinacumab-dgnb) Injection, for Intravenous 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.
Evkeeza Consumer Information
Get emergency medical help if you have signs of an allergic reaction: hives, rash, itching; feeling light-headed; wheezing, difficult breathing; swelling of your face, lips, tongue, or throat.
Some side effects may occur during the injection. Tell your caregiver if you feel nauseated, itchy, feverish, or have a stuffy nose or muscle weakness.
Your evinacumab treatments may be delayed or permanently discontinued if you have certain side effects.
Common side effects may include:
- cold or flu symptoms such as fever, chills, body aches, stuffy nose, sneezing, sore throat;
- dizziness;
- pain in your arms or legs;
- nausea; or
- lack of energy.
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.
Read the entire detailed patient monograph for Evkeeza (Evinacumab-dgn for Injection)
Evkeeza Professional Information
SIDE EFFECTS
The following clinically significant adverse reactions are described elsewhere in the labeling:
- Hypersensitivity Reactions [see WARNINGS AND PRECAUTIONS]
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.
Safety data are based on pooled results from two randomized, double-blind, placebocontrolled trials that included 81 patients treated with EVKEEZA. The mean age of EVKEEZA-treated patients was 48 years (range: 15 to 75 years), 52% were women, 5% were Hispanic, 82% were White, 7% Asian, 3% Black, and 9% Other. Forty-four (54%) EVKEEZA-treated patients had HoFH. Patients received EVKEEZA as add-on therapy to other lipid-lowering therapies, including maximally tolerated statin, ezetimibe, PCSK9 inhibitors, lomitapide, and apheresis.
Adverse reactions led to discontinuation of treatment in 2 (2%) patients treated with EVKEEZA, including 1 case of anaphylaxis, and 1 (2%) patient who received placebo. The most common adverse reactions (reported in greater than 3% of EVKEEZA-treated patients and more frequently than in placebo) are shown in Table 1.
Table 1: Adverse Reactions Occurring in >3% of Patients Treated with EVKEEZA and Greater than Placebo in 24-Week, Pooled, Placebo-Controlled Trials
| Adverse Reactions | Placebo (N = 54) % | EVKEEZA (N = 81) % |
| Nasopharyngitis | 13% | 16% |
| Influenza like illness | 6% | 7% |
| Dizziness | 0% | 6% |
| Rhinorrhea | 0% | 5% |
| Nausea | 2% | 5% |
| Pain in extremity | 0% | 4% |
| Asthenia | 0% | 4% |
Other adverse reactions occurring in less than 3% of patients treated with EVKEEZA and greater than placebo included constipation, upper respiratory tract infection, nasal congestion, and abdominal pain.
Transient, mild to moderate decreases in diastolic blood pressure and increases in heart rate occurred in clinical trials of EVKEEZA infusion but did not require intervention and resolved post-infusion.
Serious Hypersensitivity Reactions
Anaphylaxis was reported in 1 (1%) patient treated with EVKEEZA and 0% in patients who received placebo.
Infusion Reactions
Infusion reactions were reported in 6 (7%) patients treated with EVKEEZA and in 2 (4%) patients who received placebo. The following infusion reactions occurred in EVKEEZAtreated patients: infusion site pruritus, pyrexia, muscular weakness, nausea, and nasal congestion.
Immunogenicity
As with all therapeutic proteins, there is potential for immunogenicity. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies to EVKEEZA in the studies described below with the incidence of antibodies in other studies or to other products may be misleading.
No patients developed treatment-emergent antibodies to EVKEEZA.
Read the entire FDA prescribing information for Evkeeza (Evinacumab-dgn for Injection)
&Copy; Evkeeza Patient Information is supplied by Cerner Multum, Inc. and Evkeeza Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.