Evolocumab (subcutaneous)

Overview

Heart disease is one of the leading causes of death worldwide, and for those whose heart disease is linked to cholesterol oral medications are often not sufficient to combat the condition. Evolocumab is an injectable medication composed of a human monoclonal antibody that works on the human liver to reduce levels of low-density lipoprotein (LDL) cholesterol circulating in the bloodstream. Evolocumab is marketed under the brand name Repatha and only available with a prescription. Evolocumab is used as part of a greater treatment plan that includes a low-fat diet and other cholesterol-lowering oral medications. It is primarily utilized to treat patients who suffer from a hereditary condition known as homozygous or heterozygous familial hypercholesterolemia. The condition contributes to heart disease by increasing levels of LDL cholesterol which can cause a variety of circulatory system problems including plaque build-up in the arteries.

When used as directed as part of a broader treatment plan, Evolocumab injections can significantly reduce the risk of conditions ranging from heart attacks to strokes in patients who are suffering from high cholesterol. However, it is important to note that is should not be used as a sole treatment of this disorder and the importance of diet changes and compliance with all other prescription use is crucial to preventing the consequences of heart disease.

Conditions Treated

  • Heart Disease
  • High Cholesterol

Type Of Medicine

  • Monoclonal antibody

Side Effects

Evolocumab injections have a certain risk of side effects that may occur in some patients along with the intended result of lowering LDL cholesterol. These will vary and may not necessarily occur at all, but if they do they may merit medical attention. Some of the more serious side effects have an instance that is not known but have occurred in some patients. If any of these serious side-effects emerge while using Evolocumab the patient should seek immediate medical care. Some patients have complained of severe weakness including a difficulty breathing or swallowing. Other patients have become nauseous while using Evolocumab and experienced high fevers. Some skin conditions have been reported as well including reddening of the skin, swelling of the facial area, hives, itching, and rashes.

Along with these serious side effect, there are some side effects that may not need medical attention because they are temporary and expected side effects of the body adjusting to the dose of Evolocumab. Such side effects are expected to subside as the body gets used to taking the medication. If these side effects are more intense or last longer than expected they should be reported to the prescribing physician as this could indicate a more serious medical condition.

Some of the more common temporary side effects include:

  • Back pain
  • Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
  • Body aches or pain
  • Chills
  • Cough
  • Ear congestion
  • Headache
  • Loss of voice
  • Muscle aches
  • Sneezing
  • Sore throat
  • Stuffy or runny nose

Along with these routine side effects, there are others that are less common but also considered temporary. These side effects include:

  • Abdominal or stomach pain
  • Bladder pain
  • Bloody or cloudy urine
  • Blurred vision
  • Diarrhea
  • Difficult, burning, or painful urination
  • Difficulty moving
  • Dizziness
  • Frequent urge to urinate
  • Loss of appetite
  • Lower back or side pain
  • Muscle aching or cramping
  • Muscle or joint pain
  • Muscle stiffness
  • Nervousness
  • Pain or tenderness around the eyes and cheekbones
  • Pounding in the ears
  • Slow or fast heartbeat
  • Swollen joints

In addition to these side effects, other side effects may occur in some patients. While this is not an all-inclusive list it does include the most notable side-effects. If symptoms occur that are not on this list the patient should have them examined by a doctor as soon as possible.

Dosage

As an injectable medication, Evolocumab is given as a subcutaneous shot directly under the skin in the area of the abdomen, thighs, or upper arms. While this may be administered by a medical professional, a patient may need to maintain and use the medicine at home. In this case, patients or caregivers should be trained and prepared on how to inject the dose of Evolocumab. It is very important to understand how to perform the injection and in what parts of the body it can be injected to prevent complications.

Depending on the patient's prescription, they may have single-dose prefilled syringes, autoinjectors, or a worn infusor with a prefilled cartridge. Which method is used will depend on several factors including the patient's overall health and the severity of their heart disease. Patients need to use a different part of the body for each injection and keep track of the last body part to receive the injection. Failure to rotate injection sites can result in skin problems or even infections. Care must also be taken not to inject it into areas that have broken skin, scar tissue, stretch marks, infections, or other unusual skin conditions.

A patient receiving the 420mg dose may have it slowly injected over 9 minutes by using the auto-infusor of with three consecutive injections within a half hour using the other injection methods. Prior to any injections, the autoinjector or syringe should be removed from any refrigeration and permitted to reach room temperature for at least a half hour prior to injection. If using the infusor it should be room temperature for no less than 45 minutes before use. This medicine should not be artificially heated or shaken prior to use. Each autoinjector pen or syringe should only be used once at a time and should be disposed of immediately after use. As this medication has a complicated injectable dosing method, patients should read all materials and instructions that come with the prescription very carefully before use.

The amount of medication that is taken will depend on what is prescribed by the doctor and may vary from directions given by the manufacturer. This may be as a result of a number of factors that are not taken into account by the average recommendations. In the event that the prescription contradicts these recommendations the prescription should be followed. Do not change doses or cease using this medication without a doctor's guidance.

Patients using injections for primary hyperlipidemia will receive either 140mg doses injected under the skin every two weeks or 420mg doses once per month. Children who need this medication can only do so under the guidance of a pediatrician. For patients treating homozygous familial hypercholesterolemia the adult dose is 420mg injected monthly. Patients under the age of 13 years old must have their dose determined by a pediatric physician. This medication is given on a very fixed schedule and if a dose is missed the patient for more than 7 days then they need to contact the prescribing physician for further guidance. In the event that the dose is taken within 7 days of missing it the original schedule is to be resumed.

Interactions

Some medicines should not be used at the same time as Evolocumab as a result of potential complications that can arise from drug interactions. In some cases, however, it is medically necessary for the doses to be taken together. In these cases, certain precautions can be taken such as changing doses or staggering dosing schedules. Patients need to ensure that their physician is aware of all prescription and non-prescription medication that is being taken as some may have a known drug interaction with Evolocumab. Additionally, Evolocumab may have a poor reaction to consumption of products such as alcohol, tobacco, or certain foods. Use of these products should be discussed with the prescribing physician in depth along with alterations to the patient's diet that will be necessary for the treatment to be successful in lowering LDL cholesterol.

Warnings

Use of Evolocumab comes with certain precautions that need to be observed while using this medication for treatment of high cholesterol. During the course of treatment, it will be very important to make all doctors appointments for regular examinations so that the doctor can monitor progress and ensure the medicine is working in the way it was intended when prescribed. Regular blood tests will be necessary to ensure a stable LDL count. The medication may need to be changed or discontinued if it is not working as intended, interacting with other drugs, or producing unwanted side effects.

When giving injections the injectable pen or syringe needs to be closely inspected before being used for an injection. Do not use an injectable that is open or has changed color. If there is anything unusual about the liquid such as particles or solids floating in it the injectable should not be used and should be disposed of. Along with a treatment plan that includes Evolocumab, the patient needs to observe a low-fat, low-sugar, and low cholesterol diet during the course of treatment. Any special orders from the prescribing doctor need to be carefully followed in order to have a successful treatment.

Evolocumab has been known to cause a severe allergic reaction in some patients. Any of the symptoms that may indicate this reaction need to be taken very seriously and emergency medical care should be immediately summoned. Symptoms of this allergic reaction include skin reactions such as itching around the injection site, redness of the skin, a spreading rash, difficulty breathing or swallowing, nausea, fatigue, and facial swelling that can close eyes or nasal passages. Additionally, patients with a known allergy to latex should not use the prefilled syringe or autoinjector pen as the needle cover contains a derivative of latex. In the case of such an allergy, an alternative single-use infusor system should be used instead.

Storage

As an injectable medication, Evolocumab should be stored with great care. The storage space needs to be far out of the reach of children who could accidentally inject the medication or be harmed by the sharps. This medication needs to be refrigerated until it is ready for use, but it should not at any point be frozen. If the medication is not refrigerated it can be maintained in its original carton at room temperature for not more than 30 days before it needs to be disposed of. Any used needles need to be disposed of in an appropriate hard-sided container that needs to be kept in as secure a location at the medication to ensure children and pets are not harmed by the sharps. Once the medication is no longer needed or expired it should be disposed of in accordance with local guidelines regarding the disposal of medical waste.

Summary

Evolocumab is often prescribed to patients who are in desperate straits and struggling with a potentially fatal bout with heart disease caused by their inherited condition. Although it is not effective in treating this condition when prescribed alone, it can be highly effective when it is part of a comprehensive treatment plan that includes other cholesterol-lowering medications and additional remedies of diet and exercise.