Are you currently using Repatha? Or perhaps, consider to start using it? Well before taking any decision, it will be better to know more information about Repatha side effects along with its other details.
Repatha is a brand name of evolocumab type of medicine. It specifically works as liver helper to reduce the levels of low-density lipoprotein or LDL, often refers to ‘bad’ cholesterol, which circulates in one’s blood.
Repatha is used along with a low-fat diet and other cholesterol-reducing medications in people with heterozygous or homozygous familial hypercholesterolemia. Both familial hypercholesterolemias are the inherited types of high cholesterol which can cause high blood levels of LDL and can be the cause of plaque building up inside the arteries.
People with atherosclerosis or arteriosclerosis also use Repatha. Atherosclerosis or arteriosclerosis is heart or blood vessel problems caused by plaque that harden or build up in the arteries. But, it’s unknown if Repatha can lower the risk of heart attack, stroke, or other heart complications in people with high blood levels of cholesterol.
Now, one question emerges as we know how good this medicine is related to reducing high cholesterol level: what are Repatha side effects? Don’t worry; we will discuss the matter in this article. Along with its side effects, how to take the medicine, dosage, and warnings that follow will also be included in the topic.
Repatha Side Effects; Precaution
Repatha shouldn’t be used by anyone who has allergy to it or by anyone younger than 13 years old without prescriptions. Taking the medicine without advice from healthcare providers only worsen the Repatha side effects on its users. Here are the things you should tell your doctors to make sure that this medicine is safe for you.
- If you have kidney or liver disease,
- If you have allergy to latex,
- If you are pregnant or planning to be pregnant at the moment, because it’s still unknown whether Repatha can harm an unborn baby or not,
- If you are breastfeeding a baby since it’s also still unknown whether the medicine will pass into breast milk or not.
Take Repatha precisely as it was prescribed to you. Depend on the amount of dose given to you, Repatha is generally taken once or twice a month. You may separately use up to three injections at one time.
Follow all the instructions and directions on your prescription package and label. Do not increase or lessen the dosage amount without doctors’ advice since there’re Repatha side effects you should concern about.
- Repatha is injected beneath the skin. You may inject the medicine yourself with the information of how to do it from your doctor.
- Repatha is available in a SureClick prefilled autoinjector. Besides that it is also available in a Pushtronex on-body infusor with prefilled cartridge, or a prefilled syringe.
- With a SureClick autoinjector or a prefilled syringe, you may take up to 15 seconds to inject the medicine. If you have to use more than one injection at a time, be sure to finish all of them in no more than 30 minutes.
- The Pushtronex on-body infusor is a special hands-free device placed on the skin that needs around 9 minutes to slowly deliver a full dose of Repatha. During that time, you can do activities like bending, reaching, or walking.
- Doctors will explain about where the perfect places in your body to inject the medicine or to place the on-body infusor. Do not use the same place twice in a row each time you give an injection.
- The prefilled syringe, injection device, or cartridge is single-use. Dispose it immediately after one use. But you can’t throw the entire medical disposal away randomly. You have to use a puncture-proof ‘sharps’ disposal container. Keep the container away from your children and pets’ reach.
- It’s safer to store Repatha in the refrigerator in its original box and protect it from heat and light. But do not freeze. Throw away any frozen medicine.
- Let the medicine cool down at room temperature for 30 to 45 minutes before you use it. Do not heat the injection device.
- If stored at cool room temperature, use it in no more than 30 days.
- Do not drop the injection device or do not use the dropped injection device.
- Do not shake the medicine.
- Do not use the medicine if it has particles in it or has changed colors.
- Do not stop taking Repatha without advice from your doctor. Otherwise, your LDL levels may rise.
- Do not inject Repatha into sore, bruised, hardened, or scarred skin.
Repatha Side Effects; Dose
The usual dose for adult with hyperlipidemia is as follows:
- 140 mg subcutaneously every 2 weeks using prefilled syringe or prefilled SureClick autoinjector, or
- 420 mg subcutaneously once a month using Pushtronex system (on-body infusor with prefilled cartridge)
The medicine with such dose shouldn’t be given in patients without atherosclerotic cardio vascular disease or familial hypercholesterolemia. Or, the Repatha side effects may occur worse than they should be.
While the usual dose for adult with homozygous familial hypercholesterolemia is as follows:
- 420 mg subcutaneously once a month
Measure low density lipoprotein cholesterol (LDL-C) levels every 4 to 8 weeks after start using the drug.
If you miss a dose, use the missed dose within 7 days after the due injection time. Skip the missed dose if you pass more than 7 days for the injection.
Repatha Side Effects
Besides causing the expected effects of reducing the high blood levels of bad cholesterol, Repatha may also cause unwanted side effects. The side effects of Repatha are categorized as common and major effects which you should get medical help if you have them.
While common Repatha side effects themselves are distinguished into more common and less common side effects. These effects occurred may not need any medical attention. They will disappear in time your body has adapted with the medicine work.
While allergic reactions to Repatha are:
- Hives, severe itching, or rash,
- Having difficulty with swallowing or breathing,
- Swelling of your face, tongue, throat, eyes, inside of the nose, or lips,
- Skin reddening, especially around the ears,
- Unusual weakness or tiredness.
Repatha Side Effects for Specific Populations
There are no data available related to the risk of using Repatha in pregnant women.
“In the animal reproduction studies, there were no effects on pregnancy. It also shows no effects on neonatal/infant development when monkeys were subcutaneously administered evolocumab from organogenesis through parturition at dose exposures up to 12 times results the exposure at the maximum recommended human dose of 420 mg for every month. In a similar study with another drug in the PCSK9 inhibitor antibody class, humoral immune suppression was observed in infant monkeys exposed to that drug in utero at all doses. You should know that the exposures where immune suppression occurred in infant monkeys were greater than those expected clinically. No assessment for immune suppression was conducted with evolocumab in infant monkeys. Measurable evolocumab serum concentrations were observed in the infant monkeys at birth at comparable levels to maternal serum, indicating that evolocumab, like other IgG antibodies, crosses the placental barrier.” (Drugs.com)
PCSK9 is proproteinconvertase subtilisin kexin 9
IgG is immunoglobulin G
The entire experiment implies that evolocumab in the brand of Repatha is safe to be used in pregnant women as the monoclonal antibodies are unlikely crossing the placenta in the first trimester.
However, the opposite occurrence is likely to happen in increasing amounts in the second and third trimeseter. All in all, the choice to use ‘likely’ and ‘unlikely’ words emphasize that there are no such things to ensure what really will happen.
Therefore, consider the benefits and risks like Repatha side effects to the fetus before prescribing the medicine to pregnant women.
There are also no data regarding any harm Repatha can cause to human milk, breastfed infant, or milk production. But still, it will be best to consider the breastfeeding health benefits and development before prescribing the medicine on breastfeeding women.
3. Pediatric Use
The Repatha safety and effectiveness in adolescents (ages 13 to 17 years old) were established and it was confirmed to be generally similar to that observed among adult patients with HoFH (homozygous familial hypercholesterolemia).
Also, the Repatha are safe and effective in pediatric patients with HoFH who are younger than 13 years old and in pediatric patients with primary hyperlipidemia or HeFH weren’t established yet.
4. Geriatric Use
There are no differences in Repatha safety and effectiveness between 1420 patients in the ages of more than 65 years old and younger patients. But we can’t rule out the greater sensitivity of the elderly.
5. Renal Impairment
No need to adjust the dose for patients with mild to moderate renal impairment.
6. Hepatic Impairment
There is also no need to adjust the dose for patients with mild to moderate hepatic impairment.
Potential Advantages and Disadvantages
Before Repatha is invented, people with high levels of bad cholesterol were treated with complicated therapy they didn’t obey which led them failed to achieve an optimal LDL-C of 100 mg/dL. At least, one in ten cardiovascular disease (CVD) events is directed right to disobedience.
Now, with the latest breakthrough in cardiology – Repatha – people with HoFH or HoFH can be treated easily with only injections that they get either once a month or once every two weeks.
Furthermore, they can do the treatment by themselves at home. The only disadvantage besides the possible occurrences of Repatha side effects is that it’s more costly than the current standard lipid-modifying therapy (LMT) treatment option.
Like has been mentioned above, before Repatha is invented, people with high cholesterol are treated with therapy. Apparently, the therapy involves Statins, the most common medications types used to help reduce cholesterol.
While Repatha is injected under the skin, Statins are taken by mouth. They come in the form of capsules or tablets. There are many types of Statins available today, including:
- Atorvastatin (Lipitor),
- Flustatin (Lescol),
- Lovastatin (Altoprev),
- Pravastatin (Pravachol),
- Rosucastatin (Crestor),
- Simvastatin (Zocor), and
- Pitavastatin (Livalo).
Unlike Repatha that can only be prescribed for certain types of people, Statins can be given to any people with high cholesterol. And since Statins has existed for much longer time (available since 1980s) than Repatha (approved by FDA in 2015), many people know how effective Statins are despite the difficulty they are used in therapy.
On the other hand, since Repatha is newer, it has much less long-term safety data. Also, the cost of Repatha is much more expensive compared to Statins.
And their major effects are liver damage, increased blood glucose levels, higher risk of type 2 diabetes, cognitive (mental) problems, and muscle damage leading to rhabdomyolysis.