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Evolocumab (subcutaneous route)

Fáanleg vörumerki

Repatha

Um þetta lyf

Evolocumab injection is used together with a proper diet, alone or together with other medicines (eg, ezetimibe, statins), to treat patients with heterozygous familial hypercholesterolemia (also called primary hyperlipidemia) or with homozygous familial hypercholesterolemia (HoFH), who need additional lowering of their LDL cholesterol. It is also used in patients with a heart and blood vessel disease to reduce the risk of heart attack, stroke, and certain types of heart surgery. This medicine is a PCSK9 (proprotein convertase subtilisin kexin type 9) inhibitor. This medicine is available only with your doctor's prescription. This product is available in the following dosage forms:

Áður en þú notar þetta lyf

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered: Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully. Appropriate studies have not been performed on the relationship of age to the effects of evolocumab injection in children younger than 10 years of age with HoFH and primary hyperlipidemia. Safety and efficacy have not been established. Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of evolocumab injection in the elderly. However, elderly patients are more sensitive to the effects of this medicine than younger adults. There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding. Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine. Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Hvernig á að nota þetta lyf

A nurse or other trained health professional will give you this medicine. It is given as a shot under your skin, usually in the stomach, thighs, or upper arms. This medicine comes with a patient information leaflet and patient instructions. Read instructions before starting this medicine and with each refill. New information may be given. Follow these instructions carefully. Ask your doctor or pharmacist if you have any questions. Evolocumab injection may sometimes be given at home to patients who do not need to be in the hospital or clinic. If you are using this medicine at home, your doctor will teach you how to prepare and inject the medicine. Be sure that you understand exactly how to use the medicine. This medicine comes in 3 forms: asingle-dose prefilled pen (autoinjector),single-dose prefilled syringe, and asingle-use Pushtronex® system(on-body infusor with prefilled cartridge). Your doctor will prescribe the type and dose that is right for you. You will be shown the body areas where this shot can be given. Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas. This will help prevent skin problems from the injections. Do not inject on skin areas that are bruised, hard, red, or tender or have cuts, scrapes, infection, scars, or stretch marks. If you are receiving the 420 milligrams (mg) dose of Repatha®, it can be given: over 5 minutes by using the single-use Pushtronex® system, or by 3 injections consecutively within 30 minutes using the single use prefilled syringe or autoinjector. The autoinjector pen or prefilled syringe should be removed from the refrigerator and be allowed to reach room temperature forat least 30 minutesbefore using, or forat least 45 minutesfor single-use Pushtronex® system. Do not shake the medicine. Use each autoinjector pen or syringe only one time. Do not save an open pen or syringe. If the medicine in the pen or syringe has changed color, or if you see particles in it, do not use it. In addition to this medicine, your doctor may change your diet to one that is low in fat, sugar, and cholesterol.Carefully follow your doctor's order about any special diet. The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so. The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine. This medicine needs to be given on a fixed schedule. If you miss a dose or forget to use your medicine, call your doctor or pharmacist for instructions. If it isless than 7 days from your missed dose:Inject the dose and resume your original schedule. If it ismore than 7 days from your missed dose and you are using an every-2-week-dose:Wait until your next dose on the original schedule. If it ismore than 7 days from your missed dose and you are using a once-a-month-dose:Inject the dose and start a new schedule using this date. Keep out of the reach of children. Do not keep outdated medicine or medicine no longer needed. Ask your healthcare professional how you should dispose of any medicine you do not use. Store in the refrigerator. Do not freeze. You may also keep the medicine in the original carton at room temperature for up to 30 days. Throw away any unused medicine within 30 days. Throw away used needles in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.

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