Description
Lerodalcibep-liga injection is used together with a proper diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C) in patients with hypercholesterolemia (high levels of cholesterol in the blood), including heterozygous familial hypercholesterolemia (HeFH).
This medicine is available only with your doctor's prescription.
Before Using
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:
Allergies
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.
Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of lerodalcibep-liga injection in the pediatric population. Safety and efficacy have not been established.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of lerodalcibep-liga injection in the elderly.
Drug Interactions
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.
Other Interactions
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.
Proper Use
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 back of the 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.
Lerodalcibep-liga 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.
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 scars or stretch marks. Do not inject with other injectable medicines at the same site. Do not inject through clothing.
To use the prefilled syringe:
- Wash your hands before and after using this medicine.
- Allow the medicine to warm to room temperature for at least 30 minutes before using it. Keep the prefilled syringe in the carton to protect from light. Do not warm it in any other way (eg, microwave). Do not shake it.
- Gently slide the plastic tray into the palm of your hand and peel off the paper seal with your other hand. Turn the plastic tray over and gently press the middle of the tray's back to release the prefilled syringe. Do not pick up or pull the prefilled syringe by the plunger rod or gray needle cap.
- Do not remove the gray needle cap until you are ready to inject it. Always hold the syringe by the barrel.
- Check the liquid in the prefilled syringe. It should be clear to brownish-yellow or amber. Do not use if it is cloudy or has particles in it. Do not use it if the seals are broken or if it has been dropped or damaged.
- Remove the needle cap. Do not twist the needle cap. Do not touch the plunger rod. Do not remove any air bubbles. Do not recap the syringe.
- Gently pinch a fold of the skin with one hand. Use a quick and dart-like motion to insert the needle into the skin at a 45 to 90-degree angle. Slowly push the plunger rod all the way down until it is empty.
Dosing
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.
- For injection dosage form (solution):
- For hypercholesterolemia:
- Adults—300 milligrams (mg) injected under your skin once a month.
- Children—Use and dose must be determined by your doctor.
- For hypercholesterolemia:
Missed Dose
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 is less than 7 days from your missed dose: Inject the dose and resume your original schedule.
If it is more than 7 days from your missed dose: Inject the dose and start a new monthly schedule using this date.
Storage
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.
If needed, you may also keep the medicine in the original carton at room temperature for up to 3 months. Throw away any unused medicine after 3 months.
Throw away used needles in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.
Precautions
It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.
Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
More common
- Fever
- headache
- muscle aches
- sore throat
- stuffy or runny nose
- unusual tiredness or weakness
Less common
- Bloating or swelling of face, arms, hands, lower legs, or feet
- rapid weight gain
- tingling of hands or feet
- unusual weight gain or loss
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
- 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
Less common
- Diarrhea
- nausea
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
DRG-80008580
