Description
Lebrikizumab-lbkz injection is used alone or in combination with other medicines (eg, topical corticosteroids) to treat moderate to severe atopic dermatitis in patients who have been treated with topical medicines that did not work well or who cannot use topical treatment.
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 lebrikizumab-lbkz injection in children younger than 12 years of age and in children 12 years of age and older weighing less than 40 kilograms (kg). 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 lebrikizumab-lbkz 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.
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Conjunctivitis (pink eye) or
- Keratitis (inflammation of the cornea of the eye)—Use with caution. May make these conditions worse.
- Parasitic infection—Use with caution. It is not known if this medicine may affect patients with this condition. Treat the infection first before using this medicine.
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 thigh, stomach area, or upper arm. This medicine may also be given at home to patients who do not need to be in a hospital or clinic. You or your caregiver may be trained to prepare and inject the medicine at home. Be sure that you understand how to use the medicine.
This medicine should come with a patient information leaflet and patient instructions. Read and follow these instructions carefully. Ask your doctor if you have any questions.
If you use Ebglyss™ at home, 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. Do not inject into skin areas that are tender, red, bruised, hard, or areas that is affected by eczema or other skin problems.
This medicine comes in 2 forms: a prefilled pen and prefilled syringe.
Allow the medicine to warm to room temperature for 45 minutes. Do not warm using heat sources (eg, microwave, hot water, sunlight).
To use the prefilled pen:
- Wash your hands with soap and water before and after using this medicine.
- Do not shake the pen.
- Check the liquid in the pen. It should be clear, colorless to slightly yellow to slightly brown. Do not use it if it is cloudy, discolored, or has particles in it. Do not use the pen if it looks damaged.
- Twist off the gray base cap. Do not put the cap back on. Do not touch the needle.
- Place and hold the clear base flat and firmly against the skin. Keep the clear base on the skin, then turn the lock ring to the unlock position.
- Press and hold the purple injection button and listen for two loud clicks. You will hear one "click" to let you know that the injection has started. It will take up to 15 seconds to inject the full dose. You will hear a second "click" when the gray plunger is visible. This means the injection is complete.
To use the prefilled syringe:
- Wash your hands with soap and water before and after using this medicine.
- Do not shake the syringe.
- Check the liquid in the syringe. It should be clear, colorless to slightly yellow to slightly brown. Do not use it if it is cloudy, discolored, or has particles in it. Do not use the syringe if it looks damaged or the needle cap is missing or not attached properly.
- Pull the needle cap straight off. Do not put the cap back on. Do not touch the needle.
- Gently pinch the skin with one hand. With your other hand, Insert the needle into the skin at about a 45 degree angle.
- Push the plunger rod all the way down. Lift your thumb to release the plunger rod until the needle is covered by the needle shield.
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 moderate to severe atopic dermatitis:
- For injection dosage form (prefilled pen or prefilled syringe):
- Adults and children 12 years of age and older weighing 40 kilograms (kg) or more—At first, 500 milligrams (mg) (two 250 mg injections) injected under the skin at Week 0 and Week 2; followed by, 250 mg every two weeks until Week 16; then, a maintenance dose of 250 mg every four weeks.
- Children younger than 12 years of age and children 12 years of age and older weighing less than 40 kg—Use and dose must be determined by your doctor.
- For injection dosage form (prefilled pen or prefilled syringe):
Missed Dose
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
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.
Protect the medicine from direct light. Keep the medicine in the original package until you are ready to use it. Do not use it if it has been frozen. You may store the prefilled pen or prefilled syringe at room temperature for up to 7 days. Throw the medicine away if it has been left out of the refrigerator for more than 7 days.
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 or your child's progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.
This medicine may cause serious allergic reactions, including angioedema and urticaria, which can be life-threatening and require immediate medical attention. Tell your doctor right away if you have itching, large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals, redness or the skin, or skin rash.
Check with your doctor right away if you have redness, irritation, or itching the of eye, eyelid, or inner lining of the eyelid. These could be symptoms of eye problems, including conjunctivitis or keratitis.
Do not have any live vaccines (immunizations) while you are being treated with lebrikizumab-lbkz. Check with your doctor before having any vaccines.
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
- Burning, dry, or itching eyes
- discharge, excessive tearing
- redness, pain, swelling of the eye, eyelid, or inner lining of the eyelid
Rare
- Black, tarry stools
- chest pain
- chills
- cough
- fever
- painful blisters on trunk of the body
- painful or difficult urination
- sore throat
- sores, ulcers, or white spots on the lips or in the mouth
- swollen glands
- trouble breathing
- unusual bleeding or bruising
- unusual tiredness or weakness
Incidence not known
- Eye redness, irritation, or pain
- itching skin
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- redness of the skin
- skin rash
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 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
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.
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