Description
Mepolizumab injection is used with other medicines to treat severe asthma. It is given to patients whose asthma is not controlled with their current asthma medicines. It is also used to treat eosinophilic granulomatosis with polyangiitis (EGPA) and hypereosinophilic syndrome (HES).
Mepolizumab injection is also used as an additional maintenance treatment for chronic rhinosinusitis with nasal polyps (CRSwNP) in patients whose disease is not controlled with nasal corticosteroids. This medicine is also used as an additional maintenance treatment for inadequately controlled chronic obstructive pulmonary disease (COPD) and a high number of blood eosinophils (a type of white blood cell that may contribute to COPD). This medicine is used to reduce the number of COPD flare-ups and helps improve breathing.
This medicine is to be given only by or under the direct supervision of your doctor.
This product is available in the following dosage forms:
- Solution
- Powder for Solution
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 mepolizumab injection to treat severe asthma in children younger than 6 years of age. Safety and efficacy have not been established.
Appropriate studies have not been performed on the relationship of age to the effects of mepolizumab injection to treat EGPA, CRSwNP, or COPD in the pediatric population. Safety and efficacy have not been established.
Appropriate studies have not been performed on the relationship of age to the effects of mepolizumab injection to treat HES in children younger than 12 years of age. 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 mepolizumab injection in the elderly. However, elderly patients are more likely to have age-related kidney, liver, or heart problems, which may require caution and an adjustment in the dose for patients receiving mepolizumab injection.
Breastfeeding
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.
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:
- Asthma attack or
- Bronchospasm or
- Chronic obstructive pulmonary disease (acute symptoms, uncontrolled, or worsening) or
- Status asthmaticus (severe asthma attack)—Should not be used in patients with these conditions.
- Parasitic infections—Should be treated first before receiving this medicine.
Proper Use
A nurse or other trained health professional will give you or your child this medicine. It is given as a shot under your skin, usually on the upper arms, stomach, or thigh once every 4 weeks.
Mepolizumab 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 or nurse will teach you how to inject the medicine. Be sure that you understand exactly how to use this.
This medicine comes with a patient information leaflet and patient instructions. Read and follow the instructions carefully . Ask your doctor if you have questions.
If you use this medicine 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 scars, moles, or skin areas that are red, bruised, tender, hard, or not intact.
This medicine is available in 2 forms. You may use a prefilled syringe or a prefilled autoinjector.
Allow the prefilled syringe or prefilled autoinjector to warm to room temperature 30 minutes before using it. Do not warm it in any other way (eg, microwave, hot water, direct sunlight).
Check the liquid in the prefilled syringe or prefilled autoinjector. It should be clear and colorless or slightly yellow to slightly brown. Do not use this medicine if it is cloudy or if there are particles in it. Do not use the prefilled syringe or autoinjector if it looks damaged, broken, or if it has been dropped.
Use all of the medicine in each prefilled syringe or autoinjector. Use each prefilled syringe and autoinjector only one time. Do not save an open syringe or autoinjector.
This medicine must be injected within 8 hours after removal from the carton. Throw away if not used within 8 hours.
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 forms (prefilled syringe or prefilled autoinjector):
- For severe asthma:
- Adults and children 12 years of age and older—100 milligrams (mg) injected under your skin once every 4 weeks.
- Children 6 to 11 years of age—40 mg injected under your skin once every 4 weeks.
- Children younger than 6 years of age—Use and dose must be determined by your doctor.
- For CRSwNP or COPD:
- Adults—100 milligrams (mg) injected under your skin once every 4 weeks.
- Children—Use and dose must be determined by your doctor.
- For EGPA:
- Adults—300 milligrams (mg) injected under your skin once every 4 weeks (given as 3 separate 100 mg injections injected 5 cm apart if given at the same injection site).
- Children—Use and dose must be determined by your doctor.
- For HES:
- Adults and children 12 years of age and older—300 milligrams (mg) injected under your skin once every 4 weeks (given as 3 separate 100 mg injections injected 5 cm apart if given at the same injection site).
- Children younger than 12 years of age—Use and dose must be determined by your doctor.
- For severe asthma:
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 this medicine from direct light. Keep it in its original package until you are ready to use it. Do not shake. You may also keep an unopened carton at room temperature for up to 7 days. Throw away any medicine left out of the refrigerator for more than 7 days.
Throw away used syringes in a hard, closed container where 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 that this medicine is working properly and to check for unwanted effects.
Serious allergic reactions, including anaphylaxis and angioedema, which can be life-threatening and requires immediate medical attention. Tell your doctor right away if you or your child have cough, rash, itching skin, large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after using this medicine.
This medicine will not stop an asthma attack that has already started. Your doctor may prescribe another medicine for you to use in case of an asthma attack.
This medicine may lead to herpes zoster infection (shingles). You may receive a vaccine before you start treatment. Tell your doctor if you have not had either chickenpox or the chickenpox vaccine.
If you are using a steroid medicine for your asthma, do not suddenly stop taking it without first checking with your doctor. You may need to slowly decrease your dose before stopping it completely.
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:
Incidence not known
- Blurred vision
- chest tightness
- confusion
- cough
- difficulty swallowing
- difficulty with breathing
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- fast heartbeat
- hives or welts, itching, or skin rash
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- noisy breathing
- painful blisters on the trunk of the body
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- redness of the skin
- sweating
- unusual tiredness or weakness
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
- 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
- difficulty in moving
- headache
- joint pain
- muscle pain or stiffness
- sore throat
Less common
- Arm or leg pain
- bladder pain
- bloody or cloudy urine
- chills
- diarrhea
- difficult, burning, or painful urination
- fever
- frequent urge to urinate
- general feeling of discomfort or illness
- loss of appetite
- lower back or side pain
- muscle aches or spasms
- nausea
- runny nose
- shivering
- skin rash, encrusted, scaly, and oozing
- sweating
- trouble sleeping
- upper abdominal or stomach pain
- vomiting
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-20165216
