Description
Reslizumab injection is used with other medicines for the maintenance treatment of severe asthma in patients with an eosinophilic phenotype. This medicine may reduce blood eosinophils. Eosinophils are a type of white blood cell.
This medicine is to be given only by or under the supervision of your doctor.
This product is available in the following dosage forms:
- 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
Use of reslizumab injection is not indicated 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 reslizumab injection in the elderly.
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, acute exacerbation or
- Bronchospasm, acute—Should not be used in patients with these conditions.
- Parasitic (helminth) infection—Should be treated first before using this medicine.
Proper Use
A nurse or other trained health professional will give you this medicine in a hospital. This medicine is given through a needle placed in one of your veins. It is usually given every 4 weeks. The medicine must be injected slowly, so your IV tube will need to stay in place for 20 to 50 minutes.
This medicine should come with a patient information leaflet. Read and follow these instructions carefully. Ask your doctor if you have any questions.
Precautions
Your doctor will check your progress closely while you are receiving this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to receive it and to check for unwanted effects.
This medicine may cause serious allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Tell your doctor right away if you have a rash, itching, lightheadedness, dizziness, or fainting, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are using this medicine.
Keep using your corticosteroid medicine to control your asthma, in addition to this medicine. This includes steroid medicines that are taken by mouth or inhaled (including cortisone, fluticasone, prednisone).
Using this medicine may increase your risk of getting skin cancer. Talk to your doctor if you have concerns about this risk.
It is important to tell your doctor that you are pregnant while you are receiving this medicine.
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 or nurse immediately if any of the following side effects occur:
Rare
- Cough
- difficulty with swallowing
- dizziness
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- fast heartbeat
- hives, itching, or skin rash
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- redness of the skin
- tightness in the chest
- 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:
Less common
- Throat pain
Incidence not known
- 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
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.
CON-XXXXXXXX
