Description
Mometasone implant is used to treat chronic rhinosinusitis with nasal polyps (CRSwNP) in patients who have had surgery in their ethmoid sinus. This is a steroid medicine.
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:
- Implant
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 mometasone implant 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 mometasone implant 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. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
- Desmopressin
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Aspirin
- Atazanavir
- Bemiparin
- Carbamazepine
- Cobicistat
- Cosyntropin
- Darunavir
- Ethinyl Estradiol
- Fosphenytoin
- Insulin Aspart, Recombinant
- Lutetium Lu 177 Dotatate
- Macimorelin
- Nadroparin
- Nirmatrelvir
- Phenytoin
- Ritonavir
- Sargramostim
- Somatrogon-ghla
- Upadacitinib
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Auranofin
- Ketoconazole
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:
- Cataracts, history of or
- Glaucoma, history of or
- Increased pressure in the eye, history of—Use with caution. May make these conditions worse.
- Chickenpox (including recent exposure) or
- Herpes simplex (virus) infection of the eye or
- Infections (virus, bacteria, or fungus), any type of or
- Measles (including recent exposure) or
- Tuberculosis, active or history of—This medicine can reduce the body's ability to fight off these infections.
- Injury to the nose, recent or
- Nose surgery, recent or
- Sores or ulcers in the nose, recent—This medicine may prevent proper healing of these conditions.
- Liver disease, severe—Use with caution. The effects may be increased because of slower removal of the medicine from the body.
Proper Use
Your doctor will insert this medicine into one of your sinuses using a Delivery System. It will dissolve and slowly release the medicine for up to 90 days. Your doctor may also remove the implant at Day 90 or earlier.
Use saline irrigations (nasal wash) or nasal sprays regularly while having this implant.
Be extra careful when sneezing and avoid forceful nose blowing during treatment with this medicine. The implant softens over time and may accidentally be removed from your nose. Call your doctor right away if you think the implant has been removed from your nose.
Precautions
It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly and to check for unwanted effects.
This medicine may cause other nasal problems. Check with your doctor right away if you have bleeding, holes, infection, or irritation inside the nose.
Check with your doctor right away if blurred vision, difficulty in reading, or any other change in vision occurs during treatment with this medicine. Your doctor may want your eyes be checked by an ophthalmologist (eye doctor).
This medicine may cause serious allergic reactions, including angioedema, which can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash, itching, hoarseness, trouble breathing or swallowing, or any swelling of your hands, face, or mouth while you are using this medicine.
You may get infections more easily while using this medicine. Tell your doctor right away if you have been exposed to someone with chickenpox or measles. Also tell your doctor if you develop white patches or sores in your nose while you are using this medicine.
Using too much of this medicine or using it for a long time may increase your risk of having adrenal gland problems. Talk to your doctor right away if you have darkening of the skin, diarrhea, dizziness, fainting, loss of appetite, mental depression, nausea, skin rash, unusual tiredness or weakness, or vomiting.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
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
- Chest tightness
- chills
- cough producing mucus
- earache
- ear congestion
- feeling faint
- fever
- headache
- lightheadedness
- loss of voice
- noisy breathing
- nosebleeds
- pain or tenderness around the eyes and cheekbones
- redness or swelling in the ear
- sneezing
- sore throat
- stuffy or runny nose
- trouble breathing
Less common
- Blurred vision
- body aches or pain
- fast heartbeat
- hives, itching, skin rash
- hoarseness
- irritation
- joint pain, stiffness, or swelling
- muscle weakness
- redness of the skin
- swelling of the eyelids, face, lips, hands, or feet
- trouble swallowing
- unusual tiredness or weakness
Incidence not known
- Burning, redness, swelling, or irritation around or inside your nose
- darkening of the skin
- diarrhea
- dizziness
- eye pain
- loss of appetite
- mental depression
- nausea or vomiting
- sores or white patches inside the nose or mouth
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-20406744
