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Nasacort HFA
Overview
What is Nasacort HFA?
Triamcinolone acetonide, USP, the active ingredient in , is a glucocorticosteroid with a molecular weight of 434.5, the chemical designation 9-Fluoro-11β,16α,17,21-tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17-acetal with acetone (CHFO), and the following chemical structure:
Triamcinolone acetonide is a white to cream-colored crystalline powder, practically insoluble in water, very soluble in dehydrated alcohol, chloroform, and methyl alcohol.
Nasacort HFA Nasal Aerosol is a metered-dose aerosol unit containing a microcrystalline suspension of triamcinolone acetonide in tetrafluoroethane (HFA-134a) and dehydrated alcohol USP 0.7% w/w. Each canister contains 15 mg of triamcinolone acetonide.
The canister must be primed with 3 actuations prior to the first use or after a period of non-use (3 days). After priming, each actuation meters 100 mcg of triamcinolone acetonide in 65 mg of suspension from the valve and delivers 55 mcg of triamcinolone acetonide from the nasal actuator to the patient. If the product is not used for more than 3 days, it should be re-primed with 3 actuations.
Each 9.3 g canister of Nasacort HFA Nasal Aerosol provides 100 metered sprays. After 100 metered sprays, this amount of medication delivered per actuation may not be consistent and the unit should be discarded. Patients are provided with a check-off card to track usage as part of the tear-off sheet.
What does Nasacort HFA look like?
What are the available doses of Nasacort HFA?
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What should I talk to my health care provider before I take Nasacort HFA?
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How should I use Nasacort HFA?
Nasacort HFA Nasal Aerosol is indicated for the treatment of the nasal symptoms of allergic rhinitis (seasonal and perennial) in adults and children 6 years of age and older.
Safety and effectiveness of Nasacort HFA Nasal Aerosol in children below 6 years of age have not been adequately established.
What interacts with Nasacort HFA?
Nasacort HFA Nasal Aerosol is contraindicated in patients with a hypersensitivity to any of the ingredients.
What are the warnings of Nasacort HFA?
In late pregnancy, as with other NSAIDs, meloxicam should be avoided because it may cause premature closure of the ductus arteriosus.
The replacement of a systemic corticosteroid with a topical corticosteroid can be accompanied by signs of adrenal insufficiency and, in addition, some patients may experience symptoms of withdrawal, e.g., joint and/or muscular pain, lassitude, and depression. Patients previously treated for prolonged periods with systemic corticosteroids and transferred to topical corticosteroids should be carefully monitored for acute adrenal insufficiency in response to stress. In those patients who have asthma or other clinical conditions requiring long-term systemic corticosteroid treatment, too rapid a decrease in systemic corticosteroids may cause a severe exacerbation of their symptoms.
The concomitant use of intranasal corticosteroids with other inhaled corticosteroids could increase the risk of signs or symptoms of hypercorticism and/or suppression of the HPA axis.
Persons who are using drugs that suppress the immune system are more susceptible to infections than healthy individuals. Chickenpox and measles, for example, can have a more serious or even fatal course in susceptible children or adults using corticosteroids. In children or adults who have not had these diseases or been properly immunized, particular care should be taken to avoid exposure. How the dose, route, and duration of corticosteroid administration affect the risk of developing a disseminated infection is not known. The contribution of the underlying disease and/or prior corticosteroid treatment to the risk is also not known. If exposed to chickenpox, prophylaxis with varicella zoster immune globulin (VZIG) may be indicated. If exposed to measles, prophylaxis with pooled intramuscular immunoglobulin (IG) may be indicated. (See the respective package inserts for complete VZIG and IG prescribing information.) If chickenpox develops, treatment with antiviral agents may be considered.
Avoid spraying in eyes.
What are the precautions of Nasacort HFA?
General
Intranasal corticosteroids may cause a reduction in growth velocity when administered to pediatric patients (see ).
Triamcinolone acetonide administered intranasally has been shown to be absorbed into the systemic circulation in humans. Patients with active rhinitis showed absorption similar to that found in normal volunteers.
Rarely, immediate hypersensitivity reactions or contact dermatitis occur after the administration of Nasacort HFA Nasal Aerosol. Rare instances of wheezing, nasal septum perforation, cataracts, glaucoma, and increased intraocular pressure have been reported following the intranasal application of corticosteroids, including triamcinolone acetonide. Because of the inhibitory effect of corticosteroids on wound healing in patients who have experienced recent nasal septal ulcers, nasal surgery or trauma, a corticosteroid should be used with caution until healing has occurred.
In clinical studies with triamcinolone acetonide administered intranasally, the development of localized infections of the nose and pharynx with has rarely occurred. When such an infection develops, it may require treatment with appropriate local or systemic therapy and discontinuance of treatment with Nasacort HFA Nasal Aerosol. As with any long-term topical treatment of the nasal cavity, patients using Nasacort HFA Nasal Aerosol over several months or longer should be examined periodically for evidence of infection or other adverse effects on the nasal mucosa.
Intranasal corticosteroids should be used with caution, if at all, in patients with active or quiescent tuberculosis infections of the respiratory tract or in patients with untreated local or systemic fungal or bacterial infections, systemic viral or parasitic infections, or ocular herpes simplex.
When used at higher than recommended doses or in rare individuals at recommended doses, systemic corticosteroid effects such as hypercorticism and adrenal suppression may appear. Therefore, larger than recommended doses of Nasacort HFA Nasal Aerosol should be avoided. If signs or symptoms of hypercorticism and/or suppression of HPA function occur, Nasacort HFA Nasal Aerosol should be discontinued slowly, consistent with accepted procedures for discontinuing oral steroid therapy.
Information for Patients
Patients being treated with Nasacort HFA Nasal Aerosol should receive the following information and instructions. This information is intended to aid them in the safe and effective use of this medication. It is not a disclosure of all possible adverse or intended effects.
Patients who are on immunosuppressant doses of corticosteroids should be warned to avoid exposure to chickenpox or measles and, if exposed, to obtain medical advice.
Patients should use Nasacort HFA Nasal Aerosol at regular intervals since its effectiveness depends on regular use (see ). Individual patients will experience a variable time to onset and degree of symptom relief, and generally takes 1 week of treatment to reach maximum benefit. The patient should take the medication as directed and should not exceed the prescribed dosage. The patient should contact the physician if symptoms do not improve by a reasonable time, or if the condition worsens. Nasal irritation occurred in 6.2% of adults who used 440 mcg/day, the maximum recommended daily intranasal dose. The patient should contact the physician if nasal irritation occurs. It is advisable for patients who experience nasal septum discomfort to re-evaluate their technique in the application of Nasacort HFA Nasal Aerosol to minimize deposition of drug onto the septum.
For the proper use of this unit and to attain maximum improvement, the patient should read and follow the accompanying patient instructions carefully. Spraying Nasacort HFA Nasal Aerosol directly into the eyes or onto the nasal septum should be avoided. It is important to shake the canister well prior to each actuation to insure that a consistent amount is dispensed per actuation. The canister should be discarded after 100 actuations.
Drug-Drug Interactions
No drug interaction studies with triamcinolone acetonide have been performed.
Carcinogenesis, Mutagenesis, Impairment of Fertility
In a 2-year study in rats, triamcinolone acetonide caused no treatment-related carcinogenicity at oral doses up to 1.0 mcg/kg (approximately 1/50 of the maximum recommended daily intranasal dose in adults and children on a mcg/m basis). In a 2-year study in mice, triamcinolone acetonide caused no treatment-related carcinogenicity at oral doses up to 3.0 mcg/kg (approximately 1/30 of the maximum recommended daily intranasal dose in adults and children on a mcg/m basis).
No evidence of mutagenicity was detected from tests (a reverse mutation test in bacteria and a forward mutation test in Chinese hamster ovary cells) conducted with triamcinolone acetonide.
In male and female rats, triamcinolone acetonide caused no change in pregnancy rate at oral doses up to 15 mcg/kg (approximately 1/3 of the maximum recommended daily intranasal dose in adults on a mcg/m basis). Triamcinolone acetonide caused increased fetal resorptions and stillbirths and decreases in pup weight and survival at doses of 5.0 mcg/kg and above (approximately 1/10 of the maximum recommended daily intranasal dose in adults on a mcg/m basis). At 1.0 mcg/kg (approximately 1/50 of the maximum recommended daily intranasal dose in adults on a mcg/m basis), it did not induce the above mentioned effects.
Pregnancy
Pregnancy category C.
Triamcinolone acetonide was teratogenic in rats, rabbits, and monkeys. In rats, triamcinolone acetonide was teratogenic at inhalation doses of 20 mcg/kg and above (approximately 2/5 of the maximum recommended daily intranasal dose in adults on a mcg/m basis). In rabbits, triamcinolone acetonide was also teratogenic at inhalation doses of 20 mcg/kg and above (approximately 4/5 of the maximum recommended daily intranasal dose in adults on a mcg/m basis). In monkeys, triamcinolone acetonide was teratogenic at an inhalation dose of 500 mcg/kg (approximately 20 times the maximum recommended daily intranasal dose in adults on a mcg/m basis). Dose-related teratogenic effects in rats and rabbits included cleft palate and/or internal hydrocephaly and axial skeletal defects, whereas the effects observed in monkeys were cranial malformations.
There are no adequate and well-controlled studies in pregnant women. Therefore, Nasacort HFA Nasal Aerosol should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Experience with oral corticosteroids since their introduction in pharmacologic, as opposed to physiologic, doses suggests that rodents are more prone to teratogenic effects from corticosteroids than humans. In addition, because there is an increase in corticosteroid production during pregnancy, most women will require a lower exogenous corticosteroid dose and many will not need corticosteroid treatment during pregnancy.
Nonteratogenic Effects
Hypoadrenalism may occur in infants born of mothers receiving corticosteroids during pregnancy. Such infants should be carefully monitored.
Nursing Mothers
It is not known whether triamcinolone acetonide is excreted in human milk. Because other corticosteroids are excreted in human milk, caution should be exercised when this product is administered to nursing women.
Pediatric Use
Safety and effectiveness have not been established in pediatric patients below the age of 6 years.
A placebo-controlled clinical growth study in children has not been conducted with Nasacort HFA Nasal Aerosol. Controlled clinical studies have shown that intranasal corticosteroids may cause a reduction in growth velocity in pediatric patients. This effect has been observed in the absence of laboratory evidence of HPA axis suppression, suggesting that growth velocity is a more sensitive indicator of systemic corticosteroid exposure in pediatric patients than some commonly used tests of HPA axis function. The long-term effects of this reduction in growth velocity associated with intranasal corticosteroids, including the impact on final adult height, are unknown. The potential for "catch-up" growth following discontinuation of treatment with intranasal corticosteroids has not been adequately studied. The growth of pediatric patients receiving intranasal corticosteroids, including Nasacort HFA Nasal Aerosol, should be monitored routinely (e.g., via stadiometry). The potential growth effects of prolonged treatment should be weighed against the clinical benefits obtained and the risks/benefits of treatment alternatives. To minimize the systemic effects of intranasal corticosteroids, including Nasacort HFA Nasal Aerosol, each patient should be titrated to the lowest dose that effectively controls his/her symptoms.
Geriatric Use
Clinical studies of Nasacort HFA Nasal Aerosol did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients.
What are the side effects of Nasacort HFA?
Clinical Trials
A total of 1176 patients with allergic rhinitis were enrolled in placebo-controlled and open-label clinical studies of Nasacort HFA Nasal Aerosol.
In the placebo-controlled trial, 220 patients were treated with Nasacort HFA Nasal Aerosol for an average of 15 days (range 1–19 days). No changes in mucous membranes were noted from physical and visual examinations during this trial.
Adverse events occurring with an incidence of 3% or greater and more commonly with Nasacort HFA Nasal Aerosol arms compared to placebo irrespective of drug relationship are presented in the following table:
Of the 396 patients enrolled in the 12-month open-label study, 75% received treatment for greater than 6 months. In this study, patients were treated with Nasacort HFA Nasal Aerosol at 220 mcg once daily for the first 2 weeks and 440 mcg once daily for remainder of the study. Adverse events that were considered possibly or probably related to Nasacort HFA Nasal Aerosol and reported at an incidence of 3% or greater included: headache, epistaxis, nasal septum discomfort, rhinitis, nasal burning, and sneezing.
In the open-label study only 2% of patients receiving recommended doses discontinued due to nasal adverse effects. In the rest of the patients the nasal adverse events usually did not interfere with treatment. Seven of the 18 patients who reported nasal septum discomfort had objective evidence of ulceration, abrasion, erosion, or excoriation of the nasal septum, and 22 of the 396 (5.5%) enrolled patients developed nasal septum disorders, of whom 8 had evidence of ulceration, erosion, or excoriation of the septum, and 14 had epistaxis. It is advisable for patients who experience nasal septum discomfort to re-evaluate their technique in the application of Nasacort HFA Nasal Aerosol to minimize deposition of drug onto the septum.
If recommended doses are exceeded, or if individuals taking Nasacort HFA Nasal Aerosol are particularly sensitive or take the drug in conjunction with other corticosteroids, symptoms of hypercorticism, e.g., Cushing syndrome, could occur.
In the event of accidental overdose, an increased potential for these adverse experiences may be expected, but systemic adverse experiences are unlikely (see ).
| Adverse Event | Nasacort HFA Nasal Aerosol110 mcg(n=107) % | Nasacort HFA Nasal Aerosol440 mcg(n=113) % | Placebo(n=111) % |
|---|---|---|---|
| Sneezing | 14.0 | 15.9 | 7.2 |
| Headache | 10.3 | 6.2 | 8.1 |
| Nasal irritation | 7.5 | 6.2 | 3.6 |
| Rhinitis | 4.7 | 3.5 | 1.8 |
Observed During Clinical Practice
In addition to adverse events reported from clinical trials, the following events have been identified during use of Nasacort Nasal Inhaler (triamcinolone acetonide CFC formulation) in clinical practice: nasal septal perforation, infection of the nose and pharynx with , cataracts, glaucoma, increased intraocular pressure, wheezing, rash, pruritus, urticaria, dizziness, paresthesia, dry mouth, nausea, coughing, dyspnea, and allergic reaction. Because they were reported voluntarily from a population of unknown size, estimates of frequency cannot be made. These events have been chosen for inclusion due to either their seriousness, frequency of reporting, or possible causal connection to triamcinolone acetonide or a combination of these factors.
What should I look out for while using Nasacort HFA?
Nasacort HFA Nasal Aerosol is contraindicated in patients with a hypersensitivity to any of the ingredients.
The replacement of a systemic corticosteroid with a topical corticosteroid can be accompanied by signs of adrenal insufficiency and, in addition, some patients may experience symptoms of withdrawal, e.g., joint and/or muscular pain, lassitude, and depression. Patients previously treated for prolonged periods with systemic corticosteroids and transferred to topical corticosteroids should be carefully monitored for acute adrenal insufficiency in response to stress. In those patients who have asthma or other clinical conditions requiring long-term systemic corticosteroid treatment, too rapid a decrease in systemic corticosteroids may cause a severe exacerbation of their symptoms.
The concomitant use of intranasal corticosteroids with other inhaled corticosteroids could increase the risk of signs or symptoms of hypercorticism and/or suppression of the HPA axis.
Persons who are using drugs that suppress the immune system are more susceptible to infections than healthy individuals. Chickenpox and measles, for example, can have a more serious or even fatal course in susceptible children or adults using corticosteroids. In children or adults who have not had these diseases or been properly immunized, particular care should be taken to avoid exposure. How the dose, route, and duration of corticosteroid administration affect the risk of developing a disseminated infection is not known. The contribution of the underlying disease and/or prior corticosteroid treatment to the risk is also not known. If exposed to chickenpox, prophylaxis with varicella zoster immune globulin (VZIG) may be indicated. If exposed to measles, prophylaxis with pooled intramuscular immunoglobulin (IG) may be indicated. (See the respective package inserts for complete VZIG and IG prescribing information.) If chickenpox develops, treatment with antiviral agents may be considered.
Avoid spraying in eyes.
What might happen if I take too much Nasacort HFA?
Chronic overdosage may result in signs/symptoms of hypercorticism (see ).
The acute topical application of the entire 15 mg contents of the canister may cause nasal irritation and headache. Acute overdosage with this dosage form is unlikely since one canister of Nasacort HFA Nasal Aerosol contains 15 mg of triamcinolone acetonide.
How should I store and handle Nasacort HFA?
Store at 20°–25°C (68°–77°F).[See USP Controlled Room Temperature]DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER.Store at 20°–25°C (68°–77°F).[See USP Controlled Room Temperature]DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER.Store at 20°–25°C (68°–77°F).[See USP Controlled Room Temperature]DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER.Nasacort HFA Nasal Aerosol is supplied with an aerosol canister which provides 100 metered dose actuations. The correct amount of medication delivered per actuation cannot be assured after 100 actuations have been dispensed, after which the unit should be discarded. Each actuation delivers 55 mcg triamcinolone acetonide through the nasal actuator. The Nasacort HFA Nasal Aerosol canister and accompanying nasal actuator are designed to be used together. The Nasacort HFA Nasal Aerosol canister should not be used with other nasal actuators and the supplied nasal actuator should not be used with other products' canisters. Nasacort HFA Nasal Aerosol is supplied with a molecular sieve sachet as a propellant adsorbent and a white plastic protective cap, and enclosed in a foil laminate overwrap pouch. Patient instructions are also provided. Net weight of the canister contents is 9.3 grams.NDC 0075-9403-43Nasacort HFA Nasal Aerosol is supplied with an aerosol canister which provides 100 metered dose actuations. The correct amount of medication delivered per actuation cannot be assured after 100 actuations have been dispensed, after which the unit should be discarded. Each actuation delivers 55 mcg triamcinolone acetonide through the nasal actuator. The Nasacort HFA Nasal Aerosol canister and accompanying nasal actuator are designed to be used together. The Nasacort HFA Nasal Aerosol canister should not be used with other nasal actuators and the supplied nasal actuator should not be used with other products' canisters. Nasacort HFA Nasal Aerosol is supplied with a molecular sieve sachet as a propellant adsorbent and a white plastic protective cap, and enclosed in a foil laminate overwrap pouch. Patient instructions are also provided. Net weight of the canister contents is 9.3 grams.NDC 0075-9403-43
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Triamcinolone acetonide, a synthetic glucocorticosteroid, is a more potent derivative of triamcinolone. Although triamcinolone itself is approximately 1 to 2 times as potent as prednisone in animal models of inflammation, triamcinolone acetonide is approximately 8 times more potent than prednisone. The clinical relevance of or animal models of potency comparison is unknown.
The precise mechanism of corticosteroid action on allergic rhinitis is not known. Corticosteroids have been shown to have a wide range of effects on multiple cell types (e.g., mast cells, eosinophils, neutrophils, macrophages, and lymphocytes) and mediators (e.g., histamine, eicosanoids, leukotrienes, and cytokines) involved in inflammation. Nasacort HFA Nasal Aerosol, like other corticosteroids, does not have an immediate effect on allergic rhinitis signs and symptoms. When corticosteroids are discontinued, symptoms may not recur for several days.
Non-Clinical Toxicology
Nasacort HFA Nasal Aerosol is contraindicated in patients with a hypersensitivity to any of the ingredients.The replacement of a systemic corticosteroid with a topical corticosteroid can be accompanied by signs of adrenal insufficiency and, in addition, some patients may experience symptoms of withdrawal, e.g., joint and/or muscular pain, lassitude, and depression. Patients previously treated for prolonged periods with systemic corticosteroids and transferred to topical corticosteroids should be carefully monitored for acute adrenal insufficiency in response to stress. In those patients who have asthma or other clinical conditions requiring long-term systemic corticosteroid treatment, too rapid a decrease in systemic corticosteroids may cause a severe exacerbation of their symptoms.
The concomitant use of intranasal corticosteroids with other inhaled corticosteroids could increase the risk of signs or symptoms of hypercorticism and/or suppression of the HPA axis.
Persons who are using drugs that suppress the immune system are more susceptible to infections than healthy individuals. Chickenpox and measles, for example, can have a more serious or even fatal course in susceptible children or adults using corticosteroids. In children or adults who have not had these diseases or been properly immunized, particular care should be taken to avoid exposure. How the dose, route, and duration of corticosteroid administration affect the risk of developing a disseminated infection is not known. The contribution of the underlying disease and/or prior corticosteroid treatment to the risk is also not known. If exposed to chickenpox, prophylaxis with varicella zoster immune globulin (VZIG) may be indicated. If exposed to measles, prophylaxis with pooled intramuscular immunoglobulin (IG) may be indicated. (See the respective package inserts for complete VZIG and IG prescribing information.) If chickenpox develops, treatment with antiviral agents may be considered.
Avoid spraying in eyes.
No drug interaction studies with triamcinolone acetonide have been performed.
Intranasal corticosteroids may cause a reduction in growth velocity when administered to pediatric patients (see ).
Triamcinolone acetonide administered intranasally has been shown to be absorbed into the systemic circulation in humans. Patients with active rhinitis showed absorption similar to that found in normal volunteers.
Rarely, immediate hypersensitivity reactions or contact dermatitis occur after the administration of Nasacort HFA Nasal Aerosol. Rare instances of wheezing, nasal septum perforation, cataracts, glaucoma, and increased intraocular pressure have been reported following the intranasal application of corticosteroids, including triamcinolone acetonide. Because of the inhibitory effect of corticosteroids on wound healing in patients who have experienced recent nasal septal ulcers, nasal surgery or trauma, a corticosteroid should be used with caution until healing has occurred.
In clinical studies with triamcinolone acetonide administered intranasally, the development of localized infections of the nose and pharynx with has rarely occurred. When such an infection develops, it may require treatment with appropriate local or systemic therapy and discontinuance of treatment with Nasacort HFA Nasal Aerosol. As with any long-term topical treatment of the nasal cavity, patients using Nasacort HFA Nasal Aerosol over several months or longer should be examined periodically for evidence of infection or other adverse effects on the nasal mucosa.
Intranasal corticosteroids should be used with caution, if at all, in patients with active or quiescent tuberculosis infections of the respiratory tract or in patients with untreated local or systemic fungal or bacterial infections, systemic viral or parasitic infections, or ocular herpes simplex.
When used at higher than recommended doses or in rare individuals at recommended doses, systemic corticosteroid effects such as hypercorticism and adrenal suppression may appear. Therefore, larger than recommended doses of Nasacort HFA Nasal Aerosol should be avoided. If signs or symptoms of hypercorticism and/or suppression of HPA function occur, Nasacort HFA Nasal Aerosol should be discontinued slowly, consistent with accepted procedures for discontinuing oral steroid therapy.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
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