Trimbow

Trimbow is a triple combination inhaler approved for the long-term maintenance treatment of asthma in adults. Trimbow contains 3 ingredients: beclomethasone, formoterol, and glycopyrrolate, and is inhaled twice daily. Trimbow is not for sudden breathing problems and does not replace a rescue inhaler, such as albuterol.

• In the US, Trimbow is approved for asthma only. In some other countries, it is also approved for COPD.

Asthma is a chronic inflammatory respiratory disease that causes airway inflammation. Symptoms include shortness of breath, wheezing, coughing, and chest tightness. Trimbow combines three drug classes that work to treat asthma in three different ways:

• Beclomethasone dipropionate is a corticosteroid that reduces airway inflammation
• Formoterol fumarate is a long-acting beta2-agonist (LABA) that relaxes and opens airways
• Glycopyrrolate is a long-acting anticholinergic that relaxes airway smooth muscle.

Trimbow (beclomethasone/ formoterol/ glycopyrrolate) received FDA approval on May 14, 2026. Approval was based on two Phase 3 clinical trials (TRIMARAN & TRIGGER) in 2,200+ adults with uncontrolled asthma. Trimbow showed better lung function than beclomethasone/ formoterol alone in both studies.

Trimbow contains formoterol fumarate. LABA medicines, such as formoterol fumarate, when used alone, increase the risk of hospitalizations and death from asthma problems. Trimbow contains an ICS, a LABA, and an anticholinergic. When an ICS and LABA are used together, there is no significant increased risk in hospitalizations and death from asthma problems.

Do not use other medicines that contain a LABA or an anticholinergic for any reason when taking Trimbow. Ask your healthcare provider or pharmacist if any of your other medicines are LABA or anticholinergic medicines.

Trimbow should not be used in children.

Do not use Trimbow:

• to treat sudden, severe asthma symptoms
• if you are allergic to beclomethasone dipropionate, formoterol fumarate, glycopyrrolate, or any of the ingredients in Trimbow. See the end of this guide for a complete list of ingredients in Trimbow.

Before using Trimbow, tell your healthcare provider about all of your medical conditions, including if you:

• have heart problems.
• have high blood pressure.
• have seizures.
• have thyroid problems.
• have diabetes.
• have liver problems.
• have kidney problems.
• have weak bones (osteoporosis).
• have an immune system problem.
• have eye problems such as glaucoma, increased pressure in your eye, cataracts, blurred vision, or other changes in vision. Trimbow may make your glaucoma worse.
• have prostate or bladder problems, or problems passing urine. Trimbow may make these problems worse.
• have any type of viral, bacterial, parasitic, or fungal infection.
• are exposed to chickenpox or measles.
• are pregnant or plan to become pregnant. It is not known if Trimbow may harm your unborn baby.
• are breastfeeding or plan to breastfeed. It is not known if the medicines in Trimbow pass into your breast milk and if they can harm your baby.

Possible Serious Side Effects

Trimbow can sometimes cause serious side effects, including:

• Fungal infection in your mouth or throat (thrush). Rinse your mouth with water without swallowing after using Trimbow to help reduce your chance of getting thrush.
• Weakened immune system and increased chance of getting infections (immunosuppression).
• Reduced adrenal function (adrenal insufficiency). Adrenal insufficiency is a condition where the adrenal glands do not make enough steroid hormones. This can happen when you stop taking oral corticosteroid medicines (such as prednisone) and start taking a medicine containing an ICS (such as Trimbow). During this transition period, when your body is under stress from fever, trauma (such as a car accident), infection, surgery, or worse asthma symptoms, adrenal insufficiency can get worse and may cause death.

Symptoms of adrenal insufficiency include:

• feeling tired lack of energy weakness nausea and vomiting low blood pressure (hypotension).
• Sudden breathing problems immediately after inhaling your medicine. If you have sudden breathing problems immediately after inhaling your medicine, stop using Trimbow and call your healthcare provider right away.
• Serious allergic reactions. Call your healthcare provider or get emergency medical care if you get any of the following symptoms of a serious allergic reaction: rash hives swelling of your face, mouth, and tongue breathing problems.
• Effects on the heart, such as increased blood pressure, a fast or irregular heartbeat, awareness of heartbeat, and chest pain.
• Effects on the nervous system, such as tremor or nervousness.
• Bone thinning or weakness (osteoporosis).
• Eye problems, including glaucoma, increased pressure in your eye, cataracts, blurred vision, worsening of narrow-angle glaucoma, or other changes in vision. You should have regular eye exams while using Trimbow.

Acute narrow-angle glaucoma can cause permanent loss of vision if not treated. Symptoms of acute narrow-angle glaucoma may include:

• eye pain or discomfort seeing halos or bright colors around lights nausea or vomiting red eyes blurred vision.

If you have these symptoms, call your healthcare provider right away before taking another dose.

• Urinary retention. People who take Trimbow may develop new or worse urinary retention. Symptoms of urinary retention may include: difficulty urinating urinating frequently painful urination urination in a weak stream or drips.

If you have these symptoms of urinary retention, stop taking Trimbow and call your healthcare provider right away before taking another dose.

• Changes in laboratory blood values, including high levels of blood sugar (hyperglycemia) and low levels of potassium (hypokalemia).
• Slowed growth in children.

Common Side Effects

The most common side effects of Trimbow are:

• bronchitis
• flu
• high blood pressure
• low red blood cells (anemia)
• back pain
• muscle spasms
• hoarseness or laryngitis
• mouth and throat pain
• upper respiratory tract infection (such as itchy, runny or blocked nose, inflammation of the nasal lining, sore throat)
• inflammation of the sinuses.

These are not all the possible side effects of Trimbow. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects to Chiesi USA, Inc. at 1-888-661-9260.

Read the step-by-step instructions in the Trimbow Patient Information leaflet.

• Do not use Trimbow unless your healthcare provider has taught you how to use the inhaler and you understand how to use it correctly.
• Trimbow comes in 2 different strengths. Your healthcare provider prescribed the strength that is best for you.
• If you have been using a different inhaler containing beclomethasone dipropionate previously, ask your healthcare provider for advice, as the effective dose of beclomethasone dipropionate in Trimbow for the treatment of your asthma may be lower than that of some other inhalers.
• Use Trimbow exactly as your healthcare provider tells you to use it. Do not use Trimbow more often than prescribed.
• Use 2 inhalations of Trimbow, 2 times each day (2 puffs in the morning and 2 puffs in the evening).
• Do not stop using Trimbow unless told to do so by your healthcare provider because your symptoms might get worse. Your healthcare provider will change your medicines as needed.

Trimbow does not relieve sudden symptoms of asthma, and you should not take extra doses of Trimbow to relieve these sudden symptoms. Always have a rescue inhaler with you to treat sudden symptoms. If you do not have a rescue inhaler, call your healthcare provider to have one prescribed for you.

Call your healthcare provider or get medical care right away if:

• your breathing problems get worse
• you need to use your rescue inhaler more often than usual
• your rescue inhaler does not work as well to relieve your symptoms.

If you miss a dose of Trimbow, take it as soon as you remember. Take your next dose at your usual time. Do not take more than 4 inhalations per day.

If you take too much Trimbow, call your healthcare provider or go to the nearest hospital emergency room right away if you have any unusual symptoms, such as worsening shortness of breath, chest pain, increased heart rate, or shakiness.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Trimbow and certain other medicines may affect each other. This may cause serious side effects.

Especially tell your healthcare provider if you take:

• anticholinergics (including tiotropium, ipratropium, aclidinium)
• atropine
• other LABA (including salmeterol, formoterol fumarate, arformoterol, vilanterol, olodaterol, and indacaterol)
• antifungal or anti-HIV medicines.

Do not use other medicines that contain a LABA or an anticholinergic for any reason. Ask your healthcare provider or pharmacist if any of your other medicines are LABA or anticholinergic medicines.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

• Before first use: Store Trimbow in a refrigerator between 36°F and 46°F (2°C and 8°C).
• After first use: Store Trimbow below 77°F (25°C) for a maximum of 2 months.
• Throw away Trimbow 2 months after you remove it from the refrigerator, or when the dose counter reaches zero “0”, whichever comes first.
• Do not put a hole in the Trimbow canister.
• Do not throw the canister into a fire or incinerator.
• Do not use or store it near heat or open flame. Temperatures higher than 122°F (50°C) may cause bursting.
• Do not freeze Trimbow.

Keep Trimbow and all medicines out of the reach of children.

Active ingredients: beclomethasone dipropionate, formoterol fumarate, and glycopyrrolate

Inactive ingredients: dehydrated alcohol, hydrochloric acid, and hydrofluoroalkane (HFA 134a)

Trimbow is supplied as an inhalation aerosol in the following strengths:

• 86 mcg/4.9 mcg/10.6 mcg (beclomethasone dipropionate 86 mcg, formoterol fumarate 4.9 mcg, and glycopyrrolate 10.6 mcg) per actuation.
• 172 mcg/4.9 mcg/10.6 mcg (beclomethasone dipropionate 172 mcg, formoterol fumarate 4.9 mcg, and glycopyrrolate 10.6 mcg) per actuation.

Trimbow is manufactured by Chiesi Farmaceutici S.p.A., 43122 Parma, Italy, for Chiesi USA, Inc., Cary, NC 27518 USA.