EAST HANOVER, N.J., Oct. 29, 2015 Novartis announced today that the US Food and Drug Administration (FDA) has approved Seebri Neohaler (glycopyrrolate) inhalation powder 15.6 mcg as a stand-alone monotherapy for COPD. Novartis expects that Seebri Neohaler will be available in the first quarter of 2016.
Seebri is delivered via the low resistance Neohaler inhaler, which makes it suitable for patients with different severities of airflow limitation.
About Seebri Neohaler
Seebri Neohaler, previously known as NVA237, is a twice-daily long-acting muscarinic antagonist (LAMA) for the long-term maintenance treatment of airflow obstruction in patients with COPD, including chronic bronchitis and/or emphysema.
Glycopyrrolate (also known as glycopyrronium bromide) was exclusively licensed to Novartis in April 2005 by Vectura and its co-development partner Sosei.
INDICATION
Seebri Neohaler ia a prescription medicine used to treat chronic obstructive pulmonary disease (COPD) in adults. COPD is a chronic lung disease that includes chronic bronchitis, emphysema, or both. Seebri is used long-term, inhaled twice a day, to improve symptoms of COPD for better breathing.
Seebri contains the anticholinergic glycopyrrolate. This medicine works by helping the muscles around the airways in your lungs stay relaxed to prevent symptoms, such as wheezing, cough, chest tightness, and shortness of breath.
Seebri is not used to treat sudden symptoms of COPD and won’t replace a rescue inhaler.
IMPORTANT SAFETY INFORMATION
Call your doctor or get emergency medical care if your breathing problems worsen quickly, if you need to use your rescue inhaler more often than usual, or if you use your rescue inhaler medicine but it does not relieve your breathing problems. Call your doctor if breathing problems worsen over time while using Seebri.
Do not use Seebri Neohaler if you are allergic to glycopyrrolate or any of the ingredients in Seebri. Ask your doctor if you are not sure.
Do not swallow Seebri capsules. Only use Seebri capsules with the Neohaler inhaler. Never place a capsule in the mouthpiece of the Neohaler inhaler.
Tell your doctor about kidney problems, eye problems such as glaucoma, prostate problems, bladder problems, problems passing urine, or other medical conditions, including if you are pregnant, planning to become pregnant or breastfeeding, before using Seebri.
Tell your doctor if you are allergic to Seebri or any of their ingredients, any other medicines, or food products. Seebri contains lactose (milk sugar) and small amounts of milk proteins. It is possible that allergic reactions may happen in people who have a severe milk protein allergy.
Tell your doctor about all the medicines you take, including prescription medicines, over-the-counter medicines, vitamins, and herbal supplements. Using Seebri with other medicines may cause serious side effects. Tell your doctor if you take anticholinergics (including umeclidinium, tiotropium, ipratropium, aclidinium, glycopyrrolate), because taking them together with Seebri can increase side effects.
Seebri may cause serious side effects, including life-threatening sudden shortness of breath immediately after use and serious allergic reactions including rash; hives; swelling of the tongue, lips, and face; difficulty breathing or swallowing. If you have any of these symptoms, stop taking Seebri and get immediate medical help.
Seebri can cause new or worsened eye problems, including acute narrow-angle glaucoma, which can cause permanent loss of vision if not treated. Symptoms may include: eye pain or discomfort, nausea or vomiting, blurred vision, seeing halos or bright colors around lights, or red eyes. If you have any of these symptoms, stop Seebri and call your doctor right away.
Seebri can cause new or worsened urinary retention. Symptoms of urinary retention may include: difficulty urinating, painful urination, urinating frequently, or urination in a weak stream or drips. If you have these symptoms, stop taking Seebri and call your healthcare provider right away.
Common side effects of Seebri include upper respiratory tract infection, sore throat, and runny nose.