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Description of product
What is OPSUMIT and how is it used?
- OPSUMIT is a prescription medicine used to treat pulmonary arterial hypertension (PAH), which is high blood pressure in the arteries of your lungs.
- OPSUMIT can improve your ability to exercise, improve some of your symptoms, and help slow down the progression of your disease. OPSUMIT can also lower your chance of being hospitalized for PAH.
- It is not known if OPSUMIT is safe and effective in children.
What are the possible side effects of OPSUMIT?
OPSUMIT can cause serious side effects, including:
Your healthcare provider will do blood tests to check your red blood cells before starting OPSUMIT. Your healthcare provider may also need to do these tests during treatment with OPSUMIT.
- Serious birth defects. See “What is the most important information I should know about OPSUMIT?”
- Some medicines that are like OPSUMIT can cause liver problems. Your healthcare provider should do blood tests to check your liver before you start taking OPSUMIT. Tell your healthcare provider if you have any of the following symptoms of liver problems while taking OPSUMIT.
- nausea or vomiting
- pain in the upper right stomach
- tiredness
- loss of appetite
- yellowing of your skin or whites of your eyes
- dark urine
- fever
- itching
- Fluid retention can happen within weeks after starting OPSUMIT. Tell your healthcare provider right away if you have any unusual weight gain or swelling of your ankles or legs. Your healthcare provider will look for the cause of any fluid retention.
- Low red blood cell levels (anemia) can occur with OPSUMIT treatment, usually during the first weeksafter starting therapy. In some cases a blood transfusion may be needed, but this is not common.
- Decreased sperm count. OPSUMIT, and other medicines like OPSUMIT, may cause decreased sperm counts in men who take these medicines. A decreased sperm count may affect the ability to father a child. Tell your healthcare provider if being able to have children is important to you.
The most common side effects of OPSUMIT are:
- Stuffy nose or sore throat
- Irritation of the airways (bronchitis)
- Headache
- Flu
- Urinary tract infection
Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of OPSUMIT. For more information, ask your healthcare provider or pharmacist.
Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1800-FDA-1088.
DESCRIPTION
OPSUMIT (macitentan) is an endothelin receptor antagonist. The chemical name of macitentan is N-[5- (4-Bromophenyl)-6-[2-[(5-bromo-2-pyrimidinyl)oxy]ethoxy]-4-pyrimidinyl]-N'-propylsulfamide. It has a molecular formula of C19H20Br2N6O4S and a molecular weight of 588.27. Macitentan is achiral and has the following structural formula:
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Macitentan is a crystalline powder that is insoluble in water. In the solid state macitentan is very stable, is not hygroscopic, and is not light sensitive.
OPSUMIT is available as a 10 mg film-coated tablet for once daily oral administration. The tablets include the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, polysorbate 80, povidone, and sodium starch glycolate Type A. The tablets are film-coated with a coating material containing polyvinyl alcohol, soya lecithin, talc, titanium dioxide, and xanthan gum.
INDICATIONS
Pulmonary Arterial Hypertension
OPSUMIT is an endothelin receptor antagonist (ERA) indicated for the treatment of pulmonary arterial hypertension (PAH, WHO Group I) to reduce the risks of disease progression and hospitalization for PAH.
Effectiveness was established in a long-term study in PAH patients with predominantly WHO Functional Class II-III symptoms treated for an average of 2 years. Patients had idiopathic and heritable PAH (57%), PAH caused by connective tissue disorders (31%), and PAH caused by congenital heart disease with repaired shunts (8%) [see Clinical Studies].
DOSAGE AND ADMINISTRATION
Recommended Dosage
The recommended dosage of OPSUMIT is 10 mg once daily for oral administration. Doses higher than 10 mg once daily have not been studied in patients with PAH and are not recommended.
Pregnancy Testing In Females Of Reproductive Potential
Obtain a pregnancy test in females of reproductive potential prior to OPSUMIT treatment, monthly during treatment and one month after stopping OPSUMIT. Initiate treatment with OPSUMIT in females of reproductive potential only after a negative pregnancy test. [see BOXED WARNING, CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS, Use In Specific Populations].
HOW SUPPLIED
Dosage Forms And Strengths
Tablets: 10 mg, bi-convex film-coated, round, white, and debossed with “10” on both sides.
Storage And Handling
OPSUMIT® (macitentan) tablets are 10 mg white, film-coated, bi-convex debossed with “10” on both sides and supplied as follows:
15 count /PVC/ PE/PVDC aluminum foil blisters in carton (NDC 66215-501-15)
30 count white high-density polyethylene bottle in carton (NDC 66215-501-30)
Store at 20°C to 25°C (68°F to 77°F). Excursions are permitted between 15°C and 30°C (59°F and 86°F). [See USP Controlled Room Temperature].
Keep out of reach of children.
SIDE EFFECTS
Clinically significant adverse reactions that appear in other sections of the labeling include:
- Embryo-fetal Toxicity [see WARNINGS AND PRECAUTIONS]
- Hepatotoxicity [see WARNINGS AND PRECAUTIONS]
- Fluid Retention [see WARNINGS AND PRECAUTIONS]
- Decrease in Hemoglobin [see WARNINGS AND PRECAUTIONS]
Clinical Trial Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
Safety data for OPSUMIT were obtained primarily from one placebo-controlled clinical study in 742 patients with PAH (SERAPHIN study) [see Clinical Studies].
The exposure to OPSUMIT in this trial was up to 3.6 years with a median exposure of about 2 years (N=542 for 1 year; N=429 for 2 years; and N=98 for more than 3 years). The overall incidence of treatment discontinuations because of adverse events was similar across OPSUMIT 10 mg and placebo treatment groups (approximately 11%).