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";s:4:"text";s:7545:"What other drugs could interact with this medication? Macitentan may therefore be taken with or without food. Advise women not to breastfeed during treatment with OPSUMIT [see Use in Specific Population (8.2)]. Monitor for signs of fluid retention after OPSUMIT initiation. Impairment of Fertility: Treatment of juvenile rats from postnatal Day 4 to Day 114 led to reduced body weight gain and testicular tubular atrophy at exposures 7-fold the human exposure. ), More about getting RSS News & Updates from DailyMed, Death due to PAH or hospitalization for PAH, This Medication Guide has been approved by the U.S. Food and Drug Administration. See the chart below for Acceptable Birth Control Options during treatment with OPSUMIT. Version: 2.01. 66215-501-30, See full prescribing information for complete boxed warning, Do not administer OPSUMIT to a pregnant female because it may cause fetal harm (, Females of reproductive potential: exclude pregnancy before start of treatment, monthly during treatment, and 1 month after stopping treatment. Counsel female patients of reproductive potential about the need to use reliable methods of contraception during treatment with OPSUMIT and for one month after treatment discontinuation. If clinically significant fluid retention develops, evaluate the patient to determine the cause, such as OPSUMIT or underlying heart failure, and the possible need to discontinue OPSUMIT. PAH is a condition in which there is high blood pressure in the blood vessels of the lungs that lead to the heart. Patients should be advised not to split, crush, or chew tablets. Consistent efficacy of OPSUMIT 10 mg on the primary endpoint was seen across subgroups of age, sex, race, etiology, by monotherapy or in combination with another PAH therapy, baseline 6MWD, and baseline WHO FC. In females of reproductive potential, exclude pregnancy prior to initiation of therapy, ensure use of acceptable contraceptive methods and obtain monthly pregnancy tests [see Dosage and Administration (2.2) and Use in Specific Populations (8.1, 8.3)]. 0 You can ask your pharmacist or healthcare provider for information about OPSUMIT that is written for health professionals. h�bbd``b`�$��� �~H�� qu@�5�R�<�2�@,oA�N�R�$B�� � $��mg�N�d�I���������w � *�g Other worsening was defined as all of the following: 1) a sustained ≥15% decrease from baseline in 6 minute walk distance (6MWD), 2) worsening of PAH symptoms (worsening of WHO FC), and 3) need for additional treatment for PAH. Biochemical Data Summary. Many of these side effects can be managed, and some may go away on their own over time. If you miss a dose, take it as soon as possible and continue with your regular schedule. View NDC Code(s)NEW! The contents herein are for informational purposes only. If you are the parent or caregiver of a female child who started taking OPSUMIT before reaching puberty, you should check your child regularly to see if she is developing signs of puberty. In some cases a blood transfusion may be needed, but this is not common. In the solid state macitentan is very stable, is not hygroscopic, and is not light sensitive. If confirmed, discontinue treatment (, Decreases in sperm count have been observed in patients taking ERAs (. Tell your healthcare provider about all your medical conditions and all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Your healthcare provider should decide if your child has reached puberty. Start with confidence: OPSUMIT as standalone therapy offers patients the simplicity of once-daily dosing without titration. The patient should contact her physician immediately for pregnancy testing if onset of menses is delayed or pregnancy is suspected. © 2019 Actelion Pharmaceuticals US, Inc. All rights reserved. The safety and efficacy of OPSUMIT in children have not been established. If a partner's vasectomy is the chosen method of contraception, a hormone or barrier method must be used along with this method. Macitentan is an endothelin receptor antagonist that inhibits the binding of ET-1 to both ETA and ETB receptors. The side effects listed below are not experienced by everyone who takes this medication. We anticipate reposting the images once we are able identify and filter out images that do not match the information provided in the drug labels. Reversible testicular tubular dilatation was observed in chronic toxicity studies at exposures greater than 7-fold and 23-fold the human exposure in rats and dogs, respectively. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor. PAH is high blood pressure in the arteries of your lungs. Search this site to access the JanssenMD® Medical Information Database, or contact us by visiting askjanssenmedinfo.com or by calling 1-800-JANSSEN (1-800-526-7736), and a response will be provided promptly. The beneficial effect of OPSUMIT 10 mg was primarily attributable to a reduction in clinical worsening events (deterioration in 6MWD and worsening of PAH symptoms and need for additional PAH treatment). Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. You may contact the Medical Information Center by visiting askjanssenmedinfo.com or by calling 1-800-JANSSEN (1-800-526-7736) 1-800-JANSSEN (1-800-526-7736) to speak to a clinical expert regarding your question or to report a possible adverse event. What form(s) does this medication come in? Your child may reach puberty before having her first menstrual period. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. If you no longer wish to have this DailyMed RSS service, simply delete the copied URL from your RSS Reader. Doses higher than 10 mg once daily have not been studied in patients with PAH and are not recommended. OPSUMIT (macitentan) is an endothelin receptor antagonist. Patients treated with OPSUMIT 10 mg (N=57) achieved a median reduction of 37% (95% CI 22-49) in pulmonary vascular resistance and an increase of 0.6 L/min/m2 (95% CI 0.3-0.9) in cardiac index compared to placebo (N=67). As well, some forms of this medication may not be used for all of the conditions discussed here. Low red blood cell levels (anemia) can occur with OPSUMIT treatment, usually during the first weeks after starting therapy. This information is intended for healthcare providers in the United States only.This page was last modified on September 22, 2020. Effects of other strong CYP3A4 inhibitors such as ritonavir on macitentan were not studied, but are likely to result in an increase in macitentan exposure at steady state similar to that seen with ketoconazole [see Drug Interactions (7.2)]. Macitentan and its active metabolite are highly bound to plasma proteins (>99%), primarily to albumin and to a lesser extent to alpha-1-acid glycoprotein. Data sources include IBM Watson Micromedex (updated 1 Oct 2020), Cerner Multum™ (updated 1 Oct 2020), Wolters Kluwer™ (updated 30 Sep 2020) and others. ";s:7:"keyword";s:18:"opsumit medication";s:5:"links";s:920:"Colonial America Map, Waarvoor Staan Cvo, Seattle Metropolitan Area Map, Queen's University Population 2019, Touch Daft Ie, Last Chance Ranch Lambert Montana, Scene Transitions In Theatre, Lifespan Careers, ";s:7:"expired";i:-1;}