OPSUMIT (Page 5 of 6)
16 HOW SUPPLIED/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 20ºC to 25ºC (68ºF to 77ºF). 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.
17 PATIENT COUNSELING INFORMATION
Advise patient to read FDA-approved patient labeling (Medication Guide).
Embryo-Fetal Toxicity
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. Females of reproductive potential must have monthly pregnancy tests and must use reliable methods of contraception while taking OPSUMIT and for one month after discontinuing OPSUMIT [see Use in Specific Populations (8.1)] .
Macitentan REMS Program
For female patients, OPSUMIT is available only through a restricted program called the Macitentan REMS Program [see Warnings and Precautions (5.2)] . Male patients are not enrolled in the Macitentan REMS.
Patients may choose one highly effective form of contraception (intrauterine devices (IUD), contraceptive implants or tubal sterilization) or a combination of methods (hormone method with a barrier method or two barrier methods).
Patients should be instructed to contact their physician if they suspect they may be pregnant. Patients should seek additional contraceptive advice from a gynecologist or similar expert as needed.
Inform female patients (and their guardians, if applicable) of the following notable requirements.
- Female patients must sign an enrollment form.
- Female patients of reproductive potential must comply with the pregnancy testing and contraception requirements [see Use in Specific Populations (8.3)] .
Educate and counsel females of reproductive potential on the use of emergency contraception in the event of unprotected sex or contraceptive failure.
Advise pre-pubertal females to report any changes in their reproductive status immediately to her prescriber.
Review the Medication Guide and REMS educational materials with female patients.
Lactation
Advise women not to breastfeed during treatment with OPSUMIT [see Use in Specific Population (8.2)] .
Hepatotoxicity
Some members of this pharmacological class are hepatotoxic. Educate patients on signs of hepatotoxicity. Advise patients that they should contact their doctor if they have unexplained nausea, vomiting, right upper quadrant pain, fatigue, anorexia, jaundice, dark urine, fever, or itching.
Fluid Retention
Educate patients on signs of fluid retention. Advise patients that they should contact their doctor if they have unusual weight increase or swelling of the ankles or legs.
Manufactured for:
Actelion Pharmaceuticals US, Inc.,
a Janssen Pharmaceutical Company
Titusville, NJ 08560, USA
For patent information: www.janssenpatents.com
© 2013 – 2019 Actelion Pharmaceuticals US, Inc. All rights reserved.
MEDICATION GUIDE OPSUMIT ® (OP-sum-it) (macitentan) tablets | ||
---|---|---|
This Medication Guide has been approved by the U.S. Food and Drug Administration. | Revised: 06/2023 | |
Read this Medication Guide for OPSUMIT before you start taking OPSUMIT and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking with your healthcare provider about your medical condition or your treatment. | ||
What is the most important information I should know about OPSUMIT? | ||
| ||
OPSUMIT can cause serious birth defects if taken during pregnancy. | ||
| ||
Females who are able to get pregnant must use two acceptable forms of birth control during treatment with OPSUMIT, and for one month after stopping OPSUMIT because the medicine may still be in the body. | ||
| ||
See the chart below for Acceptable Birth Control Options during treatment with OPSUMIT. | ||
| ||
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. Tell your healthcare provider right away if you notice that she is developing breast buds or any pubic hair. Your healthcare provider should decide if your child has reached puberty. Your child may reach puberty before having her first menstrual period. | ||
Females can only receive OPSUMIT through a restricted program called the Macitentan Risk Evaluation and Mitigation Strategy (REMS) Program. If you are a female who can get pregnant, you must talk to your healthcare provider, understand the benefits and risks of OPSUMIT, and agree to all of the instructions in the Macitentan REMS Program. | ||
Males can receive OPSUMIT without taking part in the Macitentan REMS Program. | ||
What is OPSUMIT? | ||
| ||
Who should not take OPSUMIT? | ||
Do not take OPSUMIT if you are pregnant, plan to become pregnant, or become pregnant during treatment with OPSUMIT. OPSUMIT can cause serious birth defects (see the Medication Guide section above called ” What is the most important information I should know about OPSUMIT?“). Do not take OPSUMIT if you are allergic to macitentan or any of the ingredients in OPSUMIT. See the end of this Medication Guide for a complete list of ingredients in OPSUMIT. | ||
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. OPSUMIT and other medicines may affect each other causing side effects. Do not start any new medicine until you check with your healthcare provider. | ||
Especially tell your healthcare provider if you take an HIV medicine. | ||
How should I take OPSUMIT? | ||
OPSUMIT will be mailed to you by a specialty pharmacy. Your healthcare provider will give you complete details. | ||
| ||
What should I avoid while taking OPSUMIT? | ||
| ||
What are the possible side effects of OPSUMIT? | ||
OPSUMIT can cause serious side effects, including: | ||
| ||
|
| |
| ||
The most common side effects of OPSUMIT are: | ||
| ||
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 1-800-FDA-1088. | ||
How should I store OPSUMIT? | ||
| ||
General information about OPSUMIT | ||
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use OPSUMIT for a condition for which it was not prescribed. Do not give OPSUMIT to other people, even if they have the same symptoms that you have. It may harm them. | ||
This Medication Guide summarizes the most important information about OPSUMIT. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about OPSUMIT that is written for health professionals. For more information, call 1-800-526-7736 (1-800-JANSSEN), or visit www.OPSUMIT.com. | ||
What are the ingredients in OPSUMIT? | ||
Active ingredient: macitentan | ||
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. | ||
Manufactured for: Actelion Pharmaceuticals US, Inc., a Janssen Pharmaceutical Company Titusville, NJ 08560, USA For patent information: www.janssenpatents.com © 2013 – 2019 Actelion Pharmaceuticals US, Inc. All rights reserved. |
All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.