Macitentan

tablets
10 mg
Therapeutic equivalent of OPSUMIT®†

Apotex's copay savings programs can help lower out-of-pocket costs on select products

Eligible commercially insured patients may pay as little as $0* for their existing macitentan prescription with a copay savings card.

Restrictions and eligibility requirements apply. See Terms and Conditions below for full details.

Download copay savings card
for macitentan tablets 10 mg

Macitentan

tablets
10 mg
Therapeutic equivalent of OPSUMIT®†

Apotex's copay savings programs can help lower out-of-pocket costs on select products

Eligible commercially insured patients may pay as little as $0* for their existing macitentan prescription with a copay savings card.

Download copay savings card for
macitentan tablets 10 mg

Restrictions and eligibility requirements apply.
See Terms and Conditions below for full details.

Full prescribing information including boxed warning and medication guide set forth below or in links:

Macitentan tablets 10 mg

Full prescribing information including boxed warning and medication guide set forth below or in links:

Macitentan tablets 10 mg

Using your macitentan copay savings card is simple:

  1. Download or print the copay savings card and present it at the pharmacy. Visit www.macitentancopay.com or call toll free at 833-536-7117 if you need assistance or more information on how to use the card.
  2. Ensure that your prescription is being filled with macitentan tablets manufactured and distributed by Apotex to access savings under the program.

By participating in the Apotex copay savings program for macitentan tablets, you agree to abide by the Terms and Conditions below:

  • You may not use the Apotex copay savings program if you have prescription drug coverage under Medicaid, Medicare, TRICARE, the Federal Employee Health Benefit Program, or other federal or state healthcare programs including any state prescription drug assistance programs and the Government Health Insurance Plan available in Puerto Rico (formerly known as "La Reforma de Salud").
  • You may not use the Apotex copay savings program if you are uninsured or have no prescription drug coverage for macitentan tablets.
  • The Apotex copay savings program is not valid for prescriptions that are eligible to be reimbursed by private insurance plans or other health or pharmacy benefit programs, which reimburse you for the entire cost of your prescription drugs (i.e. you have no cost-sharing obligation).
  • Offer not available for residents of California or Massachusetts or where prohibited by law.
  • This offer is good only in the U.S. and Puerto Rico.
  • You must deduct the savings received under this program from any reimbursement request submitted to your insurance plan, either directly by you or on your behalf.
  • If eligible, commercially insured patients may pay as little as $0* out-of-pocket cost with the macitentan copay savings card toward each fill, and the program will pay up to $400 per 30-day supply of the remaining cost after primary insurance coverage, up to $4,800 per calendar year.
  • The Apotex copay savings program cannot be combined with any other rebate/coupon, free trial, or similar offer for the specified prescription.
  • The Apotex copay savings program will be accepted only at participating pharmacies.
  • The Apotex copay savings program is not health insurance.
  • Apotex reserves the right, at its sole discretion, to amend, to rescind, revoke, or terminate the offer at any time.
  • There are no membership fees for this savings program.
  • If you receive co-payment assistance under the Apotex copay savings program, your personal information will be used to process payment for your prescription under such program through an Apotex vendor.
IMPORTANT SAFETY INFORMATION

What is the most important information I should know about macitentan tablets?

Macitentan tablets can cause serious birth defects if taken during pregnancy.

  • Females should not be pregnant when they start taking macitentan tablets or become pregnant during treatment with macitentan tablets.
  • Females who are able to get pregnant should have a negative pregnancy test before beginning treatment with macitentan tablets.
    • Females who are able to get pregnant are females who:
      • have entered puberty, even if they have not started their menstrual period, and
      • have a uterus, and
      • have not gone through menopause. Menopause means that you have not had a menstrual period for at least 12 months for natural reasons, or that you have had your ovaries removed.

What are macitentan tablets?

  • Macitentan tablets are a prescription medicine used to treat pulmonary arterial hypertension (PAH), which is high blood pressure in the arteries of your lungs.
  • Macitentan tablets can improve your ability to exercise, improve some of your symptoms, and help slow down the progression of your disease. Macitentan can also lower your chance of being hospitalized for PAH.

It is not known if macitentan tablets are safe and effective in children.

 
IMPORTANT SAFETY INFORMATION

What is the most important information I should know about macitentan tablets?

Macitentan tablets can cause serious birth defects if taken during pregnancy.

  • Females should not be pregnant when they start taking macitentan tablets or become pregnant during treatment with macitentan tablets.
  • Females who are able to get pregnant should have a negative pregnancy test before beginning treatment with macitentan tablets.
    • Females who are able to get pregnant are females who:
      • have entered puberty, even if they have not started their menstrual period, and
      • have a uterus, and
      • have not gone through menopause. Menopause means that you have not had a menstrual period for at least 12 months for natural reasons, or that you have had your ovaries removed.
    • Females who are not able to get pregnant are females who:
      • have not yet entered puberty, or
      • do not have a uterus, or
      • have gone through menopause, or
      • are infertile for other medical reasons and this infertility is permanent and cannot be reversed.
  • Females who are able to get pregnant should use effective birth control before starting treatment with macitentan tablets, during treatment, and for one month after stopping macitentan tablets. Talk with your healthcare provider to find out about options for acceptable birth control that you may use to prevent pregnancy during treatment with macitentan tablets. If you decide that you want to change the form of birth control that you use, talk with your healthcare provider to be sure that you choose another acceptable form of birth control.
  • Do not have unprotected sex. Talk to your healthcare provider or pharmacist right away if you have unprotected sex or if you think your birth control has failed. Your healthcare provider may talk with you about using emergency birth control. Tell your healthcare provider right away if you miss a menstrual period or think you may be pregnant.
  • If you are the parent or caregiver of a female child who started taking macitentan tablets 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.
  • If you are a female who can get pregnant, you should talk to your healthcare provider to understand the benefits and risks of macitentan tablets.

Who should not take macitentan tablets?
Do not take macitentan tablets if you are pregnant, plan to become pregnant, or become pregnant during treatment with macitentan tablets. Macitentan tablets can cause serious birth defects.

Do not take macitentan tablets if you are allergic to macitentan or any of the ingredients in macitentan tablets. See the Medication Guide for a full list of ingredients in macitentan tablets.

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. Macitentan tablets 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.

What should I avoid while taking macitentan tablets?

  • Do not get pregnant while taking macitentan tablets. If you miss a menstrual period, or think you might be pregnant, call your healthcare provider right away.
  • It is not known if macitentan passes into your breastmilk. You should not breastfeed if you take macitentan tablets. Talk to your healthcare provider about the best way to feed your baby if you take macitentan tablets.

What are the possible side effects of macitentan tablets?

Macitentan tablets can cause serious side effects, including:

  • Serious birth defects.
  • Some medicines that are like macitentan tablets can cause liver problems. Your healthcare provider should do blood tests to check your liver before you start taking macitentan tablets. Tell your healthcare provider if you have any of the following symptoms of liver problems while taking macitentan tablets.
    • nausea or vomiting
    • yellowing of your skin or whites of your eyes
    • pain in the upper right stomach
    • dark urine
    • tiredness
    • fever
    • loss of appetite
    • itching
  • Fluid retention can happen within weeks after starting macitentan tablets. 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.
  • Low red blood cell levels (anemia) can occur with macitentan tablets treatment, usually during the first weeks after starting therapy. In some cases, a blood transfusion may be needed, but this is not common. Your healthcare provider will do blood tests to check your red blood cells before starting macitentan tablets. Your healthcare provider may also need to do these tests during treatment with macitentan tablets.
  • Decreased sperm count. Macitentan, and other medicines like macitentan tablets, 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 macitentan tablets are:

  • Stuffy nose or sore throat
  • Irritation of the airways (bronchitis)
  • Headache
  • Flu
  • Urinary tract infection

Talk to your healthcare provider if you have a side effect that bothers you or does not go away. These are not all the possible side effects of macitentan tablets. For more information, ask your doctor or pharmacist.

You may report side effects to FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see full Prescribing Information, including Boxed Warning and Medication Guide, for macitentan tablets.

What are macitentan tablets?

  • Macitentan tablets are a prescription medicine used to treat pulmonary arterial hypertension (PAH), which is high blood pressure in the arteries of your lungs.
  • Macitentan tablets can improve your ability to exercise, improve some of your symptoms, and help slow down the progression of your disease. Macitentan can also lower your chance of being hospitalized for PAH.

It is not known if macitentan tablets are safe and effective in children.