Ambrisentan TABLET, FILM COATED

Get an overview of AMBRISENTAN (tablet, film coated), including its generic name, formulation (i.e. pill, oral solution, injection, inhaled medicine) and why it’s used. The medication in Ambrisentan can be sold under different names.

Refer to the “Also Known As” section to reference different products that include the same medication as Ambrisentan.

Drug Basics

Brand Name: Ambrisentan

Generic Name: AMBRISENTAN

Drug Type: HUMAN PRESCRIPTION DRUG

Route: ORAL

Dosage Form: TABLET, FILM COATED

Data Current As Of: 2019-09-09

indications & usage

Ambrisentan tablets are indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1):

  • To improve exercise ability and delay clinical worsening.

Studies establishing effectiveness included predominantly patients with WHO Functional Class II–III symptoms and etiologies of idiopathic or heritable PAH (60%) or PAH associated with connective tissue diseases (34%).

Ambrisentan tablets are endothelin receptor antagonist indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1):

  • To improve exercise ability and delay clinical worsening.

Studies establishing effectiveness included trials predominantly in patients with WHO Functional Class II–III symptoms and etiologies of idiopathic or heritable PAH (60%) or PAH associated with connective tissue diseases (34%) (1).

drug interactions

Multiple dose coadministration of ambrisentan and cyclosporine resulted in an approximately 2-fold increase in ambrisentan exposure in healthy volunteers; therefore, limit the dose of ambrisentan to 5 mg once daily when coadministered with cyclosporine [see Clinical Pharmacology (12.3)].

Cyclosporine increases ambrisentan exposure; limit ambrisentan dose to 5 mg once daily (7).

patient counseling information

Advise patients to read the FDA-approved patient labeling (Medication Guide).

Embryo-fetal Toxicity

Instruct patients on the risk of fetal harm when ambrisentan is used in pregnancy [see Warnings and Precautions (5.1) and Use in Specific Populations (8.1)]. Female patients must enroll in the PS-Ambrisentan REMS program. Instruct females of reproductive potential to immediately contact their physician if they suspect they may be pregnant.

PS-Ambrisentan REMS Program

For female patients, ambrisentan tablets are only available through a restricted program called the PS-Ambrisentan REMS [see Contraindications (4.1), Warnings and Precautions (5.2)]. Male patients are not enrolled in the PS-Ambrisentan REMS.

Inform female patients (and their guardians, if applicable) of the following notable requirements:

  • All 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)].
  • Females of reproductive potential must be counseled on the use of emergency contraception in the event of unprotected sex or known or suspected contraceptive failure.
  • Pre-pubertal females must report any changes in their reproductive status immediately to their prescriber.

Ambrisentan tablets are available only from certified pharmacies participating in the program. Therefore, provide patients with the telephone number and website for information on how to obtain the product.

Hepatic Effects

Advise patients of the symptoms of potential liver injury and instruct them to report any of these symptoms to their physician.

Hematological Change

Advise patients of the importance of hemoglobin testing.

Other Risks Associated with ambrisentan tablets

Instruct patients that the risks associated with ambrisentan tablets also include the following:

  • Decreases in sperm count
  • Fluid overload

Administration

Advise patients not to split, crush, or chew tablets.

Manufactured By:

Cadila Healthcare Limited,

Ahmedabad, India

Rev.: 08/19

Medication Guide

Ambrisentan (am" bri senʹ tan) Tablets

Read this Medication Guide before you start taking ambrisentan tablets and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking with your doctor about your medical condition or your treatment.

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

  • Serious birth defects.

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

  • F emales must not be pregnant when they start taking ambrisentan tablets or become pregnant during treatment with ambrisentan tablets.
  • Females who are able to get pregnant must have a negative pregnancy test before beginning treatment with ambrisentan tablets, each month during treatment with ambrisentan tablets, and one month after stopping ambrisentan tablets. Talk to your doctor about your menstrual cycle. Your doctor will decide when to do a pregnancy test, and will order a pregnancy test for you depending on your menstrual cycle.
    • 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. 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, or
      • who are infertile for any other medical reason and this infertility is permanent and cannot be reversed

Females who are able to get pregnant must use two acceptable forms of birth control during treatment with ambrisentan tablets, and for one month after stopping ambrisentan tablets because the medicine may still be in the body.

  • If you have had a tubal sterilization or have an IUD (intrauterine device) or progesterone implant, these methods can be used alone and no other form of birth control is needed.
  • Talk with your doctor or gynecologist (a doctor who specializes in female reproduction) to find out about options for acceptable forms of birth control that you may use to prevent pregnancy during treatment with ambrisentan tablets.
  • If you decide that you want to change the form of birth control that you use, talk with your doctor or gynecologist to be sure that you choose another acceptable form of birth control.

See the chart below for Acceptable Birth Control Options during treatment with ambrisentan tablets.

Acceptable Birth Control Options

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  • Do not have unprotected sex. Talk to your doctor or pharmacist right away if you have unprotected sex or if you think your birth control has failed. Your doctor may tell you to use emergency birth control.
  • Tell your doctor right away if you miss a menstrual period or think you may be pregnant for any reason.

If you are the parent or caregiver of a female child who started taking ambrisentan tablets before reaching puberty, you should check your child regularly to see if she is developing signs of puberty. Tell your doctor right away if you notice that she is developing breast buds or pubic hair. Your doctor should decide if your child has reached puberty. Your child may reach puberty before having her first menstrual period.

Females can only receive ambrisentan tablets through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the PS-Ambrisentan REMS. If you are a female who can get pregnant, you must talk to your doctor, understand the benefits and risks of ambrisentan tablets, and agree to all of the instructions in the PS-Ambrisentan REMS.

Males can receive ambrisentan tablets without taking part in the PS-Ambrisentan REMS.

What are Ambrisentan Tablets?

  • Ambrisentan tablets are a prescription medicine used to treat pulmonary arterial hypertension (PAH), which is high blood pressure in the arteries of your lungs.
  • Ambrisentan tablets can improve your ability to exercise and it can help slow down the worsening of your physical condition and symptoms.
  • It is not known if ambrisentan tablets are safe and effective in children.

Who should not take ambrisentan tablets?

Do not take ambrisentan tablets if:

  • you are pregnant, plan to become pregnant, or become pregnant during treatment with ambrisentan tablets. Ambrisentan tablets can cause serious birth defects. (See "What is the most important information I should know about ambrisentan tablets?" ) Serious birth defects from ambrisentan tablets happen early in pregnancy.
  • you have a condition called Idiopathic Pulmonary Fibrosis (IPF)

What should I tell my doctor before taking ambrisentan tablets?

Before you take ambrisentan tablets, tell your doctor if you:

  • have been told that you have a low red blood cell level (anemia)
  • have liver problems
  • have any other medical conditions

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Ambrisentan tablets and other medicines may affect each other, causing side effects. Do not start any new medicines until you check with your doctor.

Especially tell your doctor if you take the medicine cyclosporine (Gengraf, Neoral, Sandimmune). Your doctor may need to change your dose of ambrisentan tablets.

How should I take Ambrisentan Tablets?

  • Ambrisentan tablets will be mailed to you by a certified pharmacy. Your doctor will give you complete details.
  • Take ambrisentan tablets exactly as your doctor tells you to take it. Do not stop taking ambrisentan tablets unless your doctor tells you to stop.
  • You can take ambrisentan tablets with or without food.
  • Do not split, crush or chew ambrisentan tablets.
  • It will be easier to remember to take ambrisentan tablets if you take it at the same time each day.
  • If you take more than your regular dose of ambrisentan tablets, call your doctor right away.
  • If you miss a dose, take it as soon as you remember that day. Take your next dose at the regular time. Do not take two doses at the same time to make up for a missed dose.

What should I avoid while taking Ambrisentan Tablets?

  • Do not get pregnant while taking ambrisentan tablets. (See the serious birth defects section of the Medication Guide above called "What is the most important information I should know about ambrisentan tablets?" ) If you miss a menstrual period, or think you might be pregnant, call your doctor right away.
  • It is not known if ambrisentan passes into your breast milk. You should not breastfeed if you are taking ambrisentan tablets. Talk to your doctor about the best way to feed your baby if you take ambrisentan tablets.

What are the possible side effects of ambrisentan tablets?

Ambrisentan tablets can cause serious side effects including:

  • See "What is the most important information I should know about ambrisentan tablets?"
  • Swelling all over the body (fluid retention) can happen within weeks after starting ambrisentan tablets. Tell your doctor right away if you have any unusual weight gain, tiredness, or trouble breathing while taking ambrisentan tablets. These may be symptoms of a serious health problem. You may need to be treated with medicine or need to go to the hospital.
  • Decreased sperm count. Decreased sperm counts have happened in some men taking a medicine that is like ambrisentan tablets. A decreased sperm count may affect the ability to father a child. Tell your doctor if being able to have children is important to you.
  • Low red blood cell levels (anemia) can happen during the first weeks after starting ambrisentan tablets. If this happens, you may need a blood transfusion. Your doctor will do blood tests to check your red blood cells before starting ambrisentan tablets. Your doctor may also do these tests during treatment with ambrisentan tablets.

The most common side effects of ambrisentan tablets include:

  • swelling of hands, legs, ankles and feet (peripheral edema)
  • stuffy nose (nasal congestion)
  • inflamed nasal passages (sinusitis)
  • hot flashes or getting red in the face (flushing)

Some medicines that are like ambrisentan tablets can cause liver problems. Tell your doctor if you get any of these symptoms of a liver problem while taking ambrisentan tablets:

  • loss of appetite
  • nausea or vomiting
  • fever
  • achiness
  • generally do not feel well
  • pain in the upper right stomach (abdominal) area
  • yellowing of your skin or the whites of your eyes
  • dark urine
  • itching

Tell your doctor if you have any side effect that bothers you or that does not go away. These are not all of the possible side effects of ambrisentan tablets. For more information,ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store ambrisentan tablets?

Store ambrisentan tablets at room temperature between 68°F to 77°F (20°C to 25°C), in the package it comes in.

Keep ambrisentan tablets and all medicines out of the reach of children.

General information about the safe and effective use of ambrisentan tablets

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use ambrisentan tablets for a condition for which it was not prescribed. Do not give ambrisentan tablets 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 ambrisentan tablets. If you would like more information, ask your doctor. You can ask your doctor or pharmacist for information about ambrisentan tablets that is written for health professionals.

What are the ingredients in ambrisentan tablets?

Active ingredient: ambrisentan

Inactive Ingredients: croscarmellose sodium, lactose monohydrate, lecithin magnesium stearate, microcrystalline cellulose, partially hydrolyzed polyvinyl alcohol, polyethylene glycol, povidone, talc and titanium dioxide. Additionally, 5 mg tablet contains: FD&C red#40 aluminum lake.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Manufactured By:

Cadila Healthcare Limited,

Ahmedabad, India

Rev.: 08/19

also known as

This drug label information is as submitted to the Food and Drug Administration (FDA) and is intended for informational purposes only. If you think you may have a medical emergency, immediately call your doctor or dial 911. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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