Macitentan

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Generic Name: Macitentan Brand Name(s): Generics only. No brands available. Avability: Rx Pregnancy Category: X

Uses

What is Macitentan used for?

Macitentan is used to treat high blood pressure in the lungs (pulmonary arterial hypertension). This condition is thought to be caused by increased levels of a certain natural substance (endothelin-1). This medication blocks the effects of endothelin-1, which helps decrease the blood pressure in the lungs, slow the worsening of symptoms from the disease, and improve your ability to exercise.

How should I take Macitentan?

Take this medication by mouth with or without food as directed by your doctor, usually once daily. Swallow the tablet whole. Do not split, crush, or chew the tablet.

Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day.

Do not increase your dose or use this drug more often or for longer than prescribed. Your condition will not improve any faster, and your risk of side effects will increase.

Since this drug can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from the tablets.

Tell your doctor if your condition does not improve or if it worsens.

How do I store Macitentan?

Macitentan is best stored at room temperature away from direct light and moisture. To prevent drug damage, you should not store Macitentan in the bathroom or the freezer. There may be different brands of Macitentan that may have different storage needs. It is important to always check the product package for instructions on storage, or ask your pharmacist. For safety, you should keep all medicines away from children and pets.

You should not flush Macitentan down the toilet or pour them into a drain unless instructed to do so. It is important to properly discard this product when it is expired or no longer needed. Consult your pharmacist for more details about how to safely discard your product.

Precautions & warnings

What should I know before using Macitentan?

Before taking macitentan, tell your doctor or pharmacist if you are allergic to it; or to other endothelin receptor blockers (such as bosentan); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: anemia, other lung conditions (such as pulmonary veno-occlusive disease).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

This medication must not be used during pregnancy. It may harm an unborn baby. Since this drug can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from the tablets.

It is unknown if this medication passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.

Is it safe during pregnancy or breast-feeding?

There are no adequate studies in women for determining risk when using this Macitentan during pregnancy or while breastfeeding. Please always consult with your doctor to weigh the potential benefits and risks before taking Macitentan. Macitentan is pregnancy risk category X according to the US Food and Drug Administration (FDA).

FDA pregnancy risk category reference below:

  • A=No risk,
  • B=No risk in some studies,
  • C=There may be some risk,
  • D=Positive evidence of risk,
  • X=Contraindicated,
  • N=Unknown

Side effects

What side effects can occur from Macitentan?

Runny nose, sore throat, cough, headache, chills, or body aches may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: signs of low red blood cell count (such as unusual tiredness, rapid breathing, pale skin, shortness of breath, fast heartbeat), unusual weight gain, new or worsening swelling of the hands/ankles/feet.

Macitentan may rarely cause serious liver disease. Tell your doctor right away if you have any symptoms of liver disease, including: dark urine, persistent nausea/vomiting/loss of appetite, stomach/abdominal pain, yellowing eyes/skin.

Macitentan may decrease sperm production, an effect that may lower male fertility. Consult your doctor for more details.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

Not everyone experiences these side effects. There may be some side effects not listed above. If you have any concerns about a side-effect, please consult your doctor or pharmacist.

Interactions

What drugs may interact with Macitentan?

Other medications can affect the removal of macitentan from your body, which may affect how macitentan works. Examples include azole antifungals (such as ketoconazole), cobicistat, macrolide antibiotics (such as clarithromycin), HIV protease inhibitors (such as ritonavir), rifamycins (such as rifampin), among others.

Macitentan may interact with other drugs that you are currently taking, which can change how your drug works or increase your risk for serious side effects. To avoid any potential drug interactions, you should keep a list of all the drugs you are using (including prescription drugs, nonprescription drugs and herbal products) and share it with your doctor and pharmacist. For your safety, do not start, stop, or change the dosage of any drugs without your doctor’s approval.

Does food or alcohol interact with Macitentan?

Macitentan may interact with food or alcohol by altering the way the drug works or increase the risk for serious side effects. Please discuss with your doctor or pharmacist any potential food or alcohol interactions before using this drug.

What health conditions may interact with Macitentan?

Macitentan may interact with your health condition. This interaction may worsen your health condition or alter the way the drug works. It is important to always let your doctor and pharmacist know all the health conditions you currently have.

Dosage

The information provided is not a substitute for any medical advice. You should ALWAYS consult with your doctor or pharmacist before using this Macitentan.

What is the dose of Macitentan for an adult?

Usual Adult Dose for Pulmonary Hypertension

10 mg orally once a day

Uses: For the treatment of pulmonary arterial hypertension (PAH, WHO Group I) to delay disease progression

Renal Dose Adjustments

No adjustment recommended.

Liver Dose Adjustments

No adjustment recommended.

If hepatic dysfunction develops during treatment:

-Discontinue treatment if sustained, unexplained, clinically relevant aminotransferase elevations occur or if elevations are accompanied by an increase in bilirubin greater than 2 times the upper limit of normal, or by clinical symptoms of liver injury.

-Treatment may be reinitiated in patients who have not experienced clinical symptoms of liver injury once hepatic enzyme levels return to within normal range. Specialist advice should be sought.

Dialysis

No adjustment recommended.

Other Comments

Administration advice:

-Macitentan may be taken with or without food.

-Tablets should be swallowed whole (not split, crushed, or chewed).

Monitoring:

-Metabolic: Monitor for signs of fluid retention after initiation of therapy.

-Pregnancy: Females of reproductive potential are required to have pregnancy ruled out prior to initiating therapy and to use acceptable forms of birth control and undergo a pregnancy test every month for the duration of therapy and for one month following discontinuation of therapy.

Patient advice:

-Female patients are required to sign an enrolment form.

-Female patients of reproductive potential are required to comply with the pregnancy testing and contraception requirements.

-Patients should promptly receive any medical tests recommended by the healthcare provider.

What is the dose of Macitentan for a child?

The dosage has not been established in pediatric patients. It may be unsafe for your child. It is always important to fully understand the safety of the drug before using. Please consult with your doctor or pharmacist for more information.

How is Macitentan available?

Macitentan is available in the following dosage forms and strengths:

  • Oral tablet.

What should I do in case of an emergency or overdose?

In case of an emergency or an overdose, call your local emergency services or go to your nearest emergency room.

What should I do if I miss a dose?

If you miss a dose of Macitentan, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and take your regular dose as scheduled. Do not take a double dose.

Hello Health Group does not provide medical advice, diagnosis or treatment.

Review Date: August 10, 2018 | Last Modified: August 10, 2018

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