Macitentan

Description

Macitentan is used for the treatment of pulmonary arterial hypertension (PAH) (WHO class 1), a condition characterized by high blood pressure in the vessels carrying blood from the heart to the lungs. It is used alone or in combination with other medicines to treat PAH and improve exercise tolerance. Female patients are advised to undergo a pregnancy test to exclude pregnancy before beginning treatment with this medicine.

Side effects

Major & minor side effects for Macitentan

  • Decreased urine output
  • Pale skin
  • Weight gain
  • Unusual tiredness or weakness
  • Stomach pain
  • Lower back or side pain
  • Difficulty in breathing
  • Yellow eyes or skin
  • Muscle aches and pain
  • Fever or chills
  • Cough
  • Runny Nose

Uses of Macitentan

What is it prescribed for?

  • Pulmonary arterial hypertension
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Concerns

Commonly asked questions

  • Onset of action
    The amount of time required for this medicine to show its action is not clinically established.
  • Duration of effect
    The amount of time for which this medicine remains active in the body is not clinically established.
  • Safe with alcohol?
    Interaction with alcohol is unknown. It is advisable to consult your doctor before consumption.
  • Is it habit forming?
    No habit-forming tendencies were reported.
  • Usage in pregnancy?
    This medicine is not recommended for use in pregnant women.
  • Usage while breast-feeding?
    This medicine is not recommended for use in breastfeeding women unless absolutely necessary. All the risks and benefits should be discussed with the doctor before taking this medicine. Your doctor may advise you to discontinue breastfeeding or to discontinue the drug based on your clinical condition.

Allergy

This medicine is not recommended for use in patients with a known allergy to macitentan or any other inactive ingredients present along with it.

Pregnancy

This medicine is not recommended for use in pregnant women.
Warnings for special population

Pregnancy

This medicine is not recommended for use in pregnant women.

Breast-feeding

This medicine is not recommended for use in breastfeeding women unless absolutely necessary. All the risks and benefits should be discussed with the doctor before taking this medicine. Your doctor may advise you to discontinue breastfeeding or to discontinue the drug based on your clinical condition.
General warnings

Hepatotoxicity

This medicine may cause hepatotoxicity and should be used with caution in patients suffering from liver diseases due to the increased risk of worsening the patient's condition. Liver function should be assessed before initiating and during the therapy with this medicine. Report any signs and symptoms of hepatotoxicity such as nausea, vomiting, fever, abdominal pain or jaundice to the doctor immediately. Close monitoring of the clinical condition, appropriate dose adjustments or replacement with a suitable alternative may be required in some cases based on the clinical condition.

Use in children

This medicine is not recommended for use in patients less than 18 years of age since the safety and efficacy of use are not clinically established.

Fluid overload

This medicine may cause an increased risk of edema (swelling) in ankles and feet due to fluid retention. Appropriate corrective measures, dose adjustments, or replacement with a suitable alternative may be required based on the clinical condition.

Infertility

This medicine may reduce the sperm count in males. Discuss with your doctor all the risks and benefits before beginning treatment with this medicine.

Effective contraception

Since this medicine may cause serious fetal harm, use of highly effective contraceptive methods is advised for females of reproductive potential while on treatment with this medicine and one month after stopping the therapy to avoid pregnancy.

Missed Dose

Take the missed dose as soon as you remember. If it is almost the time for your next dose, skip the missed dose. Do not double your dose to make up for the missed dose.

Overdose

Seek emergency medical treatment or contact the doctor in case of an overdose.
All drugs interact differently for person to person. You should check all the possible interactions with your doctor before starting any medicine.
Interaction with Alcohol

Description

Interaction with alcohol is unknown. It is advisable to consult your doctor before consumption.

Instructions

Interaction with alcohol is unknown. It is advisable to consult your doctor before consumption.
Interaction with Medicine

Atazanavir

Indinavir

Fosphenytoin

Deferasirox

Erythromycin

Phenytoin

Ketoconazole

Disease interactions

Anemia

This medicine should be used with caution in patients with anemia because it may decrease the hemoglobin and hematocrit levels and worsen the patient's condition. Appropriate corrective measures, dose adjustments or replacement with a suitable alternative may be required in some cases based on the clinical condition.
Food interactions
Information not available.
Lab interactions
Information not available.
Take this medicine exactly as prescribed by the doctor. Do not take in larger or smaller amounts than advised/prescribed. Consult the doctor if you experience any undesirable side effects. Ensure that the course of treatment is completed. Do not stop the use of this medicine without consulting your doctor.
Miscelleneous

Can be taken with or without food, as advised by your doctor

To be taken as instructed by doctor

Effect on sleep is not established

How it works
This medicine works by blocking the actions of endothelin, a natural substance responsible for pulmonary arterial hypertension.
Legal Status

Approved

Approved

Approved

Approved

Classification

Category

Agents for pulmonary hypertension, Endothelin receptor antagonist

Schedule

Schedule H

[Internet]. Accessdata.fda.gov. 2018 [cited 11 December 2018]. Available from:

https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204410s000lbl.pdf

Macitentan - DrugBank [Internet]. Drugbank.ca. 2018 [cited 11 December 2018]. Available from:

https://www.drugbank.ca/drugs/DB08932

[Internet]. Medicines.org.uk. 2018 [cited 11 December 2018]. Available from:

https://www.medicines.org.uk/emc/files/pil.5223.pdf

DailyMed - Opsumit- macitentan tablet, film coated [Internet]. Dailymed.nlm.nih.gov. 2018 [cited 11 December 2018]. Available from:

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1e484a50-55db-4b85-8c57-6cd1b0353abd

Macitentan: MedlinePlus Drug Information [Internet]. Medlineplus.gov. 2018 [cited 11 December 2018]. Available from:

https://medlineplus.gov/druginfo/meds/a615033.html

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Information on this page was last updated on 30 Jan 2019

Disclaimer

We’ve made all possible efforts to ensure that the information provided here is accurate, up-to-date and complete, however, it should not be treated as a substitute for professional medical advice, diagnosis or treatment. Practo only provides reference source for common information on medicines and does not guarantee its accuracy or exhaustiveness. The absence of a warning for any drug or combination thereof, should not be assumed to indicate that the drug or combination is safe, effective, or appropriate for any given patient. Practo does not assume any responsibility for any aspect of healthcare administered with the aid of information provided above. If you have any doubts about your medication then we strongly recommend that you consult with your doctor, nurse or healthcare provider. See detailed T&C here.