AMBRISENTAN

Background and Date of Approval

The U.S. Food and Drug Administration (FDA) granted initial approval for ambrisentan on 15 June 2007 for the treatment of pulmonary arterial hypertension (PAH).

Uses

Ambrisentan is used to treat pulmonary arterial hypertension (PAH). PAH is characterized by high blood pressure in the arteries that carry blood from the heart to the lungs.

How is it administered?

Ambrisentan is usually taken orally once daily, with or without food. It's important to follow the prescribed dosage provided by your healthcare provider and to take the medication simultaneously each day to maintain consistent levels in your system. Swallow the tablet whole with water, and do not crush or chew it.

Side Effects

Ambrisentan may lead to common side effects such as headaches, nasal congestion, flushing, and peripheral edema (swelling in the arms, legs, hands, or feet). Serious side effects include liver problems, potential birth defects if taken during pregnancy, fluid retention that could worsen heart failure in certain individuals, and instances of anemia or decreased white blood cell counts.

Warnings

Ambrisentan carries several important warnings. It can lead to liver problems, including elevated liver enzymes, necessitating regular liver function monitoring. The medication is contraindicated during pregnancy due to its potential to cause serious birth defects. It may cause fluid retention, possibly exacerbating heart failure in certain individuals, and has been associated with anemia and decreased white blood cell counts.

Precautions

Ambrisentan's use should be approached with caution in those with lung conditions. It's advised to inform healthcare providers of all medications being taken, as drug interactions can occur, and lifestyle factors like alcohol consumption should be considered. Vision changes have been reported, and the potential for allergic reactions exists. It's essential to discuss these warnings with healthcare providers before using this medication ensuring its safe and appropriate use for individual patients.

Word of Advice

Liver function tests are necessary at regular intervals owing to the risk of liver injury. Ambrisentan is contraindicated in pregnancy because of the potential for birth defects. Close monitoring for fluid retention is essential, particularly in patients with a prior history of heart failure. Anaemia and reduced white blood cell counts may necessitate frequent blood testing. All medications being taken must be communicated to healthcare providers to mitigate potential drug interactions. Existing lung conditions should be reported, as the benefits and risks of the medication require careful evaluation. Alcohol consumption and smoking should be discussed with the healthcare team, and any changes in vision must be reported without delay. Patients must be aware of the possibility of allergic reactions.

References

Goodman & Gilman’s, The Pharmacological Basis of Therapeutics, Anti-arrhythmic drugs, 12th edition, 2011, 834. Cipla EU Ltd, Electronic medicines compendium (EMC), [Revised on 16 Aug 2022] [ Accessed on 28th August 2023], https://www.medicines.org.uk/emc/product/11697/smpc#gref Gilead Sciences,, US Food and Drug Administration, [Revised on November 2020], [Accessed on 28th August 2023],

Frequently Asked Questions

Is Ambrisentan a cure for pulmonary arterial hypertension (PAH)?

No, Ambrisentan is not a cure for PAH. It is a medication that helps manage the symptoms and slow down the progression of the disease, improving quality of life and exercise capacity.

Can Ambrisentan be taken with other PAH medications?

Ambrisentan can be used alone or with other PAH medications, depending on your specific condition and treatment plan. Your healthcare provider will determine the best approach for your situation.

What should I do if I miss a dose of Ambrisentan?

If you miss a dose, take it as soon as you remember. However, if it's close to the time for your next scheduled dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one.

Can Ambrisentan be used in children with PAH?

The safety and efficacy of Ambrisentan in pediatric patients have yet to be well established, and its use in children and adolescents is limited. Its use should be carefully considered under the guidance of a healthcare professional.

Does Ambrisentan cause weight gain?

Weight gain, particularly due to fluid retention, is a potential side effect of Ambrisentan. However, only some experience this side effect. Regular monitoring by your healthcare provider can help manage any weight-related concerns.

Available Brands 7

Written By: Muskan Patel, M.Pharm

Reviewed By: Dr. Vishwa Patel, MBBS