Fabhalta (Iptacopan)

Complete patient guide for uses, dosage, side effects, and safety information

Prescription Required

Quick Facts

Generic Name
iptacopan
Drug Class
Complement inhibitor
Used For
Treatment of paroxysmal nocturnal hemoglobinuria (PNH) and complement 3 glomerulopathy (C3G)
How Taken
Capsule taken twice daily

What Is Fabhalta Used For?

Fabhalta is a medication that helps manage certain blood and kidney disorders by targeting the immune system's complement pathway.

Primary Uses

Fabhalta is primarily used to treat adults with paroxysmal nocturnal hemoglobinuria (PNH) and complement 3 glomerulopathy (C3G).

How It Works

Fabhalta works by inhibiting the Factor B protein in the complement system, which helps prevent the breakdown of red blood cells in PNH and reduces protein deposition in the kidneys in C3G.

Good to know: Fabhalta is not considered addictive.

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How to Take Fabhalta

Follow your doctor's instructions carefully when taking Fabhalta to ensure effective treatment.

Dosage Instructions

The usual dose of Fabhalta is 200 mg taken twice daily, once in the morning and once in the evening. Swallow the capsule with a glass of water, and it can be taken with or without food.

What If You Miss a Dose?

If you miss a dose, take it as soon as you remember. If it's almost time for your next dose, skip the missed dose and continue with your regular schedule.

Important: Do not double the dose if you miss one.

Available Tablet Strengths

200mg
200mg Tablet Pale yellow, Hard capsule • LNP200

Side Effects

Like all medications, this medicine can cause side effects. Most are mild and temporary, but some require medical attention.

Common Side Effects

These side effects occur relatively frequently and usually don’t require emergency care:

  • Headache
  • Dizziness
  • Diarrhea
  • Joint pain
  • Stomach pain
  • Nausea
  • Common colds

Seek immediate medical attention if you experience:

  • Signs of infection (fever, chills, cough)
  • Sudden bleeding or bruising
  • Symptoms of severe infections

Impulse Control Issues

There are no specific mentions of impulse control issues associated with Fabhalta.

Important Warnings

There are several important considerations to keep in mind while using Fabhalta.

Who Should Not Take Fabhalta

Do not use Fabhalta if you are allergic to iptacopan or any of its ingredients, or if you have not been vaccinated against Neisseria meningitidis and Streptococcus pneumoniae.

Medical Conditions to Discuss

Inform your doctor if you have a serious bacterial infection, are pregnant, plan to become pregnant, or are breastfeeding.

Pregnancy and Breastfeeding

Consult your doctor if you are pregnant or breastfeeding, as they will discuss the potential risks of using Fabhalta during these periods.

Elderly Patients With Dementia: Elderly patients should be monitored closely due to potential risks associated with Fabhalta.

Drug Interactions

Certain medications may interact with Fabhalta, affecting its effectiveness.

Grapefruit interaction: There is no specific grapefruit interaction mentioned, but be cautious with medications processed by the liver.

  • Rifampicin
  • CYP3A4 substrates (e.g., carbamazepine, ciclosporin, fentanyl, tacrolimus)
  • CYP2C8 substrates (e.g., repaglinide, paclitaxel)

Alcohol & Driving

Be cautious when driving or operating machinery until you know how Fabhalta affects you.

Alcohol

There are no known interactions between Fabhalta and alcohol.

Driving and Operating Machinery

Exercise caution when driving or using machinery until you are aware of how Fabhalta affects your ability.

Storage

Store Fabhalta below 30°C in a cool, dry place away from moisture and sunlight. Keep it out of reach of children.

Overdose Information

If you suspect an overdose of Fabhalta, seek immediate medical attention by contacting your doctor or going to the nearest emergency department.

Frequently Asked Questions

Fabhalta may take some time to show its effects as it works to manage symptoms of PNH and C3G.

Yes, Fabhalta can be taken with or without food.

No, Fabhalta is not considered addictive.

Do not stop taking Fabhalta without consulting your doctor, as it may lead to a return of symptoms.

There are no known interactions between Fabhalta and alcohol.

Yes, elderly patients can use Fabhalta, but they should be monitored closely.

If you miss a dose, take it as soon as you remember, but do not double the next dose.

Important Disclaimer

This information is intended for general educational purposes only and should not be considered medical advice. Always consult your healthcare provider or pharmacist before starting, stopping, or changing any medication.

If you think you may have a medical emergency, call your doctor or emergency services immediately.

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